National Coverage Analysis (NCA) View Public Comments

Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis

Public Comments

Commenter Comment Information
Carome, Michael Title: Deputy Director, Health Research Group
Organization: Public Citizen
Date: 04/15/2011
Comment:

April 15, 2011

Louis B. Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail Stop S3-02-01
Baltimore, Maryland 21244

RE: Proposed Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis (CAG-00413N)

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Ofman, Joshua Title: Vice President
Organization: Amgen
Date: 04/15/2011
Comment:

April 15, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memorandum for Erythropoiesis Stimulating Agents for Treatment of Anemia in Adults with Chronic Kidney Disease Including Patients on Dialysis and Patients Not on Dialysis (CAG-00413N)

Dear Dr. Jacques:

Amgen

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Short, Larri Title: Outside Counsel
Organization: National Patient Advocate Foundation
Date: 04/15/2011
Comment:

April 11, 2011

Louis B. Jacques, M.D.
Director, Coverage and Analysis Group
Elizabeth Koller, M.D.
Lead Medical Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop S3-02-01
7500 Social Security Boulevard
Baltimore, MD 21244

Re: CAG #00413N: Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients Not on

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Fehmi, Hassan Date: 04/15/2011
Comment:
With additional restrictions on the use of ESAs the patients will likely become more anemic before they can be treated. One may resort to correcting iron deficiency without administering an ESA, however there is absolutely no data to support this approach. I personally believe patients will become more symptomatic and will end up getting more cardiac and other complications leading to additional use of resources and associated cost burden to the health system.
Burton, LaVarne Title: President and CEO
Organization: American Kidney Fund
Date: 04/15/2011
Comment:

March 31, 2011

Kimberly Long/Elizabeth A. Koller, M.D.
Centers for Medicare and Medicaid Services
Mail Stop C1-09-01
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Ms. Long and Dr. Koller:

The American Kidney Fund (AKF) appreciates the opportunity to provide comments on the Proposed Decision Memorandum for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not

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Wish, Diane Title: President
Organization: National Renal Administrators Association
Date: 04/15/2011
Comment:

April 15, 2011

Kimberly Long/Elizabeth A. Koller, M.D.
Centers for Medicare and Medicaid Services
Mail Stop C1-09-01
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Ms. Long and Dr. Koller:

The National Renal Administrators Association (NRAA) is pleased to provide the Centers for Medicare and Medicaid Services (CMS) comments on the Proposed Decision Memorandum recently issued as part of its National Coverage Analysis for

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Smedberg, Paul Title: Director, Policy and Public Affairs
Organization: American Society of Nephrology
Date: 04/15/2011
Comment:

April 15, 2011

Centers for Medicare and Medicaid Services

RE: Administrative File: CAG # 00413N Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis

To whom it may concern:

On behalf of the American Society of Nephrology (ASN), a not-for-profit organization of more than 12,000 physicians and scientists dedicated to promoting excellence in the care of patients

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Hartwell, Lori Title: President and Founder
Organization: Renal Support Network
Date: 04/14/2011
Comment:

Renal Support Network
1311 N. Maryland Ave.,
Glendale, CA 91207
April 15, 2011

Kimberly Long
Elizabeth Koller, MD
Centers for Medicare and Medicaid Services
Mail Stop C1-09-01
7500 Security Boulevard
Baltimore MD 21244-1850

Reference: Proposed Decision Memorandum for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis CAG# 00413N (Proposed Decision

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Szczech, Lynda Organization: National Kidney Foundation
Date: 04/14/2011
Comment:

April 14, 2011

Donald M. Berwick, MD, Administrator,
Centers for Medicare and Medicaid Services
200 Independence Ave., SW - Mailstop 314G
Washington, DC 20201

RE: National Coverage Analysis (NCA) for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis (CAG-00413N)

Dear Dr. Berwick:

On March 16, 2011, the Centers for Medicare and Medicaid Services

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Phillips, Steve Title: Director, Health Policy
Organization: Johnson & Johnson
Date: 04/14/2011
Comment:

April 15, 2011

From:
Robert Bazemore, Jr.
President, Centocor Ortho Biotech Inc
800 Ridgeview Drive
Horsham, PA 19044

To:
Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with Chronic Kidney Disease (CKD)

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Ryals, Karen Title: Executive Director
Organization: American Association of Kidney Patients
Date: 04/14/2011
Comment:

