April 11, 2007

RE: National Coverage Analysis for Erythropoiesis
Stimulating Agents (ESAs) for Non-Renal Disease
Indications (CAG-00383N)

Dear Ms. Ciccanti:

The Cancer Research and Prevention Foundation
(CRPF) ap   More...

The summary statement of the FDA black box
warning for ESAs is a reasonable one and provides
appropriate guidance for physicians. However, the
evidence for safety concerns should not be
overstated and does not in any way diminish t   More...

I previously submitted a comment suggesting that CMS does not have the authority to limit reimbursement for ESAs for non-renal disease indications based on toxicity concerns since this is a therapuetic decision, not an issue of medical reasonablen   More...

April 9, 2007

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis fo   More...

April 12, 2007

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 h   More...

As a practicing Medical Oncologist in Florida, I
would like to say that our elderly patients often
have prolonged anemia and cytopenias for many
months post-chemotherapy. "Older" bone marrows
with less reserve cannot recover from    More...

It is important to clarify:

1. If a patient is anemic from his cancer and is
to start chemotherapy for treatment, is it
reasonable to start Aranesp or Procrit on the
same day as initiating chemotherapy? I suggest
that it is   More...

Limiting the payment of ESAs for the use
particulary in myelodysplastic and other non-
renal disorders would be penny-wise and pound
foolish. Theses agents can reduce iron overload
by limiting transfusion requirements. They have <   More...

We are concerned about the possibility of CMS
defunding the use of recombinant erythropoietins
in patients with myelodysplasia. We believe that
these medications play a useful role in the care
of our patients and that the alternati   More...

There are some patients with cancer off chemotherapy who have a
non specific anemia who when treated with ESAa can be maitained
without transfusions

April 25, 2007

Centers for Medicare & Medicaid Services
Department of Health and Human Services

Dear CMS:

These comments are submitted by the Ohio\West
Virginia Hematology Oncology Society in response
to the propose   More...

The current use of ESAs for none renal disease,
including MDS,ACD,and Chemo/Radiation IS
appropriate and benefical as it cuurently
stands,prior to any proposed changes. I concure
that Hgb levels above 12 are not appropriate, but
tha   More...

Attached is a copy of the comments which were filed electronically this afternoon on the NCA for Erythropoiesis Stimulating Agents (ESAs) for
non-renal disease indications (CAG-00383N). The attachments described in the letter are included.    More...

April 13, 2007


To: Center for Medicare and Medicaid Services


I am the president of Atlanta Cancer Care, a
large hematology/oncology practice located in
Atlanta, Georgia. Annually, our providers treat
4,000 newly d   More...

As a medical oncologist in Sarasota, Florida I
see daily that it is imperative that our cancer
patients contniue to have access to epo growth
factors up to 1 year after chemotherapy. These
patients, especially the elderly have ong   More...

On behalf of patients with rare bone marrow
failure diseases, the Aplastic Anemia & MDS
International Foundation (AA&MDSIF) is submitting
its comments to CMS for its National Coverage
Analysis (NCA) on the administration of
ery   More...

You state, "CMS emphasizes that NCA comments are
expected to focus on “evidence of studies
regarding the NCD issue under review.”"

We respectfully and strongly urge you to delay
any decision until after the FDA's Oncologic
D   More...

If there is potential that the LCD for sure and
possibly the NCD will be a dual diagnosis
requirement and Aranesp is typically given for
the treatment of anemia due to whatever
specified cause.

Why would the the anemia code   More...

Thank you for the opportunity to comment re: non-
renal disease indications for ESA's. I
represent a large oncology practice that treats
a broad spectrum of patients with malignancies
and blood disorders. We submit the following <   More...

The present ESA policy does not allow
pretreatment of patient who needs chemotheratpy.
Sometimes the patient who has not yet started on
Chemotherapy but needs chemotherapy and has low
hemoglobin level needs his hemoglobin level to    More...

I feel post chemotherapy use of ESAs should be
for a duration of 1 year as many patients remain
or develop worsening anemia up to 1 year after
completion of chenotherapy and usually benefit
from ESA's. I have experience doing this    More...

On March 9, 2007, the FDA announced strengthened
safety warnings for the use of Erythropoiesis-
Stimulating Agents (ESAs). The issued alerts and
warnings refer to the use of ESAs for a number of
clinical conditions including cancer    More...

ESA's are extremely important for the treatment
of myelodysplastic syndromes. As a hematologist
many of my patients with this disorder live a
very functional life due to the increase in
hematocrit using these agents. Short of thi   More...

While I agree that further study is needed I do
feel that these agents have done a great deal to
improve the quality of life and reduce
transfussion dependency (not to mention reduce
exposure to diseases). It seems logical to
c   More...

I believe that ESA's are overprescribed,
overutilized, and overpriced. Patients and
taxpayers are being gouged by the makers of this
product, which is not cost-effective. In
addition, the companies manufacturing and
distributin   More...

April 12, 2007

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244
<   More...

We request that the diagnosis coverage be one
that allows the ICD-9 codes to establish the
reasons for treatment vs having to submit so
much additional data on the claim (such as HCT,
signs, symptoms, chemo drugs, etc)


   More...

I am a medical oncologist and feel the need for
ESAs is important in the treatment of many of my
patients. There need to be strict parameters for
their use, but I feel the benefit far outweighs
the risks if they are used appropria   More...

CMS should consider coverage for ESA use in
myelodysplastic syndromes(MDS).

ESA use in MDS was apparently not included in
the Amgen study upon which the FDA decision was
made.(I reviewed the criteria for the study entry
on   More...

