According to Reuters, CMS (the Centers for Medicare and Medicaid Services) sent a letter to doctors and others who were trying to pressure it into reviewing its newly revised strict reimbursement guidelines for Amgen’s Aranesp and Epogen and Johnson & Johnson’s Procrit used to treat chemotherapy-induced anemia in cancer patients, which stated firmly that in the absence of scientific evidence to the contrary, it felt that its new reimbursement guidelines for ESAs are in the best interest of the patients and founded upon the results of clinical studies. Amgen, along with a coalition of doctors, organizations and health centers, contends that the new reimbursement guidelines compromise the quality of care that doctors can offer their patients. Arguing that CMS’s guidelines have no scientific basis, opponents claim that the guidelines could in fact hurt patients by making hemoglobin levels to drop to dangerously low levels before allowing treatment coverage. CMS denies the claims made by the opposition and says that unless it gets some questions answered within the next 30 days, its reimbursement guidelines will remain as they are. Two specific questions that CMS wants answered are: (1) is it a requirement that chemotherapy patients’ hemoglobin levels are above 10g/dL? and (2) is ESA treatment a superior alternative to blood transfusions in order to maintain the 10g/dL level?

As it stands now, CMS will only cover ESA treatment for cancer patients who suffer from chemotherapy-induced anemia when those patients’ hemoglobin (red blood cell) level is below 10g/dL because studies have shown that treatment at higher hemoglobin levels can increase the patients’ chances of suffering heart attacks, stroke, and premature death. Until new evidence is introduced to CMS, these guidelines will remain in place not only for cancer patients but also for those undergoing kidney dialysis treatment, of which it maintains similar reimbursement guidelines for ESA treatments.

Opponents to the CMS guidelines include doctors, the American Society for Clincial Oncology (ASCO), the American Society of Hematology, US Oncology (cancer treatment center company), and other for-profit cancer and kidney treatment centers.

Reuters: “Medicare Seeks Evidence to Support Anemia Change”

Boston.com: “Medicare Unlikely to Reverse Cuts in Anemia Drug Payments”

Los Angeles Times: “Medicare to Keep Limits on Anemia Drugs”

“Medicare to Stand by Limits on Anemia Drugs Unless ‘New Evidence’ Is Submitted”

CNBC: “Medicare: We Want Proof On Anemia Drugs”