ESAFacts.org

Information for Physicians and Patients

Centers for Medicare & Medicaid Services (CMS)

Payment for the use of ESAs by cancer patients covered by Medicare and Medicaid is determined in accordance with a National Coverage Decision issued July 30, 2007 by the Centers for Medicare & Medicaid Services (CMS). You can download the full text here: (PDF entitled “CMS coverage decision”).

Points to consider as you review the statements and decisions of CMS:

1. Unlike FDA which is responsible for determining whether a drug is “safe and effective” for use for a defined clinical indication, CMS is responsible for determining whether the use of a drug is “reasonable and necessary” for a specific indication in the population of patients it covers.
2. Many insurance companies base their policies on the decisions of CMS, so any given position taken by CMS may affect the coverage of many patients who are covered by private insurance.
3. Because CMS and insurance companies must actually PAY for ESA products, they may have a more conservative bias than other organizations with no financial interest in the use of these products.