FDA Warning Prompts Reconsideration of Medicare Reimbursement for Epogen

Members of Congress and some physicians are pressuring Medicare to change its reimbursement policy for Amgen's Epogen after FDA earlier this month issued a black box warning for antianemia medications, the Boston Globe reports (Rowland, Boston Globe, 3/19). FDA on March 9 announced 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 (Kaiser Daily Health Policy Report, 3/15). Critics of Medicare's payment policy for Epogen say it provides incentive for dialysis clinics to increase doses of the drug. According to the Globe, dialysis clinics nationwide receive more than 20% of their revenue from Epogen, and the drug accounts for $2 billion in federal kidney-dialysis reimbursements.

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Dennis Cotter, president of the Medical Technology & Practice Patterns Institute, said, "In view of the lack of science supporting Medicare's current position and the announcement by FDA of further tightening of the label, Medicare should immediately clarify their policy to be consistent with what is now known." Rep. Pete Stark (D-Calif.), who criticized Medicare's reimbursement policy for the drug at a hearing in December 2006, said FDA's warning should be considered by Medicare. He said, "This isn't a lobbyist or congressman who is mad," adding, "This is the people upon whom we depend to keep our pharmaceuticals in this country safe. If we're not going to respond to them, who do we listen to?" Kent Thiry, CEO of DaVita, which operates dialysis centers, said, "We are very concerned that an overreaction to this label will hurt patient outcomes." He added, "We remain committed to working in partnership with our affiliated physicians, who make all prescription decisions, to achieve the best anemia-management practices and patient outcomes." CMS acting administrator Leslie Norwalk said, "We pay close attention to FDA black box warnings, because the safety of our Medicare beneficiaries is paramount. We will carefully examine our policies" (Boston Globe, 3/19).