CMS Proposes Reimbursement Limitations for ESA Therapy in Cancer Patients

(PYA Alert dated May 31, 2007)


On May 14th, CMS announced its proposal to limit coverage of ESA treatment to certain cancers and related neoplastic conditions, either because of harmful ESA effects on the beneficiaries’ underlying disease, or, because the underlying disease increases their risk of adverse effects related to ESA use (such as promoting tumor growth). Specifically, Medicare has suggested that ESA treatment is reasonable and necessary under certain conditions for anemia in patients with tumor types where erythropoietin receptors have been found.

Amgen, Inc. distributes ESA’s with trade names of Aranesp and Epogen, while Johnson & Johnson markets the drug Procrit. While the drugs are largely used in accordance with FDA approved guidelines, they have also been used off-label to fight fatigue as well as for use with cancer patients not receiving chemotherapy.

CMS has opened a 30-day comment period through June 13th, indicating particular interest in comments on whether the coverage of ESA therapy for beneficiaries with cancer should occur only within appropriately designed clinical research studies and where informed consent and safety monitoring can be assured. This will be followed by an additional 60-day period in which the government will finalize its coverage decision in order to issue a final decision memo by September 14th.

Have you determined the impact of this proposed CMS change to your patient population, as well as to your organization financially? PYA’s team of Clinical Compliance and Reimbursement professionals lends support to numerous clients in assessing compliance and reimbursement risks, while targeting process improvement and education opportunities. Please contact Denise Hall or Carol Eyer for additional details.

Further information and details of this decision memo may also be found on CMS’ website, referencing “CAG-00383N- NCA for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications.”

The information provided via PYA Alert, Tax Planning Alert, or Audit and Accounting Alert should not be construed as accounting, auditing, consulting, or legal advice on any specific facts or circumstances. The contents are intended for general information purposes only.  Please contact us at (800) 270-9629 to discuss your specific situation or to discuss any specific questions you may have.

back to PYA Alerts