Amgen and Johnson & Johnson continue to lobby in Washington to get Medicare’s strict reimbursement guidelines overturned. The companies—manufacturers of the anemia treating erythropoiesis-stimulating agents (ESAs) Epogen and Aranesp, and Procrit, respectively—have been trying to get Medicare’s guidelines overturned since they feel that the guidelines restrict doctors’ ability to provide adequate care to cancer patients who suffer from chemotherapy-induced anemia. According to the Medicare guidelines, ESA treatment coverage begins with patients whose hemoglobin (red blood cell) levels fall below 10 g/dL, since studies have shown that treatment at higher hemoglobin levels increases patients’ risk of heart attack, stroke, blood clots, and even death.

In early September the US Senate passed a non binding resolution calling on Medicare to reconsider its strict reimbursement guidelines. Since that time, California Democratic Rep. Anna Eshoo and Michigan Republican Rep. Mike Rogers introduced a “resolution of disapproval” that, if passed by both Congressional houses and signed by the President, would force Medicare to reverse its reimbursement policy. The Eshoo-Rogers resolution is a “Congressional Review Act joint resolution…that allows Congress to overturn regulatory decisions made by federal agencies.” Unlike the Senate’s non binding resolution, this resolution would be binding on Medicare. However, sources say that it is unlikely that such a resolution will be passed, and Rep. Rogers was quoted as saying that even though he will continue to push the bill, he and his colleagues are hoping that their efforts will “encourage CMS to reconsider it’s policy without legislation.”

Proponents of the bill, including the American Society of Clinical Oncology (ASCO), the American Society of Hematology, and cancer treatment center companies such as US Oncology, argue that CMS’s guidelines are completely baseless as they are not supported by scientific evidence. Being the case, they argue that such restrictive guidelines impose upon doctors’ ability to provide adequate care to cancer patients, which jeopardizes patients’ health. One subsidiary of J&J, Ortho Biotech, said that CMS is “disregarding substantial scientific evidence and setting ‘a serious policy precedent of inferior coverage of cancer treatments of Medicare beneficiaries.’” Amgen further claims “the policy ‘undermines clinical judgment,’ could mean more blood transfusions, and ‘effectively removes physicians’ ability to make decisions.’”

Medicare has rebutted these claims with the contention that its guidelines regulating ESA reimbursements for cancer patients is “based on the best science to date and is consistent with FDA labelling and warnings.” The FDA has backed Medicare on this last statement, finding that the guidelines are consistent with prescribing information for ESA use.

Associate Press (in Forbes): “Lawmakers Pursue Anemia Drug Long Shot”

The Hill: “Lawmakers Seek to Aid Anemia-Drug Producers in Dispute With Medicare”

The Star-Ledger: “Fed Up Allies Take On Medicare”