Medicare Coverage Database
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Content Section
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Public Comments
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| Commenter: |
Cotter, Dennis
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| Title: |
President |
| Organization: |
Medical Technology and Practice Patterns Institute |
| Date: |
8/5/2008 2:21:47 PM |
| Comment: |
Dear Sir: I am writing to introduce you to MTPPI a 501(c)3 non-profit institute established in 1986. Among other treatments, we are interested in studying the causal relationship between the therapeutic intervention epoetin in treatment of chronic anemia among dialysis patients. This could possibly be one of the most complete stories that will ever be told about the "clinical benefit" of a therapeutic intervention described in the following:
The effect of epoetin dose on hematocrit. Kidney Int. 2008 Feb;73(3):347-53.
Dialysis facility ownership and epoetin dosing in patients receiving hemodialysis. JAMA. 2007 Apr 18; 297(15):1667-74.
Translating epoetin research into practice: the role of government and the use of scientific evidence. Health Aff (Millwood). 2006 Sep-Oct;25 (5):1249-59.
Factors influencing route of administration for epoetin treatment among hemodialysis patients in the United States. Am J Kidney Dis. 2006 Jul;48 (1):77-87.
Hematocrit was not validated as a surrogate end point for survival among epoetin-treated hemodialysis patients. J Clin Epidemiol. 2004 Oct;57(10):1086-95.
Epoetin requirements predict mortality in hemodialysis patients. Am J Kidney Dis. 2004 Nov;44(5):866-76.
Challenges in establishing a clinically and scientifically robust Epoetin policy. Clin Nephrol. 2004 Jul;62(1):69-70.
We also have an epoetin safety paper in the works addressing the relationship between mortality and high dose levels of this drug. If you are interested in receiving any of these papers and/or hearing more about this topic, let me know. If you know of groups interested in this topic, I'd be happy to talk with them about the implications of our research.
Sincerely,
Dennis J. Cotter President Medical Technology and Practice Patterns Institute, Inc. 4733 Bethesda Ave., Suite 510 Bethesda, MD 20814 (301) 652-4005 fax: (301) 652-8335 dcott@mtppi.org |
| Commenter: |
Thompson, Mark
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| Organization: |
Florida Radiation Oncology Group |
| Date: |
8/8/2008 10:32:44 AM |
| Comment: |
PROTON THERAPY....There is very limited use in cancer therapy for this expensive technology. The reults in treating prostate cancer are no better than using IMRT or prostate brachytherapy which cost a fraction of PROTON therapy. All of these centers going up in the USA is madness. Until their is data to support superior results which their is not protons for prostate cancer should not be funded. Dr. Mark Thompson |
| Commenter: |
Carpenter, Larry
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| Title: |
Associate Professor |
| Organization: |
Baylor College of Medicine |
| Date: |
8/8/2008 2:20:45 PM |
| Comment: |
I am very concerned about the current rapid proliferation of proton beam radiation without sufficient evidence supporting its clinical superiority over current modalities. I have heard that MD Anderson Cancer Center is refusing to conduct randomized trials for prostate cancer comparing protons to conventional IMRT. In addition, MD Anderson uses less image guidance (IGRT) than most academic centers for prostate cancer treatment. They obtain KV imaging of the bones, but the prostate moves independently from the bones. Therefore, they may even have less accuracy in their prostate treatment than many other centers. In addition, MD Anderson uses only 2 lateral beams to treat the prostate. The penumbra for proton beam is equal or greater to that of photons beams. Therefore, since rectum and bladder may be in the penumbra we would not expect the complication rate of protons to be less than that of conventional photons. Dosimetric studies have shown that the conformality of protons is not better than current therapy with IMRT, especially since IMPT (intensity modulated proton therapy) is not generally available. Marketing of protons includes overly optimistic statements about possible safety of protons. This aggressive advertising is necessary due to the enormous capital investment of proton centers. The unsuspecting patient will feel enormous financial pressure to find money to pay for proton therapy thinking that they have found additional safety (certainly not proven). Finally, the current charges for proton therapy, around $200,000 per patient, would be very damaging to our health care system if allowed to become more widespread. |
| Commenter: |
Johnson, Douglas
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| Title: |
Radiation Oncologist/Director of Clinical Research |
| Organization: |
Baptist Cancer Institute |
| Date: |
8/8/2008 5:07:03 PM |
| Comment: |
CORRECTED: Proton therapy for prostate cancer should not be a covered service, as superior radiation treatment alternatives already exist, are proven, and can be delivered at a fraction of the cost. Proton therapy is not new: Facilities have been used to treat cancer patients since the 1950''s. Almost all the proton centers in the USA closed by the early 1990''s because there was NOT ONE clinical situation in which protons had been demonstrated to be superior to other radiation modalities. Now a new company has come on board with a better, more reliable proton-generating machine, but the fact remains that there is no proven benefit to protons over photons (x-rays)- both are low LET (linear energy transfer) radiations whose biological effectiveness is nearly identical. The sole potential benefit of protons, rather, relates to protection of nearby normal tissues. This used to be a concern with older photon (x-ray) techniques, but no longer: Modern IMRT or IGRT photon techniques also protect normal tissues greatly. Finally, the ONLY published data on the use of protons for prostate cancer comes from Loma Linda: Their long-term local control rate was only 77%, compared to better than 90% published with modern x-ray techniques that include brachytherapy (seeds) as a portion of treatment. In addition, the complication rates between protons and modern x- ray techniques are virtually identical. Using protons for prostate cancer is akin to firing up an Edsel to compete against a modern Toyota: The Edsel may look pretty, but is too expensive to run and is an antique from a bygone era addressing problems which don't exist. You can find better places to spend my money than on proton therapy for prostate cancer. I am a radiation oncologist with 28 years experience treating prostate cancer. I know. |
| Commenter: |
Cesaretti, Jamie
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| Title: |
Assistant Professor of Radiation Oncology |
| Organization: |
Mount Sinai School of Medicine |
| Date: |
8/10/2008 1:39:22 PM |
| Comment: |
I would like to comment on the reimbursement of proton therapy for prostate cancer. I was optimistic at first, as a young academic radiation oncologist, that the future of prostate cancer treatment would include proton therapy until I read with interest an article published in the International Journal of Radiation Oncology Biology and Physics by Eric Hall, D.PHIL., D.SC in 2006 entitled, “INTENSITY- MODULATED RADIATION THERAPY, PROTONS, AND THE RISK OF SECOND CANCERS.” I have sent the article as an attachment though the most impressive aspects I will quote as follows; in addition, please note figures 9 and 10 from the article Int. J. Radiation Oncology Biol. Phys., Vol. 65, No. 1, pp. 1–7, 2006. I quote page 6 paragraph 2,”the pencil beam of protons that emerges from the cyclotron or synchrotron is made simply to impinge on a scatter foil to produce a field of useful size. However, the scattering foil becomes a source of neutrons, which results in a total body dose to the patient. The consequences of this exposure are shown dramatically in Fig. 10. Passive modulation results in doses distance from the field edge that are 10 times higher than those characteristic of IMRT with X-rays.” Dr. Hall wrote the text that all radiation oncologists have used for the past 40 years to learn the science of radiobiology (Radiobiology for the Radiologist) and looms as probably the single most influential voice in the field of radiobiology. In addition, I do not think that the patients are told at these centers prior to their prostate cancer treatment that they will have to be bathed in neutron contamination in order to achieve what is a possible physical advantage without concurring clinical evidence over photon based radiation techniques. Following this, I began to see many patients with prostate cancer in my practice that followed the numerous internet links available to them begin to quote to me that “proton therapy is more precise!” I explored these insights with them and they usually answered that their information came from www.proton-therapy.org (the website of the National Association of Proton Therapy), www.protons.com (the website of the proton therapy and research center at Loma Linda) or www.floridaproton.org (the website for the Florida Proton therapy Institute in Jacksonville). I can only quote their clinical results from their press releases because other than numerous articles on dosimetric quality and prostate cancer treatment very little has been published about clinical outcomes. I refer you to the pubmed/medline website http://www.ncbi.nlm.nih.gov/sites/entrez search terms proton therapy prostate cancer on 8/10/2008. An example of such a press release from Dr. Slater (the chairman at Loma Linda) on the www.proton-therapy.org website is representative of the lack of peer reviewed justifications to reimburse more for proton radiotherapy than for “standard” radiotherapy, (“Unlike conventional radiation,” says Dr. Jerry Slater, Clinical Director of Loma Linda's Proton Therapy Center, “proton radiation has a well- defined high-dose area which can be manipulated to precisely surround an irregularly shaped target such as the prostate gland. This inherent characteristic of protons allows very little scatter to the bladder and rectal areas, higher doses to the prostate, and significantly less side effects.” ) He also states that, (Dr. Slater noted: "Our analysis shows that overall, the disease-free survival rate is running above 90 percent at four years and the side effects are considerably less than we would have expected." Currently, some 80 patients are treated each day at the Proton Center, with about half receiving prostate cancer treatment. Patients come to the center from all across the U.S., as well as from numerous foreign countries.) Clearly, the press releases from these institutions are causing individuals to make the trip to their center, which in the culture of capitalism is the reward for a successful marketing campaign. However, as a public funder the public interest should be the first consideration. High quality trials should be undertaken to prove that proton therapy is worthwhile at all; disease free survival rates of greater than 90% at 4 years are common among successful prostate cancer treatments (often at endpoints of 5 to 10 years). The problem with such a quote is that in order to publish such a result in a scientific journal and to have it be little more than hearsay one needs to have at least 2 years minimum follow-up on every patient in addition the definition of disease free survival should be stated and the patients who are being “generalized” about should be risk stratified according to an evidence based guideline such as that of the National Comprehensive Cancer Network, www.nccn.org.
I think innovation should be rewarded but proton therapy is not innovative, it has been around in clinical use for 18 years at Loma Linda and much longer at the Massachusetts General Hospital. To their credit a randomized trial was undertake between 1996 and 1999 of a proton therapy boost for prostate cancer and published in JAMA in 2005 (JAMA. 2005 Sep 14;294(10):1233-9). Of note, from the article, “Only 1% of patients receiving conventional-dose and 2% receiving high-dose radiation experienced acute urinary or rectal morbidity of Radiation Therapy Oncology Group (RTOG) grade 3 or greater. So far, only 2% and 1%, respectively, have experienced late morbidity of RTOG grade 3 or greater.” No statistical difference was seen in late or early toxicity with this mixed photon and proton approach, with over 71% and 63% of the dose given with PHOTONS in the 70.2 and 79.2 Gy arms respectively. With the majority of dose given in this trial with photons to manifest only a 1 or 2% toxicity rate in both the acute and late setting means that the advantage of a purely PROTON approach can, by definition, only be on the order of 1 or 2%! The current high public funder reimbursement for proton therapy for prostate cancer is inspiring the building of many facilities in the US (see www.proton-therapy.org ), in addition to funding an effective direct to medical consumer marketing campaign which, as delineated above, has little basis in clinical evidence.
As a young radiation oncologist, I think that it is important that the foundations of innovation for my field be more solid than claims of “more precise” and “less side-effects” in the form of press releases. Such claims should be proven in a phase III setting before continuing what has become a marketing nightmare for my patients and their families.
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| Commenter: |
harkaway, paul
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| Date: |
8/12/2008 6:03:39 AM |
| Comment: |
As I witness the profound impact that our current economic struggles are having on our communities and my patients, the seemingly profligate spending going on in the health care community befuddles me. A recent summary of major building projects in Southeastern Michigan published in a business periodical showed that many of the projects and some of the largest were in the healthcare systems. It gives the appearance of a “matrix-like” parallel reality going on in health care. Our citizens are loosing their jobs and homes. Many patients lack access to basic care. Many patients seem to be dropping healthcare coverage outright, and those who still have it have an increasing financial burden that they struggle to meet. I am seeing more and more patients who cant seem to afford needed medications including seniors covered by part D (many of whom have fallen into the dreaded “donut hole.”) There is an increasing disparity in health care between the “haves and have nots.” In the midst of all of this, the large health care systems seem to have ready access to capital for large projects. I realize that funding for these comes through a different pathway but ultimately the patients, the rest of our citizens, and all of the employers in Michigan have to foot the bill. When will that burden crush them? Has it already?
I do not know why the Health Care System (or non system as it were) has not collapsed yet, but most of us feel that this cannot go on forever and yearn for meaningful reform. For insights into why the system is still able to function, I would refer you to a recent publication in the New England Journal of Medicine: The Amazing Noncollapsing U.S. Health Care System – Is Reform Really at Hand? http://content.nejm.org/cgi/reprint/358/4/325.pdf
I assure you that the “System’s” perseverance is not because of clever design or exceptional performance. If its longevity were based on those factors alone, it would have vanished long ago.
I am not an expert on proton beam therapy, and I am not pretending to be one, but as you ponder this decision, I would suggest the following for your consideration:
· What is the strength of the evidence supporting this modality over others or over “no treatment?” · How will those who propose to provide the treatment assure that it is available to all citizens who might benefit? · How will those who propose to provide the treatment prevent “indication creep,” such that it does not end up being used where it has marginal or no proven benefit and only adds cost? If it is true that a half of the health care dollars spent on an individual are spent in the last 6 months of life, how will we protect against this being yet another modality to add in to that equation? (http://www.ahc.umn.edu/img/assets/25857/end_of_li fe.pdf · How will those who propose to provide the treatment avoid offering it under the guise of hope? How will they control the “hype” and avoid creating demand based on false hope? (As a parenthetical, I would offer to you that most health care advertising seems to fall squarely in the category of “hype.”) How will we keep this modality from becoming another example of what Ian Morrison characterizes as “expensive technology excessively and aggressively applied to the affluent and well insured.” · How many of these machines are needed in this country? How many do other industrialized countries have? As a side note, how does our country compare to those other countries when we compare the performance of the respective health care systems? · If the indications are limited and circumscribed, would it make more sense for patients to travel to other states who have already installed the modality rather than duplicating it in Michigan? Is Bloomington Indiana, Chicago Illinois, or Pittsburg Pennsylvania too far to ask patients to travel for such specialized treatment? These areas either have or will soon have this capability. · Who are the investors in this initiative? How do they intend to re-coup their investment? How much usage beyond areas of clearly defined benefit would it require for them to do so? · Is it not true that this effort by definition will have to compete for resources against other pressing healthcare system needs such as electronic communication and care tools oriented towards chronic disease, or preventative health tools and efforts? See Woolf SH, Johnson RE. The Break-Even Point: When Medical Advances Are Less Important Than Improving the Fidelity With Which They Are Delivered Ann Fam Med 2005;3:545-552. http://www.hvpa.com/Physician/education/woolfandjo hnson_article_break_even.pdf
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| Commenter: |
kluck, bryan
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| Title: |
interventional cardiologist |
| Organization: |
heart care group |
| Date: |
8/12/2008 7:20:41 AM |
| Comment: |
There can be no reasonable, non political way to justify the continued non coverage of this proceedure in the sub-population of asymptomatic patients at high risk for carotid endarterectomy. The body of literature supporting the coverage of asx. high risk CAS is huge, and of course there is no way to compare real world patients who are forced, cajoled or otherwise convinced to CEA, as there is no similar restriction on the surgical world(not even to inform them honestly about an equivalent or superior alternative). How many non endovascular surgeons are giving patients at high risk for CEA an alternative as part of informed consent?
I had the illusion that perhaps CMS had a altruistic, broader view that if they just put the brakes on for a short time, the furor would settle and perhaps even the motivated surgeons would catch on and acquire the skill set to perform the endovascular approach. That illusion would be unsupportable should this non expansion of coverage be upheld.Sufficient time has passed, and the mix of performing physicians has stablized. The only remaining logical conclusion is that the inevitable backroom politics associated with a controversial new proceedure has prevailed over the interests of medicare recipients.
I WOULD support a strong arm tactic on CMS's part to "suggest" to industry that they find a way to make this proven proceedure more cost effective, but NOT to continue the non coverage policy.
This non cverage policy puts patients in the middle of a debate between groups of physicians. That debate was carried out at the FDA level when this proceedure was approved for this group of patients. Continued non coverage is unsupportable, inexcusable and an embarassment to a body supposedly committed to providing care for its recipients. I continue to hope that wisdom will prevail here, but I must admit, my hope is fading. I think the CMS has asked the endovascular community in this country to "retrieve the witch's broom ". The community has responded by laying a stack of legitimate brooms at the wizzard's feet. Lets get this overwith. Approve it and let us ge on with the real mission -providing our patents with appropriate care, whichever techniqe happens to be best. |
| Commenter: |
Weed, Dan
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| Date: |
8/13/2008 8:55:16 AM |
| Comment: |
Proton Therapy for Prostate Cancer.
I'm a radiation oncologist. Protons offer a significant benefit in several oncologic situations. Prostate cancer is not one of those situations.
Unfortunately, however, I do believe prostate cancer treatment with protons significantly offsets the lack of reimbursement in the other clinical situations where protons are needed but not reimbursed. |
| Commenter: |
Augspurger, Mark
|
| Title: |
MD |
| Organization: |
Florida Radiation Oncology Group |
| Date: |
8/21/2008 12:17:57 PM |
| Comment: |
Proton Therapy for Prostate Cancer:
Proton therapy should not be used in the treatment of prostate cancer. Proton treatments are much more expensive than other radiation techniques. There is no proven benefit in tumor control or side effect profile to proton therapy over IMRT or brachytherapy. In fact, the opposite may be true: one article in JAMA showed that when protons were compared to seed implants the rate of Grade 2 rectal toxicity was twice as high. Other data indicate that protons may be associated with inferior biochemical (PSA) control when compared to brachytherapy. Finally, due to neutron contamination, protons may have a higher rate of secondary cancer development in the years to come. |
| Commenter: |
Holman, Paul
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| Date: |
9/2/2008 2:27:52 PM |
| Comment: |
[PHI Redacted] One difference between proton treatment and others is that you
leave feeling human and normal. That's worth everything.
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| Commenter: |
Richards, Mark
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| Date: |
9/2/2008 2:33:35 PM |
| Comment: |
Proton Beam Radiation Treatment for Cancer - Medicare Coverage:
As a health care professional, scientist [PHI Redacted] I feel strongly that Medicare should cover this state-of-the-art treatment. [PHI Redacted] 6 year cure from prostate cancer with zero side effects during treatment and since treatment. This can not be said of any other treatment option available for treatment of prostate cancer. I have read all the scientific literature and compared the results with all other treatment modalities. This treatment should be available to Medicare patients.
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| Commenter: |
whitt, william
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| Title: |
none |
| Organization: |
noww |
| Date: |
9/2/2008 2:34:44 PM |
| Comment: |
it works great and you can have all of your plumming afterwards ,,,, [PHI Redacted],,, It works dont be fooled .... and their no pain doing it ....
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| Commenter: |
Greening, Gayla
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| Date: |
9/2/2008 2:40:42 PM |
| Comment: |
Before proton therapy is denied as a viable treatment for prostate cancer, there are many not doing enough research!!! Please make sure you do an extensive study re: the after-effects of the various treatment options before dismissing protons. It is the ONLY option for those that actually do their research! Perhaps incontinence and impotence are not important issues for some men, but they certainly have proved VERY relevant to those who lose those functions with other treatments! The ability of the protons to be directed ONLY at the diseased tissue makes all the difference.
It would be wrong to disallow proton therapy as a viable option for insurance coverage. If you do your research, you will find it is, by far, the best option... if you're interested in maintaining quality of life post-treatment! |
| Commenter: |
Thurber, Marshall
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| Title: |
Attorney |
| Date: |
9/2/2008 2:45:02 PM |
| Comment: |
[PHI Redacted]
[PHI Redacted] no side effects and no surgery; it would be a crime not to continue to have this covered under medicare. [PHI Redacted] Why make men suffer with less than this type of treatment?
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| Commenter: |
Davis, Michael
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| Date: |
9/2/2008 2:49:40 PM |
| Comment: |
[PHI Redacted] a successful proton radiation receipient that was treated for prostate cancer several years ago. [PHI Redacted]
The overwhelming majority of that evidence was that other treatment methods could cure the prostate cancer, BUT, and there always seemed to be a BUT, the issue of side effects would surface. Either some level of incontinence or sexual function issue was part of the conversation. [PHI Redacted] that was all the evidence needed to decide to use proton therapy which had almost no side effect issues [PHI Redacted]
Since having proton treatment, [PHI Redacted] have not had any issues of side effects limiting lifestyle in any way. [PHI Redacted] also free of prostate cancer according to doctors. [PHI Redacted] very satisfied with proton treatment. I hope that it will still be available for men who need Medicare to pay its cost.
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| Commenter: |
Lamborn, Homer
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| Title: |
Retired |
| Date: |
9/2/2008 2:51:56 PM |
| Comment: |
[PHI Redacted] was treated by the Proton method (@ Loma Linda
CA) in 1996 and doing very well during these intervening years and can certaiinly vouch for this method of trestment.
Homer Lamborn
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| Commenter: |
Stewart, Ronald
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| Date: |
9/2/2008 2:53:54 PM |
| Comment: |
I am sending this e-mail to express my concern
for removing medicare payments for Proton
Therapy.
[PHI Redacted]
I believe the benefit of Proton Therapy was the
reduction in side effects.
I feel that Proton Therapy should be available
to everyone on Medicare who needs the treatmen.
Yours truly,
Ron Stewart |
| Commenter: |
Schick, Uwe R.
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| Title: |
Western Regional Manager |
| Organization: |
Medical Automation Systems Inc. |
| Date: |
9/2/2008 2:55:37 PM |
| Comment: |
I am amused by the intellectual bias of the many posts that attack the positive outcomes of Proton Therapy. Until these doctors face the reality of Prostate Cancer in their own lives, their data will prove whatever they want it to prove.
[PHI Redacted] Prostate cancer at 53. Declining PSA with no side effects from treatment two years later. [PHI Redacted] Choice will drive the best treatment, not clever marketing as some have posted.
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| Commenter: |
Reed, Cliff W
|
| Title: |
Disabled Veteran, Retired Civil Engineer |
| Date: |
9/2/2008 3:00:36 PM |
| Comment: |
I have heard of a proposal to stop Medicare coverage of Proton Therapy for Prostate Cancer. I am not a doctor [PHI Redacted]. My story is very important because my doctors (three) told me that due to my other illness [PHI Redacted]; that I could NOT be treated by their methods because I would die on the operating table! They all agreed that I had approximately one year to live and it would be best to just go home and wait to die! They discussed all options of treatment BUT Proton Radiation Therapy. They contacted a reputable expert at Sloan-Kettering Cancer Institute who agreed with their recommendation. I started to get my final affairs in order and informed my Sunday School teacher that my time in his class was limited. Another student heard my situation and said that can;t be right and she would find a solution. She has become my ANGEL because she found Loma Linda Medical University which was conducting Proton Radiation Therapy for Prostate Cancer. She informed me and I contacted them. [PHI Redacted]. I have had NO adverse side effects from this treatment. Some of my friends have had surgery, X-ray, and seeds for their Prostate Cancer; and all of them suffer from bowel an bladder problems and also erectile disfunction. Please do not stop your coverage of this treatment. It appears that doctors want this coverage stopped because they lose your and my money! Hippocratic oath seems to be DEAD to them! |
| Commenter: |
DeMoss, Bill
|
| Date: |
9/2/2008 3:04:28 PM |
| Comment: |
I believe that it is incredably important to retain the Medicare coverage for Proton
Radiation. Without it, the single best choice for many men diagnosed with prostate cancer will become unavailable.
[PHI Redacted] To a man, [PHI Redacted] very happy that we did not choose
the radical surgery alternative with all the horrible side effects. Regular radiation and seed therapy pale in comparison as well.
[PHI Redacted]
Eliminating this coverage from Medicare would deny men a very effective treatment with very low risk. Certainly costs can be saved elsewhere!
|
| Commenter: |
Giffels, Donald
|
| Title: |
President |
| Organization: |
Giffels Consultants Inc. |
| Date: |
9/2/2008 3:05:29 PM |
| Comment: |
I have been in contact with numerous patients who have been treated with proton beam radiation therapy for prostate cancer. The evidence is overwhelming that this form of treatment provides the best outcome for the patient with respect to collateral damage to healthy tissue and organs. The patients have had minimal side effects common to photon radiation or surgery. I am in favor of the expansion of the number of treatment centers utilizing this technology, and Medicare coverage. |
| Commenter: |
Shuey, John
|
| Title: |
Private citizen. |
| Date: |
9/2/2008 3:06:01 PM |
| Comment: |
RE: Proton Therapy
I am dismayed, though not surprized, at all the postings claiming no advantage for Proton Therapy from practitioners of competing modalities. Apparently the profit motive is more important than the science for some people. The facts are:
1) Proton Beam Radiation Therapy (PBRT) is at least as effective as any competing treatment modality; (I say "at least" because within the last few years PBRT dosages have been increased, but not enough time has yet elapsed to permit a thorough analysis of any potential gains in longer-term efficacy.) and
2) There are studies, both from researchers in California and in Europe that clearly demonstrate that PBRT results in fewer and less severe side effects than do competing modalities.
I personally know of quite a few hundred men treated with PBRT for PCa who have never experienced a side-effect of any material consequence; thus resulting in savings of untolds hundreds of thousands or millions of dollars from follow up treatments NOT required.
Finally...the cost of this treatment can and will come down as more centers are built using newer technology. As for now, those of us lucky enough to have chosen PBRT are thankful for its availability. |
| Commenter: |
Gay, Sr., Robert
|
| Date: |
9/2/2008 3:07:39 PM |
| Comment: |
The accuracy and depth-control of proton therapy made it possible to treat enlarged prostate without the expense and adverse side effects of lutenizing hormone ablation drugs. [PHI Redacted] in relatively good health, the quality of remaining years has been greatly improved. No other treatment, approved by Medicare, that could
accomplish this, is available in the US.
|
| Commenter: |
White, William
|
| Date: |
9/2/2008 3:12:13 PM |
| Comment: |
|
[PHI Redacted] I have many friends that chose other treatment methods and are suffering a wide range of terrible side effects! [PHI Redacted] suffer none of these and strongly feel it is well worth, in the long run, any additional expense to have the Proton treatment method. I urge you to not preclude Medicare coverage for this excellent solution to prostate cancer! |
| Commenter: |
Smith, Richard
|
| Date: |
9/2/2008 3:12:49 PM |
| Comment: |
The negative comments about proton therapy as it applies to prostate cancer, made by several physicians, amount to hearsay and are largely misleading in many of the details. The comments smack of panic rather than sober logical statements.
The record of success, the preservation of quality of life of prostate cancer patients, and the lack of debilitating long term effects (requiring continued coverage by insurance companies) are documented and absolutely important factors in any decision regarding termination of insurance coverage of proton therapy for prostate cancer.
|
| Commenter: |
Gustafson, Paul
|
| Date: |
9/2/2008 3:17:23 PM |
| Comment: |
[PHI Redacted] I am urging that reimbursement for treatment for prostate cancer via proton beam therapy remain intact. After doing some investigating, it seems that the majority of those that reimbursement be discontinued are those who are fully invested in some competing technology. I'm concerned about one's objectivity in those cases.
Furthermore I can state that since treatment have experienced absolutely no lifestyle change. [PHI Redacted] selected selected proton beam therapy because it appears, from a review of articles a found through a MEDLINE search, that, even though other treatment methods may have an equal success rate, the likelihood of negative side effects is less than with the other methods. All journal articles I have read that say that proton beam therapy should not be used because there are other methods with equal success rates, made no comment about the side effects. It's easy for a physician to recommend the cheaper method when he is not the one wearing diapers or a catheter.
During [PHI Redacted] treatment period [PHI Redacted] met a number of physicians (including urologists, oncologists and surgeons) who selected proton beam therapy for themselves. I respectfully encourage that current reimbursement for proton beam therapy remain in place. |
| Commenter: |
Hagemann, Lawrence
|
| Title: |
Chief Technology Officer |
| Organization: |
Digital Recorders, Inc. |
| Date: |
9/2/2008 3:17:42 PM |
| Comment: |
[PHI Redacted] I fully endorse the proton beam therapy approach and support its further coverage under medicare.
I have had friends, relatives, and acquaintances who have had the radical prostate surgery, the Brachy therapy, and the standard radiation procedures. I can only give "first-hand" data that none of the above gave them the ultimate cure and quality of life that men would like to see after 60 years of age.
[PHI Redacted]
Sure, we would like to see massive studies done. but it enough for me that very large and significant institutions in the States and abroad have put up the investment necessary to make this procedure available. And with more research and development, maybe less expensive equipment can be made to do the same work.
I am but one data point in a potential and future study. [PHI Redacted]
My vote is to give proton-beam therapy for prostate cancer a thumbs-up for continued support and coverage! |
| Commenter: |
Cooper, Stuart
|
| Date: |
9/2/2008 3:18:42 PM |
| Comment: |
I want to take this opportunity to comment on
the Proton beam therapy for prostate cancer
proposed rule change.
[PHI Redacted]
It is my understanding that the reason
medicare is considering stopping the
reimbursement for proton treatment is because
there are other procedures that work equally as
well with a lower cost. I disagree with this
premis.
I can only use [PHI Redacted] as an example of the
overall savings to the medicare system or the
private health insurance system when all aspects
of prostate cancer treatment protocal is taken
into account. [PHI Redacted] This decrease in PSA level is, I am sure
commensurate with all other forms of radiation
treatment.
However, if you take into consideration post
treatment (side effect) issues for all forms of
treatment,I believe the cost to the medicare
system would be lower when being treated with
protons. [PHI Redacted] had no additional
treatment costs incident with my prostate cancer
treatment since the conclusion of treatment.
Simply stated, [PHI Redacted] had absolutely no costs
billed to insurance company other than normal
follow up since [PHI Redacted] was treated. [PHI Redacted]
I believe this outcome is a result only due
to the proton radiation treatment. Many studies
have been done that clearly demonstrate, that
when this aftercare aspect of treatment is taken
into consideration, proton beam radiation
treatment becomes far less costly to the medicare
and health insurance system.
Yes, it is true that the proton beam kills
the cancer cells the same way as the photon beam.
The proton beam, however, is more precise and
side effects therefore are far less severe than
with the difuse photon beam. The photon beam,
even when delivered by IMRT clearly kills far
more healthy cells than the proton beam thereby
creating a greater possibility of unfortunate
side effects.
I was told by a physician at the leading
major east coast urilogical center in the U.S.
that no matter what form of treatment [PHI Redacted] chose [PHI Redacted]
would be cured. When I heard this the decision
was easy; statistically go with the least
invasive procedure, that would do the least
harm. Proton therapy was clearly the least
invasive. My choice as of this date has proven
correct. [PHI Redacted] quality of life is no different than
prior to treatment and [PHI Redacted] cost of after care has
been $0.00.
Once you take aftercare costs into account
for all treatments including surgery proton beam
will, in my opinion, prove to be the most cost
effective prostate cancer treatment available.
Medicare should, for this reason, continue to
reimburse patients who seek proton beam radiation
therapy for prostate cancer. |
| Commenter: |
Childers, Richard
|
| Date: |
9/2/2008 3:20:38 PM |
| Comment: |
I would like to comment on the reimbursement of
proton therapy for prostate cancer. [PHI Redacted] was treated
with Proton Beam therapy which was completed 2
years ago. [PHI Redacted] made [PHI Redacted] decision to use this
treatment after talking with many people that
were successfully treated with proton beam at
Loma Linda MC over the past 10 years. I also
spoke with several friends and neighbors that had
the tradition radiation or surgery. Without
exception those that I spoke with that had
traditional radiation or surgery have suffered
unpleasant side effects.
[PHI Redacted]I have encourage several friends whom
have been diagnosed with prostate cancer to go to
Loma Linda. Several have and without exception
are thankful they chose Proton Beam.
I believe in the long run and the absense of side
effects, that Proton Beam will prove less costly
and certainly improve the quality of life.
My experience has been that the surgeons all
recommend surgery and the radioligists recommend
radiation and few are knowledgable of the success
and benefits of proton beam.
My Uroligist commented it was experimental and
too new for him to recommend and didn't have a
clue that Loma Linda has been treating prostate
cancer patients since 1996. I believe if you will
do further research, and be objecttive of the
comments made by surgeons & radiologist, that you
will agree that Proton Beam is a very viable and
beneficial treatment for those that are a
candidates for the treatment.
|
| Commenter: |
Wilcox, Dale A
|
| Date: |
9/2/2008 3:33:02 PM |
| Comment: |
Proton Treatment, Prostate Cancer
[PHI Redacted] received treatment in 1993, had a PSA of 6 that
had rapidly escalated to 9. [PHI Redacted] received a PSA
readout of 3 just recently. [PHI Redacted] have had no side
affects or issues. [PHI Redacted] was advised by a physician to
wait and see that [PHI Redacted] refused.
[PHI Redacted] healthy, well and very satisfied with [PHI Redacted]
treatment and results. |
| Commenter: |
Miller, Richard
|
| Date: |
9/2/2008 3:33:18 PM |
| Comment: |
[PHI Redacted] a prostate cancer patient who was treated
with proton beam therapy ending on [PHI Redacted]. Since then [PHI Redacted] PSA has dropped
gradually and is now at 0.98. [PHI Redacted] experienced
no side effects from this treatment, i.e. no
incontinence or rectal problems. [PHI Redacted]
From [PHI Redacted] contact with other patients under this
treatment at the time of [PHI Redacted] treatment, they all
indicate similar results. [PHI Redacted] was attracted to
proton radiation therapy because of the number of
testimonies by patience on the lack of side effects. |
| Commenter: |
Bergman, Steve
|
| Date: |
9/2/2008 3:33:32 PM |
| Comment: |
In Feb. and March of this year [PHI Redacted] received 45
proton beam treatments with the only side efffects
being mild increase in frequency and urgency in
urinating which ceased after treatment was
completed. The total cost was $48,000 (including
co-pays) as a 65 year old Medicare patient. [PHI Redacted] had
no symptoms to deal with on recovery, no
incontinence, nor erectile disfunction, no rectal
bleeding, no exposure to infection, nothing. I
can't put a value on the lack of side effects or
recovery issues. At my age and hope of growing
much older and staying active....priceless. |
| Commenter: |
Gothard, Donald
|
| Title: |
Retired Engineering Director |
| Organization: |
General Motors Corporation Manufacturing Staff |
| Date: |
9/2/2008 3:38:21 PM |
| Comment: |
Proton Beam Therapy for Prostate Cancer
[PHI Redacted] was treated with protons in 2001 at the age of 66. [PHI Redacted] had subsequent PSA tests every year since [PHI Redacted] treatments and [PHI Redacted] PSA has held steady at less then 0.1 for the past 5 years and with normal DRE tests. [PHI Redacted] While being treated, [PHI Redacted] hiked the foothills in California every day. [PHI Redacted] worked out in the University athletic facility on some days and [PHI Redacted] did a lot of sight seeing during [PHI Redacted] 9 week stay. [PHI Redacted] and I have talked with many prostate cancer patients as I participate in senior's athletic progams for softball and volleyball. It saddens me when I meet men who have had surgery for their cancer and they are incontinent. I talked with one man who's cancer recurred after surgery and then he had photon radiation. He had to have both hips relaced due to the radiation. He cried while talking with me and seeing the shape that I was in - still playing volleyball with no problems.
I recommend proton therapy to all men who ask me for my opinion on what they should do. Unfortunately, most of them cannot afford to travel away from home and spend time away from their work if they are still working. I'm a black American. Prostate cancer is a major killer of black men. Prostate cancer killed[PHI Redacted] They did not get treated for their cancer because they did not want to live with the problems their friends had, and those who ended up with chemotherapy really scared [PHI Redacted] away from any treatments. So he died in pain when he probably could have been saved if he had known of a treatment like proton beam therapy and if he had seen the good results on some of his friends.
When [PHI Redacted] was looking for a treament the urologists all recommended surgery, a cryosurgeon recommended cryosurgery, and those doing photon radiation recommended their specialty along with those doing implants. However, I talked with many patients and those who had proton beam therapy were the happiest with their results and their resultant quality of life after their treatments. [PHI Redacted]
Prostate cancer is a family disease and the wives that I met in the waiting room each day,when [PHI Redacted] was being treated,were 100% behind the treatment their husbands were getting.
Please don't drop Medicare coverage for proton beam therapy. Many of the comments that I read talked about the high costs associated with proton beam therapy. There were some patients being treated when [PHI Redacted] was being treated who were paying the costs themselves. They were convinced that this was the best treatment for them. Don't take away Medicare coverage and take away the chance for a normal quality of life for those who cannot afford to bear the cost of proton beam therapy themselves. Medicare will be the only coverage many might have. All men should have the opportunity to get the best care possible for their afflictions. I think proton beam therapy is the best treatment for early stage prostate cancer.
|
| Commenter: |
Warman, Paul
|
| Date: |
9/2/2008 3:44:16 PM |
| Comment: |
Proton Therapy for Prostate Cancer:
[PHI Redacted] a proton beam radiation treated prostate
cancer survivor. The Proton Beam treatment for
prostate cancer is safer and as effective as
other external beam radiation methods. It has
fewer side effects and there is less collateral
tissue damage than happens with x-ray beam
radiation.
The only people who are denigrating proton beam
radiation are those that don''t make any money
from patients who go elsewhere for this superior
treatment. Medicine is a business!
Before selecting proton beam radiation for [PHI Redacted]
treatment [PHI Redacted] interviewed a couple of radiation
oncologists who use x-ray beam radiation for
their patients and they told [PHI Redacted] "That they could
do just as well as proton beam", they did not say
better. The over 3000 members of "The Brotherhood
of the Balloon" for the most part can verify my
statements about the lack of side effects and the
quality of life enhancements of proton beam
treatment.
The argumernt that there are few proton centers
operating at this time is also bogus. There are
several (at least 5) in operation including MD
Anderson in Houston and many more being built
including Walter Reed Army hospital in
coordination with a major Pennsylvania University
Medical Center.
Proton centers are expensive. They are used for
very specialized cancer treatments that cannot be
satisfactorily completed by other methods.
Without the large number of prostate patients to
carry the overhead, many children will not get
the life saving proton treatments that they
need.
|
| Commenter: |
Cornwall, Fred
|
| Date: |
9/2/2008 3:48:14 PM |
| Comment: |
Re: Proton Treatment for Prostate Cancer.
[PHI Redacted] 65 year old man who was treated earlier
this year for prostate cancer with proton
therapy. [PHI Redacted] selected this form of treatment after
six months of studying alternatives and [PHI Redacted] can
attest to the fact that the proton treatment is
ideal for a healthy man [PHI Redacted], who is
concerned about the two common side effects of
other treatments: incontinence and/or impotence.
[PHI Redacted] completed the proton treatment regimen,
and [PHI Redacted] can tell you that [PHI Redacted] NO side effects at
all. The less expensive alternatives all seem to
have statistics of between 10% and 40%
incontinence and slightly higher impotence
rates. Instead of preventing men from receiving
this treatment method, the government should
encourage the building of new treatment
facilities and generate more competition in the
proton field. This is truly the state of the art
treatment that avoids surgery completely. |
| Commenter: |
Bevan, John
|
| Date: |
9/2/2008 3:54:11 PM |
| Comment: |
I read with concern the proposal by CMS to exclude proton
therapy for prostate cancer from Medicare reimbursement. In
2004, [PHI Redacted]was diagnosed with prostate cancer at the time of [PHI Redacted] 68th birthday. [PHI Redacted] was promptly offered radical prostatectomy by
the chief of urology at a well-known Boston hospital; he also
told [PHI Redacted] that[PHI Redacted] would incur impotence and urinary incontinence
as a result. However, based on conversations with a former
colleague who had chosen proton therapy under similar
circumstances and who incurred neither of these side-effects, [PHI Redacted]
also opted for that treatment mode. As a physicist, [PHI Redacted]
immediately grasped the ability of proton radiation to mitigate
radiation side-effects to adjacent organs. Now, over 4 years
later, neither [PHI Redacted] nor [PHI Redacted] wife could be anything but happy with the
results. [PHI Redacted] PSA level rapidly declined post-treatment and it has
leveled out at at 0.1 ng/dL; plus, [PHI Redacted] zero problems with
impotence, incontinence or any other related dysfunction.
Surgery and other treatment modalities all have their place, and
the outcomes of the various treatments on prostate cancer per
se may well be equivalent. But I strongly believe that lower levels
of side-effects from proton therapy are a fact and this has a
definite effect on Quality-of-Life issues.
On behalf of all proton therapy patients, I urge you to reconsider
your proposal.
|
| Commenter: |
MAKINSON, JOHN
|
| Date: |
9/2/2008 4:01:51 PM |
| Comment: |
[PHI Redacted] completed proton beam therapy for [PHI Redacted] prostate
cancer on 8/4/08 and intuitively feel this was
the best decision[PHI Redacted]. It would not be
possible if Medicare did not cover it.
[PHI Redacted] treatment was actually HDR temporary seeds and
then 28 proton treatments. [PHI Redacted] been suffering
terribly from GI and GU side effects since [PHI Redacted]
HDR. Because of the timing I do not believe it
is caused by the protons.
Please continue to cover this superior treatment
for the patient's sake. |
| Commenter: |
Schaeffer, Hugo
|
| Title: |
Retired Human Resource Director |
| Date: |
9/2/2008 4:11:11 PM |
| Comment: |
[PHI Redacted]68 years old and consider [PHI Redacted] lucky to
have choosen proton therapy over the other
choices as it is non evasive and all the men [PHI Redacted]
had spoken to prior to [PHI Redacted] choosing it indicted [PHI Redacted] that the results were outstanding. It has
been 3 1/2 years since having proton therapy and
[PHI Redacted] had no side effects and everything works
as it should. [PHI Redacted] PSA score is .5 [PHI Redacted] so
thankful that Medicare paid for the treatment as
[PHI Redacted] might not have been able to afford this highly
syccessful prostate treatment. |
| Commenter: |
Ford M.D., Ken
|
| Date: |
9/2/2008 4:12:51 PM |
| Comment: |
I have a 39 year medical background: Orthopedic
Surgeon graduating from Medical School at The
University of Texas in 1969; also I was a U.S.
Air Force Flight Surgeon 1970-1972.
[PHI Redacted]diagnosed with prostate cancer 3 years ago
and performed extensive research before reaching
an obvious decision (Proton Radiation) to be
treated by the best treatment available to not
only cure [PHI Redacted] cancer but to let [PHI Redacted] continue a
wonderful quality of life without urinary
incontinence or impotence. These unwanted side
effects are a significant factor in other forms
of treatment.
Proton radiation was chosen primarily due to
personally talking to over 100 patients treated
by all methods. The overwhelming evidence of
excellent long term results without side effects
made my decision easy.
Please don't take away the ability for someone to
make a well educated decision about their quality
of life following cancer treatment. If you
exclude this treatment it will obviously trickle
down to private health and have a negative effect
on thousands of lives.
Thank you. |
| Commenter: |
Lee, Douglas
|
| Title: |
Managing Director |
| Organization: |
WESST Enterprise Center |
| Date: |
9/2/2008 4:27:47 PM |
| Comment: |
Please do not discontinue Medicare reimbursement
for proton radiation therapy for treatment of
prostate cancer! [PHI Redacted] spent months researching the
various options available [PHI Redacted] for PC treatment
and came to the conclusion that proton treatment
promised the least offensive side-effects. [PHI Redacted]
2.5 years out of treatment and [PHI Redacted] PSA is down to
1.0 and [PHI Redacted] none of the other side effects
which [PHI Redacted] had a 50/50 chance of experiencing from
the current state-of-the-art treatments:
impotence, incontinence, protracted recovery.
Please give others the same chance [PHI Redacted] had to
survive prostate cancer without serious side effects.
Simply put, this technology is AMAZING and should
be supported by our government.
Please feel free to contact me if you have any
questions. |
| Commenter: |
Walker, Ethel
|
| Title: |
RN (retired) |
| Date: |
9/2/2008 4:27:53 PM |
| Comment: |
[PHI Redacted] was diagnosed with prostate cancer 5 years ago. After much research into the various paths of treatment, he opted to have proton beam radiation. Today his PSA is 0.5 holding steady, and he has had no problems from the radiation. This was a painless, bloodless, safe treatment with no damage to healthy tissues.
|
| Commenter: |
Gapp, William
|
| Title: |
Retired CEO |
| Organization: |
Privately owned company |
| Date: |
9/2/2008 4:33:18 PM |
| Comment: |
[PHI Redacted] elected to have [PHI Redacted] prostate cancer treated by
protron radiation in October of 2003 after
researching all [PHI Redacted] options, including direct
conversations with in excess of 60 men who were
treated with other forms of therapy as well as
proton. In addition [PHI Redacted] consulted with numerous
other facilities who did not offer this form of
treatment. Please note that the research [PHI Redacted]
performed resulted in [PHI Redacted] ascertaining that almost
all treatments eradicated the cancer, assuming
that the cancer cells were encapsulated in the
prostate organ. The major difference, however,
was that the side effects from the other forms of
therapy as reported by many patients resulted in
undesirable side effects (ie. incontinence,
impedency, etc.) whereas the proton form of
treatment was essentially void of these
undesirable results. It appeared that most
urologists [PHI Redacted] consulted with (including my own who
is the head of Urology at a major university
hospital and who I had been a patient of for over
10 years) tried to discourage [PHI Redacted] by saying that
they didn't know anything about it other than
it 'wasn't any good'. Obviously their negative
opinions were a result of their inability to
provide this form of treatment as opposed to
their personal knowledge and experience. |
| Commenter: |
Dunlap, James
|
| Title: |
Captain |
| Organization: |
Frontier Airlines |
| Date: |
9/2/2008 4:34:32 PM |
| Comment: |
Proton Therapy,
Medicare and Medicad should continue to offer
Proton Therapy as a treatment for Prostate
Cancer.
Last summer, [PHI Redacted] completed proton therapy for
prostate cancer and could not be happier with
the outcome a year later. [PHI Redacted] insurance company
approved the treatment plan and paid for proton
therapy. If [PHI Redacted] insurance company had not
approved the procedure, it would have been a
real hardship [PHI Redacted] to incur the cost and may
have prevented [PHI Redacted] getting the treatment. [PHI Redacted]would have had a hard time facing the reality
that Proton Therapy was not an option because it
was deemed too expensive by the insurance
company.
And, is it really cheaper to have surgery to
remove the prostate and then incur all of the
cost on follow up visits/medications due to side
effects and disfunctions that surgery causes.
Yes, [PHI Redacted] initial Urologist said you need surgery
and don't worry about incontience or
impotence, "we have drugs for that". In my
opinion this attitude is not doing what is right
for the patient, but what is right for the
surgeons/drug companies and their pocket books!
Just take a look at who is responding against
Proton Therapy. However, if the shoe was on the
other foot and the prostrate surgeon had
prostrate cancer, which treatment would he seek
for himself? Let me tell you the answer from
several DOCTORS I met who were going through
treatment [PHI Redacted] last summer- Proton Therapy
without a doubt!
[PHI Redacted] lived the nightmare of Prostate Cancer
and survived without the complications that my
friends are having who chose surgery. I thank
my fellow coworker everytime I see him for
telling me about Proton Therapy (He had the
treatment 8 years ago! and is doing great). If
it was not for him [PHI Redacted] would most likely be
wearing diapers and impotent at age 43. I thank
God for this coworker, the doctors/staff at the
proton center, and the fact that this wonderful
option for treatment was an approved procedure.
I sincerely hope proton therapy will be
available to anyone with this type of cancer.
By far, this option is the best decision you
will ever make. [PHI Redacted] continuing to enjoy life
with absolutely no complications and [PHI Redacted]. [PHI Redacted]been able to continue working and
supporting [PHI Redacted] family with little down time and
no side effects. [PHI Redacted]was never sick, did not lose
[PHI Redacted] hair, and played tennis everyday with [PHI Redacted]
family after the treatment! I hope it will be
the wave of the future in treating many types of
cancer.
It would be a crime for anyone to take away this
option for treatment under their insurance
benefit.
Sincerely,
Captain James K. Dunlap |
| Commenter: |
Wadsworth, Craig
|
| Title: |
Certified General Contractor |
| Date: |
9/2/2008 4:40:35 PM |
| Comment: |
Regarding Medicare Coverage of Proton Beam
Radiation:
[PHI Redacted] opted for Proton Beam Radiation treatment for
stage 2C prostate cancer in early 2002; because [PHI Redacted]
could see from the published scientific evidence
that it was the most accurate form delivering the
highest dose of radiation with,the least chance
of collateral damage. [PHI Redacted]
Now that M D Anderson, U of Florida Shands, Mass.
General and several other leaders in cancer
treatiment have made the commitment to construct
these new Proton facilities; I am reassured that
regardless of the cost, Protons are a superior
modality. Medicare should not be looking for the
cheapest treatment or excluding Protons from a
doctor/patient's pallate.
Craig D. Wadsworth
CGC1507136 |
| Commenter: |
Randolph, Benjamin
|
| Date: |
9/2/2008 4:40:39 PM |
| Comment: |
[PHI Redacted] a recipient of very successful proton beam
treatment for prostate cancer. [PHI Redacted] choices
because of health and age were very limited and
[PHI Redacted] research into a very highly researched subject
included a consultation at Johns Hopkins. [PHI Redacted] I believe the total cost was in the
neighborhood of $50,000. Statistically, the
results of Proton Beam therapy was comparable to
other therapies and much less invasive to
adjoining organs, thus had fewer side effects.
[PHI Redacted]PSA is and has been less than 0.1
since treatment. Honestly, I believe that this
treatment is a life saver.
benjamin O randolph
|
| Commenter: |
Benchoff, Donald
|
| Title: |
CAPT |
| Organization: |
Retired |
| Date: |
9/2/2008 4:50:43 PM |
| Comment: |
I want to lend my support for the continued Medicare support
for proton beam therapy for prostate cancer. [PHI Redacted] I can attest to the
fact that the side effects are minimal to none. The effectiveness
of the treatment, in terms of rendering the PSA to less than .01
in less than 6 months post treatment, in effect was a cure. The
treatment itself, was painless and free from the side effects of
other modalities. The loss of one's sexuality, incontinence, etc,
were not problems[PHI Redacted] to deal with [PHI Redacted] other forms of treatment (traditional radiation, surgical
removal of the prostate, cryosurgery, etc.). I am thankful I
learned about proton beam therapy [PHI Redacted] |
| Commenter: |
Hartwigsen, Charles
|
| Date: |
9/2/2008 5:03:14 PM |
| Comment: |
[PHI Redacted] a former Prostate Cancer patient. [PHI Redacted] PSA was
9.8 in May of [PHI Redacted]. The doctor said because of [PHI Redacted]
Leukemia (CML), raditation was [PHI Redacted] only option to
fight the cancer. After [PHI Redacted] spoke with the
radiologist and heard the side effects to expect,
[PHI Redacted]. [PHI Redacted] chose
Proton therapy, Medicare paid for it. [PHI Redacted] had no
side effects. Therefore, Medicare did not have to
pay any additional expenses for follow-up care.
[PHI Redacted]PSA was 0.8 and [PHI Redacted] doing very
well. Many of my friends who chose other types
of treatments are continuing to have health
problems and ongoing treatments. I think in [PHI Redacted]
case, Medicare saved money by paying for [PHI Redacted]
treatment. When there is a better treatment, why
not use it. When [PHI Redacted] told the first radiologist [PHI Redacted]
choice, she said "we will all be doing it that
way in the future." |
| Commenter: |
Richardson, Jack
|
| Title: |
Mr. |
| Organization: |
Retired |
| Date: |
9/2/2008 5:10:16 PM |
| Comment: |
I believe Medicare's proposal to stop paying for proton beam therapy as a treatment for prostate cancer is a serious mistake. The proposal is based on a mistaken belief that it is too costly and is not better than alternative treatments. The 7 year study has been posted which shows that proton beam therapy is every bit as effective, if not more so, in treating prostate cancer as the best alternative methods of treatment. Further, those of us who have had their prostate cancer cured by proton beam therapy know that there are virtually no side effects with proton beam therapy. That is not true of any of the other forms of treatment. Many types of treatment will kill the cancer, but proton beam therapy is the only one with virtually no side effects, resulting in a better quality of life for the patient.
It is interesting to note that the people who support the position of stopping the payment for this treatment are the professionals who offer an alternative treatment. It looks like they are trying to eliminate a superior treatment with which they cannot compete.
I believe it would be a mistake to discontinue tose payments. They are critical to allowing many patients to obtain this treatment. |
| Commenter: |
Waldbauer, Donald
|
| Date: |
9/2/2008 5:12:48 PM |
| Comment: |
This comment relates to the use of Proton Beam
treatment for Prostate Cancer. [PHI Redacted] was diagnosed
with prostate cancer 6 years ago. After
extensive research and interviews of many others
diagnosed and various treatments, [PHI Redacted] chose Proton
treatment. That proved to be the right choice.
Limited side affects, great results, a PSA .02
within 1 year and still the same 5 years later.
I personally have referred in excess of 10 people
for same treatment with the same positive
results. The consideration of not including this
treatment makes no sense to me. |
| Commenter: |
Cook, Charles F.
|
| Title: |
Retired Corporate Executive |
| Date: |
9/2/2008 5:15:20 PM |
| Comment: |
As a 69 year old, healthy, active man, [PHI Redacted] was
diagnosed with prostate cancer in [PHI Redacted]. [PHI Redacted] due diligence on all available treatments
including proton beam tehrapy. [PHI Redacted] research
included contacting men who had selected each of
the available protocalls to understand their
experience and status after various lengths of
time after their treatments. [PHI Redacted] also compiled
information from personal friends and two family
related members who had surgery, brachytherapy,
andIMRT. [PHI Redacted] lost two very close friends who died of
prostate cancer years after they had surgery -
very sad and difficult deaths. [PHI Redacted] also
compared the experiences of patients who chose
other treatments. While many were fine, there
were just too many whose experiences had changed
their lives in a negative manner. [PHI Redacted] choose proton
therapy and [PHI Redacted] in continuous communication with
over 100 other proton graduates. All have
experienced very little or no side effects and
continue the quality of life that they enjoyed
prior to proton therapy.(a very positive
incentive)[PHI Redacted] now completing two years of post
treatment[PHI Redacted]
I am concerned that too many of the critics of
proton therapy for prostate cancer are
individuals/organizations with competing treatment
alternatives. |
| Commenter: |
Shein, F. Richard
|
| Date: |
9/2/2008 5:22:13 PM |
| Comment: |
[PHI Redacted] was successfully treated for prostate cancer
with protons at Loma Linda Hospital four years
ago. That hospital has ten years of
scientifically accurate research attesting to
it's extraordinary ability to successfully treat
the patient with virtually no incontinence and
less impotence than the alternatives as a result.
It is understandible that there is resistence
from the medical field, for there is safety in
sticking with what you know and do. |
| Commenter: |
Spruell, Alfred
|
| Title: |
Captain |
| Organization: |
USN (Ret) |
| Date: |
9/2/2008 5:26:23 PM |
| Comment: |
Funding of Proton Therapy to treat Prostate
Cancer; It would be a huge mistake to withdraw
Medicare Funding for Proton Therapy for Prostate
Cancer (PCa). [PHI Redacted]
This is a wonderful, and highly effective
treatment that leaves no side effects for over
95% of those treated. That statement cannot be
made by any other PCa treatment regimen. Many
doctors, particularly Urologists, do not want
this treatment to be funded because it threatens
their surgical livlihood. But if the truth is
known, this is the most effective treatment
available. I realize that only five Proton
Treatment Centers are currently operating, but I
understand that five more are under construction,
and 40 more are in planning. To reduce the
Medicare funding for this therapy, would be to
deny the best treatment available to combat this
disease for a huge number of men. Over 250,000
men are diagnosed with PCa each year, with over
40,000 deaths attributed to this dread disease.
Thank you, Alfred Spruell, Capt.,USN(Ret) |
| Commenter: |
Barna-Lloyd, John
|
| Title: |
None |
| Organization: |
None |
| Date: |
9/2/2008 5:31:19 PM |
| Comment: |
I just read the postings to this forum on Medicare
coverage of treatment of Prostate Cancer by Proton
Bream Therapy. So far all were written by
physicians who offer treatment other than Proton
Beam. [PHI Redacted] was successfully treated by Proton beam
therapy in the year [PHI Redacted] after 2 failed treatments
by other mean beginning in [PHI Redacted]. All modes of
treatment can kill the cancer. All will have side
effects of the treatment. The proven fact is that
of all patients within the same diagnostic groups
(same PSA and Gleason score ranges) have less side
effects when treated with Protons. (Loma Linda
University Medical Center Published Studies.) The
reduction of side effects and the maintenance of a
high quality of life standard is the principle
reason for continued use of Proton Therapy. I urge
you to continue support of this medical necessity
by Medicare.
|
| Commenter: |
Allen, Lloyd
|
| Date: |
9/2/2008 5:35:00 PM |
| Comment: |
I wish to speak in behalf of continuing Medicare
coverage for proton therapy. [PHI Redacted] was diagnosed with
prostate cancer in [PHI Redacted]. [PHI Redacted] received 40 proton
treatments with no side effects or recurring problems. I
have visited with other cancer victims and have not
found anyone that had any other type of treatment with
the success that [PHI Redacted] had with proton. All other patients
suffer from some type of incontinence or become
impotent. This is a painless treatment and to not allow
medicare reimbursement is not in the best interest of
those who are unfortunate to have the problems. I am
truthful when I say that it is the only treatment I would
have in the future. |
| Commenter: |
McMillan, J Richard
|
| Title: |
Attorney at Law |
| Date: |
9/2/2008 5:37:26 PM |
| Comment: |
It is interesting to note that the major
opposition to proton radiation treatment for
prostate cancer patients comes from physicians
(primarily urologists) whose practices are
threatened by this more advanced technology and
one not available in their locale. It is
important to remember that urologists are
surgeons and, most (not all) will recommend
surgical procedures rather than exploring those
non-surgical options having fewer undesirable
side effects with their patients. [PHI Redacted]This was my
personal experience with three well known Dallas
urologists I consulted in Dallas. One would
hardly expect an economy car dealer to refer his
prospective customer to the Lexus dealership.
While proton radiation is currently the more
expensive treatment, the opening of new
facilities nationwide will make this highly
desirable form of treatment more cost effective.
As more facilities are opened, the unit cost per
treatment will be reduced substantially, making
it available to many citizens at a lower cost
not just the wealthy few. The important
consideration is the improved quality of life
provided to those having this option made
available to them as compared to traditional
surgical and external beam radiation treatments. |
| Commenter: |
Woods, Bert
|
| Date: |
9/2/2008 5:39:56 PM |
| Comment: |
[PHI Redacted] I wish to say that the proton therapy
treatment is the best for prostate cancer. I believe it's success rate
is as good or better than any other modality, and it has negligable,
if any, side effects. It is non invasive, also. The fact that so many
facilities are on line already, or under construction, is testimony to
it's recognized worth. For Medicare to stop reimbursements for
this form of treatment is foolish in my opinion. More and more
insurance companies are coming on board. Don't even think of
reversing this direction. |
| Commenter: |
Elmes, Gordon
|
| Date: |
9/2/2008 5:49:50 PM |
| Comment: |
[PHI Redacted] very satisfied recipient of proton
radiation therapy in 2004. The absolute absence
of any side effects and the diminished need for
follow-up medical treatment makes this method of
treating prostate cancer a very viable
alternative. [PHI Redacted] PSA, lifestyle, and overall
health are evidence of this being a superior
treatment. Any attempt to reduce or eliminate
the coverage for this methodology would be a
grave mistake. In contrast, I would suggest that
those advocating not covering proton radiation
would educate themselves more completely by
communicating with the patients who have been
treated and comparing the cost of medication,
follow-up procedures, and patient problems
between those who have been treated by other
methods with proton patients. [PHI Redacted] in excellent
health without any pain, incision, medication, or
side effects due to the proton treatment. |
| Commenter: |
Locke, Richard
|
| Date: |
9/2/2008 6:11:13 PM |
| Comment: |
Proton Radiation for Prostate Cancer
[PHI Redacted]
While you are in the decision making process I
implore you to seek out data on the relative rates
of side effects such as impotence and incontinence.
If, as I'm reading there are no unbiased data, I
suggest you leave things as they are until
unbiased data is developed.
Also please consider "learning curve" effects.
Protons are less used, and therefore there will be
a steeper learning curve and cost reduction in the
future compared to more mature technologies.
I'm an engineer and recognize that the Bragg Peak
effects make protons inherently more directable
than un-ionized particles. Stopping the use in
prostate cancer will slow an inherently better
technology from developing.
It would be like stopping development of
semiconductor memory in the 1970s because it
wasn't yet proven more cost effective than ferrite
cores.
Please reconsider.
Thank you |
| Commenter: |
taylor, hugh
|
| Title: |
Pres. |
| Organization: |
Taylor & Associates, Inc |
| Date: |
9/2/2008 6:11:30 PM |
| Comment: |
[PHI Redacted] I can say
with confidence, that proton treatment of
prostate cancer was effective [PHI Redacted]
since 2001-other than skin cancer, prostate
cancer is the most common of cancers.
In my view, until another treatment is proven
superior (with less potential side affects)let's
keep proton therapy available as an alternative
to surgery & other forms of radiation and
prostate cancer treatment.
As a 44 year veteran working in the insurance
industry, I have seen far too many
patients/clients who resisted (delayed) surgery
or developed complications from surgery or photon
radiation & thought they were cured, but the
cancer returned and metastasised.
In my personal conversations with medical
professionals, it's been very difficult to find
professionals (including MD's) who are unbiased
about the cancer treatment process they've been
trained in - proton thrapy was the perfect
alternative for me, as well as for many of my
friends who were treated for prostate cancer at
Loma Linda.
It would seem that as the availability of proton
treatment centers increase around the country,
and the # of cancer patients being treated
increase, the costs should also decrease over
time.
Rationing health care & eliminating coverage for
proton treatment of prostate cancer is NOT the
answer. Not now!
Please, let's not "throw the baby out with the
bath water". Until a treatment evolves that
proves to be better, keep proton treatment
reimbursement available to the nearly one qtr
million men who are diagnosed with PC annually.
Rationing health care in this area - makes no
sence to me. The cost of alternative treatments
to proton therapy for prostate cancer could prove
more costly in the long run-when one considers
the higher degree of failure of other forms of
treatment. |
| Commenter: |
Gadd, Joseph
|
| Title: |
Retired |
| Organization: |
None |
| Date: |
9/2/2008 6:15:47 PM |
| Comment: |
Proton Prostate Treatment
[PHI Redacted]was diagnosed with
prostate cancer, and completed the 45 session
proton treatment regimen. [PHI Redacted] experienced no pain,
incontinence, impotence, bleeding, loss of energy,
or any side effects that may affect patients
undergoing prostate treatment. The non-invasive
proton treatment for [PHI Redacted] was superior in terms of
cancer free status and low PSA post-treatment, and
lack of any unpleasant or damaging side effects
during and post-treatment, as compared to men whom
I know who underwent surgery, brachytherapy, and
conventional radiation. The democracy of the
proton treatment is attested to by some other
proton patients who were refused
surgery/brachytherapy/conventional radiation
(S/B/CR) due to particulars of their cases, such
as large prostate, previous S/B/CR treatment,
Gleeson or PSA scores, etc. I urge you to retain
proton treatment for prostate cancer as an
approved Medicare benefit. |
| Commenter: |
Sauer, John
|
| Date: |
9/2/2008 6:29:34 PM |
| Comment: |
[PHI Redacted] received proton radiation therapy for prostate
cancer last year. I have been in the engineering
medical field for 35 years and did very extensive
research on the methods and outcomes of variuos
prostate cancer treatments. [PHI Redacted]had a good
outcome with quick reductions in PSA levels. [PHI Redacted]had no side affects of
any kind. [PHI Redacted] quality of life is fantastic and
future is bright. I know many others who have had
other treatment options and have had significant
side affects. The long term no-cost followup of
having no side affects offsets any added cost of
the treatment. What price do you assign to the
quality of life? |
| Commenter: |
Vollhardt, Peter
|
| Title: |
Professor |
| Date: |
9/2/2008 6:34:12 PM |
| Comment: |
Proton beam therapy for prostate cancer: I have studied the subject matter thoroughly. As a scientist, I have access to the primary medical literature, and I have carefully scrutinized over 100 publications on the subject. I have also had discussions with over 20 men who had so-called conventional treatments (radical prostatectomy, various forms of external beam radiation, and two forms of brachytherapy), in addition to 30 men who had proton therapy. My conclusions are that, indeed, as argued by several contributors to this compilation, all forms of treatment are equally successful. The difference lies in the side effects, particularly posttreatment.
My particular concerns with respect to treatment are the minimization of the chances for urinary (i.e. incontinence) and sexual (i.e. erectile dysfunction) complications. My research shows that proton radiation offers a much better chance of avoiding such complications than conventional treatment. Some adverse medical literature notwithstanding, there are numerous reports in primary publications, most significant among them those by doctors/researchers without a vested interest in any of the forms of therapy, which point to the superior aspects of proton radiation in these respects. These papers show that it has become a standard alternative to other methods, that quality of life issues have become paramount for men afflicted with prostate cancer, and that the choice of treatment should be left to the patient.
The statement that there are no rigorous studies the compare modern conventional IMRT with proton radiation therapy is correct. What is incorrect, indeed disingenuous, is to construe this as an argument against proton radiation as a treatment choice. There are no studies that show that conventional treatment is better or even equal to protons. However, there is unequivocal science. Nobody can argue with the existence of the Bragg peak and therefore the corresponding reduction in exposure of nontarget tissue.
I therefore would have to vehemently disagree with the proposal to stop Medicare reimbursements for proton therapy in the treatment of prostate cancer.
|
| Commenter: |
Bruno, Fred
|
| Date: |
9/2/2008 6:55:17 PM |
| Comment: |
[PHI Redacted] recieved Proton radiation for prostate
cancer from [PHI Redacted]. The results are
nothing short of fantastic. [PHI Redacted] experienced no side
effects while recieving treatment and no side
effects after treatment. There probably is no
difference in the effacy of Photon treatment
versus Proton treatment as far as eradication of
the prostate cancer. There is however, a very big
difference in the side effects and the resultant
quality of life between Proton radiation and
Photon radiation. Bowel burns, incontinence,
bladder burns,and erectile disfuntion are
uncommon with Proton radiation. This NOT true
with IMRT Photon radiation. When [PHI Redacted] was advised
that needed to recieve radiation and was
directed to Photon radiation, was told that would become impotent and that incontinence was
likely and that bladder burns and bowel burns
could occur. Instead chose Proton and couldn't
be happier. Don't take the shortsighted view.
These recurrent issues of Photon radiation will
cost much more in the long run of a persons life.
I am a board member of the Prostate Cancer
Educational Council and I see these issues
associated with Photon radiation all the time.
Many hospitals across the country are considering
installing Proton Radiation centers. There is a
very good reason this is happening.
Fred Bruno |
| Commenter: |
Plummer, Cecil
|
| Title: |
retired |
| Date: |
9/2/2008 6:57:21 PM |
| Comment: |
I believe that proton therapy has the most benefits to the ordinary patient. The non invasive treatment allows the patient to carry on a normal lifestyle without weeks or months of physical side effects that are present with other treatments for prostate cancer. I would compare it to breast treatments for the importance of the treatment to the individual. |
| Commenter: |
Eberhardt, Charles
|
| Title: |
Apt. Owner |
| Organization: |
NA |
| Date: |
9/2/2008 7:04:33 PM |
| Comment: |
re: Medicare reimbursements for proton therapy for treating prostate cancer
[PHI Redacted]was diagnosed with prostate cancer. After six months of rigorous medical research, plus personal interviews with professionals in the field, as well as anyone [PHI Redacted] could locate that had gone through treatment for prostate cancer such as friends or friends of friends, [PHI Redacted] came to the only conclusion that made any sense for proton therapy. [PHI Redacted] considered nerve-sparing surgery, seeding, 3-D conformal radiation, and proton therapy. [PHI Redacted] chose proton treatment because of the following indisputable facts: less invasive than surgery, less chance of complications from surgery, less recovery time, and less chance of adverse side-effects such as incontenance and impotency with effectively the same success rate as surgery. HMO refused to pay for treatment because they said proton therapy was not necessary, more costly, and that no current, comparative studies have been conducted to prove it was better than conventional prostate cancer treatments. [PHI Redacted] paid for [PHI Redacted] treatment, then lodged a formal complaint, and eventually, because of solid evidence to the contrary, was reimbursed by HMO. [PHI Redacted] healthy and fully functioning.
I notice on this website that most of the people opposed to this therapy are professionals in direct competition. I think it is very, very important that Medicare research the facts and the data and not rely on personal opinions to guide them. This, of course, is my personal opinion, but I wanted to convey to you my alarm at the possibility that Medicare would not continue to cover proton therapy because I feel it is a highly viable choice for those who qualify.
Sincerely,
Charles Eberhardt
|
| Commenter: |
Schnabel, Rudolph
|
| Date: |
9/2/2008 7:22:29 PM |
| Comment: |
|
[PHI Redacted] did extensive research before deciding on
pursuing Proton Radiation Therapy for [PHI Redacted]
treatment for many reasons, several of which are:
Proton Radiation treatment, according to the
reseach reports read, proved to be be highly
effective in 90+% of cases completed. It has now
been used for 18 years with excellent results. [PHI Redacted]
did not experience any side effects such as
impotence and incontinence and was able to carry
on all normal activities during treatment
including bike riding, snow skiing, hiking,
swimming and working out at the gym. [PHI Redacted]
cancer free for the past 6 years and continue to
do all activities as before. I know that the
PSA is indicative and controversial as a measure
of success, yet is a measure that is availble.
PSA has been 0.7 for the past 3 years. [PHI Redacted]
completely satisfied with treatment choice and
highly recommend Proton Radiation Therapy to friends and anyone who asks about their
treatment choices.
I am extremely disturbed tha CMS is considering
redacting that treatment and considering not
paying for it in the future. Without Medicare it
would have been an exteme economic hardship [PHI Redacted] to use Proton Radiation Therapy as my
treatment choice. Please continue to pay for
this exellent and effective treatment.
Yours sincerely,
Rudolph Schnabel |
| Commenter: |
Gimbel, howard
|
| Title: |
MD |
| Organization: |
Loma Linda University |
| Date: |
9/2/2008 7:22:32 PM |
| Comment: |
Regarding Proton Therapy for Prostate cancer:
I graduated with an MD degree in 1960. Two members of my class developed prostate cancer about the same time in 2001. One had proton treatment and never missed a day of work and had virtually no symptoms during treatment or since. The other was off work for weeks and had a period of incontinence for weeks. Their experience and that of other proton therapy patients that I have talked to convinces me that there is a significant benefit to proton treatment for this condition as well as spinal cord tumors etc. |
| Commenter: |
Harris, Roger
|
| Date: |
9/2/2008 7:24:09 PM |
| Comment: |
Proton radiation therapy for prostate cancer.
[PHI Redacted] was diagnosed with prostate
cancer after a biopsy. PSA=14.9 and a Gleason
score of 9. [PHI Redacted] was accepted for proton and photon
therapy at Loma Linda University after Medicare
and secondary Insurance carrier agreed to pay
for it. [PHI Redacted] 9 week treatment ended [PHI Redacted]. [PHI Redacted]
just had a 4 month complete evaluation. PSA 0.2,
clear Ct scan and no sign of cancer. All urinary
problems are gone, ([PHI Redacted] Sexual function has returned to
an almost normal state. [PHI Redacted] I would hate to see Medicare turn it's
back on such an important and effective prostate
cancer treatment option. Roger Harris |
| Commenter: |
Jones, Fuller C.
|
| Title: |
Project Engineer (Retired) |
| Organization: |
NASA Shuttle Launch Operations |
| Date: |
9/2/2008 7:34:30 PM |
| Comment: |
I believe that Proton Therapy is a valid and useful treatment for prostate cancer. As a graduate mechanical engineer and retired NASA employee, I feel that my experience qualifies me to do the research necessary to sort out the true facts regarding proton therapy.
I have done so and it is apparent that those individuals who seem to be saying that proton therapy centers should not be built, and that Medicare should not reimburse a patient for the cost of proton therapy. are serving their own purpose and not that of the individual patient.
Proton therapy is uniquely applicable to treat many forms of cancer, including prostate cancer. When the cost of follow-on care is included for radical prostatectomy (surgery), the cost of proton therapy suddenly seems much more comparable.
It appears to me that there is an element of fear (loss of income) apparent in those who suddenly are speaking out against proton facilities. So long as Loma Linda University Medical Center was alone in providing the treatment, then after about ten years, Massacusetts General Hospital joined them, the threat was so small as to be ignored. There were no complaints and protests about the use of protons and the insurance coverage of same for over fifteen years.
Now, with the advent of more amd more proton centers, it suddenly has caused a great uproar!
I say foul! Those of you with a medical and/or scientific background should study the real issues here and when you do you will become proton advocates instead of enemies.
Fuller Jones |
| Commenter: |
Freedman, Barry
|
| Title: |
retired financial advisor |
| Date: |
9/2/2008 7:37:58 PM |
| Comment: |
How about listening to a patient who went through
Proton Beam therapy for Prostate Cancer instead
of just listening to Drs who have a vested
interest in their own treatment methods. [PHI Redacted]
oncologist recommended and was within days of
surgery. By accident [PHI Redacted] learned of proton beam
therapy. After much research [PHI Redacted] approached the
surgeon and asked him what he would, and he said
surgery is always on option later if the proton
bean doesn't work so go with the proton beam for
now. Not only was it successful, but PSA
levels have dropped from a high of about 5.0
to .1 - now after 5 years since treatment. No
Loss of function, no surgery, etc. How could you
not want to continue this coverage through
medicare? You should be encouraging more proton
beam centers not less. Yes, the building of a
cyolotron is expensive...but it beats the hell
out of the prospects of surgery or broad beam
radiation especially when caught early. Please be
sensible... |
| Commenter: |
Bunten, Ted
|
| Date: |
9/2/2008 7:54:59 PM |
| Comment: |
[PHI Redacted] prostate cancer survivor with
an undergraduate degree in engineering. [PHI Redacted]
choice of treatment was Proton Therapy at Loma
Linda University Medical Center.
More than eight years after treatment [PHI Redacted] cancer
free, [PHI Redacted] psa is below 0.10 and [PHI Redacted] do not have any
problems with side effects.
I can not speak with scientific authority since I
am neither a oncologist or physicist but based on
[PHI Redacted] experience, proton treatment for
prostate cancer was definately worth the cost. |
| Commenter: |
burnidge, william
|
| Date: |
9/2/2008 8:18:37 PM |
| Comment: |
|
[PHI has been redacted from this comment]
receive Proton Radition Therapy for a very aggressive type of Prostate Cancer in . Readings were over 5 for Psa and a Gleason count of over 9. This preculeded from having seeding done. Regular Radiation would have caused other problems because of the . Removal of the prostate was not a good solution as would have been intontinent . already had some urinary problems because of the previous surgery. Proton Radiation was only home. was accepted as a patient after Eurologist, Gastroentologist and Internist all recommended that have this treatment. They all contacted LLUMC on behalf. At this date a PSA of 0.02. treatment was in May, and June of . what received in treatment was not only only hope but probably saved from either being further disabled or havine cancer continue to take life. How can you say it is too expensive. Is it better to have people go through procedures that lessen their quality of life for a few dollars? Please reconsider this proposal!!!! |
| Commenter: |
Tipton, Howell
|
| Date: |
9/2/2008 8:51:27 PM |
| Comment: |
|
After a biopsy in 2006, [PHI Redacted] was told that [PHI Redacted] had
prostate cancer. [PHI Redacted] was shocked. Being an
engineer, [PHI Redacted] wanted more data. [PHI Redacted] first
recommendation was surgery. [PHI Redacted] researched the
complications and rejected this option. [PHI Redacted] then
had a consultation with an oncologist that
specialized in radioactive seeding. These
complications were not acceptable[PHI Redacted]. [PHI Redacted] then
consulted with a radiologists on the merits of
intensity modulated radiation. This seemed [PHI Redacted]
to be better than seeding or surgery, but had its
own complications. I heard from a friend about
his success with protron treatment and visited
the Loma Linda Cancer Center. I live near Loma
Linda in California so I was able to visit and to
learn more about proton treatment. As an
engineer, I understand the difference between
photon and proton radiation. That convinced [PHI Redacted] to
go with protron treatment. After treatment, [PHI Redacted] gone from a PSA of 6 to 0.45 and continuing
to drop. Just as important [PHI Redacted] not been
inflicted with any side effects of the kind that
worried [PHI Redacted] with the other treatments. Please
continue to let all prostate cancer patients to
make the choice that is right for them. Do not
eliminate the financial ability for those on
medicare to opt for the proton treatment. Thank
you. |
| Commenter: |
Arnold, Hubert
|
| Date: |
9/2/2008 8:57:12 PM |
| Comment: |
|
In [PHI Redacted] had a PSA of 25. After consulting with
a urologist [PHI Redacted] was informed that surgery was [PHI Redacted]
only viable option. After research [PHI Redacted] decided to
undergo proton therapy. Side effects were and
are minimal and [PHI Redacted] PSA for 2 years has been
between 0.00 and 0.04. |
| Commenter: |
Lester, Leonard
|
| Date: |
9/2/2008 8:59:21 PM |
| Comment: |
I understand that reimbursement for proton beam
therapy for prostate cancer is in danger of being
reduced or eliminated. I wish to voice my
concern that the most effective treatment out
there will be unavailable to the people who would
benefit the most. [PHI Redacted] The sad
stories of friends and loved one's who have had
on-going complications from other treatments and
the dearth of complaints from the dozens of
proton graduates I know have convinced me that
the research and antidotal evidence I have
discovered is accurate. Proton treatment is far
away the preferred treatment. |
| Commenter: |
Siano, Paul
|
| Date: |
9/2/2008 9:10:22 PM |
| Comment: |
[PHI Redacted] was diagnosed with prostate cancer.
