MEDICARE REVIEWING ERYTHROPOIESIS STIMULATING AGENTS (ESAS) POLICIES
IN RESPONSE TO FDA’S RECENT BLACK BOX WARNING AND PUBLIC HEALTH ADVISORIES
The Centers for Medicare & Medicaid Services (CMS) announced today it is closely reviewing all Medicare policies related to the administration of Erythropoiesis Stimulating Agents (ESAs) in light of the Food and Drug Administration (FDA) recent issuances of new warnings regarding the use of ESAs.
“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. “We will carefully examine the effect of these labeling changes on Medicare’s policies and we encourage treating physicians to review the warnings and to take them into account when prescribing ESAs for their patients.”
CMS also announced today the opening of a National Coverage Analysis (NCA) on the use of ESAs for the conditions other than end-stage renal disease (ESRD). This is the first step toward issuing a National Coverage Determination (NCD).
“We will review the scientific evidence to determine the appropriate use of ESAs for multiple clinical indications. It is important to provide the correct coverage of ESAs for each specific clinical indication,” said Barry Straube, MD, chief medical officer for CMS.
ESAs are anti-anemia biologics, distributed as Epogen®, Procrit ®, and Aranesp®. They are man-made versions of erythropoietin, a hormone that is produced in the kidney and stimulates the bone marrow to make more red blood cells. ESAs are FDA approved for the treatment of anemia in chronic kidney failure patients, in patients with cancer whose anemia is caused by chemotherapy, in patients with human immunodeficiency virus that are using Zidovudine (also known as AZT) and to reduce the number of transfusions in patients scheduled for major surgery (except heart surgery).
In addition, CMS is currently reviewing its Erythropoietin (EPO) monitoring policy for patients with ESRD, and who are dialyzed in renal facilities. The Medicare benefit policy is consistent with the National Kidney Foundation and current kidney disease industry guidelines to maintain a target hemoglobin level in the range of 10 g/dl to 12 g/dl (or hematocrit level of 30 – 36 percent). Under the EPO monitoring policy, CMS initiates a payment reduction if the hemoglobin exceeds 13 g/dl (or hematocrit level of 39 percent) unless the provider provides includes information with the claim that the dosage has already been reduced.
Additional information on the National Coverage Analysis (NCA) can be found at:
FDA information on Erythropoiesis Stimulating Agents (ESAs) can be found at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01582.html