MEDICARE ISSUES PROPOSED COVERAGE DECISION ON ERYTHROPOESIS STIMULATING AGENTS
IN RESPONSE TO FDA'S RECENT BLACK BOX WARNING AND PUBLIC HEALTH ADVISORIES
The Centers for Medicare & Medicaid Services (CMS) announced today its proposed decision to limit coverage of erythropoiesis stimulating agent (ESA) treatment for beneficiaries with certain cancers and related neoplastic conditions, either because of a deleterious effect of the ESA on the beneficiaries’ underlying disease or because the underlying disease increases their risk of adverse effects related to ESA use.
The proposed national coverage decision (NCD) was made in response to a Food and Drug Administration (FDA) black box warning regarding the use of ESAs. FDA recently announced concerns about the use of ESAs by adding Black Box warnings to all ESA labels.
This led CMS to open a National Coverage Analysis (NCA), on March 14, 2007, on the use of ESAs for conditions other than end-stage renal disease (ESRD), which was the first step toward issuing this proposed NCD.
FDA also conducted an Oncologic Drug Advisory Committee meeting on May 10, 2007 that raised concerns about the use of ESAs in oncology patients.
“We pay close attention to FDA black box warnings because the safety of our Medicare beneficiaries is paramount,” said CMS Acting Administrator Leslie V. Norwalk, Esq. “We have carefully examined the evidence surrounding these labeling changes and have issued this proposed decision to protect our beneficiaries.”
CMS proposes that ESA treatment is only reasonable and necessary under specified conditions for the treatment of anemia in certain cancers.
CMS is seeking public comments on this proposed decision. The public comments period is open until June 13. Medicare local contractors have the discretion to make reasonable and necessary determinations for all uses of ESA therapy for beneficiaries with cancer whose condition is not addressed in the proposed decision memorandum.
“Because there is a preponderance of emerging data for ESA use in the oncology setting, we have narrowed the focus of the national coverage analysis to ESA use in cancer and related neoplastic conditions,” said Barry M. Straube M.D., Chief Medical Officer for CMS and Director of the Agency’s Office of Clinical Standards and Quality.
ESAs are anti-anemia biologics, distributed as Epogen and Aranesp and as Procrit. They are manmade versions of erythropoietin, a hormone that is produced in the kidney, and stimulate the bone marrow to make more red blood cells.
ESAs are FDA-approved to treat anemia in patients with ESRD and reduce the need for blood transfusions in patients with ESRD and chronic kidney failure, as well as in cancer patients whose anemia is caused by chemotherapy. Epogen and Procrit are also approved for some patients scheduled for major surgery to reduce potential blood transfusions, and for the treatment of anemia due to zidovudine therapy in patients with human immunodeficiency virus (HIV).
This proposed decision is the latest step in CMS’ efforts to closely review the use of ESAs in the Medicare population. In addition to this proposed NCD, CMS continues to review its monitoring policy for the use of ESAs in the ESRD setting.
“Medicare beneficiaries with cancer and renal disease are among our most vulnerable patients, and we are dedicated to ensuring that they are receiving appropriate care,” said Dr. Straube.
For national coverage decisions, the Medicare Modernization Act of 2003 requires CMS provide a 30-day period for public comment on the proposed decision and make a final decision no later than 60 days after the conclusion of the public comment period.
Details of Medicare coverage policy are available at the CMS coverage Web site at www.cms.hhs.gov/center/coverage.asp.