ESA's such as Procrit and Aranesp are essential
for maintaining the quality of life of patients
following chemotherapy. In older adults the bone
marrow may take longer to recover. Limiting the
time ESA's can be used post chemothera   More...

As a practicing Medical Oncologist in a large
practice in Florida I would like to state
emphatically that in my elderly patients post
chemotherapy ESAs are extremely important for
maintaining an adequate Hemoglobin level and
mi   More...

It is important that any change in policy
include modifications to the ICD codes.
Currrently, there is only one approved choice
for non-renal use of ESAs: 285.22. We have to
use this for both chemo induced anemia as well
as    More...

The policy should not have been changed at all.
All the changes that have already been made
affect oncology and hematology patients that
have benefited from the use of these drugs.

Dear Dr. Koller, Dr. Feinglass and Ms. Ciccanti:

The Medical Oncology Association of Southern
California represents more than 350 oncologists
in California. Since 1990 the mission of the
Medical Oncology Association of Southern   More...

The recent changes in your policy regarding the use of erythropoietin stimulating agents (ESAs) would pose a significant problem for patients who have anemia of chronic disease. These patients were excluded from the new criteria detailed in our Lo   More...

I am a physician and on the CAC for vermont. I
would also ask that we consider a delay in
therapy in addition/or instead of a dose
reduction when possible. I find that some pts
continued on the same dose of aranesp given
ever   More...

I am a practicing Hematologist. I treat patients with inflammatory conditions, especially Chrohn's, and Rheumatois Arthritis, with erythropoietin and, when necessary, iron. I no longer have to give blood transfusions to these patients. I am confid   More...

I feel strongly that anemia frm cancer should be
covered. Many patients are anemic from thier
disease yet are not recieving chemotherapy. The
adverse ffects from recent studies occured
because the high hemogloblins attempted. Th   More...

The Medical Oncology Society of New Jersey
represents almost all of the practicing medical
oncologists and hematologists in NJ. We feel
that unless there is good supporting clinical
study information that the current
erythropo   More...

As a member of International Oncology Network’s
(IONs) Large Practice Advisory Committee, we ask
that you consider the following when determining
the allowance and reimbursement for
erythropoiesis stimulating agents (ESAs).

   More...

Whether for non kidney disease or kidney disease
there needs to be not only protection but a means
to conduct studies for those of use who do not
have MD after our names, but do have the benefit
of small scale research studies which m   More...

The Medical Oncology Association of Southern
California (MOASC)represents more than 350
Oncologists in California. Since 1990 the mission
of MOASC is to advance and protect the ability of
cancer patients to obtain, and the ability    More...

The use of epos in clinical practice is justified
and supported by data--as long as appropriate
guidelines are followed. Anemia is a costly
toxicity when induced by chemotherapy resulting
in overwhelming fatigue limiting activitie   More...

AMERICAN ASSOCIATION OF KIDNEY PATIENTS RESPONDS TO FDA BLACK BOX WARNING ON ESAs

Tampa, Fla.- Today the American Association of Kidney Patients (AAKP) issued a response to the recent Food and Drug Administration’s (FDA) warning ad   More...

As a nurse delivering care to oncology patients, I have seen a
visible difference in quality of life -voiced by less fatigue and more
energy, ability to acitivites of daily living. Much less use of blood
transfusions for anemia with t   More...

Please be sure to maintain coverage for
myelodysplasia. Many of my patients would be
forced back onto weekly transfusions and very
expensive Exjade (to chelate iron) in the absence
of this coverage.
Eric Seifter

Thank you for allowing me to respond to these
changes in Medicare policy in regard to red cell
growth factors. As you know, the institution of
growth factors has not only made a huge
improvement in the quality of life and reduced    More...

Many patients with CML on Gleevec develop anemia
as a complication of the drug therapy, even
though they may be in a complete cytogenetic
remission. For these patients, Aranesp may be an
effective way to support their Hgb at a safe   More...

As a medical oncologist who has successfully
treated dozens of patients with ESAs for non-
renal disease indications I am dismayed that CMS
has made the determination not to pay for this
class of drugs for many of my patients. Becau   More...

While I would agree that ESAs are often over-
used, there are clearly patients w/
myelodysplastic syndromes, anemia of chronic
disease and other cancer related anemias who
respond well to the ESAs and no longer require
transfusi   More...

This comment is from Hematology Oncology
Managers of New York, HOMny:
HOMny is an educational organization for
hematology and oncology practices in the state
of New York. We are responding during the
comment period regarding th   More...

The decision not to cover ESAs for myelodysplasia
is a terrible one which will impact many such
patients with low risk disease. There is no
evidence this intervention is detrimental to this
unique population, and impairment of qual   More...

I am an oncology certified nurse working in this
field for 17 years. Since we started using ESAs
we have seen a significant improvement of our
patient's quality of life, both on and off
chemotherapy. We have also seen a significa   More...

I care for many patients undergoing chemotherapy
for cancer. They frequently develop serious and
symptomatic anemia during or after therapy. This
consequence of chemotherapy can be effectively
treated with ESA's. It is my opinion   More...

As a practicing Medical Oncologist in a busy
practice in Florida I would like to state
emphatically that in elderly patients post
chemotherapy ESAs are extremely vital for
maintaining an adequate Hgb level, and hence
performanc   More...

Y-ME National Breast Cancer Organization believes
that breast cancer patients deserve access to
medications necessary both to treat their disease
and to combat serious side effects.
Erythropoiesis Stimulating Agents (ESAs) enable    More...

The optimal duration of Procrit use post
chemotherapy completion is not determined by an
arbitrary length of time, but by the recovery of
the hemoglobin. Some patients will require more
than the current proposed 90 day duration of    More...