July 30, 2007, CMS issued a determination that restricts the use of ESAs by Medicare recipients. Prior to the adoption of the ruling, I joined 234 of my colleagues in the House of Representatives in signing a letter to CMS expressing significant concern with the proposed restriction on the use of ESAs because of its potential impact upon Medicare-eligible cancer and related neoplastic patients. As I understand it, ESAs – which contain a protein that stimulates red blood cell production – have been an extremely effective treatment to combat anemia and reduce transfusions in cancer patients undergoing strong chemotherapy. By restricting access to these agents, many people feel that CMS’ ruling will force many elderly cancer patients to potentially undergo unnecessary blood transfusions with all of their inherent risks and discomforts.

CMS argues that it reviewed more than 2,600 public comments from various interested public parties, including the physician community, patient groups, and drug manufacturers, and that their ruling is consistent with the U.S. Food and Drug Administration (FDA) recently enacted “black box” warning on all marketed ESA products – which was prompted by recent research studies which found an increased chance of serious and life-threatening adverse effects with the use of ESAs in cancer and non-cancer treatments.

Opponents argue, however, that the policy change includes many coverage restrictions for ESA treatment that are not based on the totality of scientific data and which were roundly criticized by the oncology community, including the American Society of Clinical Oncology (ASCO), U.S. Oncology, the American Society of Hematology (ASH), the National Patient Advocate Foundation (NPAF), Amgen and others.

I have deep concerns about letting government bureaucrats interfere in the doctor/patient relationship by effectively dictating when medicines can be prescribed; especially if those bureaucrats disregarded the concerns of such groups as the American Society of Clinical Oncology, the national society of physicians who specialize in the treatment of cancer.