[PHI Redacted] PSA was 6.1 and had a Gleason score of 9. (4+5)
[PHI Redacted] prostate was the size of a grapefruit. After
considering all available options, [PHI Redacted] chose proton
radiation at Loma Linda because the morbidity rate
was similar to other options but the risk of side
effects seemed to be reduced. After proton,
conventional radiation, and two years of hormone
ablation therapy, [PHI Redacted]
PSA is 0.45 with no side effects. [PHI Redacted] will
always be grateful to the wonderful people who
helped [PHI Redacted] through treatment and to those who
developed this technology so that [PHI Redacted]
enjoy the quality of life [PHI Redacted] after
treatment more than five years ago. The
increasing number of proton radiation centers is
clearly a good thing. As time goes on, as the
technology improves, and as knowledge expands,
this outstanding treatment will become available
to even more people who hear their Doctors say,
"The results of your biopsy were positive. You
have cancer." Proton therapy works. "Side
effects" are more than just words. |
| Commenter: |
Schwartz, Bruce
|
| Date: |
9/2/2008 9:50:59 PM |
| Comment: |
[PHI Redacted] diagnosed with prostate cancer but [PHI Redacted]
refuse to accept the barberic choices that are
offered as conventional protocol. [PHI Redacted] found out
about the proton beam therapy and [PHI Redacted] desire is to
have that option available to me. However, [PHI Redacted] a
member of Kaiser Permanente and they refuse to
cover the cost. The cost is far more that [PHI Redacted] can
affore to pay for [PHI Redacted]. Since Kaiser's policy
perpetuates this archaic and brutal protocol and
does not permit the less invasive and far
superior therapy of proton beam there is a chance
that [PHI Redacted] will succumb to the prostate cancer.
However, it is better to die that to undergo the
conventional choices of cut, burn or poison. [PHI Redacted]
plan is/was to change medical providers so that [PHI Redacted]
can use [PHI Redacted] Medicare to cover the cost of the
proton beam therapy. I hope that nothing happens
to prevent the Medicare coverage for proton beam
therapy and, possibly, resulting in [PHI Redacted] death. |
| Commenter: |
Healey, Robert
|
| Date: |
9/2/2008 10:09:21 PM |
| Comment: |
| [PHI has been redacted from this comment]
This comment is in support of Proton Beam Therapy
(PBT) for treatment of prostate cancer.
Early in was diagnosed with prostate cancer
and the local medical practitioners each
predictably recommended treatment using their area
of expertise; surgery, conformal beam xray
radiation, or seeds. When found out about PBT
looked for diverse sources of information and,
using background in engineering and physics,
concluded that PBT was the obvious treatment which
had the highest probability of success with the
least side effects. When announced decision
to use PBT, the local medical practitioners tried
to convince that the treatment was
"experimental, unproven, a thing of the past and
if it was any good why weren't there many more
centers delivering PBT."
As expected, health insurance Co. refused to
approve it, but, thankfully, was able to move to
Medicare and obtain the PBT.
It has been 7 years since treatment. There was
no discomfort, pain, or side effects during
treatment and none over the 7 years since. family doctor has reported continuing improvement
in prostate condition via blood test and
digital examination annually.
Now that the success of the PBT treatment has been
broadly recognized, there are many more centers
opening both in the U.S. and other countries.
Before a decision is made to deprive Medicare
patients of this excellent treatment, CMS should
at least undertake an unbiased evaluation of PBT
vs. other treatments which are supported by
practitioners who have a vested interest in
removing PBT from the choices available to
Medicare cancer patients.
While undertaking this evaluation, CMS might also
subsidize studies aimed at cost reduction of PBT,
since cost seems to be the only remaining argument
in use against PBT. Just as other arguments have
proven false, I wonder if this one will also prove
false when such things as re-treatment, etc. are
considered relative to the other treatments available.
Respectfully submitted,
Robert Healey |
| Commenter: |
hagen, Weldon J.
|
| Date: |
9/2/2008 10:12:45 PM |
| Comment: |
|
[PHI Redacted] had treatment 11 years ago with no side
effects.Many of the men that have other treatment
have adverse side effects that I would prefer not
to have. I feel that [PHI Redacted] received the best treatment
possible.[PHI Redacted] welcome the chance to share [PHI Redacted]
experience
with anyone considering prostate treatment. |
| Commenter: |
Drescher, Thomas
|
| Date: |
9/2/2008 10:35:59 PM |
| Comment: |
In [PHI Redacted] received proton
radiation for prostate cancer.[PHI Redacted] satisfied
with the results. [PHI Redacted] no major side effects. [PHI Redacted]
walk a couple miles most days with [PHI Redacted] walking
group at work. [PHI Redacted] also use weight resistance
training two to three times a week, and use [PHI Redacted]
Nordic Track ski-machine two to three times a
week.
Before the proton radiation treatment, [PHI Redacted] local
urologist had recommended [PHI Redacted] a second opinion;
radiation or proton radiation since [PHI Redacted]. [PHI Redacted] checked with a local Harvard and
University of Michigan trained MD, radiation
oncologist, who reviewed [PHI Redacted] lab information, but
[PHI Redacted] decided against Thera-Seeds. |
| Commenter: |
Virgil, Schulenberg
|
| Date: |
9/2/2008 10:43:11 PM |
| Comment: |
I just received an email that the CMS has made a
proposal to Medicare to discontinue reimbursement
for proton treatment of prostate cancer. [PHI Redacted]
living proof that this procedure is the BEST. [PHI Redacted]
had the procedure in [PHI Redacted]. While [PHI Redacted]
there, at least 1/3 of the 140 being treated
during that 2-mth period were there because they
had surgery and the cancer came back. Loma
Linda "cleaned" them up.
[PHI Redacted] had an HMO policy which initially said they
would cover [PHI Redacted] treatment as the secondary
insurance but once got to Loma Linda, they
decided not to. To make a long story short, the
Federal Judge decided in [PHI Redacted] favor (after several
contested letters by [PHI Redacted] to their staff
physician who initially said the procedure was
experimental but later rescinded that statement).
Medicare paid 80% and [PHI Redacted] insurance paid $5000.
Had it not been for Medicare, [PHI Redacted] would not have
been able to receive the proton radiation beam
treatment.
Not only do they have a 95% cure rate, the
treatments are painless (lasting 1 min and 45
seconds 5 times a week)and you are not
incontinent, impotent nor radioactive. [PHI Redacted] carried on normal life during the
40 treatments. It''s nearly 7 years now and [PHI Redacted]
PSA is 0.11.
I''ve had several friends who opted for surgery
and yes, the cancer came back.
We''ve had some local doctors open a clinic
specifically for prostate cancer treatment.
Their quote in the local newspaper was "Medicare
covers this treatment better than insurance
companies and we wanted to make sure the $$$$$
came to us".
To date they have built a facility in TX, FL,
Boston, Indiana and Seattle, WA is going to build
one. The medical profession is going to have to
accept the fact that this is a proven treatment
and surgery, chemo, photon radiation or seeds are
not the answer - plus the fact that there is no
guarantee that one is cured after you have
endured such radical treatment.
[PHI Redacted] was diagnosed shortly after [PHI Redacted]
arrived home from Loma Linda and after going to 3
urologists, he asked the third one why they
weren''t telling men about the proton radiation
beam procedure. The Dr.''s comment was "What
would happen to my practice if I sent my patients
1000 miles away?"
Tell me what is more important to the doctors in
the USA?
Please DO NOT take away Medicare''s help to so
many men who are being diagnosed with prostate
cancer.
Virgil D. Schulenberg |
| Commenter: |
Robinson, William
|
| Date: |
9/2/2008 10:55:38 PM |
| Comment: |
I would like to address the issue of discontinued
coverage for Proton Beam Therapy for Prostate
Cancer. I believe it would be a disservice to men
diagnosed with Prostate Cancer. [PHI Redacted] was diagnosed
with Prostate Cancer in [PHI Redacted]. After extensive
research on the available treatments [PHI Redacted] chose
Proton Beam Therapy. There have been studies
showing the effectiveness of the treatment and the
quality of life post treatment.
In [PHI Redacted] case quality of life was very important.
Since receiving the treatments [PHI Redacted] cancer seems to
be gone. [PHI Redacted] experienced NO side effects. There
was no pain, no incontinence, no bladder or rectal
bleeding, no impotence.
The only evidence that points to [PHI Redacted] receiving
Proton Beam Therapy is [PHI Redacted] PSA test results and [PHI Redacted]
personal Physicians reports which show the cancer
is gone.
|
| Commenter: |
Horner, Gene
|
| Organization: |
Los Angeles County Fire Dept. Retired |
| Date: |
9/2/2008 11:08:09 PM |
| Comment: |
I understand that CMS has made a proposal to stop Medicare reimbursement for Proton therapy for Prostate cancer treatments. Why?
Don't prostate cancer patients deserve a chance to receive the best available treatment? Are you looking to cut costs by condemning men to inferior treatments with More severe side effects? If so, you will incur additional Medicare expenditures to treat those severe problems (I know four men who have had surgery and all need ongoing treatments to deal with their incontinence.... two of them have had the cancer recur).Is it your plan to condemn prostate cancer patients to problems for the rest of their lives? Proton therapy is the new "gold standard" in regards to treating this type of cancer.
I am writing my senators and representative in regards to your plan.
Gene Horner ghornerhb@mac.com |
| Commenter: |
smulders, louis
|
| Title: |
EVP |
| Organization: |
Mairita L.P. |
| Date: |
9/2/2008 11:08:55 PM |
| Comment: |
[PHI Redacted] had Proton Beam Treatment for prostate cancer
from [PHI Redacted].[PHI Redacted] was 63
at the time. Treatment was given at the center at
Loma Linda, California. [PHI Redacted] PSA has been below .5
since [PHI Redacted]. There have been no side effects. No
moneys have been spent since treatment was
concluded, other than semi-annual check-ups at
small costs. [PHI Redacted]
[PHI Redacted] also retained excellent bladder control.
The treatment was painless. When adding to the
cost of other prostate cancer treatments, the
cost of follow up care, plus a monetary value for
the pain and the loss of potency and continence,
the beam treatment is probably not all that much
more expensive anymore. |
| Commenter: |
Dudley, Jack
|
| Date: |
9/3/2008 12:05:46 AM |
| Comment: |
|
Dear Sirs:
I am quite perplexed that some wish to stop
Medicare coverage of proton beam theoropy for the
treatment of prostrate cancer. [PHI Redacted] recieved proton
theropy a year ago. [PHI Redacted] PSA was 5.4. The
treatment [PHI Redacted] recieved was in no way a drudgery.
45 treatments were administered over nine weeks.
The beauty of and advantage of proton beam
theropy over all the other options is that NO ill
side efects were encountered during or after the
treatment. The quality of [PHI Redacted] life if anything
was enhanced during the treatment. Since the
treatment [PHI Redacted] PSA has dropped to 2.6 at four
months, and is now at 1.5 after ten months.
[PHI Redacted] kept in contact with many of the 150
patients who were undergoing treatment at the
same time[PHI Redacted]. ALL have reported similar drops
in their PSA, and NONE have reported ANY side
effects from the treatment.
I would urge you that quality of life during
and after prostrate cancer treatment must be a
high consideration when determining whether or
not to fund the treatment. To my knowledge, no
other form of treatment yeilds such a high
percentage of positive results nor such a low
rate of side effects which impair quality of
life.
Please continue the Medicare coverage of
Proton Beam Theropy for prostrate cancer
treatment. It was truly a Godsend [PHI Redacted], and I
would be greatly saddened if men who follow [PHI Redacted]
were to be denied the quality of life [PHI Redacted] enjoy by
having Medicare coverage of this wonderful
treatment stopped.
JCD
|
| Commenter: |
Nygard, Kenneth
|
| Date: |
9/3/2008 12:12:29 AM |
| Comment: |
Re: Proton therapy for prostate cancer.
I am concerned about the campaign to eliminate
Medicare coverage for the treatment of prostate
cancer by proton radiation.
[PHI Redacted] was diagnosed in 2002 with prostate cancer and
obviously was concerned that treatment would be
effective and also allow a normal life after
treatment. [PHI Redacted] read several books, spoke with
people who had various treatments, sought counsel
from various physicians and came to the
conclusion that there were several treatments
that would probably rid [PHI Redacted] the cancer -
none that were 100%. Every treatment had some
side effects but proton therapy is very effective
and allows the quality of life to continue almost
the same as before treatment. What do I mean
when I write "quality of life"? This means [PHI Redacted] did
not fear rectal burning or tissue injury,
incontinence for an extended period, impotence
for the rest of [PHI Redacted] life or other everyday
problems. [PHI Redacted] spoke with others who had various
treatments. Everyone who had surgery suffered
from impotence, all but one had extended
incontinence and recovery from surgery required a
great deal of time. Those who had conventional
radiation suffered from impotence or partial
impotence, some had intestinal bleeding or real
problems with diarrhea, some had incontinence of
varying degress. Seed implants were also troubled
with various side effects.
One of the physicians [PHI Redacted] consulted explained [PHI Redacted]
the 'medical philosophy of doctors'. He stated
that the medical profession is dedicated to
patient survival and in the case of cancer, to
rid the body of the cancer. He indicated
that 'quality of life' after treatment is not a
priority.
[PHI Redacted]
Starting in [PHI Redacted], [PHI Redacted] began proton therapy at
Loma Linda Mediacal University, finishing [PHI Redacted] There have been no symptoms of cancer in
six years and there were/are no side effects -
none! [PHI Redacted]
because Medicare and [PHI Redacted] supplemental insurance
paid for the treatment, the "quality of life"
continues.
[PHI Redacted]the treatment did not cost a lot
more than surgery and certainly was much less
stressful!
As a final comment, [PHI Redacted] asked one of the urologists
why he had not suggested proton therapy as one of
the alternatives available. The answer was, "if
we sent our patients out of state, we would all
probably go broke"!
I wonder if the campaign by physicians to remove
proton therapy from Medicare covered procedures
is motivated more by financial concerns than by
empathy for patients suffering from a potentially
fatal disease.
I hope that "quality of life" will become part of
the criteria when ascertaining what medical
procedures should or should not be covered. |
| Commenter: |
Montgomery, Ron
|
| Title: |
Chemical and Petroleum World Wide Consultant |
| Organization: |
IBM |
| Date: |
9/3/2008 12:32:26 AM |
| Comment: |
I understand that Proton Beam Therapy is being
reviewed by the Governing Medicare Policy board
for elimination of coverage due to spurious
reasons of not being significantly better than
the typical treatment (i.e. Prostate Removal). [PHI Redacted] a recipient of Proton Beam therapy. [PHI Redacted]
treatement occured at the age of [PHI Redacted]. Although [PHI Redacted] had private
insurance, [PHI Redacted] had to struggle to get [PHI Redacted] treatment
covered. [PHI Redacted] able to jsutify this to [PHI Redacted]
private Carrier Blue Cross Blue Shield at the
time in large part due to the fact that Medicare
was covering this treatment. Had this no been
the case [PHI Redacted] would have had to pay out of [PHI Redacted]
pocket fo what is clearly a superior treatment
over surgery. After much study it was clear
[PHI Redacted] that [PHI Redacted] urologists did not give a damn about
surgical side effects like incontenance or
sexual function loss and worse that he was not
up to speed on advanced non invasive treatments.
Also it was clear that Porton Beam therapy had
significantly less treatment side effects and
was able to achieve equal if not superior
efficacy compared to surgery. [PHI Redacted]6 full years past [PHI Redacted] treatment and maintain
a PSA below 1.0 usually .7 to .9. Also, [PHI Redacted]
still able to have adequate sexual function and
have zero side effects with urination etc.
[PHI Redacted]
I am strongly opposed to elimination for
medicare coverage for Proton eam therapy and
strongly feel that this movement to eliminate
Medicare benefits is a marked conspriracy of the
Urologists who rail against this program due to
loss of income an worse sheer hubris and the
well known medical conditioned called "Not
Invented Here". [PHI Redacted] spoken to several
Urologist since [PHI Redacted] treatment and despite y
[PHI Redacted] success tey consisitently stick to
their one and only position of cut cut cut and
lets schedule it tomorrow before the patient
discovers there are options. Losing Medicare
Funding for Proton Beam therapy sentences
thousands of men to serious side effects and
significant loss of "Quality of Life".
Please here my comment and continue to fund
Proton Beam Therapy. |
| Commenter: |
Pacetti, Greg
|
| Title: |
Self Employed builder |
| Date: |
9/3/2008 12:40:00 AM |
| Comment: |
Well this has been a very interesting read.
[PHI Redacted]
[PHI Redacted] Urologist was a surgeon and of course he wanted [PHI Redacted] to get
a Radical here locally with in the next three months. So, much
research was taken on [PHI Redacted]. Prostate cancer seems to be a
very different beast than most other cancers. What [PHI Redacted] learned was
a Urology Surgeon wants surgery and a radiologist wants you to
have Radiation. It seems everyone wants to have good mortality
stats for they''re portfolio and the hell with the quality of life
issues. [PHI Redacted] decision to have proton therapy was based on getting
information from post treatment patients of many different
therapies including Proton Therapy and also there is a good
chance that no treatment is appropriate.
When [PHI Redacted] Dentist spoke [PHI Redacted] about Proton Therapy
it was all over. [PHI Redacted]PSA was well below one and
on a down hill trajectory the last [PHI Redacted] checked and of course with
very minor side-affects. The plumbing still works. [PHI Redacted] still feel for
[PHI Redacted] it was an appropriate treatment decision. One should
interview any medical personnel that have had this treatment.
[PHI Redacted] And there''s plenty data on potential side-
affects from other therapies.
Life is still a gamble nothing is for certain. |
| Commenter: |
wetzel, joe
|
| Date: |
9/3/2008 5:01:48 AM |
| Comment: |
Please continue paying for proton therapy. It is the most logical treatment for many kinds of cancer. |
| Commenter: |
Garrott, Fred
|
| Date: |
9/3/2008 8:06:06 AM |
| Comment: |
I believe Medicare Coverage should continue to
cover Proton Therapy Radiation for prostate
cancer and a variety of other diseases. The
alternative radiation therapys may be acceptable
for physicians and patients who do not have
access to proton therapy. [PHI Redacted] 5th year
since diagnosis and treatment of prostate cancer
with proton therapy. The advantage of proton
therapy and surgery is in the cure plus the
elimination of significant negative after effects.
Also, to my knowledge no one has ever died from
proton treatment. However, a significant number
die from surgury. I know a man in his mid-
fifties who recently had prostate cancer surgery
who had a stroke on the operating table and now
is disabled for life. We often say if it will
save one life it will be worth it. |
| Commenter: |
Lipscomb, Earle
|
| Date: |
9/3/2008 9:25:12 AM |
| Comment: |
Recognizing the conflicting interests of
contributors to this discussion, I comment only as
[PHI Redacted] who did [PHI Redacted] homework
prior to treatment for prostate cancer. I am
convinced of the superior three dimensional
targeting with protons based on physics, and the
resultant lack of collateral damage as evidenced
by [PHI Redacted] absence of ANY symptoms or side effects
during treatment and persisting at 18 months
post-treatment, with all signs pointing to
success. If I can get the same or better cure
rate, and better quality of life, what's not to
like about protons? I only hope that conclusive
comparative studies will soon be completed to
confirm my belief in proton treatment. |
| Commenter: |
Englert, Bernard A
|
| Date: |
9/3/2008 9:32:40 AM |
| Comment: |
[PHI Redacted] 82 year old man in Louisville ,Ky who had
41 Proton Beam treatments in Jacksonville ,Fl. in
[PHI Redacted] and now a PSA reading
of .23 and a lot better quality of life
since [PHI Redacted] prostate cancer is gone. [PHI Redacted] not
have afforded the cost of the treatments without
Medicare coverage as [PHI Redacted] secondary insurance would
not have paid unless Medicare paid first so I
strongly recommend that you re-consider and
continue to allow payment for Proton Beam
patients! Thank You |
| Commenter: |
Pezick, George
|
| Title: |
Mr. |
| Organization: |
none |
| Date: |
9/3/2008 9:39:45 AM |
| Comment: |
Proton Therapy:
[PHI Redacted] had Proton Therapy in the summer of [PHI Redacted] at
Loma Linda, at age 68, with a PSA of 8.4. [PHI Redacted]
thoroughly researched all [PHI Redacted] options at that
time. [PHI Redacted]had no side effects and in good
health seven years later with a PSA of 0.06. I
would recommend this Proton treatment to everyone!
- George
|
| Commenter: |
Kalin, Ken
|
| Date: |
9/3/2008 9:43:34 AM |
| Comment: |
[PHI Redacted] treated in 2oo6 For Prostat cancer at Loma
Linda Hospital in Calif. It was the best
treatment with no down side. It wold be a mistake
to not allow this great treatment for medicare
patients.
Ken Kalin |
| Commenter: |
brown, Dave
|
| Date: |
9/3/2008 9:51:42 AM |
| Comment: |
In 5 months, [PHI Redacted] PSA went from 5.9 to 1.27 as a
result of Proton Therapy. The main advantage of
this treatment is the fact that [PHI Redacted] experienced no
side affects. As we look to the future, less
invasive treatments should be investigated.[PHI Redacted] was
covered by [PHI Redacted] employer's health insurance;
however at [PHI Redacted] current age [PHI Redacted]; it culd have
been a Medicare situation if [PHI Redacted] retired.
Protn Therapy should not be eliminated from
Medicare coverage.
Dave Brown
Vice-Chairman
EWI Worldwide |
| Commenter: |
Christopher, M.D., Robert P.
|
| Title: |
Professor of Medicine (Retired) |
| Organization: |
University of Tennessee College of Medicine-Memphis |
| Date: |
9/3/2008 10:01:38 AM |
| Comment: |
I strongly oppose the elimination of funding for
proton therapy by Medicare. For thirty-three
years, I served as Associate Professor then
Professor of Medicine at the University of
Tennesee College of Medicine. [PHI Redacted] diagnosed
with prostate cancer in [PHI Redacted] and had proton
treatment in 1996. In the nearly 12 years since
that treatment, [PHI Redacted] PSA has remained in the range
of 0.3-0.4. It was 11.6 prior to treatment.
During that 12 year perion, [PHI Redacted] able to
maintain a fully functional lifestyle with no
side effects from the treament. I realize that
[PHI Redacted] experience is anecdotal but through the
newsletter of the proton therapy alumni group, I
have been able review hundreds of similar cases.
It is obvious that those espousing conventional
radiation therapy are beginning to feel the
competition and wish to destroy this treatment
modality for economic reasons regardless of the
obvious benefit to society. The minimal
morbidity and the positive effects on lifestyle
must be considered along with the obvious
effectiveness of proton therapy in making any
decision about future funding. I have reviewed
numerous papers on the topic and the statement
that there are no comparitive studies with older
forms of treatment are not true. While the
effectiveness of proton therapy may be no better
or worse than other forms of treatment, the
difference in lack of morbidity and maintenance
of lifestyle are striking with proton therapy far
superior.
I strongly urge that the CMS take these factors
into consideration and continue to fund proton
therapy. |
| Commenter: |
Goodnight, Michael
|
| Title: |
Engineer / Training Consultant |
| Date: |
9/3/2008 10:05:29 AM |
| Comment: |
re: Proton beam therapy for prostate cancer
As one who has been researching Proton Beam
Therapy, specifically existing facilities, I am
dismayed at the prospect of coverage no longer
being extended to this treatment option for
prostate cancer patients.
As one who has taught a rationale Problem
Solving and Decision Making course for the past
15 years, I used those same methods in looking
at [PHI Redacted] a course of treatment for early
stage prostate cancer. With the evidence of
little to no urinary incontinence (a major
concern among patients) and statistical cure
rates (cNED and bNED) at least as good as
radical prostatectomy, the choice is clear.
This falls into the category of equal benefit
but less side effects and risk, or "duh!, choose
it!"
It also appears to me that those entering early
comments against this treatment have a vested
interest in competing treatment options. But
look at the more recent comments from those with
patient-side experience. If you're researching
an automobile to purchase, who do you believe
more; the manufacturer, the competing
manufacturer, or those who have bought into the
product?
I urge you to continue coverage for this
treatment option for prostate cancer. |
| Commenter: |
Tuggey, Howard
|
| Title: |
Colonel USA Retired |
| Organization: |
None |
| Date: |
9/3/2008 10:08:24 AM |
| Comment: |
Regarding Medicare Payment for Protons
[PHI Redacted]
Nine years ago, [PHI Redacted] was treated for Prostate Cancer
at Loma Linda University's Proton Treatment
Center, in California, started on [PHI Redacted]
and finished on [PHI Redacted]. Each day, the
actual Proton treatment was less than 5 minutes.
Traditional radiation treatments use X-Rays up to
and including “Cyberknife” while protons are NOT
X-Rays, and have the unique capability of being
more precisely controlled for application to the
cancer or benign tumor.
I believe that a decision must be made to allow
and even expand financial support of proton
Therapy by Medicare. [PHI Redacted]
“Market Forces” will come into play as more
Proton Centers are added to the medical community
and cost reductions based increased availability
and changes in the customer base. Protons are the
rapidly growing approach to treat Prostate Cancer
and many other diseases with Protons as below and
should not be denied to anyone.
Protons are the real deal and treats Choroidal
Melanoma, Pituitary, Acoustic Neuroma,
Meningioma, Astrocytoma,Other Brain, Head and
Neck, Prostate, Other Pelvis,
Craniopharyngioma,Orbital, Paraspinal Tumors,
Chordoma/Chondrosacoma, Sarcoma, Other chest,AVM,
Other Abdominal, SNVM, Breast, Lung, & Liver.
Sincerely yours,
Howard J. “Jim” Tuggey
Colonel, DMOR Retired, U.S. Army |
| Commenter: |
rickard, marvin
|
| Title: |
Pastor Bth, Bsl, DD |
| Organization: |
Christian Church |
| Date: |
9/3/2008 10:17:16 AM |
| Comment: |
Alomost 9 years ago [PHI Redacted] had proton radiation
therapy for prostate cancer. [PHI Redacted] free from
cancer today and have continued in [PHI Redacted] profession
during these nine years. Side effects were
minimal and the results phenomenal.
At the time [PHI Redacted] was diagnosed with cancer a good
friend and [PHI Redacted] were similarly
diagnosed. Each of them opted for other forms of
treatment. Each of them has experienced a
return of their cancers. One is holding it at
bay through hormones, complete with hot flashes
and other side effects. The other will
apparently wait it out and let the disease take
its toll. According to my own research, no
treatment for prostate cancer has the long-term
success rate of proton particle radiation |
| Commenter: |
Manning, Richard
|
| Title: |
Ph.D |
| Date: |
9/3/2008 10:20:01 AM |
| Comment: |
[PHI Redacted] was devastated by a diagnosis of prostate
cancer. Initial research revealed a range of
treatments with relatively similar cure potential.
In my detailed research, I read several books,
talked to dozens of prostate cancer survivors and
read several hundred first person accounts of
treatment. My conclusion was that proton beam
therapy was as effective as any other treatment
but with significantly fewer side effects. Two
other observations:
1. The best treatment for you is the one you
choose after doing appropriate research.
2. Everyone you talk to is biased- doctors based
on what they do and patients even more so on what
they did.
Please do not take the proton option away from
future Medicare recipients who are diagnosed with
prostate cancer.
|
| Commenter: |
Neubauer, Donald
|
| Title: |
Retired Elevator Installer |
| Organization: |
none |
| Date: |
9/3/2008 10:29:45 AM |
| Comment: |
[PHI Redacted] was treated for prostate cancer in [PHI Redacted] with Protons and Photons. [PHI Redacted] PSA at treatment
time was 32. [PHI Redacted] 5 years out from treatment,PSA
undectable. Since the time of [PHI Redacted] treatment [PHI Redacted]
had NO side effects. This continues to this day.
I am aware that there are meany treatments
available for PC. I am also aware that most if
not all may have very negative side effects. None
of the men recieveing treatment at the time [PHI Redacted]
treated (about 150)reported any severe side
effects.
I am a 75 year old who promotes Proron treatment
at every opportunity. I will be very upet if it
is made less available. |
| Commenter: |
Greany, Patrick
|
| Organization: |
PDG Consulting |
| Date: |
9/3/2008 10:36:18 AM |
| Comment: |
Two issues have been brought up by others in this commentary that should be addressed:
1) Regarding the concern that proton therapy for prostate cancer has no additional benefit above and beyond conventional IMRT photon treatments, please take into account the recent report from the Harvard Dept. of Radiation Oncology which shows a 50% reduction in secondary malignancies associated with proton treatments as compared with photon treatments. This report follows: _________________________________________________ ____________________ C.S. Chung, N. Keating, T. Yock, N. Tarbell, Comparative Analysis of Second Malignancy Risk in Patients Treated with Proton Therapy versus Conventional Photon Therapy, International Journal of Radiation Oncology*Biology*Physics Volume 72, Issue 1, Supplement 1, Proceedings of the American Society for Therapeutic Radiology and Oncology 50th Annual Meeting, American Society for Therapeutic Radiology and Oncology 50th Annual Meeting, 1 September 2008, Page S8. www.sciencedirect.com/science/article/B6T7X- 4T85W5M-10/2/096f1b7ef9fa2085f4daa917e93c7361) ¡°Background: Compared to photon radiation, proton radiation improves dose distribution to the target and decreases dose to adjacent normal tissues. The most common method of delivering proton radiation involves passive scattering. However, passive scattering produces secondary low-dose neutrons, which may induce late radiation-induced malignancies. The magnitude of second cancer risk in patients treated with proton radiation compared to photon radiation therapy has not been reported to date. Purpose/Objective(s): To quantify the risk of a second malignancy associated with the use of proton radiation therapy compared to photon radiation therapy. Materials/Methods: Matched retrospective cohort study of 1,450 patients treated with proton radiation therapy from 1974-2001 at the Harvard Cyclotron in Cambridge, MA, and patients treated with photon therapy in the Surveillance, Epidemiology, and End Results (SEER) cancer registry. We matched patients by age at radiation treatment, year of treatment, cancer histology, and site of treatment. We restricted the study to patients with ¡Ý1 year of follow-up. The primary endpoint was the risk of a second malignancy in any site after radiation therapy. Results: We matched 503 Harvard Cyclotron proton patients with 1591 photon patients from the SEER registry. 6.4% of proton patients (32 patients) developed a second malignancy, while 12.8% of photon patients (203 patients) developed a second malignancy. The median duration of follow-up was 7.7 years in the proton cohort and 6.1 years in the photon cohort. The median age at treatment was 56 years in the proton cohort and 59 years in the photon cohort. After adjusting for gender and the age at treatment, treatment with photon therapy was significantly associated with an increased risk of a second malignancy (Adjusted Hazard Ratio 2.73, 95% CI 1.87 to 3.98, p < 0.0001). Conclusion: The results of our preliminary analysis indicate that the use of proton radiation therapy is associated with a significantly lower risk of a second malignancy compared to photon radiation therapy. Additional analyses are required, and ongoing close surveillance of these patients is necessary, given the prolonged latency period for the development of second cancers.¡± _________________________________________________ __________________________
2) The other issue being discussed is the issue of neutron production and whether proton treatments at therapeutic doses cause greater neutron production than photon (X-ray) treatments. This notion was dispelled recently by Dr. Harald Paganetti of Harvard University (Mass General Hospital). As clearly indicated in the video at http://www.oncolink.org/tv/astrola/astroplayer.ht ml, Dr. Paganetti shows that IMRT photon treatments actually yield a higher, rather than lower, rate of neutron production than proton treatments under normal conditions.
Intellectual honesty compels everyone concerned to take these reports into account in evaluating the relative virtues of proton treatments vs. photon treatments. As far as costs are concerned, economic cost-benefit analyses should be performed to evaluate long-term costs as it may be shown that proton treatments actually result in lower cost to insurers, including Medicare and Medicaid, than other forms of treatment because of the increased ability to avoid damage to non-target tissues.
Patrick D. Greany, Ph.D. pgreany@ufl.edu
|
| Commenter: |
Otey, Rick
|
| Title: |
Steering Committee Member |
| Organization: |
Us TOO PEORIA |
| Date: |
9/3/2008 10:40:56 AM |
| Comment: |
|
[PHI Redacted] a three year prostate cancer survivor who
received Proton Beam Therapy at Midwest Proton
Radiotherapy Institute in Bloomington, Indiana.
[PHI Redacted] found Proton Beam Therapy to be a God send as
far as cure rate as well as NO SIDE EFFECTS.
Medicare and Medicaid should continue to provide
this treratment option to men with prostate
cancer.
I beleive that if more centers were built that
people would be served as well as with
competition, the cost would decrease.
Thank you,
Rick Otey
|
| Commenter: |
archer, john
|
| Title: |
Vice President[retired] |
| Organization: |
Ashland inc. |
| Date: |
9/3/2008 10:50:22 AM |
| Comment: |
|
[PHI Redacted] completed proton radiaton at Loma Linda
Hospital in California August [PHI Redacted].[PHI Redacted] last follow
up PSA last year was still undetectible.Several
of my friends locally used radiation offered by
the local hospital.One is dead today and I know
he did not feel well in his final months.I also
recommend Loma Linda Hospital because of the care
and attitude of the staff at all levels.Loma
Linda has collected data from [PHI Redacted] on [PHI Redacted] Psa
tests,why don't you ask them for their 10-15 year
data bank.John Archer |
| Commenter: |
Melendez, Eliezer
|
| Title: |
Minister |
| Organization: |
Retired |
| Date: |
9/3/2008 10:50:22 AM |
| Comment: |
[PHI Redacted] was treated with proton beam radiation theraphy
for prostate cancer at the end of [PHI Redacted]
through the month of [PHI Redacted] up to the 15th,
2008,45 treatments in total. [PHI Redacted] follow up
after 4 months of therapy and [PHI Redacted] PSA was 0.054.
No side effects up to now. [PHI Redacted] suffer from
other diseases, no prescribed medications after
treatment, being a 77 year old man. Isn't this a
blessing!
[PHI Redacted] so greatful to received the treatment of [PHI Redacted]
choice with no side effects at all. [PHI Redacted]
Continue with [PHI Redacted] passion of working with children
and youth and [PHI Redacted] spiritual life is connected with
God.
I am in favor of the expansion of the treatments
centers utilizing this technology, and Medicare
coverage. |
| Commenter: |
Hodgdon, Steven
|
| Organization: |
Individual |
| Date: |
9/3/2008 10:51:26 AM |
| Comment: |
RE the proton radiation treatment for prostate
cancer. [PHI Redacted] had the "traditional" treatment of
prostate cancer which was surgical removal of
the prostate along with seminal vesicles and
lymph nodes, and four years after the surgery
the prostate cancer teturned. [PHI Redacted] was all set to
get "conventional" radiation treatments for the
returned cancer and [PHI Redacted] found out about the
possible side affects from this (incontinence
and impotentcy) [PHI Redacted] asked radiologist if there
wasn't a better way to do this. He replied "If
I were you, I would consider proton radiation
therapyit has virtually no side affects". [PHI Redacted]
then researched the facilities that offered
proton treatments, read more about the process
and decided to have the proton radiation
treatments done. I am happy to say that after
two years of having the proton radiation
treatments the prostate cancer is gone (PSA
count is ZERO)and [PHI Redacted] NO side affects.
Furthermore, if [PHI Redacted] urologist had suggested
proton radiation treatments initially instead of
surgery, [PHI Redacted] would have had it done then and
avoided the EXTRA COST of having to go through
the proton radiation when the cancer returned.
There are many [PHI Redacted] who have had the cancer
returned that could have been prevented if
proton radiation treatments had been done
instead of surgery or other methods. Considering
this, the cost of post surgery radiation
treatments multiplied by thousands of cases
makes proton radiation treatments a feasible way
to go. I highly recommend that you retain the
current poicy of having this type of treatment
covered by your program. Thank you for your
consideration and allowing my comments. Steven
D. Hodgdon |
| Commenter: |
Osbourn, Kenneth
|
| Date: |
9/3/2008 11:18:32 AM |
| Comment: |
re: Proton Therapy
[PHI Redacted] a previous proton therapy patient treated for
prostate cancer over five years ago and suffering
no side effects, [PHI Redacted] this this treatment
offers better post-treatment quality of life than
competing therapies. I have several friends who
have been treated with the "gold standard" of
radical prostectomy and every single one of them
has had problems with either incontinence,
impotence and/or severe infections. They find it
hard to believe [PHI Redacted] received [PHI Redacted] therapy and never
missed a single day of exercise or normal daily
activities.
It's interesting that so many negative comments on
this subject are from doctors invested in the
competitive technologies. The success of proton
treatment is evidenced by the rapidly expanding
number of proton centers being constructed.
"Build a better cancer treatment and they will come!" |
| Commenter: |
Carter, Ian
|
| Title: |
Former Chairman & CEO of publicly traded company |
| Date: |
9/3/2008 11:49:11 AM |
| Comment: |
[PHI Redacted] there is no
question in my mind that Proton Radiation Therapy
is far superior to any other form of prostate
cancer treatment. When [PHI Redacted] first learned that [PHI Redacted]
had prostate cancer [PHI Redacted] began research to determine what treatment would be the
most beneficial to in the short term and the
long term. [PHI Redacted] spent hundreds of hours
researching and through all of this research found a bias and lack of information forthcoming
from the medical profession regarding Proton
Radiation. I almost missed finding out about
this treatment until a friend told me about their
experience and their results with Proton
Radiation. [PHI Redacted] was ready to have surgery with a
prominent West Coast surgeon who never mentioned
the alternative of Proton Radiation, although he
advised [PHI Redacted] of every other alterntative to
surgery. The MD's and medical college professors
intentionally ignore Proton Radiation and based
on [PHI Redacted] personal experience it is difficult to
understand why.
The treatment has been around long enough to
prove that statistically it is better than every
other form of prostate cancer treatment with less
chance of long term disabilities such as
incontinence and impotence. At a time in our
lives when the quality of life becomes important
it is incredible that CMS is considering not
paying for Proton Radiation Treatment for
Medicare patients. Men who need this treatment
have paid years of payments toward Medicare and
they deserve to have Medicare pay for a treatment
that is proven to eliminate prostate cancer and
is far superior to any other treatment available
today.
I had one friend who had surgery and he learned
several years later that the cancer was outside
of the prostate and he had to go through severe
chemotherapy and radiation treatment. Had he had
Proton Radiation Treatment there is a high
probability that the ongoing treatment and the
cost of that treatment would have been avoided.
I had another friend who was advised by an MD
that his recommended treatment was to "wait and
see". While he was "waiting and seeing" he died.
Had he had the Proton Radiation Treatment that
could have been avoided. Another friend was
convinced by his surgeon to have surgery over
Proton Radiation. Now he wears a diaper and will
for the rest of his life. His quality of life is
so dismal that in hindsight he wished that
someone in the medical profession had advised him
about Proton Radiation Therapy. There are
thousands of men just like these who were sold by
their MD's on a mediocre treatment for Prostate
Cancer and now their quality of life is
diminished by long term diabilities that could
have been avoided had the medical profession
advised them of the benefits of Proton Radiation
Therapy. In talking to all three of these
friends of mine none of them was ever advised of
the benfits of Proton Radiation by anyone in the
medical profession.
[PHI Redacted]a cancer survivor who knew that there was a
high probability that [PHI Redacted] cancer had gone outside
of the prostate survived because of Proton
Radiation Treatment I can say without reservation
that this treatment allowed [PHI Redacted] to continue [PHI Redacted]
quality of life. After [PHI Redacted] learned what [PHI Redacted] Gleason
reading represented that there was a probablility
that [PHI Redacted] cancer may be outside of prostate
asked surgeon if he could guarantee he would
be able to cut out all off the cancer that was
potentially in and outside of prostate. His
answer was that he could not. Since Proton
Radiation kills the cancer cells not only within
the prostate but also for a large area outside of
the prostate that was enough evidence to
convince that Proton Radiation was far
superior to surgery or any other form of
treatment. had to determine this fact for
it was never brought to may attention by
any medical professional outside of the Proton
community.
While [PHI Redacted] was going through this treatment [PHI Redacted] was
the Chairman and CEO of a public company that
required services. [PHI Redacted] was able to go through
treatment and to continue working without any
break in schedule. It was hard [PHI Redacted] but it
was possible. Surgery could have afforded
this benefit.
The Proton Radiation treatment centers around the
world are maxed out and even if Medicare decides
not to pay for this treatment these centers will
continue to increase in numbers and will continue
to serve men like [PHI Redacted]. The reason being is
that Proton Radiation Treatment is without
question the best form of treatment for Prostate
Cancer and for many other forms of cancer. The
simple fact is that it works. To take the
availability of Proton Radiation Therapy away
from Medicare patients is wrong. Prostate Cancer
patients have paid money for years to qualify for
Medicare and Medicare needs to be their for them
with a treatment for Prostate Cancer that they
know works. Proton Radiation Therapy should be
available to all men not just the ones who can
afford it without Medicare. |
| Commenter: |
Severe, Errol
|
| Title: |
President |
| Organization: |
Aviation Cadet Museum, Inc. |
| Date: |
9/3/2008 12:10:09 PM |
| Comment: |
Proton Therapy: [PHI Redacted] underwent this procedure just
over a year ago. [PHI Redacted] PSA was 17.2 before beginning
treatment,since then it has been checked at 6
month intervals and has been 0.3 both times.
There are no lasting side effects. Everything
works normally, which cannot be said for my
friends who underwent any other form of prostate
cancer therapy.
As far as [PHI Redacted], and any other prostate cancer patient
that underwent this therapy that I have
communicated with, there is no other treatment
nearly as good!
Captain, Delta Airlines (Ret.) |
| Commenter: |
Kohlin, Ronald
|
| Title: |
(Retired) |
| Date: |
9/3/2008 12:18:31 PM |
| Comment: |
PROTON THERAPY for PROSTATE CANCER: [PHI Redacted] was treated
with Proton Therapy in [PHI Redacted]. [PHI Redacted] suffered no significant side effects during
or after treatment, which is more than I can say
many who have chosen other treatment modalities.
Since being diagnosed and treated, [PHI Redacted] spoken
with others who chose IMRT, Brachy therapy, or
surgery, and have found that not only were those
courses of treatment more difficult, but in some
cases recovery was long, painful, and extended.
Issues of incontinence and impotence were also
more common. Issues of "quality of life" are, to
me, more important than cost.
I find it interesting that members of the medical
community who are against Proton therapy for
Prostate cancer are typically practitioners of
some other method of treatment. They don't quibble
about cost when it is they who are collecting the
fee. It is disturbing to me to see that medical
professionals are less interested in the outcome
for the patient and his quality of life, than they
are in ensuring their own income stream.
I would recommend proton therapy for prostate
cancer to anyone based on [PHI Redacted] experience, and that
of others I know who have had the same treatment.
I also base my recommendation on what I know of
the results of other treatments, and the quality
of life issues during and after treatment. It
would be a shame for the best alternative to be
unfunded; I urge you to continue to help provide
the best health care to Americans. |
| Commenter: |
Kinney, Don
|
| Title: |
retired |
| Date: |
9/3/2008 12:27:27 PM |
| Comment: |
[PHI Redacted] had proton radiation ten years ago at 57 years
of age and I can say that without a doubt it was
the best action that [PHI Redacted] could have taken to treat
cancer.
[PHI Redacted] had no negative side effects and [PHI Redacted]
cancer free. Proton radiation in my "un-
professional" opinion is the best treatment for
this type of cancer.
Many of my friend that had other types of
treatment have commented to me - "why didn't you
talk me into proton treatment!" All who have
said this to me have had major side effects from
their form of treatment.
I realise that this information is based upon
personal feelings without the benefit of
professional study, but [PHI Redacted] would have the same
treatment again. |
| Commenter: |
Fancher, Jack
|
| Title: |
Retired teacher |
| Organization: |
Brotherhood of the Balloon |
| Date: |
9/3/2008 12:29:02 PM |
| Comment: |
To begin with, [PHI Redacted] was assured that Medicare would
cover 80% of [PHI Redacted] Proton Therapy costs; they
covered LESS than 50% & [PHI Redacted] paid the balance.
The program is totally successful & was worth
every cent!! Had [PHI Redacted] had to pay the entire bill, would have. This is truly the ONLY non-invasive
procedure available & more such treatment centers
should be in placeSOON!! Why have "the knife"
when it is totally unnecessary!
This would be a dreadful mistake if Medicare
pulls out; instead, MORE Insurance programs
should include & cover expenses for this most
ourstanding, successful therapy.
|
| Commenter: |
Humbert, Sam
|
| Date: |
9/3/2008 1:08:22 PM |
| Comment: |
I have been informed that CMS has made a proposal
to stop Medicare reimburseents for proton therapy
for treating prostate cancer. I would like to
please ask them to reconsider their proposal. [PHI Redacted]
had prostate cancer and after much research and
talking to others that were treated with various
other options [PHI Redacted] chose to have proton therapy. I
believe for [PHI Redacted] it was the only choice to make. [PHI Redacted]
have completed therapy and had first
PSA test and everything is great. Please
remember in your decision making that the
personal feelings of the patient is more
important than only the dollar. A stress free and
illness free treatment is the only way to go for
the patient. Thank you |
| Commenter: |
Cook, Ralph
|
| Date: |
9/3/2008 1:13:14 PM |
| Comment: |
I am concerned about the possibility the Proton
Beam Radiation Therapy is even being considered of
disqualification for payment by the Medicare
Organization.
[PHI Redacted] was diagnosed with prostate cancer and found out
research before selecting a treatment was worth
the time and effort.
Thanks to a friend who discovered the Proton Beam
type treatments and was treated at Loma Linda U.
Medical Center I did more research.
Two urologist suggested treatment of IMRT
radiation but research indicated this was
invasive with the risk of side effects.
The many "side effects" heard about from various
other patients convince to select the Proton
Beam treatments.
[PHI Redacted] received the treatments and was able to talk one
on one with some of the alumni of these
treatments. Several had "no side effects" many had
very minor side effects which were dissipating in
a month or 2.
I am happy to report after treatments at Loma
Linda Medical Center,[PHI Redacted] had very minor side effects
which have sub sided within 2 months.
The impact of Medicare coverage would have made it
extremely difficult to obtain the benificial
Proton treatments as [PHI Redacted] retired on S.S. payments
and a very small pension.
[PHI Redacted] spoke with some other patients while be treated
and they were in a similar situation.
The "negative" comments I find on this comment
page seem to be from health professionals who have
either not done research since the Proton
Radiation Therapy by LLU began in 1991. They
obviously have not read the recent report data
concerning proton therapy by Loma Linda U..
Currently LLU is treating 44 types of cancer with
an excellent success rate and most patients verify
they only had none or minor side effects.
[PHI Redacted] had two episodes of breast cancer and
received photon radiation treatments 2 times and
after 6 years has radiation burns on her chest.
She was very interested in the Proton treated
patients for breast cancer she spoke with while [PHI Redacted]
was undergoing treatments. She was surprised
they only need 10 treatments and they had "no"
side effects.
The bottom line: Medicare should continue to
support this cutting edge treatment of the Proton
Radiation which is so beneficial to many people &
their quality of health. |
| Commenter: |
Shinn, Raymond
|
| Title: |
Retired Executive |
| Date: |
9/3/2008 1:20:57 PM |
| Comment: |
Dear Sirs,
[PHI Redacted] was diagnosed with prostate cancer in June of
[PHI Redacted]. Living in Sun City West, Arizona,a
retirement community, I have many friends who
have had prostate cancer and have experienced a
variety of treatment regimens from radical
surgery, conventional radiation, Chryotherapy,
hormone therapy and wait and monitor. After
talking with many of these friends and
investigating other forms of treatment. [PHI Redacted] elected
proton beam therapy. In March of [PHI Redacted] completed
45 treatments without experiencing any side
effects except for slight fatigue which is now
gone, and most recent PSA was .5. [PHI Redacted]
Comparing [PHI Redacted] experience with my friends and
acquaintances who had other therapies I highly
recommend proton beam. One friend opted for the
wait and monitor system. He eventually died from
prostate cancer.Others are experiencing erectile
dysfunction and or incontinence and or bowel
problems and all experienced negative side
efffects while participating in the original
therapies.
I think quality of life after treatment should be
a factor in determining what treatment method to
select.
Sincerely,
Raymond D. Shinn |
| Commenter: |
Sands, Russell
|
| Date: |
9/3/2008 1:23:20 PM |
| Comment: |
Proton beam therapy cures prostate cancer and [PHI Redacted] the side affects are
minimal. Other therapies also work, but many of my friends have experienced debilitating side affects.
If Medicare doesn't continue to cover the cost, only the wealthy will have access to this
treatment because of its expense. That is extremely unfair.
|
| Commenter: |
Laue, Clarence
|
| Date: |
9/3/2008 2:11:26 PM |
| Comment: |
Proton beam therapy for Prostate Cancer: The notice CMS is planning to discontinue helping with the treatment of prostate cancer by Proton beam therapy is unthinkable. This treatment with little or no side effects has been provided for years with great results and is in demand so that large sums are being spent to construct new ficilities. Workers have purchased insurance(Medicare) most of their working lives to cover such expense and now to have Medicare not cover some of the cost is not treating then in good faith. I urge this objective be reconsidered. |
| Commenter: |
Furlong, Robert (Bob)
|
| Date: |
9/3/2008 2:24:04 PM |
| Comment: |
[PHI Redacted] received Proton Therapy for Prostate Cancer and
had no adverse side effects. I feel that
Medicare should continue to cover this form of
treatment. Initially Proton Therapy may be more
expensive, but in the long run it will be cheaper
due to the fact that most patients that receive
Proton Therapy Treatments do not suffer from the
known side effects caused by other form of
treatment. This is not only beneficial to the
patient, but to Medicare and other forms of
insurance as their overall cost will be less in
the long run as there will not be additional
health problems associated with other forms of
treatments. I feel that receiving Proton Therapy
for [PHI Redacted] Prostate cancer was the best decision that
[PHI Redacted] ever made. I hope and pray that
Medicare will continue to provide coverage to all
of the men that will be diagnosed with Prostate
Cancer in the future. At the present time there
are only 5 Proton Therapy Centers operating in
the country, but there are at least 10 additional
Proton Centers in the process of coming on line
in the near future. As these new centers become
available, the cost of treatment will eventually
go down. |
| Commenter: |
Williams, Ivan
|
| Date: |
9/3/2008 2:29:33 PM |
| Comment: |
In [PHI Redacted], [PHI Redacted] was diagnosed with prostate cancer. [PHI Redacted]
was offered several options for treatment, chose
proton therapy.
The treatments caused no pain or discomfort during
or after the treatments. [PHI Redacted]
Routine follow-up exams and lab tests show no
cancer. Now [PHI Redacted] live a normal life.
I can recommend proton therapy as the best
treatment for prostate cancer.
Medicare helped make [PHI Redacted] treatment possible. |
| Commenter: |
Bradley, USAF (Ret.), Lt. Col. John B.
|
| Date: |
9/3/2008 2:46:10 PM |
| Comment: |
Proton Treatment of Cancer
As an Engineer, with a BS from the U. S. Naval
Academy and an MSIE from Stanford University, CA,[PHI Redacted], I feel I
am well qualified to comment on the mistaken
approach CMS wants to take. The rational is
solely to avoid paying the cost of Proton
treatments instead of using that better treatment
regimen that has far better results for the
Dollar. The cost rational instead of the
patients well being is a cheap shot at cancer
sufferers.
I have seen and read most of the comments
by "Doctors" who have one main goal, make money
from their barbaric methodology of treating
Prostate Cancer. Three percent of all their
touted methods result in absolutely disastrous
side effect to ones quality of life, let alone
the likely hood of reoccurrence of the Cancer.
One example of the many men going though
treatment[PHI Redacted], was a gentleman 45 years
old who had a total radical prostectomy. Guess
what, his cancer came back. I cannot say it was
the result of incompetence on the part of the
surgeon, but that procedure has horrible side
effect. Nerves are cut, yes accidently, by
incompetence, leaving the individual in depends,
or worse and his ability to have a continuing
love life with his wife is gone for good. Is it
worth that chance, no way in hell? That is an
antiquated procedure, which should be ethically
prohibited.
IMRT, although less likely to sever nerves,
photon radiation is a killer in itself. Why, the
radiation goes in one side of the body to the
cancer. It does not stop there but continues out
the other side of the body destroying absolutely
good tissue for no good reason other than making
money by that procedure.
Cryo, Bronco, Radioactive Seeds and the rest are
just as destructive or just an ineffective at the
three percent level or even higher.
[PHI Redacted] had 45 78 gray scale proton radiation
treatments with absolutely 100@ NO SIDE
EFFECTS!!! starting treatment with a Gleason 7
cancer even though the PSA was only 2.0. Can the
other old treatments do that? No way. Sorry
doctors, slice and dice are not for anyone with a
brain. Why is that procedure successful, it is a
matter of physics. The beam is constrained to
the outline of the prostate in [PHI Redacted] case. A 3-D
scan of the prostate is sent to a physics lab to
lathe out the material that constrains the
distance the protons travel as vies separately
from the left and right side of the incoming
radiation. As the depth of the cuts is less
where the beam is to go the farthest without
exiting the opposite side of the prostate, all
energy is expending within the prostate
destroying the ability of the cancer to recreate
itself. Different depths of course a made for
the opposite side, thus ensuring again the
radiation does not leave the prostate. What a
wonderful concept compared to IMRT and then the
Seeds, which have been known to travel to a
patients lungs.
You cannot control the depth of penetration of
photon radiation like one can with protons, that
is pure simple physics.
As for studies on results, the initial facility
at Loma Linda University Medical Center with any
kind of patient handling capability has been
doing this since 1990. They have amassed
tremendous amounts of data relating to incoming
PSA levels versus survival rates as one example.
All one has to do is take off their blinders from
praising ancient technology and get the data from
that university. Two new facilities are up and
running although he Florida center stupidly
bought a cheap Belgian Cyclotron versus a U. S.
Made Synclotron. Why do I say stupid? A
Synclotron goes radioactively cold in minutes not
days like in the Cyclotron. Repairs are made and
the system is usually up and running that same
afternoon. Disturbance to patient treatment is
minimal. That is particularly compounded when
that repair didn't solve the problem. The
Cyclotron again has to wait 2 days before it can
be accessed again. At 150 patients a day,
financial losses are significant as well as being
a detriment to the patients.
Several of my Academy classmates have had
prostate cancer and every one, IMRT, Robotic
Surgery, etc. all have had horrible quality of
life consequences as a direct result of the
procedure.
Why any Hippocratic Oath taking doctor would put
a patient through such hell for the sake of their
making money when there is a magnitude better way
of curing that kind of cancer.
One glaring example of incompetent surgery. The
45-year-old [PHI Redacted] has a wife who
had a tumor on her optic nerve. The surgeon blew
it and severed a facial nerve. Now her left eye
looks upward at a 45 deg angle to the right and
her pretty face is totally distorted on the left
side. Two days before her husband was finished
with his treatment, one gentleman came out of his
last treatment session for exactly the same
problem, tumor on his optic nerve. He was
hollering, I can see, I Can see, as he was swing
this Bola, the physical device that was put
through the lathe to limit depth of the proton
penetration. Not only that, his face had a grin
from ear to ear. You should have seen the look
on that lady's face, and if she would have known
about Protons for treating cancer, she too could
have been saying I can see with a smile on her
face. Such butchery should be prohibited.
In short, do not ever stop funding Proton Therapy
for treating cancer, as not only can it do
prostate treatment, but brain, nerve and other
such tumors without the damage of a slipping
scalpel. A better alternative to Proton therapy,
there is none, the only reason for the old
methods is the entrenched blinded doctors wanting
money for their method without regard to new
technology, and what is really the best treatment
with no side effect on a patients continuing life.
John B. Bradley
Lt. Col. USAF (Ret.) |
| Commenter: |
Halsted, Tom
|
| Date: |
9/3/2008 2:56:34 PM |
| Comment: |
[PHI Redacted] opted for proton therapy because, in the absence of clinical
trials, [PHI Redacted] became convinced through experiential data and
anecdotal evidence obtained from dozens of personal interviews
with patients and practitioners that proton therapy would
provide with the fewest side effects. [PHI Redacted] had a dramatic
drop in PSA and no side effects whatever, which makes [PHI Redacted]
yet another satisfied proton customer. Naturally, [PHI Redacted] was also
greatly influenced by the fact that unlike IMRT, protons would
expose far less healthy tissue to radiation damage. Any patient
presented with the option between the two would choose
protons if it were available. Access to this relatively benign,
successful therapy should certainly not be restricted to wealthy
cancer patients alone.
Rather than criticize the proliferation of proton facilities,
skeptics might consider the cost savings that will inevitably
result as treatment regimes involve fewer, stronger, doses, and
collateral damage is diminished through the use of more precise
patient positioning and tumor localization techniques. |
| Commenter: |
Miller, Bruce
|
| Title: |
Retired |
| Date: |
9/3/2008 3:31:27 PM |
| Comment: |
| My comment is in regard to Medicare considering
no longer providing coverage for Proton treatment
to prostate cancer patients.[PHI Redacted] completed Proton
treatment three years ago having been diagnosed
with that condition. [PHI Redacted] not experienced one
single noticable side effect since the conclusion
of series of forty four Proton treatments. [PHI Redacted]
recently underwent a colonospsy that showed there
was no evidence damage to intestinal tract. To
remove Proton treatment from the Medicare
choices of coverage for those diagnosed with
prostate cancer would deprive thousands of
american men of obtaining the single option of
them continuing to live a quality life of
normalacy following prostate cancer treatment. I
am a veteran of the United States Navy , a
retired police lieutennant with a degree in
criminal justice. [PHI Redacted] did not choose Proton
treatment without first giving consideration to
all existing options for prostate cancer
treatment. Please totally compare the existing
options and rule in favor of keeping Proton
treatment as a covered procedure under the
Medicare program. All American men should have
the option of selecting Proton treatment as a
viable option among the numerous choices
currently offered for treatment of prostate
cancer.
Thank You, Bruce W. Miller |
| Commenter: |
KLUGE, PETER
|
| Title: |
member |
| Organization: |
Brotherhood of the balloon |
| Date: |
9/3/2008 4:34:28 PM |
| Comment: |
I am more than a little disturbed that medicaid or medicare are
being advised to discontinue coverage of proton radiation therapy
for prostate cancer. The urging seems to come from other
professionals who offer competing therapies. [PHI Redacted] I can see why; it works better than any other
form of treatment available today. It is a little more expensive than
other treatments at this time, but this is changing; more facilities
are being built and the use of the technology is expanding. All I
can say is, that the results are worth every penny spent. |
| Commenter: |
Jensen, Donald
|
| Title: |
Retired Pilot |
| Organization: |
American Airlines |
| Date: |
9/3/2008 4:48:51 PM |
| Comment: |
It has come to my attention that some powerful
forces are trying to stop Medicare and Medicade
funding for Proton Radiation treatment for
Prostate Cancer.
I don't know what their motives are but their
efforts are certainly very regretable. [PHI Redacted]
recieved treatment at Loma Linda Medical Center
for Prostate Cancer. The results were
phenominal. [PHI Redacted] PSA is now 0.03. Digital exams
show very positive results. [PHI Redacted] no side
effects from this treatment. About one year post
treatment [PHI Redacted] did have some rectal bleeding. That
is cured and caused no problem. Know many folks
who had other type treatments. None had as fine
an outcome as [PHI Redacted] experienced.
When you look at cost you should look at all cost
including extra hospital stays, various morbidity
issues, etc.
[PHI Redacted] treatment was funded by Medicare as it should
be. [PHI Redacted]
We don't need those who want to push their
favorite program to kill one that has immense
value. |
| Commenter: |
Horwitz, Harold
|
| Title: |
Retired/Inactive Attorney |
| Organization: |
California State Bar; ABA |
| Date: |
9/3/2008 5:31:54 PM |
| Comment: |
[PHI Redacted]82 years old and in excellent health, which
[PHI Redacted] attribute primarily to Proton Beam therapy at
Loma Linda University in [PHI Redacted]. Prior
to that time, [PHI Redacted] had been dianosed with prostate
cancer and you are welcome to review [PHI Redacted] then
current condition, along with the treatment
modalities.
However, prior to undertaking treatment at Loma
Linda, [PHI Redacted] interviewed Medical professionals
(Doctors) in competing technologies in search of
the best treatment with fewest negative
problems, without regard to cost or
inconvenience of treatment location. Without
exception, Doctors in competing technologies
always recommended their specialty as being
superior.
[PHI Redacted] was fortunate in having a technical (BS-
Physics/UCLA) as well as a legal background (JD-
WSU) which allowed [PHI Redacted] to evaluate the various
approaches to ameliorate the cancer.
[PHI Redacted] now 8 years post treatment and have no side
effects from the treatment.
I urge a careful study, in addition to the
negative remarks from professionals in competing
technologies, before you discontinue the
remarkable treatment now available at Loma Linda
and other facilities.
Two interesting commentaries follow:
(1) When [PHI Redacted] evaluated the various options to
treat the prostate cancer, [PHI Redacted] was fortunate
enough to interview a well-known MD/Professor at
a renowned institution for his advice. He
recommended Proton beam therapy, although it was
not offered at his institution.
(2) Before [PHI Redacted] had heard of Loma Linda Proton beam
center, had heard of MD Anderson treatment
center and almost traveled there for surgical
removal of the prostate cancer. However, [PHI Redacted] was
shocked to learn that they would not treat because of age. At that time [PHI Redacted] was 74. They
told [PHI Redacted] that they were not accepting patients
over 65!
To sum up, [PHI Redacted] very positive results from experience at Loma Linda and urge you to not
eliminat this treatment as it has saved [PHI Redacted] life
and other lives of similarly treated people.
Sincerely,
Harold C. Horwitz
|
| Commenter: |
Wright, Thomas
|
| Title: |
Retired |
| Date: |
9/3/2008 5:41:47 PM |
| Comment: |
|
I think it would be a grave error to not fund proton therapy for
prostate cancer. [PHI Redacted] I can attest to the fact that it
is the best treatment available. [PHI Redacted] |
| Commenter: |
Rehkemper, Alan
|
| Title: |
Medicare Reimbursement for Proton Radiation |
| Date: |
9/3/2008 5:47:51 PM |
| Comment: |
[PHI Redacted] received proton radiation treatment during
[PHI Redacted], and very satisfied
with the results: no incontinance or impotence,
no pain during treatment, and presently a PSA
level below 1.0.
[PHI Redacted] also had
prostate cancer. One [PHI Redacted] died of
prostate cancer in 2006. [PHI Redacted] treatment was
reimbursed by Medicare and Tricare [PHI Redacted].
Please continue Medicare reimbursement for this
highly effective treatment with no painful side
effects. |
| Commenter: |
Owings, Allen
|
| Date: |
9/3/2008 6:40:01 PM |
| Comment: |
[PHI Redacted] experienced proton beam
radiation therapy treatment for prostate cancer,
and can honestly say that the side effects, with
the exception of minor urinary discomfort, were
basically non-existant. After nine months [PHI Redacted] PSA
droppped to 1.7 from 7.5, urine function is
normal and sexual functions remain good. [PHI Redacted]
fellow patients share the same views. At first
[PHI Redacted] Medicare Advantage plan would not approve
proton therapy, but appeal was later upheld.
[PHI Redacted] was determined not to settle for anything
less. I strongly urge Medicare to continue their
coverage of proton therapy treatment for prostate
cancer so that others diagnosed with this illness
can have the same opportunity. |
| Commenter: |
White, Steven
|
| Date: |
9/3/2008 6:46:32 PM |
| Comment: |
[PHI Redacted]
I had [PHI Redacted] who had surgery and had
considerable discomfort and incontinence for the
rest of their lives. One had reccurance of
cancer which caused his death. Also, [PHI Redacted] had surgery about 8 years ago, his PSA is
going back up now. He has had incontinence and
depression and other problems related to that
treatment.
While it is true that other modes of treatment
are cheaper initially, if you consider recurring
medical costs and suffering, as well as loss of
function and quality of life, the Proton Therapy
seems to be a much safer and better method of
treatment to me.
It seems a shame to me that some doctors who
provide other forms of treatment often want to
discredit Proton Therapy. Of the dozens of
fellow patients that I became acquainted with in
Florida, all seemed thrilled to be there and to
have found that method. Many had stories of how
their doctors at home had called Proton
Therapy "experimental" and discouraged them from
doing it. Yet nobody that I met had any
incontinence or impotence when they were done.
The call to have more studies is valid. I hope
accurate data can be compiled to compare the
various treatment methods. From [PHI Redacted]
experience, my guess is that Proton Therapy will
show to be far easier on the patient, with better
long term sucess.
I hope Medicare doesn't decide to quit funding
Proton treatment. I'm sure it is a superior
treatment for certain brain and spinal tumors as
well. [PHI Redacted]. |
| Commenter: |
Young, Barbara
|
| Date: |
9/3/2008 6:50:26 PM |
| Comment: |
I am not a doctor or a nurse or medical
practitioner of any kind. So, I feel like I'm
battling the Goliaths (Doctors) who have already
addressed this topic: - Proton Therapy for
Prostate Cancer- here in this comment forum.
Their education, knowledge and years of
experience seem to carry a lot of weight no
matter who's reading these comments and many of
them (that I've come into contact with) seem to
want to be crowned immediately. I'm just a
[PHI Redacted] of a [PHI Redacted] with prostate
cancer who would like to see Medicare leave the
choices for treatment of prostate cancer up to
the person whose life and well-being are at stake.
I know 2 other men who have prostate cancer and
who have both been treated with seed implants.
Both have and, in at least one case, are still
experiencing much discomfort from the procedures
they had done (in different parts of the USA).
[PHI Redacted], on the other hand, who had Proton
(and Photon) treatments, NEVER once experienced
any problems whatsoever and 2 years after
treatment has a PSA of .01. Luckily, [PHI Redacted] had
private insurance, but if [PHI Redacted] had been a
little older, would be relying on Medicare.
I would like to think that Medicare would pay at
their normal rate no matter what treatment a
person chooses. Maybe some facilities are better
than others at providing this Proton treatment.
Generally speaking, so are hospitals and
doctors. It's up to the consumer to choose the
best according to their judgment.
Why would Medicare want to get into
the "doctoring" business by dictating what kind
of treatment a person should get? Unless someone
can prove that Proton Therapy is a TOTAL waste
(which no one has argued), the proliferation of
negative comments point to a kind of egocentric
envy. |
| Commenter: |
Fitzner, Dale
|
| Title: |
Professor (Retired) |
| Date: |
9/3/2008 6:51:22 PM |
| Comment: |
[PHI Redacted]I am amazed that Medicare would
consider removing this effective prostate cancer
treatment from its payment list! [PHI Redacted], along with
the thousands of other prostate cancer survivors
who were cured by proton beam therapy (without
the side effects of incontinence, impotency and
cancer reoccurance associated with other prostate
cancer treatments) over the past 15 years that
proton therapy has been approved and provided
would be very concerned about future prostate
cancer patients not having the proton beam
therapy option.
The negative comments/critiques I have read in
these public comments seem to have come from
individuals in the medical field whose livelihood
depends on the income they derive from providing
treatments other than proton beam therapy!
Comments from those sources should be suspect!
Taxpayers should be concerned that, if Medicare
does not provide payment for the proton beam
treatment for men in the future who have prostate
cancer, they will be paying taxes to provide
medical treatment to deal with the side effects
that often result from prostate treatments other
than proton treatment. We all know men who have
suffered impotency, incontinence and cancer
recurrance after surgery or radiation seeds.
Compare the side effects/after effects of
prostate cancer patients treated with proton
versus other prostate cancer treatments. Don''t
allow proton beam tharapy to be derailed by
professional jealousy or greed!
Dr. Dale Fitzner |
| Commenter: |
Hopkins, Philip
|
| Date: |
9/3/2008 7:02:32 PM |
| Comment: |
[PHI Redacted] received the proton treatment for prostate
cancer last year. [PHI Redacted] had no adverse problems
from this treatment. One year after the treatment
[PHI Redacted] had two PSA tests. The first was 1.4 and
the second was 1.1.
[PHI Redacted] more that satisfied with the proton
treatment and would recommend it to anyone who
has prostate cancer. There was no discomfort as [PHI Redacted]
had the treatments.
Some of my friends who have had other forms of
treatment, including regular radiation have had
severe problems after those treatments.
I request that you nor take proton teatment from
your list of approved treatments for prostate
cancer.
Thank you,
Phil Hopkins |
| Commenter: |
Teague, Gayle
|
| Date: |
9/3/2008 7:57:40 PM |
| Comment: |
Five years ago [PHI Redacted] let doctors talk [PHI Redacted] into surgery
to try and get rid of prostate cancer. [PHI Redacted]
been incontinent for five years now and the
cancer has come back. [PHI Redacted] just finished
proton radiation therapy and PSA is on the way
down.
The five years [PHI Redacted] lived with incontinence
could have been avoided and could have been
free of cancer five years ago with no side
effects. If only the six doctors [PHI Redacted] consulted had
told about Proton Radiation Therapy. Proton
Radiation Therapy is painless and free of side
effects. I have talked face to face with at
least 30 men who have been cured for one to five
years after treatment, and they still have no
side effects. What more could one ask?
[PHI Redacted] disgusted with the doctors have consulted
with this problem. Initially, [PHI Redacted] doctors did not
even mention the proton option. After [PHI Redacted] mentioned
it they get angry and won't discuss it, or they
deny knowledge of it. I have had men tell me that
their doctor just left the room and didn't
return, or would not return phone calls after the
patient mentioned proton therapy, or told the
patient to find another doctor. I believe they
are afraid they will lose business. It's
obviously about money. What happened to "do no
harm?" Gayle Teague |
| Commenter: |
Hebbard, Le Roy B., Jr.
|
| Title: |
Captain US Navy ( ret.) |
| Date: |
9/3/2008 8:24:08 PM |
| Comment: |
[PHI Redacted] I believe the
cestation of payment for Proton Beam Therapy for
the treatment of Prostate Cancer would be a huge
mistake. [PHI Redacted] thoroughly researched the different
forms of cancer treatment availbale, when diagnosed. The absolute deciding factor for [PHI Redacted]
after consulting with patients who had been
treated with proton beam therapy versus those
treated with normal xrays, surgery, and hormone
treatment, was the apparent almost total lack of
side effects associated with proton beam therapy.
Listening to the tales of major life impacting
side effects from other patients not treated with
Proton beam therapy, convinced [PHI Redacted] to opt for
that treatment. [PHI Redacted] enjoyed a completely
normal life style afer completion of treatment.(2
1/2 yrs)
I strongly second the comments made by Prof.
Peter Vollhardt (9-2-08). His comments regarding
the Bragg Energy Peak are particularly pertinent.
In my opinion the treatment may be expensive, but
please remember , " you get what you pay for".
Le Roy B Hebbard, Jr
Capt USN retired |
| Commenter: |
Darling, Eugene F.
|
| Title: |
Retired |
| Date: |
9/3/2008 8:32:41 PM |
| Comment: |
[PHI Redacted] received Proton therapy last fall. [PHI Redacted], and
felt that the treatment much was much less
invasive then regular radiation treatment. [PHI Redacted] was
considered a high risk patient, with a Gleason
score of 7 and a PSA of 10.7. Almost a year
following treatment [PHI Redacted] PSA is still 0.0.
I have talked with patients that had general
radiation and their side effects have been more
dramatic then [PHI Redacted] or other Proton treated
patients that I have talked with.
Many of the patients receiving Proton treatment
[PHI Redacted] were also receiving Medicare[PHI Redacted], but it was interesting to note that their
were also many younger patients receiving Proton
treatment because it was considered the better
treatment to receive.
Sincerly,
E.F. Darling |
| Commenter: |
Murphy, Thomas R.
|
| Organization: |
Private Citizen |
| Date: |
9/3/2008 9:04:31 PM |
| Comment: |
[PHI Redacted] was diagnosed with prostate cancer in 2006, at
age [PHI Redacted]. Testing established that [PHI Redacted] was otherwise
in good health.
I bagan my own research, interviewing many
doctors, representing many treatments, from
traditional surgery to robotic (DaVinci method)
surgery, to the newest types of traditional
radiation (photon)and seed implants. I found each
of them encouraged their own specialty
as, "proven the best".
I also interviewed many men who had been through
those various treatments. Most had unfortunate
side effects. Some would even qualify their
treatment as not successful.
I was quite discouraged, until I was told about
Proton Therapy treatments by a nationally
recognized oncologist who had treated prominent
persons in Washington DC. While he did not
administer proton therapy himself, he told me it
is unquestionably the best treatment for prostate
cancer. I spoke with him personally, as he is
related to a personal friend I have known for
years.
After [PHI Redacted] proton therapy was completed in [PHI Redacted], PSA dropped from a pre-treatment reading
of 13 as a high, to 1.27 in 6 months, then .08 in
one year. In addition, ALL SYSTEMS WORK!
Since then, I have spoken with men who have had
various treatments, as well as many others who
have had proton therapy. By this measurement, In
my judgement, proton therapy is by far the
safest, most effective treatment, with little or
no side effects. It would be immoral to eliminate
this therapy from Medicare's approved list.
Thomas R. Murphy |
| Commenter: |
Test, Sandra
|
| Date: |
9/3/2008 9:48:10 PM |
| Comment: |
[PHI Redacted] went thru the protron treatment at
Loma Linda Medical Center in CA. Please, please
don't listen to urologists, most of whom don't
recomend or understand proton treatment and are
only looking out for themselves and their pocket
books bcause they do sugery not proton radiation
treatment. Patients do not go thru any pain or
recovery time or the primary side effects that
surgery patients do. Radical prosectomy surgery
always results in incontinance short term,
sometimes permenently and always experience a
total loss of sexual potency, that means no
erections or orgasums ever again with or without
drugs. Does this sound like a comparable
treatment to you? No!!!!! Proton radiation almost
never results in incontenance and over 70% of
proton radiarion patiants can still have sexual
potency with and without drugs like viagra. The
costs of proton radiation will come down in time
as more facilities come on line. The American
Cancer Society approves this process and so
should everyone else. The statistical survival
rate of proton radiation treatment collectively
has improved over time and is equal to or better
than surgery today and is the future for treating
this form of cancer and many other forms of
cancer. You need to research this more before
making any decisions that could affect future
patients with prostrate cancer. Go to Loma Linda
and talk to the staff there and get the
statistics and the facts - PLEASE.
|
| Commenter: |
Flygare, Gordon
|
| Date: |
9/4/2008 1:32:17 AM |
| Comment: |
My experience with Proton Therapy for the
treatment of prostate cancer is that there have
been NO side effects during or following
treatment.
There have been no continence or bowel control
problems and no erectile function effects. No
pain or discomfort at any time.
During treatment, [PHI Redacted] needed no "Care Giver" at
any time.
Following the proton treatment there was no
recovery time and [PHI Redacted] was 100% ready to resume normal activities the day returned from
treatment.
I don't think other therapies can begin to
compete with Proton Therapy's lack of adverse
impact on the patient's life during or after
treatment. |
| Commenter: |
Alwert, Dave
|
| Date: |
9/4/2008 2:21:13 AM |
| Comment: |
I am writing this comment on Proton Beam
Radiation treatment for prostate cancer as [PHI Redacted]. [PHI Redacted] last treatment was on [PHI Redacted] and most recent PSA, taken on
[PHI Redacted], was .28. I have had several friends
undergo just about all the other treatments
available and I have been able to compare not
only the results of the cancer treatment, but
also the resulting side effects of the treatment.
