Medicare Announces Review of Coverage Policy for Medicare Policy on Covering Anemia Medications Linked to Side Effects

March 15, 2007 – The Centers for Medicare and Medicaid Services (CMS) has announced plans to review the Medicare coverage policy for darbepoetin alfa and epoetin alfa after recent studies have linked the treatments with increased risk for serious side effects (see Bloomberg/New York Times, 3/15). CMS will review coverage of the medications for uses other than in dialysis, as well as a “monitoring policy” that requires a reduction in Medicare reimbursements for the treatments when the red blood cell counts of beneficiaries exceed a certain level. The review follows a March 9 announcement by the Food and Drug Administration (FDA) that manufacturers of the medications must include black box warnings on the labels to physicians and patients about the increased risk for serious side effects linked with the treatments. In addition, FDA advised physicians that they should use only the lowest dose of the medications necessary to avoid the need for blood transfusions caused by anemia.

Based on the FDA safety alert, CMS issued instructions to local Medicare Carriers to prohibit Medicare coverage of erythropoietin-stimulating agents (ESAs) – Aranesp, Epogen, Procrit – when used for the treatment of the anemia of cancer (ICD-9 code 285.22). ESAs used for treatment of anemia due to chemotherapy would not be affected by this change in policy. Some Medicare Part B Carriers have begun to announce new local carrier decisions that will require that ESAs should be used only in accordance with its approved product labeling.

What ASH Is Doing About This

• ASH continues to encourage coverage policies that assure patient safety and quality of care.
• ASH is currently reviewing the latest studies concerning patient safety and will be working with clinical and scientific experts to comment on the CMS policy as well as local carrier decisions. Of particular concern will be changes in the use of ESAs for treatment of anemia associated with myelodysplastic syndromes.
• ASH also is in the process of updating its guideline “Use of Epoetin in Patients with Cancer” jointly published by ASH and ASCO.
• ASH will be working with the FDA’s Oncologic Drugs Advisory Committee (ODAC) which is tentatively scheduled to review additional trial data on ESAs in May 2007.
• ASH will make information available to its members as it becomes available. In the meantime, please contact the ASH Government Relations and Practice Department at 202-776-0544 with any questions or comments.