Medicare may restrict access to growth factors -- unless we speak up

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What happened

In March 2007 the U.S. Food and Drug Administration (FDA) issued a "Public Health Advisory" about growth factors used to treat anemia resulting from chemotherapy. (Growth factors are also called ESAs, for erythropoiesis-stimulating agents.)

The FDA's concerns were based on studies of patients with conditions other than bone marrow failure such as chronic kidney failure.

Many MDS patients are currently being treated with growth factors (Aranesp, Epogen, Procrit) to reduce or eliminate their need for transfusions. While the FDA's concerns may be legitimate for those other diseases, the findings do not appear to be relevant to bone marrow failure diseases. Scientific research continues to support the use of growth factors for patients with bone marrow failure diseases.

The problem

Despite the scientific evidence, the Centers for Medicare and Medicaid Services (CMS) reviewed its coverage for growth factors and on May 14 proposed that growth factors no longer be covered for cancer, chronic kidney failure, and other diseases such as MDS.

The proposal is called "Proposed Coverage Decision Memorandum for the Use of Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions (CAG-00383N)."

This proposal could affect all MDS patients. If you are on Medicare, this proposal could remove coverage you currently have. If you have other insurance, it could still affect you because many private insurers follow the CMS policies and could drop coverage for growth factors.

What you can do about it

There are three actions you can take. Instructions are in the next post below.

1. Contact the CMS, which is accepting public comments on this issue through June 13.
2. Contact your representatives in Washington, DC to tell them of your opposition to the CMS proposal.
3. Spread the word that others should do the same.

This kind of advocacy campaign by patients can and does work. We urge all MDS patients and their family members in the U.S. to take these steps to let the CMS and Congress know your opinion.

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How to send comments to the CMS

Let the Centers for Medicare and Medicaid Services know your opinion about the proposal CAG-00383N.

To comment on this proposal, use their public comment form. You must submit this form by Wednesday, June 13.

The CMS wants individual messages, not form letters, so tell your personal story and describe how you would be personally affected if you no longer had coverage for growth factors for MDS.

Make it clear that you oppose the proposed change because it would apply to MDS.


How to contact your congressional representatives

Urge your representatives to make sure that CMS decisions about drug coverage are based on the latest medical research, and ask them to oppose the CMS proposal that could lead to loss of Medicare coverage for growth factors used in treating MDS.

You can find your representatives here:

U.S. House of Representatives

U.S. Senate

Below is a sample letter you can use.

Email or fax your letter to your Representative and Senators. Do not send postal mail or courier mail because mail delivered to Congressional offices must be irradiated and can take weeks to arrive. This is a time-sensitive issue!

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). The proposal title is "Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications (CAG-00383N)."

(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 noted by the Aplastic Anemia and MDS International Foundation, the MDS Foundation, and the American Society of Hematology 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 patients with bone marrow failure diseases.

CMS's ESA coverage proposal is simply not supported by science with respect to MDS. On behalf of your constituents affected by this proposal, please contact CMS and remind them 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 MDS treatment.

Sincerely,
(Your Name)

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Organizations opposing the proposal

A number of medical organizations, as well as individual physicians, oppose the CMS proposal. Many have issued statements or written letters stating their reasons.

Among them:

• American Society of Clinical Oncology
• Amgen, Inc.
• Aplastic Anemia & MDS International Foundation (see their Urgent Advocacy Alert for All MDS Patients)
• Association of Community Cancer Centers
• Community Oncology Alliance
• National Patient Advocate Foundation (letter1, letter2)

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Originally Posted by Marrowforums

The Centers for Medicare and Medicaid Services (CMS) reviewed its coverage for growth factors and on May 14 proposed that growth factors no longer be covered for cancer, chronic kidney failure, and other diseases such as MDS.

On June 13, the Aplastic Anemia & MDS International Foundation (AA&MDSIF) 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 diseases and has been seeking support from key members of Congress, including members serving on the Ways and Means Committee, to keep ESA coverage in place.

In response to pressure from the AA&MDSIF, other organizations, and the public, 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 CMS to preserve coverage of ESAs for the treatment of myelodysplastic syndromes (MDS). You can read of copy of this ESA letter (PDF file, 156K).

The CMS will be finalizing its decision any day now so it is important that members of the Ways and Means committee hear from their constituents about this issue. If you are from the home state of one of the members of the Ways and Means committee shown below, 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 the 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.

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

Illinois

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

Kentucky

Ron Lewis (202) 225-3501

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

Nevada

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

New Jersey

Bill Pascrell (202) 225-5751

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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On July 30, CMS issued its final National Coverage Decision (NCD) regarding the use of ESAs in treating non-renal (non-kidney) disease. In its proposed decision issued in May, CMS had planned to eliminate all coverage of ESAs for MDS patients. Those arguing against this decision, including the Aplastic Anemia & MDS International Foundation, opposed the proposal on the grounds that the science did not support that decision. At risk was access to ESAs for Medicare beneficiaries as well as for patients whose private health insurers follow CMS policy.

It is important to note that CMS did not say that ESAs must be covered but said only that it was not removing coverage. The final policy allows Medicare contractors "to make reasonable and necessary determinations on all uses of ESAs that are not determined by NCD," including MDS. However, contractors are expected to cover ESAs for MDS.

Complete details of the Decision Memo are available at the CMS website.