CMS Says It Will Review Medicare Policy On Covering Anemia Medications Linked To Side Effects

CMS on Wednesday announced plans to review Medicare coverage policies for the anemia medications Aranesp and Epogen, manufactured by Amgen, and Procrit, manufactured by Johnson & Johnson, after recent studies have linked the treatments with increased risk for serious side effects, Bloomberg/New York Times reports (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 (CQ HealthBeat, 3/14). The review follows a March 9 announcement by 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. Leslie Norwalk, acting director of CMS, said, "We pay close attention to FDA black box warnings because the safety of our Medicare beneficiaries is paramount." She added, "We will carefully examine the effect of these labeling changes on Medicare's policies." Josh Ofman, vice president of reimbursement and payment policy at Amgen, said that review is appropriate "in light of the new FDA labeling changes" (Bloomberg/New York Times, 3/15).

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