ESA

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• June 4, 2007 at 2:36 am #18466
  KATHY1

  Member

  Just thought this might interest some of you. Hope you are all doing well.

  Kathy

  May 31, 2007

  Urgent Advocacy Alert Regarding an Important Drug for Patients – Your Action is Needed Now!
  As you may have heard in the news and from recent AA&MDSIF ebulletins, the Food and Drug Administration (FDA) earlier raised some concern about the use of erythropoiesis-stimulating agents (ESAs), also known as growth factors, that treat anemia. However, the FDA’s concerns affected cancer and kidney patients, not patients with bone marrow failure. In the Spring, after the FDA issued its new warning about the use of growth factors, the Centers for Medicare and Medicaid Services (CMS) also began to examine its coverage for growth factors. Unfortunately CMS proposed no longer covering growth factors for myelodysplastic syndromes (MDS) when it issued, on May 14, its “Proposed Coverage Decision Memorandum for the Use of Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions.” (CMS has also proposed not covering ESAs for other non-bone marrow failure conditions.) Many MDS patients are currently being treated with ESAs, reducing or eliminating their need for transfusions, and research supports the use of ESAs for patients with bone marrow failure. As noted in the background information (click here), the AA&MDSIF is firmly opposed to CMS’s proposed coverage policy on MDS.

  The public comment period ends on June 13, so it is critical you contact CMS and your Congressional representatives and senators in Washington, quickly telling them of your opposition to the CMS proposal. Sample letters and talking points are provided below.

  It is imperative that all MDS patients and caregivers contact CMS and their elected officials even if they are not on Medicare because many private insurers follow CMS’ policies.

  Click here for sample letters, talking points, and links to CMS and your three Congressional representatives.

  Remember – all comments to CMS must
  be received by June 13. Please ACT NOW!

  How You Can Make a Difference!
  Please help AA&MDSIF in our advocacy efforts to reverse these proposed changes in Medicare coverage, changes that may be adopted by private insurance companies as well. Whether you or a loved one is now personally affected by this policy change or not, you may be later. We encourage you, as someone affected by bone marrow failure, to take action and make a difference in two ways:

  1. Submit a public comment to the Centers for Medicare and Medicaid Services (CMS) Wednesday, June 13, the close of the public comment period. Tell your personal story, and describe how you may be personally affected if Medicare no longer covers growth factors for your disease. Click here to submit your comment.

  2. Contact your Members of Congress and urge them to make sure that CMS makes all decisions about what drugs to cover according to the current medical research. Please click the links to determine who represents you in the U.S. House of Representatives and the U.S. Senate.

  Below is a sample letter that can be used. Please email or fax your letter to your Representative and Senators. Please do NOT send mail sent via the U.S. Postal Service or courier service, as it must be irradiated and can take four weeks to deliver to Congressional offices.

  SAMPLE LETTER

  Dear (Member of Congress):

  I am writing to express my concerns about a recent proposal by the Centers for Medicare and Medicaid Services (CMS) to remove Medicare coverage for erythropoiesis-stimulating agents (ESAs) for the treatment of anemia of myelodysplasia or myelodysplastic syndromes (MDS).

  (TELL PERSONAL STORY ABOUT HOW YOU OR YOUR LOVED ONE HAS MDS AND HOW YOU WANT TO MAKE SURE IT IS AVAILABLE WHEN YOU OR YOUR LOVED ONE NEEDS IT. EXPLAIN IF YOU HAVE EVER TAKEN GROWTH FACTORS AND THE BENEFITS OF THE GROWTH FACTORS IF THAT IS THE CASE.)

  Recent concerns have been raised by both CMS and the Food and Drug Administration (FDA) about the overuse of ESAs in treating anemia that results from chemotherapy. These concerns may be valid for other disease groups, but, as the FDA noted, they do not apply to individuals like me/my loved one suffering from bone marrow failure diseases like MDS. As the Aplastic Anemia and MDS International Foundation, the MDS Foundation, and the American Society of Hematology all noted in their public comments to CMS, several studies support the use of ESAs in MDS patients. No adverse effects from the use of ESAs in this patient population are known, and ESAs have a preferable risk-benefit ratio compared to blood transfusions. Studies used by CMS to justify their findings did NOT include MDS or other bone marrow failure disease patients.

  CMS’s ESA coverage proposal with respect MDS is simply not supported by science. On behalf of your constituents affected by this proposal, please contact CMS and remind CMS that they must make their decisions based on scientific research and that you support preserving Medicare coverage of ESA treatment for MDS. Without proper scientific justification, CMS must not change its coverage policy for this vital medical treatment.

  Sincerely, {Your Name}

  What the AA&MDSIF Is Doing
  We are thoroughly examining the proposed policy and preparing comments to be submitted to CMS opposing their change.
  We are planning to meet with CMS officials to clearly state the impact of the proposed policy on MDS patients and why ignoring scientific evidence is harmful to patients and a poor precedent.
  We have met and are continuing to meet with key members of Congress to express our opposition to this change and to seek their support. Several key members have already expressed their support for our position.
  We are working with the American Society of Hematology – the physicians’ society – and other organizations to coordinate our respective efforts.
  We are working with the media and and op-ed articles for media outlets.
  We are issuing “Advocacy Alerts” to everyone on our email lists seeking assistance.
  For More Information on this issue visit http://www.aamds.org/EPO.