Re: AAKP’s Comments on Proposed Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis (CAG # 00413N)

Dear Dr. Jacques and other members of the Coverage and Analysis Group:

AAKP applauds you for your proposed decision to not issue a national coverage determination for erythropoiesis stimulating agents (ESAs) for the treatment of anemia in adults at all stages of

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Blaser, Robert Date: 04/14/2011
Comment:

April 13, 2011

Louis Jacques, MD
Director, Coverage Analysis Group
Office of Clinical Standards and Quality,
Centers for Medicare and Medicaid Services
Mailstop S3-02-0
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis (CAG-00413N)

Dear Dr. Jacques,

The

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Hubsher, Jay Title: Nephrologist
Organization: Nephrology Medical Associates
Date: 04/13/2011
Comment:
I believe EPO/PROCRIT/ARANESP have been extremely helpful in taking care of my CKD patuients. Almost EVERY study done looking at quality of life show significant improvement in QOL with ESA's. There certainly have been downsides in studies but risk/benefit in my experience is HIGHLY in favor of their use and I believe strongly they should be covered for CKD patients.
webb, Martin Date: 04/13/2011
Comment:
I would like to applaud CMS for deciding that a National coverage Decision is not needed for ESAs in Nephrology.
BESARAB, ANATOLE Title: Director of Clinical Research , Div of nephrologyb
Organization: Henry Ford health System
Date: 04/13/2011
Comment:

I am very concerned about any change to the current recommendations for a change in the Hb range of management. For years I have argued that the range has been made to narrow (was 11-12 per NKF and then 10-12 g/dL per FDA guidelines) and that there is absolutely no data that states that patients with

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Brunelli, Steven Date: 04/12/2011
Comment:

Dear Members of the Committee:

I laud the Committee’s proposed decision not to render a national coverage determination (NCD) for the use of erythropoiesis stimulating agents (ESAs) for treatment of anemia in adults with CKD. As medical director of a small, hospital based unit, I recognize the importance of ESAs in the ongoing management of hemodialysis patients.

I respectfully disagree with the Committee’s commentary on the status of the evidence regarding the effects

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Scott, Nancy Title: Board President
Organization: Dialysis Patient Citizens
Date: 04/11/2011
Comment:

Dialysis Patient Citizens (DPC) would like to thank the Centers for Medicare and Medicaid Services (CMS) for its recent decision not to issue a National Coverage Determination (NCD) for the use of erythropoiesis stimulating agents (ESAs) to manage anemia in patients who have chronic kidney disease (CKD). We believe this is a positive move for kidney patients because it places no extra barriers for patients and physicians to make decisions about the treatment of anemia. With over 22,000

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Miranda, Katherine Title: Executive Director
Organization: American Society for Histocompatibility and Immunogenetics
Date: 04/11/2011
Comment:

The American Society for Histocompatibility and Immunogenetics (ASHI) supports the Proposed Decision Memorandum issued by CMS in regard to the use of Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis (CAG-00413N). ASHI agrees that a national coverage determination should not be made at this time. We would like to reiterate our position that blood transfusions can sensitize patients with CKD to HLA

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Krevolin D.O., Larry Date: 04/10/2011
Comment:
The use of ESA's has become a necessary part of the medical management of our patients with CKD and ESRD. Excellent data exists that demonstrates improved outcomes (hospitalizations, morbidity and mortality, improved SIP and KDQ scores) with judicious use of ESA's. Further government intrusion will only hamper our ability to manage our patients. In the late 90's, the HMA decision had to be revised after there was a noticeable decline in patient H/H.
Lester, Kathy Organization: Kidney Care Partners
Date: 04/07/2011
Comment:

April 7, 2011

Kimberly Long
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244-1850

Elizabeth A. Koller, M.D.
Centers for Medicare and Medicaid Services
Mail Stop C1-09-01
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Ms. Long and Dr. Koller:

On behalf of Kidney Care Partners, I would like to thank you for the opportunity to comment on the

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Cotter, Dennis Title: President
Organization: Medical Technology & Practice Patterns Institute (MTPPI)
Date: 04/05/2011
Comment:

April 6, 2011

Dennis Wagner
Acting Director
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 2 1244

RE: Proposed Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis (CAG-00413N)

Dear Mr. Wagner:

The CMS National Coverage Determination

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