Without exception [PHI Redacted] quality of life side effects
have been superior to the other treatments, this
is easy [PHI Redacted] to say as [PHI Redacted] have not suffered any
side effects at all. Since defeating prostate
cancer is the goal of all treatments and the
information that I gained through research before
selecting treatment told [PHI Redacted] that all
treatments will be effective if the cancer is
caught early and has not escaped the prostate,
what is left is the quality of life after
treatment. If you read of all the possible side
effects that prostate cancer patients can suffer,
I belive you would want for yourself the
treatment that leaves you with a quality, normal
life!
I would therefore submit that Proton Beam
Treatment should continue to be paid for through
medicare |
| Commenter: |
DeMailly, Jr., Charles
|
| Title: |
retired |
| Date: |
9/4/2008 9:16:07 AM |
| Comment: |
[PHI Redacted] was diagnosed with prostate
cancer and chose proton beam therapy treatment
after carefully examing all available treatments.
I strongly believe this treatment is superior to
alternative procedures; especially when I compare
the outcome with friends and acquaintances who
have chosen alternative options.
With Proton Beam Therapy you have no lost working
time, no incontinents regarding sexual activity
or inability to restrain a natural discharge such
as urine, no scars, and no pain. [PHI Redacted] biopsy was
much more invasive than the prodedure.
[PHI Redacted] PSA is down to .4
Anyone who would like to hear more - give me a
call. |
| Commenter: |
Kippley, John
|
| Date: |
9/4/2008 10:52:38 AM |
| Comment: |
Proton treatment for Prostate Cancer
The value of Proton Beam treatment for prostate cancer appears to be beyond dispute if patient satisfaction with the lack of side effects counts for anything.
The value of the proliferation of Proton Beam treatment centers is an entirely different issue. Is there a health need for two such treatment centers just west of Chicago? or two in Oklahoma City?
Is there anything that the Federal government can do to restrict the number of centers without in effect giving a monopoly to the ones permitted to be built and operated and funded with tax dollars?
The best answer to skyrocketing treatment costs is prevention. Two papers published in JAMA in 1993 found a statistical relationship between vasectomy and subsequent prostate cancer. Among men who had vasectomies for more than 22 years, there was an 85% increased risk. Should Medicare restrict or reduce its prostate cancer funding for those who have voluntarily had a vasectomy and subjected themselves to this risk?
Such logic would require its application to other areas of tax-supported health care. If done gradually and with compassion for ignorance, this might be the greatest step the federal government could do to reduce the incidence of self-induced disease.
|
| Commenter: |
Karlstrum, Delmar
|
| Date: |
9/4/2008 10:53:34 AM |
| Comment: |
I am very diappointed to hear that CMS has
proposed to stop Medicare reimbursements for
Proton Therapy for treating Prostate Cancer.
[PHI Redacted] was diagnosed with Prostate
Cancer. [PHI Redacted] PSA 7.0 Gleason of 5.0. [PHI Redacted] recieved
Proton Theraphy in [PHI Redacted] with the help of
Medicare. [PHI Redacted] had no side effects, Cancer is
gone, in [PHI Redacted] PSA is 0.02. [PHI Redacted] healed
and feel great at age 79. I feel sorry for any
man who has Prostate Cancer and is denied
treatment because Medicare will not help with
payment. It is the best treatment for Cancer a
man can get. |
| Commenter: |
Price Jr., M.D. F.A.C.S., joshua e
|
| Title: |
Board certified Surgeon |
| Organization: |
American citizen,USA veteran. |
| Date: |
9/4/2008 11:28:42 AM |
| Comment: |
[PHI Redacted] treated for advanced prostate cancer at LLU s proton
treatment facility and cured. [PHI Redacted] PSA went from 34 to less
than0.9. [PHI Redacted] disease fre 4 yrs after treatment.
[PHI Redacted] not had to be treated with expensive proceedures to deal
with complications and side effects.
Proton therapy is VERY cost effective. Not covering the treatment
option would be shameful and lead to more expensive treatment
options,not to consider the guality of life issues.
How dare you consider not provideing coverage of this proceedure!
We will not stand for it!!!!!!!! YOU will be the ones that GO!!!!! |
| Commenter: |
Gershon, Robert
|
| Title: |
Retired Information Technology Professional |
| Date: |
9/4/2008 11:30:07 AM |
| Comment: |
During a routine examination, [PHI Redacted] family doctor
noticed a small rise is PSA 2.7 to 3.7 in a 12-
month period. To be on the safe side, she
referred [PHI Redacted] to an urologist. A biopsy was taken
and the results were t1c and a Gleason of 3+3 =
6. For various reasons, [PHI Redacted] chose Proton Therapy.
It has been three weeks since [PHI Redacted] completed the 45
proton treatments. The treatment was painless
and [PHI Redacted] experienced no side effects. |
| Commenter: |
Stytz, Jeffrey
|
| Date: |
9/4/2008 11:36:42 AM |
| Comment: |
Proton beam therapy for prostate cancer.
The call came on Friday, [PHI Redacted]. This is Dr. XX
calling with your biopsy results the voicemail
said. When he heard this he knew it probably
wasn’t good news. Doctors never called before,
it was always the nurse or the office with test
results. Eventually reaching the doctor hours
later, the fear was confirmed. “There is an
adenocarcinoma in the left base involving one
core with a Gleason score 3+3=6.” “It appears to
be localized, but we don’t know for
sure” “. ”Call my office and schedule a
prostate cancer consultation for Monday”. As he
hung up with the doctor, the knot in his gut was
a lot harder and bigger all of a sudden. He
turned to his wife and said simply “I got it” and
walked out of the room.
All the time, he was suppressing the memories of
seeing his grandmother crying when her son, his
uncle, was dying of cancer years ago. Although
he was a young boy and didn’t understand all what
was going on, he knew it must be pretty bad for
his grandmother to be so upset. Here was a woman
who raised 13 children baking bread and making
dinners on a wood burning stove; never a
complaint and never a harsh word. How cruel it
was years later for her to die of the same cancer
that took her son. He could remember her
screaming and his Dad and his aunts and uncles
crying when they went to see her. The doctor
explained it was cancer and the only thing he
could do was to try to ease her pain with drugs.
The cancer had spread and she was dying.
So these memories and memories of other aunts and
uncles dying of cancer started a panic he tried
to suppress. Cancer was always a death
sentence. No one knew how it happened and, years
ago, people stayed away from people dying of
cancer for fear it might be contagious. Sounds
somewhat primitive, but that is how people
thought years ago.
[PHI Redacted] People get calls like this
every day with worse news. What is a prostate
anyway? How important is it? I guess it could
be removed, no big deal. Let’s go on the
Internet and do some research. I have all
weekend and I should be able to find some answers
before Monday.
As he researched the disease, there was a lot of
information to take in. What a prostate is, what
it does, where it’s located and treatment
options. So he did what he always did when
facing a problem. Identify the issues, find the
solutions and put the data in a spreadsheet. It
also helped keep his mind focused away from the
bad memories and the “superstitions” of cancer.
Using the internet as a resource, he was
accumulating a tremendous amount of information;
radical prostectomy, laparoscopic surgery, nerve
sparing da Vinci prostatectomy, external beam
therapy, intensity modulated radiation therapy,
3D conformal radiation therapy, low dose or high
dose seed implant radiation, cryosurgery, hormone
therapy and proton therapy. He decided to sort
the data by procedure, advantages, disadvantages
and of course survival rates.
As he built his spreadsheet for Monday’s meeting,
the side effects and post treatment statistics
for surgery and radiation therapy were quite
depressing. It seemed that he was going to have
to deal with issues of incontinency and impotency
as well as cancer. The chances of one or both
happening seemed a given. However, the one
treatment called proton therapy seemed to offer
cure rates similar to surgery with less side
effects than the other radiation therapies and
less likelihood of incontinency and impotency.
He decided to ask his doctor about it on Monday
and see what he would recommend. So on Monday he
asked the doctor, “What would you do if you were
me?” The doctor recommended daVinci
prostatectomy or seed therapy. “Given your age
of 53, you are a good candidate for either one.”
What about proton therapy he asked? It seems to
offer a cure rate similar to surgery but with
less chance of side effects as well as less
chance of incontinency and impotency. The
doctor was somewhat familiar with proton therapy,
but it wasn’t a topic covered in as much detail
as other procedures when he was in medical
school. By the time the consult was completed,
there appeared to be four choices, daVinci
surgery, seed implant, watchful waiting and
proton therapy.
He knew he would need to tell his family and
friends what was going on so he called a number
of them over the next few days and gave them the
news. It’s somewhat curious how telling someone
you have prostate cancer leads to others telling
you of a father, grandfather, uncle or brother
who had it and were doing fine years later. When
he asked if anyone of them had proton therapy,
all said no. They had surgery or radiation,
never heard of proton therapy. In speaking with
the men who had surgery or radiation, the details
were a little different. Yes, the cancer was
gone but there were some other things gone as
well. In one on one conversations, it was
revealed that there were still problems with
incontinency and of course impotency. The
incontinency was better though, as many were
using only one or two pads a day not five like
they had been. Their sex life was more
regimented than they would and some men needed to
inject Viagra directly into their penis. “Be
sure you are going to have relations with your
wife as you don’t want to do this on a whim” was
one comment. Not good. All the talk of being
better seemed to have an air of avoidance or
resignation of the issues so tightly tied to
being a man.
Time to talk to the proton therapy candidates and
see what the true story was here. He couldn’t
believe what he was hearing, and not just from
the younger men, but older men as well. There
were some issues during treatment, but they were
short term. Not only was there no significant
side effects during treatment, there seemed to be
no long term side effects. This can’t be right
he thought. How can you have treatment for
cancer and not experience problems or side
effects? He also talked to men who had surgery
or hormone therapy that were undergoing proton
treatment currently to eliminate the last bits of
the cancer.
More and more he was convinced that proton
treatment was the best way for him. It seemed to
offer the benefits of surgery with the least risk
of short term and long term side effects or
diminishment of quality of life. It wasn’t the
case of avoiding pain, though no one likes pain.
It was more of a sense of logic and elegance that
proton therapy could treat the disease, targeted
to the specific area of concern and leave all the
healthy tissue untouched. It seemed like to him
using a specific tool for a specific job unlike
the other options that seemed like using an
elephant gun to kill a mosquito.
So he went for a consult and found he was a
viable candidate for proton therapy and started
down the road. Pod forming, CT scans, marker
implant and virtual simulation all led to first
day of treatment many days ago. Not once have
there been any regrets or worry and the feeling
of being cured and feeling blessed and lucky to
have this treatment available are overwhelming.
There is a sense of sadness for all the other men
who could have benefitted from this treatment and
didn’t know about it. But there is a sense of
hope and optimism that, for all the men who
choose proton therapy, they will tell others.
They will provide the first hand information and
understanding to help more men deal with the
issue of prostate cancer with a sense of hope,
dignity and quality of life. |
| Commenter: |
Maggio, Ted
|
| Date: |
9/4/2008 12:02:38 PM |
| Comment: |
When [PHI Redacted] was diagnosed with prostate cancer with a
PSA of 7.0 and a 7.5 Gleason Index, investigated options. I talked to many men
who had surgery or regular radiation. They all
had similar side affects, i.e., incontinence and
impotence for several years following treatment.
[PHI Redacted] chose proton radiation because of no side
affects combined with it's very high cure rate.
Eight years later [PHI Redacted] cancer free. If Medicare
had not approved proton radiation, could not
have afforded the treatment. Since [PHI Redacted]
treatment, I have told eight men who had prostate
cancer and also opted for proton radiation. They
have all had the same positive results. All of
them would not have been able to afford it had
Medicare not covered it. |
| Commenter: |
Wolfe, Robert
|
| Title: |
Captain U.S. Navy retired |
| Date: |
9/4/2008 12:03:33 PM |
| Comment: |
Proton Radiation
At age 72, I believe the Lord led [PHI Redacted] to proton
treatment for prostate cancer. I also believe
that proton radiation has cured [PHI Redacted] prostate
cancer as evidenced by three years post treatment
semi-annual PSA readings of
The number of years that life has been
extended remains to be determined. I am very
grateflull that Medicare coverage made this
option possible.
[PHI Redacted] urologist advised that cancer was too far
advancaed for surgery to be an option and
recommended controlling cancer cell activity with
hormone therapy. This stop-gap non-cure option
was not appealing as the best method for dealing
with this dreadful disease. Fortuntely I learned
about proton beam treatment and both Medicare and
Tricare=for-Life agreed that it was an
appropriate investment in [PHI Redacted] health care.
The cost of health care for our nation is rising
at alarming rates. To consider reducing options
for aging souls as a "balancing-the'budget"
measure seems unfair to those whose contributions
have made Medicare possible in the first place.
In [PHI Redacted] case, this cancer may have been the result
of being exposed to agent orange in Viet Nam.
Not that [PHI Redacted] should be treated any diffently than
anyone else, I will be extremely disappointed if
Medicare chooses to eliminate protron therapy as
a treatment option.
Respectfully,
Robert E. Wolfe
Captain U.S. Navy retired. |
| Commenter: |
Klein Ph.D., Paul
|
| Organization: |
Independent Consultant |
| Date: |
9/4/2008 12:49:06 PM |
| Comment: |
I have a Ph.D. in Nuclear Engineering/Physics and feel that I should comment on the therapeutic use of protons for a variety of cancers including prostate. I have no special knowledge of details of cancer itself, or the cellular biology involved. However, I do understand the physics of the energy loss of charged particles and radiation in matter. The desirability of using protons over using x-rays(IMRT), is really quite easy to understand.
First let’s follow what an x-ray beam does: Imagine that we have a lump of cancerous tissue to be targeted and that it lies inside the body. An x-ray beam needs to first traverse body tissue to get to the target, producing unwanted damage to this beam entrance material. Next, the residual beam hits the target, and finally the residual beam damages the remaining tissue before the beam can exit the body. So we have both entrance and exit unwanted damage. X-ray beams have another undesirable characteristic. They tend to produce unlocalized radiation which results whenever an x-ray interacts. This radiation in turn contributes to damaging good tissue that is not in the desired target area.
Next, for comparison, let’s follow a proton through the same situation of target tissue embedded within other healthy tissue. Protons have a unique range depending upon their energy. Another interesting property of protons is that the slower they go, the more damage they produce around their track. As they finally stop, they deliver an extra burst of energy loss, and hence damage, in the immediate location of the stopped proton. So, proton treatment involves tuning the beam energy to be sure that the protons are stopped within the target tissue. As the beam enters the patient, damage along the track is relatively low, until the beam starts to slow. The proton then enters the target and delivers its maximum damage. And finally there is no exit beam resulting in no damage in the region where x- rays continued to produce damage. Finally there is less spreading of secondary radiation around the beam than was present with x-rays.
I think it is safe to say that the physics indicates that there are definite advantages to using a proton beam over IMRT as far as the fraction of energy expended in the target, and producing less unwanted side effects. I apologize for this simple exposition, and I am well aware that there are many other factors to consider, but I hope it will help to clarify the important and preferred role of proton therapy. Physics demonstrates the clear advantage of protons over x-rays. There is little question about that. The only remaining question is whether our society is willing to pay for it. I, for one, hope so.
Paul R. Klein Ph.D. spklein2003@yahoo.com .
|
| Commenter: |
Bloodgood, Charles
|
| Title: |
Concerned Citizen |
| Date: |
9/4/2008 12:59:17 PM |
| Comment: |
With regards to the CMS proposal to stop coverage
for Proton Treatment for Prostate Cancer I
respectfully request that you DO NOT stop this
very important coverage. [PHI Redacted] was treated with this
procedure and when [PHI Redacted] was admitted to the facility
PSA was 9.8 with a gleason score of 9. [PHI Redacted] had
twelve biopsy samples that were all cancer. [PHI Redacted]
just recently had second PSA check up after
treatment and for both check up's the results
show 0.0 This along with hundred's of friends
that have experianced the same results should
prove that it is the best treatments. I have one
friend that had implants and spent 2 months with
a catheter in him and recently told me that his
PSA is climbing again.[PHI Redacted] had his removed
at age 69. He is now 83 and is still wearing
diapers. Immediatly after receiving Proton
treatments each day [PHI Redacted] went and played racket
ball, basketball, and some days participated in
areobics. I have certainly never found anyone who
had any of the options doing that.
Again, PLEASE do not stop this important
coverage. Thank you for taking my comments into
consideration and pray that you will decide in
favor of continuing this very important coverage. |
| Commenter: |
Schimmelman, Arthur
|
| Date: |
9/4/2008 2:03:20 PM |
| Comment: |
|
[PHI Redacted] I wish to
make this confirming notice that [PHI Redacted] treatment was
PROTON THERAPY. Course of treatment was completed
in [PHI Redacted]. [PHI Redacted] monitor PSA and it remains
below .90. An indication of cure. [PHI Redacted] enjoyed
no side affects or debilitating bodily function
as a result of this treatment protocal. Had [PHI Redacted] not
received medical health coverage could not have
afforded this excellent treatment and cure.I know
I speak for 100's of patients when I make the
above statement. Proton is the least invasive
procedure and should be available to all
suffering from this killer disease! |
| Commenter: |
Collins, David
|
| Date: |
9/4/2008 2:49:01 PM |
| Comment: |
Any radiation is harmful to healthy tissue. Proton treatment minimizes the entry radiation dose, maximizes the dose to the tumor and has negligible exit dose. Beacause the radiation dose to healthy tissues is less with protons, the dose to the tumor can be greater leading to higher cure rates and fewer side effects. Proton treatments should be available to all prostate patients.
David Collins, very satisfied patient |
| Commenter: |
Kumpula, Les
|
| Date: |
9/4/2008 3:31:33 PM |
| Comment: |
|
The idea to remove medicare coverage for proton
treatment of prostate cancer would be a major step
backward. As a scientifically trained person, [PHI Redacted]
made the decision to get this treatment six years
ago because it was the only method that could
accurately treat cancer deep in the body without
destruction of the outer tissues. Proton beam
radiation penetrates outer tissue without damage
before destroying the inner targeted area, whereas
conventional photon radiation destroys any tissue
on contact and loses its strength as it travels
deeper. This accurate targeting of deep tissue is
what makes the elimination of side effects possible.
This is the reason that many new proton centers
are being built. Most treatments for prostate
cancer are effective, but only proton therapy
achieves highly effective results without any side
effects. The cure of [PHI Redacted] prostate cancer without
any side effects made cancer a minor issue instead
of a life altering problem. Without Medicare
coverage, this wouldn't have been possible.
The total cost to medicare for [PHI Redacted] treatment was
about $26,000, which seems to be reasonable
compared to other methods.
Please keep in mind that physicians that treat
prostate cancer with the old methods and do not
have access to these high tech facilities have a
lot to lose due to the competition of this
scientific advancement. |
| Commenter: |
Miller, Billy B.
|
| Date: |
9/4/2008 5:37:30 PM |
| Comment: |
9-4-2008
Dear CMS,
I want to comment on Proton Beam Radiation Treatment for Prostate Cancer. [PHI Redacted] was
diagnosed with Prostate Cancer at the Veterans Administration in late [PHI Redacted]. [PHI Redacted]
consultation was with a lady doctor, in charge of the surgery treatment area for the VA.
Their treatment at the VA was limited to either surgery or traditional radiation, and
they required a patient consult with both heads of each department, and come to their
own decision as to which type of treatment to accept. [PHI Redacted] went back to lady doctor
surgeon to tell her [PHI Redacted] was ready to accept the surgery as soon as possible. That very,
very wise lady suggested that [PHI Redacted] attend some of The American Cancer Society, Cancer
Survivor Meetings that were being held at multiple locations here in the metroplex. [PHI Redacted]
attended 3 of the different meetings at different locations. [PHI Redacted] found that the large majority of the "survivors" were mostly pleased to survive, but also observed that most
of the "survivors" suffered a wide variety of side effects and problems.
[PHI Redacted] also observed not only were there many problems, but very good odds that the cancer
could return or was not totally removed or destroyed. After a few meetings [PHI Redacted] discovered
a small group of guys that had been to California to a Proton Beam Radiation medical
center. They without a doubt way exceeded the results of all the varied procedures that
were available. At that time ([PHI Redacted]) there were not any other choices for this
procedure, with their years of success and experience. There was another place using
another form of Proton Beam treatment in combination with a confusing mix of other
stuff, but I could not find success or experience at that facility.
[PHI Redacted] made decision for treatment at the medical center in California. [PHI Redacted] talked to
lady surgeon doctor at the VA, who congratulated [PHI Redacted] for what she thought was a wise
decision. [PHI Redacted] and all of my Cancer Survivor friends all believe Proton Beam Radiation
treatment for Prostate Cancer is far better and in the long run "Less Expensive" than
alternate procedures. If your operation is trying to save budget money by eliminating
Proton treatment, I strongly believe you are on the wrong track. [PHI Redacted]
"BOB" (Brotherhood of The Balloon) represents thousands of Cancer Survivors that have
experienced Proton Beam Radiation Treatment. I have yet to ever find or run into a
Prostate Cancer patient from that facility and method of Proton Beam Radiation that
was not very pleased with their loving and through care and healing.
Yours Truly,
Billy B. Miller
[PHI Redacted] |
| Commenter: |
gray, carroll
|
| Organization: |
individual |
| Date: |
9/4/2008 5:43:11 PM |
| Comment: |
I am puzzled as to why no comparative studies
have been conducted between proton and photon
raidation treatment. [PHI Redacted], I researched all
availalble therapies and believe the best case
for effective treatment of [PHI Redacted] condition is proton
therapy. Killing the cancer with protons is as
effective with fewer side effects for the
individual, which is often overlooked in this
debate. |
| Commenter: |
KENDEL, Michael
|
| Date: |
9/5/2008 12:27:22 AM |
| Comment: |
It is foolish to stop Medicare payments for proton beam
radiation treatments. [PHI Redacted] was treated in [PHI Redacted] at Loma
Linda Hospital with proton beam radiation for prostate cancer.
To this date, there is no clinical evidence of any recurrence of
cancer[PHI Redacted]. This technology was most
definitely the best available at the time of my treatment and it
proved itself to be very effective. I believe, from followup
studies, that proton beam radiation is the most effective and
precise radiation treatment available that also protects, more
effectively, healthy tissues and prevents some of the more
unpleasant side effects of that treatment to cure cancer. Even
the most modern photon radiation (IMRT) is not as accurate and
side effect minimizing as modern proton beam radiation
treatment. [PHI Redacted] I would also encourage any other person that I know to
check out proton beam radiation treatment before choosing any
other treatment. Medicare should continue to support this
wonderful medical technology and the elderly patients that are
stricken by cancer and need that treatment to save their lives. |
| Commenter: |
Mack, Michael
|
| Date: |
9/5/2008 1:04:08 AM |
| Comment: |
[PHI Redacted] received Proton Beam treatment in [PHI Redacted]. [PHI Redacted] PSA was 11.2,Gleason was 4 and Staging was T1C. [PHI Redacted] PSA today is .6. [PHI Redacted] never had any incontinence, sexual dysfuntion or side effects. [PHI Redacted] urologist said that Surgery was the only cure. How wrong these Doctors are. The same happened to many friends of mine who followed [PHI Redacted]. Please do not take away the hope of others who would benefit from this incredible Medical Advancement. You or someone you love might need it some day.
|
| Commenter: |
Weaver, Park
|
| Date: |
9/5/2008 10:48:39 AM |
| Comment: |
PROTON THERAPY: I write to urge continuation of
Medicare reimbursement for Proton Beam Ratiation
Therapy (PBRT). [PHI Redacted] diagnosed with prostate
cancer in [PHI Redacted], and discussed case with
several top urologists in Southern Calif. All of
them wanted to immediately perform surgery. None
even suggested reading about PBRT. After [PHI Redacted] read
voluminous information about the various
treatments possible to treat prostate cancer [PHI Redacted]
chose PBRT at Loma Linda University Medical
Center. [PHI Redacted] chose it because it was non-invasive,
had minimal side effects (particularly when
compared to the other possible treatments), and
was all out-patient. [PHI Redacted] PSA has been under 0.7
since completion of PBRT in [PHI Redacted].
It would appear that all of the medical people
writing to oppose Medicare reimbursement for PBRT
have a monetary interest in opposing; they are
losing money when persons such as [PHI Redacted] chose
PBRT over expensive surgery/hospital/etc.etc.
treatments.[PHI Redacted] |
| Commenter: |
Clark, Robert
|
| Title: |
retired mechanical engineer |
| Date: |
9/5/2008 1:36:45 PM |
| Comment: |
I was fortunate enough to learn of proton therapy
from a friend [PHI Redacted]. [PHI Redacted] underwent ten weeks of
proton therapy four years ago without any side
effects whatsoever, during treatment or since.
[PHI Redacted] most recent PSA was 0.34 in April 2008. All
of [PHI Redacted] plumbing operates as originally intended.
For all practical purposes, it is as though [PHI Redacted]
never had the disease. [PHI Redacted] belong to a local
Prostate Cancer Support Group and strongly
encourage all newly diagnosed members to
investigate proton therapy, and to read the book
You Can Beat Prostate Cancer by R.J. Marckini
before choosing a course of therapy for
themselves. I have freinds who have had
Brachytherapy and surgery and they have resulting
quality of life issues that [PHI Redacted] other proton
graduates who belong to Prostate Cancer
Support Group have never had to deal with. I
believe that if urologists were truly impartial,
and not trained surgeons, they would all
recommend proton therapy because it is non-
invasive, does minimal damage to surrounding
tissue, and typically does not cause any
reduction in quality of life. Medicare and
Medicaide should continue to fund proton therapy
for prostate cancer. |
| Commenter: |
Morgan, D.Min, J. P.
|
| Title: |
Doctor |
| Organization: |
Retired |
| Date: |
9/5/2008 3:46:09 PM |
| Comment: |
|
Proton beam therapy for prostate cancer appears
in your 7/30/2008 document as a potential topic
for discussion in the third quarter of 2008. In
the paragraph devoted to this topic you
state, “no current comparative trials comparing
(it) to usual therapy”. I presume you are
referring to randomized clinical trials (RCTs),
since it is my understanding that even those
requesting RCTs (e.g. Brada et al. Journal of
Clinical Oncology 25:965-970. 2007) do not
contest the various arguments that favor protons
over x-rays. Even if those studies showed no
difference among the treatments, it would be “the
lack of equipoise in the arms of any trial” that
would fail to meet the central requirement for
performing an RCT.
Any discussion on proton beam therapy must
include consideration of the quality of life
issue. During and after treatment those receiving
radiation via a proton beam are usually able to
lead a normal, productive life. [PHI Redacted] had about four uncomfortable nights
during nine weeks of treatment. Other than that,
it was business as usual. In my current book,
Faith and Proton Therapy vs. Prostate Cancer
(ISBN: 978-1-934666-29-6), I document how [PHI Redacted]
actually gained strength while being exposed to
radiation, in stark contrast to what can take
place when x-rays rather than a proton beam
delivers it. |
| Commenter: |
Jackson, Roy
|
| Date: |
9/5/2008 4:12:47 PM |
| Comment: |
I believe it is extreamly important that Medicare
continues to cover Proton therapy for prostate
cancer. Side effects and cure rate are very
important considerations when selecting a medical
procedure.[PHI Redacted]
|
| Commenter: |
Jordan, Jack
|
| Organization: |
Brotherhood of the Balloon |
| Date: |
9/5/2008 4:20:52 PM |
| Comment: |
CMS Consideration in No Longer Providing
Reimbursement for Proton Beam RX for Prostate
Cancer.
[PHI Redacted] received proton beam therapy for
prostate cancer paid for by Medicare and I am a
proponent of Medicare continuing to pay for this
treatment. I was fortunate to know someone in
the southern California area who brought to my
attention the proton beam radiation therapy
being offered by Loma Linda University Medical
Center in [PHI Redacted]. After considerable
research into the modalities of treatment for
this disease I concluded that, [PHI Redacted], it was
the best treatment available. [PHI Redacted] medical
history was one that very strongly discouraged
surgery as a good choice. I personally found
those who had undertaken other modalities and
were suffering many long term side effects.
Additionally, when [PHI Redacted] asked urologist about
this treatment, because of his having been
previously located near Loma Linda, he knew
about the proton beam therapy and recommended
that [PHI Redacted] pursue this type of therapy. [PHI Redacted]
After about a 9 month to one year period
following treatment [PHI Redacted] PSAs fluctuated some (but
overall had a downward course; [PHI Redacted] PSAs now for
over six years have been below 1.0 and most of
those were below 0.1. [PHI Redacted] felt good during
treatment and no side effects from it. I
think that CMS should give careful consideration
to the lack of side effects. Treating
undesirable side effects for years can also
become very expensive. Certainly consideration
should be given to the improved quality of life
that the absence of these side effects allows
the patient. My vote is for CMS to continue to
pay for proton beam readiation for prostate
cancer. I hope tha CMS will have at least one
or two men on the board making the decision who
have had severe and/or chronic side effects of
other types of therapy for this disease. |
| Commenter: |
MacKay, Mark
|
| Date: |
9/5/2008 5:41:41 PM |
| Comment: |
|
I'm not going to pull any punches here but the detractors of
Proton Beam treatment specifically in regard to Prostate Cancer
treatment are usually specialists in other treatments. Hardly an
unbiased segment of the medical ''profession''. [PHI Redacted] ran into the
same bias when weighing the options [PHI Redacted]
discovered that had Prostate Cancer.
Every Dr. [PHI Redacted] spoke with decried all other treatments as
barbaric, and their methods as the only way to treat it. I've seen
better behavior from used car salesmen. The University of Utah
Huntsman Cancer Center professed to have never heard of the
treatment! Talk about not keeping up with the happenings in
your field of supposed expertise. As for the advantages of
Proton treatment, well they are many.
1. no invasive surgery and it's possible problems.
2. side effects limited to a sunburn on your hips and a slight
burning when urinating during treatment.
3. NO IMPOTENCE. if that's not reason enough, well then go
ahead with other treatments.THEY cannot claim this but will
utter vague statements about ''nerve saving techniques'' all of
which are total B.S.
4. 2 years later, with a recent biopsy, [PHI Redacted] NEGATIVE for cancer.
5. [PHI Redacted] continue a career as an airline pilot virtually unhindered by
Proton Beam Radiation Treatment.
If I was 60 years old, fat and comfy in my field of practice as a
prostate cancer surgeon or trained in other methodologies,
wouldn't I decry Proton Beam Treatment as it totally obsoleted
my procedure and devastated my bottom line?
Wouldn't I try and stop Medicare coverage of this procedure that
renders me obsolete? |
| Commenter: |
Odom, John
|
| Date: |
9/5/2008 6:28:08 PM |
| Comment: |
Re: PSA Testing and proton beam treatment for
prostate cancer.
I have read news reports that a discontinuance
of coverage for these items is being considered.
I believe this is a huge mistake. The reasons
cited in the news reports were alleged were
economic and "quality of life" issues.
Several of my friends have had surgery or
cryotherapy for prostate cancer, with or without
hormone therapy, and most do have serious
quality of life issues. [PHI Redacted] chose proton beam
therapy and had NO side effects and 5 years
of constantly low PSA. [PHI Redacted] had NO discomfort at
the time of treatment. I have also had several
aquaintances who did not have screening, and
because of delayed diagnosis have since died,
or are dying a painful death from metastatized
prostate cancer.
The evidence is overwhelming that in the
majority of cases, proton beam therapy is
superior to every other therapy for this
condition. It is safe, medicaly effective and
cost effective. It should be retained on the
covered options list as should PSA screening. |
| Commenter: |
Haas, Louis
|
| Title: |
President |
| Organization: |
Fine Refrigeration |
| Date: |
9/5/2008 8:01:14 PM |
| Comment: |
Re: PROTON RADIATION THERAPY FOR PROSTATE CANCER
My comments for the continuing reimbursement by
Medicare for proton radiation treatment for
prostate cancer are heartfelt and are based on
my own personal experience.
[PHI Redacted] was diagnosed with prostate cancer 2.5 years
ago. As an engineer by trade, I made a
concerted and extensive study of all the
treatments available for this type of cancer. [PHI Redacted]
concluded after research, going through the
treatment and post treatment testing and side
effects that Proton Radiation is the finest
treatment currently available throughout the
various facilities in the United States. After
talking with various physicians during my
researach, I concluded that Proton Radiation was
not only state-of-the-art treatment, but chances
of having any lingering after effects in
comparison to other treatments was much, much
better.
It would be a tragedy for people currently
covered by Medicare and needing treatment to be
denied this option. It is unfortunate that many
physicians are not even aware of the treatment,
or choose not to mention it in favor of their
own methodology. The existing facilities, and
those currently in the planning stages, require
considerable investment; but the treatment gives
a larger number patients a quality of life
during and post treatment that many other types
of treatment do not seem to offer.
Medicare offers "older" people the best health
insurance coverage in the world. Please do not
diminish this expectation; continue to offer
coverage for Proton Radiation as an option for
treating forty (40) different forms of cancer!
[PHI Redacted] would not have been able to avail
[PHI Redacted] of this treatment if I had to pay for it
on. Thanks for covering this fine
program!
Louis M. Haas
September 4, 2008 |
| Commenter: |
Keyser, Keith
|
| Date: |
9/5/2008 10:19:36 PM |
| Comment: |
I am commenting on the potential removal from
Medicare Coverage of proton radiation for
prostate cancer.
[PHI Redacted] was diagnosed with prostate cancer in [PHI Redacted]. [PHI Redacted] [PHI Redacted] had died at 95, [PHI Redacted] died two years later
at 93. [PHI Redacted]
[PHI Redacted] began attending a
prostate cancer support group to learn as much
from their experiences. I had
discussions with Urologists, Radiation
Oncologists and Surgeons. Since most of the men
in the prostate support group had surgery for
their treatment and claimed to be happy with the
results, [PHI Redacted] scheduled surgery. At the next
meeting, prior to surgery, [PHI Redacted] heard from a man
that was totally incontinent after his surgery.
Even though the men in the support group claimed
to have an acceptable sexual life after surgery
(I’ve since learned that is very subjective), [PHI Redacted]
had accepted that [PHI Redacted] might have a reduced sexual
capability, but [PHI Redacted] was not willing to accept a
life of incontinence. I later learned of two
other men in the immediate “network” of patients
that were totally incontinent after their surgery.
[PHI Redacted] canceled surgery and began research for
other alternatives. [PHI Redacted] selected proton radiation
because it was the only treatment for which could find a reasonable database of men who had
the treatment and were willing to document and
talk about their results. A year after
treatment ended [PHI Redacted] cancer free, am totally
continent[PHI Redacted].
(As a side note, the radition oncologist and the
surgeon [PHI Redacted] had talked to were visible angry with
[PHI Redacted] for choosing proton treatment.)
I can’t find any reliable information about the
side effects from normal radiation treatment or
surgery for prostate cancer. A recent NY Times
article “August 27, 2008, 9:26 am Regrets After
Prostate Surgery” indicated that nearly 20% of
men who had surgery were later sorry they had the
surgery.
What seems to be needed, rather than knocking
proton radiation as a treatment, is a clear
definition and measurement of the side effects
for all prostate cancer treatments. I believe it
is becoming more commonly accepted that there
isn’t a question about whether there is
incontinence after surgery, it is a matter of the
degree of incontinence. The same is probably
true about sexual performance.
As we all live longer and expect to have a good
quality of life later in our lives, the quality
of life issue should be considered very seriously
before any cutting back on proton support is
made.
There is a database of at least 3500 men that
have had proton radiation treatment for prostate
cancer. I don’t know that all of them are 100%
satisfied with the treatment, but at least it
gave me reliable first hand information about
side effects that I could not find for any of the
other prostate cancer treatments.
Please don't remove Medicare support for proton
treatment of prostate cancer until there is
reliable data that other treatments do not cause
any more side effects than proton radiation. |
| Commenter: |
Mille, Rick
|
| Date: |
9/6/2008 9:36:32 AM |
| Comment: |
[PHI Redacted] I too was
troubled by lack of comparative trials between
modalities. It seems that the best head-to-head
study would involve a randomized test of
treatments involuntarily assigning patients the
modality of treatment. Clearly few would agree to
that, if it were ethical. So we use multivariate
analysis, holding some variables constant. To me
the first problem is that the population of those
undergoing surgery has to be fitter, and probably
younger, and more likely to have organ contained
disease than those undergoing radiation—just to
withstand the rigors of and to justify the
surgery. Controlling for age would be easy, but
controlling for amount of disease is another
problem. For example, [PHI Redacted] gleason score of six,
ten years ago, would probably have been a five,
according to a study by the University of Chicago.
This grade inflation, the Will Rogers affect,
makes it tough to control for a category that has
changed in the last decade. Another problem is
the changing protocols. For example, the proton
radiation dose ten years ago was less than it is
today. Surgery now has a robotic option. Data
are not available for these newer methods. Lack
of data, lack of comparative trials does not
justify lack of funding.
Prostate cancer patients are the majority at
proton beam centers. [PHI Redacted] are treated more
efficiently than other cancer patients and keep
the gantries full, lowering the cost per treatment
to all. Reducing funding of prostate cancer
patients may have the adverse effect of reducing
the treatment and research on other forms of
cancer—head, neck, spine, and , possibly soon,
breast cancer. Can you imagine adversely
effecting breast cancer treatments? Encourage
comparative trials, but please don’t cut the funding.
|
| Commenter: |
Bullock, Dan
|
| Title: |
Retired |
| Organization: |
Law Enforcement Executive/Consultant |
| Date: |
9/6/2008 11:42:31 AM |
| Comment: |
[PHI Redacted] a successful patient of Proton Radiation
Treatment, and an aggressive and vocal
proponent of that treatment option for the past
five years. I was shocked to learn that
Medicare coverage for this excellent treatment
option may be discontinued.
Since [PHI Redacted] was only 58 years old when went
through the 8 week proton treatment regimen, [PHI Redacted]
did not qualify for Medicare coverage, but,
instead, relied upon private medical coverage
to cover the majority of the treatment costs.
Since many of my friends with Prostate Cancer
are covered by Medicare, I am always quick to
point out to them that Medicare does cover
Proton Radiation Treatment. That fact seems to
help them to focus their study on treatment
options, based on all the factors, not just
cost/medical coverage.
[PHI Redacted], like many of fellow Proton Radiation
Treatment patients, experienced no negative side
effects during and post treatment.
I believe there are 5 and 10 year studies that
show that Proton Radiation Treatment is at least
as effective as standard radiation treatment and
surgery (The Gold Standard). I, for one, am
very glad that [PHI Redacted] elected Proton Radiation
Treatment over the surgery previously
scheduled.
For the thousands of men who are dianosed with
Prostate Cancer each year, please do not
discontinue Medicare funding for Proton
Radiation Treatment.
Sincerely,
Dan Bullock |
| Commenter: |
Turns, Craig
|
| Date: |
9/6/2008 5:47:24 PM |
| Comment: |
[PHI Redacted] was treated for prostate cancer using protons. [PHI Redacted] not suffered from any of the common side
affects of other treatments. I consider this a
superior form of treatment. Clearly the increase
in centers across the nation are proof this is a
superior form of cancer cure. |
| Commenter: |
Bell, Skip
|
| Date: |
9/6/2008 5:54:08 PM |
| Comment: |
[PHI Redacted] received proton beam therapy for prostate
cancer and wish to comment that the treatment was
effective, with very little side effect, and has
reduced any need for folllow-up. Please continue
to make it available to medi-care patients.
Skip Bell |
| Commenter: |
Ralph, Joseph R.
|
| Title: |
Retired building contractor |
| Date: |
9/6/2008 6:08:13 PM |
| Comment: |
Please do not cut medicare coverage for PROTON
BEAM THERAPY to treat cancer it is the best, [PHI Redacted]
received PBT [PHI Redacted] and doing fine PSA 0.01
Last four checkups. |
| Commenter: |
Wickes, Bob
|
| Title: |
Business Owner |
| Organization: |
SDA |
| Date: |
9/6/2008 6:47:31 PM |
| Comment: |
Proton Beam Treatments for Prostate Cancer Patients
After being diagnosed with Prostate cancer in
[PHI Redacted], [PHI Redacted] did a great deal of research to determine
what treatment would best keep [PHI Redacted] alive. The
research included; talking to Medical Doctors,
researchers, patients of all current treatment
methods (some of which were being re-treated as
their choice did not remove all of the cancer),
reading from various professional writings and
visiting, with orientations wherever possible, the
different treatment centers. The research also
included patient results from the different
treatments.
This research led [PHI Redacted] to one conclusion, if wanted the best results, with the fewest side
effects, then the Proton Beam treatments was the
only way to go.
In the long run, I am sure that [PHI Redacted] saved the
insurance company a great deal of money since
there have been no side effects that may have led
to additional expenses.
Thank God discovered the Proton Beam.
Bob Wickes |
| Commenter: |
Steele, Lee
|
| Date: |
9/6/2008 9:32:53 PM |
| Comment: |
I wish to comment on the proposals to not cover
Medicaid coverage for Proton Beam Radiation for
Prostate Cancer. [PHI Redacted] received Proton Beam
Radiation for prostate cancer under
Medicaid/supplement insurance coverage in
February,March and April [PHI Redacted]. The treatment was
very successful in eliminating the cancer with
virtually no side effects. During treatments
[PHI Redacted] was able to work 30 hours per week in a custom
cabinet shop, which would have been impossible
had [PHI Redacted] chosen surgery, regular radiation or other
current accepted treatments. [PHI Redacted] quality of life
remained virtually normal and has continued since
treatment. Why should medicaid coverage be
denied for Proton Beam Radiation treatment for
prostate cancer, when there are numerous sites
under construction or which have opened just
because those sites may not be in the local
proximity to where the individual lives? We who
have become eligible for medicaid coverage should
not be deprived of treatment benefits when we
have worked for so many years to be eligible for
its benefits just because other treatment
modalities claim to be able to treat prostate
cancer but cannot back up their claims of
effectiveness, cost and above all maintain the
quality of life cancer victims should expect. To
eliminate medicaid coverage for Proton Beam
Radiation for prostate cancer victims will be a
tremendous step backward. |
| Commenter: |
Smith, Lee
|
| Date: |
9/7/2008 8:29:19 AM |
| Comment: |
Only individuals who have not personally
experienced prostate cancer could reasonably
suggest that the cost comparison in this debate
should begin and end with the fact that survival
rates are equivalent.
Follow-on costs and quality of life are
legitimate cost factors in the equation.
Individuals and government alike pay enormous
sums for improved quality of life in countless
ways. Why would these sums be left out of
equivalency calculations in this one issue? Not
to be maudlin about it, but the absence of the
classic side effects of surgery and photon
radiation is priceless.
[PHI Redacted] a 72 year old chemical engineer two years
post proton radiation treatment for prostate
cancer. [PHI Redacted] had no side effects. PSA is
holding below 1.0.
[PHI Redacted] chose proton radiation because of extensive
data, widely available, showing minimal side
effects from proton radiation compared to
surgery, photon radiation in all its forms, and
hormone deprivation therapy.
In fact, [PHI Redacted] employed hormone deprivation therapy
for almost six years as a least-worst alternative
to surgery and photon radiation. [PHI Redacted] Fortunately, about the time that
the therapy was becoming less effective, [PHI Redacted]
stumbled upon proton therapy on the internet. [PHI Redacted]
immediately arranged for that treatment.
If Medicare really wants to save money long term,
it should be subsidizing construction of proton
treatment centers. |
| Commenter: |
Smith, Wayne
|
| Title: |
Maj USArmy (ret), Principle Engineer Xerox Corp |
| Date: |
9/7/2008 11:41:45 AM |
| Comment: |
The post Proton prostrate cancer treatment
support group that [PHI Redacted] joined enlightened to the
extreme side effects of radical, DiVinchi
surgery, and x-ray beam treatments which [PHI Redacted] had
previously considered. None of the members had
heard of Proton therapy. [PHI Redacted] was embarassed to
describe treatment with its lack of side
effects. Surely this treatment should remain a
funded tool for medicare. A impartial statistical
study will reveal the total value of Proton
Therapy as compaired to old methods.
[PHI Redacted] regained aviation medical and live a
full and active life in every way, should this
chance be denied my fellow citizens?
[PHI Redacted] Proton Beam was from Feb - 2 May [PHI Redacted]. [PHI Redacted] psa
is still decreasing from 9.0 pretreatment
currently 1.4. A slight ache in [PHI Redacted] hips which
lasted 6-7 months was the only side effect. [PHI Redacted]
treatment was about $63,000 plus out of pocket
travel and rooming expenses of about $10,000.00
over the 3 months in California. Preferred
care and Tricare covered 100% the $63k even
though it was out of the coverage area. They
recognize the value of absence of post treatment
expense for side effects. |
| Commenter: |
Tantlinger, Keith
|
| Date: |
9/7/2008 4:41:46 PM |
| Comment: |
Dear Sirs,
When an [PHI Redacted] associate told me of his
complete cure for his prostate cancer by Proton
radiation, as a professional mechanical engineer
and holder of seventy-nine United States patents,
I am of course interested in anything technical.
Although my innovations are in the transportation
field rather than the medical field, I was
fascinated by my friend’s immediate and complete
recovery, with absolutely no side effects. Years
later [PHI Redacted] was told had prostate cancer, level
Gleason 9. [PHI Redacted] urologist, who had seen [PHI Redacted]
regularly every six months for the previous 20
years (but didn’t detect prostate cancer until
it had progressed to Gleason 9) suggested radical
surgery.
While waiting admission for Proton radiation, [PHI Redacted]
checked with the group in Seattle who are
supposed to be the leaders in the implantation of
radioactive “seeds” in the prostate gland.
Because [PHI Redacted] cancer had progressed to Gleason 9,
the Seattle group advised that was beyond the
stage of prostate cancer that was treatable by
their seed technique.
As you can imagine, I recommend Proton treatment
to anyone I meet who has prostate cancer.
Many come up with stories they learn from
practitioners of other corrective measures. Most
recently a lifelong friend told me he wouldn’t
consider Proton radiation because he “wouldn’t
want a catheter inserted for months in his
urinary canal”, and that he feared
the “incontinence rendered by Proton radiation”.
[PHI Redacted] completed Proton treatment about five years
ago. I never even heard the word catheter. [PHI Redacted]
drove pickup truck 70 miles for each Proton
treatment and drove it 70 miles home,[PHI Redacted]
of course, then drove farm tractor each day
after returning from treatment. ([PHI Redacted] had retired
from the engineering profession.) [PHI Redacted] never
once suffered from incontinence. [PHI Redacted] PSA is 0.02
and current urologist ([PHI Redacted] changed urologists,
of course) now refuses to give further PSA
tests because of age and low PSA readings.
[PHI Redacted] only discomfort between the time [PHI Redacted] learned of
prostate cancer and today,[PHI Redacted], are the hot
flashes due to the Lupron hormone shots that [PHI Redacted]
previous urologist gave without telling me
about the side effects. Curiously, the hot
flashes were accidentally cured by another
medication prescribed by family doctor for a
completely unrelated purpose.
[PHI Redacted]based on my
personal contact with many other Proton radiation
devotees, our preference is due to the precision
by which Proton radiation can be controlled, not
only by area, but by depth. In [PHI Redacted] case never
experienced even the slightest pain and totally free of any side effects (except the hot
flashes [PHI Redacted] experienced before Proton treatment).
I could never recommend any other type of
treatment for prostate cancer.
Keith W. Tantlinger
Licensed Profession Mechanical Engineer
Life Member, and Fellow Grade Member, Society of
Automotive Engineers
Life Member, American Society for Materials
Life Member, National Rifle Association
|
| Commenter: |
Smith, David
|
| Date: |
9/7/2008 5:16:02 PM |
| Comment: |
Re: Proton Therapy for prostate cancer [PHI Redacted]
received proton therapy from [PHI Redacted]. The treatment was painless, quick, and
effective. There were NEVER any side effects. [PHI Redacted]
was able to continue a comfortable life-style. [PHI Redacted]
last PSA was 0.08 and the DRE revealed healing
with no rough scar tissue. [PHI Redacted] couldn't have
afforded this treatment without the help of
Medicare and supplemental insurance. [PHI Redacted]
feeling wonderful knowing that this cancer has
been eliminated with no lingering health
problems. Life is great again!! What a terrific
feeling it is to know that you longer need to
worry about this cancer. [PHI Redacted] Proton
therapy is a great treatment for many reasons,
and should not be denied to those who cannot
afford to pay for it themselves. |
| Commenter: |
Leyman, James G.
|
| Title: |
Private Citizen |
| Date: |
9/7/2008 5:37:49 PM |
| Comment: |
Please not remove CMS approval for Proton Beam
therapy under Medicare. [PHI Redacted] was sucessfully
treated with Proton Beam Therapy at
UFPTI the fall of [PHI Redacted]. [PHI Redacted] had a very aggressive
form of Prostate Cancer with a PSA of 10.7 and a
Gleason score of 9..[PHI Redacted] had virtually no side
effects of any kind. You only need to see who,s
ox is being gored to determine the opposition to
this funding. Not many urologists know or want
their patients to find about PROTON. mEDICINE IS
A BUSINESS. |
| Commenter: |
Sullivan, Ed
|
| Date: |
9/8/2008 9:11:02 AM |
| Comment: |
Three years ago [PHI Redacted] was diagnosed with prostate
cancer. [PHI Redacted] reviewed the various choices available
and selected proton beam therapy. [PHI Redacted] [PHI Redacted] no side effects and the cancer
is gone. I have heard from otherswho have had the
proton therapy and tey have no side effects. Many
people I know in my area have had other
treatments (seeds, x-ray radiation, etc.) and
they have side effects sexual and urinary. Many
are wearing diapers for the rest of theit lives.
Some have had treatments that cost additional
money. |
| Commenter: |
Watts, Nelson
|
| Title: |
Director |
| Organization: |
University of Cincinnati Bone Health and Osteoporosis Center |
| Date: |
9/8/2008 9:35:02 AM |
| Comment: |
Regarding bisphosphonate treatment for osteoporosis and osteonecrosis of the jaw, there is no reason to believe that the route of administration is a risk factor. Dose (i.e., higher doses given IV for cancer) increase the likelihood of ONJ, but the osteoporosis IV dose is approximately 1/10 of the dose given for cancer. This is addressed in the ASBMR task force report. Khosla S, et al. Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res 2007;22:1479-1491. |
| Commenter: |
Wepsic, H. Terry
|
| Title: |
Former Cheif of Staff and Professor Emeritus |
| Organization: |
Veteran Administration Hospital and Univ Calif. Irvine |
| Date: |
9/8/2008 3:05:40 PM |
| Comment: |
I am a [PHI Redacted] retired academic Pathologist
who taught at the University of California San
Diego, Loyola University Medical School, and the
University of California at Irvine. I had a long
time affiliation with the Department of Veterans
Affairs and held the position of Chief of Staff
at Long Beach VA Hospital from 1990-2001. I have
been retired for about five years. When [PHI Redacted] was
diagnosed with early stage prostate cancer in
December of [PHI Redacted], very carefully look at all of
the various treastment possibilities for early
stage prostate cancer. [PHI Redacted] chose Proton Therapy at
Loma Linda University for several clear reasons.
The first reasons is that the way protons deliver
their energy is through the phenomenon of the
Bragg Peak that causes 90% of the energy to be
released when the protons stop. This means that
there is minimal side effect scatter to adjacent
soft tissue and adjacent structures. IMRT
delivers approximately 60-70% of the energy from
gamma particles to the prostatic bed. The second
reason [PHI Redacted] chose proton therapy was that there was
very precise targeting to the prostate, to 1.2 cm
beyond the prostate capsule and to the adjacent
seminal vesicles. The tumors arise in the
periphery of the gland and recurrence is in the
adjacent soft tissue and in the adjacent seminal
vesicles. The third reason why [PHI Redacted] chose proton
therapy is that they had a very low sideeffect
profile including no incontinence, minimal effect
on potency and minimal rectal bleeding from
neovascularization. The fourth reason why [PHI Redacted]
chose proton therapy was that they had excellent
outcomes which were clearly as good as any other
treatments. [PHI Redacted] rejected brachytherapy because could now be assured of the dosage of irradiation
that was delivered to the periphery of the
prostate gland and very little to no irradiation
was delivered to the seminal vesicles. Because I
had done academic tumor biology research for over
30 plus years, I was highly qualified to review
all of the appropriate medical literature. [PHI Redacted] made
the right conclusion and [PHI Redacted] been free of
prostate cancer for over five years with no
sideeffects
The current controversary around proton therapy
vs brachytherapy appears to be focused on the
associated costs of each therapy. The physics
involved and the precise targeting associated
with proton therapy certainly caused me to select
proton therapy. I strongly feel that this should
continue to be a clinical option that is
reimbursed through Medicare as it is a very
effective treatment with minimal to no
sideeffects. |
| Commenter: |
Rosenblatt, Murray
|
| Date: |
9/8/2008 4:31:13 PM |
| Comment: |
[PHI Redacted] a cancer survivor thanks to Proton radiation.
[PHI Redacted] completed radiation in [PHI Redacted] with absolutely
no side effects what so ever..[PHI Redacted] enjoying a great lifestyle..I have
encouraged other males to at least look into
proton radiation before selecting other methods
of treatment..Please all forms of treament are
great but let us not get into a war of words and
do what is best for the patient.. |
| Commenter: |
Boley, John
|
| Date: |
9/8/2008 5:08:53 PM |
| Comment: |
|
[PHI Redacted] was treated with proton radiation three years
ago and very distressed that Medicare is
considering removing coverage of this vital
cancer treatment. When [PHI Redacted] was diagnosed and began
research on treatment options it became obvious
that there were grim choices for long term
quality of life among the traditional surgical
and photon radiation treatments. I did extensive
research which including many discussions with
men who had been treated with the traditional
methods. Almost without exception they would,
after initially saying it went OK, begin to tell
me about the various problems with incontinence
and impotence that they lived with. It was very
depressing and caused a great deal of anxiety[PHI Redacted].
[PHI Redacted] I talked with and
corresponded with many who had experienced this
treatment and they reported minimal if any long
term deterioration of their quality of life. My
conclusion is that true all of the treatments
have similarity in outcomes as far as treating
the disease; but the potential long term side
effects are a very real concern. Many
practitioners of the ‘standard’ treatments focus
on the cure and pass over or minimize side
effects. [PHI Redacted] urologist was very hostile to proton
treatment with insinuations that it was some kind
of voodoo. My sense, and it may only be
perception, is that many radiologists and
urologists feel that proton treatment threatens
their practice in some way.
It seems to be very dismissive to focus on the
cure and ignore the long term side effects as if
we were lucky to be cured and just live with
them. Before you come to any conclusion I urge
you to survey the opinions of the men who have
had the various treatments to really understand
the extent of deterioration of quality of life in
each. |
| Commenter: |
GALL, ERNEST
|
| Title: |
Retired US Navy |
| Date: |
9/8/2008 6:18:57 PM |
| Comment: |
[PHI Redacted]received 8 weeks of Proton & 3D
therapy for Prostate Cancer - No complications!
[PHI Redacted] had a prostatectomy - spent 10 days in
the hospital, he suffered from incontinence &
erectile dysfunction.
His medical costs as a in-patient for 10 days
exceeded charges for 8 weeks treatment as a
out-patient.
[PHI Redacted] -ERNIE GALL-
|
| Commenter: |
Pulliam, Morris
|
| Organization: |
Morris W. Pulliam, M.D., LLC |
| Date: |
9/8/2008 11:11:07 PM |
| Comment: |
I am a neurosurgeon certified by the American Board of Neurological Surgery in May 1979. I was Chairman of Neurosurgery and residency program director for 10 years at the National Naval Medical Center, Bethesda, MD. I have been in private practice in Warren and Youngstown Ohio for the past 9 years.
In the past 6-7 years I have preformed well over 500 kyphoplastys. Before that I had performed several vertebroplastys. I have treated vertebral compression fractures in patients with osteoporosis and metastatic disease. Before adopting vertebroplasty and kyphoplasty, I had treated such patients with very unsatisfactory medical modalities with analgesics and bracing. Bracing in particular was a waste of time and money in that very few of the people that I ordered braces for ever wore them for more than a few days and most patients continued suffer unremitting pain for months with frequent exacerbations as fractured vertebrae continued to collapse further and further.
I feel strongly that patients with vertebral compression fractures in osteoporsis or metastases should be treated with kyphoplasty ACUTELY. This allows rapid return to premorbid levels of functional activity but, importantly, prevents not infrequent additional vertebral collapse with increased pain and reaching a degree of severe collapse wherein kyphoplasty (or vertebroplasty) are rendered impossible.
In my experience with 500 plus kyphoplastys I have achieved 90 percent or more pain relief in 85 to 90 percent of patients. I have had no deaths, infections, neurological or cardiopulmonary complications. Leakage rates have been less than 3 percent. 97 percent of patients have been discharged to premorbid living arrangements in less than 24 hours of performance of the kyphoplasty. Over 85 percent are discharged on nothing stronger than acetomenophen or ibuprofen for pain.
This experience clearly demonstrates the health benefits of kyphoplasty for pain relief and restoration of a high level of functional activity. This applies to both tumor and osteoporosis patients.
I am convinced that the partial restoration of vertebral height achieve by kyphoplasty (more than seen in vertebroplasty) reduces spinal imbalance and muscular strain which is part of the reason for the excellent level of pain relief achieved with kyphoplasty. Anyone having observed patients undergoing medical management (anlagesics and bracing) and kyphoplasty would consider use of medical management as cruel and unusual punishment.
CMS should seek less patient abusing means of cost control than the dollars that might be saved by placing unwarranted restrictions, financial or otherwise, on performance of kyphoplasty.
Thank you for your consideration of the above.
|
| Commenter: |
Vaughn, Catherine
|
| Date: |
9/9/2008 1:37:27 AM |
| Comment: |
Proton Beam Radiation Treatment for Prostate
Cancer.
[PHI Redacted] finished treatment, [PHI Redacted], at
Loma Linda, Ca. for Prostate Cancer. There has
been zero side effects and he feels wonderful,
At his 4 month checkup, his PSA dropped from 12.4
to 2.o.
It is expensive, but in the long run, it is
cheaper because there are no side effects
afterwards. therefore,there is no other costs
involved except his regular check up and PSA
tests. |
| Commenter: |
Clark, Charles
|
| Date: |
9/9/2008 12:24:00 PM |
| Comment: |
It is disheartening to read postings from 'medical professionals' that only consider the technical and first appearance cost aspects of cancer treatment and not the final outcome. At first glance it appears these 'professionals' are concerned from a competitive outlook about a completely proven treatment that might cut into their profit centers. I didn't read in a single posting about the care or side effects of the 'customers' they serve. I have several friends that have each gone through the therapies listed in the postings and each of them have had severe and awful long term problems - I know of no such problems with any of the proton treatment customers I have met and talked with! It is also interesting to note that many of the patients I met at Loma Linda going through treatment had gone through some of these other treatments and now had to come to the Proton Center to clean up what these 'medical professionals' had missed or screwed up - so now what is the real cost to Medicare to pay twice for these treatments when the first treatment would have cured the problem? My opinion is that the proton treatment should be the only option Medicare should consider for the treatment of prostate cancer! |
| Commenter: |
Horton, Billie
|
| Date: |
9/9/2008 12:58:57 PM |
| Comment: |
|
[PHI Redacted] had the proton treatment,it is the best
procedure and worth all the money and time doing
it. No problems after seven years. [PHI Redacted] had this
done at 80 after Dr. said we do not operate
on men of your age. |
| Commenter: |
Church, Thomas
|
| Title: |
Director of Interventional Radiology |
| Organization: |
St. Rita''s Medical Center |
| Date: |
9/9/2008 5:58:40 PM |
| Comment: |
Both Kyphoplasty and Vertebroplasty have worked extremely well in my practice. I have experience with over 500 cases, and the results are nearly miraculous. People who come into my suite barely able to ambulate, leave one hour later pain-free. These procedures work well for Any kind of painful fracture whethr osteoporotic, traumatic , or neoplastic in nature. I Strongly urge you to remove Kyphoplasty and Vertebroplasty from any NCD policy. |
| Commenter: |
Simroth, Don
|
| Title: |
Retired |
| Date: |
9/9/2008 7:13:38 PM |
| Comment: |
[PHI Redacted] received Proton Radiation treatment for prostate
cancer which was covered by Medicare because of age (71).Being a retired chemical engineer, I
carefully studied the cure rates and side effects
of the various treatment options.[PHI Redacted] selected Proton
radiation because the cure rares were the same as
for surgery and conventional radiation but the
side effects were much less.[PHI Redacted] Proton treatment
has proven choise to be the correct one as [PHI Redacted]
have no sign of cancer reoccuring after 4 years
and absolutely no side effects from Proton
radiation treatment.
I believe that Medicare should continue to cover
this procedure in the future.When I first started
to explore proton thearpy, only two sites were
available.Now there are several around the country
and more seem to be on the horizon. I believe this
is happening because of the minimual side effects
from proton radiation.
When considering costs, the additional costs
associated with side effects should be included in
the other treatment oprions.
|
| Commenter: |
Farmer, Merle
|
| Date: |
9/9/2008 10:22:41 PM |
| Comment: |
Proton treatment for prostate cancer
[PHI Redacted] I cannot
express strongly enough my belief that it should
continue to be covered.
[PHI Redacted] had zero side-effects from the treatment
(unlike many of my associates who have suffered
from incontinence and impotence after both
surgery and seed implant treatments). Quality of
life is something that is impossible to measure.
Since treatment [PHI Redacted] PSA has remained at 0.1 and
follow-up exams show no evidence of any
problems.
In fact, my Family Doctor has stated that he will
absolutely have the same treatment should he
develop prostate cancer.
As a side note - [PHI Redacted] decision to have Proton
Treatment was not made due to financial
considerations but due to word-of-mouth research
[PHI Redacted] did with others who had had all types of
treatment and Protons were the overwhelming
winner for both lack of side effects and long-
term prognosis. |
| Commenter: |
marquis, richard
|
| Date: |
9/10/2008 12:11:39 AM |
| Comment: |
[PHI Redacted] a survivor of prostate cancer, and I
attribute the cure to the proton beam treatment
[PHI Redacted]. [PHI Redacted] PSA level is now 0.1.
Medicare approved the procedure and without
Medicare's help, [PHI Redacted] would not have been able to
receive this treatment which I believe was much
better than radical surgery. [PHI Redacted] urologist
strongly recommended radical surgery but 2 yrs
after received the proton beam treatment, he
told [PHI Redacted] that made the right decision. [PHI Redacted] I strongly
recommend that Medicare continue to help pay for
the proton beam treatment. |
| Commenter: |
Wederich, Robert P
|
| Date: |
9/10/2008 6:19:48 AM |
| Comment: |
[PHI Redacted] former prostate cancer patient who was
treated with proton therapy under Medicare
approximately six years ago. [PHI Redacted] suffered no side
effects from the therapy, and PSA has hovered
near zero since the therapy was completed. Some
of my acquintances had far less successful
results from other therapies. I urge you not to
discontinue Medicare payment for proton therapy. |
| Commenter: |
Edison, MD, MPH, Jay
|
| Title: |
MD, MPH |
| Date: |
9/10/2008 10:14:21 AM |
| Comment: |
| I wish to comment on the threat of withdrawal of
Medicare funding of proton beam therapy for
prostate cancer. I am a retired family physician,
who had a second career in international public
health with an NGO. [PHI Redacted] proton beam therapy was a
positive experience with no side effects other
than mild fatigue and dysuria, which resolved soon
after completion of treatment. [PHI Redacted] From [PHI Redacted] experience,
and discussions with other proton patients, I am
totally convinced of the value of proton therapy
in avoiding the high level of morbidity associated
with other modalities. I admit that I began to
have some doubts when reading the comments of
distinguished researchers who oppose proton
therapy. Then I learned of the recent comparative
analysis of proton and photon patients relative to
risk of 2nd malignancy (C.S. Chung, N. Keating, T.
Yock, N. Tarbell,
Comparative Analysis of Second Malignancy Risk
in Patients Treated with Proton Therapy versus
Conventional Photon Therapy, International
Journal of Radiation Oncology*Biology*Physics
Volume 72, Issue 1, Supplement 1, Proceedings of
the American Society for Therapeutic Radiology
and Oncology 50th Annual Meeting, American
Society for Therapeutic Radiology and Oncology
50th Annual Meeting, 1 September 2008, Page S8).
Now, I am more convinced than ever of the
superiority of proton over photon therapy. Maybe
proton recipients will not live longer than
photon patients, but more of us will live better! |
| Commenter: |
Wulf, Marcus
|
| Title: |
Individual |
| Organization: |
None |
| Date: |
9/10/2008 10:15:05 AM |
| Comment: |
[PHI Redacted] a recovering prostate cancer patient who
received proton treatment. [PHI Redacted] experience-and
that of the hundreds of other proton patients
with whom I have had contact-was outstanding.
The tumor was controlled, and the side-effects
were minimal-or none.
In contrast, of the many people who I know that
have had other treatments, the vast majority have
had problems-even including death(either from
recurrence or surgery-related). Many have had to
endure additional treatment, and many have had to
live out their lives with some kind of impairment
of their normal functions.
It is inconceivable that you would restrict
access to proton treatment for prostate cancer
because cheaper treatments are available-they
are also less successful.
|
| Commenter: |
Caliguri, John
|
| Date: |
9/10/2008 11:39:42 AM |
| Comment: |
|
My comment is with respect to the following
proposal;
Proton beam therapy for prostate cancer: Proposed
as means to concentrate radiation therapy and
reduce side effects. Very high upfront cost to
build these facilities and thus only at very few
facilities. For prostate cancer treatment, no
current comparative trials comparing to usual
therapy.
[PHI Redacted] had succesful treatment for prostate
cancer by proton beam radiation. [PHI Redacted] was treated
six years ago, PSA prior to treatment was 23.
Since treatment, PSA is steady at 0.7. [PHI Redacted]
little or no side effects from the treatment.
In the meantime, two friends had conventional
radical prostitectomy, both endured incontinence
and impotence after the surgery. One of them
died later still wearing his depends. Another
aquaintance was treated with cyrotherapy and
still sufferes from the effect of the treatment
on the surounding tissues. I convinced yet
another person to seak treatment by Proton beam
radiation. He [PHI Redacted], as I am, very satisfied with his
treatment and recovery.
The upfront costs are higher because of the
costs of building the facility. However, the
benefits must be well documneted because, since
[PHI Redacted] treatment, three more facitities have opened
and more are currently under construction.
Construction costs will continue to fall as more
are built.
There was sufficient documented evidence, when
[PHI Redacted] was trying to decide on treatment, of the
benefits of the treatment by proton beam
radiation, less side effects and reduced damage
to surrounding tissue. [PHI Redacted] had to arrange follow
up coverage with a local oncologist after treatment. Before treatment he said he
thought traditional radiation therapy would do as
good a job. Subsequent to treatment he
said "You really made the right choice".
I think the statement in the proposal saying
that there are no current studies that show
benefits of proton beam radiation for the
treatment prostate cancer is misleading. The
evidence was clearly there when [PHI Redacted] made decision. I think it should be the
responsibility of "conventional" therapies to
prove that they are as good as Proton Beam
Radiation.
|
| Commenter: |
Armstrong, Eugene
|
| Date: |
9/10/2008 12:05:39 PM |
| Comment: |
Between [PHI Redacted], [PHI Redacted] was treated
for prostate cancer at Loma Linda Medical Center.
[PHI Redacted] was treated with Proton Therapy. [PHI Redacted] made this
decision because of the successful record of
treatment with NO side effects.
As of this date, [PHI Redacted] had NO side effects, PSA continues to go down and the quality of life is as good as it ever was.
I firmly believe that this form of treatment
offers the best chance that the cancer victim
will not suffer the side effects of incontenance
and/or impotence and gives a good quality of
life during and after treatment.
After much research, I am very happy with this
choice and I encourage others to investigate
Proton therapy.
I feel it would be a tragedy to deny payment for
Proton therapy based on the cost. You cannot put
a price on QUALITY OF LIFE after treatment.
Thank you, Eugene H. Armstrong |
| Commenter: |
Sellers, Don
|
| Date: |
9/10/2008 12:54:11 PM |
| Comment: |
[PHI Redacted] underwent Proton therapy treatment for Prostate
Cancer in 2005. I learned of this cancer
treatment thru my dentist whose father-in-law had
the treatment 16 years earlier( & is still cancer-
free). After being approved for the treatment
and insurance coverage, [PHI Redacted] began treatment with
no side effects. It is amazing and I have
recommended this to some co-workers who have been
diagnosed and know of 2 who have done this
treatment with great success. [PHI Redacted] PSA has gone
down to 1.0 with no sign of cancer returning.
There were no side effects during or after
treatment. I feel it is very important to keep
proton treatment as a treatment for Medicare
patients. It is very effective with less side
effects than other treatments and should be made
available thru Medicare for those who take the
time to research treatments and discover this
method. It would be very sad to think that if [PHI Redacted]
cancer returns at a later date that Medicare
would not cover this treatment as I KNOW that it
WORKS! Please consider the mental well being of
cancer patients along with the physical. I feel,
as do former proton treatment patients,
that Proton should be available to any person in
the US who would choose it as it is effective! |
| Commenter: |
Williams, Paul
|
| Title: |
President |
| Organization: |
Paul Williams and Assoc. |
| Date: |
9/10/2008 12:56:15 PM |
| Comment: |
SUBJECT: Response to The Possibility of CMS Eliminating
Payment for Proton Beam Radiation Therapy for Prostate Cancer
[PHI Redacted] received proton beam radiation therapy Gy 18 months ago to
cure prostate cancer. [PHI Redacted] had daily treatments providing in
total about 80 Gy to prostate. If given on whole
body at one time, this would be about 10 times a lethal dose.
The radiation to good tissue was so low that [PHI Redacted] had no significant
negative side effects. Treatment was painless and there were no
restrictions on physical activity. [PHI Redacted] PSA before treatment
was 11 ng/ml and has continued going down. Today it is 1.5
ng/ml. About 100 other prostate cancer patients being treated
at the same time had similar results.
The dose distribution with protons to the prostate is
significantly better than treatment with neutrons or x-rays,
permitting more radiation to the cancer and a better cure rate
with no major adverse side effects in most cases. James Metz,
MD at the Abramson Cancer Center of the University of
Pennsylvania, compares the acute and long term side effects of
protons, photons (x-rays), and prostatectomy in a report, dated
June 29, 2006. His comparison is summarized below.
The acute complications of proton versus photon therapy are:
Grade 2 GU toxicity - Protons 0%, Photons 28%
Grade 2 GI toxicity - Protons 0%, Photons 35%
Either GU or GI morbidity - Protons 0%, Photons 53%
Acute complications of a prostatectomy are:
Hospitalization - 5 to 7 Days
Absence from work - 4 to 6 Weeks
Death - 0.3%
Pulmonary embolism/ DVT - 2.6%
Myocardial infarction or arrhythmia's - 1.4%
Wound Complications - 1.3%
Lymphocele - 0.6%
Surgical Rectal Injury - 1.5%
Long term complications for protons, photons and
prostatectomy are:
Impotence - Protons 30%, Photons 60%, prostatectomy 60%
Incontinence requiring a pad - Protons prostatectomy 32%
Bladder Neck contracture - Protons 0%, Photons 3%,
prostatectomy 8%
Chronic Cystitis - Protons 0.4%, Photons 5%, prostatectomy n/a
Grade 3 GU toxicity severe frequency - Protons 0.3%, Photons
2%, prostatectomy 36%
Grade 3 GI toxicity rectal bleeding requiring transfusion severe
pain - Protons 0%, Photons 7%, prostatectomy n/a
Rectal Stricture - Protons 0%, Photons 0.5%, prostatectomy n/a.
In addition to the above, the AMA in 2005 published a report
stating that those patients having a prostatectomy will have a
reoccurrence of cancer within 10 years.
Also, protons may treat tumors within 0.4 inches of nerves or
vital organs without damage to these items. This is not possible
when treatment is done with x-rays. This fact helps to confirm
that proton beam therapy reduces radiation to good tissue for
prostate treatment.
Yes, treating prostate cancer is more expensive with protons
than treatment with x-rays. Conversely, cost for treatment of
acute and long term complications with standard treatment are
substantial. This may involve treatment with chemotherapy,
radiation, hormones and more, plus a negative effect upon the
patient’s quality of life, lost time, hospitalization and other
complications. I do not know the cost of a prostatectomy, but
based upon the cost of [PHI Redacted] one day in the hospital to place a
stent in an artery ($40,000), the cost of a prostatectomy is
probably at least as high as proton therapy.
Some claim that proton therapy is experimental. Over 55,000
cancer patients have been treated with protons. 25 facilities in
the world now treat prostate cancer and about 50 other cancers
with protons in a clinical environment, and at least 15 more are
building or planned. About 200 insurance companies support
proton therapy for cancer including prostate cancer.
One of your responders stated that proton therapy costs
$200,000 per patient. Wrong. For 44 days of treatment to cure
[PHI Redacted]prostate cancer the cost was $56,000, paid by Medicare and
supplemental insurance company.
Some claim that the 5 hospitals in the USA providing proton
therapy are enough. Again, wrong. These facilities can treat, at
most, 12,000 patients per year. As estimate for today indicates
that about 300,000 cancer patients per year could benefit from
proton therapy. An oncologist at a large hospital stated to me
that due to the aging population, this number could reach
1,000,000 within 10 to 15 years.
Robert J. Marckini ([PHI Redacted])
published a book in 2006 entitled, “You Can Beat Prostate
Cancer and You Don’t Need Surgery To Do It.” This book was
written after studying proton and standard treatments and
discussion with many doctors and patients. His book is now one
of the best selling medical books on amazon.com. He also
established a prostate cancer support group, now numbering
over 3,500 patients.
In all due respect, if Medicare should eliminate payment for
proton therapy for prostate cancer, it would be a disservice to
patients, negatively effect their lives and in the long run,
increase Medicare cost. With further technology improvements
planned for existing and planned proton treatment facilities, its
cost will decrease.
Sincerely,
Paul .C Williams |
| Commenter: |
Becker, Irving
|
| Title: |
Retired CEO |
| Organization: |
Food Safety Concern |
| Date: |
9/10/2008 1:51:01 PM |
| Comment: |
Proton beam therapy for prostate cancer: Proposed
as means to concentrate radiation therapy and
reduce side effects. Very high upfront cost to
build these facilities and thus only at very few
facilities. For prostate cancer treatment, no
current comparative trials comparing to usual
therapy.
My response to this issue:
[PHI Redacted] was treated for prostate cancer at the Loma
Linda University Medical Center in January to
March 2004. [PHI Redacted] had a PSA of 5 and a Gleason Score
of 3+2 for a total of (5). [PHI Redacted] biopsy showed cancer was a stage T1C. [PHI Redacted] prostate was enlarged
to about 80 grams.
[PHI Redacted] had 40 proton treatments and PSA has
continued to decline and is now 0.2 after 4 and a
half years. Following Proton therapy treatment [PHI Redacted] no side affects from the treatment. [PHI Redacted] take Flomax and Finasteride (Proscar) to
offset the normal issues of an enlarged prostate.
Proton therapy has cured [PHI Redacted] prostate cancer and
allowed to have a normal life without urinary
or sexual side affects. [PHI Redacted] very thankful that was able to have this proton therapy versus other
options that usually have life changing negative
side affects.
Irving L. Becker |
| Commenter: |
Bayko, John
|
| Date: |
9/10/2008 2:42:36 PM |
| Comment: |
My Perspective [PHI Redacted] Concerning Medicare
Funding of Proton Beam Therapy
[PHI Redacted] I submit the following for your
consideration.
Prior to selecting PBT, [PHI Redacted] researched, read books
on different modalities, and talked with many
former PBT patients. Some of them can be
contacted by phone or e-mail here:
http://www.protonbob.com
After treatment, [PHI Redacted] had one minor side affect
which resolved in two days (blood in urine …
checked by cystoscopy.) The opinion of the
radiation oncologist is that it was the normal
process of blood cells renewing themselves.
[PHI Redacted] feel well and able to maintain the level of
energy and good general health that [PHI Redacted] had before
the Proton Beam Therapy.
I have read with dismay of the side effects
suffered by those who had surgery. A patient my
family knows had brachytherapy. Due to a seed
moving where it was not supposed to go, this man
nearly lost his life. Instances like this
reinforced [PHI Redacted] decision to choose PBT.
[PHI Redacted] incurred considerable personal expense
traveling 6000 miles round trip to the PBT
facility. Why did [PHI Redacted] choose to do that when a
world renowned IMRT center was only 100 miles
from home? It was because of the excellent
results, with few side effects, expressed in many
testimonials for PBT and because of research.
