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 Public Comments
Commenter: Cotter, Dennis
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
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
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
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
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.



Commenter: harkaway, paul
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



Commenter: kluck, bryan
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
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
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.



Commenter: Richards, Mark
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.



Commenter: whitt, william
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 ....



Commenter: Greening, Gayla
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
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?



Commenter: Davis, Michael
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.



Commenter: Lamborn, Homer
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



Commenter: Stewart, Ronald
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.
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.



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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. A significant percentage of “beam time” in the operating facilities is dedicated to research. This research will cease if the proton centers close down.
  7. 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.
  8. 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




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
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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
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6) Ortolani P, Ardissino D, Cavallini C, et al.
Effect of sirolimus-eluting stent in diabetic
patients with small coronary arteries (a SES-
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(10):1393-8. Epub 2005 Sep 27

ISAR SMART
7) Mehilli J, Dibra A, Kastrati A, et al.
Randomized trial of paclitaxel- and sirolimus-
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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
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of the DIABETES trial. European Heart Journal. 28
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10) Sabate M, Jimenez-Quevedo P, Angiolillo DJ.,
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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
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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)
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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
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al. Drug-eluting compared with bare-metal
coronary stents among elderly patients. J Am Coll
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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.
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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
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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
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in posterolateral lumbar fusions. Eur Spine J.
2005 Sep;14(7):623-9.

Vaccaro AR, et al. A pilot study evaluating the
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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]



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