Oncologists Protest Government Interference in Medical Decisions

Fifty of the country's leading oncologists met in Chicago to discuss the new National Coverage Decision (NCD) regarding the use of Erythropoiesis Stimulating Agents (ESAs) in cancer treatments for Medicare patients. ESAs are synthetically produced drugs of a naturally occurring protein called erythropoietin. Erythropoietin is manufactured by the kidney. ESAs allow patients to cope better with chemotherapy by boosting red blood cell counts.

In July, 2007, the Centers for Medicare and Medicaid Services (CMS) limited the use of ESAs when hemoglobin levels were less than 10g/dL, limiting treatment duration to a maximum of 8 weeks, limiting the starting dose, and limiting dose escalation levels. These limitations were imposed due to the Food and Drug Administration's (FDA) warning regarding the use of ESAs. The FDA found that ESAs increased the risk of stroke, blood clots, heart attacks, tumor growth, and death. This FDA finding led to revised product warnings, a new box warning, and a modification to dosage instructions.

When speaking of the NCD regarding ESAs, the Centers for Medicare and Medicaid Acting Deputy Administrator Herb Kuhn said, "Our goal was to maintain physician autonomy while ensuring the safety of our Medicare beneficiaries." However, oncologists and patients across the country do not see it this way. They are concerned that the NCD creates a two-tiered system of care where doctors are forced to choose between standard of care and what Medicare's coverage will reimburse.

The American Society of Clinical Oncology and the American Society of Hematology have released a joint guideline on the use of ESAs which suggests hemoglobin can be raised to a concentration of 12. Under the current NCD, Medicare patients under the hemoglobin level of 10 would be subjected to blood transfusions which expose patients to added health risks.