Further, it was because [PHI Redacted] had a right nephrectomy
in [PHI Redacted] and nephrologist recommended that [PHI Redacted]
not choose IMRT because of side effects.
The cost of [PHI Redacted] treatment to Medicare was not the
total of the charges submitted by the Proton
Center. It was 80% of the Medicare “approved
charges”. The difference was significant.
Medicare has been at the forefront of providing
medical care for seniors. Regardless of a man’s
age, it is imperative that he be given a chance
at a full and healthy life.
If you were to be a candidate for treatment of
prostate cancer, what would you recommend that
Medicare do?
Please consider the material I have included
here – when making a decision on continuing
Medicare funding of Proton Beam Therapy.
Thank you.
John S. Bayko
|
| Commenter: |
Cory, Charles
|
| Date: |
9/10/2008 6:05:03 PM |
| Comment: |
In [PHI Redacted] developed prostate cancer and
researched all the different treatments and
decided, without a doubt, on Proton Therapy. [PHI Redacted] now cancer free and so thankful that
Medicare and Blue Cross covered the cost. It is
an absolutely marvelous treatment. No Hospital
stay, no discomfort and no side effects. I have
many friends who did other treatments and almost
every one suffered from side effects such as
incontinence and impotency, which creates more
expense and follow-up treatment and surgery.
Please continue funding the Proton Therapy cure
for cancer. Thank you.
Charles Cory
|
| Commenter: |
Moody, Robert
|
| Date: |
9/10/2008 6:51:52 PM |
| Comment: |
[PHI Redacted] a Prostate Cancer Survivor. [PHI Redacted] had Proton
Beam Radiation on Prostate and writing to
encourage you to continue financial support for
this type of treatment that I would say is
superior to all others. [PHI Redacted] Family Physician
suggested that [PHI Redacted] investigate Proton Beam
Radiation when it was proven that [PHI Redacted] had
aggressive cancer of the Prostate through
biopsies by Urologist. [PHI Redacted] purposely did not
chose Surgery due to a disastrous, near death,
encounter with surgery on a poisonous, infected
Gall Bladder. [PHI Redacted] was aware of radiation burns from
X-Ray Radiation. I talked with men having had
Proton Beam Radiation and they all related
positive experiences. I have had 35 years
experience as a Research Engineer in Major
Electronic Instrumentation Companies so I applied
good research methods to find the best solution
for [PHI Redacted] need. [PHI Redacted] was grateful to travel 500 miles
and be a short term resident for 8 weeks of
treatment. [PHI Redacted] not experienced any side
effects after 5 years from treatment. [PHI Redacted] PSA has
been near zero for over 4 years. I am very
grateful that Proton Beam Radiation was
recognized for its quality treatment and covered
by Medicare. I encourage you to continue that
coverage. |
| Commenter: |
Becker, Irving
|
| Title: |
Retired CEO |
| Organization: |
Food Safety Concern |
| Date: |
9/10/2008 6:53:12 PM |
| Comment: |
Ablation for atrial fibrillation: If medication
is not effective or not tolerated for atrial
fibrillation, a nonsurgical procedure called
catheter ablation may be chosen. Focal and
circumferential catheter ablation for atrial
fibrillation is still being studied in
investigational trials but may be done in
selected patients to try to cure atrial
fibrillation. Is the evidence adequate to
demonstrate health benefits in the patients who
receive the procedure?
My response to this issue:
[PHI Redacted] was treated for atrial fibrillation by Dr.
[PHI Redacted] at the Cleveland Clinic in April,
[PHI Redacted] by the use of focal and circumferential
catheter ablation. [PHI Redacted] was 66 years old at the
time, and was otherwise in health
[PHI Redacted] had recurring and chronic atrial fibrillation
for about 5 years preceding the ablation. [PHI Redacted] took
a number of different drugs to control the Afib,
but all of them made [PHI Redacted] sick and prevented from living a normal and active life. [PHI Redacted] could
not easily walk up stairs or play any favorite sports such as tennis, hiking, camping,
etc.
The circumferential catheter ablation immediately
returned [PHI Redacted] to normal sinus rhythm and been in normal sinus rhythm for over 5 years
since the ablation. The ablation basically gave
[PHI Redacted] life back. The drugs were not able to do
that[PHI Redacted]. For [PHI Redacted] circumferential catheter
ablation was a life saver.
[PHI Redacted] 71 now, and about a month ago [PHI Redacted] was under
considerable stress. For the first time since
the ablation [PHI Redacted] had a short bout of Afib. It was
treated with Propafenone HCL (Rythmol) and immediately returned to normal sinus rhythm
again. [PHI Redacted] cardiologist believes it is likely will able to stop taking Rythmol in month or so.
It is very important to [PHI Redacted] to maintain sinus
rhythm without taking heart rhythm drugs as they
all have serious and harmful side affects.
[PHI Redacted] very thankful that was able to have
circumferential catheter ablation so could
return to normal sinus rhythm and enjoy an active
and healthy life style.
Irving L. Becker |
| Commenter: |
Hallock, Lowell
|
| Date: |
9/11/2008 12:32:15 AM |
| Comment: |
[PHI Redacted] was diagnosed with prostate cancer in [PHI Redacted]. [PHI Redacted]
doctor recommended proton therapy treatment. [PHI Redacted]
accepted that advice. [PHI Redacted] received the 8-week
treatment and feel that it is by far the best
there is available today. [PHI Redacted] PSA is checked every
6 months by Urologist and it has remained
under 1.0. [PHI Redacted] was completely satisfied with every
aspect of treatment and would not hesitate to
recommend proton treatment to anyone diagnosed
with prostate cancer. |
| Commenter: |
Lee, Arthur
|
| Title: |
Partner |
| Organization: |
Wellington Orthopedics and Sport Medicine |
| Date: |
9/11/2008 9:47:58 AM |
| Comment: |
I have been a practicing Orthopedic Surgeon
performing total hip arthoplasty for over 21
years. The BHR resurfacing arthoplasty
represents a dramatic improvement in this
proceedure. The BHR is a total hip in that both
the acetabulum and femoral head are resurfaced
and therefore it does represent a "stop gap"
type proceedure. In actually the longevity of
this operation is almost identical to convential
total hip replacement. However, the BHR
patients have less bone removed, recover faster,
have less pain, a lower dislocation rate, and
higher overall patient satifaction. It is
clearly the superior operation and I perform
this proceedure on all patients who are
candidates for it because of its superiority.
It would be a travesty not to have this
proceedure available to our Medicare and
Medicaid population
Sincerely, Arthur F.Lee M.D. FACS
|
| Commenter: |
Ronald, Bruce
|
| Title: |
Emeratus Professor of Chemistry |
| Organization: |
A retired private citizen!!!!!!!!!!!!!!!!!!!!!!! |
| Date: |
9/11/2008 2:48:26 PM |
| Comment: |
Proton Beam Therapy is the most effective method
for treatment of prostate cancer. It has the
best statistics for complete recovery without the
serious side effects that are characteristic
of 'seeds, surgery, and x-rays'. [PHI Redacted] a walking,
completely functioning testament to the success
of proton beam therapy treatment. It would be a
tragedy if future generations of prostate cancer
victims were denied this form of treatment. In
essence such denial sentences future prostate
cancer suffers to a life of misery and pain. I
know this for a fact because my friends and
neighbors who chose other methods of treatment
currently suffer from their sides effects, they
feel embarrassed in public and suffer from
continuous pain. As the agent amd gardian of
health care for the aged medicare and its minions
OWE it to the men of this nation to continue to
support proton beam therapy as a treatment option
for prostate cancer. |
| Commenter: |
Zenz, Joe
|
| Date: |
9/11/2008 6:41:33 PM |
| Comment: |
Proton Treatment for Prostate Cancer
[PHI Redacted] recently
completed 45 proton treatments for prostate
cancer. [PHI Redacted] cannot express the gratitude for
being able to receive this treatment. [PHI Redacted] NO
side effects from this treatment. NONE. I talked
to friends that had surgury for prostate cancer
and and still wearing diapers 3 years later. I
talked to men who have incontient problems and
are impotent. [PHI Redacted] NONE of this problems.
Without Medicare many of us could not have this
treatment. I urge whomever is voting on this not
to discontinue this coverage. |
| Commenter: |
Braren, Warren
|
| Date: |
9/11/2008 9:40:18 PM |
| Comment: |
Eliminating Medicare coverage for the treatment of prostate cancer with proton beam therapy is very ill-advised. Attention instead should be to bring down the cost of treatment in the years ahead.
After months of careful investigation in [PHI Redacted], [PHI Redacted] chose to have prostate cancer treated with protons at Loma Linda University Medical Center. Why? [PHI Redacted] lead a very active life and wanted to avoid debilitating side effects that not only would affect life going forward but that of wife. [PHI Redacted] made the right choice. Except for some slowing of urination, which possibly is due to aging anyway, [PHI Redacted] side effect free.
Cancer has been on my agenda for many years at no small cost to myself. I was a director of the broadcast industry's Radio and Television Codes heavily involved in the self-regulation of TV advertising. In 1969, I blew the whistle on cigarette advertising before Congress leading to the legislation banning cigarette commercials from radio and TV. As a result, the broadcast industry lost countless of millions of dollars and I lost my broadcast career but many lives were saved.
Why do I mention this? Because money is not the sole determing factor when decisiona on health issues are involved. Medical coverage and the treatment method impact one's health and lifestyle for years to come. Decisions have to be made based upon the quality of treatment, its outcome and minimal side effects - not just the cost. In that regard. proton beam therapy for prostate cancer ranks at or near the top. [PHI Redacted]
|
| Commenter: |
Kelley, Darlene
|
| Date: |
9/12/2008 7:14:45 PM |
| Comment: |
I am not medical never have been nor will I ever
be but what I do know from experience. [PHI Redacted] was diagnosed with prostate cancer over
two years ago. He weighed many options but the
only one that made sense to him was Proton
therapy. He had proton and photon treatments.
He is doing great. I would hate for Medicare to
discontinue the coverage of proton therapy. [PHI Redacted] has no side effects never any
incontinence, no pain. Feels great.
We have/had friends who used other methods of
treatments and [PHI Redacted] has not experienced any
of their side effects. They have had problems
with incontinence and their sex life wasn't all
that great after treatment.
Please let the person with the prostate cancer
make the decision as to what kind of treatment is
best for them. Just knowing that they have
cancer is a hard pill to sollow and then be told
they can't have the treatment they want. |
| Commenter: |
Williams, Paul
|
| Title: |
President |
| Organization: |
PTher |
| Date: |
9/12/2008 9:59:42 PM |
| Comment: |
There is an error in my comment The paragraph "In addition to the above, the AMA in 2005 published a report stating that over one third of those patients having a prostatectomy will have a reoccuranceof cancer within 10 years."
' over one third" was not included in the submittal. Sorry for the error. PCW |
| Commenter: |
GENUINO, RAFAEL
|
| Title: |
D.V.M. |
| Organization: |
(retired) USDA, FSIS, IP, FOREIGN PROGRAMS |
| Date: |
9/13/2008 4:58:23 AM |
| Comment: |
I am a retired USDA Veterinary Medical Officer
(Foreign Programs Officer) [PHI Redacted]. [PHI Redacted] was treated succesfully by proton
beam radiation with practically no untoward
effects or complications. [PHI Redacted] In contrast, [PHI Redacted] had radical
operation(removal of prostrate) at Sloane-
Kettering Memorial Hospital. He had so many
complications and after effects and worst of all,
he became impotent. He had to undergo further
expensive surgeries and treatments at Cornell
Medical Hospital in New York so he could be
intimate with his wife again. His quality of life
was severely affected by the surgical removal of
his prostrate. Two years later, his prostrate
cancer showed up again and was successfully
treated by proton beam radiation at Loma Linda.
[PHI Redacted] proton beam treatment was over four years ago
and psa is now 0.6 and prostrate shrunk
considerably that urine flows easily and
normally. [PHI Redacted]
Your plan to stop reimbursing proton beam
treatment expenses will be a great mistake and
will be a step backward to more humane treatments
of cancer. Quality of life must be considered in
your decision. Thank you. |
| Commenter: |
Metzler, Bruce
|
| Date: |
9/13/2008 10:55:14 AM |
| Comment: |
[PHI Redacted] was diagnosed with prostate cancer in July of [PHI Redacted] and spent
six months analyzing all the treatment options (including
surgery, IMRT, proton beam therapy and seeds), deciding on
Proton Beam Therapy. [PHI Redacted] decision was heavily weighted by the
probability of the side effects from the various modalities,
possibly resulting negative effects on life style. [PHI Redacted] finished treatment at Loma Linda Medical Center in March of [PHI Redacted]. To
date the treatment lived up to expectations - psa has
continued to fall and there have been no side effects, ie, no
incontinence, no erectile dysfunction and no rectal issues.
Needless to say [PHI Redacted] quite happy with decision to use Proton
Beam Therapy. |
| Commenter: |
Althoff, David
|
| Title: |
Retired |
| Date: |
9/13/2008 12:29:19 PM |
| Comment: |
|
This is in regards to Medicare possibly dropping
medicare recipients from receiving aid for Proton
Radiation treatments for prostate cancer. [PHI Redacted] After witnessing [PHI Redacted]
with prostate cancer at age 58; his surgery; and
his very painful death 7 weeks later I knew I
would never have surgery. [PHI Redacted] had surgery on his prostate 4 years ago.
It is now a horror story and it has come back.
His demise is in the near future. After much
research, I discovered the proton treatment. [PHI Redacted] had 35 treatments with NO SIDE EFFECTS.
The proton treatment seems to have a much higher
success rate than surgery with a very minimum
amount of side effects. And others that I have
spoken to who has had this proton treatment has a
very low PSA count many years later with a very
good quality of life. My reason for writing to
you is to please advise those requesting medicare
to drop this treatment that this is a very
successful treatment and should not be stopped.
If you know anyone who has protate cancer, please
have them check into proton treatments. This
treatment is saving [PHI Redacted] life! Thank you for
reading my letter. |
| Commenter: |
Young, Robert
|
| Date: |
9/13/2008 1:15:51 PM |
| Comment: |
|
Re: Proposal to stop Proton Medicare reimbursements:
[PHI Redacted] a Prostate Cancer survivor who owes life to having been
able to receive Proton Therapy seven years ago. [PHI Redacted] cancer,
Gleason 9, was sufficiently aggressive that precise pin-pointing of
the radiation beam was required. This was possible with Proton
Therapy, but not with conventional radiation. The result was not
only an undetectable PSA, but, very importantly, reduction of major
long-lasting side effects. |
| Commenter: |
Gift, Gary
|
| Date: |
9/13/2008 2:01:31 PM |
| Comment: |
I am commenting on the proposal to discontinue
reimbursement by Medicare for Proton Radiation
Therapy. [PHI Redacted] had Proton Therapy for prostate
cancer and the reason [PHI Redacted] selected Proton over all
the other options was because of quality of life
concerns. [PHI Redacted] experience is that [PHI Redacted] had zero
issues related to sexual, urinary or intestinal or
any other function during or since treatment.
I know other men who have had other
treatments surgery and radiation seed implants,
who have had significant and progressively
worsening issues since their treatments.
Not only is their quality of life deteriorating,
but their medical costs continue to mount as they
try to correct or lessen the symptoms of their
problems.
I believe it would be a mistake by Medicare to
discontinue Proton treatment reimbursement because
of the initial cost of the treatment. You need to
include the after treatment costs of the other
methods surgery, regular radiation and seed
implants, as well as the potential deprivation of
quality of life benefits for Proton patients.
In addition, continuing improvements in Proton
methods is bringing the costs down and the future
costs will be much more competitive. |
| Commenter: |
Medley, Edward
|
| Date: |
9/13/2008 2:12:52 PM |
| Comment: |
Proton Therapy Treatment for Prostate Cancer
Based on [PHI Redacted] experiance I strongly
urge CMS to continue to cover Proton Therapy
Treatment for prostate cancer. [PHI Redacted] PSA is down
to .05 and never had issues with incontinence
or impotence. [PHI Redacted] had no infection, bleeding or
pain. This treatment is far superior, and safer
than traditional surgery for the above reasons.
|
| Commenter: |
Kallstrom, James
|
| Date: |
9/13/2008 2:25:05 PM |
| Comment: |
[PHI Redacted] did a lot of research and consulted several
doctors before choosing proton therapy for
treating [PHI Redacted] prostate cancer. I think proton
therapy is best for many man due to the
minimalizaiton of side effects, which must be
taken into account in determining "cost", which
must surely decrease as time goes on.
Please do not take away this treatment choice |
| Commenter: |
Jehn, George
|
| Date: |
9/13/2008 3:50:43 PM |
| Comment: |
Dear Sir or Madam,
I cannot fathom the proposal to disallow Medicare
reimbursement for Proton therapy treatment. This
issue should not be about the cost of the
treatment, but rather its effectiveness and lack
of side effects, which results in a much better
quality of life for the cancer patient. I watched
[PHI Redacted] lose all of his quality of life after
having prostate removal surgery no more fishing,
golf, or anything he used to enjoy tremendously.
When [PHI Redacted] was diagnosed decided upon proton therapy
because of 1) it's overall effectiveness and 2)
because of minimal side effects.
[PHI Redacted] received proton treatment at Massachusetts
General Hospital for prostate cancer over three
years ago. [PHI Redacted] PSA was 4.7 before treatment and as
of last test had decreased to 1.2, with no side
effects whatsoever.
The issue here should NOT be about cost, because
if you remove that from the equation, the overall
best and most effective option for the treatment
of prostate cancer is proton therapy.
The money saved via this poorly-thought-out
proposal would be better spent going after doctors
who convince unknowing, uneducated patients to
undergo needless surgery, or surgery where it is
quickly discovered that the patient needs some
form of radiation treatment because the Medicare
paid for surgery did not remove all the cancer.
You should be ENCOURAGING patients to receive
proton therapy rather than trying to remove this
option from the acceptable Medicare treatments.
This proposal is a giant step backwards.
George Jehn |
| Commenter: |
Bates, Christopher
|
| Date: |
9/13/2008 4:00:10 PM |
| Comment: |
RE: Medicare/Medicaid Coverage of Proton Therapy
for Treatment of Prostate Cancer
There is no question in my mind that proton
therapy offers the best available treatment
option for men diagnosed with early- or
intermediate-stage prostate cancer. Medicare and
Medicaid should continue to grant full coverage
to these treatments. This will also help ensure
that most private insurance companies continue to
cover this proven therapy – an important fact for
those of us who have not yet reached retirement
age. I hope HHS will take the educated patient’s
perspective into account when making its decision
on this matter.
[PHI Redacted] I learned
about this option by chance and word-of-mouth.
Specialists offering alternative treatments don’t
like to talk about proton therapy or have done
little to inform themselves about it. They leave
it up to motivated patients interested in their
own well-being to do the research. [PHI Redacted] urologist
who diagnosed [PHI Redacted] was more objective than many I
have heard about from my friends on the subject
of proton therapy. He said he had heard of it
but did not know a lot about it, encouraged research and was genuinely neutral in his
recommendation of treatments.
I extensively researched proton therapy and
compared it to the many alternatives[PHI Redacted]. I discovered there are lots of
studies on surgical and traditional radiation
options, but most are based on what most people
would consider to be small patient sample sizes –
300 to less than 1,000 in most cases. Further,
most of these studies were sponsored by medical
institutions with a vested interest in the
therapy being studied.
The long-term survival rates of patients in these
studies were roughly the same for all of the
analyzed treatments, but the frequency of
undesirable side-effects was high, quite variable
and affected significantly by the choice of
physician who performed or managed the
treatment. [PHI Redacted]
In contrast to photon therapy, proton therapy is
performed at only a few facilities in the United
States, is comparatively “new,” and not
surprisingly has fewer published studies to
document its growing success. There is a rather
extensive study published by Loma Linda that
should be closely reviewed. It documents that
proton therapy for prostate cancer patients is
producing results equivalent or somewhat better
than those for IMRT and other more widely
practiced radiation therapies.
In addition, I encourage CMS to carefully review
the just-released Harvard study that is mentioned
in one of the comments posted in this online
comment section of the HHS website. That study
covered 1,450 patients treated between 1974 and
2001 and controlled for age, year of treatment,
site of treatment, and cancer histology.
The Harvard study found a remarkable 50 percent
lower incidence in secondary malignancies in
proton patients than in those who had received
photon radiation treatments. Apart from the
lower frequency and intensity of post-treatment
side-effects, this is one of the important
claimed benefits of proton therapy – which now
has been documented in a solid, peer-reviewed
study.
[PHI Redacted] recently
completed therapy at the Florida Proton Therapy
Institute with very positive results and an
exceptional experience: no pain, quality care,
accessible physicians and nurses, and
professionals who were eager to explain proton
therapy and its likely impacts. [PHI Redacted] was able
to continue a very active telecommuting work
routine throughout 8 weeks of proton therapy
and maintain usual, active lifestyle
throughout.
With average life expectancy rising and earlier
diagnosis of prostate cancer occurring, the
economics of proton therapy has become clear.
This miraculous treatment option should be
encouraged and fully funded. Proton therapy is
good medicine and good public policy. HHS would
not have placed this therapy on its covered list
previously if it did not agree with this
conclusion.
Proton therapy is both reasonable and necessary.
Thousands of patients who have experienced it
believe this is true and there are recent, valid
studies that show the genuine immediate and long-
term benefits of this therapy in comparison with
other alternatives.
Thank you for considering these comments.
Sincerely,
Chris Bates |
| Commenter: |
Fisher, Gerry
|
| Title: |
Director of Purchasing |
| Organization: |
Precoat Metals, a division of Sequa Corporation |
| Date: |
9/13/2008 5:10:14 PM |
| Comment: |
| I watched [PHI Redacted] suffer incontinence,
impotence, and urethra blockage following
prostate surgery. So, when [PHI Redacted] was diagnosed, I
was determined to find a better therapy. I
quickly learned that all of the prostate cancer
therapies have comparable cure rates, so my quest
was for the one that would preserve quality of
life. [PHI Redacted] had consultations with some of the best
doctors practicing each therapy - [PHI Redacted] at Northwestern University Med. Center
for open surgery, [PHI Redacted] at the Henry
Ford Hospital in Detroit for robotic laparoscopic
surgery, [PHI Redacted] at Washington
University Med. Center in St. Louis for hand
laparoscopic surgery, and [PHI Redacted] at
Washington University Med. Center for IMRT and
Bracytherapy. All of these doctors said that
theirs' was the best therapy for prostate cancer,
but none could give assurance that [PHI Redacted] would not
suffer the life-changing side-effects [PHI Redacted] was
trying to avoid. Also, none of these doctors
could produce data on the percentage of patients
using their therapy that had these side-effects,
and they would not provide access to former
patients that could testify on the subject.
Things were different when I investigated proton
therapy at Loma Linda University Med. Center. Of
course, Loma Linda doctor would not rule out
the possibility of impotence or incontinence, but
they had a 15 year study that showed outstanding
results. In addition, I found a pool of hundreds
of past patients in the Brotherhood of the
Balloon that gave compelling testimony to
proton's effectiveness and lack of morbidity. [PHI Redacted]
chose protons at Loma Linda, and underwent
treatment from October [PHI Redacted] to January [PHI Redacted]. [PHI Redacted]
not had the slightest incontinence or
impotence, and PSA has fallen steadily. I
know scores of past proton patients, and don't
know a single one that has suffered this
morbidity, and has not had curative results. I
also know many patients that had very advanced
cancer that was written-off by the other therapy
practitioners, but were effectively treated at
Loma Linda. There is a reason that large
investments are being made in new proton centers -
this therapy offers superior results. If
allowed to flourish, proton treatment will be the
standard treatment for prostate cancer in the
future. You would be making a grave error to
disallow Medicare coverage for proton treatment
of prostate cancer. |
| Commenter: |
Haley, Shirley
|
| Date: |
9/14/2008 9:07:12 AM |
| Comment: |
|
[PHI Redacted] After checking out several alternative
treatments [PHI Redacted] decided on Proton. There are very
few side effects with this treatment. Just a
little red spot on one hip was the extent of [PHI Redacted]
side effects. When compared with what [PHI Redacted]
urologist was recommending (hormone shots and
radiation) this was a breeze! Hormone shots were
not necessary. At one time [PHI Redacted] PSA was 29 (after a
biopsy) and now it is 2.9 and will continue to go
down. [PHI Redacted] was a 7 Gleason Score. [PHI Redacted] 80 years old
and am glad that did not do the "watch and
wait" theory either. The treatment was great and
so were the people at the Florida Proton Center.
I would recommend Proton treatments for anyone
with cancer. |
| Commenter: |
Krutenat, Richard
|
| Title: |
Ph.D., MIT, Materials Science/Engineeing |
| Organization: |
personal |
| Date: |
9/14/2008 9:18:58 AM |
| Comment: |
|
I am concerned that CMS will remove proton
therapy from coverage by medicare, based on the
biased and uneducated responses of many
oncologists and radiologists who favor IMRT. Many
of the comments I have read so far demonstrate a
lack of knowledge about the advanced proton
procedures and a failure to take into account the
reports of patients on the success of their
treatment. Patient follow up has been done and is
continuing to be done contrary to the opinions of
several commentors and extensive documentation is
available. Advances have been made in proton
therapy and accurate beam modulation is done,
specifically designed for each patient, and
prostate location is also done with x-ray
location by gold fudicial markers during each
exposure and after exposure as well. As a
scientist familiar with radiation effects in
materials, selection of proton therapy based on
Bragg effects was a fundamental in [PHI Redacted] selection
of proton therapy. Costs of proton therapy are
coming down, and research to provide advanced
treatment with IMRT sized machines is underway. I
believe strongly that to stop reimbursement for
proton therapy is a serious mistake. Please do
not stop coverage! |
| Commenter: |
Gaskin, Don
|
| Date: |
9/14/2008 11:57:04 AM |
| Comment: |
I am [PHI Redacted] and a retired air
Force veteran. I strongly oppose the emlimina-
tion of funding of Proton Therapy from Medicare.
[PHI Redacted] a one year survivor who had Proton Therapy.
[PHI Redacted] experienced no significant side-effects during
treatment nor after. [PHI Redacted] was able to continue a
fairly active lifestyle including cycling. [PHI Redacted]
rode bicycle almost 800 miles during treatment
which [PHI Redacted] could not have done under any other
treatment protocol I know of.
Please consider lifestyle and quality of life
factors in your evaluation and keep funding
Proton Therapy as it is the best overall package
today in my view. |
| Commenter: |
Black, Dwight
|
| Date: |
9/14/2008 1:25:02 PM |
| Comment: |
It is imperative that proton therapy be covered by medicare! Opponents(all who seem to be motivated by reduction in the income from their specialties) state things like "brachytherapy has equal result to proton therapy". No one has had a seed migrate with protons! |
| Commenter: |
Lucietto, Ledo
|
| Date: |
9/14/2008 8:35:08 PM |
| Comment: |
Response to question of effectiveness of Proton
Treatment: Proton treatment has Successfully
treated prostate Cancer in 2004. [PHI Redacted] I am definitely a proponent of
Proton Treatment. Thank You |
| Commenter: |
Schaefer, charles
|
| Date: |
9/14/2008 11:36:55 PM |
| Comment: |
Regarding the funding of proton radiation treatment for prostate cancer: Consideration should be given to the fact that many of the patients were not acceptable for other cancer treatments because of the higher grades of their cancer or their complications like organs out of place or a stroke candidate. These higher risk patients could be accepted for proton treatment. Other treatments could accept only the low risk patients so the data must take this into consideration, Then the efficiency of proton radiation will be truly indicated.
|
| Commenter: |
Blaney, Charles
|
| Date: |
9/15/2008 2:05:22 AM |
| Comment: |
[PHI Redacted] was diagnosed with Prostate Cancer
and thought it was the end of the world. [PHI Redacted]
doctors told [PHI Redacted] to "pick poison"; i.e.
surgery, seeds, or radiation. All have lasting
side effects especially incontinence and
impotance. After careful study [PHI Redacted] found out
about and chose Proton Beam Therapy. [PHI Redacted] Cancer cured
and absolutely no lasting side effects. All
treatments are not equal. Proton Beam Therapy
is by far the best. Please do not deny Medicare
coverage for this treatment.
Thank you,
Charles BlaneyI though |
| Commenter: |
Brinning, Ronald
|
| Title: |
Member |
| Organization: |
Brotherhood of the balloon |
| Date: |
9/15/2008 9:32:55 AM |
| Comment: |
Proton beam therapy is definatly saving lives in all age groups from babies to 80 year olds. Some procedures are not even possible especially on small children except with Proton beam therapy. The almost total lack of side affects alone is worth keeping this mode of treatment funded. It would be a crime against mankind to drop Medicare payments for this mode of treatment. Charges for Proton Therapy will no doubt go down as more facilities become available. Several sights are planned for and or being built now. Consider this as an argument to do all we can to promote Proton Therapy. Back in the 70's solar energy was trying to make it's place in our country as a partial solution to world oil shortages. They said Solar Cells would come down in cost with more usage. If we would have nurtured that technology think how it would be helping us now with the cost of energy. I'm sure the same kind of people who put down Proton Therapy today would have put down Solar Energy back in the 1970's. In a word, those kind are all about greed and care nothing about the general welfare of mankind. |
| Commenter: |
Doran, Carlos
|
| Date: |
9/15/2008 11:20:30 AM |
| Comment: |
To Whom It May Concern:
[PHI Redacted] Almost [PHI Redacted] years ago, [PHI Redacted] began
proton radiation treatment at Loma Linda
University Medical Center for prostate cancer. [PHI Redacted]
started with a PSA of 10+, today it is .2 . [PHI Redacted]
cancer was considered stage 3. Today [PHI Redacted]
prostate cancer free and one of thousands of
men that have been treated and healed with proton
radiation at Loma Linda University Medical
Center. I have friends that chose different
forms of treatment. All are impotent, and some
will wear diapers the rest of their lives. [PHI Redacted]
came through the treatment with basically NO side
effects. Which treatment do you think is better
for your senior years???
Sincerely,
Carlos M. Doran |
| Commenter: |
Biddle, Ray
|
| Date: |
9/16/2008 10:40:54 AM |
| Comment: |
[PHI Redacted] I
believe that proton therapy should continue to be
covered by Medicare. [PHI Redacted] received news that [PHI Redacted] had prostate
cancer. [PHI Redacted] elected to undergo proton therapy.
Other than a brief period of urinary frequency
while undergoing the therapy, [PHI Redacted] had no side
effects and there has been no impact on the
quality of life. Moreover, PSA has improved
dramatically. If [PHI Redacted] had been age 70 or more, [PHI Redacted]
could foresee not having undergone proton therapy
(or even surgery). |
| Commenter: |
Schwager, Frederic
|
| Title: |
Retired |
| Date: |
9/16/2008 2:32:27 PM |
| Comment: |
The case for proton therapy can readily be made
in all three areas currently being discussed,
i.e., cost, effectiveness, and quality of life
during and after treatment.
Cost - The perception is generally accepted and
widely disributed that proton therapy is
significantly more expensive than other forms of
therapy. However, I have yet to see an analysis
of costs which includes all cost factors, such as
hospitalization, recovery, follow up,
medications, treatment of side effects, treatment
of ongoing adverse conditions, etc. The costs
noted are largely borne by Medicare and private
insurance. Loss of income, however, is a
significant cost which is borne by the patient.
[PHI Redacted] I met a
number of patients who continued during the
entire treatment process, stopping at the
treatment center either on the way to or from
work.
I suspect that if a complete and honest study of
costs were done it would show proton therapy to
be cost-competitive with other treatments.
Effectiveness- The usual mantra from "the
establishment" is "There is no side by side study
which shows proton therapy to be superior to
other treatments." The obvious answer is that
there also is no side by side study which shows
that other treatments are superior to proton
therapy. There is plenty of data, however, which
shows cure rates to be about the same for all
availabe treatments, including proton therapy.
The claimed advantage of proton therapy is in a
large reduction of side effects. There is a
growing mountain of data supporting this claim,
and anecdotal evidence also supports the
superiority of proton therapy in greatly reducing
side effects. Every proton therapy patient I
know has stories about being free from side
effects while friends or relatives who have
undergone other treatments are permanently
impotent or incontinent or require follow up
procedures, or etc., etc., etc..
Quality of life - Proton therapy delivers a
superior quality of life during and after
treatment. During treatment there is no
hospitalization, no restricted activities, no
pain, no medications, no anesthetics, no
catheters, no invasive procedures. Life goes on
as normal. For some patients the is no treatment
facility near home, temporary housing must be
arranged.) A typical treatment requires the
patient to be at the treatment faclity for
approximately 1/2 hour per day. The rest of the
day is free to do whatever he wants to do. Play
golf run errands, work, volunteer, visit, go to
the gym, or whatever. When the course of
treatments is completed, follow up consists of
routine visits to a local urologist for psa tests
and a DRE. It's just take your last treatment
and return to life as normal. Contrast this to
other treatments, such as surgery, which requires
hospitalization, slow recovery at home,
restricted activity, follow-ups to remove the
catheter and deal with side effects
(incontinence, impotence, etc.) and loss of
earnings if you work.
Summary - When all the above factors are
considered, proton therapy is clearly a superior
treatment for prostate cancer, probably at equal
or less cost than other therapies, if all factors
are considered. I urge you to continue Medicare
coverage for proton therapy. |
| Commenter: |
Wyatt, Jim
|
| Date: |
9/16/2008 4:35:02 PM |
| Comment: |
"The prime function of government is the
protection of life and property."
Any government agency that is responsible for the
welfare of its citizens, should put its citizens
first especially with health care. I researched
what form of treatment would be best [PHI Redacted] for
nearly a year. I interviewed doctors that
provided all the treatments avalible [PHI Redacted]. I
believe it would be a grave error for medicare to
restrict any form of "successful life saving
treatment" that appears to to be only a money
driven drive that would dicriminate against the
elderly.
Respectfully,
Jim Wyatt |
| Commenter: |
James, DC
|
| Title: |
Lets Keep Proton Treatment For Prostate Cancer |
| Organization: |
Harmony Bay Publishing & Productions |
| Date: |
9/16/2008 4:39:02 PM |
| Comment: |
I have personally met a number of people who have had proton treatment for prostate cancer The level of vigorous physical activity those men demonstrated during and after their treatment, the sexual potency they reported and their lack of incontinence, and the benign nature of the treatment, should give pause to even the staunchest detractors. If we can send people to the moon, lets find a way to preserve this wonderfully humane treatment. Please.
|
| Commenter: |
Osberg, Fred
|
| Title: |
retired |
| Date: |
9/16/2008 6:31:04 PM |
| Comment: |
Many persons covered by Medicare are on fixed imcomes and can not or may not be able to afford the costs of Proton radiation treatment. By removing this benifit many people would have to choose a method of treatment that although is affective is plagued with many permanate side affects and in some cases do not elimate all traces of the cancer. Recurring cancer costs (in some cases) should be considered before a final desision is made to eliminate Proton coverrage. |
| Commenter: |
Brookes, Jr., Albert Sidney
|
| Title: |
none retired senior citizen |
| Organization: |
None |
| Date: |
9/17/2008 2:31:08 PM |
| Comment: |
Having read several books on prostate cancer and
talked with a number of friends with prostate
cancer, I believe that proton therapy is a very
viable treatment option for this type of cancer
and should be kept in the arsenal of treatment
options covered by Medicare and hence also by
many other insurance policies. For many men it
has the potential of less side results and even
has documented results of less side effects.
[PHI Redacted] urologist told [PHI Redacted] proton radiation therapy for
prostate cancer was highly experimental. This is
a case of either he does not know the literature
or his vision is obscured by NIH, not invented
here!
After reviewing all the options, [PHI Redacted] selected
proton radiation therapy as the best treatment
(least side effects) for prostate cancer[PHI Redacted].
|
| Commenter: |
Hart, Richard
|
| Date: |
9/17/2008 7:18:21 PM |
| Comment: |
I am deeply troubled by the proposal to remove
Medicare coverage of proton beam therapy for
prostate cancer.
[PHI Redacted]
Granted, many candidates for proton therapy
cannot take the time, nor would they have the
means for housing, if they cannot reach a proton
center for treatment on a daily basis. This is
why it is heartening to see growth in the number
of facilities available. Even more exciting than
the effectiveness of proton treatment for
prostate cancer is similar treatments evolving
for other cancers – some that presently have no
viable alternative.
My opposition to the proposal to remove proton
therapy from Medicare coverage is many fold:
-
If Medicare coverage for proton treatment
is discontinued, most other insurance providers
will likely follow suit. Since prostate
treatment is the mainstay of most of proton
therapy facilities, they may not be able to
survive financially. This will effectively
remove one of most effective options for, not
only prostate cancer, but also other cancers,
such as pancreatic, brain and brain stem, spinal
cord, pediatric cancers and potentially many
others as protocols are developed.
-
Five proton therapy centers are in
operation now with several in the pipeline for
the future. This will increase access to this
option to individuals as the word gets out about
its effectiveness and reduced side effects. The
proposal to eliminate coverage will likely kill
off these projects underway along with the
existing operating centers.
-
Effectively treating prostate cancer, as
a criterion, can not be evaluated without
consideration of the side effects and their
resulting affect on the patient’s quality of
life. This would be like discontinuing coverage
for prosthetic legs because the patient can still
use a wheel chair to get around.
-
From personal experience, this proposal
seems to be driven by urologists and conventional
radiation oncologists afraid of loosing
business. I frequently wonder if the time will
come when someone who has received bad side
effects from surgery or conventional radiation
will sue his urologist for not providing facts on
ALL of the options, specifically including proton
therapy, for cancer treatment.
-
The proposal to discontinue coverage for
proton beam treatment of prostate cancer is in
direct conflict with the popular “Stand Up for
Cancer” movement, supported by both presidential
candidates, to attack cancer of all kinds.
-
A significant percentage of “beam time”
in the operating facilities is dedicated to
research. This research will cease if the proton
centers close down.
-
Successful development of “one room”
proton beam equipment – which might ultimately
result in significantly lower costs for proton
treatment – would likely not continue if CMS
succeeds in their “effectiveness” argument for
current proton-beam treatment.
-
This proposal, coupled with a recent
recommendation to discontinue prostate
surveillance for men over age 70, regardless of
state of health, is age discrimination at its
worst. Proton therapy is an extremely viable
treatment for older men who would be ill advised
to undergo surgery but who would otherwise have a
long life expectancy. Where does CMS get off
determining the value of an older individual and
his quality of remaining life?
I urge CMS and Medicare to reject any proposal to
reduce coverage of proton beam treatment of
prostate cancer. The continued enjoyment of key
functions of life without compromise following
treatment for cancer is too valuable to disregard
as unimportant! |
| Commenter: |
Renzi, Sam
|
| Title: |
Pastor |
| Organization: |
Seventh-day Adventist |
| Date: |
9/17/2008 8:29:54 PM |
| Comment: |
Dear CMS
I understand that CMS may stop Medicare payments
for prostate cancer patients using proton
therapy. Please reconsider this drastic action
for the following reasons.
1. The COST of proton treatment is reasonable
compared to the total cost of other treatments,
during and after treatment. Experiments are soon
to be announced to bring the cost down by
reducing the number of treatments, and treating
more patients.
2. The QUALITY of life during and after proton
treatment is the big advantage.
3. MORE proton treatment centers are being built
or have plans to build making this treatment more
widely available—such as Oklahoma, Virginia,
Pennsylvania , Illinois, Florida, Atlantic City,
New Jersey San Diego, CA, Seattle, Birmingham,
Alabama, Ohio, Nassau, Bahamas, Sidney,
Australia, United Arab Emirates Germany etc. (I
read that about 40 proton centers are being
considered.) If it wasn’t successful why are so
many willing to invest millions of dollars? At
the Loma Linda University Medical Center,
patients have come from all 50 states and more
than 25 countries. Surely it will be more widely
available.
4 All prostate cancer treatments are equally
effective, but [PHI Redacted] chose proton because it is:
1.precise, 2 non-invasive , 3 fewer side effects,
4 better quality of life during and after
treatment.
I strongly urge that CMS take these factors into
consideration and continue to fund proton therapy.
Pastor Sam Renzi |
| Commenter: |
Staples, Robert
|
| Title: |
Mr. |
| Organization: |
Retired IBM |
| Date: |
9/18/2008 9:24:09 AM |
| Comment: |
|
Please continue medicare coverage for proton
therapy.
The cause of death on [PHI Redacted] death
certificate states "carcinoma of the prostate
gland". You may be assured [PHI Redacted] carefully checked
documented statistics and consequently had proton
radiation therapy at age [PHI Redacted] ending in June [PHI Redacted].
Today , over five years later [PHI Redacted] no residual
side effects and remain fully active with a
quality of life as good or better than before
treatment. (last psa was 0.04.) Should my son
of grandson have prostate cancer, please do not
deny them this superior treatment if they are not
among the wealthy.
To get the full cost (not just the initial
treatment), you need to use your medicare
database to see what the total (Medicare cost of
treatment) and all followup treatment for two,
three or five years is including hormones Dr.
visits as well as any followup treatment. In [PHI Redacted]
case a psa reading and digital rectal exam once a
year along with annual physical. (no
additional cost)
[PHI Redacted] had a choice to have protons with less
radiation going in with a burst of energy in the
tumor to destroy the cancer with zero radiation
beyond the tumor (that may effect vital organs),
and proton treatment was logical choice.
Please do not deny others this choice. |
| Commenter: |
Ford, Pamela
|
| Date: |
9/18/2008 11:04:43 AM |
| Comment: |
I have mailed this letter in its full form
anticipating that parts of this will have to be
deleted due to the "Posting Policy"...
I have no medical degree, but I have learned more
in the past few years than I ever thought I would
know about blood and medicine.
[PHI Redacted]
was diagnosed with ITP over 4 years ago and since
that diagnosis has endured numerous treatments
that have failed to control his severely low
platelet counts.
I am aware that this particular topic is
referring to the adult use of drugs like Nplate,
but please allow me to state a strong case
regarding why this drug is needed, has been
needed and will continue to be needed for adults
and children alike. Please note that limiting
access to patients by not covering its use would
hinder the progress that is being made in this
area of medicine.
[PHI Redacted] received his first IVIg 12 days after his
initial diagnosis, to which he had a severe
reaction. The 2nd infusion was less than 2 weeks
later, pre-treated to ease the side effects.
This form of treatment has, continued throughout
the 4 years as his “standard” emergency
treatment. He responds for 2-3 days and then
drops back down to what is considered
his “normal” platelet count of less than 10k.
High dose steroids failed next, followed by a
short therapy of Vincristin w/ Cyclosprine and
steroids. Short because after the second dose,
he suffered a life threatening paralytic ileus
reaction to the Vincristin. This information is
relevant because it shows his limits for future
types of treatments.
7 months after his diagnosis his spleen was
removed. [PHI Redacted] moved down the list of treatments,
almost in clinical order. The splenectomy
resulted in a recovery of counts in the 40k’s –
60k’s range for about a year before plummeting
back to his normal range again. This particular
year was a blessing for the mere reason that [PHI Redacted] who is an excessive, frequent and spontaneous
bleeder was free from his two and a half hour
nose bleeds for that year.
Once the year of “somewhat peace” was over, we
were in what seemed to be worse condition than
before. His body seemed to reject all
treatments. That year we tried Rituximab, 6MP,
Dapsone, and Cellcept.
His next treatment was a combination therapy of
high dose infusions of prednisone, IVIg and
WinRho injections supplemented by daily oral meds
of Decadron and Azathioprine. He received the
infusions every Wednesday because they only held
his counts for 2-4 days before they drop
dramatically. Each Wednesday appointment his
counts are less than 10k.
[PHI Redacted] doctors have told [PHI Redacted] on
numerous occasions that this is the worst case of
ITP they have seen at their hospital. The mix of
the persistently low count with the excessive
bleeding and the side effects to standard
treatments has been a challenge for all of us.
The doctors would consistently reach out to the
leading specialists. Their recommendations had
all begun to turn to the new thrombopoietin lines
of treatments like Nplate which gave us renewed
hope.
[PHI Redacted] is now in the pediatric clinical trial for
Nplate. He is showing great progress. All of
the treatments he has tried before were used “off-
label” to attempt to treat his ITP. THIS drug is
designed TO TREAT his ITP, not some other
disorder/disease/illness. Unlike the other
treatments, he has had NO side effects at all.
NONE. He is progressively getting his life back
and [PHI Redacted].
I am a member of the Platelet Disorder Support
Association. I communicate daily with parents of children with ITP as well as adults
that are currently in or were in one of the
clinical trials for this drug. We are excited
and anxious for this desperately needed drug to
become available for children and just as excited
that it is now available for adults. I am aware
that the “numbers” of patients with ITP are not
great, that the level of attention “our” illness
receives is much lower than some higher profile
illnesses. Please keep in mind though that the
effects are still the same. The life-threatening
risk of a brain bleed is no different if a
patient has low platelets due to ITP or due to
another illness with low platelets as a “side
effect”. The difference comes into play when you
are able to treat the “other” illnesses and the
platelet function returns. With ITP, there is no
other alternative than to treat the platelet
issue.
FDA’s job was and continues to be watching to
make sure these drugs are safe. It is my
understanding that data is coming in on a regular
basis to ensure that safety. That should not be
a concern for anyone beyond their group, it is
their expertise. There are many of us that are
and will continue to benefit from the use of this
drug. Please do not allow that number to be
limited by the lack of coverage some families
will need in order to obtain the treatments. In
my honest opinion, it just seems natural to me
that our government agencies would allow our
physicians to make treatment decisions with their
patients based on what is best for the patient.
FDA approving the drug might be viewed by some as
an agreement with that statement. Questioning
coverage determination seems to undermine all
parties involved (FDA, doctors and patients) and
at what expense? |
| Commenter: |
Walter, Patricia
|
| Title: |
Owner/Webmaster |
| Organization: |
Joint Health Sites LLC |
| Date: |
9/18/2008 1:20:27 PM |
| Comment: |
I want to support the discussion of Hip
Resurfacing and Medicare coverage of Hip
Resurfacing.
I am [PHI Redacted] a Patient
Advocate and Owner/Webmaster of a large Hip
Resurfacing Website called Surface Hippy.
http://www.surfacehippy.info
The website receives over 9000 unique visitors a
month and generates almost 100,000 page views a
month. It is the largest Patient to Patient Hip
Resurfacing Website and is consistently rated 4-
6th on Google for Hip Resurfacing.
A large number of patients that choose hip
resurfacing are in the 50 -70 age category. I
have a Patient Survey from the Yahoo Surface
Hippy Group posted on my website and you can see
that out of 855 patients that participated, 470
people were 50 years of age or older.
http://www.surfacehippy.info/survey/hipresurfacing
survey.php
Most of these patients only received one hip
resurfacing and will most likely need their other
hip done at some time in the future. That means
that they could easily be of Medicare age when
they need the second hip resurfaced. If Medicare
does not approve hip resurfacing, these people
will be forced to pay for their own surgeries or
travel overseas for their hip resurfacing.
[PHI Redacted] was 61 when had Hip Resurfacing and had to
travel to Dr. [PHI Redacted] in Belgium because [PHI Redacted] did
not have health insurance. [PHI Redacted] I certainly hope Medicare
will cover Hip Resurfacing[PHI Redacted].
[PHI Redacted] had a hip resurfacing and find it to be the
best bone conserving option for a hip
replacement. [PHI Redacted] an active person and chose a
hip resurfacing to remain active[PHI Redacted]. Hip Resurfacing is a viable
option for people over 65 years of age. Hip
resurfacing candidates are not chosen by their
age, but by the quality of their bones, their
activity level and their physical condition. Many
patients in the 60’s, 70’s and even 80’s receive
Hip Resurfacing overseas. It is an excellent
option for active people over 65 years of age.
As [PHI Redacted] a Patient Advocate and Owner/Webmaster of a
large Hip Resurfacing Website – I encourage
Medicare to support the discussion of Hip
Resurfacing and to cover the Hip Resurfacing
Procedure. |
| Commenter: |
Hartley, F
|
| Date: |
9/18/2008 2:50:50 PM |
| Comment: |
Proton Therapy is not invasive, has an excellent cure rate and does not have side effects. For most men this is the first choice of treatment. PROTON THERAPY:
To consider not covering proton therapy for prostate cancer is unconscionable. No other way can a man be successfully treated for this disease and not suffer the rest of his life. None from the effects of this therapy but many effects from any of the other treatments. Add the cost of other therapys the treating and caring for the many side effects Consider that and the cost of Proton Therapy is very comparable. |
| Commenter: |
Morlock, Patricia
|
| Date: |
9/18/2008 3:13:05 PM |
| Comment: |
I want to support the discussion of Hip
Resurfacing and the Medicare coverage of
Hip Resurfacing.
[PHI Redacted] had hip resurfacing surgery (BHR) from Dr
[PHI Redacted] in Honolulu in August and find it to
be the best bone conserving option for a hip
replacement. [PHI Redacted] an active person and chose a
hip resurfacing to remain active. [PHI Redacted] may need a
second hip resurfacing at some time in the future
and definitely think Medicare should cover the
surgery and procedure as did HMSA insurance.
[PHI Redacted]
Hip Resurfacing is a viable option for people
over 65 years of age. Hip resurfacing candidates
are not chosen by their age, but by the quality
of their bones, their activity level and their
physical condition. Many patients in the
60's, 70's and even 80's receive hip resurfacing
overseas. It is an excellent option for active
people over 65 years of age.
Thank you,
Patricia Morlock |
| Commenter: |
O''Malley, Paul
|
| Date: |
9/18/2008 4:12:05 PM |
| Comment: |
I would like to support the discussion of
covering hip resurfacing under Medicare. [PHI Redacted] Resurfacing is a
great procedure, and its appropriateness is not
determined by age, but rather by theindividual
patient's bone density and activity level. The
procedure is routinely done for patients older
than 65 in other parts of the world.
Thank you,
Paul O'Malley |
| Commenter: |
Brydon MD, William
|
| Date: |
9/18/2008 8:19:59 PM |
| Comment: |
My comments are in reference to the proposal
of medicare and medicaid to no longer pay for
proton radiation treatment for prostate cancer.
I am now retired but was a board certified
immunologist with a practice in allergy, asthma
and immunology. [PHI Redacted] biopsy
confirmed the diagnosis of prostate cancer. At
the onset of treatment PSA was almost 10
and Gleason score was 9.4. Although [PHI Redacted]
urologist admitted he knew little about protron
radiation therapy because articles about it did
not appear in the urologic literature, he refered
[PHI Redacted] for external beam conformational proton
radiation therapy. [PHI Redacted] results have been
excellent. PSA is now 0.2 and has been for
well over two years. [PHI Redacted] had no complications.
During the three years since treatment four of
my good friends have also had similar therapy.
All of them have had no significant
side effects and all lead active lives. During
this time also, however, five or more of my
friends have undergone other forms of treatment.
All of these have suffered one or more
complications/side effects, and one unfortunate
gentleman is now wearing a colostomy bag and
another a permanent supr-pubic catheter.
The medicare/medicaid proplem with this
therapy relates to cost. The initial cost of
proton radiation is somewhat greater, but when
surgeon fees, anesthesia fees, hospitilization,
drugs, lab work, etc is added up, the difference
isn't so much. The big difference is is the
treatment of complications. Proton therapy leads
to very few complications and of those the vast
majority are mild and require little or no Rx.
The amount of money paid by medicare and the
insurance company for the gentleman noted above
has cost more than the combined proton therapy
for [PHI Redacted] and my four friends. All of the costs of
therapy, including those that relate to
deterioration of life style must be considered.
[PHI Redacted]
Sincerely,
William L. Brydon MD
|
| Commenter: |
cepuran, Laura
|
| Date: |
9/18/2008 8:38:19 PM |
| Comment: |
I want to support the discussion of Hip
Resurfacing and the Medicare coverage of Hip
Resurfacing.
[PHI Redacted]
Hip Resurfacing is a viable option for people over
65 years of age. Hip resurfacing candidates are
not chosen by their age, but by the quality of
their bones, their activity level and their
physical condition. Many patients in the 60's,
70's and even 80's receive hip resurfacing
overseas. It is an excellent option for active
people over 65 years of age. |
| Commenter: |
Darr, John
|
| Date: |
9/18/2008 9:09:27 PM |
| Comment: |
I want to support the discussion of Hip
Resurfacing and the Medicare coverage of Hip
Resurfacing.
[PHI Redacted]
Hip Resurfacing is a viable option for people
over 65 years of age. Hip resurfacing candidates
are not chosen by their age, but by the quality
of their bones, their activity level and their
physical condition. Many patients in the 60's,
70's and even 80's receive hip resurfacing
overseas. It is an excellent option for active
people over 65 years of age. |
| Commenter: |
Winchell, Larry
|
| Title: |
Retired |
| Date: |
9/18/2008 10:43:21 PM |
| Comment: |
Proton Therapy for Prostate Cancer.
[PHI Redacted] completed proton therapy for prostate cancer in
May [PHI Redacted]. latest PSA was .04 which indicates
that [PHI Redacted] on the road to being cancer free which
is great news. During the
treatment and post treatment periods [PHI Redacted] not
had any quality of life issues (incontinence or
impotency). Many of my friends and acquaintences
who have had other types of treatments for
prostate cancer have not been so fortunate.
I strongly urge you to keep funding Proton
Therapy for prostate cancer. |
| Commenter: |
Rosenbaum, Karen
|
| Date: |
9/18/2008 11:57:57 PM |
| Comment: |
I hope the government will cover N-plate and the other new TPOs as treatments for ITP. So few treatments are available for those of us who have this platelet disorder, and these new TPOs sound so promising. |
| Commenter: |
Nowlin, Robert
|
| Date: |
9/19/2008 12:53:00 AM |
| Comment: |
|
I want to support the discussion of Hip
Resurfacing and the Medicare coverage of Hip
Resurfacing.
[PHI Redacted]
I definitely think Medicare should cover the
surgery and procedure. As an engineer I view the
resurfacing option as vastly superior in its
method of bone loading, and can envision where it
could contribute to better overall bone density
for an older person (this opinion is based on a
correlation to the NASA studies that show bone
density to be directly related to femur loading,
and loading with resurfacing would remain much
closer to standard anatomical approach).
Hip Resurfacing is a viable option for people over
65 years of age. Hip resurfacing candidates are
not chosen by their age, but by the quality of
their bones, their activity level and their
physical condition. Many patients in the 60's,
70's and even 80's receive hip resurfacing
overseas. It is an excellent option for active
people over 65 years of age.
|
| Commenter: |
mcnulty, karen
|
| Title: |
none |
| Organization: |
none |
| Date: |
9/19/2008 1:20:00 AM |
| Comment: |
|
Hip Resurfacing
[PHI Redacted] it is a bone conserving surgery.
An analogy would be if you had a hang nail, would you
amputate your finger ...no of course not ....then if
you have no cartilage left from osteoarthritis would
you cut off the the femoral head of the femur in and
replace it with a ball and spike or would you sand
of the femur and pop it back in with a metal cap and
small spike.....i think this a no brainer....your
best bet is the body part the you were made with and
if there is a surgery and a surgeon who has the
gift to give this to you than that is truly a
miracle in medicine!!!!! [PHI Redacted] Thanks for letting me share.
Karen McNulty
RHR Conserve +
Amstutz 8/29/06 |
| Commenter: |
Hardie, Eben
|
| Date: |
9/19/2008 10:20:21 AM |
| Comment: |
[PHI Redacted] was a recipient of a birmingham hip resurfacing
in [PHI Redacted] and would strongly encourage the
Government to approve this procedure as an
alternative to a full hip replacement.
While slightly more invasive, the long term
savings to the patient and to the Government as a
result of the lower likelihood of a repeat
surgery make it a much preferred procedure for
the patient and less expensive for the
Government. Strikes me as a "win-win".
As a matter of fact, [PHI Redacted] headed this week to
play in the over 50 National Clay Court Tennis
Championships, a pretty good testimonial tot he
effectiveness of the surgery. |
| Commenter: |
Petrick, Susan
|
| Date: |
9/19/2008 12:41:57 PM |
| Comment: |
|
I want to support the discussion of Hip
Resurfacing and the Medicare coverage of Hip
Resurfacing.
[PHI Redacted]
Hip Resurfacing is a viable option for people
over 65 years of age. Hip resurfacing candidates
are not chosen by their age, but by the quality
of their bones, their activity level and their
physical condition. Many patients in the 60's,
70's and even 80's receive hip resurfacing
overseas. It is an excellent option for active
people over 65 years of age. |
| Commenter: |
Leffel, Rick
|
| Title: |
Professional Engineer |
| Date: |
9/19/2008 8:21:28 PM |
| Comment: |
Proton Therepy should not be elimnated from medicare,. This therapy is state of the art, precise and effective. We do not start treatment with the old drugs because they are cheeper. We use all the modern advancement to save lives. With proton for prostate you have the most up to date accurate and least damaging and least side effect trearment |
| Commenter: |
French, Estella
|
| Date: |
9/19/2008 9:38:14 PM |
| Comment: |
I want to support the discussion of Hip
Resurfacing and the Medicare coverage of Hip
Resurfacing.
[PHI Redacted]
Hip Resurfacing is a viable option for people
over 65 years of age. Hip resurfacing candidates
are not chosen by their age, but by the quality
of their bones, their activity level and their
physical condition. Many patients in the 60's,
70's and even 80's receive hip resurfacing
overseas. It is an excellent option for active
people over 65 years of age. |
| Commenter: |
ALMEIDA, HILARY
|
| Date: |
9/20/2008 1:49:54 PM |
| Comment: |
Coronary angioplasty and stenting (PCI=Percutaneous Coronary Intervention ) is second in volume only to diagonostic coronary angiogrphy.In patients with ACS( acute coronary syndrome,i.e. acute MI or unstable angina) , PCI has been clearly shown to improve outcomes and is recognized as a Class I indication. However this indication accounts for only a small fraction of PCI performed, the vast majority , about 85% being performed in patients with stable coronary artery disease, in which the benefit of PCI over medical therapy alone has not been shown see COURAGE Trial Research Group Optimal Medical Therapy With or Without PCI for stable coronary disease NEJM 2007;356:1503-16 The American College of Cardiology in the guidelines and recommendations for PCI recognizes this as a Class II indication It was hoped by me and many observers that good sense would prevail in the face of such evidence but the reality has been otherwise. In the meanwhile thousands of CMS beneficiaries are subject annually to PCI with no scientifically proven benefit. CMS needs to consider whether PCI in this setting ( stable coronary artery disease ) should continue to be a covered service,especially in asymptomaic/minimally symptomatic patients, and ones in which an adequate trial of medical therapy has not been made Thank you |
| Commenter: |
Civello, Roy
|
| Title: |
Mechanical Engineer |
| Date: |
9/20/2008 4:41:19 PM |
| Comment: |
[PHI Redacted] found out that had prostate cancer [PHI Redacted]. As an
engineer [PHI Redacted] began and exhaustive research on the
type of treatment and side effects as well as the
possible impact on your quality of life these
various treatments had. So [PHI Redacted] decided on Proton
treatment and now that [PHI Redacted] just completed treatments the hours of research spent was well worth it and hardly any side
effects whatsoever.
[PHI Redacted] played golf, went to health club 3-4 times a
week, movies, zoo, long walks, shopping to name
it. [PHI Redacted] What other type of treatments can
compare to this and is non-invasive. Therefore,
before Medicare considers stop paying for Proton
treatment for prostate cancer they should ask
themselves what treatment would they chose for
their love ones and why? Also, you may want to
ask yourself why is there so many Scientists,
Engineer, Doctors, Surgeons, Lawyers, Professors,
School Teachers that decided to be treated with
Proton therapy? You cannot put cost before
someone’s health and that should never be a
consideration. Again, I implore Medicare not to
suspend payments for Proton Treatment for prostate
cancer.
Thank you
Roy Civello |
| Commenter: |
Siris, Ethel
|
| Title: |
Director, Toni Stabile Osteoporosis Center |
| Organization: |
Columbia University Medical Center, New York Presbyterian Hospital |
| Date: |
9/21/2008 8:41:35 PM |
| Comment: |
Reagrding BISPHOSPHONATES, I am strongly opposed to an NCD for zoledronic acid. This agent is an excellent drug for post menopausal osteoporosis as well as for prevention of a recurrent fracture after a hip fracture, especially in patients either intolerant of, unable to absorb, or unable to be adherent to an oral bisphosphonate. Some older patients are on many different medications taken daily, for a myriad of medicaal problems, and a once yearly therapy is very helpful also in that setting. Many patients are in one of these categories, and the availability of zoledronic acid once yearly at the 5 mg dose is very important. The risk of osteonecrosis of the jaw appears to be very rare at the osteoporosis doses for both oral and iv bisphosphonates, and the benefits of these agents greatly outweigh the risks. Zoledronic acid is also a valuable asset for patients with Paget's disease as it appears to be superior to oral Actonel, the other first line therapy.
The issue is not one of "convenience", but rather an alternative mode of effective adminsitration which is necessary in a subset of older and elderly patients for whom it is preferred for the reasons stated above. It would be wrong to deny clinicians the opportunity to utilize this agent in appropriate patients. |
| Commenter: |
Hansen, John
|
| Title: |
retired |
| Date: |
9/22/2008 7:08:08 AM |
| Comment: |
|
[PHI Redacted] completed proton therapy for prostate cancer[PHI Redacted].
After a couple months of reading studies in the field, talking
with men who had received proton treatment, and with others
who had received other forms of treatment, the choice was
rather easy.
Existing studies don't show a significant difference in expected
lifespan no matter what form of treatment is selected. But it
appears that researchers, as well as practitioners of other
approaches, don't want to consider the aspect that is equally
important to patients — the quality of their remaining life.
I know of five men [PHI Redacted] who have been
treatmed for their prostate cancer, and among them they have
had surgery, conventional radiation, and seeds. ALL of them
have had significant complications from their treatment. One
who had surgery is unable to sit without often-severe pain, and
has been going from doctor to doctor for the past year trying to
find a solution. At the same time, I have been unable to find a
single proton recipient who has had more than minor
complications.
The side effects that [PHI Redacted] had during treatment were so trivial
that [PHI Redacted] wouldn't have noticed most of them if hadn't had attention focused on them by the daily treatments. They quickly
went away after the end of treatment, and [PHI Redacted] had no
complications since.
One side note: with the current (and expected future) progress
of medical treatments, there seems to be limited value in making
judgments based on 5- and 10-year studies. All forms of
treatment are changing so fast that these studies are of more
historical interest than predictive value.
Proton therapy costs are coming down, and will continue to do
so. Let's allow people to keep all their options open. |
| Commenter: |
Smith, Wendy
|
| Date: |
9/22/2008 8:21:26 AM |
| Comment: |
I want to support the discussion of Hip
Resurfacing and the Medicare coverage of Hip
Resurfacing.
[PHI Redacted]
Hip Resurfacing is a viable option for people
over 65 years of age. Hip resurfacing candidates
are not chosen by their age, but by the quality
of their bones, their activity level and their
physical condition. Many patients in the 60's,
70's and even 80's receive hip resurfacing
overseas. It is an excellent option for active
people over 65 years of age.
Because we live some much longer these days,
there is a very good chance that any type of hip
replacement done even into the 60's will wear out
in our lifetimes. Doing a hip resurfacing as a
first option affords the possibility of having a
simple total hip replacement if this occurs
rather than another total hip revision which is
much more complicated, more expensive, and has
much less satisfactory outcomes. |
| Commenter: |
hopson, rex
|
| Date: |
9/22/2008 9:20:45 AM |
| Comment: |
[PHI Redacted] prostate cancer was zapped successully with
proton radition. Side effects were almost non
existrant during treatment and NO side effects
since. Thank goodness Medicare covered this
important cancer treatment. |
| Commenter: |
Johnson, Paul
|
| Date: |
9/22/2008 10:21:06 AM |
| Comment: |
Please don't stop reimbursement of Proton
Radiation Terapy. To do so is to sentence many to
a life of impotence an incontinance or, for those
with health problems that prohibit conventional
therapy, a sentence to die. [PHI Redacted] went through PRT
over 5 years ago and [is] clinically cured with no
side effects. |
| Commenter: |
Epstein, Jacob
|
| Title: |
Student |
| Organization: |
University of Michigan |
| Date: |
9/22/2008 12:15:24 PM |
| Comment: |
It is a miracle drug. Life changing and the key to the ITP dilemma. It is imperative to keep this drug afloat, and to do whatever is necessary to make it accessible and affordable for all ITP patients. |
| Commenter: |
Stabler, Sally
|
| Title: |
Professor of Medicine |
| Organization: |
University of Colorado School of Medicine |
| Date: |
9/22/2008 12:16:36 PM |
| Comment: |
I am the co-division chief of Hematology at the University of Colorado Health Sciences Center and see patients with ITP frequently. I support the coverage of Nplate for patients with relapsed/refractory ITP. Such patients have few options except high dose steroid treatment which has toxicity when continued for years. |
| Commenter: |
Smith, Erik
|
| Date: |
9/22/2008 12:18:49 PM |
| Comment: |
Regarding ITP and a need for more efficacious drugs,
[PHI Redacted] hematologist gave the option of either a
spleenectomy or oral prednisone to bring up platelet count. Neither was a good option as long
as [PHI Redacted] [is] in a "safe" range. [PHI Redacted] The
allopathic medication choices now are quite
limited and the homeopathic drugs only have
anecdotal results. In the longer term [PHI Redacted] would
like to have an FDA approved option besides
steroids or surgery. Please pursue the
development of a new and effective ITP drug. |
| Commenter: |
Brooks, Maureen
|
| Organization: |
PDSA |
| Date: |
9/22/2008 12:26:40 PM |
| Comment: |
There must be more durgs made accesible, especially for people with ITP. Since some of the drugs have no effect on sustaining a normal platlet count making day to day living difficult |
| Commenter: |
GIAQUINTA, NORMA
|
| Date: |
9/22/2008 12:29:52 PM |
| Comment: |
I sincerely hope that the Centers for Medicatre
and Medicaid do not send the drug NPLATE to
determinations. [PHI Redacted] a Chronic ITP Patient who
already is impacted by one drug and cannot
receive it because the insurance companies have
labled it a Tier 3 and 4 so therefore it is not
affordable and physician is frustrated because
it worked [PHI Redacted].
[PHI Redacted] |
| Commenter: |
Gobbi, Michelle
|
| Date: |
9/22/2008 12:31:13 PM |
| Comment: |
[PHI Redacted] I
have been following the approval track of Nplate
and similar drugs with anticipation. For some ITP
patients, Nplate and similar class drugs, will
provide a much tolerable treatment. Many times,
the treatment is worse than the disease. [PHI Redacted] had to
take steroids as course of treatment. The side
effects are horrible and really took a toll on life as well has family. [PHI Redacted] [has] two small
children to take care of and the steroids made it
very difficult to do that. Also, as you know,
steroids are not a long term solution. Please
reconsider putting NPlate and similar drugs on
your list. Thank you. |
| Commenter: |
Guinigundo, Andrew
|
| Title: |
Nurse Practitioner |
| Organization: |
Oncology and Hematology practice in Cincinnati, Ohio |
| Date: |
9/22/2008 12:31:16 PM |
| Comment: |
RE: Platelet stimulating factors (romiplostim). The FDA (the agency responsible for determining efficacy and safety of drugs) has approved this drug based on data submitted by the manufacturer. The FDA have also put into place an exhaustive tracking system for adverse reactions to the drug. To limit or outright deny Medicare patients access to this drug is without merit and based solely on finanacial reasons. Data is minimal as this is a new drug, but what is available has a very favorable safety profile. CMS should not let its negative view of ESAs cloud its judgement or in anyway weigh into this decision. This is a new and distinct molecule just as G-CSF is distinct from ESAs and platelet stimulating agents. |
| Commenter: |
Jasinski, Jason
|
| Date: |
9/22/2008 12:33:58 PM |
| Comment: |
My understanding is that Nplate (romiplostim) is
being considered for an NCD, which may severely
limit its use for certain patients. I wish to
share my views and experiences with ITP, and the
treatment options that have been available.
[PHI Redacted] was given Prednisone, which
has a host of terrible side effects, and was on
that for 9 of the past 15 months. Because blood type is o-positive, not able to use
many of the medications that are specific to RH-
patients. After first treatment with
Prednisone alone, TP came back 7 weeks later.
This time was given Rituxan infusions for 8
weeks, at a cost of nearly $6000 per week. Right
now, been off prednisone for 4 months and
blood counts have been holding steady.
However, if symptoms return, only remaining
option might be a splenectomy.
[PHI Redacted]
I celebrated the day I saw Nplate received FDA
approval, and hope it will be made available to
all who might require it. |
| Commenter: |
Thornburg, Teresa
|
| Date: |
9/22/2008 12:35:10 PM |
| Comment: |
[PHI Redacted] was diagnosed with ITP two years ago. [PHI Redacted]
platelet counts keep decreasing monthly and if
all goes as is [PHI Redacted] will be in the high danger zone
by [PHI Redacted] with counts below 10,000. The
prednizone treatment did not help at all, and
other options are very costly and very temporary.
[PHI Redacted] [is] able to work now, but will need to apply for
disability if it becomes too dangerous to
work or body is just too tired to be mobile. I
am anxious for new options and I hope that Nplate
will be available [PHI Redacted]. |
| Commenter: |
Mortimore, Dorothy
|
| Date: |
9/22/2008 12:36:34 PM |
| Comment: |
[PHI Redacted] I [PHI Redacted] request that you consider
the continued availability and affordability to
the chronic ITP patient as recommended by the
patient's physician. Thank you.
|
| Commenter: |
Hertogs, Kathy
|
| Date: |
9/22/2008 12:44:43 PM |
| Comment: |
[PHI Redacted] was diagnosed with ITP in Oct [PHI Redacted].
He has not responded well to "typical"
treatments, i.e. steroids. Thus, he tried
multiple types of treatments. Since they don't
know what causes ITP, it is very hard to treat it.
Ultimately, it was rituxin that helped [PHI Redacted]. This is a more common cancer drug, but
it helped [PHI Redacted].
Thus, I request that you do not put any hamper to
potential drugs that could help ITP patients.
Since there is no cure to the disease, it is up
to the doctor and patient to try and find out
what works for each individual patient.
Thank you.
|
| Commenter: |
Sweder, Kim
|
| Date: |
9/22/2008 12:47:21 PM |
| Comment: |
[PHI Redacted] was diagnosed with ITP in '[PHI Redacted] we
exhausted many treatment options and eventually
decided to be splenectomized. There are not many
options that we haven't already exhausted if ITP
was to re-occur.
|
| Commenter: |
Earle, Bonnie B
|
| Title: |
Ms. |
| Date: |
9/22/2008 12:53:51 PM |
| Comment: |
I think that this must be a wonderful drug
however, it is so difficult for any of the ITP
patients to find a good doctor that with MeiCare [PHI Redacted]I hope that you understand. |
| Commenter: |
Bitseff, Tonie
|
| Title: |
Employee Benefits Attorney |
| Organization: |
Thelen LLP |
| Date: |
9/22/2008 12:55:27 PM |
| Comment: |
I am writting to encourage broad coverage of
Nplate (romiplostim)for ITP patients.
[PHI Redacted]
[PHI Redacted]this treatment offers an important
treatment for ITP patients.
In refractory ITP patients or ITP patients who
have problems with predisone (due to diabetes or
other reactions)that need to treat, this is the
only option other than anti-D that does not
require blood products or involve a chemotherapy
type drug.
Anti-D is not an option for those of us who have
had our spleen removed, for anyone with hemolitic
anemia (evan's syndrome), or for anyone with the
wrong blood type. Additionally anti-D can have
dangerous side effects in some patients. [PHI Redacted] was
given the drug before having spleen removed
and it caused extensive red blood cell
destruction and [PHI Redacted] needed red cell transfusions
during pregnancy.
Spleen removal also has consequences. [PHI Redacted]
I will also note that IViG, which is a viable
treatment for some people, is very expensive and
requires multiple blood donors, which is resource
intensive and has its own risk factors for the
patients. [PHI Redacted] These
treatments were both expensive and unsuccessful.
Nplate is also important to other forms of
autoimmune conditions. ITP is somewhat unique in
that it is an autoimmune condition that is
measurable (while most autoimmune conditions are
difficult to diagnose, much less quantify). Any
treatments or study of ITP patients provides the
medical community with needed information on the
treatment and control of autoimmune disorders
generally. This is an important drug therapy and
its use is important to the ITP community and the
treatment of autoimmune conditions generally.
|
| Commenter: |
Springer, Carol
|
| Date: |
9/22/2008 12:58:47 PM |
| Comment: |
Too limit this drug would be so wrong, no one can
understand the roller coaster ride that TIP puts
you on...[PHI Redacted] has been on all of the
current treatments, his platelets have been at
1,ooo to 215,000. He has had eye bleeds, nose
bleeds, unbelieveable bruising etc.along with
bleeding in his urine. Recently he was started on
N-Plate, within 4 days his count went from 7,000
to 49,000. This is life saving...please consider
how many people have been waiting years for this
lifeline. Do not take away this hope. |
| Commenter: |
Kretlow, Allison
|
| Date: |
9/22/2008 1:00:01 PM |
| Comment: |
I am writing this to support improved access to
new ITP treatments. [PHI Redacted] Less intrusive medications that have
stronger long-term effects are desperately needed
for this under-researched disorder. The one thing
we know about ITP is that it is a life-long
disease. Relapse is a given at some point. Please
support the access to new treatments for patients
[PHI Redacted] who do not have a cure and desperately
need hope for living a normal life. |
| Commenter: |
Cain, Patricia
|
| Date: |
9/22/2008 1:03:03 PM |
| Comment: |
| Allowing Nplate to be used by Medicare patients is really important now that I am reaching that Medicare age. Although, I have my own insurance, once I reach that magic 65 I HAVE to rely on medi- care. This drug is important to the ITP community and we need access to it.
|
| Commenter: |
Falsey, Richard
|
| Date: |
9/22/2008 1:04:49 PM |
| Comment: |
Thrombopoiesis stimulating agents
Severe bruising and a fear of being cut and
bleeding to death have really changed [PHI Redacted] life.to
have drugs that can remedy this would be a
blessing. |
| Commenter: |
Ashley, Saundra
|
| Organization: |
None |
| Date: |
9/22/2008 1:16:21 PM |
| Comment: |
It is imperative that topic of Coverage should include anyone who has ITP and that it be available at a reasonable cost, through conventional insurance programs with no restrictions. . |
| Commenter: |
Emdee, Phyllis
|
| Date: |
9/22/2008 1:21:15 PM |
| Comment: |
ITP totally took over [PHI Redacted] life. [PHI Redacted] had to go 60
miles away once a week for rutuxaban treatments
which did not do any good. [PHI Redacted] was on doses as
high as 80 mls. of prednisone which totally
messed up head. [PHI Redacted] couldn't even read. [PHI Redacted] even
went to a dr. in Penn. for a consult. It was 2
years of shear hell. [PHI Redacted] finally had a splenectomy
which.so far thank God, has help platelet
count up. [PHI Redacted] |
| Commenter: |
Ensign Jr., Frank B.
|
| Organization: |
retired |
| Date: |
9/22/2008 1:22:27 PM |
| Comment: |
I hope this new FDA approved blood-platelet drug
is approved for [PHI Redacted] bone-marrow disorder is severe
and at times life-threatening. Lowered blood
platelets cause everyday topical hematomas on the
skin, and if one were to happen in [PHI Redacted] brain.. at
any moment.. [PHI Redacted] could have a cerebral hemorrhage
and die. [PHI Redacted] in the event platelets
dropped even 10 points to have to take this new
medication the FDA approved recently. I vote to
have the new platelet drug approved immediately
for ITP patients are a minority but are many
suffering patients. For example, [PHI Redacted] cannot have
any surgery without having a platelet boost first
or [PHI Redacted] bleed.. to death; platelets directly help
with coagulation of blood. [PHI Redacted] [is] fatigued to the
extreme and this aspect is debilitating too.
Please approve this in alignment with the FDA's
approval. People depend on platelet drug-regimes
at the most critical times.
Sincerely
Frank B. Ensign Jr. |
| Commenter: |
Towe, Kyatanya
|
| Date: |
9/22/2008 1:44:31 PM |
| Comment: |
[PHI Redacted] was diagnosed with ITP two years ago, and
I have watched her go through so many changes
with this disease. The scariest time is when she
has a "bleeding episode". We prayed so hard when
she had her spleen removed that it would be the
answer, unfortunately we found out recently that
her platelets are back in the low numbers. Any
hope that Nplate can give [PHI Redacted] we are thankful for it. Can you imagine what it
must be like living in fear of bleeding to death?