  July 25, 2007 at 11:53 pm #18467
  yvonne

  Member

  I am new to the forum and joined primarily to find out about the CMS devastating proposal to stop funding ESAs for MDS patients. My husband’s life was saved by Procrit when he began treatments in February 2007 and now he may be in danger again. His hematologist didn’t tell us about the threat until a regular July 16 office visit! And he has already cancelled all future treatments. Since we missed the public comment period, is there any use in appealing to our congressional reps? Is there anything we can do at this late date?

  July 26, 2007 at 2:52 am #18468
  Zoe

  Member

  Yvonne,

  Here is some updated info.

  Zoe

  URGENT eAlert on Medicare and ESAs

  July 20, 2007

  We are pleased to announce that U.S. Representative Richard Neal (D-MA) has agreed to circulate a letter among his colleagues on the House Ways and Means Committee urging the Centers for Medicare and Medicaid Services (CMS) to preserve coverage of ESAs for the treatment of myelodysplastic syndromes (MDS).

  As you may know, on May 14, CMS issued a proposed decision memorandum in which it recommended that ESAs like Procrit® and Epogen® no longer be covered by Medicare for “the anemia of myelodysplasia.” On June 13, the Aplastic Anemia & MDS International Foundation (AAMDSIF) submitted public comments and strongly objected to this proposed coverage change. The Foundation also met with CMS staff to reiterate the importance of ESAs for people with bone marrow failure.

  Since that time, AA&MDSIF has been seeking support from key Members of Congress to keep ESA coverage. We are talking to staff of Members serving on the Ways and Means Committee.

  To complement our efforts, we need your immediate assistance. CMS will be finalizing its decision any day now. Please see the list of Ways and Means committee members below. If you are from the home state of one of these members, please contact them and urge them to sign on to the letter that is being circulated by Rep. Neal. If you are currently using ESAs, please let them know how CMS’ decision would personally impact you and your family.

  When you call your Member of Congress, please ask to speak to the legislative assistant who handles health care!

  Thank you very much for your help, and please call the Foundation if you have any questions about this crucial issue.

  Alabama
  Artur Davis 202.225.2665

  California
  Xavier Becerra (202) 225-6235
  Wally Herger (202) 225-3076
  Devin Nunes (202) 225-2523
  Pete Stark (202) 225-5065
  Mike Thompson (202) 225-3311

  Connecticut
  John Larson (202) 225-2265

  Florida
  Kendrick Meek (202) 225-4506

  Georgia
  John Lewis (202) 225-3801
  Jon Linder (202) 225-4272

  Kentucky
  Ron Lewis (202) 225-3501

  Illinois
  Rahm Emanuel (202) 225-4061
  Jerry Weller (202) 225-3635

  Louisiana
  Jim McCrery (202) 225-2777

  Maryland
  Chris Van Hollen (202) 225-5341

  Michigan
  Dave Camp (202) 225-3561
  Sander Levin (202) 225-4961

  Minnesota
  Jim Ramstad (202) 225-2871

  Missouri
  Kenny Hulshof (202) 225-2956

  New Jersey
  Bill Pascrell (202) 225-5751

  Nevada
  Shelley Berkley (202) 225-5965
  Jon Porter (202) 225-3252

  New York
  Joe Crowley (202) 225-3965
  Michael McNulty (202) 225-5076
  Charles Rangel, Chairman (202) 225-4365
  Tom Reynolds (202) 225-5265

  North Dakota
  Earl Pomeroy (202) 225-2611

  Ohio
  Stephanie Tubbs Jones (202) 225-7032
  Patrick Tiberi (202) 225-5355

  Oregon
  Earl Blumenauer (202) 225-4811

  Pennsylvania
  Phil English (202) 225-5406
  Allyson Schwartz (202) 225-6111

  Tennessee
  John Tanner (202) 225-4714

  Texas
  Kevin Brady (202) 225-4901
  Lloyd Doggett (202) 225-4865
  Sam Johnson (202) 225-4201

  Virginia
  Eric Cantor (202) 225-2815

  Washington
  Jim McDermott (202) 225-3106

  Wisconsin
  Ron Kind (202) 225-5506
  Paul Ryan (202) 225-3031

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  AA&MDSIF, P.O. Box 310 Churchton, MD 20733 U.S.A. | 800.747.2820

  July 30, 2007 at 8:23 pm #18469
  yvonne

  Member

  Zoe,
  Thank you so much for the info. I wrote a letter and hand delivered it to our local Congressman asking him to urge the committee member from Virginia to support the letter and to oppose the CMS plan. The Congressman’s staff was very interested and had not heard about it until then. I also called the Virginia representative on the committee and asked my friends and family to do so also.

  Thanks again.

  Yvonne

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