No, well that's what people with ITP go through
everyday, and that's what [PHI Redacted] goes through.So
far [PHI Redacted] has had to fight for each treatment
has receiving for the ITP. Please don't limit
access to this medication so severely that people
like [PHI Redacted] will not have access to it. |
| Commenter: |
Chester, Jennifer
|
| Date: |
9/22/2008 2:00:18 PM |
| Comment: |
[PHI Redacted] was diagnosed with ITP 7 years ago. [PHI Redacted] [has]
utilized Rituxin, Steroids, IVIG and the only
thing that has worked for short term
periods of tiem is WinRho. After 4 years of
using this it is starting to not have the same
impact. [PHI Redacted] spleen removal is
not an option. Since it only has a 50%
success rate.
It is so important that we have new treatment
options available. |
| Commenter: |
Graham, Courtney
|
| Title: |
Engineer |
| Organization: |
NASA |
| Date: |
9/22/2008 2:32:37 PM |
| Comment: |
Please do not send Nplate through an NCD process. There are so many people with ITP out there that are running out of options to live a normal life without resorting to surgery or other medications that have other deteriorating effects on the rest of their lives - i.e. diabetes from the continual use of Prednisone. This is one step that research has taken in the direction of finding more treatment options and possibly a cure for a disorder that not much is known about. If this medication goes through a NCD, then other insurance companies will deny coverage to other patients as well. |
| Commenter: |
Su, Edwin
|
| Title: |
Orthopaedic Surgeon |
| Organization: |
Hospital for Special Surgery |
| Date: |
9/22/2008 3:00:58 PM |
| Comment: |
I am writing to support the Medicare coverage of hip resurfacing as an alternative to traditional hip replacement. As an orthopaedic surgeon with experience with both hip replacement and hip resurfacing surgery, I feel that hip resurfacing surgery is more than just an interim treatment for end-stage arthritis. As a newer treatment, hip resurfacing may not have the data to support its longevity yet, but ongoing research does suggest the possibility of lasting as long or longer than a hip replacement. Furthermore, the determination of candidacy for hip resurfacing should be based more upon a patient's bone quality than their chronologic age. The ability to preserve femoral bone with a resurfacing has several potential advantages if there is a need for future surgery, including: a less complicated revision surgery and thus a less costly repair; quicker recovery from a revision procedure, and more options for revision surgery.
A recent article published in the orthopaedic literature found that older patients who had hip resurfacing had equivalent results to younger patients (Journal of Bone and Joint Surgery, 2008, suppl 3, 27-31).
In conclusion, I feel strongly that hip resurfacing should be covered by CMS because it provides an alternative treatment to total hip replacement that has proven efficacy and potential advantages. |
| Commenter: |
Pezanowski, Diana
|
| Date: |
9/22/2008 3:01:27 PM |
| Comment: |
|
Unfortunately,[PHI Redacted] passed away recently
due to a fall that had caused her to bleed to
death because of ITP. She had hit her head and
broke her nose and they could not stop the
bleeding. Please continue to send me updates as I
am very interested. Thank you. |
| Commenter: |
Morris, Lynne
|
| Date: |
9/22/2008 3:03:19 PM |
| Comment: |
Regarding the new treatment for ITP...[PHI Redacted] [has] had
ITP for 10 years. It is always exciting to hear
of any new treatments on the horizon for us. Not
only does it give us hope but it is wonderful to
hear that companies are still trying to find new
things. |
| Commenter: |
hale, connie
|
| Date: |
9/22/2008 3:06:24 PM |
| Comment: |
[PHI Redacted]
The point is, those who have ITP really need
new and improved options to boost platelet levels,
ones that can raise platelet counts without such
severe side effects. While there are other
treatments than steroids, those currently being
used often have their own severe side effects, and
what works for one person might not work for
another. We need more treatment options, and ones
that aren't worse than the disease! |
| Commenter: |
Boyce, John
|
| Date: |
9/22/2008 3:51:10 PM |
| Comment: |
|
I want to support the discussion of Hip
Resurfacing and the Medicare coverage of Hip
Resurfacing.
[PHI Redacted]
Hip Resurfacing is a viable option for people
over 65 years of age. Hip resurfacing
candidates are not chosen by their age, but by
the quality of their bones, their activity level
and their physical condition. Many patients in
the 60's, 70's and even 80's receive hip
resurfacing overseas. It is an excellent option
for active people over 65 years of age. |
| Commenter: |
Partsch, Diane
|
| Title: |
member |
| Organization: |
PDSA |
| Date: |
9/22/2008 4:59:32 PM |
| Comment: |
I am commenting in regard to "ITP". All people
with this illness need to have all treatments
available to them (including the coverage of
nplate). [PHI Redacted] |
| Commenter: |
Barron, Linda
|
| Date: |
9/22/2008 5:08:19 PM |
| Comment: |
|
[PHI Redacted] is 21 years old and one year ago was
diagnosed with ITP. Her course of treatment at
the time was high doses of steroids for the first
year. The steroids did increase her platelets
only while she was on them, then dropped
drasically. After a year, she had to go off the
steroids and has tried Rituxan (this past July).
Although her platelets are responding beautifully
right now the side effects of the Rituxan has
taken a large toll on her and she is being
treated at college for high anxiety and medical
problems related to the rituxan. I worry
constantly about her future and what it will mean
should her platelts count drop. Any new drug that
can improve or cure, not just [PHI Redacted] life,
but so many others MUST be considered and
approved with dosage & treatment determined by
doctors and health care professions making any
new treatment available to all who need it, not
just a chosen few. If you knew of someone who
hade an illness and they were denied treatment
because they did not fall into a specific
category how devastating that would be to you,
especially a child. This illness affects so many
people and compassion has to be at the forefront
of any decision made. Thank you. |
| Commenter: |
Desai, Pooja
|
| Date: |
9/22/2008 5:28:40 PM |
| Comment: |
[PHI Redacted]
Living a life with ITP is like walking on egg shells. You get up
one day and the medicine that was suppressing your immune
system does not work and the platelets are at a dangerous level
and all you can do is trial and error to figure out which of the
current drugs will work. But since Nplate has the ability to
stimulate more platelet production lots of patients feel more safe
and secure with it. So I would please request to keep the options
open to all patients and leave the discretion to our doctors who
are trying their best to help us out. Thanks |
| Commenter: |
Brass, Barry
|
| Date: |
9/22/2008 5:36:15 PM |
| Comment: |
[PHI Redacted] I strongly support availability
of any treatments which could assist a post splenectomy patient
who still needs to increase their platelet count to safe levels. |
| Commenter: |
Strong, Diane
|
| Date: |
9/22/2008 6:17:32 PM |
| Comment: |
[PHI Redacted] I request that patients and doctors
have ease of access to bone marrow producing
platelet agents such as Nplate (romiplostim). It
is my undersanding that by designating this to
National Coverage Determinations it may slow or
limit the access to the product for patients and
their physicians and insurance companies may
limit coverage and access due to NCD status. [PHI Redacted]
blood disease is an immediate care action
disorder and delay of treatment is life
threatening. Current treatment options are
limited and this option may provide a safe and
rapid alternative to traditional treatment
options such as splenectomy. [PHI Redacted]
A
delay in access to treatment utilizing such
products could be life terminating. Thank you
for your consideration of not regulating these
thrombopoiesis stimulating agents under NCDs. |
| Commenter: |
Turnberg, M
|
| Date: |
9/22/2008 7:53:23 PM |
| Comment: |
|
[PHI Redacted] has chronic ITP, and I would be
outraged to hear that there was indeed a
treatment available to help her heal, but that I
personally could not get it for her. Thta doens't
seem fair, why make everyone involved suffer that
much more. Equal rights for all. EVERYONE should
have the same ability to receive needed
treatments. |
| Commenter: |
titcomb, mary jane
|
| Date: |
9/22/2008 8:00:48 PM |
| Comment: |
It would be crime if we are not able to receive this treatment, when it could allow persons with severe ITP start a productive life again. How do you explain what it feels like to have had the life sucked out of one's self overnight.
|
| Commenter: |
Buck, Merle
|
| Date: |
9/22/2008 8:03:51 PM |
| Comment: |
|
To whom it may concern
I have a [PHI Redacted] who has ITP and we have
now tried Steroid treatment for two weeks and
then Rituxin for 4 weeks. So far niether
treatment has stablised the platelet count . They
went as high as 58,000 with steroids but went as
low as 4,000 one week after treatment. Rituxin
only took them up to 21,000 but after 3rd
tratment they were back down to 8,000. [PHI Redacted] is in college and has been having to miss
3 classes a week while underging treatments for
the past month and a half. Now he is more than
likely headed for a splenectomy. If that does not
work I dont know what the next treatment would
be. If Nplat would be a viable treatment I would
hope that Insurance would cover as he is already
into some pretty high medical bills. |
| Commenter: |
Ford, Loura
|
| Title: |
Retired Missouri Public School Teacher |
| Organization: |
none |
| Date: |
9/22/2008 8:10:24 PM |
| Comment: |
It is most urgent that no restrictions be put on
this medication. Rarely, are the symptoms the
same, and even though the same medicine may be
used for each patient, it is imparative that the
industry realizes that other health factors come
into play. [PHI Redacted]
Please put no restrictions on this new medicine.
[PHI Redacted] It will work for many.
Loura Ford |
| Commenter: |
Greene, Jane
|
| Date: |
9/22/2008 8:17:50 PM |
| Comment: |
I am deeply concerned about the possibily of an NCD on Nplate. Those of us who suffer every day with immune thrombocytopenic purpura are hoping that this drug may be the answer for some ITP sufferers. To restrict it with an NDC and possibly make it unavailable to some patients is a sad thought. We have so litle available in treatment options. Please do not restrict this one. |
| Commenter: |
Coffey, Kristin
|
| Date: |
9/22/2008 8:21:54 PM |
| Comment: |
[PHI Redacted] being diagnosed with ITP has been very
stressful on the family. Sometimes other drugs
like Rituxin and Predinose do not work and a
splenectomy is called for. The only down side is
that a lot of people are not good surgical
candidates...like [PHI Redacted]. Having more medicines
on the market could give people more options for
treatment and would be much more cost effective
when a splenectomy has the potential in some
patients to cause other very adverse side effects
or death. I would like to see more treatments
available for people dealing with ITP. Not
everyong responds well to all treatments. We
need more options. |
| Commenter: |
Barnett, Ruth
|
| Date: |
9/22/2008 8:33:54 PM |
| Comment: |
[PHI Redacted] has ITP for 8 years. SHe is 23 now.
She had used Whinrho and had to have heparin lock
inserted every three months for her medicine.One
time it took 5 times to find a good vein.It was
very truamatic for the first 4 years.SHe had to
go around with needle marks and hiding them with
long sleeves I think by having Nplate
(romiplostim) would be a long awaited miracle for
itp patients. I think it should be covered with
insurances. Also it is cheaper I am sure then
having iv supplies and Whinrho.
|
| Commenter: |
ALOIA, RICHARD
|
| Date: |
9/22/2008 8:40:29 PM |
| Comment: |
Please do not include NPlate in your list of topics to be considered for National Coverage Determination. ITP is a life threatening autoimmune disease with very little treatment options available for the afflicted. Please don't take the chance of limiting the use of this treatment. The use must be determined by the primary care physician and him/her only. Any other controls will compromise the health of the patient. |
| Commenter: |
Kittel, Louise
|
| Date: |
9/22/2008 10:45:11 PM |
| Comment: |
|
I wish to support the new drug Nplate, which is
shown to be safe and effective in the treatment
of ITP (immune thrombocytopenic purpura),now
under discussion for the NCD. [PHI Redacted] I can tell you that this disease is
extremely difficult to live with, making even the
simplest of life's activities painful and
dangerous. When you have platelet counts as low
as 2,000, even just lying in bed can cause
hematomas where the body meets the mattress.
Spontaneous hemoraghing from your gums makes you
look like a vampire and feel like a social
pariah. You feel constantly under threat of
having a fatal bleed-out at a place or time where
no help is readily available. For too many ITP
patients, this help, in the form of current
treatments, either does not work at all, works
only temporarily, and /or has terrible side-
effects that actually make you sicker than you
already are.
As you consider Nplate, it is important to
realize that there is no one-size fits all
solution to ITP. Patients prognoses are wide and
varied. One person can take a 3 day course of
decadron and be done with it. another person,
like me, has to take 60 mg. of prednisone for
weeks before even minimum improvement begins, and
then must stay on a tapered dose for up to a year
for the effect to hold. Doctors need better
options and much latitude to find the right
course of treatment for each very different ITP
patient.
[PHI Redacted] However, I also hope
that new and better drugs will become available
for our doctors to choose from and administer
according to their knowledge of each individual
patient. I believe that many would welcome a
safe, reliable, and easy to take pill that would
return the body to a normal platelet count and
help sustain it there. Nplate seems to be such a
godsend. Please give doctors both the drug, and
the latitude they need in order to effectively
prescribe it. |
| Commenter: |
Langenmayr, Matthew
|
| Date: |
9/22/2008 10:47:14 PM |
| Comment: |
Please, I implore you to consider your decision
carefully. Imagine going to bed with a house full
of children and praying that an intracranial
hemorrhage doesn't take your life at some time
during the night. ITP is a very serenity
depriving illness not only for the immediately
afflicted but for their families as well.
Treatment options are limited and all have
serious side effects. [PHI Redacted] A safe treatment alternative is
long overdue with this disorder. Please consider
the sufferers and their families when you make
your decision. Thank you for the consideration
and opportunity to write.
Sincerely,
Matthew Langenmayr
|
| Commenter: |
Panayoti, Gregory
|
| Date: |
9/22/2008 11:57:10 PM |
| Comment: |
I am concerned about Nplate coverage being
restricted, or not covered sufficiently as to
provide access to patients across the board who
suffer from chronic immune thrombocytopenic
purpura (ITP). [PHI Redacted] Being able to afford access
to new cutting edge medicines like Nplate could
mean the difference between life or death, or
perhaps the change that gets a person from
sickness back into life and productive work.
Please consider the plight of those with chronic
immune thrombocytopenic purpura (ITP). It's a
terrible way of life for so many. |
| Commenter: |
Ouellette, Carol
|
| Date: |
9/23/2008 12:17:51 AM |
| Comment: |
[PHI Redacted] has had ITP for over 7 years
and tried many treatments the first year that
failed to eliminate her ITP. We then adopted a
no treatment plan which has worked well for her
at this time, however if the situation ever
changed I would want all available treatment
opportunities open to her, so I would be opposed
to anything that would restrict those
opportunities. |
| Commenter: |
Lanham, Brandy
|
| Date: |
9/23/2008 1:27:22 AM |
| Comment: |
[PHI Redacted] has been living with ITP for a few
years now. It has definetly had it's ups and
downs. Some families are not as lucky as we have
been with dealing with it, so if there is any
other kind of hope with new medicines and such,
please approve it and maybe other families and
individuals may benefit from this also.
|
| Commenter: |
Fedor, Jeff
|
| Date: |
9/23/2008 4:09:31 AM |
| Comment: |
|
I strongly encourage CMS to include Nplate in its
coverage in the future. [PHI Redacted] Having new
treatment options like Nplate opens other
potential avenues of treatment. [PHI Redacted]
Please cosider continued coverage of this new
treatment. Thank you.
|
| Commenter: |
Blake, Joan
|
| Date: |
9/23/2008 8:46:30 AM |
| Comment: |
[PHI Redacted] I feel it is imperative that
NPLATE remain available as a treatment for ALL
people, irrespective of their insurance carrier
(including Medicare and Midicaid). To be
otherwise would be unconsciousable!!! |
| Commenter: |
Rhodes, lynn
|
| Date: |
9/23/2008 8:48:09 AM |
| Comment: |
U.S. Food and Drug Administration recently approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). There are so few options available for ITP patients, Please do not take any option away from us! |
| Commenter: |
Giles, Ian
|
| Title: |
Director of Scientific Affairs |
| Organization: |
Sysmex America |
| Date: |
9/23/2008 9:13:15 AM |
| Comment: |
Hi If there is a need to determine if platelet destruction is due to bone marrow suppression, or peripheral destruction prior to deciding how to treat with thrombopoietic agents (and it would make sense to do that). Sysmex has a reticulated platelet count as part of their routine CBC. In thrombocytopenia in Hep C patients for example, the causes range from peripheral (hypersplenism) to central (decreased production). In ITP, the same thing is evident (some decreased production, some increased destruction). Publications state that the causes of thrombocytopenia are multifactorial, therefore use a thrombopoietic agent. There might be an opportunity for a more rational, targeted approach, using the Sysmex IPF parameter. Why would you artificially boost platelet production if the platelets wil be destroyed in the spleen? If you need additional info, please let me know. N Engl J Med 2007;357:2227-36 Thanks a lot
Ian Giles |
| Commenter: |
O''Hara, Colleen
|
| Date: |
9/23/2008 9:16:20 AM |
| Comment: |
|
[PHI Redacted] I believe it is
important to cover Nplate treatments for ITP
under Medicare and Medicaid in addition to other
private insurers. There are not many proven ITP
treatments so when a new one comes along that
could help people with ITP, it is important that
it be made avaialble to all and not restricted.
Thanks. |
| Commenter: |
Foote, MD, Robert
|
| Date: |
9/23/2008 10:08:26 AM |
| Comment: |
Steve Phurrough, M.D. Director, Coverage and Analysis Group Centers for Medicare and Medicaid Services 7500 Security Blvd. Baltimore, Maryland 21244.
Formal Request for National Coverage Determination (NCD) Track # 3-Internally Generated Request Proton Beam Therapy for Prostate Cancer Medicare Benefit Category: Physician Services
Dear Dr. Phurrough:
Thank you for the opportunity to comment on the potential National Coverage Determination for Proton Beam Therapy for prostate cancer as posted July 30, 2008 on the CMS Medicare Coverage Database webpage. While we applaud the effort for coverage, we are concerned about the creation of a national coverage decision (NCD) for a single tumor site. We recommend that there be uniform coverage for Proton Beam Therapy for relevant cancer types that would benefit all patients that currently have radiation oncology services for cancer treatment.
We believe that proton beam therapy would be advantageous and effective for a number of different types of cancers. Therefore, a NCD should be established to assure that beneficiaries afflicted with cancer, regardless of tumor site, are afforded the same treatment options and that there is reasonable coverage for these services. The NCD should not be limited to prostate cancer. There have been numerous and effective studies performed on the use of proton beam therapy in breast, lung and other cancers. In addition, we believe the development of comparative evidence through randomized clinical trials is an unnecessary and expensive undertaking. The dose distribution models have overwhelmingly convincing surrogate evidence that proton therapy is superior to conventional x-ray therapy and the outcome results previously published negates the need for comparative studies. We have provided clinical articles and findings for your review.
The National Cancer Institute defines proton beam radiation therapy as a type of high-energy, external radiation therapy that uses streams of protons (small, positively charged particles) that come from a special machine. Most radiation therapy for cancer is delivered using x-rays. The x-rays pass all the way through the body causing collateral damage to the normal organs and tissues that surround the cancerous tumor or tissues. Protons are charged particles that have a physical advantage when compared to x-rays or photons. Therefore it is our belief that protons are a more targeted form of treatment than x- rays. When the protons enter the body, there is a very low dose of radiation given to the normal tissues or organs that they pass through in order to get to the cancer tumor or cancerous tissues. Once the protons reach the cancer, they deliver their dose of energy and then they stop, they do not continue to pass through the body. Therefore, they do not give any collateral energy, dose or damage to the normal organs or tissues beyond the cancer. This results in less collateral damage to the normal organs and tissues which results in fewer side effects and complications. It also allows a higher dose of radiation therapy to be administered to the cancer which lowers the recurrence rate and prolongs the patient's survival.
Radiation therapy is unique in the fact that there are very well established models for the distribution and effects of radiation treatments in the human body. Unlike many other therapies, the effects of radiation on cancerous and normal tissues are relatively well-understood and very predictable/reproducible.
The current state of the art treatment modality, Intensity Modulated Radiation Therapy (IMRT), was widely adopted without comparative trials based on the same type of surrogate dose distribution modeling that supports the case for proton therapy. We believe that conducting randomized comparative clinical trials would do unnecessary harm to patients as this would expose the normal tissues to needlessly high levels of radiation. While we agree that clinical research on proton therapy needs to continue, the existence of well established surrogate models and published data has already been established. Therefore, we believe the development of comparative evidence through randomized clinical trials is an unnecessary and expensive undertaking.
In conclusion, we request that CMS analyze this information and develop a NCD to assure that beneficiaries afflicted with cancer, regardless of tumor site, are afforded the same treatment options and that there is reasonable coverage for these services. The NCD should not be limited to prostate cancer.
Additional attachments will be sent to CAGinquiries@cms.hhs.gov.
|
| Commenter: |
Hayes, Carol
|
| Date: |
9/23/2008 10:25:29 AM |
| Comment: |
[PHI Redacted] Although some people regain their
normal platelet count and go on with their lives,
for a large number of ITP patients the disease
becomes chronic and refractory to any known
treatments. Chronic ITP patients can experience
fear, different types of bleeding from mild to
severe, and even death.
[PHI Redacted] a number of
treatments for this disease which include
prednisone, splenectomy, platelet transfusions,
IVIG, Winrho, Danazol, and Rituxan. All of these
treatments have a variety of undesirable
side-effects, which include high blood pressure,
weight gain, psychological problems, diabetes, an
increased risk of infection, and that is just part
of the list.
This is a frightening disease with persistent fear
of serious bleeding, in addition to living with
bad side effects, very frequent blood draws,
doctor visits, and hospital admissions, as well as
the financial hardships that go along with these
things.
I am pleased that researchers have continued to
look for better treatments for ITP. Nplate is a
new medication used to increase platelet count
which has shown promise in clinical trials and now
has been approved by the FDA.
I feel it is very important that Nplate be made
available to all patients with chronic ITP,
whether they be Medicare, Medicaid, or private
insurance patients. ITP patients need all the
tools that are available, in order to live with
this disease, and, in some cases, even go into a
remission.
Thank you for your consideration in this matter. |
| Commenter: |
McLeod, David
|
| Date: |
9/23/2008 2:14:48 PM |
| Comment: |
[PHI Redacted] ITP. Today there are limited
treatments with serious side affects. If there
are any other options for ITP patients they need
to be considered. |
| Commenter: |
Adams, David
|
| Date: |
9/23/2008 2:17:36 PM |
| Comment: |
To whome it may concern. [PHI Redacted] I have
learned about hip resurface and understand
Medicare soes not cover hip resurface[PHI Redacted]. So If my vote counts I wold like you to
consider covering Hip Resurface in the near
future. Thanks in Advance Dave Adams |
| Commenter: |
Collins, Heather
|
| Date: |
9/23/2008 2:23:56 PM |
| Comment: |
I am particularly disturbed to learn that after
the recent exciting news of the approval of
Nplate (romiplostim) by the FOod and Drug
Administration, there is the possibility that
access to this life-changing and much-needed drug
may be limited by its inclusion on the list of 20
topics being considered as NCDs by CMS. THis drug
has been long-awaited by those of us who have
lived with ITP, a debilitating and emotionally
devasting blood disorder for much of our lives.
THe prospect of a treatment that does not
engender toxic side effects, has proven effective
in lengthy clinical trials and could prove useful
to many adults, both those with spleens and
without, is a milestone in the treatment of this
orphan disease. Please do not prevent its
availability to the many thousands who have
looked forward to its release for a long time.
We are counting on Nplate to carry us to a point
in the future when understanding of ITP will be
at a new level.
THank you very much.
Heather Collins
|
| Commenter: |
Cutler, Doris
|
| Date: |
9/23/2008 3:51:55 PM |
| Comment: |
Hip Resurfacing
[PHI Redacted] I would like to request Medicare to
cover the resurfacing procedure, which would be
much less traumatic. [PHI Redacted]
I will appreciate your including this resurfacing
procedure in your benefits soon. It has been used
overseas for over 10 years and seems successful. |
| Commenter: |
Dawson, Sharon
|
| Date: |
9/23/2008 4:53:34 PM |
| Comment: |
[PHI Redacted] I am
concerned abouth the possible NCD for Nplate for
the treatment of this condition. [PHI Redacted] I
personally know of others who have been suffering
with life altering issues as a result. Although
this may not have the same incident rate as
diabetes, cancer and other illnesses, for those
who are affected, it is very real and can have a
devastating impact on the quality of life.
Thank you for your consideration. |
| Commenter: |
Trapasso, Joseph
|
| Date: |
9/23/2008 6:16:06 PM |
| Comment: |
Thank you for, and I applaude the current review being undertaken by CMS concerning the conundrum of proton beam therapy. Though it is and remains a reputable and effective treatment with clear indications for certain specific malignacies, there should be grave concern for what I see is a concerted effort to apply it, at great added cost, to cancers with minimal to no PROVEN added benefit in terms of cure and complication rates, ie. prostate cancer. The proton beam industry has now focused a substantial amount of marketing resources in an effort to convince the public with unsubstantiated claims of superior benefits of proton beam in comparison to the current available alternative cost efficient treatments. There are hundreds of thousands of men who are pleased after having undergone alternative treatments (surgery, IMRT, IGRT, brachytherapy) that have been so maligned by the proton beam activists. What is clear is that our tax funded health care dollars and resources are strained to the breaking point of insolvency under the weight of these expensive endevours, with little existing credible evidence of improved outcomes or side effects/complications. The significant premium reimbursement now being paid by CMS for proton beam treatment has encouraged the proton beam cottage industry to accelerate in entering financial partnerships with health networks to construct these astoundingly expensive proton beam facilities. I do not see the justification in allocating our limited health care resources for this, and request a thorough critical analysis of proton beam therapy relative to other therapies for prostate cancer before reimbursement for this treatment continues.
|
| Commenter: |
LaRoy, Timothy
|
| Date: |
9/23/2008 7:56:09 PM |
| Comment: |
Chronic Immune Thrombocytopenic Purpura (ITP) is a horrendously debilitating condition and the current treatments are even worse. Any alternative treatment options such as Nplate should be encouraged.
Please consider coverage of Nplate for Medicare and Medicaid recipients in the forthcoming National Coverage Determinations.
Thank you. |
| Commenter: |
Bruns, Nelson
|
| Title: |
President (Retired) |
| Organization: |
M-E-I Consultants, Inc. |
| Date: |
9/23/2008 8:17:03 PM |
| Comment: |
I find it hard to believe that the best form of
prostate cancer cure (Proton Therapy) is even
being considered for non coverage by Medicare. [PHI Redacted]
[PHI Redacted] all I found
from doctors were those touting their own
treatment specialty. In all cases the response my
questions regarding side effects was an ambiguous
answer that there are muscle training techniques
and medication.
Every person I know that has undergone other
types of treatment have had negative side
effects.
Why would the government even consider not paying
for the most effective least invasive procedure?
Doesn't the quality of life mean anything? |
| Commenter: |
Raynolds, John
|
| Date: |
9/23/2008 9:11:21 PM |
| Comment: |
PROTON BEAM THERAPY
Commenter: John F. Raynolds, J D and LLD {Hon}
Former President and CEO,Outward Bound USA}
[PHI Redacted] I serve on
their Board of Advisors for proton treatment. In
June [PHI Redacted] was diagnosed with a very aggressive
prostate cancer with a Gleason score of 10, which
had spread to the vesicles.The Mayo Clinic, for
whom I have great respect, told [PHI Redacted] they could try
photon radiation, but that the likelihood was
that [PHI Redacted] had 6 months to live and to get affairs
in order. They put [PHI Redacted] on a high dose of androgen
blocking hormones
Through the internet I became aware of LLUMC and
its pioneering work in PBRT. I then contacted 10
former patients who all told me PBRT was the most
effective treatment and had the fewest side
effects.
[PHI Redacted]
received both proton and photon because cancer
had spread. Now, 6 years later [PHI Redacted] [is] doing very
well - PSA is 0.25.
I believe it would be tragic mistake to end
Medicare coverage of PBRT because it is clearly
the most effective treatment and has the fewest
life diminishing side effects.
[PHI Redacted]
Sincerely,
John F. Raynolds |
| Commenter: |
Taylor, Mary Paull
|
| Date: |
9/23/2008 10:35:24 PM |
| Comment: |
heading somewhat towards the age for medicare i think that it would be quite upsetting to know that there could possibly be a treatment to help with my disorder, only to be turned down because it's not covered for those on medicare/medicaid. Since it sometimes seems that 'seniors' don't handle illnesses as well as those younger, i would think that it would be in the best interst of the medical field to make sure that the elders have the treatments to make them somewhat better. i would think that the cost of the treatment would in the long run be far cheaper than hospital stays if treatment was not available |
| Commenter: |
Kaper, Bertrand
|
| Title: |
Orthopaedic Surgeon |
| Organization: |
Orthopaedic Specialists of Central Arizona |
| Date: |
9/24/2008 12:29:26 AM |
| Comment: |
Hip Resurfacing needs to be considered as a viable option to standard total hip replacement surgery. |
| Commenter: |
Felty, James
|
| Date: |
9/24/2008 6:38:07 AM |
| Comment: |
Regarding Nplate
I have been involved [PHI Redacted] in both the
Phase II and Phase III clinical trial (over four
years) for Nplate by Amgen. I have seen where it
has helped the majority of the ITP patients lead a
more normal life due to elevated platelet counts.
[PHI Redacted] [improved] quality of life
by reducing the amount of the petekei, and the
amount and extent of bruising and bleeding.
To restrict the use of the drug, in my opinion
could be detrimental to patients treatment plan
and their quality of life. |
| Commenter: |
Pruitt, David
|
| Title: |
Medical Director |
| Organization: |
St. Joseph''s Mercy Cancer Treatment Center |
| Date: |
9/24/2008 9:37:56 AM |
| Comment: |
The efficacy is so high and the toxicity so low with modern photon therapy that it is extremely unlikely that a prospective randomized trial would be able to show a significant benefit towards proton therapy. CMS would be well advised to discontinue payment for proton therapy until the prospective randomized data becomes available showing a significant benefit of proton therapy relative to photon therapy for prostate cancer. |
| Commenter: |
Edwards, Dave
|
| Title: |
Orthopedic Surgeon, MD |
| Organization: |
Orthopaedic Consultants |
| Date: |
9/24/2008 10:00:41 AM |
| Comment: |
re hip resurfacing- Hip resurfacing is an excellent procedure for certain pts with hip arthrosis. Age is not the only determinate for deciding what is the best implant choice. Activity level and bone quality are important factors. Studies have shown acceptable results for resurfacing in selct pts over 65. Thank you, Dave Edwards |
| Commenter: |
Glassman, MD, Steven
|
| Title: |
Co-Chair |
| Organization: |
Professional Society Coalition Task Force on Lumbar Fusion |
| Date: |
9/24/2008 10:27:21 AM |
| Comment: |
Response to Posting of Potential CMS NCD Topics September 28, 2008
On behalf of the Professional Society Coalition Task Force on Lumbar Fusion, representing the North American Spine Society, American Association of Neurological Surgeons, American Academy of Orthopaedic Surgeons, Congress of Neurological Surgeons and the Scoliosis Research Society, we appreciate the opportunity to comment regarding the recently released CMS posting of potential national coverage determination (NCD) topics. In particular, our attached comments refer to two of the proposed NCD topics, Bone Morphogenetic Proteins (BMP) and lumbar fusion for degenerative disc disease, which relate to our primary goal of evidence development surrounding lumbar fusion surgery. We hope that, following review of these comments by the Centers for Medicare & Medicaid Services (CMS) staff, we will have a further opportunity to pursue our cooperative effort to optimize both care and resource utilization for Medicare patients needing lumbar fusion surgery. CMS Proposed NCD Topic-Bone Morphogenetic Protein (BMP): Members of the BMP family are potentially useful as therapeutics in areas such as spinal fusion. BMP-2 and BMP-7 have been shown in clinical studies to beneficial in the treatment of a variety of bone-related conditions including delayed union and non-union. BMP-2 and BMP-7 have received Food and Drug Administration (FDA) approval for human clinical uses. Certain off- label uses in cervical spine fusion may be associated with life-threatening complications. Is the evidence adequate to demonstrate health improvements in the Medicare population?
Since the initial approval of rhBMP-2 for anterior interbody fusion in 2002, BMPs have been widely used for lumbar spine fusion. However, the majority of use has been “off-label” in posterior spine applications such as posterolateral fusion (PSF) or transforaminal interbody fusion (TLIF). To a much lesser extent, cervical spine applications have been reported and, as noted in the proposed topic posting, complications related to anterior cervical applications are a significant concern. Given the primary Task Force mandate regarding evidence surrounding lumbar fusion, these comments do not specifically address cervical applications.
While the body of literature evaluating BMPs in posterior spine fusion is somewhat limited by its relative recent clinical availability, the literature is growing rapidly and includes a number of high quality studies. We have included some discussion of studies still in the editorial review process in order to demonstrate an appropriate response to the CMS staff’s expressed concern that ongoing critical evidence development should be undertaken once new technologies reach clinical practice. Several general issues are important in the evaluation of this literature. Firstly, variations in the specific BMP used, as well as dose, concentration, and carrier for each BMP may significantly affect risks or benefits. The studies evaluating high dose rhBMP-2 (40 mg, 2.0 mg/ml), lower dose rhBMP-2 (12 mg, 1.5 mg/ml), and rhBMP-7 all contribute to our overall understanding of biologics in lumbar fusion, but cannot necessarily be considered interchangeably. Secondly, the initial experience suggests that risks and benefits may differ based upon site (lumbar versus cervical) and application technique (PSF versus TLIF).
Posterolateral Spine Fusion (PSF)
The most significant available body of evidence examines the use of rhBMP-2 in posterolateral lumbar fusion. In 2002, Boden reported on a pilot study comparing rhBMP-2 (40mg, 2.0 mg/ml) and iliac crest bone graft (ICBG) which suggested better fusion rates in the rhBMP-2 patients (Boden S., Spine 2002; 27(21):2396-2408). This led to an FDA approved randomized controlled investigational device exemption (IDE) trial for rhBMP-2 and a compression resistant matrix (CRM) versus ICBG in single level posterolateral fusion. Two-year results from two centers participating in the IDE trial for rhBMP-2 (40 mg, 2.0 mg/ml) in single level posterolateral fusion have been reported (Dimar J., Spine; 31 (22):2534-2539). This subset of the randomized controlled trial (RCT) indicates better fusion rates, equivalent clinical outcomes and no increase in complications with rhBMP-2 versus ICBG. It is important to note that the dose/concentration of rhBMP-2 used in this study (40 mg, 2.0 mg/ml) was significantly greater than the dose/concentration (12 mg. 1.5 mg/ml) in the clinically available Infuse Bone Graft™ product (rhBMP-2/ACS). This raises the question of whether similar fusion rates will be achieved with the product in clinical use, but also affords a test of safety for posterolateral fusion, as complications were not seen with the much higher dose IDE protocol. A second published study from the same IDE trial data reports that the use of rhBMP-2 offsets, at least in part, the adverse effect of cigarette smoking on lumbar fusion rate (Glassman S., Spine; 32 (15):1693-1698). The complete IDE trial data set has been presented at national meetings, but is not yet published.
Several case series reports have been published on the use of clinically available Infuse Bone Graft™ (rhBMP-2 12 mg, 1.5 mg/ml) in an off-label posterolateral fusion application. One study examines the combination of rhBMP-2/ACS and ICBG, reporting better fusion rates at two years postoperatively as compared to ICBG alone (Singh K., J Spinal Disord Tech 2006;19(6):416-423). Another study reports on rhBMP-2/ACS in combination with several non-ICBG bone graft extenders, including local bone, demineralized bone matrix and bone bank bone (Glassman S., Spine J 2007; 7:44-49). This study reports fusion rates equal to or better than ICBG in single and multilevel posterolateral fusion cases. Neither study identifies complications related to the use of rhBMP-2/ACS. An additional study examines repeated exposures to rhBMP-2 without evident adverse consequences (Carreon L., Spine 2008; 33(4):391-393). An IDE pilot study comparing rhBMP-2 (12 mg, 1.5 mg/ml) combined with a ceramic bulking agent versus iliac crest bone graft in posterolateral lumbar fusion has been undertaken. It has been presented and is in editorial review (Bae H., Spine J 2007;7:IS-163S).
Most recently, a non-industry sponsored RCT comparing Infuse Bone Graft™ (rhBMP-2/ACS) versus ICBG in patients over 60 years of age has been completed. The study examined clinical outcomes, fusion success, and directly measured economic parameters. Initial perioperative cost data from this RCT demonstrated an increased initial cost for the hospital, but a net savings for the payer over a three month period with the use of rhBMP- 2/ACS (Glassman S., Spine J 2008; 8:443-448). The two-year data revealed similar health related quality of life outcomes, but better fusion on CT scan, fewer complications, lower revision rate and lower overall cost in the rhBMP-2/ACS group. This two-year RCT data has been presented, and received the Outstanding Paper Award, at the International Meeting for Advanced Spine Techniques (IMAST) in 2008. The study has been accepted for publication in SPINE, but has not yet reached its publication date. Despite this, the CMS staff may want to consider this data because it so directly addresses the issues raised in the proposed NCD topic question.
The literature assessing rhBMP-7 (OP-1) in posterolateral spine fusion is less robust, but also suggests safety, and probable efficacy, based on an RCT comparing rhBMP-7 and ICBG in single level fusion for degenerative spondylolisthesis (Vaccaro A., Spine 2005; 30:2709-2716). This study resulted in FDA approval of OP-1 putty, through the humanitarian device exemption process, as an alternative to ICBG in compromised patients. An additional small RCT comparing rhBMP-7 and ICBG in instrumented posterolateral fusion revealed equivalent radiographic success, however nonunion was detected at exploration in 4 of 7 patients (Kanayama M., Spine 2006; 31:1067-1074.).
Transforaminal Lumbar Interbody Fusion (TLIF)
A second common off-label application for rhBMP is in Transforaminal Lumbar Interbody Fusion (TLIF). No Level 1 data exists regarding the role of BMP in TLIF surgery. Several case series have been reported with variable findings. Two initial studies reported high fusion rates and minimal complications using rhBMP-2 for open and minimally invasive TLIFs (Schwender J., J Spinal Disord Tech 2005; 18 Suppl:S1-6) (Villavicencio A., J Neurosurg Spine 2005;3(6):436-443). Subsequently, concerns have been raised regarding the risk of heterotopic bone formation associated with the use of rhBMP-2 in TLIF. Conflicting evidence includes a prospective CT analysis which documented asymptomatic heterotopic bone in 20% of cases (Joeseph V., Spine 2007; 32(25):2885-2890.) and a report of five patients seen at a referral center with heterotopic bone and radiculopathy (Wong DA, Spine J 2007; Nov 21. [E-pub ahead of print]). Whether or not the risk for symptomatic heterotopic bone formation is dependent upon surgical technique, rhBMP-2 dose or any other surgical variable, remains undetermined. No data regarding the use of rhBMP-7 in TLIF is available.
Summary
In summary, while the indications for the use of BMPs in spinal surgery in the Medicare population are not fully defined, substantial evidence exists supporting the efficacy and cost effectiveness of BMP in posterolateral fusions compared to ICBG. Posterolateral fusion, in conjunction with decompression for stenosis or deformity correction, in spondylolisthesis, or degenerative scoliosis, is the most common spinal fusion technique performed in the Medicare population. The Professional Society Coalition Lumbar Fusion Task Force believes that it would not be appropriate to exclude the use of BMPs in the Medicare population. We also believe that ongoing additional investigation will contribute to refinements in dose, carriers and site specific applications for these valuable biologic technologies.
CMS Proposed NCD Topic-Lumbar Fusion for Degenerative Disc Disease:For certain patients, a two level spinal fusion may be an effective treatment for debilitating back pain from two degenerated lumbar discs. Multilevel fusion as a primary treatment for low back pain from degenerated discs is a controversial topic in spine medicine. However, lumbar fusion of three or more levels of the low back as a primary treatment for back pain is rarely recommended, and many surgeons recommend against it in all cases of multilevel degenerative disc disease. Is the evidence adequate to specify groups that do and do not benefit from the lumbar fusion procedure?
Our primary concern with regard to the proposed NCD topic on multilevel lumbar fusion revolves around the difficulty in clearly defining the population in question. It is agreed that there is no high quality or even consistent lower quality evidence indicating that multilevel (three or more level) fusion is effective as a treatment for isolated back pain without neurological deficit, deformity, or stenosis. Evidence to definitively support or refute the efficacy of such procedures is not likely to be available in a reasonable timeframe because these procedures are uncommonly performed in any patient population. According to MedPar data, a grand total of 688 such procedures were performed in the United States during 2007 (out of approximately 57,000 fusions performed for degenerative disease). Given difficulties with the fidelity of administrative databases, it is likely that the true incidence is even lower due to failure to code for associated diagnoses. Furthermore, when such procedures are performed, they are performed in an elective fashion on younger patients. These are “boutique” procedures that are not performed in the Medicare or Medicaid population. Therefore, the interest of the CMS in multilevel fusion for low back pain is somewhat puzzling.
Answerable questions must be used as the basis for reasoned debate when policy decisions are proposed. For example, at the 2006 MCAC meeting on lumbar fusion, the published MCAC question, similarly described as fusion for isolated low back pain in the Medicare population, was not able to be addressed. The majority of data reviewed by the speakers, and much of the panel discussion, addressed the utilization of lumbar fusion in completely different patient populations. Nonetheless, the panel was required by procedure to vote on the atypical use of fusion for low back pain in the Medicare population, as this was the specific MCAC question. As there was no evidence relevant to the Medicare or Medicaid population, the panel was forced to conclude that such procedures were not supported by high quality evidence. This conclusion, supported by a draft tech report, has been published and used to inappropriately limit access to lumbar fusion in other populations.
It is also imperative that fusion procedures for isolated low back pain are not confused with multilevel fusion procedures that are performed for the purposes of deformity correction, correction of instability, or following destabilizing decompressive procedures in the elderly. There is substantial evidence indicating that the use of fusion in such situations improves functional outcome. In particular, data from the SPORT study, which has been presented and published since the 2006 MCAC meeting, provides high quality evidence supporting the benefit of lumbar fusion in appropriately selected patients (Weinstein JN, N Engl J Med 2007;356(22):2257-2270). Also, consistent with the CMS call for evidence development surrounding lumbar fusion in the Medicare population (Schafer J, Spine 2007;32 (22):2403-2404), several studies examining the role of single and multilevel fusion in older patients have now been published, or are awaiting publication (Glassman SD, Spine J 2007;7(5):547- 551) (Okuda S, J Bone Joint Surg Am. 2006;88-A (12):2714-2720) (Glassman SD, Spine J. E-pub 2008) (Bridwell K, SRS 2008) (Ghogowala, Benzel, etc). The Professional Society Coalition Task Force on Lumbar Fusion would welcome any and all opportunity to discuss the appropriate use of multilevel fusion in the Medicare population. We agree that demonstration of benefit for lumbar fusion, or any surgical intervention, limited to simple cases and idealized populations is not ultimately sufficient to predict value in standard clinical practice. We believe that additional and ongoing evidence development is critical to guide appropriate resource utilization in the Medicare population. It is our assertion that identification of the most specific and relevant question for analysis is critical in order to maximize the utility of the subsequent analysis. We do not believe that the proposed NCD topic on multilevel lumbar fusion meets this standard.
Steven D. Glassman, MD Co-Chair
Daniel K. Resnick, MD Co-Chair Professional Society Coalition Task Force on Lumbar Fusion
|
| Commenter: |
Armstrong, David
|
| Date: |
9/24/2008 11:47:31 AM |
| Comment: |
Proton Beam Therapy
I urge you to continue reimbursing proton beam
therapy (PBT) treatment for prostate cancer
(Pca).
[PHI Redacted]
Last year, when [PHI Redacted] was diagnosed with Pca, I did
my research and discovered PBT. The research I
did showed that PBT has 5 year survival rates at
least equal to other treatment options, but with
vastly reduced incidence and extent of both
short and long term side effects. When [PHI Redacted] met
with urologist, he outlined non-proton
treatment options and the risks of side
effects. But [PHI Redacted] came away with the feeling that
the issue of side effects and long term
complications was dismissed, with an attitude
of, we know how to deal with them and we will
just cross that bridge when we come to it.
Well, [PHI Redacted] didn’t want to cross that bridge and
chose PBT. [PHI Redacted] pre-treatment PSA was 5.3, it is
now .8 and have had no side effects.
I understand the issue with reimbursement is
that PBT costs more than other treatments at
least initially. But what is the value of
quality of life and what is the “lifetime cost”
associated with different treatments options?
If an individual can get treated for prostate
cancer (at a one-time, higher initial cost),
continue a high quality of like and have no
complications or side effects, doesn’t that make
sense to consider compared with the
alternatives? The alternatives being non-PBT
treatments, that may have a lower initial cost,
compromise quality of life and require numerous
and costly on-going medical interventions to
deal with the numerous and documented side
effects associated with those treatments.
In other words, what is the “life cycle cost” of
PBT (one treatment protocol) versus the “life
cycle cost” of an on-going series of
interventions for other treatment options that
begins with an initial intervention with an on-
going series of other procedures to deal with
side effects and complications?
|
| Commenter: |
Gibbs, Garry
|
| Date: |
9/24/2008 1:00:16 PM |
| Comment: |
Regarding Medicare coverage for Proton Therapy
for prostate cancer. In reviewing the comments
posted, I see that many appear to be from
practitioners of alternative (competitive)
treatment approaches contrasting with proton
therapy. I find it exceptional that this proton
therapy would generate the kinds of responses,
and the attacks on the efficacy and benefits of
proton therapy from this group of "profesionals."
I think I speak for many of literally thousands
of patients who have undergone proton therapy for
prostate cancer, and who are extremely satisfied
with the results and the major benefit of few if
any side effects. Having explored many of the
different options available, and having been
scheduled for surgery at a major university
cancer center in Los Angeles, [PHI Redacted] found that not
one of the doctors consulted even brought up,
much less discussed proton therapy as an option.
Additionally, [PHI Redacted] found that lingering side effects
and quality of life issues after surgery, or with
other approaches, received little discussion and
was really down played (contrary to some of the
evidence found in some medical studies in
the medical research literature on proton
therapy).
[PHI Redacted]
[PHI Redacted] I know that
the support for the proton therapy approach comes
from the personal experiences and results
achieved by thousands of satisfied patients with
prostate cancer. I don't know how you can get a
stronger endorsement than that.
To the rest of the medical establishment - shame
on you for your parochial (sp?) attacks, your
time and efforts are better spent with your
patients. |
| Commenter: |
Schulman, Kevin
|
| Title: |
Professor of Medicine and Business Administration |
| Organization: |
Duke University |
| Date: |
9/24/2008 1:02:43 PM |
| Comment: |
I appreciate the opportunity to comment on the potential NCD topics for the third quarter of 2008. I would like to strongly recommend that you open an NCD for proton beam therapy for prostate cancer (and proton beam therapy more broadly). This exciting technology has not been subject to randomized clinical trials to assess it’s unique benefits for Medicare beneficiaries. Further, the lay press has widely reported on business models for this technology well in advance of the clinical evidence to support it’s appropriate dissemination. Given the large sums involved in building dedicated facilities for this technology, we must work now to assess the potential of this technology today before hospitals make substantial further investment in this area.
One issue that was raised in the Wall Street Journal is whether a clinical trial of this technology is appropriate at this stage of technology development. While this seems to be an issue within the radiation oncology community, we must remember that the same arguments were raised for lung-volume reduction surgery when it was felt to be the standard therapy for patients with COPD. If the technology is not yet mature enough to determine the correct dose and method of administration, than it cannot be mature enough to be reasonable and necessary for the practice of medicine.
|
| Commenter: |
southerland, vickie
|
| Date: |
9/24/2008 1:20:13 PM |
| Comment: |
|
[PHI Redacted] I feel Nplate would
be very beneficial since there are not many
options for treatment. ITP is a very difficult
disease because you don't know when and why your
platlets will drop to be able to just take a shot
once a week to keep your platlets at a safe level
would be very beneficial to those who have to
take steroids or go to outpatient care often.
Especially when steroids causes so many side
effects. [PHI Redacted] I feel this medication is
well worth using. [PHI Redacted] |
| Commenter: |
Tomei, Mario
|
| Title: |
Professor Emeritus, Rowan University |
| Date: |
9/24/2008 3:12:59 PM |
| Comment: |
Proton Beam Therapy
Dear Sirs:
I wish to add my testimony in support of
proton beam therapy for prostate cancer.
[PHI Redacted] was diagnosed with an advanced prostate
cancer and was advised to seek radiation
treatment.
After a thorough review of research,
medical and patient literature, [PHI Redacted] was convinced
that proton therapy would be the most effective
treatment with the higest probability of
eradication, and with the fewest negative side
effects, plus a minimal effect on daily
activities.
After undergoing the proton treatments, [PHI Redacted]
experienced virtually no side effects, [is] cancer
free and living a good emotional and physical
life. It should be noted, that in addition, [PHI Redacted] had
some photon radiation treatments to the pelvic
area which did have immediate negative side
effects although not severe.
The benefits of proton therapy outweigh the
short term and possible long term insurance costs
in addition to the obvious humane aspects, in my
judgement.
No one would probably submit to a double
blind prostate study once he learns about proton
therapy, one of the "best kept secrets" among the
many doctors [PHI Redacted] consulted. Hence, this and other
testimonials should assume great significance in
your deliberations.
I urge you to allow other fellow Americans
to continue to benefit from proton therapy by
continuing medicare insurance payments and hence
other insurance support.
Yours truly,
Mario Tomei, ED.D. |
| Commenter: |
Conway, Craig
|
| Title: |
Executive Director |
| Organization: |
Platelet Disorder Support Association |
| Date: |
9/24/2008 3:15:20 PM |
| Comment: |
September 24, 2008
Thank you for the opportunity to provide comments to the Center for Medicare and Medicaid Services (CMS) on potential NCD topics. I am submitting comments on behalf of The Platelet Disorder Support Association (PDSA). Our organization represents more than twenty thousand families with ITP, immune (idiopathic) thrombocytopenic purpura, worldwide.
ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. Recognized as an orphan disease, chronic ITP is considered an unmet need by the FDA.
On July 31, 2008, CMS included Nplate™ (romiplostim) as a topic for a potential NCD by specifically listing “thrombopoiesis stimulating agents (platelet growth factors, e.g. romiplostim)” and noting that “long-term safety data are lacking.”
On August 22, 2008, the FDA approved Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic ITP. The FDA approval of Nplate was based on efficacy and safety results from two pivotal Phase 3 studies of adult patients with chronic ITP, including both splenectomized and non-splenectomized patients.
As a policy, the PDSA does not take a formal position on the recommendation of any specific treatment, however, we are concerned that an NCD would affect many ITP patients by excluding or restricting coverage of Nplate for Medicare and Medicaid recipients and may influence commercial or private payer coverage decisions.
ITP can be a difficult disease to treat. Often the first line of treatment, corticosteroids, usually prednisone, offers only a brief reprieve from a dangerously low platelet count. Most patients are then left to deal not only with the return of their low platelet count, but also the side-effects of the corticosteroids. These side- effects can include significant weight gain, cataracts, muscle loss, diabetes, osteoporosis and steroid psychosis.
After prednisone, many people with ITP have a succession of other treatments. Some have minimal toxicity, except in very rare cases, and provide short-term relief. Others compromise the immune system, sometimes permanently, or are highly toxic, carrying a black box warning. An often-cited research study concludes that as many people with ITP die from the treatments as the disease.
Our organization is very sensitive to the balance between safety and efficacy for all of the treatments for ITP. At the PDSA, we believe it is important that thrombopoiesis stimulating agents are available to those patients who would benefit from that choice, and that any program not exclude or restrict coverage, which may reduce access for those patients who might be helped by this new treatment approach.
For those suffering from ITP, the daily fear of experiencing a serious bleeding episode can be emotionally stressful and extremely difficult for both patients and their families. We hope you will strongly consider these facts when making your decision about placing Nplate on the NCD list.
Thank you again for the opportunity to submit these comments. Please let us know if you have any questions or need clarification.
Craig Conway Executive Director Platelet Disorder Support Association
|
| Commenter: |
Nelson, Tom
|
| Title: |
Orthopedic Surgeon, MD |
| Organization: |
Orthopaedic Consultants PA |
| Date: |
9/24/2008 3:25:14 PM |
| Comment: |
Hip Resurfacing,
There are many patients of medicare age that would be excellent patients for a resurfacing procedure. Age by itself should not be a criteria for implant or procedure selection. |
| Commenter: |
McCarter, T. Kerry
|
| Title: |
CEO |
| Organization: |
Soluble Systems, LLC |
| Date: |
9/24/2008 4:04:09 PM |
| Comment: |
On behalf of Soluble Systems, LLC, I am pleased to present comments regarding CMS’ request for comments on a list of potential topics for future National Coverage Determinations (NCD). Soluble Systems, LLC, a start-up medical device manufacturer, is the maker of TheraGauze™, the precise moisture regulating wound care product that is absolutely non-stick. Created in 2007, TheraGauze™ has helped many patients suffering from diabetic foot ulcers as well as other ailments, not only helping to heal, but helping to do it more rapidly.
On July 30, 2008, the Centers for Medicare & Medicaid Services (CMS) released a list of potential topics for future National Coverage Determinations (NCDs). While many topics were identified in that document, Soluble Systems, LLC is particularly interested in the topic, “Biological therapies for treatment of chronic wounds: Clinicians' understanding of and ability to achieve wound healing has increased significantly over the past few years, particularly as a result of advances in molecular biology such as the use of growth factors, the ability to grow cells in vitro and the development of bioengineered tissue. Is the evidence for any specific modalities adequate to demonstrate improved health outcomes for selected wound patients while avoiding side effects seen with other growth hormones?”
Our comments revolve around two issues: comparable or better evidence-based outcomes for an inert, inherently-safe non-biological; and the reimbursement for products that have been shown to positively influence outcome of biological therapies.
1. Data Shows Inert Non-Biological Product Can Yield Outcomes At Least Equal To Biological Therapies With Significantly Reduced Safety Risk
A new class of wound care products is demonstrating improved health outcomes while avoiding side effects. For example, products designed to precisely regulate moisture differentially across a wound provide healing support without any chance of adverse side effects, since they are biologically inert. There is a growing body of evidence showing improved health outcomes provided by the first of this new class of products, TheraGauze™, manufactured by Soluble Solutions, LLC.
In a randomized clinical study of patients with diabetic foot ulcers, TheraGauze™ and its precise moisture control resulted in an increase in the percentage of wounds closing as well as an increase in the rate of wound progression. The closure rate increased by nearly +40% within 12 weeks and nearly +50% over 20 weeks when compared to saline-moistened gauze, and +35% within 12 weeks and +24% over 20 weeks when compared to standard Regranex® therapy. It is believed that by regulating and continuously adjusting the moisture content of the wound, there is a greater period of time where conditions are optimal for wound healing.
An upcoming issue of JAPMA will include the full study conducted to compare the healing rates of diabetic foot ulcers when treated with TheraGauze™ alone or TheraGauze™ and Regranex® (becaplermin) vs. Regranex® only and a placebo control. Clinical experience (soon to be confirmed by a clinical study) has also shown that TheraGauze™, when used as a cover to bioengineered skin, increases the "take" rate of grafts and success of the graft therapy. Soluble Systems endorses a full comparison of any and all data related to wound care that will improve patient outcomes. In light of the health outcomes data currently available on TheraGauze™ and various other studies underway, precise moisture control therapies should be included in this analysis of available biological therapies.
2. Companion Dressings That Positively Influence Biological Therapies Outcomes Should Be Reimbursed
Currently, secondary dressings for biologic therapies for chronic wounds are not separately reimbursable. There is now a new class of advanced secondary dressing that will enhance the take rate for Living Skin Equivalents (LSE) and other advanced biologic therapies by differentially regulating moisture over the LSE. Improving the wound healing rate of these expensive biologic therapies using this new class of wound dressing would result in reduced medical expenditures. There should be a separate reimbursement code for secondary products that have been proven to show an increased rate of success for biologic therapies. The ‘increased rate of success” could include higher take rate, fewer applications of high cost biologics, better quality of graft, and reduced use of staff resources.
Soluble Systems, LLC appreciates the opportunity to provide our comments and looks forward to working with the Agency to address the issues discussed in this letter.
|
| Commenter: |
Schreiber, Brian
|
| Title: |
Vice President,Medical Affairs |
| Organization: |
Sigma Tau Pharmaceuticals |
| Date: |
9/24/2008 4:46:16 PM |
| Comment: |
September 23, 2008
Steve Phurrough, MD Director, Coverage & Analysis Group Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, MD 21244-1850
Re: Potential topics for national coverage determinations – use of levocarnitine in patients on dialysis
Dear Dr. Phurrough,
On July 30, 2008, CMS published and requested comment on a list of potential NCD topics for the third quarter of 2008. Sigma-Tau Pharmaceuticals has prepared this response to your request related to the use of levocarnitine in dialysis.
On the list of potential NCD topics CMS wrote that: Levocarnitine has unclear benefits in the ESRD population. Recent revisions of K-DOQI guidelines suggest a paucity of evidence to support some uses.
We comment on the use of levocarnitine in the ESRD population especially in regard to the use of levocarnitine in the context of EPO resistant anemia since it is this application that was the subject of the recent recommendations by the K- DOQI anemia working group cited by CMS in its list of potential topics for review. We therefore place particular emphasis on the additional data supporting the application of levocarnitine in the context of ESA therapy generated since the adoption of the levocarnitine NCD in 2004 and the significant flaws in the K-DOQI guidelines concerning levocarnitine and ESA use that were highlighted during the review period for that K- DOQI and have become even more apparent since the publication of that guideline.
As there have been no new clinical trials on the use of levocarnitine for dialysis related hypotension since the issuance of CAG-00077N, we do not believe that there is a compelling basis for modification of coverage for that indication.
Evidence for benefit of levocarnitine in the context of ESA therapy for anemia in dialysis patients
In crafting its NCD for levocarnitine in dialysis, CMS performed an extensive review of the literature concerning the effect of levocarnitine therapy on parameters of the anemia of chronic kidney disease including both an independent effect on improvement of hemoglobin and hematocrit levels as well as reduction of EPO requirements for maintenance of specified anemia treatment targets in the ESRD population. In performing its analysis, CMS adhered to strictly defined criteria for selection of appropriate literature for review. Research qualified for inclusion in the analysis only if it met the following criteria:
• Clinical trial • Human ESRD subjects • Minimum of 10 subjects • Published after 1980 • Clinically relevant outcome measures
The application of these criteria allowed inclusion of eleven papers related to levocarnitine and anemia treatment in dialysis patients. Eight of these studies were randomized control trials. Five of the eleven studies examined the effect of levocarnitine therapy on EPO requirements. In 3/5 studies the EPO requirement decreased in association with levocarnitine therapy; in an additional study, the EPO requirement remained stable compared with an increase in the control group. In only one study was the change in EPO requirement similar in both the carnitine treated and control group. As a result of this analysis, CMS concluded:
“the evidence is adequate to conclude that the use of levocarnitine to treat ESRD patients with erythropoietin-resistant anemia (persistent hematocrit < 30% with treatment) that has not responded to standard erythropoietin dosage with iron replacement, and for which other causes have been investigated and adequately treated is clinically effective, and, therefore, reasonable and necessary.
This conclusion, based upon a systematic analysis of the literature chosen according to clearly specified selection criteria is thought to represent an accurate interpretation of the available data. Given the appropriateness of the analytical strategy, it would seem that the sole valid reason for questioning the conclusion of the analysis would be the subsequent availability of more recent data suggesting the lack of efficacy of levocarnitine in reducing ESA requirements in dialysis patients. In order to judge whether such data provides the basis for a reasonable challenge to the NCD, one must examine the data that has emerged subsequent to the NCD evaluation. As the most recent study included in the CMS analysis of L-carnitine and anemia in dialysis patients dated to May 2001(Brass et al), it is worthwhile to review the results of studies related to intravenous L-carnitine and renal anemia published since the NCD deliberations that satisfied the literature selection criteria used by the MCAC.
1) Vesela E et al,July 2001
Twelve chronic hemodialysis patients were treated with IV L-carnitine 15mg/kg after each hemodialysis session for 6 months. The clinical outcomes were compared with non-carnitine treated patients. Whereas there was no significant change in either hemoglobin level or EPO requirement in the non-carnitine treated controls, six months treatment with IV L-carnitine was associated with an increase in hematocrit from 27 to 34 with a concomitant reduction in rHuEPO dose from a mean of 5500 units to 3500 units per week. 1
2) Savica 2005
48 chronic hemodialysis patients were treated with IV L-carnitine 20mg/kg three times weekly for six months. Outcomes were compared with 65 patients treated for 6 months with placebo Carnitine treated patients had a mean increase in HgB level from 9.6 to 10.7 as opposed to no increase in HgB in the placebo treated patients who started from a similar baseline HgB and treated according to the same EPO regimen. 2
3) Kadiroglu AK et al (2005) Seventeen maintenance hemodialysis patients were treated with rHuEPO plus L-carnitine 1 gram IV after each dialysis and compared over a sixteen week treatment period with 17 patients treated with rHuEPO without L-carnitine therapy. Iron status was similar in both groups .Whereas the target HgB was achieved in both groups, the carnitine treated group had a 20% greater reduction in EPO requirements in the course of the study compared with non-carnitine treated patients, (p<.05) 3
4) Steiber et al 2006
A double blind, randomized, placebo controlled trial in which 50 hemodialysis patients were treated with either 2 grams IV L-carnitine or placebo for 24 weeks. For maintenance of HgB within a desirable range, the erythropoietin dose over the 24 week period was reduced from baseline in the carnitine treated group relative to the placebo group(-1.62 +/-.91 vs. 1.33 +/- .79 units erythropoietin/dry weight/Hgb concentration respectively<.05). 4
5) Arduini et al 2006 A double blind, placebo controlled study of 29 stable hemodialysis patients. Patients treated either with L-carnitine IV 20mg/kg after each dialysis or placebo (normal saline) for 24 weeks. The primary endpoint was red blood cell (RBC) survival. Baseline RBC survival was similar in the carnitine and placebo groups (T1/2 40.2 +/- 8.9 days placebo,39.1+/- 7.5 days L carnitine).RBC survival measured by Cr51 labeling increased by 3.6 days in the carnitine treated group and decreased 4.8 days in the placebo group. Estimate of the treatment related difference was 8.5 days (95% CI .3, 17.2). Median EPO dose decreased in the L-carnitine treated patients and increased in the placebo treated patients though the actual units of EPO for this secondary endpoint are not shown in the paper. 5
It can therefore be seen that all studies conducted subsequent to the levocarnitine national coverage decision have confirmed the efficacy of levocarnitine either in reducing EPO requirements or independently increasing hemoglobin or hematocrit.Since the data available to the MCAC was said to support the use of L- carnitine as adjunct treatment of dialysis related anemia and studies since that time have provided additional support for this application of levocarnitine, there appears to be no compelling reason to re-visit this indication for levocarnitine use in dialysis patients.
As to the recent K-DOQI anemia recommendation concerning the use of L-carnitine for EPO resistance, the negative sentiment communicated in the guidelines was the result of both an incomplete data analysis and an incorrect reading of the data cited. Sigma Tau commented extensively on these errors during the open response period following the issuance of the preliminary guidelines.However, despite endorsement of Sigma Tau’s corrections by several members of the DOQI anemia committee, there was no feedback to Sigma Tau by the committee chairman, Dr.Van Wyck.The entire critique of the DOQI guideline concerning L-carnitine and the anemia of ESRD is attached to this document but is briefly summarized as follows:
The DOQI committee had three principal criticisms of the evidence supporting the use of L-carnitine as adjunctive treatment for the anemia of ESRD:
The first criticism was the supposed lack of data supporting specific mechanisms of action by which L-carnitine could enhance the response to ESAs. No less than five published studies were cited by Sigma Tau which demonstrated improvement with the use of L-carnitine in factors known to be associated with resistance to ESAs. These mechanisms included the following:
• Improvement in red blood cell deformability6 • Stabilization of red cell osmotic resistance7 • Reacylation of red cell membrane phospholipids8 • Reduction in C-reactive protein levels 9 • Reduction in free oxygen radicals 1
Preservation of the integrity of the red cell membrane by the various mechanisms cited above results in an improved red cell life span as demonstrated by Arduini et al (2006).Improvement in red cell survival reduces the requirement for red cell production stimulated by ESAs .Furthermore, as chemical mediators of vasospasm have been demonstrated to be released by lysed red cells, improvement in red cell membrane integrity and red cell survival would be expected to reduce the release of those vasoactive substances which might consequently reduce the endothelial dysfunction documented in dialysis patients. 10In omitting much of the published literature on mechanisms of benefit on anemia associated with L-carnitine, the DOQI committee seems to have limited the scope of its literature review to a significant degree.
The second criticism questioned the quality of the data supporting the efficacy of L-carnitine in reducing EPO requirements in dialysis patients. Specific objection was raised to the methodologies employed in the Labonia study (1995).11 As part of its review of the K-DOQI guidelines, Sigma Tau highlighted several elements of the Labonia study that were characteristic of an acceptable methodology. These included random assignment to a control or placebo group, clear characterization of inclusion and exclusion criteria, clear description of additional therapies for anemia such as iron, B12, and folate, and employment of a similar dialysis regimen for the placebo and treatment groups. As to the K-DOQI criticism of the size of the patient population, Sigma Tau stated as follows:
“The Labonia study showed a reduction in EPO dose of 38% - no reduction was demonstrated in the placebo treated group. The reduction in dose was significant for the carnitine treated patients at a p value of <.02. The fact that this level of significance for the reduction was achieved in a small study group of 24 patients lends support to the hypothesis of a reduction in EPO requirements with carnitine use. The fact that the guideline faults the study for being small ignores the basic principles of study design where the number of subjects necessary for a study is determined by the effect size and standard deviation on the measurement rather than some arbitrary characterization and “large” or “small.”
The conclusion of benefit for L-carnitine in improving the response to EPO has been supported by the positive results of controlled clinical trials conducted since the adoption of the most recent K-DOQI guideline as summarized above.
The last criticism of the efficacy data concerned the meta-analysis of carnitine and EPO response authored by Hurot and published in JASN in 2002.12This meta-analysis clearly demonstrated the efficacy of L-carnitine for reducing the required dose of EPO for maintenance of a target hemoglobin or hematocrit level. This study included features indicative of a carefully done meta-analysis. Prospective standards were adopted for the selection of studies to be included in the analysis. Retrospective trials as well as nonrandomized and uncontrolled trials were excluded from the analysis. These strict study criteria restricted the included studies to 17 published trials of the 620 references initially identified.
The effect measure analyzed in the carnitine- anemia trials was that endorsed by the K-DOQI anemia committee to be most significant is the difference between carnitine and control in the change in EPO dose from baseline. The conclusion of the authors of this meta-analysis is as follows:
“A reduction in EPO dose was achieved in the carnitine treated groups in five of the six studies while maintaining comparable target hemoglobin in both the carnitine and control groups. The EPO dose was significantly smaller as compared with the control groups in four trials. A common effect size of -.75 (random effect model) was observed, with a statistically significant level of heterogeneity (p heterogeneity=.02). This indicates that a patient in the 50th percentile of EPO dose distribution in the placebo group would reduce his/her EPO dose to the 23rd percentile if treated by L carnitine.”
The strongest objection of the K-DOQI to this meta-analysis concerned the heterogeneity of response in the studies included in the Hurot meta-analysis. This objection demonstrated an incomplete grasp of the significance of the random effects model used in the meta-analysis. During its review of the K-DOQI reccomendations, Sigma Tau answered the criticisms of the K-DOQI in regard to heterogeneity as follows:
In regard to the heterogeneity cited by Hurot, et al., the authors properly addressed these issues by use of a random effects meta-analysis. Heterogeneity among studies could invalidate the meta-analysis only if the studies literally contradicted one another, with an ambiguous conclusion about whether the effect was beneficial or not. As seen in the lower half of Figure 3 from Hurot, et al., [2002, page 711], there was no such ambiguity regarding the impact of LC on EPO use. Only one study of seven had an effect in the opposite, non-beneficial, direction and its confidence interval included zero (no effect). The other six studies were concordant in direction (lower EPO dose with LC usage), five of them significantly favoring LC. Among the seven studies, heterogeneity of effect size was discovered in stage 1 and appropriately addressed in the stage 2 random effects meta-analysis. Rather than making LC efficacy seem less credible, a significant finding based on a conservative
In summary, the negative conclusions of the most recent K-DOQI in regard to the efficacy of L- carnitine in the treatment of dialysis related anemia are not supported by the primary literature sources or the analytical procedures employed in the cited studies. Sigma Tau sent detailed comments to the K-DOQI anemia committee during the period allowed for review but no response was ever received to these comments.
CMS has an impressive record of basing coverage decisions on data Any further restriction to the coverage for levocarnitine in dialysis is inconsistent with the data both prior to and subsequent to the present levocarnitine NCD and is likely to have negative consequences in regard to outcomes in patient with ESRD.
Thank you for the opportunity to comment on this important issue.
Sincerely,
Brian Schreiber, M.D. Vice-President, Medical Affairs Sigma Tau Pharmaceuticals 9841 Washingtonian Blvd., Suite 500 Gaithersburg, MD 20878
References 1) Vesela E,Racek J,Trefil L,Jankovych V,Pojer M : Effect of L-carnitine supplementation in hemodialysis patients Nephron 2001;88:218-223
2) Savica Vincenzo,MD,Santoro Domenico MD,Mazzaglia Giampiero,MD et al L-Carnitine Infuctions May Suppress Serum C-Reactive Protein abd Improve Nutritional Status in Maintenance Hemodialysis Patients Journal of Renal Nutrition,2005 Vol 15,No2 ;225-230
3) Kadiroglu AK,Yilmaz ME,Sit D,Kara IH,Isikoglu B The evaluation of postdialysis administration L- carnitine administration and its effect on weekly requiring doses of rHuEPO in hemodialysis patients Renal Failure 2005;27(4):367-372
4)Steiber AL,Davis AT,Spry L,Strong J,Buss ML,Ratkiewicz MM,Weatherspoon LJ Carnitine Treatment improved quality of life measure in a sample of Midwestern hemodialysis patients JPEN J Parentter Enteral Nutr 2006 ;30 (1) :10-15
5) Arduini A,Bonomini M,Clutterbuck EJ,Laffan MA,Pusey CD Effect of L-carnitine administration on erythrocyte survival in hemodialysis patients Nephrol Dial Transplant 2006; 21(9):2671-2
6) Nikolaos S,George A,Telemachos T ,Maria S,Yannis M,Konstantinos M Effect of L-carnitine supplementation on red blood cells deformability in hemodialysis patients Ren Fail 2000 ;22 (1): 73-80
7) Vlassopoulos DA,Hadjiyannakos DK,Anogiatis AG,et al Carnitine action on red cell osmotic resistance in hemodialysis patients J Nephrol 2002 ;15(1)68-73
8)Arduini A,Tyurin V,Tyuruna Y,et al Acyl- trafficking in membrane phospholipid fatty acid turnover:the transfer of fatty acid from the acyl- L-carnitine pool to membrane phospholipids in intact human erythrocytes Biochem Biophys res Commun.1992 ;187 (1):353-358
9) Duranay M,Akay H,Yilmaz FM et al Effects of L- carnitine on inflammatory and nutritional markers in hemodialysis patients Nephrol Dial Transplant 2006;21(11 :3211-4
10) Link TE,Murakami K,Beem-Miller M,Tranmar BI,Wellman GC Oxyhemoglobin-induced expressio of R-type Ca2+ channels in cerebral arteries Stroke 2008 39(7):2122-8
11) Labonia WD L-Carnitine effects on anemia in hemodialyzed patients treated with erythropoietin Am L Kidney Dis 1995;26(5):757-64
12) Hurot JM ,Cucherat M,Haugh M Fouque D Effects of L-carnitine supplementation in maintenance hemodialysis patients: a systematic review J Am Soc Nephrol 2002 Mar;13 (3) 708-714
|
| Commenter: |
rogerson , john
|
| Date: |
9/24/2008 5:09:52 PM |
| Comment: |
Hip resurfacing:
I have performed 332 hip resurfacings over the last 2 1/2 years and feel that the best criteria as to who should recieve the procedure is what the patients physiologic (not chronologic) age is, the patient''s bone density, activity level and aspirations are, and weight and sex. There are many 60-65 year old patients with severe arthritis who have excellent bone density and aspire to continue to be physically active. These patients do extremely well with resurfscing and are likely to avoid total hip replacement later by doing resurfacing or at least make future revision much easier. In summary, chronologic age is not a good determiner as to who should have resurfacing . Should instead be determined on patient''s bone density, weight, activity level and aspirations and bony femoral head cysts. Sincerely, John S. Rogerson, MD
|
| Commenter: |
poff, susan
|
| Date: |
9/24/2008 7:18:36 PM |
| Comment: |
Why the government should pay for treatment with thrombopoietin drugs. There are very few drugs used to treat Immune Thrombocytopenia Purpura and related blood disorders. The newest and most effective treatments are the new thrombopoietin drugs such as Romniplastin(NPlate). These drugs save the lives of persons who are refractory and have no other options to keep their bodies from destroying their platelets. If Medicare does not pay for them, they are essentially stopping the doctors form prescribing life saving treatment. Why not let the doctors make the decisions about what treatment will work best for each patient? The government should certainly allow this option for its citizens.
Another issue is that all other treatments are more expensive than this one treatment. Also persons with this blood disorder are oftne hospitalized due to hemorrhaing problems so in the long run adding this drug to the treatmens paid for by the government is actually less costly and a savings. |
| Commenter: |
Levins, Lynn
|
| Date: |
9/24/2008 8:55:31 PM |
| Comment: |
[PHI Redacted] has had ITP for quite some time nothing
has helped long term. She is dealing with a
platelet count of less than 30,000 consistently.
Further research must be done. Especially
concerning those who have had splenectomies. Her
doctor just died and she is quite concerned.
Please be sure that the doctors get the info on
new treatments quickly.
Thank you,
Lynn Levins
|
| Commenter: |
Goodson, Michael
|
| Organization: |
Stephen Saunders Residence |
| Date: |
9/24/2008 11:19:00 PM |
| Comment: |
Consumer,[PHI Redacted] request presently for
access to the New ITP Treatment called Nplate
(romiplostim). Patient-Consumer,[PHI Redacted]
examination of a "bone marrow biopsy" relate to
the diagnosis that identify with ITP/immune
thrombocytopenic purpura. Surgical lab reports
and procedure of bone marrow biopsy uphold lab
reports and diagnosis. Medical results relate to
patient-consumer having an "enlarge liver spleen"
that traps and destroy red/white blood cells.
Presently,patient-consumer suffer with a low
count of plasma protein cells and platelets.
Patient-Consumer,[PHI Redacted] receives
Medicaid Benefits/insurance under New York State
Medicaid Services. This procedure of "Bone Marrow
Biopsy" resides under the following case/
registrations and numbers.
[PHI Redacted]
Please assist this legal document and comment of
patient-consumer,[PHI Redacted] (ASAP) thank you. |
| Commenter: |
Owens, Holly
|
| Title: |
Director of Legislative and Regulatory Affairs |
| Organization: |
Renal Physicians Association |
| Date: |
9/25/2008 6:57:37 AM |
| Comment: |
RPA recommends that ESA use in CKD not be addressed in an NCD.
The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to insure optimal care under the highest standards of medical practice for patients with renal disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with renal disease.
We are writing with regard to the list of proposed National Coverage Determination (NCD) topics that include Erythropoiesis Stimulating Agents (ESAs) used in the treatment of anemia in beneficiaries with chronic kidney disease (CKD) who are not yet on dialysis. It is our recommendation that this topic not be addressed in an NCD, and this letter outlines the reasons why RPA does not support the inclusion of ESA use in CKD as the topic of an NCD.
RPA is committed to ensuring patient safety when it comes to the delivery of healthcare services to renal patients. We are of course aware that recent studies (known as CHOIR and CREATE) in adults with chronic kidney disease have shown a higher risk of death or cardiovascular events with target Hb level 13.5 Gm/dL than with lower target Hb levels. It should be noted that the recent findings from the CHOIR study also confirm that achieved Hb at higher levels is associated with a better outcome. Nephrologists use evidence-based guidelines to inform their prescribing practice, and these studies have surely raised RPA’s concerns – just as they have raised concerns at the Food and Drug Administration and CMS.
RPA believes that clinical practice guidelines in renal care, like those in other medical disciplines, should be evaluated on the basis of the strength of evidence, an assessment of harms and benefits, and should benefit from robust physician and multidisciplinary input and review. Guidelines developed with these considerations in mind can only enhance the delivery of high quality patient care and help ensure kidney patient safety. However, it is important to remember that clinical practice guidelines are just that—guidelines, not required protocols. Because every patient is unique, when it comes to ESA dosing, each patient must be considered individually – not in the aggregate— based on consultation between the nephrologist and the patient.
RPA is concerned that initiating an NCD could establish a new standard of practice for the treatment of anemia in CKD patients that is not necessarily in the best interest of those patients. Currently, there are widely accepted, evidence-based guidelines on the treatment of anemia in CKD patients established by the National Kidney Foundation’s (NKF’s) Kidney Disease Outcomes Quality Initiative (K-DOQI). These guidelines were recently updated following publication of the CHOIR and CREATE studies. Quite appropriately, most Medicare contractors have followed those widely accepted guidelines in their local coverage determinations (LCDs), with consideration given to local practice patterns and physician input gathered through the Carrier Advisory Committee (CAC) process. This heterogeneity has been an effective incubator for innovation in anemia care in CKD.
As more information is published on the risks and benefits of ESA treatment, an NCD may deserve consideration in the future. For example, RPA is aware that Amgen is currently conducting an important clinical study (referred to as the TREAT study) that compares the use of an ESA to a placebo in patients who are not yet on dialysis. TREAT is a randomized, placebo-controlled, double- blind, clinical-outcomes trial with more patients enrolled than the CHOIR or CREATE trials combined. This study is designed to provide important information regarding the safe use of ESAs, especially with respect to the hemoglobin goals of ESA therapy. RPA strongly believes that it would be both prudent and most efficient for CMS to wait for the conclusion of the TREAT study before proceeding with national policy development in this area. Any questions or comments regarding this document should be directed to RPA’s Director of Legislative and Regulatory Affairs, Holly Owens, at 301-468-3515, or by email at howens@renalmd.org.
|
| Commenter: |
Woll, Douglas
|
| Title: |
Senior Vice President and Chief Medical Officer |
| Organization: |
Blue Care Network of Michigan |
| Date: |
9/25/2008 7:14:41 AM |
| Comment: |
To Whom It May Concern:
We are writing in regards to the issue of proton beam therapy as a treatment modality for prostate cancer. As major health insurers, we are extremely concerned over the anticipated proliferation of this technology which we believe is both unwarranted and potentially detrimental. In our home state of Michigan, proton beam therapy has become an extremely controversial and highly debated topic among hospitals, private payers, large employers, state legislators, and even the governor. Numerous health systems have now sought approval to build a proton beam treatment facility in the state. It now appears Michigan will have at least one center by 2010 and there may be as many as three additional centers constructed. Given the population of Michigan and the currently accepted indications for this therapy as outlined in the scientific literature, there is absolutely no need to have four proton beam therapy centers in our state.
The drive to build these centers seems to be driven, in large part, by the fact that Medicare will reimburse them for treatment and that they can become huge profit centers. While there are some clinical indications to treat a very small subset of cancers with proton beam therapy, prostate cancer is not one of these indications. The literature clearly indicates that this form of treatment is not superior to either surgery or traditional photon beam treatment for prostate cancer. If existing proton therapy centers treated only cancers with documented clear clinical indications, there would be no need for all the facilities now being planned across the nation. Of course, the proton beam therapy centers are treating many forms of cancer, and these centers are seeking patients who are willing to be treated for other cancers such as lung and breast cancer.
We ask that Medicare obtain a formal coverage decision about proton beam therapy for prostate cancer through its National Coverage Determination process. We believe that a review of the medical literature will indicate that proton beam therapy for prostate cancer is not superior to other forms of treatment and is therefore not medically necessary. A formal NCD of “no coverage” for prostate cancer will help stop the unwarranted proliferation of this technology in Michigan and across the nation. Given the cost and clinical implications of the above, we are requesting that Medicare evaluate proton beam therapy in the context of its value in the overall health care system.
Sincerely,
Thomas Simmer, MD Senior Vice President and Chief Medical Officer Blue Cross Blue Shield of Michigan
Douglas Woll, MD Senior Vice President and Chief Medical Officer Blue Care Network of Michigan
|
| Commenter: |
Goldberg, Tyler
|
| Date: |
9/25/2008 7:57:23 AM |
| Comment: |
Hip resurfacing is a viable option for a certain population that may be unfit for an immediate total hip. I would appreciate careful consideration for approval. |
| Commenter: |
Larson, Gary
|
| Organization: |
RADIATION ONCOLOGY ASSOCIATES |
| Date: |
9/25/2008 9:50:44 AM |
| Comment: |
I have seen many advances in cancer treatment since I began my residency in radiation oncology twenty seven years ago. Many of my patients were treated with Cobalt tele-therapy machines. When these machines were introduced in the sixties, radiologists could increase the energy of their photons four fold. Up until my fifth year in private practice, we still used cobalt for a significant proportion of our patients. During this period, linear accelerators gradually took the place of the last Cobalt machines. Tumor control rates increased. Acute side effects and long term complications decreased. It took a decade for the benefits of linear accelerators to be fully realized. Since then, further advances have included conformal radiation therapy, intensity modulated radiation therapy and image guidance. There were never controlled trials between linear accelerator treatment and Cobalt therapy. No one could have ethically randomized patients to Cobalt therapy since the advantages of linear accelerator treatment were undeniable.
We are positioned to take another giant leap in our ability to treat tumors. Protons will allow us to decrease the high dose given to normal tissues, decreasing long term complications. Furthermore, the risk of secondary cancers will be greatly reduced due to the lessening of low dose irradiation to large tissue volumes.
It costs about one fifth as much to cure a patient with cancer as we spend on the ones who are not ultimately cured. Also, long term complications of curative treatment place a lifelong drain on healthcare dollars.
I agree that other modalities are equally effective at controlling prostate cancer. Complications such as rectal ulcers, sometimes leading to colostomy, and intractable urinary frequency with urgency incontinence, are the price some patients pay for cure. Side effects such as profound fatigue are sometimes complletely debilitating during treatment. If we can cure a patient of prostate cancer without these side effects, why shouldn’t we?
I suggest that reimbursement for proton therapy be contingent on the following:
The data from every patient should be analyzed and evidence presented as to the superiority, or lack thereof, of proton therapy for all tumor types treated. As this evidence accumulates, it can be decided whether or not proton therapy should be reimbursed for specific tumor types. At this point, however, there is too little data (due to the lack of availability of this modality) on proton therapy to exclude specific tumor types from reimbursement.
|
| Commenter: |
Sanjeevi, Arunkumar
|
| Title: |
MD |
| Organization: |
Medical center clinic |
| Date: |
9/25/2008 9:51:23 AM |
| Comment: |
I am concerned that an NCD would affect many ITP patients by excluding or restricting coverage of Nplate for Medicare and Medicaid recipients and may influence commercial or private payer coverage decisions.
I am a hematologist and there are no treatment options for patients with chronic refractory ITP who have failed multiple options and Nplate is a valuable asset. Restricting or excluding coverage of this drug will affect patient care. |
| Commenter: |
Wilson, Emily
|
| Title: |
Director of Government Relations |
| Organization: |
American Society for Therapeutic Radiology and Oncology (ASTRO) |
| Date: |
9/25/2008 10:02:25 AM |
| Comment: |
The American Society for Therapeutic Radiology and Oncology (ASTRO)[1] is pleased to provide comments to the Centers for Medicare & Medicaid Services' (CMS) on a potential National Coverage Determination (NCD) for proton therapy for prostate cancer. The agency has noted: “Proton therapy, proposed as means to concentrate radiation therapy and reduce side effects. Very high upfront cost to build these facilities and thus only at very few facilities. For prostate cancer treatment, no current comparative trials comparing to usual therapy.” Since this form of therapy is utilized exclusively by Radiation Oncologists, we believe that it is incumbent upon ASTRO to offer comments prior to any ultimate NCD decision by the Agency.
ASTRO recognizes that proton therapy may offer the potential of improved outcomes for prostate cancer patients, in comparison to other available forms of radiation therapy. However, the cost and complexity of developing proton facilities has imposed significant limitations on its availability and the ability to conduct randomized clinical trials to compare the efficacy of this important new technology. The lack of clinical trials, coupled with the undeniable economic impact and societal cost of proton beam radiation therapy suggest this treatment modality might be an appropriate candidate for consideration of a NCD.
ASTRO, as the largest society of radiation oncologists in the world, is taking a leadership role in evaluating this technology. The Board of Directors has charged the Emerging Technology Committee to study this issue and is creating a task force specifically on proton therapy. In addition, ASTRO is facilitating the convening of a consortium comprised of representatives from ASTRO and the Center for Medical Technology Policy (CMTP) who are currently in the process of developing a Coverage with Evidence Development (CED) registry trial entitled, “Comparison of Patient Reported Outcome of Proton Beam and Intensity Modulated Radiation Therapy (IMRT) in the treatment of Patients with Low and Intermediate Risk Prostate Cancer in a Parallel Arm Cohort Study (PIPPAC).”
Recently, a meeting was held at the Agency for Health Research and Quality (AHRQ) in which a CMS representative participated in the discussions about proton therapy. Other parties who have commented and shown interest in the process include representatives from the health insurance industry as well as the National Cancer Institute (NCI) and AHRQ. The study developers would prefer a randomized clinical trial, and discussions in that regard are proceeding with several of the clinical proton beam radiation therapy sites.
This comparative registry study (possibly with a parallel randomized clinical trial arm) is likely to provide meaningful answers on the safety and effectiveness of proton beam radiation therapy in the treatment of prostate cancer in the context of current clinical practice. The projected study calls for the accrual of 1,600 patients over a period of two to three years, with measurement of the primary end-point; patient reported Quality of Life (QOL) at three years. ASTRO recommends that the “coverage with study participation” (CSP) policy be applied to the trial so as to ensure broad participation of the existing proton facilities and to assure coverage for their participation in the trial.
In summary, ASTRO is supportive of steps to facilitate appropriate health policy decision-making, while at the same time, ensuring that our patients have access to the potential benefits of technological improvements. We look forward to working in close collaboration with the Agency on decisions with regard to proton therapy and its potential to improve outcomes for our patients.
Sincerely,
Laura I. Thevenot Chief Executive Officer
[1] ASTRO is the largest radiation oncology society in the world, with more than 8,500 members who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, biology and physics, the Society is dedicated to the advancement of the practice of radiation oncology by promoting excellence in patient care, providing opportunities for educational and professional development, promoting research and disseminating research results and representing radiation oncology in a rapidly changing healthcare environment.
|
| Commenter: |
Fesler, Douglas
|
| Title: |
Associate Executive Director |
| Organization: |
American Society for Bone and Mineral Research |
| Date: |
9/25/2008 11:23:36 AM |
| Comment: |
The American Society for Bone and Mineral Research (ASBMR) is pleased to have the opportunity to submit comments to the U.S. Centers for Medicare and Medicaid Services (CMS) on the topics of Bisphosphonates and Vertebroplasty and Kyphoplasty, which are currently being considered for National Coverage Determinations (NCD). The ASBMR is the foremost professional, scientific and medical society in the world for the promotion of bone and mineral research and the translation of that research into clinical practice.
Bisphosphonates ASBMR strongly feels that the benefits of intravenous bisphosphonate therapy outweigh the risks for most patients with osteoporosis. In treating any disease, the physician and patient must assess the risks and benefits of therapy. In patients with osteoporosis, jaw necrosis is a rare side effect, whereas osteoporotic fracture is common. We therefore urge CMS to continue coverage for intravenous bisphosphonates. Intravenous bisphosphonate therapy is an important therapeutic option for patients unable to tolerate oral bisphosphonates, for patients with contraindications to oral bisphosphonates, and for patients who, due to poor compliance or malabsorption, experience new fractures or a decline in bone mass despite oral bisphosphonate therapy.
At doses used to treat osteoporosis, jaw necrosis rarely occurs in patients receiving either oral or intravenous bisphosphonate therapy. Among osteoporosis patients, rates of jaw necrosis have been estimated to be between 1 in 263,158 patients and 1 in 2,260 [1,2]. In a double-blind placebo-controlled trial of approximately 8,000 postmenopausal women with osteoporosis randomized to intravenous zoledronate or placebo once yearly for three years [3], two cases of adjudicated jaw necrosis occurred, one in the placebo arm and one in the zoledronate arm. There is a much higher frequency of jaw necrosis observed in cancer patients, who not only receive intravenous bisphosphonates much more often and at higher doses than do osteoporosis patients, but also have other risk factors for jaw necrosis (e.g. corticosteroid drugs and radiation therapy). The true frequency of osteonecrosis of the jaw in osteoporosis patients has yet to be determined, but there is no evidence that intravenous bisphosphonates (at osteoporosis dosage and frequency) increase the risk, compared to oral bisphosphonates.
Not having intravenous bisphosphonates for selected osteoporosis patients would likely lead to more fractures. Many patients with osteoporosis are unable to take oral bisphosphonates due to gastrointestinal side effects or the presence of a contraindication to their use (e.g. esophageal dysmotility or stricture). Still other osteoporosis patients experience new fractures or declines in bone mass despite oral bisphosphonate therapy. The lack of response may be due to poor adherence to oral therapy. For such patients, once yearly intravenous bisphosphonate therapy is very appealing.
Clinical trials document that two intravenous bisphosphonates, ibandronate and zoledronate, reduce the risk of osteoporotic fracture by approximately 50% to 70%. By contrast, the rate of jaw necrosis is extremely uncommon when intravenous bisphosphonates are administered at osteoporosis doses.
References:
1. Mavrokokki T, Cheng A, Stein B, Goss A. Nature and frequency of bisphosphonate-associated osteonecrosis of the jaws in Australia. J Oral Maxillofac Surg. 2007 Mar;65(3):415-23.
2. Khosla S, Burr D, Cauley J, Dempster DW, Ebeling PR, Felsenberg D, Gagel RF, Gilsanz V, Guise T, Koka S, McCauley LK, McGowan J, McKee MD, Mohla S, Pendrys DG, Raisz LG, Ruggiero SL, Shafer DM, Shum L, Silverman SL, Van Poznak CH, Watts N, Woo SB, Shane E Bisphosphonate associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2007 Oct; 22 (10):1479-91.
3. Black D.M, Delmas P.D., Eastell R., Reid I.R., Boonen S., Cauley J.A., Cosman F., Lakatos P., Leung P.C., Man Z., Mautalen C., Mesenbrink P., Hu H., Caminis J., Tong K., Rosario-Jansen T., Krasnow J., Hue T.F., Sellmeyer D., Eriksen E.F., and Cummings S.R.. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med, 2007. 356(18): p. 1809-22.
Vertebroplasty and Kyphoplasty
ASBMR believes there is enough evidence to support the use of Vertebroplasty and Kyphoplasty to relieve pain following vertebral fracture in selected patients There is a very recent study demonstrating an increase in vertebral compression fractures in patients who had undergone a vertebroplasty or kyphoplasty [1]. However, the investigators were unable to determine if the patients had received treatment of underlying osteoporosis. It is very likely that they did not receive osteoporosis treatment. This is illustrated by another recent study that indicated that kyphoplasty does not increase the risk of vertebral fracture when compared to nonsurgical care provided concomitant medical treatment is provided [2]. However, further studies in this area are needed. A painful compression fracture is often the first and cardinal sign of osteoporosis and as such, should prompt appropriate diagnostic studies followed by osteoporosis medication to lessen the risk of another fracture. As pain improves in most patients within about 6 weeks after the acute fracture without any intervention, the procedures should be reserved for patients who do not improve over the initial 6 weeks or so. The procedure should also be considered for patients whose pain cannot be controlled with prescription analgesia. There is good evidence that vertebroplasty [3] and kyphoplasty [1,2] relieve pain sooner than conservative treatment. However, to prevent future vertebral fracture after vertebroplasty and kyphoplasty, it is imperative that the underlying cause of the initial vertebral fracture be treated.
References:
1. Mudano A.S., Bian J., Cope J.U., Curtis J.R., Gross T.P., Allison J.J., Kim Y., Briggs D., Melton M.E., Xi J., Saag K.G., Vertebroplasty and kyphoplasty are associated with an increased risk of secondary vertebral compression fractures: a population-based cohort study, Osteoporosis International e-published September 18, 2008.
2. Cummings S.R., Wardlaw D., Van Meirhaeghe J., Bastian L., Tillman J., Ranstam J., Eastell R., Shabe P., Talmadge K., Boonen S.. A Randomized Trial of Balloon Kyphoplasty and Nonsurgical Care for Acute Vertebral Fracture: Who Responds Best? J Bone Miner Res., 2008. Vol 23(Sup 1): p. S68.
3. Nakano M., Nirano N., Ishihara H., Kawaguchi Y., Watanabe H., Matsuura K. Calcium phosphate cement-based vertebroplasty compared with conservativetreatment for osteoporotic compression fractures: a matched case-control study J Neurosurg Spine, 2006. Feb;4(2):110-7.
|
| Commenter: |
Kaushansky, Kenneth
|
| Title: |
President |
| Organization: |
American Society of Hematology |
| Date: |
9/25/2008 11:51:29 AM |
| Comment: |
Dear Mr. Weems:
The American Society of Hematology (ASH) represents over 11,000 hematologists in the United States who are committed to the treatment of blood and blood-related diseases. ASH members include hematologists and hematologist/oncologists who regularly render services to Medicare beneficiaries. ASH is pleased to have the opportunity to comment on the list of potential National Coverage Decision (NCD) topics released by the Centers for Medicare and Medicaid Services (CMS). In this comment letter we would like to specifically address the following two topics: • Thrombopoiesis stimulating agents (platelet growth factors e.g. romiplostim) • Pharmacogenomic testing
ASH does not believe that an NCD on thrombopoiesis-stimulating agents is appropriate at this time. While thrombopoiesis-stimulating agents provide a new therapeutic approach to increase platelet production, the FDA-approved restricted distribution program currently obviates the need for an NCD.
As we discussed in our response to the Pharmacogenomic Testing for Warfarin Response (CAG-00400N), ASH believes that it is premature for the implementation of a coverage policy on pharmacogenomic testing. Bleeding is the primary adverse event associated with warfarin use and pharmacogenomic testing has been used to study a patient’s response to warfarin. At this time, significant uncertainty remains regarding this new and emerging technology, and ASH does not support the use of pharmacogenomic testing to guide the initial dosing or ongoing treatment of warfarin. While the scientific developments in this area merit continued attention and study, ASH does not believe this meets criteria used to open a national coverage decision identified by CMS in its announcement of potential NCD topics. We support the use of pharmacogenomic testing of warfarin in the context of a clinical trial to greater understand the safety and the efficacy of this approach but as this technology is still fairly new, ASH does not support the release of a NCD on this topic at this time.
Thank you for the opportunity to submit these comments. Please do not hesitate to have your staff contact Carol Schwartz, Senior Manager, Policy & Practice at ASH (202) 292-0258 or cschwartz@hematology.org for any additional information.
Sincerely, Kenneth Kaushansky, M.D. President
|
| Commenter: |
Warman, Carol
|
| Date: |
9/25/2008 1:29:47 PM |
| Comment: |
I am [PHI Redacted] of a man treated at Loma Linda
with proton beam therapy last year. I’m certainly
not a medical professional so please take my
comments in that context. [PHI Redacted] turned 65
during the two month treatment period and so
Medicare paid for exactly half of the 42
treatments he received. We are very grateful that
Medicare covered this.
I compare [PHI Redacted] side effects (only some
urinary urgency which disappeared about a month
post treatment) with that of men we know who had
traditional photon radiation treatment (IMRT in
many cases) and I see that the side effects of
proton treatment, as many of us know, were
significantly less than that of photon radiation.
I realize this is anecdotal but
sometimes "anecdotal" is the most important
factor for us laypeople.
With new proton centers currently under
construction, if Medicare elects to not cover
proton treatment, it will only be a matter of
time before other insurers follow suit. If that
happens, what will happen to those centers
currently under development? Will they be
completed or will they be abandoned? These new
centers will, no doubt, treat not only prostate
cancer patients but also children with other
forms of cancer, some of whom we saw during our
two month stay at Loma Linda. Yes, there are
other treatment options for men with prostate
cancer but are there other options for children
currently (and in the future) being treated with
proton therapy?
Yes, it certainly sounds strange to say this but
the future of these children is undeniably in
Medicare’s hands. |
| Commenter: |
Link, Mark
|
| Title: |
Physician |
| Organization: |
Tufts Medical Center |
| Date: |
9/25/2008 2:11:53 PM |
| Comment: |
I am writing regarding ablation in atrial
fibrillation. Atrial fibrillation can be
debilitating to patients. And while ablation is
certainly not for everyone, I have had numerous
patients who have had ablation for atrial
fibrillation which has been successful, and
there lives have been changed. There is a wealth
of data on ablation for atrial fibrillation and
the results are quite concordant: 60-80% of
patients are improved after an atrial
fibrillation ablation. Please do not take this
option away from CMS patients. [PHI Redacted] |
| Commenter: |
Michaud, Gregory
|
| Date: |
9/25/2008 2:20:11 PM |
| Comment: |
Atrial fibrillation RFA: We as electrophysiologists have tried to move away from the concept of cure for atrial fibrillation, but we recognize that radiofrequency ablation is an important adjunct to medication in treating atrial fibrillation. From my own experience, it is clear that patients derive a significant benefit from left atrial ablation in terms of quality of life. i.e many fewer atrial fibrillation episodes and lower drug dosage requirements. In select patients, it is possible to eliminate episodes without antiarrhythmic medication. Although the possibility of cure is lower and need for continued drug therapy is higher, even more difficult patients with persistent atrial fibrillation derive a significant benefit.
At experienced centers, such as in Boston, MA, the complication rate is low enough to offer ablation as a treatment option for the patient with symptomatic episodes of atrial fibrillation when drug therapy is no longer satisfactory.
Thank you for your attention
Gregory Michaud
|
| Commenter: |
Clinical Endocrinologists, American Association of
|
| Organization: |
AACE |
| Date: |
9/25/2008 2:31:14 PM |
| Comment: |
Bisphosphonates
The American Association of Clinical Endocrinologists appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) Potential National Coverage Determination (NCD) topics for the third quarter of 2008.
The American Association of Clinical Endocrinologists (AACE) represents over 6000 endocrinologists in the United States and in 84 countries. AACE is the largest association of clinical endocrinologists in the world. The great majority of AACE members are certified in Endocrinology and Metabolism and concentrate on the treatment of patients with endocrine and metabolic disorders including diabetes, thyroid disorders, osteoporosis, growth hormone deficiency, cholesterol disorders, hypertension and obesity, and are committed to providing the highest quality of care to the patients they serve.
The potential topics cover a broad range of items and services that are accessed by Medicare beneficiaries. One of the potential NCDs listed by CMS relates to the coverage of bisphosphonates, particularly longer acting intravenous preparations. AACE is particularly interested in CMS’ policy regarding this class of drugs and looks forward to continuing to work with the agency and its contractors to ensure that Medicare beneficiaries have continued access to these important therapies.
AACE strongly feels that the benefits of intravenous bisphosphonate therapy outweigh the risks for most patients with osteoporosis. In treating any disease, the physician and patient must assess the risks and benefits of therapy. In patients with osteoporosis, jaw necrosis is a rare side effect, whereas osteoporotic fracture is common. We therefore urge CMS to continue coverage for intravenous bisphosphonates. Intravenous bisphosphonate therapy is an important therapeutic option for patients unable to tolerate oral bisphosphonates, for patients with contraindications to oral bisphosphonates, and for patients who, due to poor compliance or malabsorption, experience new fractures or a decline in bone mass despite oral bisphosphonate therapy.
At doses used to treat osteoporosis, jaw necrosis rarely occurs in patients receiving either oral or intravenous bisphosphonate therapy. Among osteoporosis patients, rates of jaw necrosis have been estimated to be between 1 in 263,158 patients and 1 in 2,260 [1, 2]. In a double-blind placebo-controlled trial of approximately 8,000 postmenopausal women with osteoporosis randomized to intravenous zoledronate or placebo once yearly for three years [3], two cases of adjudicated jaw necrosis occurred, one in the placebo arm and one in the zoledronate arm. There is a much higher frequency of jaw necrosis observed in cancer patients, who not only receive intravenous bisphosphonates much more often and at higher doses than do osteoporosis patients, but also have other risk factors for jaw necrosis (e.g. corticosteroid drugs and radiation therapy). The true frequency of osteonecrosis of the jaw in osteoporosis patients has yet to be determined, but there is no evidence that intravenous bisphosphonates (at osteoporosis dosage and frequency) increase the risk, compared to oral bisphosphonates.
Not having intravenous bisphosphonates for selected osteoporosis patients would likely lead to more fractures. Many patients with osteoporosis are unable to take oral bisphosphonates due to gastrointestinal side effects or the presence of a contraindication to their use (e.g. esophageal dysmotility or stricture). Still other osteoporosis patients experience new fractures or declines in bone mass despite oral bisphosphonate therapy. The lack of response may be due to poor adherence to oral therapy. For such patients, once yearly intravenous bisphosphonate therapy is very appealing.
Clinical trials document that two intravenous bisphosphonates, ibandronate and zoledronate, reduce the risk of osteoporotic fracture by approximately 50% to 70%. By contrast, the rate of jaw necrosis is extremely uncommon when intravenous bisphosphonates are administered at osteoporosis doses.
The public health benefits of osteoporosis therapy with intravenous bisphosphonates is very clear and there is little question as to their value. AACE appreciates your review of these comments and looks forward to working with you to ensure that Medicare coverage of intravenous bisphosphonates continues to meet the needs of Medicare beneficiaries.
Thank you for your consideration of these views. Sincerely,
Daniel S. Duick, MD, FACP, FACE President
References:
1. Mavrokokki T, Cheng A, Stein B, Goss A. Nature and frequency of bisphosphonate- associated osteonecrosis of the jaws in Australia. J Oral Maxillofac Surg. 2007 Mar;65 (3):415-23.
2. Khosla S, Burr D, Cauley J, Dempster DW, Ebeling PR, Felsenberg D, Gagel RF, Gilsanz V, Guise T, Koka S, McCauley LK, McGowan J, McKee MD, Mohla S, Pendrys DG, Raisz LG, Ruggiero SL, Shafer DM, Shum L, Silverman SL, Van Poznak CH, Watts N, Woo SB, Shane E Bisphosphonate-associated osteonecrosis of the jaw: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2007 Oct; 22(10):1479-91.
3. Black D.M, Delmas P.D., Eastell R., Reid I.R., Boonen S., Cauley J.A., Cosman F., Lakatos P., Leung P.C., Man Z., Mautalen C., Mesenbrink P., Hu H., Caminis J., Tong K., Rosario-Jansen T., Krasnow J., Hue T.F., Sellmeyer D., Eriksen E.F., and Cummings S.R.. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med, 2007. 356(18): p. 1809-22.
|
| Commenter: |
Ladd, Virginia T.
|
| Title: |
President and Executive Director |
| Organization: |
American Autoimmune Related Diseases Association |
| Date: |
9/25/2008 2:51:07 PM |
| Comment: |
Statement on the potential inclusion of Nplate (romiplostim) for future National Coverage Determinations (NCDs).
Although American Autoimmune Related Diseases Association (AARDA) does not take formal position on the recommendation of any specific treatments, we are very concerned that an NCD would affect many patients by excluding or restricting coverage of Nplate for Medicare and Medicaid receipients, which may also influence other payer coverage decisions. We strongly believe that patients have the right to expect that their medical decisions will be made by their own medical providers. The inclusion of Nplate under a NCD may impact usage, dosage, and timing which ultimately would result in the elimination of medical judgement on behalf of a medical professional.
|
| Commenter: |
Biegel, Roberta
|
| Title: |
Senior Director |
| Organization: |
National Osteoporosis Foundation |
| Date: |
9/25/2008 3:13:47 PM |
| Comment: |
September 28, 2008
Steven Phurrough, MD Director, Coverage and Analysis Group Centers for Medicare and Medicaid Services Mail Stop C1-12-28 7500 Security Boulevard Baltimore, MD 21244
Dear Dr. Phurrough:
Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) Potential National Coverage Determination Topics for the third quarter of 2008.
NOF is the nation’s leading voluntary health organization solely dedicated to osteoporosis and bone health. Its mission is to prevent osteoporosis, promote lifelong bone health and help improve the lives of those affected by osteoporosis and related fractures and find a cure. NOF achieves its mission through programs of awareness, advocacy, public and health professional education and research. NOF is a leading authority for anyone seeking up-to-date, medically-sound information and educational material on the causes, prevention, detection and treatment of osteoporosis.
Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures, especially of the hip, spine and wrist, although any bone can be affected.
Osteoporosis is the most common bone disease in humans. In the United States, it is a public health threat for 44 million Americans, 55 percent of the people 50 years of age and older. Ten million Americans are estimated to already have the disease and almost 34 million more are estimated to have low bone mass, placing them at increased risk for osteoporosis. Of the ten million Americans with osteoporosis, eight million are women and two million are men. The former Surgeon General states in his report on bone health and osteoporosis, unless the US makes a concerted effort, “in 2020 one in two Americans over the age of 50 will have, or be at high risk of developing, osteoporosis.
Osteoporosis often is called a “silent disease” because bone loss occurs without symptoms. People may not know that they have osteoporosis until their bones become so weak that a sudden strain, bump or fall causes a fracture or a vertebra to collapse. Collapsed vertebrae may initially be felt or seen in the form of severe back pain, loss of height, or spinal deformities such as stooped posture.
Comments
NOF believes that CMS should not proceed to a National Coverage Determination on bisphosphonates and vertebroplasty and kyphoplasty since local Medicare carriers are currently providing adequate coverage of these services throughout the United States for Medicare patients. NOF believes that the decision-making process should occur between the patient and their physician. NOF would like to provide further information below in particular on the two potential topics that relate to osteoporosis: bisphosphonates and vertebroplasty and kyphoplasty.
Bisphosphonates
To prevent fractures, which can cause long- lasting problems that affect a person’s quality of life, many people with osteoporosis take one medication from the group of drugs called bisphosphonates, which includes alendronate, ibandronate, risedronate, and zoledronic acid. These medicines are approved by the Food and Drug Administration (FDA) and have proven efficacy for reducing fracture risk. Studies report that bisphosphonate medications reduce bone loss, increase bone density in most people and reduce the risk for broken bones. For example, some studies suggest that these medications reduce the risk of hip fracture in people with osteoporosis by up to 40 or 50 percent.
For many patients, oral medications are not an option, and they need to take intravenous (IV) bisphosphonates. These include patients who cannot sit or stand for long periods of time, which is necessary for taking oral medications, and patients who have gastrointestinal problems, such as difficulty swallowing, inflammation of the esophagus and gastric ulcer. IV bisphosphonates can provide optimum adherence to a regimen of bisphosphonate drug therapy.
Recently, osteonecrosis of the jaw (ONJ), a serious and extremely rare condition which can cause severe damage to the jawbone, has been reported in some patients who have taken bisphosphonates. However, ONJ has occurred mostly in people receiving extremely high doses of bisphosphonates through an intravenous infusion, and 94 percent of all people with ONJ are cancer patients receiving intravenous bisphosphonates at higher doses than those used to treat osteoporosis. About 6 percent of people with ONJ have taken oral bisphosphonates to treat osteoporosis. Cancer patients also have other risk factors for jaw necrosis (e.g. corticosteriod and radiation therapy). The actual risk of getting ONJ while taking oral or IV bisphosphonate medications to treat osteoporosis has yet to be determined, but there is no evidence that intravenous bisphosphonates for treatment of osteoporosis increase the risk compared to oral bisphosphonates. For most patients, the benefits of receiving bisphosphonates outweigh the potential risk of ONJ. Patients for whom bisphosphonates are appropriate would be at a higher risk of fractures without any treatment and susceptible to painful, disabling and costly fractures that severely impact their quality of life.
Vertebroplasty and Kyphoplasty
NOF believes that there is enough evidence to support the use of vertebroplasty and kyphoplasty to relieve pain from vertebral fracture but that these procedures are adjunct procedures and not a substitute for treating the underlying osteoporosis. The recent literature shows that kyphoplasty does not increase the risk of vertebral fracture when compared with nonsurgical care. But further studies are needed in this area. To prevent future vertebral fracture after vertebroplasty and kyphoplasty, NOF believes that it is vital to require that patient to take an appropriate osteoporosis medication following either procedure to treat the underlying cause of the fracture. Because pain improves in most patients in about six weeks after an acute fracture (and the time allows for healing without an intervention), the procedures should be conducted on patients who do not improve during this initial period. NOF also believes that individuals with painful vertebral fractures that fail conservative management may be candidates for emerging interventions, such as kyphoplasty or vertebroplasty, when performed by experienced practitioners. These procedures have been shown to be effective in patients with painful vertebral compression fractures compared to continued medical treatment thus significantly improving the quality of life for patients. The procedure also should be evaluated for patients whose pain cannot be controlled with prescription medication.
Conclusion
Bisphosphonate medications provide a significant benefit to patients as many studies have shown they can reduce bone loss, increase bone density in most people and reduce the chance of broken bones. For many patients, the benefits of receiving bisphosphonates outweigh the potential risk of ONJ since these patients would be at a higher risk of fractures without any treatment and susceptible to painful, disabling and costly fractures that severely impact quality of life. In addition, CMS must remember that many osteoporosis patients are unable to take oral bisphosphonates and instead must take IV bisphosphonates because of other health problems.
In addition, vertebroplasty and kyphoplasty have been used widely to reduce or eliminate pain from vertebral compression fractures for patients that have not responded to conventional treatment.
In conclusion, NOF believes that CMS should not proceed to a National Coverage Determination on bisphosphonates and vertebroplasty and kyphoplasty since local Medicare carriers are currently providing adequate coverage of these services throughout the United States for Medicare patients.
Thank you again for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) Potential National Coverage Determination Topics for the third quarter of 2008. If you have any questions, or would like further information, please do not hesitate to contact NOF staff, Roberta Biegel, NOF Senior Director of Government Relations and Public Policy, at Roberta@nof.org or (202) 721-6364.
Sincerely,
Thomas A. Einhorn, MD Co-chair Advocacy Committee
C. Conrad Johnston, Jr., MD Co-chair Advocacy Committee
Ethel S. Siris, MD Co-chair Advocacy Committee
Citations:
U.S Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General, 2004: 4
National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. 2008.
Woo, S, Hellstein, JW, Kalmar, JR. Systematic Review: Bisphosphonates and Osteonecrosis of the Jaws. Ann Intern Med. 2006; 144:753-61.
S.R. Cummings, D. Wardlaw, J. Van Meirhaeghe, L. Bastian, J. Tillman, J. Ranstam, R. Eastell, P. Shabe, K. Talmadge, S. Boonen. A Randomized Trial of Balloon Kyphoplasty and Nonsurgical Care for Acute Vertebral Fracture: Who Responds Best? JBMR, 2008. Vol 23(Sup 1): p. S68.
National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. 2008.
|
| Commenter: |
Anderson, Kurt
|
| Title: |
Medical Doctor |
| Organization: |
Orthopaedic Consultants P.A. |
| Date: |
9/25/2008 3:26:12 PM |
| Comment: |
The metal-on-metal Birmingham Hip Resurfacing (BHR) System received PMA approval from the FDA in May of 2006 for use in patients requiring primary hip arthroplasty for non-inflammatory or inflammatory arthritis. Smith & Nephew, Inc., the manufacturer of the BHR System, has a comprehensive training program in place in keeping with the FDA post approval protocol to insure that only qualified surgeons are able to order the device and perform the procedure. There is ample published clinical data and registry evidence that demonstrates the safety and efficacy of the procedure using the BHR System for the approved indications. I urge CMS to retain coverage for FDA approved devices and indications. In the announcement of the list of potential National Coverage Analyses CMS describes hip resurfacing as an interim therapy to delay THA. This is not accurate. Hip resurfacing is an alternative to THA. Registry data indicate that the life of the resurfacing implant is comparable to a total hip. One of the challenges with primary total hip arthroplasty is that revision surgery is difficult and expensive. An advantage of hip resurfacing is that it preserves bone, retaining the femoral neck and the majority of the femoral head. If a revision is necessary, it essentially is a THA. Factors that increase the risk of revision surgery include a high activity level. Evidence suggests that it is becoming the procedure of choice for patients, including Medicare patients, who wish to maintain a relatively active lifestyle. While there are not a large number of Medicare patients who would be candidates for hip resurfacing based on the above indications and contraindications a small patient population should not be used as a rationale for denying access to Medicare patients who are candidates for the procedure and wish to preserve an active lifestyle. Age is not a contraindication for hip resurfacing. Nor is it a predictor of the success of the procedure. The PMA trial included data for almost 200 patients over 65 who fulfilled the selection criteria based on indications and contraindications. The results for this subset demonstrated comparable efficacy and safety to the under 65 population.
|
| Commenter: |
Baim, Sanford
|
| Title: |
President |
| Organization: |
International Society for Clinical Densitormetry |
| Date: |
9/25/2008 3:34:33 PM |
| Comment: |
The International Society for Clinical Densitometry (ISCD) welcomes the opportunity to comment on the “Posting of Potential NCD Topic” issued by CMS on 7/30/2008. We address two of the proposed topics “bisphosphonates” and “vertebroplasty and kyphoplasty.” The ISCD is a multidisciplinary, nonprofit organization that provides a central resource for scientific disciplines with an interest in bone mass measurement and its role in the diagnosis and treatment of osteoporosis. Presently, the ISCD has 5862 members in 56 countries. 93% of our members practice within the United States; 60% are physicians and 40% are densitometry technologists. Our membership spans more than 20 health care disciplines including Endocrinology, Family Practice, Gynecology, Internal Medicine, Nephrology, Orthopedics, Radiology, and Rheumatology.
Bisphosphonates
“Bisphosphonates, particularly longer acting parenteral preparations, have been associated with osteonecrosis of the mandible (jaw) in patients who have dental procedures. Given the ready availability of oral preparations it is unclear if the convenience afforded by the less frequent administration (of) parenteral agents outweighs the potential harm(s).”
Two parenteral bisphosphonates, ibandronate and zoledronic acid, are FDA-approved for the treatment of osteoporosis in post-menopausal women. The FDA does not require that patients treated with a parenteral bisphosphonate first be treated with an oral preparation. It is unclear from the wording of the above proposal whether CMS is considering not reimbursing for use of all parenteral bisphosphonates or would require that patients first try and fail an oral preparation before a parenteral bisphosphonate would be covered. In either case, CMS would be setting a significant and potentially disturbing precedent by overriding FDA approval. A National Coverage Determination ( NCD) that limits or restricts the use of an FDA approved drug that appears to be based upon safety concerns would violate CMS policy that recognizes the FDA’s leading role in determining safety and effectiveness of regulated products. The Medicare Benefit Policy Manual states as a condition of coverage that the “use of the drug or biological must be safe and effective and otherwise reasonable and necessary,” and that “[d]rugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective for purposes of this requirement when used for indications specified on the labeling” [1]. In reviewing products, the role of CMS is to adopt the FDA’s determinations of safety and effectiveness. From there, CMS evaluates “whether or not the product is reasonable and necessary for the Medicare population” [2].
Moreover, the CMS proposed topic implies that parenteral bisphosphonates are more likely than oral bisphosphonates to cause osteonecrosis of the jaw (ONJ). While it is correct that the majority of reported cases have occurred in patients receiving intravenous bisphosphonates, it is important to appreciate that the vast majority of these patients were individuals with malignancies who were receiving doses much higher than utilized for osteoporosis treatment. ONJ in the oncology population has been reported most frequently in patients with metastatic cancer (esp breast cancer and myeloma) in which bisphosphonate therapy is indicated to correct hypercalcemia and/or limit spread of tumor to bone. In addition to receiving parenteral bisphosphonate doses far greater than used to treat post-menopausal osteoporosis, many such individuals have also received additional agents including corticosteroids, radiation therapy and other chemotherapy drugs. In this setting, the estimated risk of ONJ ranges from 0.8% to 12% [3].
In contrast, among women taking a bisphosphonate for post-menopausal osteoporosis (PMO) the estimated risk of ONJ is in the range of 0.01- 0.04% [4]. As the parenteral bisphosphonates have only recently been approved for osteoporosis, these numbers reflect the experience to date with oral bisphosphonates; alendronate is the most frequently reported oral bisphosphonate associated with ONJ reflecting its more widely prescribed use. The clinical experience for IV bisphosphonates in treating osteoporosis is much more limited. However, in a double-blind placebo-controlled trial of 7,765 postmenopausal women with osteoporosis randomized to intravenous zoledronic acid or placebo once yearly for three years [5], only one case of adjudicated jaw necrosis occurred in the zoledronic acid group and one case in the placebo group. No ONJ cases were seen in a second large study (N = 2,111) of men and women following hip fracture or in trials of glucocorticoid induced osteoporosis (N = 833) or in men (n = 302)[6]. Based on these clinical trial results, the risk of ONJ in patients treated for osteoporosis with a parenteral bisphosphonate is similar to placebo, similar to oral bisphosphonates, and (for patients in whom bisphosphonate therapy is indicated) much lower than the risk of osteoporotic fracture.
Parenteral bisphosphonates are an important therapeutic option in osteoporosis treatment. Though a minority of patients may receive parenteral bisphosphonates due to convenience, it has been our experience that most receive these agents for one of the following reasons: • pre-existing conditions precluding oral bisphosphonate treatment, e.g., esophageal stricture or motility disorder. • oral bisphosphonate intolerance • documented failure of oral bisphosphonate therapy • issues with compliance/persistence with oral bisphosphonates, a phenomenon common with many oral medications
In conclusion, the true frequency of osteonecrosis of the jaw (ONJ) has yet to be determined, however, there is no evidence that intravenous bisphosphonates increase the risk to a greater degree than oral bisphosphonates in osteoporosis patients. Given the high risk for fractures in individuals for whom bisphosphonates are indicated, the poor compliance noted with chronic oral therapies and the high cost to society of osteoporotic fractures, flexibility in treatment options regarding oral and parenteral bisphosphonates should be preserved.
References 1. Medicare Benefit Policy.Chapter 15, Covered Medical and Other Health Services, 50.4.1, page 51,www.cms.hhs.gov/Manuals/downloads/bp102c15pdf. 2. Notice, Medicare Program; Revised Process for Making National Coverage Determinations, Centers for Medicare and Medicaid Services, 68 Fed. Reg. 55,636 (Sept. 26, 2003). 3. Khan AA, Sandor GKB, Dore E, Morrison AD, Alsahli M, Amin F, Peters E, Hanley DA, Chaudry SR, Dempster D, Glorieux FH, Neville AJ, Talwar RM, Clokie CM, Al Mardini M, Paul T, Khosla S, Josse RG, Sutherland S, Lam DK, Carmichael RP, Blanas N, Kendler D, Petak S, St. Marie LG, Brown J, Evans AW, Rios L, Compston JE. National Clinical Practice Guidelines for Osteonecrosis of the Jaw (ONJ). J Rheumatol 2008; 1391-7. 4. Mavrokokki T, Cheng A, Stein B, Goss A. Nature and frequency of bisphosphonate-associated osteonecrosis of the jaws in Australia. J Oral Maxillofac Surg 2007; 65(3) :415-23. 5. Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer EF, Eriksen EF, Cummings SR. Once yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007; 356 (18):1809-22. 6. Grbic J, Black D, Lyles K, Reid D, Bucci- Rechtweg C, Mesenbrink P, Orwoll E, Eriksen E. Osteonecrosis of the Jaw: Zoledronic Acid 5 mg Experience in a Variety of Osteoporosis Indications. JBMR 2008; 23:S69.
Vertebroplasty/Kyphoplasty
“… Is the evidence adequate to demonstrate health benefits from pain reduction in selected patients?”
Clinical osteoporotic vertebral fractures result in substantial pain, morbidity and mortality.1 Percutaneous vertebral augmentation (PVA; vertebroplasty and kyphoplasty) are minimal access procedures intended to relieve pain of osteoporotic and other pathologic vertebral fractures.2 Incontrovertible Level I evidence demonstrating positive health benefits from pain reduction and improved quality of life after PVA is not yet convincingly available.3 Nevertheless, since CMS reviewed the scientific evidence pertaining to PVA in 20054, 5 considerable high-quality, prospective clinical data has accumulated to demonstrate that these interventions, in appropriately selected patients, dramatically relieve fracture pain, increase physical function and improve quality of life in older adults with painful osteoporotic vertebral fractures and that these benefits are durable one to two years following the procedure.6, 7, 8 All meta-analyses of PVA published thus far have reached the same conclusion.9, 10 Prospective, randomized trials will be necessary to prove positive health benefits from PVA and these studies are currently enrolling patients.11, 12 Until definitive results are available from these trials, the ISCD recommends that PVA continue to be accessible for appropriately selected patients with painful osteoporotic vertebral fractures and that PVA procedures are embedded in a comprehensive program of osteoporosis treatment and rehabilitation.
References
1. Silverman SL, Quality-of-life issues in osteoporosis. Curr Rheumatol Rep 2005;7:39-45. 2. Deramond H, Saliou G, Aveillan M, Lehmann P, Vallée JN. Respective contributions of vertebroplasty and kyphoplasty to the management of osteoporotic vertebral compression fractures Joint Bone Spine 2006;73:610-3. 3. McKiernan FE, Kyphoplasty and vertebroplasty: how good is the evidence? Curr Rheumatol Rep 2007;9:57-65. 4. http://www.cms.hhs.gov/mcd/viewtechassess. asp?where=index&tid=26 5. http://www.cms.hhs.gov/mcd/viewtechassess. asp?where=index&tid=25 6. McKiernan FE, Faciszewski T, Quality of life following percutaneous vertebroplasty, J Bone Joint Surg (Am) 2004;86(12):2600-6 and Quality of life following percutaneous vertebroplasty: 1 year follow-up. J Bone Joint Surg Am. 2006 Jan 31. http://www.ejbjs.org/cgi/eletters/86/12/2600#1658 7. Diamond TH, Bryant C, Browne L, Clark WA, Clinical outcomes after acute osteoporotic vertebral fractures: a 2-year non-randomised trial comparing percutaneous vertebroplasty and conservative therapy. Med J Aust 2006;184:113-7. 8. Cummings SR, Wardlaw D, Van Meirhaeghe J, Bastian L, Tillman J, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S, A Randomized Trial of Balloon Kyphoplasty and Nonsurgical Care for Acute Vertebral Fracture: Who Responds Best? J Bone Mineral Res 2008;23(Sup 1):S68. 9. Eck JC, Nachtigall D, Humphreys SC, Hodges SD. Comparison of vertebroplasty and balloon kyphoplasty for treatment of vertebral compression fractures: a meta-analysis of the literature. Spine J 2008;8:488-97. 10. Hulme PA, Krebs J, Ferguson SJ, Berlemann U, Vertebroplasty and kyphoplasty: a systematic review of 69 clinical trials. Spine 2006;31:1983- 2001. 11. http://clinicaltrials.gov/ct2/show/record/ NCT00323609?term=vertebroplasty&rank=5 http://clinicaltrials.gov/ct2/show/NCT00068822? term=vertebroplasty&rank=3
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| Commenter: |
Madison, Fiona
|
| Date: |
9/25/2008 3:38:49 PM |
| Comment: |
Research and effective treatments are essential
for disorders involving platelet reduction. [PHI Redacted] is suffering from Waldenstrom
Macroglobulinemia. Very little is know about
this condition, and there is no cure. He is
constantly tired due to a low platelet count and
his life is restricted as a result. He finds it
a constant strain that this disease could get
worse at any time, and that there is nothing that
can be done about it. More research and
treatments are essential. |
| Commenter: |
Reddy, Vivek
|
| Title: |
Director, Electrophysiology |
| Organization: |
University of Miami |
| Date: |
9/25/2008 4:17:53 PM |
| Comment: |
With regards to Ablation for Atrial Fibrillation:
It is important to recognize that AF ablation is performed for patients who have failed medications (because either the medications didnt work or intolerable side-effects), and their alternatives are limited. The only other effective approach is surgical ablation of AF (the MAZE or mini-MAZE procedure), and typically, patients are understandably reluctant to undergo an invasive surgical procedure. On the other hand, catheter ablation is an effective procedure that can eliminate the patient symptoms. And it is of particular importance for us to have a separate CMS decision specifically on AF ablation since this is a procedure that requires considerably more time and expertise as compared to a standard ablation of an SVT. |
| Commenter: |
Lewis, William
|
| Organization: |
MetroHealth Medical Center |
| Date: |
9/25/2008 6:13:22 PM |
| Comment: |
The evidence for the safety and efficacy of ablation therapy for atrial fibrillation is significant. There are two large randomized trials evaluating ablation therapy compared to drug treatment for atrial fibrillation which demonstrate the superiority of ablation. The American Heart Association/American College of Cardiology/European Society of Cardiology guidelines for atrial fibrillation state that: Catheter ablation is a reasonable alternative to pharmacological therapy to prevent recurrent AF in symptomatic patients with little or no LA enlargement. |
| Commenter: |
Epstein, Laurence
|
| Title: |
Cheif Arrhythmia Service |
| Organization: |
Brigham and Women''s Hospital |
| Date: |
9/25/2008 6:30:24 PM |
| Comment: |
Ablation for atrial fibrillation: Atrial fibrillation is becoming a national epidemic. A recent study suggested over 6 million Americans suffer from AFib. AFib prevalence increases with age. As the population ages the incidence will continue to grow. While some patients can be managed with simple rate control and anticoagulation, many symptomatic patients cannot tolerate this approach. Unfortunately antiarrhythmic drug therapy for AFib is lacking. Drugs at best have a 50% efficacy and can be associated with side effects and even life-threatening "pro arrhythmia." Therefore non pharmacologic approaches are required. Catheter ablation has proven to be a safe and effective approach to the treatment of AF in selected patients. In patients with paroxysmal atrial fibrillation and reasoable left atrial size, the success rate (cure) approaches 80%. I strongly urge that CMS approve catheter ablation for the treatment of AFib as outlined in the guidelines recently published by HRS/AHA/ACC |
| Commenter: |
Field, Jean
|
| Date: |
9/25/2008 8:13:58 PM |
| Comment: |
I am writing regarding the prescriptive use of
NPlate for the treatment of chronic ITP.[PHI Redacted] Current medical treatments for
ITP have distressing side effects, and NPlate
shows the promise of maintaining a safe level of
platelets without endangering major bodily organs
(liver, heart, arthritis,and emotional
disregulation). Treatment with Prednisone, the
first level of treatment is brutal. Undergoing
and withdrawing from this treatment is
debilitating from lack of sleep, irritability,
weight gain, disfigurement, muscle cramps,
increased osteoarthritis, etc. The second line
of drugs can be more dangerous steroids, or
chemical treatments that can endanger the body's
organs. The last line of treatment, a
spleanectomy, renders the person with a
compormised immune system.
Needless to say, current treatments are
threatening and discouraging. Prior to surgery,
an ITP patient requires a boost of platelets.
This can entail IVIG, which entails concentrating
a large dose of other people's blood parts at
great expense and some short term painful side
effects.
The prospect of having a treatment that targets
the growth of platelets, has few side effects,
and can enable people with ITP to live active
lives and not be in fear of uncontrolable
bleeding is such a hopeful thing. The ability to
not be concerned about a brain bleed, or bruising
and bleeding internally because you do not have
enough platelets to rescue you to normally clot,
that ability is a promise that people deserve to
have.
I recognize the drug is new. The disease is
not. It has had a deep impact on those stricken,
and continues to do so. They, (We) deserve the
opportunity to have a less invasive and
debilitating medical choice.
I active advocate for individuals with ITP to be
given coverage and accerss to a drug that shows
both progress and promise for helping to
normalize their lives.
Pardon me for speaking in generalities. Your
privacy notice means that were I to be any more
specific, I would be "deleted". It is difficult
to be an advocate, give testimony, and maintain
the current standards of privacy.
Thank you. |
| Commenter: |
Goodson, David
|
| Date: |
9/25/2008 10:38:57 PM |
| Comment: |
Dear Sirs,
[PHI Redacted] one of thousands of satisfied seniors that
has been treated by Proton Beam radiation for
prostate cancer. I have friends in my
neighborhood and in other parts of my town that
have expressed regrets for their choice of other
treatments for their prostate cancer. [PHI Redacted] I want other seniors to have
proton treatment available to them so that they
might have every reason to enjoy life.
Thank you( I hope).
David L. Goodson
Eureka, California |
| Commenter: |
Stephens, Don
|
| Date: |
9/26/2008 2:51:45 AM |
| Comment: |
[PHI Redacted]
I don't understand why medicare has not evaluated hip
resurfacing procedure one or two years ago.
The FDA approved the technique two years ago. Europe has
been performing this procedure for 10 years. This procedure is
successfully performed in India.
Why is medicare behind the times? Is this what I have to look
forward to when I retire- medicare behind the times? |
| Commenter: |
Jones, Scott
|
| Title: |
Executive Director, Healht Policy |
| Organization: |
Novartis Pharmaceuticals Corporation |
| Date: |
9/26/2008 7:56:46 AM |
| Comment: |
Novartis Pharmaceuticals Corporation (Novartis) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’(CMS) Potential National Coverage Determination (NCD) Topics for the third quarter of 2008 (Potential Topics). Novartis is a leading global pharmaceutical manufacturer that is dedicated to the discovery, development and marketing of innovative products to cure diseases, to ease suffering, and to enhance the quality of life. Novartis manufactures both traditional pharmaceuticals and physician-administered drugs and biologics, many of which are covered under Medicare Part B.
The Potential Topics cover a broad range of items and services that are accessed by Medicare beneficiaries. Novartis appreciates that CMS issued the Potential Topics list for public comment before initiating an NCD on any of the items or services. One of the potential NCDs listed by CMS relates to the coverage of bisphosphonates, particularly longer acting parenteral preparations. As a leading manufacturer of bisphosphonates, Novartis is particularly interested in CMS’ policy regarding this class of drugs and looks forward to continuing to work with the agency and its contractors to ensure that Medicare beneficiaries have continued access to these important therapies.
To this end, Novartis believes that patient access to bisphosphonates is best ensured by leaving coverage decisions to Medicare contractors, as is now the case. Moreover, given the factors that CMS has identified as influential in determining when to open an NCD, Novartis does not believe that opening an NCD on bisphosphonates is warranted. In CMS’ guidance document entitled, “Factors CMS Considers in Opening a National Coverage Determination,” (Guidance Document) CMS lists several circumstances that may prompt the agency to generate an NCD on an existing technology. The circumstances are when: (1) providers, patients or other members of the public have raised significant questions that are supported by data about the health benefits of the item or service; (2) changes may be warranted in light of the interpretation of new evidence or the re- interpretation of previous evidence; (3) local coverage policies are inconsistent or conflict with each other to the detriment of Medicare beneficiaries; or (4) program integrity concerns exist. For the reasons discussed below, we do not believe that any of these warrant establishing an NCD for bisphosphonates. Therefore, we believe that CMS should remove bisphosphonates as a potential NCD topic.
Summary of Our Response: Pursuing an NCD on this topic is not necessary because the FDA has recently and carefully evaluated the full risk/benefit profile of parenteral bisphosphonates in connection with its osteoporosis, bone metastases and other indications. The benefits of bisphosphonates in treating osteoporosis are well established and are highly effective in reducing the risk of fractures in osteoporotic patients. In addition, clinical data and expert opinion clearly support the substantial population health advantages unique to parenteral bisphosphonates in osteoporosis, specifically the Novartis product Reclast® (zoledronic acid) Injection.3 We also believe that because oral bisphosphonates are neither FDA-approved for cancer-related bone disorders nor recommended by any CMS recognized compendia, an NCD in this area that would compare oral to infused bisphosphonates would be inconsistent with the “factors” described above. Only parenteral bisphosphonates, including the Novartis products Zometa® (zoledronic acid) Injection4 and Aredia® (pamidronate disodium for injection)5, carry cancer-related FDA approvals and compendia listings. Therefore, in evaluating the clinical literature as part of the NCD, CMS would have to compare FDA- approved products to those that are not FDA labeled nor entitled to receive special treatment pursuant to section 1861 (t)(2) of the Social Security Act, which provides for off-label coverage of oral anti-cancer medications if listed in a CMS recognized compendium. The Potential Topics made reference to osteonecrosis of the jaw (ONJ). ONJ has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including Zometa. Many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ. The role of bisphosphonates in the pathogenesis of ONJ is unclear. Parenteral bisphosphonates offer distinct benefits for patients with osteoporosis
Osteoporosis is a chronic, progressive bone disease that affects over 10 million women and men in the United States. It is the main cause of hip and spine fractures in older adults and leads to large health care expenditures, estimated at $19 billion per year. The U.S. Surgeon’s General Report in 2004 was a call to action for increased diagnosis and treatment of this disease. The net public health benefits of osteoporosis therapy with parenteral bisphosphonates is very clear and there is little question as to their value. In approving both oral and parenteral bisphosphonates, the FDA carefully weighed risks and benefits before drug approval. The studied populations included many Medicare-age patients, and the risk/benefits were weighed by the FDA across both the whole population and relevant subgroups. In cases where FDA is concerned that the risks of a new drug under its review may outweigh its benefits, the agency may decline to approve the drug or require highly restrictive labeling such as limiting the approved use of a drug to a narrow population where the net risk/benefit is favorable. There are no such special restrictions on the use of Reclast, which was approved by the FDA in 2007.
Novartis has extensively studied the safety of parenteral bisphosphonates for the treatment of osteoporosis
Reclast is a once-yearly treatment for osteoporosis and has received approval for reducing fractures at the spine, hip, and other non-vertebral sites. It is dosed once per year and given over 15-minutes as a simple IV infusion. It has high affinity for bone and inhibits the excess bone resorption that is the cause of bone loss in osteoporosis.5 The HORIZON Pivotal Fracture Trial was conducted over 3 years in 7736 women with postmenopausal osteoporosis and formed the basis for FDA approval. The key findings from this trial demonstrated a significant reduction in spinal fractures by 70% and hip fractures by 41%. Fractures were also significantly decreased at other key skeletal sites. The reduction of 70% in spinal fractures was the largest reduction ever demonstrated in an osteoporosis study.
The safety of Reclast has been carefully monitored in all osteoporosis clinical trials and the mean age of patients in these studies is greater than 65 years. In addition, Reclast has been used in over 200,000 patients worldwide since being approved for postmenopausal osteoporosis. Overall, Reclast is safe and well tolerated.6, , ,
Parenteral bisphosphonates are indicated in cancer-related conditions
Novartis has developed two of the parenteral bisphosphonates that are FDA-approved for treatment of cancer-related conditions: Aredia (pamidronate disodium for injection) and Zometa (zoledronic acid) Injection . These agents fill a significant need for many cancer patients as bone metastases and bone loss are a common complication of cancer therapy. Metastatic bone disease is frequently associated with severe pain, increased risk of pathologic fractures and other bone complications, and the need for costly ongoing therapeutic interventions. Parenteral bisphosphonates can result in significant decrease in risk of fracture across all tumor types as well as improvement in quality of life for cancer patients with bone metastases. The use of these parenteral agents has become standard of care in the treatment of multiple myeloma and bones metastases from solid tumors as evidenced by their inclusion in the National Comprehensive Cancer Network (NCCN) treatment guidelines .
The Potential Topics made reference to the availability of oral bisphosphonates. However, no oral bisphosphonate is FDA- approved in the U.S. for the treatment of cancer-related conditions. As a matter of law, section 1861(t)(2) of the Social Security Act requires Medicare to cover the off-label uses of anti-cancer regimens if the use is listed in a CMS recognized compendium. Novartis is not aware of any CMS recognized compendium that lists an oral bisphosphonate for the treatment of cancer-related conditions. Novartis, therefore, does not understand the agency’s implication that it may require the use of an oral drug that is neither FDA approved or compendia recommended in cancer patients. Therefore, Novartis believes that for cancer- related conditions at a minimum a national coverage decision is not required. There are several possible risk factors for ONJ which include: recent history of dental extraction, periodontal disease, dental trauma, poor oral hygiene, current bacterial or fungal infection, alcohol or tobacco use, and diabetes. Some treatments exist to help manage ONJ. In population health terms, the clinical benefits of parenteral bisphosphonate therapy in cancer- related conditions, such as reduction of pathologic fractures, far outweighs the small risk of ONJ.
Osteonecrosis of the Jaw In Osteoporosis
Osteonecrosis of the jaw (ONJ) is usually defined as exposed bone in the oral cavity that persists for at least 8 weeks despite appropriate dental care. The vast majority of reports of ONJ have been in patients with advanced cancer being treated with multiple drug therapies, including parenteral bisphosphonates for bone metastases. Many of these reports are in patients who have had a dental procedure such as an invasive tooth extraction. A very small number of cases have been reported in the literature in patients taking oral or parenteral bisphosphonates for osteoporosis alone. These risks are noted in the prescribing information for both oral and parenteral bisphosphonates in all indications. The current estimate of incidence is less than 1 in 100,000 patients treated for osteoporosis. Risk factors for patients who might develop ONJ are recognized and treatments exist to manage the very rare instance in which patients develop ONJ .
In the Reclast clinical trial program for osteoporosis, there were no adverse events reported as ONJ during the course of any of the completed studies.6-9 Further, an independent panel of dental experts reviewed any report of a dental adverse events.6,9, After a thorough review of all of the dental events in more than 12,000 patients studied, the dental panel noted symptoms consistent with ONJ in one patient who had been treated with placebo and in one who had been treated with zoledronic acid.6,13 Both patients had subsequent healing with antibiotics and appropriate dental care.6,20 Thus the clinical trial program found no increased incidence of ONJ in association with the use of zoledronic acid in patients with osteoporosis.6,20 The post-marketing surveillance safety data with over 200,000 patients treated worldwide with Reclast since regulatory approval are consistent with the clinical trial experience.
In light of the foregoing, the reports of ONJ should not be a basis for denying patients the clinical benefits of parenteral bisphosphonate therapy in osteoporosis and cancer-related conditions.
Conclusion
Pursuing an NCD for parenteral bisphosphonates is not necessary because they offer distinct advantages for osteoporosis and cancer-related disorders. For patients with osteoporosis, Reclast offers an excellent first-line treatment option and is the only bisphosphonate FDA- approved for reducing fractures at the hip, spine and non-vertebral sites. For cancer patients, Zometa offers protection against bone complications that may result from bone metastases or multiple myeloma. There are no oral bisphosphonates approved for these uses.
We appreciate your review of these comments and look forward to working with you to ensure coverage that meets the needs of the Medicare beneficiaries. We would be happy to meet with you to review any of this data in further detail. |
| Commenter: |
Callans, David
|
| Date: |
9/26/2008 8:03:19 AM |
| Comment: |
I am writing in support of catheter ablation for atrial fibrillation. Catheter ablation is very important for selected patients with atrial fibrillation, particularly given the failings of pharmacologic therapy. It is true that ungoing research will be necessary to clarify its exact role, but I am certain that this will increase over time and become more cost effective |
| Commenter: |
morse, patrick
|
| Date: |
9/26/2008 8:36:57 AM |
| Comment: |
Hip resurfacing has been followed clinincally for many years, with an excellent success rate in treating patients that would not have been good candidates for conventional total hip arthroplasty. It is definitely a new approach to caring for this patient population, and will be used for many years to come. |
| Commenter: |
Hook, Bruce
|
| Title: |
Director, Arrhythmia Center |
| Organization: |
Lahey Clinic |
| Date: |
9/26/2008 8:53:22 AM |
| Comment: |
Ablation for atrial fibrillation.
I have been performing catheter ablation for atrial fibrillation for approximately 9 years and have found patients to benefit tremendously from elimination of this arrhythmia. In addition to my anecdotal experience, the data in the medical literature is overwhelmingly convincing. Side effects and potentially increased mortality from antiarrhythmic medication often presents a significant limitation to treatment. I urge CMS to approve this national coverage decision for catheter ablation of atrial fibrillation. |
| Commenter: |
Carson, Barbara
|
| Date: |
9/26/2008 9:50:46 AM |
| Comment: |
Nplaate (romiplostim) is the first and only drug that stimulates
production of platelets. I urge CMS to provide coverage to
patients.
[PHI Redacted] ITP is serious - massive spontanneous bleed, larage doses of
prednisone which are less and less effective, and transfusions
which are expensive and not long-lasting. [PHI Redacted] |
| Commenter: |
Corcoran, Molly
|
| Date: |
9/26/2008 10:25:16 AM |
| Comment: |
I oppose an NCD for Nplate. Nplate is the first
drug manufactured specifically for ITP (a blood
disorder effecting the platelet count). I fear
that if an NCD is in effect for Nplate that many
people who can benefit from this new drug will
not have access to it. An estimated 200,000
people in the United Stated have ITP.
[PHI Redacted] has had ITP for over 3
years. He has been treated with steriods, IVIG,
and Rituximab. All of these treatments are
simply bandaids for ITP. For some patients these
treatments do not work at all. ITP effects every
person differently and it would be wrong to
exclude or restrict how Nplate is to be used. |
| Commenter: |
Collins, Allan
|
| Organization: |
National Kidney Foundation |
| Date: |
9/26/2008 10:36:37 AM |
| Comment: |
September 16, 2008
Steve Phurrough, MD Director, Coverage and Analysis Group Office of Clinical Standards and Quality Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244
Dear Dr. Phurrough:
As President of the National Kidney Foundation, I am responding to the request for comments on potential NCD Topics for the third quarter of 2008. In particular we believe that a review of ESA use in CKD and dialysis patients is not warranted and that the agency should not open an NCD at this point in time.
The request for comments mentions the following considerations in discussing the need for an NCD for ESA use to treat anemia in Medicare beneficiaries with kidney disease: (l) The long term benefits and harms in the ESRD population are unclear; (2) It is unclear if ESAs are being used appropriately in the CKD population. In addition, it is stated that ESAs constitute a large cost in current ESRD treatment strategies.
As to long term benefits and harms, a clear long term benefit of ESA use in both CKD and ESRD patients is reduction in the need for transfusion. Not only does this reduction minimize the risk of exposure to blood borne pathogens (and the human and economic cost of the consequences of such exposure) but it also reduces the possibility that a kidney patient will become sensitized and, as a result, may not be able to be considered a candidate for transplantation. For appropriate patients, transplantation is the most cost-effective modality of treatment for Medicare beneficiaries with ESRD. For this reason, the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI) recommends that red blood cell transfusions should be used judiciously. Finally, red blood cell transfusions can lead to iron overload.
According to the 2008 Annual Report of the United States Renal Data System (USRDS), the use of transfusions in the outpatient setting has dropped dramatically since the early days of the dialysis program. In the late 1970s and early 1980s, 15–19 percent of hemodialysis patients received at least one transfusion in a three- month period. This number fell after the introduction of EPO, and since the middle of 2002 has been at less than 1 percent.
There has been no safety signal with regard to anemia therapy for dialysis patients. In fact there has been a decrease in the mortality rate of dialysis patients since ESAs were made available for anemia therapy in this population. As indicated in the USRDS 2008 Annual Report, the adjusted annual mortality rate per thousand patient years at risk for dialysis patients has declined from 238.1 in 1990 to 201.2 in 2006. These data alone do not demonstrate a cause/effect relationship between the use of ESAs and the decline in the mortality rate. On the other hand, the decline in the mortality rate would suggest that concerns about long term harm from ESA use should not be the basis for a review of payment policy.
As for the cost of ESAs to the Medicare program, after rising steadily through the 1990s and into the early 2000s, total Medicare spending on ESAs appears to have plateaued, as demonstrated by a cost increase of only 0.5 percent between 2005 and 2006. (Please see USRDS 2008 Annual Report.)
There are little data about the appropriateness of ESA use in the CKD population and an NCD proceeding would shed little light on that aspect of anemia therapy. CMS recently instituted a requirement that hemoglobins be provided when providers bill for ESA therapy for non-dialysis patients. It is too early to draw any conclusions from these data. Finally, as noted in the 2007 Update of Hemoglobin Target for the KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease, ongoing and future trials in patients with CKD are expected to provide more information on ESA use and hemoglobin targets, including treatment with ESAs compared with placebo, and higher compared with lower Hb targets.
Thank you for your consideration of these comments.
Sincerely,
Allan J. Collins, MD President National Kidney Foundation
|
| Commenter: |
Thompson, Ann
|
| Title: |
Director, Payer Relations |
| Organization: |
Cordis |
| Date: |
9/26/2008 10:40:51 AM |
| Comment: |
September 26, 2008 Title: Potential NCD for Off-Label Use of Drug- eluting Coronary Stents (As posted to the CMS website July 30, 2008)
Cordis Corporation appreciates the effort CMS has taken to make available the list of potential National Coverage Determination (NCD) topics and to elicit public comment, prior to opening an NCD. The topic, off-label use of drug-eluting coronary stents, raises the question of whether adequate evidence is available to determine which patient groups benefit from treatment with coronary stents. We have thoughtfully reviewed the off-label use of drug-eluting coronary stents and find the evidence strongly supports continued coverage for both on-label and off-label use.
Drug-eluting stents approved for use in the United States have similar, although not identical, labeling. The CYPHERâ sirolimus- eluting coronary stent (SES) is indicated for improving coronary luminal diameter with symptomatic ischemic disease due to de novo lesions of length £ 30mm in native coronary arteries with a reference vessel diameter of ³ 2.50 to £ 3.50 mm.
Based on an extensive body of evidence, interventional cardiologists around the world have realized the clinical impact and patient benefits of drug-eluting stents (DES) and as a result, have proactively chosen to treat 3 million patients with SES. Outcomes data has been collected through more than 70 studies conducted since launch in on-label and in many off-label patient populations, such as diabetic patients, patients with small vessels, patients who suffer an acute myocardial infarction with an emergent need for immediate revascularization, patients who experience in-stent restenotic lesions, and patients with multi- vessel disease, lesions longer than 30mm, ostial lesions or lesions that are located in saphenous vein grafts, bifurcations, or in an unprotected left main coronary artery. From launch in March 2003 to current date, the CYPHERâ sirolimus-eluting coronary stent has been the most studied DES in the United States and abroad. Below is an overview of the vast array of randomized controlled trials (RCTs) and non- RCTs that have evaluated the safety and efficacy of on-label and off-label use of DES. It is important to mention that of the 46 RCTs, 8 represent mostly on-label use while the remaining 38 represent off-label use of DES. All of these studies provide important data on the safety and efficacy outcomes for varying patient and lesions types. This extensive body of evidence illustrates that “off-label” does not mean “not studied.” While the FDA has not made a final determination of DES safety and efficacy in these populations, substantial clinical data exists in these patient and lesion types to allow physicians to make informed medical judgments regarding the appropriateness of DES treatment for their individual patients.
SLIDE ON FILE WITH CMS
Cordis will provide details on the specifics of each study upon request.
Several meta-analyses of these RCTs comparing DES and bare metal stents (BMS) were published in peer review journals in 2007. 1,2,3,4 Of note, the ACC/AHA/SCAI Practice Guidelines 2006 (http://circ.ahajournals.org) state meta-analysis of multiple RCTs is the highest level of evidence.
In the RCT meta-analysis comparing CYPHERâ to BMS, there was a significant reduction in the combined risk of death, myocardial infarction, or re-intervention (hazard ratio, 0.43; 95% confidence interval [CI], 0.34 to 0.54) associated with the use of SES. There was a slight increase (not statistically significant) in the risk of stent thrombosis associated with SES after the first year. However, there was no significant difference in the overall risk of stent thrombosis at 12 to 59 months of follow-up with SES vs. BMS (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). The overall risk of death (hazard ratio, 1.03; 95% CI, 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving SES vs. BMS at 12 to 59 months follow- up. Of note, the authors also reported outcomes by on- and off-label RCTs in a follow-up meta- analysis of 17 RCTs. In this analysis, there was no evidence that off-label use of SES was associated with compromised safety compared to BMS .1,2 Additional safety and efficacy evidence of DES use was found in a more comprehensive network meta-analysis of 38 RCTs (18,023 patients) with a follow-up to 4 years, comparing either CYPHERâ vs. BMS, Taxus (paclitaxel-eluting coronary stent) vs. BMS, or CYPHERâ vs. Taxus, published in the Lancet 2007. In this study, Stettler et al. noted that mortality was similar in the three groups: hazard ratios (HR) were 1.00 (95% credibility interval 0.82-1.25) for SES vs. BMS, 1.03 (0.84-1.22) for paclitaxel-eluting (PES) versus BMS, and 0.96 (0.83-1.24) for SES vs. PES. Other key findings noted that SES were associated with the lowest risk of myocardial infarction (HR 0.81, 95% credibility interval 0.66-0.97, p=0.030 vs BMS; 0.83, 0.71-1.00, p=0.045 vs. PES) and that there were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with PES (HR 2.11, 95% credibility interval 1.19-4.23, p=0.017 vs. BMS; 1.85, 1.02-3.85, p=0.041 vs. SES). In addition, the reduction in target lesion revascularization seen with DES compared with BMS was more pronounced with SES than with PES (0.70, 0.56- 0.84; p=0.0021). Overall, the authors indicated the risks of mortality associated with DES and BMS were similar and noted that SES seemed to be clinically better than BMS and PES in this analysis.2
Database and registry data also contribute to a better understanding of the safety and efficacy of DES use in all-comer populations. Patient level data from 3 Medicare beneficiary database analyses comparing 2-year patient outcomes among >50,000 DES and BMS recipients, found that the widespread adoption of DES into routine practice was associated with a significant survival benefit among the elderly, a decline in the need for repeat revascularization procedures and a similar risk for death or ST-elevation myocardial infarction when compared to BMS.35,36,37 Furthermore, studies from the National Heart, Lung and Blood Institute Dynamic Registry and the Wake Forest Registry have had similar findings relevant to the widespread use of DES.38,39
Among the many RCT analyses, real world registry data and non-randomized studies that are noted in peer reviewed journal publications, there is a consistent body of evidence indicating the use of DES in on-label and many off-label settings is associated with a sustained reduction in the need for reintervention and that the safety is comparable to that seen with BMS. 1,2, 3
Cordis encourages CMS to explore the extensive body of evidence related to the long-term safety and efficacy in off-label use of the CYPHERâ sirolimus-eluting stent and other drug-eluting stents, and welcomes the opportunity to work with CMS in this regard.
Sincerely,
Ryan H. Saadi, M.D., M.P.H. Vice President, Health Economics and Reimbursement Cordis Corporation
References:
Meta-Analyses 1) Kastrati A, Mehili J, Pache J., et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007 Mar 8;356(10):1030-9. Epub 2007 Feb 12.) 2) Stettler C, Wandel S, Allemann S., et al. Outcomes associated with drug-eluting and bare- metal stents: a collaborative network meta- analysis. Lancet 2007 Sep 15;370(9591):937-48 3) Schomig A, Dibra A, Windecker S., et al. A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel- eluting stents in patients with coronary artery disease. J Am Coll Cardiol. 2007 Oct 2;50 (14):1373-80. 4) Kastrati A. Schomig A. Drug-eluting stents is their future as bright as their past? J Am Coll Cardiol. 50(2):146-8, 2007 Jul 10.
SES SMART 5) Ardissino D, Cavalli C, Bramucci E, et al. Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial. JAMA. 2004 Dec 8;292 (22):2727-34 6) Ortolani P, Ardissino D, Cavallini C, et al. Effect of sirolimus-eluting stent in diabetic patients with small coronary arteries (a SES- SMART substudy). Am J Cardiol. 2005 Nov 15;96 (10):1393-8. Epub 2005 Sep 27
ISAR SMART 7) Mehilli J, Dibra A, Kastrati A, et al. Randomized trial of paclitaxel- and sirolimus- eluting stents in small coronary vessels. Eur Heart J. 2006 Feb;27(3):260-6. Epub 2006 Jan 9.
PARK Long Lesion II 8) Kim YH, Park SW, Park DW., et al. Sirolimus- eluting stent versus paclitaxel-eluting stent for patients with long coronary artery disease. Circulation. 2006 Nov 14;114(20):2148-53. Epub 2006 Oct 23
DIABETES TRIAL 9) Jimenez-Quevedo P, Sabate M, Angiolillo DJ., et al. Long-term clinical benefit of sirolimus- eluting stent implantation in diabetic patients with de novo coronary stenoses: long-term results of the DIABETES trial. European Heart Journal. 28 (16):1946-52, 2007 Aug. 10) Sabate M, Jimenez-Quevedo P, Angiolillo DJ., et al. Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial. Circulation. 112(14):2175-83, 2005 Oct 4.
DECODE 11) Charles Chan, MD, Robaayah Zambahari, MD, Upendra Kaul, MD DM., et al. A randomized study with sirolimus-eluting BX velocity balloon- expandable stent in the treatment of diabetic patients with native coronary artery lesions. AHA Oral Presentation 2005
SCORPIUS 12) Baumgart D, Klauss V, Baer F., et al. One- year results of the SCORPIUS study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients. Journal of the American College of Cardiology, Volume 50 , Issue 17 , Pages 1627 – 1634
CARDIA 13)Coronary Artery Revascularization in Diabetes Trial. The Heart.org and Oral presentation ESC 2008 DESSERT 14) Maresta A, Varani E, Balducelli M., et al Comparison of effectiveness and safety of sirolimus-eluting stents versus bare-metal stents in patients with diabetes mellitus (from the Italian Multicenter Randomized DESSERT Study). Am J Cardiol. 2008 Jun 1;101(11):1560-6. Epub 2008 Apr 11
ISAR DIABETES 15) Dibra A, Kastrati A, Mehilli J., et al. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005 Aug 18;353(7):663-70. Epub 2005 Aug 16.
KOREAN Study 16) Kim MH, Hong SJ, Cha KS., et al. Effect of Paclitaxel-eluting versus sirolimus-eluting stents on coronary restenosis in Korean diabetic patients. J Interv Cardiol. 2008 Jun;21(3):225- 31. Epub 2008 Mar 13.
DECLARE 17) Lee SW, Park SW, Kim YH., et al. Drug-eluting stenting followed by cilostazol treatment reduces late restenosis in patients with diabetes mellitus the DECLARE-DIABETES Trial (A Randomized Comparison of Triple Antiplatelet Therapy with Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Diabetic Patients). J Am Coll Cardiol. 2008 Mar 25;51(12):1181-7.
SWEDISH RTC 18) Jensen, L, Maeng M, Thayssen P., et al. Extent and patterns of neointimal hyperplasia distribution after drug-eluting stent implantation in diabetic patients assessed by intravascular ultrasound. WCC 2008; Circ 2008 Buenos Airies
ITALIAN RCT 19) Tomai F, Reimers B, De Luca L., et al. Head- to-head comparison of sirolimus- and paclitaxel- eluting stent in the same diabetic patient with multiple coronary artery lesions: a prospective, randomized, multicenter study. Diabetes Care. 2008 Jan;31(1):15-9. Epub 2007 Oct 1.
PRISON II 20) Suttorp MJ, Laarman GJ, Rahelll BM., et al. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation. 2006 Aug 29;114(9):921-8. Epub 2006 Aug 14.
SISR 21) Holmes DR Jr., Terstein P, Statler L., et al. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare- metal stents: the SISR randomized trial. JAMA. 2006 Mar 15;295(11):1264-73. Epub 2006 Mar 12.
RIBS II 22) Alfonso F, Perez-Vizcayno MJ, Hernandez R., et al. A randomized comparison of sirolimus- eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial. J Am Coll Cardiol. 2006 Jun 6;47(11):2152- 60.
INDEED 23) Park SW, Lee SW, Koo BK., et al. Treatment of diffuse IN-stent restenosis with Drug-Eluting stents vs. intracoronary bEta-raDiation therapy: INDEED Study. Int J Cardiol. 2008 Jan 9.
TYPHOON 24) Spaulding C, Henry P, Teiger E., et al. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med. 2006 Sep 14;355(11):1093-104.
SESAMI 25) Menichelli M, Parma A, Pucci E., et al. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). J Am Coll Cardiol. 2007 May 15;49(19):1924-30. Epub 2007 Apr 30.
MISSION, 26) van der Hoeven BL, Liem SS, Jukema JW., et al. Sirolimus-eluting stents versus bare-metal stents in patients with ST-segment elevation myocardial infarction: 9-month angiographic and intravascular ultrasound results and 12-month clinical outcome results from the MISSION! Intervention Study. J Am Coll Cardiol. 2008 Feb 12;51(6):618-26.
STRATEGY 27) DeLuca L, Sardella G., et al. Tirofiban plus sirolimus-eluting stent vs abciximab plus bare- metal stent. JAMA. 2005 Oct 5;294(13):1617; author reply 1617- 8.
STRATEGY II 28)Valgimigli M, Campo G, Arcozzi C., et al. Two- year clinical follow-up after sirolimus-eluting versus bare-metal stent implantation assisted by systematic glycoprotein IIb/IIIa Inhibitor Infusion in patients with myocardial infarction: results from the STRATEGY study. J Am Coll Cardiol. 2007 Jul 10;50(2):138-45. Epub 2007 May 22
DIAZ 29) Diaz de la Llena LS, Ballesteros S, Nevado J., et al Sirolimus-eluting stents compared with standard stents in the treatment of patients with primary angioplasty. Am Heart J. 2007 Jul;154 (1):164.e1-6 DiLorenzo 30) DiLorenzo E, Varricchio A, Lanzillo T., et al. Paclitaxel and Sirolimus Stent Implantation in Patients with Acute Myocardial Infarction. Scientific Sessions 2005
pROSIT 31) Lee JH, Kim HS, Lee SW., et al. Prospective randomized comparison of sirolimus- versus paclitaxel-eluting stents for the treatment of acute ST-elevation myocardial infarction: pROSIT trial. Catheter Cardiovasc Interv. 2008 Jul 1;72(1):25-32
SCANDSTENT 32) Kelbaek H, Kløvgaard L, Helqvist S., et al. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non- Stress/Benestent Disease) trial. J Am Coll Cardiol. 2008 May 27;51(21):2011-6.
PRISC 33) Vermeersch P, Agostoni P, Verheye S., et al. Randomized Double-Blind Comparison of Sirolimus- Eluting Stent Versus Bare-Metal Stent Implantation in Diseased Saphenous Vein Grafts. American College of Cardiology. 48(12):2423-31, 2006 Dec 19.
34) Agostoni P, Vermeersch P, Semeraro O., et al. Intravascular ultrasound comparison of sirolimus- eluting stent versus bare metal stent implantation in diseased saphenous vein grafts (from the RRISC [Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus- Eluting Stent] trial). American Journal of Cardiology. 100(1):52-8, 2007 Jul
Medicare Database Studies 35) Groeneveld PW, Matta MA, Greenhut AP., et al. Drug-eluting compared with bare-metal coronary stents among elderly patients. J Am Coll Cardiol. 51(21):2017-24, 2008 May
36) Malenka DJ, Kaplan AV, Lucas FL., et al. Outcomes following coronary stenting in the era of bare-metal vs the era of drug-eluting stents. JAMA. 299(24):2868-76, 2008 Jun 25.
37) Wang F, Uretsky B, Freeman J., et al. Survival advantage in Medicare patients receiving drug-eluting stents compared with bare metal stents: Real or artefactual? Catheterization and Cardiovascular Interventions 71:636–643 (2008)
NHLB Institute 38) Marroquin O, Selzer F, Mulukutla S., et al. A Comparison of Bare-Metal and Drug-Eluting Stents for Off-Label Indications. NEJM. 358:331- 341
Wake Forest 39) Applegate RJ, Sacrinty MT, Kutcher MA., et al. "Off-label" stent therapy 2-year comparison of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 51(6):607-14, 2008 Feb 12.
|
| Commenter: |
Fike, Ruthita
|
| Title: |
Chief Executive Officer |
| Organization: |
Loma Linda University Medical Center |
| Date: |
9/26/2008 10:41:01 AM |
| Comment: |
Loma Linda University Medical Center hereby submits this comment regarding the July 30, 2008 listing by the Centers for Medicare & Medicaid Services of potential National Coverage Determination topics.
I. Introduction
On July 30, 2008, the Centers for Medicare & Medicaid Services (“CMS”) listed Proton Beam Therapy (“PBT”) for prostate cancer as a potential topic it would consider opening for a National Coverage Determination (“NCD”). In its notice, CMS described PBT for prostate cancer as: “[p]roposed as means to concentrate radiation therapy and reduce side effects. Very high upfront cost to build these facilities and thus only at very few facilities. For prostate cancer treatment, no current comparative trials comparing to usual therapy.” (“Potential NCD Topics” CMS, July 30, 2008.) This comment will address reasons why PBT for prostate cancer is a reasonable and necessary treatment option and therefore should continue to be reimbursed by Medicare. (42 U.S.C. § 1395y(l)(1))
II. PBT is a Reasonable and Necessary Therapy to Treat Prostate Cancer
Over two decades ago, Loma Linda University broke ground on the world’s first clinically-based proton treatment center. Since 1990, Loma Linda University Medical Center (“LLUMC”) has treated over 13,000 patients with PBT in the James M. Slater, MD Proton Treatment and Research Center. In fact, LLUMC has treated patients from every state in the nation from young children to senior citizens. On a typical day, as many as 150 patients may be treated for any of the following disease sites, including prostate cancer:
• Brain and Spinal Cord (Arteriovenous Malformations (AVMs); Isolated Brain Metastases; Pituitary Adenomas)
• Base of Skull (Acoustic Neuromas; Chordomas and Chondrosarcomas; Meningiomas)
• Eye (Uveal Melanomas)
• Head and Neck (Nasopharynx; Oropharynx Cancer)
• Chest and Abdomen (Chordomas and Chondrosarcomas; Early Lung Cancer)
• Pelvis (Chordomas and Chondrosarcomas; Prostate Cancer)
• Tumors in Children (Brain Tumors; Orbital and Ocular Tumors; Sarcomas of the Base of Skull and Spine)
There is virtually no debate in the scientific literature regarding the effectiveness of PBT to treat prostate cancer. In fact, PBT is considered a reasonable and necessary form of treatment for several reasons. First, plentiful scientific data show that PBT is well recognized as an effective way to treat many cancers, including prostate cancer. Second, PBT’s inherent characteristics afford the physician unparalleled ability to determine how and where the radiation is distributed—and not distributed; in other words, it allows the physician to maximize the dose in the target volume while minimizing the dose to normal tissues outside the target. The latter is particularly important, as normal-tissue irradiation is the major limitation in tumor control. The third reason arises from the second: the controllability of PBT. The ability to minimize dose to normal tissues- allows for higher doses to be given to target volumes, thus promoting increasing rates of tumor control even as no increase occurs in rates of treatment-related toxicity.
Each of these reasons is examined in greater detail below.
A. PBT is well known to be effective in treating prostate cancer
PBT has been used to treat prostate cancer for many years, and evidence has accumulated steadily to show that it is clinically effective. (Zietman, Anthony L. “The Titanic and the Iceberg: Prostate Proton Therapy and Health Care Economics” JOURNAL OF CLINICAL ONCOLOGY, Vol. 25: No. 24 (2007) p. 3565 [PBT “has been in use for many decades. . . .”]; Slater, Jerry et. al., “Conformal Proton Therapy for Prostate Cancer” INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY, BIOLOGY, PHYSICS, Vol. 42: No. 2 (1998) p. 299 [“Protons have been used to treat prostate carcinoma since the late 1970s.”]) Scientific data show that PBT is effective for treating localized solid tumors, and provide evidence that PBT can permit dose escalation without significantly increasing complications to normal tissue. (Rossi, Carl et. al., “Particle Beam Radiation Therapy in Prostate Cancer: Is There An Advantage?” SEMINARS IN RADIATION ONCOLOGY, Vol. 8: No. 2 (1998) p. 117)
Proton therapy, like all forms of radiotherapy, works by aiming energetic ionizing particles into a targeted volume of cancerous tissue. The ionized particles damage cells’ DNA and eventually kill them. This is true of photons and protons; both have similar biologic effects in tissue. (Levin, WP et. al., “Proton Beam Therapy” BRITISH JOURNAL OF CANCER, Vol. 93: No. 8 (2005) p. 849) However, PBT has clear advantages over conventional photon therapy when treating prostate cancer. Specifically, PBT reduces the exposure and subsequent damage caused by radiation therapy surrounding healthy tissue.
Unlike photons, which, because of their lack of mass, scatter when entering the body and thus deliver the majority of their radiation in normal tissues “upstream” from the target volume, protons deliver their maximum radiation to the target. Protons are much more massive than photons and have a positive charge. Both of these properties allow protons to scatter much less when entering tissue. Hence, protons have a low entrance dose relative to the target, with the maximum dose occurring at a predetermined point called the Bragg peak. This peak can be adjusted to conform precisely to the target volume and can be stopped within 2-3 mm of that volume. Hence there is no exit dose of radiation into normal tissues. (Levin, WP et. al., “Proton Beam Therapy” BRITISH JOURNAL OF CANCER, Vol. 93: No. 8 (2005) p. 849) This phenomenon is not possible with photons; all individual photon beams deliver not only the greater part of their dose to normal tissues as they enter the body, but also irradiate normal tissues “downstream” from the target volume.
B. PBT, as compared to IMRT, reduces the amount of harmful radiation to normal tissue
It is accepted that radiation harms human cells. Data suggest that higher radiation doses to cells result in higher risks of cell death. (DeWeese, Theodore & Song, Danny Y “Radiation Dose Escalation as Treatment for Clinically Localized Prostate Cancer: Is More Really Better?” JAMA, Vol. 294: No. 10 (2005) p. 1274) No dose, no matter how low, is considered “safe”. Therefore, it behooves the radiation oncologist to irradiate normal cells as little as possible, and to avoid such radiation whenever possible. One of the major advantages of PBT over other forms of radiation therapy is PBT’s unsurpassed ability to minimize radiation exposure to normal cells, not only because of reduced scatter and the Bragg peak phenomenon, but also because PBT can deliver a highly conformal dose to the target volume with relatively few radiation portals (sites of beam entry into the body). The result is a greater volume of normal tissues not exposed to any dose of radiation, and a minimal dose delivered to normal tissues that are exposed.
There have been advancements in radiation therapy other than PBT. One of these is intensity-modulated radiation therapy ("IMRT"), which uses computerized x-ray accelerators to deliver radiation to the target volume with greater precision than traditional photon radiation allows. Some have claimed that IMRT is as effective as PBT.
The essence of IMRT is that it delivers radiation to the target via several portals—often many more than are used in standard x-ray therapy. In this it is reminiscent of the rotational arc therapy that was employed decades ago. But, IMRT uses computer assistance to vary the position of the portals and intensity of the beam, thus enabling it to reduce the dose to selected normal tissues near the target while still delivering a high dose to the target cells. The price paid for this target-volume comformality, however, is a larger volume of normal tissues exposed to radiation. In fact, the cumulative dose throughout this volume (the volume integral dose) is higher with IMRT than with standard photon radiation. The dose to most of the tissues in this larger volume is relatively low (albeit IMRT can have significantly more hot spots than are seen with protons or other forms of x-ray delivery), but it remains to be seen whether the greater volume exposed to radiation eventuates in long-term sequelae. (Suit, Herman et. al., “Should Positive Phase III Clinical Trial Data Be Required Before Proton Beam Therapy Is More Widely Adopted? No” RADIOTHERAPY AND ONCOLOGY, Vol. 86 (2008) p. 151. [“There is solid evidence that the risk of secondary radiation cancer after a low radiation dose continues to increase with post-exposure time for at least 52 years.”])
Thus, while both PBT and IMRT are effective in treating prostate cancer, PBT can be distinguished from IMRT based on both the volume of normal tissue treated by the radiation and the amount of radiation exposure to normal tissue. With the IMRT approach, instead of a single volume of normal tissue receiving a high dose of radiation, multiple areas of normal tissue are exposed to lower doses of radiation. This exposure still can lead to a second malignancy or other unwanted side effects to the normal tissue, which may take years, perhaps decades, to develop. (Levin, WP et. al, “Proton Beam Therapy” BRITISH JOURNAL OF CANCER, Vol. 93: No. 8 (2005) p. 849.) (Suit, Herman et. al., “Should Positive Phase III Clinical Trial Data Be Required Before Proton Beam Therapy Is More Widely Adopted? No” RADIOTHERAPY AND ONCOLOGY, Vol. 86 (2008) p. 151) The end result is that patients receiving IMRT are exposed to two to three times more radiation to normal tissue than with PBT. (Goitein, Michael & Cox, James D. “Should Randomized Clinical Trial Be Required for Proton Radiotherapy?” JOURNAL OF CLINICAL ONCOLOGY, Vol. 26: No. 2 (2008) p. 175)
C. PBT also allows patients to benefit from increased total doses of radiation per course of treatment
Because PBT minimizes both the dose delivered to normal tissues and the volume of normal tissues receiving radiation, PBT can provide dose escalation, while not harming normal tissues, in ways that photon radiation—whether delivered by IMRT or otherwise—does not permit. (Levin, WP et. al., “Proton Beam Therapy” BRITISH JOURNAL OF CANCER, Vol. 93: No. 8 (2005) p. 853) It is generally agreed among radiation oncologists that higher total doses increase the likelihood of disease control for most solid cancers, and in the case of localized prostate cancer, it has been demonstrated that an increased radiation dose delivered to the prostate decreases the chances of a recurrence. (DeWeese, Theodore & Song, Danny Y. “Radiation Dose Escalation as Treatment for Clinically Localized Prostate Cancer: Is More Really Better?” JAMA, Vol. 294: No. 10 (2005) p. 1275) A study performed by researchers at Massachusetts General Hospital and Loma Linda University found that treating men with clinically localized prostate cancer with a high-dose combination therapy of conventional radiation along with PBT instead of just a conventional dose of external radiation therapy led to the patients being more likely to be free from increased prostate-specific-antigen (PSA) levels 5 years later, and less likely to have locally persistent disease. (Zietman, Anthony et. al., “Comparison of Conventional-Dose vs High-Dose Conformal Radiation Therapy in Clinically Localized Adenocarcinoma of the Prostate: A Randomized Controlled Trial” JAMA, Vol. 294: No. 10 (2005) (reprinted) p. 1238)
Dose escalation with photon radiation, even with modern methods such as IMRT, is difficult to achieve because increasing the dose to the target volume also will increase the scattered and “downstream” dose to normal tissues. In contrast, because PBT can localize the dose to the target volume and minimize exposure to normal tissue, higher doses can be delivered without significantly increasing the toxicity and harmful side effects of the radiation. (Slater, Jerry et. al., “Proton Therapy for Prostate Cancer: the Initial Loma Linda University Experience” INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY, BIOLOGY, PHYSICS, Vol. 59: No. 2 (2004) p. 351) Therefore, a major benefit of PBT over photon radiation is the ability to increase the total dose administered per course of treatment. (Suit, Herman et. al., “Should Positive Phase III Clinical Trial Data Be Required Before Proton Beam Therapy Is More Widely Adopted? No” RADIOTHERAPY AND ONCOLOGY, Vol. 86 (2008) p. 148)
PBT, then, is effective in treating prostate cancer and protects normal tissues to a greater extent than is possible with photon irradiation. It therefore meets the requirement of being a “reasonable and necessary” treatment option. (42 U.S.C. § 1395y(l)(1)) Nevertheless, some insist that in order to “prove” the effectiveness of PBT, a phase III clinical trial is required.
III. Randomized Phase III Clinical Trials for PBT Are Unnecessary and Would Be Unethical
A randomized phase III clinical trial is not necessary to prove the benefits of PBT for prostate cancer; these benefits have already been demonstrated, as noted herein. If PBT is at least as effective as conventional or IMRT photon irradiation in treating cancerous tissue, and has the added benefit of reducing radiation exposure to normal cells, logic leads to the conclusion that PBT has a beneficial role in the treatment of prostate cancer.
There are several reasons why there have not been any phase III trials comparing conventional photon radiation to PBT. One is that some in the field do not find any scientific need or benefit to conducting such phase III trials. (Suit, Herman et. al., “Should Positive Phase III Clinical Trial Data Be Required Before Proton Beam Therapy Is More Widely Adopted? No” RADIOTHERAPY AND ONCOLOGY, Vol. 86 (2008) pp. 152-153) Another is that, in the judgment of some, conducting a phase III randomized clinical trial would be unethical. (Goitein, Michael & Cox, James D. “Should Randomized Clinical Trials Be Required for Proton Radiotherapy?” JOURNAL OF CLINICAL ONCOLOGY, Vol. 26: No. 2 (2008) p. 175)
The latter opinion arises from the fact that the major clinical difference between modern photon irradiation (IMRT) and PBT lies in the volume of normal tissue exposed to radiation. Hence, the main point of a comparative trial would be to determine whether (if one assumes the same total dose delivered to the target volume) the difference in volume integral dose results in detectable clinical differences—presumably in side effects and second malignancies—over time. In order to conduct such a clinical trial, the study must be approved by institutional review boards, which are charged with ensuring, among other things, that human research subjects are not harmed. (45 C.F.R. § 46.116) Yet, a phase III study comparing photons to protons would require researchers to expose patients in the photon therapy group to normal-tissue radiation. Since there is overwhelming evidence that all radiation is harmful, how could one ethically design a study wherein half of the participants would be receiving two to three times more radiation to normal tissue with no expected clinical benefit? It would certainly be difficult, if not impossible, to find patients willing to participate in such a study and to find an institutional review board willing to approve such an experiment. (Suit, Herman et. al., “Should Positive Phase III Clinical Trial Data Be Required Before Proton Beam Therapy Is More Widely Adopted? No” RADIOTHERAPY AND ONCOLOGY, Vol. 86 (2008) pp. 149, 152-153)
It is worth noting that, just as there have been no phase III trials comparing conventional photon radiation to PBT, there have been no phase III trials comparing conventional photon radiation to IMRT. Most proposals for a phase III trial call for a comparison between IMRT and PBT, on the assumption, one presumes, that IMRT is merely the most advanced form of photon radiation. Given the greater volume integral dose associated with IMRT, however, such an assumption may be premature. For this reason, as well as the demonstrated effectiveness of PBT in treating prostate cancer, the lack of phase III studies comparing IMRT to PBT is not an appropriate basis to eliminate Medicare coverage for either IMRT or PBT. Both technologies are still maturing.
IV. Cost Should Not be Considered in Deciding Whether to Open an NCD
Some may argue that because of the supposedly high cost associated with PBT, it should not be covered by Medicare. Such an argument is misplaced in the NCD process and seems to have missed CMS’s stance on cost. Simply put, cost effectiveness is not considered in CMS’s evaluation regarding whether to open an NCD. CMS has clearly stated:
"Cost effectiveness is not a factor CMS considers in making NCDs. In other words, the cost of a particular technology is not relevant in the determination of whether the technology improves health outcomes or should be covered for the Medicare population through an NCD." (“Factors CMS Considers in Opening a National Coverage Determination” CMS, April 11, 2006)
Thus, the alleged “[v]ery high upfront cost to build [PBT] facilities” should have no bearing on whether PBT improves health outcomes (which it does) and should be covered by Medicare. Indeed, it is a bit perplexing that this cost was even mentioned in the NCD potential topics listing.
If cost were a proper issue for discussion, it is important to consider that virtually every new technology or new scientific procedure would be precluded from Medicare coverage. In fact, similar arguments about cost have been made in the past about “new technologies” that today are considered standard medical practice. For example, arguments were made about the “high cost” of cobalt-60 teletherapy machines and even IMRT in its earlier days. (Goitein, Michael & Cox, James D. “Should Randomized Clinical Trial Be Required for Proton Radiotherapy?” JOURNAL OF CLINICAL ONCOLOGY, Vol. 26: No. 2 (2008) p. 176)
Further, the reality is that the costs for PBT will very likely decrease over time. (Konski, Andre et. al., “Is Proton Beam Therapy Cost Effective in the Treatment of Adenocarcinoma of the Prostate?” JOURNAL OF CLINICAL ONCOLOGY, Vol. 25: No. 24 (2007) p. 3603) One reason for a decrease is the effect of improvements and greater use of the technology. It is a virtual truism: new technologies decrease in cost with time. The costs and expense of PBT per patient will likely decrease as more facilities are built and greater numbers of patients are treated. (Goitein, Michael & Cox, James D. “Should Randomized Clinical Trial Be Required for Proton Radiotherapy?” JOURNAL OF CLINICAL ONCOLOGY, Vol. 26: No. 2 (2008) p. 176) Indeed, a number of new PBT facilities are under construction and another is in development. (The National Association for Proton Therapy website, available at: www.proton-therapy.org) Additionally, increased interest in PBT will likely lead to greater free-market competition, the building of smaller and less expensive facilities to house the proton beam, and reimbursement rate normalization as rates begin to reflect the real cost of the treatment. (Goitein, Michael & Cox, James D. “Should Randomized Clinical Trials Be Required for Proton Radiotherapy?” JOURNAL OF CLINICAL ONCOLOGY, Vol. 26: No. 2 (2008) p. 176)
Another reason that PBT costs will decrease arises from the ability to employ hypofractionation, which essentially means delivering the same total dose in fewer fractions, or individual treatments. That is, by increasing the daily radiation dose, overall treatment time decreases. PBT makes this possible for the same reason that it enables dose escalation: its unsurpassed ability to spare normal tissues. An overall decrease in treatment time leads to a decrease in the total cost of treatment. Thus, even though the cost of each individual treatment for PBT may be higher than for IMRT or other therapies, if the number of treatments can be reduced with PBT, the end result would be an equal cost for the different therapies. Investigators at LLUMC have successfully employed hypofractionated regimens for other forms of cancer, and have seen no increase in radiation-related sequelae. (Bush, DA et. al, “High-dose Proton Beam Radiotherapy of Hepatocellular Carcinoma: Preliminary Results of a Phase II trials” GASTROENTEROLOGY, Vol. 127(5 Suppl 2)(2004) p. 189-193; Bush DA et. al., “Hypofractionated Proton Beam Radiotherapy For Stage I Lung Cancer” CHEST, Vol. 126: No. 4 (2004) p. 1198) It is expected, therefore, that hypofractionation can be employed in prostate cancer, and a phase II trial to evaluate this is underway.
V. Conclusion
As this comment has explained, PBT has demonstrated proven benefits in the treatment of prostate cancer. It is, therefore, a reasonable and necessary treatment that Medicare should continue to cover for its enrollees.
|
| Commenter: |
Galinsky, Dennis
|
| Title: |
Principal |
| Organization: |
DuPage Oncology Center |
| Date: |
9/26/2008 10:52:39 AM |
| Comment: |
PROTON THERAPY CMS should not reimburse proton therapy for prostate cancer until further research proves the results are superior.
Protons are a proven modality, with better results than standard photons for pediatric malignancies and certain malignant and benign neurological diseases. However, there have been no randomized studies showing any benefit of the much more expensive protons over present day modern photon therapies in the treatment of diseases such as lung cancer, breast cancer or prostate cancer. If one looks at the dose distribution of protons compared to photon therapy there is a small additional amount of radiation given with photons that has no clinical significance and does not produce enough dose to damage or kill surrounding normal cells.
Proton therapy is not new and has been available for over 30 years. Newer photon modalities have evolved allowing the treatment of tumors with great precision while sparing normal tissues. These modalities include intensity modulated radiation therapy, image-guided therapy, and robotic driven stereotactic surgery. Although expensive, the $6.8 million dollar cost for this latter modality pales in comparison to the $120+ million expense of protons.
Organizations hoping to turn proton centers into profit centers are not counting on the proven cases (pediatrics, etc.) to turn a profit. They are counting on the general application of protons to all tumor sites without regard to a sound basis in proven research. More importantly, they are counting on CMS to be the cornerstone of these profits.
CMS must act responsibly with the taxpayers' money and deny payment for unproven proton treatments of prostate cancer. |
| Commenter: |
Poole, Colin
|
| Title: |
Doctor/ Orthopaedic Surgeon |
| Date: |
9/26/2008 10:57:51 AM |
| Comment: |
Continued coverage by CMS for FDA approved BHR Hip replacement system. Hip resurfacing has proved to an excellent alternative to total hip replacement and is not considered to be an interim treatment in an attempt to delay a hip replacement surgery.There are a number of recently published studies showing excellent short and longterm outcomes in patients over 65 years old having undergone BHR replacement. Numerous registeries have compelling data show excellent long term survival of the BHR system rivaling and often exceeding that of total hip replacement surgeries. I strongly urge you to maintain coverage for this FDA approved device for the affore mentioned reasons. |
| Commenter: |
Krop, M.D., Julie
|
| Title: |
Vice President, Clinical and Regulatory Affairs |
| Organization: |
Stryker Biotech |
| Date: |
9/26/2008 11:13:23 AM |
| Comment: |
RE: Bone Morphogenetic Protein (BMP)
Dear Sirs: As the Vice-President of Clinical and Regulatory Affairs for Stryker Biotech, the manufacturer of Bone Morphogenetic Protein-7, the following relevant information is shared to help CMS appreciate that BMP-7, also known as OP-1 Putty, need not proceed to a national coverage determination.
The U. S. Food and Drug Administration (FDA) granted market clearance to OP-1 Putty as a Humanitarian Use Device on April 7, 2004 (# H020008). As defined in the Federal Food, Drug, and Cosmetic Act (21 CFR 814.124), the definition of a Humanitarian Use Device (HUD) is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year. Therefore, as a Humanitarian Use Device, the number of patients who have access to OP-1 Putty in any given year is very limited, especially eligible patients who are sixty-five years of age or older. In addition, under the HUD exemption, there are significant controls on how and where in the body OP-1 Putty can be used.
The medical necessity of and patient selection criteria for OP-1 Putty is best expressed by its intended use - as an alternative to autograft in compromised patients requiring revision of a failed posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes. Spine surgeons implant OP- 1 Putty in a very select group of patients who have exhausted conventional treatment options for their lumbar pain. Conventional practices and procedures have either failed or are not feasible. Patients who have undergone prior autograft harvest are often not candidates for further autograft procedures. In addition, patients who are obese, advanced in age, have poor bone quality (osteoporosis) and/or concurrent medical co-morbidities will likely suffer unacceptable donor site morbidity and risk of future anatomic disruption. OP-1 Putty is an important biologic advancement that fills an unmet clinical need in select patients. CMS recognized this need when it granted OP-1 Putty new technology add-on payment in FY2005. In receiving new technology add-on payment, CMS determined that OP-1 Putty represented an advance in medical technology that substantially improved patient care relative to technologies previously available.
In conclusion, OP-1 Putty, as a humanitarian use device, is a major advancement in spine surgery for a small patient population that has been unable to attain acceptable health outcomes with conventional interventions. FDA developed and published the Safe Medical Devices Act on June 26, 1996 to provide an incentive that would encourage innovative manufacturers, such as Stryker Biotech, to pursue discovery and development of devices that would benefit only a small patient population each year. Because OP-1 Putty is an HUD, Stryker Biotech and U.S. hospitals that purchase it must comply with certain FDA requirements. Specifically, as an Humanitarian Use Device, OP-1 Putty may only be used after a hospital’s Institutional Review Board (IRB) has approved its use for appropriately selected patients consistent with its labeling intended use. Stryker Biotech’s sales team works very closely with its hospital customers to ensure that OP-1 Putty is only used in patients requiring revision of a failed posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. In addition to this brief comment, I would be happy to speak with interested medical professionals at CMS, as well as facilitate introductions to key opinion leaders and clinical investigators for peer-to- peer discussions. At your convenience, I can be reached at Stryker Biotech, 35 South Street, Hopkinton, Mass. 01748. My office phone number is (508) 416-5326 In the meantime, the following bibliography of peer-reviewed publications is shared for your review. In advance, thank-you for your time and consideration.
Bishop GB, Einhorn TA. Current and future clinical applications of bone morphogenetic proteins in orthopaedic trauma surgery. Int Orthop. 2007 Dec;31(6):721-7. Epub 2007 Aug 1.
Carlisle E, Fischgrund JS. Bone morphogenetic proteins for spinal fusion. Spine Journal. 2005:5:240S-249S.
Govender PV, et al. Use of osteogenic protein-1 in spinal fusion: literature review and preliminary results in a prospective series of high-risk cases. Neurosurg. Focus. 2002 Dec;13 (6): article 4.
Johnsson R, et al. Randomized radiostereometric study comparing osteogenic protein-1 (BMP-7) an autograft bone in human noninstrumented posterolateral lumbar fusion. Spine. 2002;27 (23):2654-2661.
Vaccaro AR, et al. The safety and efficacy of OP- 1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: minimum 4-year follow-up of a pilot study. Spine J. 2008 May-Jun;8(3):457-65.
Vaccaro AR, et al. Comparison of OP-1 Putty (rhBMP-7) to iliac crest autograft for posterolateral lumbar arthrodesis: a minimum 2- year follow-up pilot study. Spine. 2005 Dec 15;30 (24):2709-16.
Vaccaro AR, et al. A 2-year follow-up pilot study evaluating the safety and efficacy of op-1 putty (rhbmp-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions. Eur Spine J. 2005 Sep;14(7):623-9.
Vaccaro AR, et al. A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis. Spine. 2004 Sep 1;29(17):1885-92.
Vaccaro AR, et al. A pilot safety and efficacy study of OP-1 putty (rhBMP-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions. Eur Spine J. 2003 Oct;12(5):495-500
|
| Commenter: |
Ennis, DO, MBA, FACOS, William
|
| Title: |
President |
| Organization: |
Association for the Advancement of Wound Care |
| Date: |
9/26/2008 11:25:17 AM |
| Comment: |
September 26, 2008
Dr. Barry Straub Centers for Medicare and Medicaid Services Coverage and Analysis Group 7500 Security Blvd Baltimore, Maryland
Dear Dr. Straub:
The Association for the Advancement of Wound Care (AAWC) is a multi-disciplinary wound care specialty organization of physicians, physical therapists, nurse practitioners, clinical nurse specialists, researchers and certified wound care experts. As the largest professional organization dedicated to the advancement of wound care, the AAWC respectfully submits our comments regarding the intent by the Centers for Medicare & Medicaid Services (CMS) to include biological therapy for wound care in future National Coverage Determinations (NCD).
As part of the topic biological therapy for wound care, the CMS specifically asked the question “Is the evidence for any specific modalities adequate to demonstrate improved health outcomes for selected wound patients while avoiding side effects seen with other growth hormones?”
Our comments are centered on the need for concern about side effects of biological therapy used in wound care treatment, and a better understanding of what products/devices are actually included by CMS in the category of ‘biological therapy’.
In the treatment of chronic and complex wounds, several modalities are currently available under the general umbrella of ‘biological therapy.’ • Exogenous growth factor PDGF-BB (Regranex® Gel, Johnson & Johnson • Autologous growth factors (multiple growth factors extracted from the patient’s own blood which is centrifuged and/or activated by reagents to produce a platelet rich gel (i.e. Autologel®, Cytomedix Inc., Thrombocyte Concentrate PRP, Curasan AG, etc.) • Bioengineered Skin Substitutes: o Human cell-based tissue: (e.g. Apligraf®, Organogenesis Inc., Dermagraft®, Advanced Biohealing) o Acellular-based tissue: (e.g. Integra®, Integra LifeSciences Corp., OASIS® Wound Matrix, Healthpoint, Graftjacket® Matrix, Wright Medical Technology)
We believe there is ample evidence for many of the specific modalities mentioned, to demonstrate improved health outcomes for specific wound types. This data has been evaluated by CMS on an ongoing basis. However, biological therapy based technology is evolving and warrants a diligent ongoing evaluation of the clinical evidence to support continued use.
To date, Bioengineered Skin Substitutes have been assessed for coverage by CMS under the Local Coverage Decisions process. These policies have been updated on a regular basis as new data becomes available. In addition, the policies are being reviewed as part of the ongoing transition of Fiscal Intermediaries and Carrier to Medicare Administrative Contractors (MACs). The human- based Bioengineered Skin Substitute products are developed from human foreskin cells and are tested for blood-borne viruses and abnormal cells as part of the manufacturing process. Since they are derived from normal physiologically functioning human cells, there is no expected risk that the growth factors released by these cells would pose a threat or side effects. The acellular Bioengineered Skin Substitutes products contain no human cells and do not in themselves release growth factors, hence it would not be expected they would likely produce abnormal side effects seen with other growth hormones.
Autologous growth factor therapy for wound care is derived from a person’s own blood and has been thoroughly evaluated by CMS as part of a national coverage determination process. To date, there has not been a national coverage determination issued. In the course of the research evaluations, CMS has not discussed in the non- coverage decision any data that suggests abnormal side effects produced by a person’s own platelet derived growth factors. It seems highly unlikely this would be expected.
We are aware of the recent FDA black label notice for PDGF-BB (Regranex®), a bioengineered growth factor that has been FDA approved and marketed since 1997. Many of our members have used this product for many years and have not reported any development of abnormal side effects seen with other growth hormones. In addition there were no safety issues in any of phase 1, 2 or 3 studies utilizing this product; however, this may be an area for further research. AAWC members are specialists in the care and treatment of complex wounds, many of which, even with the application of evidence-based best practice wound care, will not progress to healing. Our members use a wide variety of products, including biological treatments to assist these wounds to progress to closure. We value the evaluations CMS has conducted both at the Local Coverage Decision level and the National Coverage Determination level for biological therapies and rely on CMS decisions to ensure that safe and effective treatments are available to our Medicare patients.
AAWC would like to propose that CMS conduct an expert panel to more clearly address questions concerning biological treatments in wound care. AAWC would welcome the opportunity to call upon our membership and provide a variety of experts to participate with CMS to assist in identifying areas of concern, issues that warrant further research, and to collect any information that CMS might require Through our network of wound experts, who practice in various clinical settings, we can provide CMS with clinical evidence and real world practice data on thousands of patients treated with biological therapies from our members with clinical databanks.
The AAWC appreciates the opportunity to provide our comments and we look forward to working with the CMS to support your efforts related to biological treatments in wound care. Please feel free to contact me directly if you have any questions or concerns.
Sincerely,
William J. Ennis DO, MBA, FACOS President AAWC Professor of Clinical Surgery, Chief Section of Wound Healing and Tissue Repair, Division of Vascular Surgery. University of Illinois at Chicago
Peggy Dotson, AAWC Wound Care Specialty Executive Council, Regulatory Department
Scott LaRaus, PT, AAWC Wound Care Specialty Executive Council Co-chair Regulatory Department
|
| Commenter: |
Barry, MPH, MSN, RN, Kathryn
|
| Title: |
Health Policy Specialist |
| Organization: |
Stryker Spine |
| Date: |
9/26/2008 11:27:39 AM |
| Comment: |
RE: Artificial Cervical Discs
Artificial intervertebral disc arthroplasty for the treatment of degenerative disc disease of the cervical spine is expected to be an effective minimally invasive alternative for a select group of patients who are typically under the age of 65 years. On behalf of Stryker Spine, we would welcome the opportunity to share with CMS the results of our CerviCore IDE clinical trial once market clearance has been issued by FDA. This market clearance is not anticipated until 2011. Until that time, we would request that Medicare delay proceeding with a formal decision to open a National Coverage Determination for cervical artificial discs.
CerviCore’s clinical trial is designed to compare the safety and effectiveness of the CerviCore Intervertebral Disc to spinal fusion in the treatment of cervical radicular symptoms, such as upper extremity pain, and/or neurological deficit, associated with loss of disc height, disc/osteophyte complex, or herniated disc at a single level between C3 and C7. Surgical candidates eligible to enroll in the CerviCore IDE clinical trial must be between the ages of 18 and 65 years.
Since the vast majority of patients eligible for a cervical disc arthroplasty will not be Medicare beneficiaries, access by local carrier discretion should be preserved for select Medicare beneficiaries deemed candidates for disc replacement by their surgeons. Of note, numerous private payers, such as Aetna, Horizon-BCBS in New Jersey, BCBS-IL and BCBS-SC, have issued medical policies that consider cervical artificial disc replacement medically necessary for skeletally mature adults with cervical disc disease at one level from C3-C7; who have failed or been unresponsive to at least 6 weeks of conservative medical management, and have documented radiographic evidence of disc herniation. Without disc replacement, these patients would otherwise be surgical candidates for single-level cervical fusion. For appropriately selected patients of any age, cervical intervertebral disc artthroplasty is intended to restore the natural biomechanics of the intervertebral segment and reduce further degeneration of adjacent levels.
Until there is a full complement of cervical disc devices available to surgeons, along with sufficient time to publish long-term clinical outcomes in the peer-reviewed literature, pursuit of a national coverage determination at this time would be premature. In comparison to the number of procedures posed as potential NCD topics, cervical disc replacement is probably the least likely procedure offered to Medicare beneficiaries at this time. If offered to a Medicare beneficiary, local carrier discretion should be preserved in order to facilitate the surgeon’s treatment plan formulated solely upon the surgeon’s assessment of the patient’s disabling symptoms.
As CMS considers the continuum of care alternatives for patients with cervical degenerative disc disease, peer-to-peer discussions with key opinion leaders and clinical investigators involved in the CerviCore clinical trial are available by contacting me at Stryker Spine, 2 Pearl Court, Allendale, New Jersey 07401, phone (203) 271-3366. In advance, thank- you very much for your time and consideration.
|
| Commenter: |
Howard, Alonzo
|
| Title: |
member |
| Organization: |
Brotherhood of the Balloon |
| Date: |
9/26/2008 12:11:26 PM |
| Comment: |
[PHI Redacted] a recepient of Proton therapy for prostate
cancer in late [PHI Redacted]. [PHI Redacted]
completely cured with no after treatment or side
effects. On annual exam P.S.A.remains
consistent at prostate gland. Statistics show over 99% cure
rate. No other approaches for treating PC comes
close to this.
All other methods of treating prostate cancer
have higher percentages of failures. Many
require treatment for the rest of their lives,
some with eventual renal failure and death.
Before denying treatment for proton therapy
make a comparison of long term costs for care of
men with complications.
As for lack of proton treatment centers, there
are now five centers in operation, five more
centers in completion stage. There are ten
center in the planning stages all; in the U.S.A..
I urge careful consideration by CMS before
denying coverage for proton therapy for Prostate
Cancer. Sincerely , Alonzo E. Howard, D.V.M. |
| Commenter: |
Hartwell, Lori
|
| Title: |
Founder and President |
| Organization: |
Renal Support Network |
| Date: |
9/26/2008 12:34:41 PM |
| Comment: |
|
Re: COMMENT ON PROPOSED NATIONAL COVERAGE
DETERMINATION LANGUAGE ON ESAs
The Renal Support Network (RSN) is a nonprofit,
patient-focused, patient-run organization that
strives to help patients develop their personal
coping skills, special talents, and employability
by educating and empowering them, as well as
their family members, to take control of the
course and management of the disease.
I am writing to you as the President and Founder
of the Renal Support Network [PHI Redacted], Specifically, I would like to
provide the patient’s perspective on the
following statement on erythropoiesis stimulating
agents (ESAs) that is proposed in the national
coverage language:
Proposed: ESAs have known serious adverse effects
in patients who have cancer or pre dialysis
chronic kidney disease (CKD). Their long term
benefits and harms in the ESRD population are
unclear. ESAs are a large cost in current ESRD
treatment strategies.
The Renal Support Network respectively contests
the statement that the long-term benefits of ESA
therapy are unclear. To the contrary, as patients
who live with CKD we believe that the clinical
literature as well as our own personal
experiences refutes this proclamation. Let me
begin by discussing how ESA therapy has
demonstrated a long-term patient benefit in
reducing or eliminating blood transfusions for
the vast majority of patients with Stage 5 CKD
who are on dialysis.
Prior to the development of ESA’s, patients with
CKD who were on dialysis often had extremely low
hemoglobin levels and required constant blood
transfusions. A wide range of significant and
potentially serious side effects accompanies
blood transfusions, including iron overload and
infection. People seem to forget that, when blood
transfusions were widely used before the
introduction of ESAs, iron levels would often be
so high that clinicians were forced to
phlebotomize (bleed) patients to drain off excess
iron. Transfusions also cause a tremendous drain
on the patient due to many factors, such as: (a)
the constant variability (up and down changes) in
hemoglobin that occurs between blood transfusions
(negatively affecting patient quality of life),
(b) the need for extra visits to a doctor’s
office or clinic to receive a blood transfusion
(negatively affecting patient quality of life),
and (c) the need to actually suffer through the
transfusion process (trust me, not a pleasant
experience and negatively affecting patient
quality of life). Blood transfusions are like
playing Russian roulette with our health. Some
patients experience only the less serious side
effects from transfusions, such as fever and
chills or an allergic reaction, such as hives.
However, others have much more serious reactions
to transfusions that can have a significant and
long lasting impact on their health, and even
increase their risk for mortality.
In addition, blood transfusions can severely
affect a patient’s ability to receive a kidney
transplant. The reactive antibodies received from
blood transfusions result in fewer potential
kidney matches from donors. I would like to share
a representative example from a woman who shared
her experience with me. This woman had CKD since
she was a small child, and received a number of
blood transfusions before ESAs were available.
Although she had not received blood transfusions
in some time, the effect of those transfusions
continued to haunt her, and as recently as a few
months ago she had a reactive antibody percentage
level of 81. As a result, the number of potential
kidney donors with which she was a compatible
match was severely limited. The transplant team
at her center was not confident that she would
ever find a match within her region. As a result,
they encouraged her to multi-list at other
centers to increase the pool of potential donors.
However, she did not have the economic resources
or the knowledge to work the system and give
herself a better chance for finding a compatible
kidney. Although she was doing her best, she
confronted an interminable wait for a matched
kidney. Sadly, this woman’s condition continued
to deteriorate, and she recently died before
being able to receive a compatible kidney
transplant. There are thousands of other
disadvantaged individuals like her across the
country who do not have the economic resources to
travel around the country and increase their odds
of finding a suitable kidney for transplantation.
For almost two decades we have enjoyed a
significant decrease in the need for blood
transfusions due to the benefits that ESAs
provide in increasing hemoglobin levels. The RSN
is concerned that any change in the policy on how
ESAs should be used—and especially a statement
discounting all benefits—will result in a
dramatic increase in the number of patients with
low hemoglobin levels, and a consequential
increase in the need for blood transfusions. We
believe that any increase in the need for blood
transfusions will significantly increase the
percent of patients who experience the
debilitating symptoms of anemia; increase the
number of patients who will have difficulty
receiving a matched kidney transplant (especially
among economically disadvantaged patients); and
represent a severe setback in the care of
patients with CKD.
One final point on transfusions: Although our
organization’s focus is on patient’s with CKD, we
also believe you should consider how the
erroneous statement that there are no clear
benefits of ESA therapy could negatively affect
not only our patient population, but also the
country’s blood supply. Before ESAs were
available patients on dialysis used a significant
percentage of the nation’s blood supply. Over the
intervening years, the number of patients on
dialysis has more than tripled, and the
population is projected to continue to grow in
the future. As part of the evaluation CMS should
consider how a return to the pre-ESA days of
constant blood transfusions may challenge the
country’s already overtaxed blood supply,
including the availability of blood for patients
with critical emergencies.
The second benefit of ESA therapy that we would
like to address is how these medications have
benefited the quality of life for patients with
CKD. We realize that there are not many double-
blind studies that have addressed this issue.
Further, no such studies are likely to be
conducted since it would be unethical to withhold
ESA treatment from patients just to see how they
feel with or without therapy. In this case, we
believe that common sense should prevail. There
are thousands of reports from patients who have
stated that their quality of life improves
dramatically following use of ESAs. We strongly
believe that if you ask people who had CKD before
the availability of ESAs to self-report on
whether ESAs have positively affected their
quality of life you would hear a resounding—YES.
Many people who have CKD can relate experiences
of how anemia has affected them personally.
Symptoms may include chest pain, feeling cold,
feeling tired, low energy levels even doing
routine activities of daily living, poor
appetite, shortness of breath, depression, a poor
sense of well-being, and an inability to work,
manage a home, or volunteer –in short, loss of a
meaningful life.
[PHI Redacted]
I believe that my experience is very
representative of the patient community, as
evidenced by the following quotes from Renal
Support Network members:
“When I was first diagnosed I had to have blood
transfusions every month in order to fight
anemia. ESA’s did not exist at this time. The
introduction of EPO had a huge impact on my life.
It improved my energy level, which allowed me to
get back to living life instead of just
surviving. I was healthier, more productive, and
much happier. I was able to complete college,
work full time and enjoy life.” [PHI Redacted]
“Why is quality of life important? Think of a
time when you were very sick, maybe with the flu.
Your body was weak, and you didn’t have much
energy. Would you like to live your whole life
feeling like that, or worse? That’s what it feels
like to have a low hemoglobin level. You’re
frustrated because you don’t have energy to do
the things you want to do. When quality of life
decreases, physical and emotional health
decreases as well.” [PHI Redacted]d
“When I was anemic, I could barely get out of bed
and walk to the bathroom. One time I passed out
in the bathroom. Quality of life is simply being
able to walk without the fear of passing out.”
[PHI Redacted]
“When I am anemic, I can’t walk as far as the
mailbox, grocery shop, do much housework or find
the energy to go to work.” [PHI Redacted]
“When EPO wasn’t available, I spent most of my
days in bed or on the couch. If it was a school
day, I had to push myself to go to classes and to
do my dialysis exchanges. Once I started on EPO,
I was able to get to class and was no longer
lethargic. I was able to do my dialysis without
any help.” [PHI Redacted]
“My quality of life was greatly impacted when I
was anemic. I could barely walk from one side of
the house to the other without sitting down
because I was out of breath. I went to school
during this time but my husband had to drop me
off because I did not have the energy to walk
from the parking lot to the classroom without the
fear of passing out.” [PHI Redacted]
“I have been a patient for over thirty-five years
and during my first blood transfusion, I
contracted Hepatitis C.” [PHI Redacted]e
“Being anemic impacts my livelihood. My job
involves numbers and when I am anemic, I cannot
concentrate. If you don’t have a job, it
definitely impacts your quality of life!” [PHI Redacted]
“Before ESAs and mostly because of anemia, my
husband's legs would jerk uncontrollably during
sleep, the friction actually causing holes in the
bed sheets. He also woke up numerous times each
night. Frequently he would comment, 'A good
night's sleep! It's been so long, I don't
remember what that feels like.” [PHI Redacted]
We believe that these brief quotes are
representative of hundreds of thousands of
patients with CKD who currently enjoy the quality
of life benefits provided by higher hemoglobin
levels subsequent to ESA therapy. When drafting
your policy, please recall that patients visit
doctors out of what they sense about themselves
(i.e. “how we feel”). We simply have no other way
to communicate. The goal is to preserve or regain
our quality of life. Quality of life is centered
on the foundation of hope and the belief that
life is still worth living. To not consider
quality of life as a major goal in managing
anemia is the same as simply ignoring the needs
of patients.
RSN is deeply concerned that patients will suffer
tremendously if the draft statement on use of
ESAs is not altered to more accurately reflect
the potential benefits of therapy. As currently
worded, the draft statement may inadvertently
lead to insurance providers limiting or
eliminating coverage for ESA therapy. This
concern is accentuated by the severe decrease in
ESA use that has resulted from the recent
National Coverage Decision for oncology.
Unlike patients with cancer, patients with CKD
are permanently affected by anemia, and we have
experienced first hand the devastating effects of
a punitive reimbursement policy for ESAs. When
reimbursement policies are not well thought out
and tested, it is the patient who suffers. To
avoid such a scenario, the Renal Support Network
supports the 2006 Centers for Medicare and
Medicaid Services Anemia Management Policy, which
follows recommendations found in both the
prescribing information and the guidelines of the
National Kidney Foundation’s Kidney Disease
Outcomes Quality Initiative (KDOQI™). This policy
allows physicians to order an ESA dose to achieve
a target hemoglobin between 10 and 12 g/dL. The
policy correctly acknowledges that there are
considerable differences in how different
patients respond to ESAs, and contains provisions
for appropriate dose adjustments based on
hemoglobin levels.
This policy is unique in that it has melded
current science with reimbursement policies,
thereby encouraging clinicians to gradually
reduce ESA doses rather than holding doses or
reducing doses dramatically. This prevents the
patients’ hemoglobin levels from plummeting,
which has been associated with poorer outcomes
and may increase the need for blood transfusions.
This is consistent with CMS’s policy of patient-
centered care, for which patients are grateful—
CKD treatment is not an exact science, and CMS
has demonstrated an understanding of the fact
that there is a delicate balance between research
and clinical practice.
We would like to emphasize that we are not
downplaying the safety concerns highlighted by
clinical trials that have been published on the
use of ESAs. However, all drugs carry risks and
patients deal with these risks everyday in every
facet of medicine. We are reminded of the risks
of taking medication every time we see or hear a
commercial on TV, or talk with our health care
team. There are still a lot of questions about
anemia management and the effect of ESA therapy,
and more studies need to be conducted to clarify
these issues. However, patients are also acutely
aware that the potential risks associated with
drug therapy need to be weighed against the
benefits. I would like to reiterate that anemia
is one of the most devastating conditions that
affect those of us who have CKD. As a result, we
recommend that physicians should retain the
ability to individualize ESA therapy in response
to an individual patient’s needs. If these
therapies are restricted, and the patient is
consequentially forced to lead a lower quality of
life, one wonders why that patient is being kept
alive in the first place! It is existing, not
living.
Finally, the Renal Support Network acknowledges
the portion of the draft statement that addresses
the expense of ESA therapy, and recognizes the
need to conserve healthcare resources whenever
possible. However, we urge CMS to review the
patient holistically, and not just the cost of a
single medication. When viewed from this
perspective, we believe that the benefits of ESA
therapy are clear. We respectfully request that
any policy change does not unintentionally lead
to decreased patient access to medications that
are crucial to our quality of life.
Thank you again for considering the patients’
perspective. Please feel free to contact me at
any time if you would like assistance in
developing the final policy from patients who
have experienced anemia firsthand |
| Commenter: |
Hopkins, Dawn
|
| Title: |
Director of Reimbursement & Health Policy |
| Organization: |
Society of Interventional Radiology |
| Date: |
9/26/2008 12:35:30 PM |
| Comment: |
Comments from the Society of Interventional Radiology (SIR)
RE: Potential NCD Topics Vertebroplasty/Kyphoplasty and Peripheral Arterial Stenting and Vascular Intervention
SIR does not find that the topics Vertebroplasty/Kyphoplasty and Peripheral Arterial Stenting and Vascular Intervention meet the criteria identified for development of National Coverage Determinations (NCDs). These fairly well-established procedures are well supported by a body of scientific evidence that continues to slowly and steadily evolve, which is typical for procedures for which efficacy has been previously established. The greater weight of the current available literature, and the personal experience of those performing these procedures, clearly supports that patients are benefiting from these procedures and that they currently have reasonable access to them.
SIR finds that local and commercial coverage policies addressing Peripheral Arterial Stenting and Vascular Intervention are fairly consistent and we have not received any complaints from patients or providers regarding coverage for these services within the last seven years. For Vertebroplasty/Kyphoplasty, SIR finds that, with the exception of a minority of the commercial BlueShield carriers, every other major insurance carrier (that make their coverage policies available to the public) including Aetna, CIGNA, Humana, United Healthcare and the vast majority of Medicare carriers have policies that support coverage for these services.
SIR is aware that there have been measurable increases in utilization of peripheral arterial stenting and vascular interventions. However, for the most part, the increases in the utilization of endovascular therapies are believed to be fairly proportionate to the decreases in alternative open surgical therapies. Additionally, the advances in the application of endovascular therapies is commonly supported by better disease detection, a significant increase in the number of providers with the necessary skills to treat patients with complex disease and enhanced devices that enable the treatment of vessels that were previously inaccessible from an endovascular approach.
SIR finds that engagement in the NCD process requires a significant commitment of societal resources, SIR urges CMS to use prudence in initiating these activities.
|
| Commenter: |
Miller, Amy
|
| Title: |
Public Policy Director |
| Organization: |
Personalized Medicine Coalition |
| Date: |
9/26/2008 12:37:51 PM |
| Comment: |
To: Centers for Medicare and Medicaid Services Re: Potential National Coverage Determinations Date: September 26, 2008 Submitted electronically
The Personalized Medicine Coalition is writing to comment on the list of Potential National Coverage Determinations (NCDs) released by the Centers for Medicare and Medicaid Services (CMS) on July 30, 2008. This letter focuses on gene expression profiling tests and pharmacogenomic testing, as both of these technologies are elements of personalized medicine. Representing a broad spectrum of academic, industrial, patient, provider and payer communities, the Personalized Medicine Coalition seeks to advance the understanding and adoption of personalized medicine concepts and products for the benefit of patients.
We are pleased that CMS is engaging the healthcare community in conversation about its activities and urge CMS to maintain and expand this dialog. Steps to promote transparency and predictability in CMS’ national coverage process are important for the companies engaged in the field of personalized medicine, many of which are small start-ups. For some, it is unclear how CMS makes NCDs for personalized medicine products. The request for public comment on potential NCDs is an excellent demonstration of that process and should serve as a means for improving the dialog between CMS and the stakeholder groups in personalized medicine. It also indicates the willingness of CMS to take a leadership role in personalized medicine.
Gene expression profiling tests and pharmacogenomic testing offer great promise for changing clinical decision making, improving health outcomes and increasing the quality of patient care. However, as this is an emerging industry, a negative NCD could have the unintended consequence of stifling further adoption and development of these important tools and restrict patient access to new diagnostic options. That can be avoided if a transparent, measured approach is taken.
To improve transparency and predictability, CMS should specify how it will decide whether to initiate national coverage analyses for items on the potential NCD list, and should make clear that it will update the list on a regular basis. Maintaining a current list, and providing an explanation for the decision to initiate a NCD or remove an item from the list, are important for product innovators; merely being placed on the potential NCD list could have the unintended consequence of creating a negative impression about a particular product in the clinical, policy or investment communities.
Should CMS proceed with NCDs for pharmacogenomic testing or gene expression profiling tests, we suggest it conduct a Coverage with Evidence Development (CED) of the Coverage with Study Participation (CSP) subtype as outlined in the Innovators’ Guide to Navigating CMS. We recommend that CMS work with stakeholders to create a process that is sufficient to develop evidence, does not stifle patient access or innovation, and is not overly burdensome. Our reasoning is outlined below.
For some new medical technologies related to personalized medicine [such as new medicines subject to review by the Food and Drug Administration (FDA) and approval based on data from randomized controlled trials] CMS coverage determinations are straightforward, as evidence developed in support of FDA approval provides a sufficient basis for Medicare coverage. For other personalized medicine technologies, however, the different approaches taken by the FDA and CMS in their evaluation of the evidence to cover the cost of the test for patients pose significant challenges to bringing products to market. For personalized medicine to advance and improve the quality of patient care and for innovative companies to continue to assume risks necessary to develop personalized medicine products, decision-making procedures and evidence standards must be clear at each stop along the regulatory/reimbursement continuum, including that required by CMS. To improve clarity about the evidence CMS will require for coverage of gene expression profiling testing and pharmacogenomic tests, we request that the agency meet with members of the PMC to define appropriate evidence requirements and reasonable pathways for developing the evidence.
The recent NCD for warfarin pharmacogenomics provides a useful perspective for this discussion. Review of public comments indicates that there is no consensus of opinion regarding the value of pharmacogenomic testing for initial warfarin dosing. Some respondents believe that the additional information provided by pharmacogenomic testing is valuable, improves the quality of patient care, and may save the system costs incurred by avoiding serious adverse events and reducing the time and repeated testing necessary to reach a stable dose. They cite research to support their arguments. Others argue that the evidence does not show improved patient outcomes and suggest that CMS await the findings of randomized clinical trials (RCTs) before making an NCD on warfarin testing.
However, RCTs may not be the appropriate study design for pharmacogenomics and gene expression profile testing. Evidence of clinical utility requires understanding how new technologies affect health outcomes; research participants are followed for some time, and long-term follow-up may be required. This poses a challenge for molecular diagnostic companies because the understanding of molecular genetics is developing rapidly. Scientific progress in this field is such that, by the time the results of an RCT are available, the diagnostic in question may have gone through several generations of improvements. For example, by adding an additional genetic biomarker, the newer version of a test may account for significantly more of an outcome’s variance. That is not to say that any assessment of the clinical utility or medical necessity of a test is rendered invalid by subsequent technological advancements, but to point out that delays in the issuance of coverage decisions can keep valuable state-of-the-art clinical tools out of the hands of clinicians longer than may be necessary. Once a coverage determination is made, it is important to update the NCD quickly to keep pace with emerging data.
High quality clinical evidence for new diagnostic tests is frequently available through other study methodologies in addition to RCTs. The PMC would like to work with CMS on alternatives to RCTs for evidence development. Such alternative approaches could include patient registries, observation studies, and adaptive clinical trials. Furthermore, PMC would like to work with CMS on developing a system for rating the quality of evidence when making coverage determinations for molecular diagnostics.
Regardless of what type of system for evidence development is designed, it is clear that the regulatory system for product approval and the regulatory system for CMS payment are not designed to be aligned. However, clarification of evidence requirements could help facilitate the development and adoption of personalized medicine. For example, FDA examined the evidence that genotyping for VKORC1 and CYP2C9 provides additional information that is helpful for initial warfarin dosing, and recommends testing for these metabolism and sensitivity genotypes, although information on how to use test results to modify treatment is not provided. Following the re-labeling of warfarin, a number of companies asked for and were granted FDA clearance for tests that quickly measure relevant biomarkers. In the recent CMS posting of the NCD regarding this testing, CMS indicated that it was “concerned by the paucity of evidence available to determine what effect on overall health outcomes, if any, can be confidently attributed to treatment strategies that include pharmacogenomic testing in the determination of dosing.”
PMC would like to hold a joint forum with CMS to further explore the issues outlined in this letter. We propose convening a workshop that would: examine systems for evidence evaluation for coverage determinations by both public and private payers and discuss the appropriateness of the various evidence evaluation systems for personalized medicine. Such a dialog would allow CMS to develop a system for coverage decisions that would keep pace with the development of personalized medicine products. Stakeholders could give their perspectives and work with CMS on possible solutions to the evidence barrier surrounding coverage decisions for pharmacogenomics and gene expression profiling tests. Such a forum may reveal more appropriate evidence models for personalized medicine products and could be used to develop a rating system to determine the quality of evidence regarding them. Such a discussion should include a plan for developing evidence that is not overly burdensome for any one stakeholder.
We offer these comments as a starting point for a dialog between CMS and PMC, an organization that represents key stakeholders in personalized medicine. A favorable NCD on pharmacogenomics or gene expression profiling will support timely adoption of evidence-based personalized medicine technologies, while a negative decision may restrict patient access and stifle innovation in personalized medicine. As there is no established path for personalized medicine products at CMS, we urge CMS to work with PMC to develop one. By working with stakeholders, CMS will be able to develop a uniform system that fairly evaluates personalized medicine products.
Personalized medicine promises to improve the quality of patient care, yet it does not fit within the traditional health care system and currently faces significant barriers to adoption. This letter has addressed only one such barrier. PMC member organizations are committed to addressing barriers and finding solutions to them. We look forward to working with CMS and can be contacted at 202-589-1770 or amiller@personalizedmedicinecoaltion.org.
Sincerely,
Amy Miller, PhD Public Policy Director
Personalized Medicine Coalition 1225 New York Ave. NW, Suite 450 Washington, DC 20005
|
| Commenter: |
Lynch, Ann-Marie
|
| Title: |
Exec., V.P. Payment and Health Care DeliveryPolicy |
| Organization: |
Advanced Medical Technology Association (AdvaMed) |
| Date: |
9/26/2008 12:49:08 PM |
| Comment: |
September 26, 2008
Steve E. Phurrough, MD, MPA Director, Coverage and Analysis Group Centers for Medicare and Medicaid Services U.S. Department of Health & Human Services Mail Stop C1-09-06 7500 Security Boulevard Baltimore, Maryland 21244-1850
Re: CMS Posting of Potential NCD Topics
Dear Dr. Phurrough:
The Advanced Medical Technology Association (AdvaMed) welcomes the opportunity to provide comments on the July 30, 2008 posting by the Centers for Medicare and Medicaid Services (CMS) of a list of “Potential NCD Topics” (the “Potential NCD Topics list”), which is identified as being a “Topic List for Third Quarter 20008.”
As you know, AdvaMed has a longstanding interest in Medicare’s national coverage determination (NCD) process and has provided comments in the past on various CMS guidance documents, issuances, and developments related to both coverage and evidence issues. In general, AdvaMed has encouraged and supported the agency’s efforts to increase transparency and openness in the NCD process. We see the CMS Potential NCD Topics list as consistent with this approach. We understand that this list has been discussed by CMS representatives for some time, and was specifically mentioned in the CMS guidance document on “Factors CMS Considers in Opening a National Coverage Determination,” dated April 11, 2006 (hereinafter the “Guidance Document”). Accordingly, AdvaMed members have an appreciation of the overall interest CMS has in identifying potential NCD topics.
In discussions we have held with AdvaMed members, we have found that the Potential NCD Topics list does raise a number of questions that we have provided in an attachment to this letter. These questions and comments are grouped into the following three areas: (I) the process questions related to the generation of this list and future lists; (II) the topics placed on this list, as well as the rationales for including them on the list; and (III) the relationship of the proposed NCD topics list to other CMS initiatives. We look forward to working with you to address these questions.
AdvaMed appreciates your ongoing willingness to discuss Medicare coverage and evidence issues with industry. As you go forward with future iterations of the proposed NCD topics list, AdvaMed would welcome the opportunity to meet with you (via conference call, if necessary, and at your convenience) to discuss these, and any other issues. Should you or your staff have any questions, please contact me or Teresa Lee (tlee@advamed.org or 202/434-7219).
Sincerely,
Ann-Marie Lynch
Cc: Barry Straube
Attachment
Attachment
Questions and Comments on the “Potential NCD Topics” List
I. Process
The following are process questions that AdvaMed members would like to have clarified related to the Potential NCD Topics list:
• The posted list of potential NCD topics is referred to as the “Topic List for Third Quarter 2008.” The Guidance Document also mentions a “quarterly” timeframe. Does CMS plan to post a similar list for each calendar quarter? • Will all internally-generated NCD topics be posted on this Potential NCD Topics list prior to initiation of an NCD? • Will the initial July 30, 2008 Potential NCD Topics list be trimmed, or topics refined, in light of public comments? • CMS has posted comments that have been made on this posting of the Potential NCD Topics list. Will CMS provide any responses to these comments? What will the commenter and/or the public hear back from CMS? • Will the public learn the disposition of each topic after CMS considers all comments? • If a topic is taken off the Potential NCD Topics list, and if an NCD is not internally generated by CMS, does this indicate that CMS is no longer interested in opening an NCD on the topic? • If a topic is kept on the list, even after CMS considers comments, will the new list be prioritized in any way, and, if so, based on what criteria? • Will time periods be specified regarding when CMS intends to initiate an NCD for the topics remaining on the list? • CMS has already internally generated at least one NCD request for a topic that is on the currently-posted list. It seems contradictory to post an item as a “potential” NCD topic, while simultaneously making it a current NCD topic. We urge CMS to consider not internally generating NCDs on topics that appear on the Potential NCD Topics list during the designated comment period for the list.
II. Topics and Rationales
• The scope of several topics on the list is unclear. Will CMS clarify the scope of a topic and the rationale for that scope of interest in its postings? • CMS states that the “circumstances” specified in the Guidance Document regarding what prompts CMS to internally generate an NCD request are the factors that CMS used to vet the potential NCD topics. Will CMS identify which of these circumstances or factors was responsible for the inclusion of each topic on the list? We believe that transparency as to the concerns or factors that exist regarding a particular topic will enable more informed comments on those topics. • If a topic has appeared on the Proposed NCD Topics list as a result of an external request, will CMS make public who the requester was? • Did the 731 Advisory Group have a role in presenting topics for inclusion on the list? If so, who are the members of the Advisory group? What were the results of its deliberations?
III. Relationship to Other CMS Initiatives
As you know, AdvaMed has provided comments on the CMS efforts to develop “Medicare Evidence Priorities.” Our members have taken a keen interest in both of the Medicare Evidence Development and Coverage Advisory Committee meetings that have taken place over the last year on this topic.
• Does the Potential NCD Topics list relate in any way to the “Medicare Evidence Priorities” list posted on the CMS website? If so, how are they related? • Is CMS contemplating any additional changes to the local coverage determination process in relation to the NCD process or the Medicare evidence priorities list?
|
| Commenter: |
Stoneback, Allen
|
| Title: |
retired |
| Date: |
9/26/2008 12:58:12 PM |
| Comment: |
The reimbursement of proton therapy for prostate
cancer must continue. [PHI Redacted] currently receiving
this treatment. [PHI Redacted] made the decision to have
this treatment after reading the "numerous"
testimonials from men who were treated with
proton beam radiation at Loma Linda MC over the
past 10 years. [PHI Redacted] also talked to friends that had
received the tradition radiation or had
undergone the radical surgery. [PHI Redacted] decided that
the traditional radiation, surgery and/or
hormone therapy were not for [PHI Redacted]. This decision
was due to the reports of the pain and suffering
experienced by the surgery and the many reports
of the unpleasant side effects from all of the
above. All afffecting the quality of life of
these men.
I am thankful that this treatment is available
for prostate cancer...no one wants to take the
risk of being incontinent or having a colostomy
if there is a treatment that virtually avoids
these hazzards. I also believe in the long run
that Proton Beam treatment will prove less
costly by avoiding these hazzards. [PHI Redacted] the experience [PHI Redacted] has been that the
surgeons all recommend surgery and the
radioligists all recommend conventional
radiation and very few know or admit knowledge
of the "success and benefits" of proton beam
radiation. Could it be because of the negative
economic impact this referral would have on
their own practice?
This treatment would not be afforable for [PHI Redacted]
many other seniors if medicare did not cover
most of the cost. Surgery and IMRT or GMRT
would not be affordable for many of us either if
medicare did not assist in the coverage. After
paying into the system all of their working
years men should have the option to choose the
type of treatment available for their disease.
They should not be forced to settle for less
than proton when the alternatives would
adversely affect their quality of life. |
| Commenter: |
Rozynski, Edward
|
| Title: |
Vice President, Global Government Affairs |
| Organization: |
Stryker |
| Date: |
9/26/2008 1:10:31 PM |
| Comment: |
Re: Hip Resurfacing – Potential NCD Topics
Dear Doctor Phurrough:
On behalf of Stryker Corporation (“Stryker”), our physician and hospital customers, and their patients, we thank you for this opportunity to comment on CMS’ recently published list of potential National Coverage Determination (“NCD”) topics. By way of background, Stryker is a global leader in medical technology that consistently delivers exceptional results. Stryker is committed to bringing the best possible solutions to patients, providers, and Medicare. This philosophy has placed Stryker at the forefront of medicine’s most promising breakthroughs in joint replacements, trauma, spine, and orthobiologics among other products and procedures.
This letter will focus on the inclusion of total hip resurfacing on the list of possible NCD topics. We are preparing additional comments on other procedures included on CMS’s list, which we will submit separately. We do not believe an NCD is appropriate for this procedure total hip resurfacing because –
The clinical benefits associated with total hip resurfacing are well-established;
Surgeons and the payer community are in agreement on the patient selection/indications for total hip resurfacing; and
Coverage decisions for total hip resurfacing are consistent, positive, and non- controversial.
However, if CMS does select total hip resurfacing for review, we urge the Coverage and Analysis Group to issue a positive decision that ensures patients will continue to have access to this important procedure.
I. Cormet Hip Resurfacing System
Stryker’s Cormet total hip resurfacing system is an FDA-approved device intended for -
Resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function skeletally mature patients having the following conditions:
(1) non-inflammatory degenerative arthritic such as osteoarthritis and avascular necrosis;
(2) inflammatory arthritis such a rheumatoid arthritis.
Additionally, “the Cormet Hip System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.” (FDA PreMarket Approval Letter dated July 3, 2007.)
The Cormet Hip System is one of only two FDA- approved total hip resurfacing on the market. Although there are legitimate questions about total hip resurfacing devices that lack FDA approval, there is considerable clinical evidence of safety and effectiveness for the FDA-approved total hip resurfacing devices.
For example, the results of several multi-center trials involving hundreds of total hip resurfacing patients have been published in the past several years. These articles document that the clinical benefits (e.g., bone conservation, return of normal functionality and normal kinematics) have held up to the test of time. Researchers/surgeons have published follow up results for many patients extending more than five years (see C.B. Hing, The Results of Primary Birmingham Hip Resurfacing at a Mean of Five Years – Independent Prospective Review of the First 230 Hips, J Bone Joint Surg 2007; 89-B (attached))
For your convenience, we have also attached a few additional scientific articles that describe total hip resurfacing and its benefits, including A. Shimmin, P. Beaule, and P. Campbell, Current Concepts Review: Metal-on-Metal Hip Resurfacing, J Bone Jont Surg Am. 2008; 90: 637-654.
In addition, there are well defined inclusion and exclusion criteria for this procedure. As noted in the FDA approval, numerous positive coverage policies, a positive Blue Cross Blue Shield Technology Assessment (see attached), a positive National Institute for Health and Clinical Excellence (NICE) review, and peer-reviewed clinical articles, total hip resurfacing is indicated for active adults in whom additional surgery may be required within their lifetime based upon their age, activity level and other factors. In fact, in reviewing the request for ICD-9 codes for total hip resurfacing, medical officers at CMS working in conjunction with the ICD-9 Coding Committee noted the following
Hip resurfacing is intended as a primary joint replacement for patients who are at risk of requiring more than one hip joint replacement over their lifetimes. Factors that increase the risk of revision surgery include younger age and/or a high activity level. Hip resurfacing can delay total hip replacement and potentially eliminate the need for a revision. Evidence suggests that it will become the procedure of choice for patients who wish to maintain a relatively active lifestyle.
The Summary went on to say
The all patient 5 year survivorship was 98.4%. Comparable survivorship is seen in patients 65 years of age and older. See March 23 ICD-9 Coordination and Maintenance Committee Summary attached.
A. Conventional Hip Replacement
In a conventional hip replacement, the ball and the socket are replaced. The ball at the top of the thigh bone (femur) is removed to allow a stemmed component to be placed in the marrow cavity of the thigh bone. The stemmed component has a ball applied to the top. The ball articulates with the socket (acetabulum) that is fitted into the pelvis (see image below).
In total hip resurfacing operations, only the diseased or damaged surfaces of the head of the femur are shaved, and the femoral head is fitted with a spherical shell and the hip socked is lined with a spherical cup.
B. Total Hip Resurfacing
Like hip replacement, the objective with total hip resurfacing is to eliminate pain for the osteoarthritic patient by removing the damaged cartilage in the hip joint. However, total hip resurfacing differs from hip replacement in that total hip resurfacing conserves the proximal femoral bone.
Total hip resurfacing does not involve the removal of the femoral head and neck nor removal of bone from the femur. Rather, the head, neck and femur bone are preserved in an effort to facilitate future surgery should it be necessary and to enable the patient to take advantage of newer technology or treatments in the future.
Total hip resurfacing is anatomically and biomechanically more similar to the natural hip joint, resulting in the potential for increased stability, flexibility and range of motion. Further, the potential for dislocation is virtually eliminated, and higher activity levels are typically achieved with less risk than with a total hip replacement should a revision ever be necessary. These benefits are realized because the head diameter that results from resurfacing is very similar to the patient’s normal head diameter and these larger head sizes are typically much larger than the femoral balls utilized in conventional total hip replacement.
Accordingly, total hip resurfacing allows patients to preserve their current active lifestyle, facilitates future surgery, and enables the patient to take advantage of newer technology or treatments in the future.
Total hip resurfacing, however, is typically not appropriate for:
• Patients with a family history of severe osteoporosis, or severe osteopenia;
• Patients with active or suspected infection in or around the hip joint;
• Patients who are skeletally immature or with bone stock inadequate to support the device;
• Patients with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery;
• Patients with known moderate or severe renal insufficiency;
• Patients who are immunosuppressed with diseases such as AIDS or persons receiving high doses of corticosteroids;
• Patients who are severely overweight;
• Patients with known or suspected metal sensitivity (e.g., jewelry).
Total hip resurfacing should also not be performed with devices that are not FDA-approved.
II. Recommendations
Because there is no controversy about the effectiveness of total hip resurfacing, the safety of total hip resurfacing, the usefulness of total hip resurfacing, or the selection criteria for total hip resurfacing, we do not see a compelling reason for CMS to use limited time and resources to generate a national coverage decision at this time.
However, if the agency determines that there is a benefit to establishing a national coverage determination, we are confident that total hip resurfacing meets and exceeds all criteria for a positive decision. When performed with FDA approved devices, total hip resurfacing is an important treatment option for adults who would like to maintain an active lifestyle but presently suffer from hip damage.
If you have any questions, please do not hesitate to contact me.
Sincerely,
Ed Rozynski
Attachments:
1. March 23 ICD-9 Coordination and Maintenance Committee Summary 2. BCBSA TEC – Metal-on-Metal Hip Resurfacing
3. Selected clinical literature:
Results of Primary Birmingham Hip Resurfacing at a Mean of Five Years – Independent Prospective Review of the First 230 Hips, J Bone Joint Surg 2007; 89-B
Current Concepts Review: Metal-on-Metal Hip Resurfacing, J Bone Joint Surg Am. 2008; 90: 637- 654 |
| Commenter: |
John, Roy
|
| Title: |
MD |
| Organization: |
Brigham and Women''s Hospital, Boston |
| Date: |
9/26/2008 1:24:21 PM |
| Comment: |
I am writing in relation to the procedure of ablation for atrial fibrillation. Atrial fibrillation is a common problem requiring frequent hospitalization, sick time off work, and requirement for potentially dangerous antiarrhythmic drugs. In a significant proportion of patients, especially the markedly symptomatic patients with paroxysmal atrial fibrillation, the arrhythmia originates from the pulmonary veins. Electrical isolation of the veins by using radiofrequency ablation is effective in the prevention of atrial fibrillation in the majority (>70%) of patients. Some patients may require a repeat procedure for complete isolation of the veins but often result in dramatic responses and symptomatic relief from atrial fibrillation.
Antiarrhythmic drugs has generally been disappointing in the treatment of atrial fibrillation. It requires that patients take drugs for unforseen periods of time and eventually the arrhythmia breaks through drug therapy anyways. Hence, a potentially curative procedure such as ablation has tremendous value.
I would therefore urge the continued support for the development and use of ablations for atrial fibrillation. In its present form, it is effective in preventing recurrent arrhythmias in about 80% of patients with paroxysmal atrial fibrillation and 70% of patients with persistent atrial fibrillation.
Thanking you |
| Commenter: |
Emch, Hansjuerg
|
| Title: |
President |
| Organization: |
Synthes Spine |
| Date: |
9/26/2008 2:20:53 PM |
| Comment: |
Kerry Weems Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services 7500 Security Boulevard Baltimore, MD 21244 September 26, 2008
Re: Potential NCD List Published July 30
Dear Mr. Weems:
One of the most critical tasks facing the Centers for Medicare & Medicaid Services (CMS) is determining appropriate coverage of item and services under Medicare. The process for making national coverage determinations (NCDs) thoughtfully weighs the available clinical evidence and provides important opportunities for public input. As a leading global medical device company, Synthes Spine shares CMS’ commitment to thorough evaluation of clinical data. We rely on such data to develop safe, innovative, effective products that ensure reliable surgical procedures facilitating rapid recovery with optimal clinical results post surgery. Through our commitment to research and development, we bring innovative products to market responsibly and with careful deliberation. We recognize that CMS must exercise similar deliberation in determining Medicare coverage policies.
Synthes Spine commends CMS for this openness by requesting public comment on potential topics for future NCDs.
Synthes Spine develops, produces, and markets instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the skeleton and its soft tissues. Therefore, our comments will focus on three potential NCD topics that treat spinal disease and injury.
We recommend that CMS not initiate NCDs on these topics at this time. • Artificial cervical discs; • Vertebroplasty and kyphoplasty; and • Lumbar fusion for degenerative disc disease.
Our response below answers the specific questions CMS has posed regarding the evidence for:
Artificial Cervical Discs
In October 2007, Synthes Spine’s ProDisc-C ™ Total Disc Replacement (ProDisc-C) was approved by the Food and Drug Administration (FDA) to treat symptomatic cervical disc disease. Total disc replacement with this product is intended to reduce pain and provide the potential to preserve motion in the affected area. Clinical trials with the ProDisc-C have demonstrated a significant improvement of pain and disability, a high rate of patient satisfaction, and fewer re- operations compared to the standard of care, anterior cervical discectomy with fusion (ACDF) . Last year, the FDA also approved another cervical disc product, Medtronic’s PRESTIGE® Cervical Disc System to treat similar patients with similar symptoms; intractable radiculopathy and/or myelopathy.
(1) Synthes Spine, “ProDisc-c Total Disc Replacement IDE Clinical Study”, http://products.synthes.com/prod_support/Product% 20Support% 20Materials/Brochures/SPINE/SPBROProDiscC8406A.pdf
CMS asked if the evidence is adequate that use of artificial cervical discs results in improved health for the Medicare population. Synthes strongly believes that there is adequate and strong evidence to support the use of cervical discs in the population studied in both randomized controlled trials. However, use of the available cervical discs in a relevant age group has had limited study during one randomized controlled trial and given the recent introduction of these products, clinical experience in the Medicare population is limited.
Synthes Spine recommends that CMS not initiate a NCD on artificial cervical discs until sufficient data are available on the application of cervical discs in the Medicare population. We believe that the mechanism exists for Medicare beneficiaries to receive a cervical disc allowing Medicare to collect data. Through the local coverage process, Medicare will be able to collect claims data on Medicare beneficiaries. As this procedure has great promise, we believe consideration of a national coverage or non- coverage decision before more experience with a senior population has developed would be premature.
Vertebroplasty and Kyphoplasty
Percutaneous vertebroplasty and kyphoplasty are surgical procedures that provide mechanical stabilization to compressed and/or fractured vertebrae. These procedures reduce pain and restore function in patients suffering from osteoporotic fractures. CMS asked whether the evidence is adequate to demonstrate health benefits from pain reduction from these procedures in selected patients.
There is a significant body of evidence demonstrating both a reduction in pain and an increase in back function/stability and quality of life following vertebroplasty or kyphoplasty. This evidence has been used by the Medicare claims-payment contractors to ensure appropriate access for Medicare beneficiaries to these valuable treatments through the local coverage determination process. As a result, although the evidence would strongly support coverage on a national level, we do not believe a NCD is necessary at this time. However, should CMS decide to pursue a NCD in the future, Synthes Spine is concerned that the question posed in the July 30 list is not sufficiently specific to develop a meaningful dialogue with the medical community. For example, we are unsure what the agency means by the “health benefit from pain reduction”. We recommend, if further action, such as an NCD, is taken on vertebroplasty or kyphoplasty, that CMS clarify the issues it would like to address regarding Medicare coverage and allow additional opportunity for public comment and input on the refined questions.
Multi-Level Lumbar Fusion for Degenerative Disc Disease
Spinal fusion uses metal constructs, bone grafts and sometimes bio-materials to fuse together two or more vertebrae. The procedure is intended to limit spinal motion and thereby reduce the pain caused by that motion. Often, spinal fusion involves one vertebral segment or level. As CMS notes, for certain patients, a two-level spinal fusion may be an effective treatment for debilitating back pain caused from two degenerated lumbar discs, but fusion of three or more levels is rarely recommended. In considering future NCDs, CMS asked whether the evidence is adequate to identify groups that do and do not benefit from this lumbar fusion procedure.
Synthes Spine respectfully cautions Medicare on the broad subject of “back pain’ and on degenerative disc disease. The question posed refers to multi-level fusions for DDD. The body of evidence showing the benefit of single-level fusion for patients with chronic back pain caused by DDD is considerable. It is much less definitive but still substantial for fusions involving two levels but is not conclusive for three or more spinal segments in the treatment of DDD. Regardless, such procedures are rarely performed, especially in the Medicare population. The terms and definitions in this topic are very important. For example, discogenic back pain must be distinguished from DDD or spinal stenosis.
We submit that any National Coverage Analysis would have to define the issue CMS seeks to resolve. It is unnecessary to undertake a NCD on multi-level fusions for discogenic back pain since clinical practice does not encourage performing such procedures for patients with DDD. While CMS may want to monitor Medicare utilization, we believe that initiating a NCD on multi-level fusions for the treatment of discogenic back pain in a Medicare population is unnecessary given the probability that this procedure is very rare in Medicare beneficiaries.
Conclusion
Synthes Spine respects the integrity of the Medicare coverage determination process and shares CMS’ interest in determining through scientific evidence the appropriate patient population for specific procedures to treat back pain. We also recognize the time and resources required to undertake a national coverage determination. Given the limited use of multi- level fusions for DDD, especially in the Medicare population, Synthes would suggest that there is little or no need for CMS to consider using resources in the preparation of an NCD for this procedure. However, we recommend that CMS continue to monitor utilization of artificial cervical discs and vertebroplasty and kyphoplasty in the Medicare population but that the agency not initiate NCDs on these topics at this time. Thank you for this unprecedented and welcomed opportunity to comment on these important issues.
Sincerely,
Hansjuerg Emch President Synthes Spine
|
| Commenter: |
Ofman, Joshua
|
| Title: |
Vice President |
| Organization: |
Amgen, Inc. |
| Date: |
9/26/2008 2:25:27 PM |
| Comment: |
Dear Dr. Phurrough:
Amgen Inc. (Amgen) is writing regarding the Centers for Medicare and Medicaid Services’ (CMS) June 30, 2008, publication of and request for comment on potential National Coverage Determination (NCD) topics. As a science-based, patient-driven company committed to using science and innovation to dramatically improve people’s lives, Amgen has always been dedicated to meeting the very highest standards with regard to patient safety, as well as to ensuring access to innovative drugs and biologicals for Medicare beneficiaries. For these reasons, we are submitting comments on the use of erythropoiesis stimulating agents (ESAs) to treat anemia in patients with end-stage renal disease (ESRD), which was among the topics included in the CMS potential NCD topic list for the third quarter of 2008.
As the information in our separately submitted detailed comments will indicate, we believe that the current US Food and Drug Administration (FDA) labeling and prescribing instructions specify the benefits and risks of ESA therapy and instruct providers about how to appropriately utilize ESAs in different clinical situations. Additionally, current CMS policies for ESAs in ESRD appropriately enable individualized treatment of patients in accordance with current FDA prescribing information while imposing financial penalties for physicians who do not appropriately reduce ESA doses in response to hemoglobin levels above the target range. Recent hemoglobin trend data (through June 2008) demonstrate that nephrologists have responded to the CMS ESA Monitoring Policy (EMP), as well as to new clinical data and recent label changes. Therefore, it is unclear what additional benefits to Medicare beneficiaries would be conferred by any new or revised Medicare policies for ESAs in ESRD.
Analysis of real world data suggests that physician ESA prescribing behavior has evolved as a result of several factors including the body of evidence on the benefits and risks associated with ESAs in ESRD, analysis of recent safety data in the literature and at a joint session of the FDA’s Cardiovascular and Renal Drugs Committee and the Drug Safety and Risk Management Advisory Committee (CRDAC/DSARM), the recent revisions to FDA prescribing information for ESAs in chronic renal failure (CRF), and the recent changes to the CMS EMP. Key points, which are explained further in our separately submitted detailed comments, include the following:
• EPOGEN® (Epoetin alfa), first approved by the FDA in 1989, revolutionized the care of dialysis patients with anemia by dramatically reducing the need for red blood cell transfusions and improving patient reported outcomes. • ESAs are safe and effective when used in accordance with FDA labeling. • Current product labeling, updated in 2007 after important questions on safety and appropriate use of ESAs in patients with kidney disease were raised, reflects the affirmation of the FDA and its advisory committees of the positive risk benefit profile of ESAs in chronic renal failure when dosing is individualized to achieve and maintain a hemoglobin concentration in the range of 10 to 12 grams per deciliter (g/dL). • It has been recognized that safety concerns associated with ESAs in ESRD may be the result of targeting higher hemoglobin values particularly in hyporesponsive patients, and thus important information regarding appropriate hemoglobin range and dosing modifications have been implemented in the FDA prescribing instructions to address this. • Anemia management and appropriate utilization of ESAs in dialysis patients have been CMS priorities since the 1990s. Current CMS policies, including Clinical Performance Measures (CPMs), ESA coverage policy, and the ESA Monitoring Policy (EMP) effectively support FDA prescribing information. • Data show that nephrologists have responded to safety concerns, the new label, and recent CMS EMP revisions with improved hemoglobin management of dialysis patients. • It is unclear what additional benefits to Medicare beneficiaries would be conferred by any new or revised Medicare policies for ESAs in dialysis.
Amgen appreciates this opportunity to provide important information and looks forward to working with you to ensure that Medicare beneficiaries continue to have appropriate to important therapies. Please contact Sarah Wells Kocsis by phone at (202) 585-9713 or by email at wellss@amgen.com to arrange a meeting or if you have any questions regarding our response. Thank you for your attention to this important matter.
Regards,
Joshua J. Ofman, MD, MSHS Vice President, Global Coverage and Reimbursement and Global Health Economics
|
| Commenter: |
Conterato, Dean
|
| Title: |
Director of Radiation Oncology |
| Date: |
9/26/2008 3:02:45 PM |
| Comment: |
Subject: Protons for prostate cancer
It has come to my attention that CMS is seeking opinions in regard to the use of proton therapy for the treatment of prostate cancer. Normally, I am reluctant to voice my opinion as to the usefulness of new and developing technology. Generally, I am in favor of such activity as this is how the radiation oncology field has developed and implemented new therapies. However, as a practicing radiation oncologist both at the Chicago Prostate Cancer Center and at a community hospital who specializes in treatment of prostate cancer, I would like to strongly voice my opposition to the concept that protons are better at treating prostate cancer than presently available treatment options. Loma Linda Hospital has been using proton therapy for many years and to date they have not published a single randomized trial comparing photon radiation versus proton radiation. There is absolutely no proof that protons have improved cure rates, decreased complications, or decreased the duration of treatment for patients as compared to treatments such as prostate brachytherapy or IMRT radiation therapy. Protons do not deliver higher doses of radiation to the prostate as compared to IMRT and considerably less radiation than brachytherapy. What is clear is that the cost of proton therapy machinery is prohibitively more expensive and quadruples the cost of treating an individual as compared to IMRT and is six times as expensive as brachytherapy. I am not saying that proton therapy should not be developed but in these times of economic crisis shouldn’t we demand proof that such therapy is warranted beyond that of the research scope? Let someone prove that it is better or more cost effective.! |
| Commenter: |
Farup, MD, MS, Christina
|
| Title: |
Vice President, Evidence Based Medicine |
| Organization: |
Depuy Inc |
| Date: |
9/26/2008 3:16:49 PM |
| Comment: |
DePuy Spine, Inc., a Johnson & Johnson company, is one of the world’s leading designers, manufacturers and suppliers of orthopedic devices and supplies. We are dedicated to the development of innovative and high quality products to treat and enhance the quality of life of patients with spinal disorders.
We are appreciate the opportunity to provide comments on the recent posting by the Centers for Medicare and Medicaid Services (CMS) regarding the inclusion of the following topics: 1) artificial cervical disc and 2) vertebroplasty and kyphoplasty as potential NCD topics.
Artificial Cervical Disc Cervical degenerative disc disease has been treated via anterior cervical discectomy and fusion (ACDF) with success rates above 90%(1-2). However, possible acceleration of adjacent-level disease in ACDF patients – theoretically due to the lack of motion at index-level – prompted the development of cervical arthroplasty devices (3). Three devices recently completed clinical trials: the Bryan™, the Prestige-ST™, and the ProDisc-C™. The data generated to date on cervical disc prostheses demonstrate that cervical arthroplasty is at least as effective as cervical fusion. While these studies included patients older than 65, cervical arthroplasty is focused on patients outside of the Medicare population, as osteopenia and osteoporosis are counter indications.
It is important for CMS to consider the impact of initiating a NCD on this topic for a procedure with evidence of benefit to a broader patient population. As there may be less data available on cervical arthroplasty for Medicare patients, a restrictive national Medicare coverage policy may affect subsequent coverage decisions for populations that may benefit from this technology.
Vertebroplasty and Kyphoplasty
The safety and effectiveness of vertebroplasty and kyphoplasty procedures was recently described in the Position Statement of the American Society of Interventional and Therapeutic Neuroradiology, the Society of Interventional Radiology, the American Association of Neurological Surgeons/Congress of Neurological Surgeons and American Society for Spine Radiology (4). In this statement, the Societies reviewed the evidence of these procedures and concluded that “percutaneous augmentation with vertebroplasty and kyphoplasty is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures when performed in a manner in accordance with published standards.” In addition, there is largely consistent coverage of these technologies through the local coverage determination process of Medicare. We recommend that CMS continue to leave coverage decisions for these cases to the local contractors.
DePuy Spine Inc, appreciate the opportunity to submit our comments to CMS.
Sincerely,
Christina Farup, MD, MS Vice-President of Evidence Based Medicine DePuy Inc.
Reference List
(1) Jagannathan J, Shaffrey CI, Oskouian RJ et al. Radiographic and clinical outcomes following single-level anterior cervical discectomy and allograft fusion without plate placement or cervical collar. J Neurosurg Spine 2008 May;8 (5):420-8.
(2) Fraser JF, Hartl R. Anterior approaches to fusion of the cervical spine: a metaanalysis of fusion rates. J Neurosurg Spine 2007 April;6 (4):298-303.
(3) Hilibrand AS, Robbins M. Adjacent segment degeneration and adjacent segment disease: the consequences of spinal fusion? Spine J 2004 November;4(6 Suppl):190S-4S.
(4) Jensen ME, McGraw JK, Cardella JF, Hirsch JA. Position Statement on Percutaneous Vertebral Augmentation: A Consensus Statement Developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. Journal of Vascular & Interventional Radiology 2007;18:325-30.
|
| Commenter: |
Sale, Katherine
|
| Organization: |
American Association of Orthopaedic Surgeons |
| Date: |
9/26/2008 3:20:58 PM |
| Comment: |
September 26, 2008
Kerry N. Weems, Acting Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1385-FC Mail Stop: C4-26-05 7500 Security Blvd. Baltimore, MD 21244-1850
Dear Mr. Weems:
The American Association of Orthopaedic Surgeons (AAOS), representing over 17,000 board-certified orthopaedic surgeons, welcomes the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) first quarterly listing of potential national coverage determination (NCD) topics. We believe that input from stakeholders, such as the AAOS, will provide CMS with additional context in which to consider the impact of proposed NCDs on the patients covered under Medicare.
The circumstances outlined in the “Factors CMS Considers in Opening a National Coverage Determination” guidance document to vet topics and generate the list provide for diverse sources of input. The AAOS encourages CMS to rank these circumstances to afford the greatest weight to those that address the utilization of the technology and the availability of comparable alternatives. As worldwide leaders in the advancement of novel therapies and diagnostics, physicians and payers in the United States are able to make new technologies available to patients across the spectrum of coverage and access. It is important that this practice be maintained as technologies mature, from both a clinical and a research perspective.
The Food and Drug Administration (FDA) has recognized the need for continued study of a product once it is marketed through the Medical Device Postmarket Transformation Initiative. The initiative seeks to identify, analyze, and act on postmarket information in order to improve the safety and effectiveness of medical devices with the intent of ensuring a continuum of safety and public health as medical devices move from design concept, to accepted use in health care delivery and ultimate replacement as new versions of improved devices and novel technologies are developed. Through this program the FDA is able to make new products available to patients while continuing to monitor the technology as it matures.
CMS has the opportunity to increase access to these technologies through the Coverage with Evidence Development (CED) program. The AAOS believes CED is crucial to product development as it pertains to the CMS population. Time and budget constraints do not provide for the study of all available products in every potential patient population. Because of this, many safe and effective products that are reasonable and necessary treatment options for the Medicare and Medicaid populations do not have substantial bodies of evidence supporting their use in these groups. CED presents an environment wherein these products can be proven, either through study participation or appropriateness determinations.
The AAOS considers many of the potential NCD topics to be under the umbrella of CED eligibility. For example, the role of bisphosphonates in the treatment of prevalent bone disorders affecting women is evolving as the specific actions of these compounds are becoming more understood. Several studies exist that illustrate the effectiveness of bisphosphonates in reducing the risk of vertebral fractures in postmenopausal women but also highlight the adverse effects associated with oral bisphosphonates – dyspepsia, nausea, acid reflux, gastritis and gastric ulcers.1,2,3,4,5 Additional evidence, which could be developed with CED, may provide the information needed to determine if parenteral administration and its published risks yield sufficient beneficial outcomes to recommend continued coverage.
Bone morphogenetic protein (BMP) has received significant attention from the media and from the FDA in recent months, particularly with regard to its use in anterior cervical spine fusion. The potential NCD list queries “Is the evidence adequate to demonstrate health improvements in the Medicare population?” The orthopaedic community has been seeking answers to this question but has done so cautiously due to the issues inherent in the study of off-label product use. While there is literature to suggest an increased risk of swelling complications when BMP is used in anterior cervical spine applications as compared to bone graft alone,6 the authors also note the effectiveness of patient outcomes and fusion. Similar complications have not been noted in lumbar spine applications, despite a significantly larger volume of cases. Several studies call for additional research to determine the optimal dose of BMP to promote cervical spine fusion.7,8,9 Also, there are patients at risk for nonunion who may benefit from rh-BMP induced osteogenesis7. CMS is in a unique position to support the efforts of orthopaedic surgeons and researchers to determine the value of this treatment through coverage with evidence development.
The AAOS appreciates the challenging position of CMS as it strives to provide cost effective quality care for growing ranks of patients with limited resources. We understand the need to carefully evaluate treatment options for their reasonableness and necessity so as to ensure the best possible care for the greatest number of patients. However, we encourage CMS to continue to embrace the potential of new technologies as they may yield improved outcomes, reduce the need for future treatment, and increase patients’ ability to lead functional, productive lives. The AAOS looks forward to assisting CMS in meeting these goals through ongoing assessment of treatment options for our patients.
Sincerely,
E. Anthony Rankin, MD President, American Association of Orthopaedic Surgeons
References
1 Black DM, et al., Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996. 348(9041): p. 1535-41. 2 Liberman UA, et al., Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med 1995. 333(22): p. 1437-43. 3 Bone HG, et al., Ten years' experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 2004. 350(12): p. 1189-99. 4 Sorensen OH, et al., Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience. Bone 2003. 32(2): p. 120-6. 5 Borah B, et al., Long-term risedronate treatment normalizes mineralization and continues to preserve trabecular architecture: sequential triple biopsy studies. Bone 2006. 39(2): p. 345-52. 6 Butterman GR. Prospective nonrandomized comparison of an allograft with bone morphogenic protein versus an iliac-crest autograft in anterior cervical discectomy and fusion. Spine J 2008. 8: 426-435. 7 Perri B, et al., Adverse swelling associated with use of rh-BMP-2 in anterior cervical discectomy and fusion: a case study. Spine J 2007. 7: 235-239. 8 Shields LBE, et al., Adverse effects associated with high-dose recombinant human bone morphogenetic protein-2 use in anterior cervical spine fusion. Spine 2006. 31(5): 542-547. 9 Smucker JD, et al., Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine. Spine 2006. 31(24): 2813-2819.
|
| Commenter: |
Estes, III, MD, FHRS, N. A. Mark
|
| Title: |
President |
| Organization: |
Heart Rhythm Society |
| Date: |
9/26/2008 3:21:22 PM |
| Comment: |
September 26, 2008 Re: Potential National Coverage Decision Topics: Ablation for Atrial Fibrillation
Dear Mr. Weems:
The Heart Rhythm Society (HRS) welcomes the opportunity to provide written comments on the Centers for Medicare & Medicaid Services’ (CMS) list of potential National Coverage Determination (NCD) topics. HRS comments pertain to relevant evidence on whether a review should proceed prior to the formal decision to open a NCD for:
“Ablation for Atrial Fibrillation: If medication is not effective or not tolerated for atrial fibrillation, a non-surgical procedure called catheter ablation may be chosen. Focal and circumferential catheter ablation for atrial fibrillation is still being studied in investigational trials but may be done in selected patients to try to cure atrial fibrillation. Is the evidence adequate to demonstrate health benefits in the patients who receive the procedure?”
HRS is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Founded in 1979, HRS is the preeminent professional group representing almost 5,000 specialists in cardiac pacing and electrophysiology, consisting of physicians, scientists, and their support personnel. HRS’ members perform electrophysiology studies and curative catheter ablations to diagnose, treat, and prevent cardiac arrhythmias. Electrophysiologists also implant pacemakers and cardioverter defibrillators (ICDs) in patients who are indicated for these life-saving devices. After device implantation, electrophysiologists then monitor these patients and their implanted devices.
HRS believes there is adequate evidence to demonstrate health benefits in the patients who receive an ablation for atrial fibrillation (AF); especially patients in whom medications for managing their AF are either not effective or not tolerated. Catheter ablation therapy for the treatment of atrial fibrillation is currently established as a clinically useful treatment option for the treatment of symptomatic patients who have either failed pharmacologic treatment or are intolerant to antiarrhythmic drugs. The ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation1 provide a consensus of expert opinion after a thorough review of the available current scientific evidence and recommends catheter ablation as a reasonable alternative to pharmacologic therapy to prevent recurrent AF in symptomatic patients. In addition, the HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Personnel, Policy, Procedures and Follow-up2 states that the primary indication for catheter ablation to treat AF is the presence of symptomatic AF refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.
While the initial therapy for patients with symptomatic AF remains antiarrhythmic drug therapy, there are many patients in whom this approach is not successful due to lack of efficacy or drug intolerance. In addition there are safety concerns that frequently arise related to serious adverse effects. Amiodarone, one of the most commonly used antiarrhythmic medications today, can cause several cardiac and extra-cardiac side effects that necessitate stopping the medication in 18% of patients after 18 months of use.1 Significant side effects that necessitate stopping the medication are not the only limitation to the use of antiarrhythmic medications; their efficacy in patients with AF is sub-optimal as well. Approximately 50% of patients on these medications develop recurrent AF within 1-year of follow-up.3 Five randomized controlled clinical trials that compared pulmonary vein isolation with an antiarrhythmic medication provide the most robust data on the efficacy and safety of the ablation procedure for treating AF.4-8 The number of patients enrolled in each clinical trial ranged from 30 to 198 with 581 patients enrolled in all clinical trials.4-8 Two clinical trials were single center studies.4, 6 Two clinical trials did not report power calculations. The other three clinical trials that did report power calculations had 90% statistical power to show a significant difference in the primary endpoint between the two groups, and these trials all enrolled their target number of patients.5-7 Three of the clinical trials enrolled patients with either paroxysmal or persistent AF, one clinical trial enrolled only patients with persistent AF, and one clinical trial enrolled only patients with paroxysmal AF.4-8 The mean age of patients ranged from 48.6±15.4 years to 62.3±10.7 years. The primary endpoint of all five clinical trials was freedom from AF at 12 months of follow-up.4-8 In all clinical trials, freedom from AF was significantly higher in the pulmonary vein isolation arm compared with the antiarrhythmic medication arm.4-8 In the three clinical trials that reported on cardiovascular hospitalizations, pulmonary vein isolation was associated with a significant decrease in such hospitalizations compared with medical therapy.6-8
The same five randomized controlled clinical trials that compared pulmonary vein isolation with an antiarrhythmic medication provide data on complications.4-8 Major complications in the catheter ablation group included pulmonary vein stenosis (n=2), pericardial effusion (n=2), phrenic nerve paralysis (n=1), and thromboembolic events (n=3). The overall complication rate was 2.7% (n= 8/291). A thromboembolic event occurred in 3 patients randomized to catheter ablation and 1 patient randomized to medical therapy. No patient, in any of the clinical trials, developed severe pulmonary stenosis (defined as stenosis > 70%) or death.4-8 Data on the effect of AF catheter ablation on other endpoints such as quality of life look promising. In one randomized clinical trial, quality of life assessed at 6 months was determined to be significantly better in the ablation group than the antiarrhythmic drug group.8 In a prospective non-randomized study of 63 patients, 86% of patients were free of symptomatic recurrence at 12-month follow-up, and successful ablation resulted in a significant improvement in quality of life at 3 months that was maintained at 12 months.8 In another study of 89 patients undergoing AF ablation, within a 6-month follow-up period after ablation, quality of life was restored to equivalence with an age-matched, healthy control population.9 Other observational studies have also suggested that catheter ablation for AF is associated with a significant improvement in left ventricular function, exercise capacity, symptoms, and quality of life.10,11
For selected patients with AF in whom medication is not effective or not tolerated, catheter ablation is the preferred management option. The substantial body of completed and published observational data and randomized trails supports this position. The role of catheter ablation for the treatment of AF is recognized in national and international guidelines statements including the ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation1 as well as the HRS/EHRA/ESC Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation.2 Consequently, continued Medicare coverage for this procedure is essential. As noted in the HRS/EHRA/ESC Expert Consensus Statement2, the remaining issues being addressed in a wide range of studies are: sufficiently powered studies, randomized mortality studies, multi-center outcomes studies, industry-sponsored device approval studies, and carefully constructed single and multi-centered registry studies.
HRS is a strong supporter of evidence-based medicine and believes that the best available evidence should inform all health care decisions. The ultimate goal of evidence-based medicine is to enhance quality of care and serve the patient’s best interests. When properly understood and applied, evidence-based medicine benefits both Medicare beneficiaries and the health care system. If you have any specific questions, please contact Joel C. Harder, Director of Quality Improvement & Outcomes at (202) 464-3489 or jharder@HRSonline.org.
Sincerely,
N.A. Mark Estes, III, MD, FHRS President, Heart Rhythm Society
CC: Richard I. Fogel, MD Chair, Health Policy Committee
James H. Youngblood CEO, Heart Rhythm Society
Kathryn M. Pontzer Vice President, Health Policy |
| Commenter: |
Rohan, Barbara
|
| Title: |
Vice President, Government Affairs |
| Organization: |
Smith & Nephew, Inc. |
| Date: |
9/26/2008 3:22:46 PM |
| Comment: |
September 26, 2008
Steve Phurrough, M.D., M.P.A. Centers for Medicare & Medicaid Services Coverage and Analysis Group Mailstop C1-09-06 7500 Security Boulevard Baltimore, Maryland 21244
RE: Hip Resurfacing
Dear Dr. Phurrough and the Coverage and Analysis Group:
Thank you for the opportunity to provide comments on the CMS list of potential National Coverage Determination topics. Smith & Nephew, Inc. develops and markets innovative medical devices including the Birmingham Hip Resurfacing System (BHR), which was the first hip resurfacing device to receive FDA approval. The BHR is indicated to relieve hip pain and improve hip function in hips damaged by non-inflammatory degenerative joint diseases such as osteoarthritis, avascular necrosis, dysplasia/DDH, and inflammatory degenerative joint disease such as rheumatoid arthritis.
Hip resurfacing is a conservative treatment alternative to total hip arthroplasty. It provides considerable advantages including bone preservation, restoration of biomechanics, and the advantages of an advanced bearing and stability that provides enhanced confidence in more active patients. The procedure has widespread coverage among private payers as well as Medicare. There is ample published clinical literature that demonstrates its clinical value. In addition, there are well defined and widely accepted patient selection criteria. It is considered a safe and effective treatment when performed using FDA approved devices in appropriately selected patients.
Hip resurfacing is an important option for patients who wish to preserve their active lifestyle, including patients over age 65 who meet the patient selection criteria. The BHR PMA trial included almost 200 patients over age 65. An over-65 subgroup analysis was presented to CMS by Dr. Robert Bourne on March 3, 2006. The data demonstrate that the survival rate (99%) is comparable to the ¡Ü65 year old group, high OSHIP scores and satisfaction are maintained over time, and the safety profile is similar to those subjects in the ¡Ü65 year old group. Overall, the evidence supports that BHR is a very reasonable choice for use in an older population.
We believe that Medicare should continue to cover hip resurfacing using FDA-approved devices. If CMS should decide to pursue a National Coverage Determination, we urge you to preserve Medicare Beneficiary access to the technology by issuing a positive coverage policy. We would be happy to answers any questions you might have and provide any additional information you might need.
Sincerely, Barbara Rohan Vice President, Government Affairs
|
| Commenter: |
Sugarman, Mitchell
|
| Title: |
Senior Director, Health Economics Policy & Pymt |
| Organization: |
Medtronic CardioVascular |
| Date: |
9/26/2008 3:45:43 PM |
| Comment: |
September 26, 2008
Steve Phurrough, MD, MPA
Centers for Medicare & Medicaid Services
Coverage and Analysis Group
Mailstop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244
ELECTRONICALLY SUBMITTED
RE: Potential NCD Topics – DRUG-ELUTING
STENTS and
PERIPHERAL ARTERIAL STENTING
Dear Dr. Phurrough:
Medtronic, Inc. is one of the world’s leading
medical technology companies, specializing in
implantable and interventional therapies that
alleviate pain, restore health, and extend
life. We are committed to the continual
research and development necessary to produce
innovative, high-quality therapies that improve
health outcomes. We appreciate the opportunity
to comment on CMS’s list of potential NCD
topics, published on July 30, 2008. Our
comments reflect Medtronic’s long history of
working directly with CMS to improve the
national coverage determination (NCD) process
and to review numerous NCDs involving our
technologies.
Medtronic supports CMS’s overarching goal of
ensuring that Medicare beneficiaries receive
appropriate, high-quality health care, including
access to life-saving and life-enhancing medical
advancements. Medtronic engages in a wide range
of activities to refine the use of our products,
better define appropriate indications, and
enhance the understanding of their value. We
appreciate the need to invest in robust clinical
and economic evidence to support appropriate
adoption of device therapies by patients,
providers, and payers.
We commend CMS’s commitment to transparency by
posting potential NCD topics to the coverage web
site. The April 2006 guidance document, “Factors
CMS Considers in Opening a National Coverage
Determination,” encourages the public to comment
on potential topics and to provide relevant
evidence on whether a review should or should
not proceed prior to the formal decision to open
an NCD.
Many of the medical device technologies included
on the list of potential NCD topics are
currently covered through the local coverage
determination (LCD) process, and several are
also involved in ongoing studies to fully assess
the benefits of the technologies and therapies.
For many medical device technologies, the LCD
process is an appropriate evidence-based
alternative to a national coverage
determination.
Unlike the NCD process, the LCD process is more
likely to result in policies that are accepted
by the local medical community since the local
medical community is afforded the opportunity to
directly participate in the formulation of the
policies. In addition, the LCD process allows
for flexible evidence-based decision-making as
new clinical data become available. It enables
contractors to use mechanisms that many private
payers use (such as case by case coverage) to
allow appropriate patient access to new
technologies without granting unrestricted
coverage.
In certain instances, NCDs can be a premature or
inappropriately rigid coverage mechanism for
those medical device technologies where the
evidence-base has been established, but for
which additional studies have been initiated to
generate evidence to expand indications and
identify clinically appropriate populations.
Some of these studies will take years to
complete. Others are FDA pre-market approval
studies (investigational device exemptions) or
FDA-mandated post-market studies. Assessing the
scope and anticipated timetable of ongoing
clinical research for specific topics is
essential to ensure that premature NCDs do not
limit or stop the collection of clinical data
and prevent patient access to treatment options
with significant potential for improving patient
outcomes.
Medtronic strongly supports the LCD process
because it permits recognition of the fact that
medical device technologies evolve through
iterative innovation, allowing for a natural
diffusion process that balances coverage
decision-making with physicians’ clinical
judgment and the development of ongoing clinical
evidence. With this general background in mind,
we have comments on specific topics included on
CMS’s potential NCD list.
Off-Label Use of Drug-Eluting Coronary Stents
Medtronic CardioVascular is particularly
interested in commenting on CMS’ consideration
of off-label use of drug-eluting coronary
stents. CMS states that “[l]imited data are
available on the off-label use of drug-eluting
stents (DESs) in clinical practice” and
asks, “is that evidence adequate to specify
groups of patients that do benefit from
treatment with coronary stents or clearly do not
benefit?” Medtronic believes it is important to
emphasize that clinical trials are deliberately
designed to minimize variables where possible to
limit the effect of artifact or outlying data.
The use of rigorous inclusion/exclusion criteria
in such trials is intended therefore to generate
data on a homogeneous population and not to
evaluate all patients who may potentially
benefit from the investigational therapy.
DES studies designed for pre-market approval
(PMA) applications have routinely excluded
patients with conditions such as acute
myocardial infarction, multiple vessel/multiple
lesion disease or in-stent restenosis.
Nonetheless, Medtronic is committed, through the
proactive collection of post-approval, real-
world patient data, to fully characterize the
clinical utility of our devices in those patient
populations not routinely studied in formal pre-
approval clinical trials. Toward that end, we
have concluded the 8,000 patient Endeavor V
registry study on the Endeavor® Zotarolimus-
Eluting Coronary Stent System. This “all-comers”
study with results out to 1 year (and a subset
out to 2 years) suggests broad benefit in the
general population consistent with those
benefits seen in the randomized pre-market
approval studies. Additionally, Medtronic has
initiated a number of studies and registries
that will yield information on the effectiveness
of our DES programs in broad, real-world
populations. These include:
• The PROTECT TRIAL: A randomized stent
trial with 8,800 patients in approximately 200
hospitals, which is designed to evaluate whether
Medtronic’s drug-eluting Endeavor stent PROTECTS
against late stent thrombosis resulting in less
deaths and myocardial infarctions. The primary
objective is to compare the overall stent
thrombosis rate of the Endeavor® Zotarolimus-
Eluting Coronary Stent System versus the Cypher®
Sirolimus-eluting Coronary Stent in a patient
population requiring stent implantation. As
an “all-comers” trial, inclusion criteria
state: “all lesions requiring interventions
(target lesions – one to a maximum of four) in
one or more native coronary arteries are
amenable for implantation of one or more
Endeavor® Zotarolimus-Eluting Coronary Stent
System or Cypher® Sirolimus-eluting Coronary
Stent.”
• The RESOLUTE-III Trial (now re-named the
Resolute All-Comers Trial): A prospective,
multicenter, randomized, two-arm, international,
non-inferiority, open-label study with 2,300
patients at 15-20 centers. The study is a "real
world, all comers" study with a primary
objective to compare the Medtronic Endeavor-
Resolute (Zotarolimus-Eluting stent) system with
the Abbott XIENCE V (Everolimus-Eluting stent)
system with respect to cardiac death, myocardial
infarction (not clearly attributable to a non-
target vessel), Target Lesion Revascularization
at 1 year in a "real world" patient population.
The Endeavor-Resolute stent is an
investigational product in the United States
that is being studied under an investigational
device exemption (IDE) from the FDA.
Beyond studies by Medtronic, other manufacturers
of drug-eluting stents are also conducting
trials and registries aimed at developing
information on the clinical effects of DES in
the general population. We are attaching a
comprehensive list of the studies that are
underway.
Medtronic recognizes CMS’s potential interest in
developing a national coverage determination but
feels that such a determination should be timed
to fully consider the plethora of currently
ongoing post-market studies and registries.
Patient follow-up data generated in these real-
world settings appropriately reflects
physicians’ professional judgment and
interpretation of available clinical evidence.
It is therefore important that this real world
experience be taken into full account to
appropriately assess the off-label use of drug-
eluting stents.
In addition, Medtronic believes that the current
focus on the clinical utility of DES may be
misdirected in the absence of a similar
evaluation of alternative therapies. Neither
bare metal stents nor medical management have
been evaluated in the context of an NCD and
without these therapies undergoing similar
scrutiny, Medtronic believes the current
discussion may be compromised by a lack of
comparative reference information.
Peripheral Arterial Stenting and Vascular
Intervention
Similarly, Medtronic believes that an NCD on
peripheral arterial stenting and vascular
intervention at this time would be premature.
Medtronic is currently enrolling patients in an
Investigational Device Exemption (IDE) trial
evaluating the use of stenting in the treatment
of peripheral artery disease. The Medtronic
Complete® Self-Expanding Stent and Stent
Delivery System Registry is a non-randomized
prospective, multicenter, consecutive registry.
The purpose of this study is to show if a new
delivery system with a modified stent is safe in
treating occluded iliac arteries in patients
with peripheral vascular disease. The modified
Complete SE delivery system is hypothesized to
assist physicians with more accurate stent
placement, reducing the likelihood of
stent 'jumping' seen with the use of many self-
expanding stent systems.
Additionally, Medtronic is actively working with
FDA to develop strategies for the study of
further devices and indications in the
peripheral vasculature in the near future. The
results of these trials and others underway by
other manufacturers will eventually lead to
information that will enable physicians to
appropriately make the best decisions concerning
the care of their patients. An NCD at this time
could potentially limit or completely stop the
collection of such data and prevent patients
from having access to the most beneficial
treatments.
As with alternatives to drug eluting stents,
alternative treatment modalities to peripheral
vascular stenting for PAD have not been
subjected to the NCD process. While this may be
due to the relatively small body of evidence
with which to evaluate these treatment
alternatives, Medtronic supports the judgment
and discretion of qualified vascular surgeons
and interventionalists to make determinations
about how to best treat their patients rather
than have those decisions proscribed by a
process that does not take all treatment options
into account.
Medtronic remains committed to high quality
research and the principles of evidence-based
medicine. It is, however, imperative that these
principles themselves don’t create unreasonable
barriers to the natural diffusion of technology,
the value of which is most appropriately
assessed through long-term, real-world
utilization and the collection of outcomes from
that utilization.
Sincerely,
Mitchell Sugarman
Sr. Director, Health Economics, Policy and
Payment
Medtronic CardioVascular
Attachment to Medtronic Comments on CMS Potential NCD List
TRIALS COMPLETE IN 2008
GISSOC II: Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions
Società Italiana di Cardiologia Invasiva
Cordis Italy a division of Johnson & Johnson Medical SpA
The objective of this study is to compare the Cypher Select-TM Sirolimus Eluting Stent (SES) with the SONIC-TM Bare Metal Stent (BMS) in the treatment of Chronic Total Occlusion lesions (CTO). The primary hypothesis is that, at 8-month follow-up, the minimal luminal diameter (MLD) of the coronary segment treated with stent implantation in CTO lesions is significantly larger with the use of SES compared to BMS. The treated segment is defined as the segment covered by the stent(s) plus 5 mm proximally and distally to the stent(s).
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Estimated Enrollment: 200
Device: Coronary placement of bare metal stent or [Cypher] drug eluting stent
Primary Outcome Measures: The minimal luminal diameter (MLD) at 8-month follow-up of the coronary segment treated with stent implantation in CTO lesions. The treated segment is defined as the segment covered by the stent(s) plus 5 mm proximally and distally to the stent(s).
Estimated Study Completion Date: May 2008
Intra-Individual Comparison of Sirolimus and Paclitaxel Coated Stent (FRE–RACE Study)
University Hospital Freiburg
Cordis Medizinische Apparate GmbH
The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting with two or more coronary artery stenoses (prospective, randomized, intra-individual comparison).
Device: Percutaneous transluminal coronary angioplasty and [Cypher or Taxus] drug eluting stent implantation
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Estimated Enrollment: 110
Primary Outcome Measures: The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography
Estimated Study Completion Date: July 2007 [But still recruiting patients]
Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)
Cordis Corporation
The objective of this study is to allow treatment with the sirolimus-eluting Bx VELOCITYTM stent in patients with a serious disease or condition for which there is no generally acceptable alternate treatment available.
Device: CYPHER Sirolimus-Eluting Coronary Stent Estimated Primary Completion
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Enrollment: 252
Primary Outcome Measures: The primary endpoint of this study is a composite of Target Vessel Failure (TVF) defined as target vessel revascularization, myocardial infarction or cardiac death at 30 days, 6mo, 12mo, 2, 3, 4, and 5 years. [ Time Frame: 30 days, 6mo, 12mo, 2, 3, 4, and 5 years ]
Date: June 2008 (Final data collection date for primary outcome measure)
The SOS (Stenting Of Saphenous Vein Grafts) Randomized-Controlled Trial
North Texas Veterans' Healthcare System
The main purpose of this study is to determine whether implantation of a paclitaxel-eluting stent (Taxus™) in saphenous vein graft lesions will reduce the incidence of in-stent restenosis after 12 months when compared to a similar bare metal stent.
Device: polymer-based sirolimus eluting stent, bare metal stent
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Enrollment: 252
Primary Outcome Measures: binary angiographic in-stent restenosis, as assessed by 12-month follow-up quantitative coronary angiography
Study Start Date: May 2005 [no end date given; still recruiting]
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
Boston Scientific Corporation
Cardialysis BV
The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).
Device: Polymer-based Paclitaxel-Eluting TAXUS Express-SR Stent
Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Enrollment: 1800
Procedure: Coronary Artery Bypass Surgery
Primary Outcome Measures: 12-month MACCE rate. MACCE is defined as:all cause death,cerebrovascular event(such as stroke,)documented myocardial infarction, and [ Time Frame: 1 year after enrollment]; repeat revascularization (PCI and/or CABG) [ Time Frame: 12 Months ]
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Treatment of Moderate Vein Graft Lesions With Paclitaxel Drug Eluting Stents: The VELETI Trial
Laval University
Boston Scientific Corporation
To evaluate by IVUS the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis progression in angiographically non-diseased SVGs segments.
Primary Outcome Measures: Ultrasound lumen area and minimal lumen diameter at follow-up at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions; Change between baseline and follow-up in ultrasound lumen area and minimal lumen diameter (% and absolute value) at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions; Change in atheroma volume (% and absolute value) as evaluated by IVUS between baseline and follow-up in an angiographically non-diseased 40 mm segment (excluding the target lesion), comparing stented vs medically treated SVGs
Device: Paclitaxel Eluting Stent
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Estimated Enrollment: 100
Estimated Study Completion Date: March 2008
Spot Drug-Eluting Stenting for Long Coronary Stenoses
Cardiovascular Research Society, Greece
Most doctors who use the new drug-eluting stents for the treatment of long coronary narrowings tend to cover the full length of the lesion with long or multiple stents.We hypothesized that a policy of spot-stenting, ie stenting of only the very tight parts of the coronary narrowing, might result in better outcomes by means of avoiding multiple stents that have been associated with significant complications such as late stent thrombosis.
Device: Drug-eluting stents (Cypher and Taxus)
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study
Estimated Enrollment: 250
Estimated Study Completion Date: December 2008
Drug-Eluting-Stents for Unprotected Left Main Stem Disease (ISAR-LEFT-MAIN)
Deutsches Herzzentrum Muenchen
Technische Universität München
The purpose of this study is to evaluate the efficacy of sirolimus- and paclitaxel-eluting stents for treatment of unprotected left main coronary artery disease.
Device: Sirolimus-eluting stent
Device: Paclitaxel-eluting stent
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measures: Major adverse cardiac events (composite of death, myocardial infarction and target lesion revascularization) at one year [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Enrollment: 607
Estimated Study Completion Date: July 2008
TRIALS COMPLETE IN 2009
Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent
French Cardiology Society
Boston Scientific Corporation
The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.
Primary Outcome Measures: Coronarography [ Time Frame: 9 months ]
Device: Percutaneous coronary intervention with Taxus stent
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Estimated Enrollment: 100
Estimated Study Completion Date: June 2009
Study to Test the Efficacy and Safety of Drug Eluting vs. Bare-Metal Stents for Saphenous Vein Graft Interventions (BASKETSAVAGE)
University Hospital, Basel, Switzerland
University of Leipzig
Prospective multicenter controlled randomized trial to compare the safety and efficacy of drug eluting vs. bare metal stents in percutaneous coronary interventions of saphenous vein grafts. Hypothesis: Survival and outcome will be significantly better in patients receiving DES than in patients receiving BMS regarding both short-term and long-term outcome.
Primary Outcome Measures: MACE (composite of cardiac death, i.e., all deaths not clearly non-cardiac, non-fatal myocardial infarction, and TVR [ Time Frame: 12 months ]
Device: Drug eluting stent
Device: Bare metal stent
Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Estimated Enrollment: 240
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
TAXUS PERSEUS Small Vessel (PERSEUS SV)
Boston Scientific Corporation
The purpose of the TAXUS PERSEUS Small Vessel trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo atherosclerotic lesions of up to 20mm in length in native coronary arteries of > 2.25 mm to < 2.75mm diameter.
Primary Outcome Measures: In-stent late loss (measured by QCA) [ Time Frame: 9 months post-index procedure ]
Device: PCI with [Taxus] drug-eluting stent implantation
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Estimated Enrollment: 224
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Efficacy Study of Drug-Eluting and Bare Metal Stents in Bypass Graft Lesions (ISAR-CABG)
Deutsches Herzzentrum Muenchen
To determine the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on limiting SVG disease progression as evaluated by IVUS; and to evaluate by IVUS the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis progression in angiographically non-diseased SVGs segments.
The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation
Device: Cypher drug-eluting stent
Device: Taxus drug-eluting stent
Device: ISAR drug-eluting stent
vs. Device: bare metal stents
Device: paclitaxel eluting stent
Prospective, Randomized Trial of Drug-Eluting Stents vs. Bare Metal Stents for the Reduction of Restenosis in Bypass Grafts.
Estimated Enrollment: 600
Estimated primary completion date: April 2009
Diffuse Type In-Stent Restenosis After Drug-Eluting Stent (DES-ISR)
CardioVascular Research Foundation, Korea
To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting stent restenosis.
Primary Outcome Measures: Binary in-segment angiographic restenosis at 9 months angiographic follow-up
Device: Sirolimus-eluting stent (cypher, J&J, Cordis)
Device: Paclitaxel-eluting stent (Taxus liberte, Boston Scientific)
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Estimated Enrollment: 200
Estimated Study Completion Date: June 2009
Choice Of Optimal Strategy For Bifurcation (CROSS)
Lesions With Normal Side Branch
CardioVascular Research Foundation, Korea
simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions
Primary Outcome Measures: Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy [ Time Frame: 8 months ]
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Estimated Enrollment: 180
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries. (ENDEAVOR SVS)
Medtronic Vascular
The Endeavor Zotarolimus-Eluting Coronary Stent System utilized in the ENDEAVOR SVS Registry is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length >14 mm and < 27 mm in native coronary arteries with reference vessel diameters of > 2.25 mm to < 2.75 mm.
Primary Outcome Measures: In-segment percent diameter stenosis at 8 months post-procedure [ Time Frame: 8 months ]
Device: Endeavor Zotarolimus-Eluting Coronary Stent
Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Estimated Enrollment: 300
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Zotarolimus-Versus Sirolimus-Versus PacliTaxel-Eluting Stent for Acute Myocardial Infarction Patients (ZEST-AMI)
CardioVascular Research Foundation, Korea
Cordis Corporation
To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. sirolimus-eluting balloon expandable stent (Cordis Johnson & Johnson, Warren, New Jersey) vs. paclitaxel-eluting stent (Taxus Liberte, Boston Scientific).
Primary Outcome Measures: The composite of death (all cause-mortality), MI (Q wave and non Q wave) and ischemia-driven target vessel revascularization, which is named as target vessel failure (TVF) [ Time Frame: At 12 months after the index procedure ]
Device: Endeavor, Medtronic
Device: Cypher, Cordis
Device: Taxus Liberte, Boston Scientific
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Estimated Enrollment: 1500
Estimated Study Completion Date: October 2009
A Study of Diabetic Patients With De Novo Native Coronary Artery Lesions (SCORPIUS)
Cordis Corporation
The main objective of this study is to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent Delivery System.
Primary Outcome Measures: angiographic in-segment late loss [ Time Frame: 8 months post-procedure ]
Device: CYPHER sirolimus-eluting stent
Device: uncoated Bx VELOCITY balloon-expandable stent
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Enrollment: 200
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease (PRECOMBAT)
CardioVascular Research Foundation, Korea
To establish the safety and effectiveness of coronary stenting with the sirolimus-eluting balloon expandable stent (Cordis Johnson & Johnson, Warren, New Jersey) compared with bypass surgery for the treatment of an unprotected LMCA stenosis. The alternative hypothesis is that the experimental strategy (coronary stenting with the sirolimus-eluting stents) is not inferior to the standard strategy (bypass surgery).
Primary Outcome Measures: Major cardiac and cerebrovascular event (MACCE): the composite of death, myocardial infarction, stroke, and ischemica-driven target vessel revascularization [ Time Frame: one-year after treatment ]
Device: Cypher, Cordis
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Estimated Enrollment: 600
Estimated Study Completion Date: June 2009
Drug Eluting Stents for In-Stent Restenosis 2 (DESIRE-2)
Deutsches Herzzentrum Muenchen
Technische Universität München
For lesions which develop restenosis after a DES, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug.
Device: Sirolimus eluting stent (Cypher)
Device: Paclitaxel-eluting stent (Taxus)
Primary Outcome Measures: Late luminal loss at follow-up angiography [ Time Frame: 6 months ]
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Estimated Enrollment: 360
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
The Study to Assess AMI Treated With Balloon Angioplasty. (TYPHOON) Cordis Corporation
The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.
Device: drug-eluting stent
Device: bare-metal stent
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measures: Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure. [ Time Frame: 1 and 6 months and at 1, 3, 4, and 5 years post-procedure. ] [ Designated as safety issue: Yes ]
Enrollment: 715
Estimated Study Completion Date: March 2009
SEA-SIDE: Sirolimus Versus Everolimus-Eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-Branch Stenosis
Catholic University of the Sacred Heart
The aims of the present study are:
1. to compare in a prospective randomized study the acute 3D angiographic results (as a measure of the impact of stent design) and the late clinical outcome of Sirolimus-eluting (SES) vs Everolimus-eluting stent (EES) obtained using a provisional TAP-stenting approach to treat bifurcated lesions.
2. to prospectively assess the clinical relevance (in terms of inducible ischemia) of suboptimal angiographic result in the SB of bifurcated lesions treated by stenting.
PRIMARY STUDY END-POINTS.
1. COMPARISON BETWEEN SES AND EES: rate of "target bifurcation failure" at 9 months. Target bifurcation failure will be defined as: occurrence of target bifurcation-related major adverse coronary events and/or, in the absence of major adverse events, documentation at follow-up angiography of >50% restenosis on the main vessel or TIMI flow < 3 on the side-branch.
2. SB-RELATED ISCHAEMIA of Group O vs Group S in patients with complete revascularization: inducible ischemia (diagnostic ST-segment changes) at the early (<8 days) exercise test or occurrence of early (<12 weeks) spontaneous ischemia related to the SB (any ischemic episode requiring unplanned coronary angiography with documentation of main vessel patency).
Device: Sirolimus eluting stent (Cypher stent - Cordis (Johnson&Johnson Company)
Device: Everolimus eluting stent (Xience stent - Abbot company)
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Estimated Enrollment: 150
Estimated Study Completion Date: October 2009
The Arterial Revascularization Therapies Study Part II. (ARTS II)
Cordis Corporation
The main objective is to compare the effectiveness of coronary stent implantation using the sirolimus-eluting Bx VELOCITY™ balloon expandable stent with that of surgery as observed in ARTS I. Effectiveness is measured in terms of Major Cardiac and Cerebrovascular Events (MACCE) free survival at 1 year.
Device: drug-eluting stent
Primary Outcome Measures: abscence of major adverse cardiac and cerebral vascular events (MACCE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Enrollment: 607
Estimated Study Completion Date: February 2009
XIENCE™ V Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE™ V USA)
Abbott Vascular
This prospective, open-label, multi-center, observational, single-arm registry is designed to evaluate XIENCE V EECSS continued safety and efficacy during commercial use in real world settings.
Device: XIENCE™ V Everolimus Eluting Coronary Stent
Primary Outcome Measures:
• Academic Research Consortium (ARC) defined stent thrombosis [ Time Frame: Annually through to 5 years ] [ Designated as safety issue: Yes ]
• Composite rate of cardiac death and any myocardial infarction (MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 5000
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
TRIALS COMPLETE IN 2010
A Multi-Center Post-Market Surveillance Registry (E-SELECT)
Cordis Corporation
This multicenter, prospective, observational registry will evaluate the safety and performance of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, and of all future generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine clinical practice. Its objective is to measure the incidence and identify the predictors of acute, sub-acute and late stent thrombosis and Major Adverse Cardiac Events (MACE). Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.
Primary Outcome Measures: acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE) [ Time Frame: 1, 6, 12, 24 and 36 months ]
Device: CYPHER SELECT™ Sirolimus-eluting Coronary Stent
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Estimated Enrollment: 15000
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
The Intra-Drug Eluting Stent (DES) Restenosis Study (CRISTAL)
Cordis Corporation
A Prospective, Randomized, Multi-Center Comparison of the Cypher Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis.
Primary Outcome Measures: In stent late loss. [ Time Frame: between 9 - 12 months ]
Device: drug-eluting stent and balloon angioplasty
CYPHER Select ™ Sirolimus-eluting Stent and any balloon brand
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Estimated Enrollment: 320
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
The SCRIPPS DES REAL WORLD Registry
Scripps Health
This study is a prospective, non-randomized, open-label registry of consecutive patients with CAD treated by stent-assisted PCI using at least one CypherTM stent. Up to 1000 pts will be included in the registry. The registry is conducted for the evaluation of the impact of CypherTM Sirolimus-eluting stent implantation in the "real world" of interventional cardiology. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study specific procedures. Consecutive patients treated with the use of the CypherTM stent will be included in the registry. Baseline and post-procedure blood samples will be used to perform platelet function analysis using the Accumetrics Ultegra RPFA (Rapid Platelet Function Assay).
Device: Sirolimus-Eluting Bx Velocity Coronary Stent (CypherTM Sirolimus-Eluting Stent)
Primary Outcome Measures: 1 yr target vessel failure (TVF), defined as the occurrence of any of the following within 1-year after the index procedure: death from cardiac causes, Q-wave or non-Q wave MI attributable to the target vessel (TV), or revascularization of the TV. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 1000
Study Start Date: March 2005 [No end date given but actively enrolling patients]
TRIALS COMPLETE IN 2011
Diabetes Drug Eluting Sirolimus Stent Experience in Restenosis Trial (The Dessert Study) (DESSERT)
Cordis Corporation
The main objective of this study is to assess the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version in reducing angiographic in-stent late loss in de novo native coronary lesions of diabetic patients as compared to the bare metal Bx SONIC balloon-expandable stent.
Primary Outcome Measures: in-stent LL [ Time Frame: 8-month post-procedure ]
Device: CYPHER Sirolimus-eluting stent
Device: Bx SONIC bare metal stent
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Enrollment: 150
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents (ADAPT-DES)
Cardiovascular Research Foundation, New York
R. Stuart Dickson Institute for Health Studies
The frequency, timing and correlates (clinical and angiographic) of drug-eluting stent (DES) thrombosis in a patient population with few clinical and angiographic exclusion criteria, the relationship of aspirin and/or clopidogrel hyporesponsiveness, and general platelet reactivity to early and late DES thrombosis in separate phases stratified by whether the patient is taking dual (aspirin plus clopidogrel) or single (aspirin alone) antiplatelet therapy, and combining the findings from the above 2 objectives, to identify a cohort representing a significant proportion of all patients at increased risk to have early and/or late DES stent thrombosis.
Device: Drug -Eluting Stent (Taxus™, Cypher®, Endeaver™)
Prospective
Estimated Enrollment: 11000
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)
The purpose of this study is to compare 5-year mortality rates in diabetic individuals with multivessel coronary artery disease (CAD) who undergo either coronary artery bypass grafting (CABG) surgery or percutaneous coronary stenting.
National Heart, Lung, and Blood Institute (NHLBI)
Procedure: Coronary Artery Bypass Graft (CABG)
Primary Outcome Measures: Composite of all-cause mortality, non-fatal myocardial infarction, and stroke [ Time Frame: Measured through Year 5 ]
Device: Percutaneous Coronary Intervention (PCI) with Taxus or Cypher
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Estimated Enrollment: 2000
Estimated Study Completion Date: December 2011
Single Blind Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)
Medtronic Bakken Research Center
The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200 hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late stent thrombosis resulting in less deaths and myocardial infarctions
To compare overall stent thrombosis rate of the Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation [ Time Frame: 3 years ]
Health Services Research, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Estimated Enrollment: 8800
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Optimal Stenting Strategy For True Bifurcation Lesions (PERFECT)
CardioVascular Research Foundation, Korea
It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.
Primary Outcome Measures: To compare the outcomes for SES treatment of bifurcation lesions with either the simple technique (main vessel stenting with provisional T-stenting of the side branch) or the crushing technique (crush and final kissing balloon dilatation) [ Time Frame: 8 months ]
Crush technique vs. provisional T stenting with Cypher
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial
Duke University
Cordis Corporation
ACROSS-Cypher® is a prospective, multi-center, open label, single arm study of the Cypher® sirolimus eluting coronary stent in native total coronary occlusion revascularization. The primary endpoint is binary angiographic restenosis at 6 months. The TOSCA-1 trial will be used as the historical control. The hypothesis is that compared with TOSCA-1 patients who were treated with the heparin-coated Palmaz Schatz stent, treatment with the Cypher® sirolimus eluting coronary stent will result in a >50% relative reduction in 6 month restenosis within the treated segment of the target vessel.
Primary Outcome Measures: Angiographic binary restenosis (>=50% diameter stenosis) in TCO treated/working length compared with restenosis outcomes in the Total Occlusion Study of Canada (TOSCA)
Device: Cypher sirolimus eluting coronary stent
Estimated Enrollment: 480
Estimated Study Completion Date: August 2011
Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing (EXCELLENT)
Seoul National University Hospital
Abbott
Boston Scientific Corporation
Objectives
1. To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting coronary stent system(SECSS) (CypherTM, Cordis Johnson & Johnson, Warren, NJ) in the treatment of coronary stenosis.
2. To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with 12-month clopidogrel therapy.
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Device: Everolimus-eluting stent (Xience or Promus)
Device: Sirolimus-eluting stent (Cypher)
Drug: 6-month clopidogrel therapy
Drug: 12-month clopidogrel therapy
Primary Outcome Measures:
• In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
• Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea.
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Estimated Study Completion Date: June 2014
EXecutive: Evaluating XIENCE™ V in a Multi Vessel Disease
Abbott Vascular
The purpose of this study is the assessment of the performance of the XIENCE™ V Everolimus Eluting Coronary Stent System (XIENCE™ V EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary Artery Disease.
Device: Coronary artery placement of a [Xience V] drug-eluting stent
Primary Outcome Measures:
• In-stent Late Loss (LL) . [ Time Frame: at 270 days (9 months). ] [ Designated as safety issue: Yes ]
• Composite endpoint of all Death, MI (Q-wave and non Q-wave), and ischemia-driven Target Vessel Revascularization (TVR) . [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 600
Estimated Study Completion Date: September 2011
TRIALS COMPLETE IN 2012
Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT)
Associations for Establishment of Evidence in Interventions
This study is conducted to evaluate the procedural, short and long term clinical outcomes of the TAXUS Express2TM stent (TAXUS) in coronary arteries of > 2.5 and < 3.75 mm in the reference vessel diameter with a lesion of < 46 mm (by visual observation) compared to the CYPHER™ stent (Cypher) in routine clinical practice in Japan.
Device: TAXUS stent
Device: Cypher stent
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measures: Target Vessel Failure (TVF) at 8 months post-procedure in Overall study population [ Time Frame: 8 months ] Designated as safety issue: Yes ]
Estimated Enrollment: 3500
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Shanghai Registry of Acute Coronary Events
Shanghai Jiao Tong University of Medicine
SRACE is an multicenter observational database of outcomes for patients who are hospitalized with an acute coronary events. SRACE includes over 20 hospitals in Shanghai China that have enrolled a total of more than 3,000 patients since 2005, with an annual enrollment of 500 patients. The major purpose of the SRACE program is to evaluate the prognosis of patients admitted to the hospital due to acute coronary events, comparing different therapeutic strategies, in-hospital transferring system, and so on. All participating physicians receive confidential quarterly reports showing ther outcomes side-by-side with the aggregate outcomes of all participating hospitals.
Device: drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent
Primary Outcome Measures: major adverse cardiac events(MACE), including death, non-fatal re-MI, and target vessel revascularization [ Time Frame: in-hospital, 30d, and long-term follow-up ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 20000
Study Start Date: March 2005 [no completion date but actively recruiting patients]
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| Commenter: |
johnson, rere
|
| Date: |
9/26/2008 3:49:24 PM |
| Comment: |
NPlate is the only drug that has been targeted to help people with ITP which currently has no cure. The maintenance treatments are steroids which have side effects, infusions of IVIG which are very expensive and keeps plates at safe levels for one to two weeks. WinRho and Rituxan work to achieve remission is some cases but many do not reactive positively to these treatmets. Living with ITP is a constant worry. We need the NPlate drug to be given to anyone who has ITP as it is life saving and desperately needed. |
| Commenter: |
Moran, Brian
|
| Title: |
Medical Director |
| Organization: |
Chicago Prostate Center |
| Date: |
9/26/2008 4:04:12 PM |
| Comment: |
At the present time, there is absolutely no clinical data, either in randomized or retrospective analyses, which demonstrate an enhanced clinical outcome for the treatment of prostate cancer, whether it is with IMRT (external beam radiation) or proton beam therapy. Proton beam therapy has been used for the treatment of prostate cancer since 1996 at Loma Linda University in California. Since that time, there are now five centers that are up and running throughout the United States. Because of the significant reimbursement that Medicare allows for the treatment of prostate cancer with proton beam treatment, there will be continued interest and effort from the venture capital market to build more facilities (1). Unfortunately, third party investment dollars have never improved patient care. Without question, proton beam therapy does demonstrate a benefit to unique and unusual tumors such as ocular melanoma or pediatric brain tumors. In reality, while this treatment is potentially beneficial in unique settings, there is no doubt that a rapid increase in development of new proton centers will far exceed the need for appropriately selected patients. My concern is that there will soon be abuse of proton technology with very common cancers such as lung cancer and prostate cancer. Public data demonstrates a dramatic 2.4 times the cost of reimbursement for conventional x-ray therapy, however, without any additional clinical benefit (2). Brachytherapy for prostate cancer is without question the most cost effective treatment available (3). While Medicare will reimburse approximately $9,000 for permanent prostate brachytherapy, studies have shown brachytherapy to be approximately 7% superior to IMRT (4). Furthermore, it is known that IMRT is as effective as proton therapy for prostate cancer (5). Therefore, by logical deduction, brachytherapy is more effective than proton beam therapy. Yet, based on a patient’s preference, he can decide to choose a treatment that is much more costly to our health care system (6,7), which is already in dire straits. I find it hard to believe that CMS would continue allowing abusive practices of inappropriate patient selection with expensive technologies. CMS may consider implementing their least costly alternative (LCA) policy for treatment of localized prostate cancer similar to the LCA policy for hormonal or LHRH agonist therapy. Unless responsible, well-informed decisions are made regarding reimbursement, it is certain that the health care industry will soon suffer the ruin and embarrassment that our financial institutions have recently undergone.
Respectfully submitted,
Brian J. Moran, MD
References
1) Goitein, M. Magical protons? (2007) IJROBP editorial, Volume 70(3), 654-656.
2) Goitein M, Jermann M. (2003). The relative costs of proton and x-ray radiation therapy. Clin Oncol (R Coll Radiol); 15: S37-50.
3) Quang, TS, Wallner KE, Herstein P et al (2007). Technologic evolution in the treatment of prostate cancer. Oncology, 21(13), 1598-1604.
4) Cohen, G.N., Hunt, M., Shippy, A.M., Yamada, Y., Zaider, M., Zelefsky, M.J. (2007) Comparison of 7-Year Outcomes Between LDR Brachytherapy and High Dose IMRT for Patient With Clinically Localized Prostate Cancer. I. J. Radiation Oncology, Volume 69, Number 3, Supplement, 2007, S178.
5) Nguyen, P., Trofimov, A., Zietman, A., Proton- Beam vs Intensity-Modulated Radiation Therapy Which is Best for Treating Prostate Cancer? Oncology, Volume 22, Number 7, 748-754.
6) Beck, J. R., Hanlon, A, Konski, A, Pollack, A., Speier, W. (2007). Is Proton Beam Therapy Cost Effective in the Treatment of Adenocarcinoma of the Prostate? Journal of Clinical Oncology, Volume 25, Number 24, 3603-3608.
7) Goodman, Alice. (2007). Study: Proton Beam Therapy Found Costly but Not Necessarily Better for Prostate Cancer Still, Analysis Limited, So Results ‘Should Not Be Used as Final Answer to This Complex Question’. Oncology Times, 12-13.
|
| Commenter: |
Glisson, JoAnne
|
| Date: |
9/26/2008 4:07:22 PM |
| Comment: |
On behalf of the members of the American Clinical Laboratory Association (ACLA), I am writing to provide comments on the Centers for Medicare and Medicaid Services’ (CMS) Posting of Potential National Coverage Decision (NCD) Topics. ACLA is an organization representing clinical laboratories throughout the country, including local, regional and national laboratories. Our comments focus on gene expression profiling tests and pharmacogenomic testing, both of which are areas of interest to our members.
Gene expression profiling tests and pharmacogenomic testing offer great promise for changing clinical decision making, improving health outcomes and increasing the quality of patient care. However, as these tools are in their infancy, it would be premature to consider development of NCDs for these technologies. An NCD could have the unintended consequence of stifling further adoption of and advances in these technologies and inhibit economic incentives for laboratories to develop these tests.
ACLA appreciates the opportunity to comment on the potential NCD topics and supports CMS’ efforts to make the national coverage process more transparent to the public.
Sincerely,
JoAnne Glisson Senior Vice President
|
| Commenter: |
Rugo, Eric
|
| Title: |
Executive Director |
| Organization: |
Alliance for Orthopedic Solutions |
| Date: |
9/26/2008 4:40:33 PM |
| Comment: |
Dear Dr. Phurrough:
The Alliance for Orthopedic Solutions (“Alliance”) thanks you for this opportunity to comment on the Centers for Medicare & Medicaid Services’ (“CMS”) list of potential National Coverage Determination (“NCD”) topics. The Alliance is a national organization that collaborates with leading clinical experts and researchers in orthopaedics and includes the leading developers and manufacturers of innovative orthopaedic devices and implants. The Alliance is dedicated to ensuring that issues impacting orthopaedics, especially innovative technology and new orthopaedic treatments are given appropriate consideration in the formation of federal health care and reimbursement policy.
We were surprised to see hip resurfacing on CMS’ recently published list of potential NCD topics. This procedure, which is indicated for relief of pain and restoration of function in patients with degenerative joint disease of the hip, is clinically proven and non-controversial. Numerous payors have issued positive coverage determinations and the highly respected Blue Cross Blue Shield Technology Evaluation Center has concluded that total hip resurfacing “improves net health outcomes.” For these reasons, if CMS does initiate a National Coverage Analysis for hip resurfacing, we recommend that the agency issue a positive coverage determination for total hip resurfacing procedures that are performed with FDA-approved devices. Our comments are summarized below and discussed in greater detail in the following sections. In brief:
• Clinical benefits of total hip resurfacing are well-documented;
• There has been no controversy about whether payors should cover this procedure;
• The patient population that is a candidate for total hip resurfacing is clearly defined;
• For these reasons, we recommend that CMS not issue a NCD for hip resurfacing at this time;
• If the Coverage and Analysis Group does issue a NCD for this procedure, the NCD should establish coverage for total hip resurfacing performed with FDA-approved devices and clarify that providers should report the appropriate ICD- 9 codes that were specifically established for hip resurfacing procedures several years ago and which distinguish codes for total hip arthroplasty and total hip resurfacing procedures.
The ICD-9 codes are as follows:
81.51 Total Hip Arthroplasty
00.85 Resurfacing hip, total, acetabulum and femoral head
00.86 Resurfacing hip, partial, femoral head
00.87 Resurfacing hip, partial, acetabulum
For your convenience we have attached selected pages from the March 2006 ICD-9 Agenda which summarizes nicely, the Committee’s review of total hip resurfacing and rationale for establishing new ICD-9 codes (see attached). I. Existing Coverage Policies Are Uniformly Positive, Clearly Define Patient Population, and Document Benefits
Coverage policies for total hip resurfacing are almost uniformly positive. For example, Aetna “considers metal-on-metal hip resurfacing a medically necessary alternative to total hip arthroplasty for physically active members with osteoarthritis of the hip, or osteonecrosis of the femoral head.” The insurer notes
Compared to total hip replacement, femoral resurfacing allows preservation of much more of the patient's own bone. The advantages of femoral resurfacing over total hip replacement is that it is less invasive, there is reduced thigh pain since there is no stem in the femoral canal, and that it may allow patients to be more active (an advantage especially for younger patients because the risk of dislocation is theoretically reduced because of the larger ball.
Similarly, Regence writes
Metal-on-metal total hip resurfacing with a fully FDA approved total hip resurfacing device (e.g., the Birmingham Hip Resurfacing System and Cormet device), may be considered medically necessary when both of the following criteria are met:
A. Patient is likely to outlive a traditional prosthesis
B. Patient would otherwise require a total hip replacement
A partial list of other insurers that cover hip resurfacing includes –
• CareFirst; • CIGNA; • Harvard Pilgrim Health Care; • HealthPartners; • Humana; • Medica; and • UnitedHealthcare.
II. Technology Assessments Support Positive Coverage using FDA-Approved Devices
The Blue Cross Blue Shied Technology Evaluation Center (“BCBS TEC”) is considered one of the preeminent technology assessment organizations in the nation. Reports prepared by BCBS TEC not only guide the nation’s Blue Cross Blue Shield Plans, but are also frequently cited by other insurers and the Medicare program. As you may know, BCBS TEC evaluates procedures on five criteria:
1. The technology must have final approval from the appropriate governmental regulatory bodies.
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
3. The technology must improve the net health outcome.
4. The technology must be as beneficial as any established alternatives.
5. The improvement must be attainable outside the investigational settings.
In a June 2007 assessment, see attached, BCBS TEC determined that total hip resurfacing satisfies each of these criteria. It noted, “use of an FDA- approved metal-on-metal total hip resurfacing device as an alternative to THA [total hip athroplasty] in patients who are likely to outlive the 10 years or more functional lifespan of a traditional MoM [metal-on-metal] prosthesis meets the TEC criteria.” (Emphasis added.) Significantly, the assessment adds
[B]ased on published clinical experience with improved current generation MoM THA, and similar 5-year survivorship rates, HR [hip resurfacing] represents a safe and effective means to defer a first THA in properly selected patients who require a total hip replacement and are subsequently likely to require replacement of the ipsilateral hip due to normal wear processes.
The National Institute for Health and Clinical Excellence (NICE) has also issued a positive review of total hip resurfacing. After carefully reviewing this technology, NICE wrote “Metal on metal (MoM) hip resurfacing arthroplasty is recommended as one option for people with advanced hip disease who would otherwise receive and are likely to outlive a conventional primary total hip replacement.”
III. Recommendations
The benefit of total hip resurfacing is clear and well documented in the scientific and clinical literature. Accordingly, if CMS moves forward with a NCD, we strongly urge the agency to -
Issue a positive coverage determination for total hip resurfacing performed with FDA- approved devices, and
Clarify and inform providers to use the appropriate ICD-9 codes that were established by CMS’s ICD-9-CM Coordination and Maintenance Committee to distinguish total hip resurfacing procedures from total hip arthroplasty procedures.
Patients should continue to have access to total hip resurfacing procedures.
We appreciate your consideration of our comments.
Sincerely,
Eric Rugo Executive Director, Alliance
Attachments:
1. ICD-9-CM Committee Agenda and Review of Total Hip Resurfacing
2. BCBSA TEC Total Hip Resurfacing
|
| Commenter: |
Smith, Richard
|
| Date: |
9/26/2008 5:01:32 PM |
| Comment: |
Coverage and Analysis Group Centers for Medicare and Medicaid Services Mailstop: C1-12-28 7500 Security Boulevard Baltimore, MD 21244
Re: Potential NCD Topics
Dear Sir or Madam:
The Pharmaceutical Research and Manufacturers of America (PhRMA) appreciates this opportunity to comment on the list of potential NCD (national coverage determination) topics released July 30 by the Centers for Medicare and Medicaid Services (CMS). PhRMA is a voluntary nonprofit organization representing the country’s leading research-based pharmaceutical and biotechnology companies, which are devoted to developing medicines that allow patients to lead longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for cures. PhRMA appreciates the steps CMS has taken in recent years to improve the transparency and predictability of its national coverage process, including the finalization of a guidance document on “Factors CMS Considers in Opening a National Coverage Determination” in April 2006 and, more recently, release of the Innovators’ Guide to Navigating CMS in August 2008. In comments on the draft guidance on factors CMS considers in opening NCDs, PhRMA supported the proposal to maintain a current list of potential NCD topics, as well as CMS’ decision to provide in the list a brief explanation for how each item met the criteria described in the guidance document.
With several improvements, we believe a list of potential NCD topics could support the goal of a transparent, predictable national coverage process. Such transparency and predictability are important for medical research companies engaged in the development of biologics and pharmaceuticals. Specifically, CMS should:
1) Clarify the factors used by CMS for including specific items on the list; 2) Modify the items on the list, and the rationales provided, to ensure they are consistent with existing policy and clearly linked to the factors in the guidance document; 3) Describe the process CMS will use to keep the list current, and; 4) Maintain a list that is commensurate with CMS’ resources for coverage analysis.
Our detailed comments on the list are provided below.
1) Clarify the factors used by CMS for including specific items on the list.
CMS should clarify, in the introductory paragraphs of the list, the description of the factors the agency considers in generating internal NCD requests so that the proposed list reflects the description of factors in the April 2006 guidance document. In particular, the guidance describes four factors the agency will consider for “an existing technology already in use,” and three separate factors to be considered for “a new item or service, an existing item or service that has been substantially modified, or for a proposed new use of a covered product.”
The potential NCD list, in contrast, condenses the descriptions of these circumstances and describes them as a single list of seven factors, without distinguishing between existing items and services and new items and services. In order to foster clarity and consistent application of these factors, CMS should include in the potential NCD list the entire text from the April 2006 guidance document describing the seven factors, or alternativel | | | | |
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