Response to CMS Proposal on ESAs

July 1, 2007

In a recent letter to Steve Phurrough, MD, of the Centers for Medicare & Medicaid Services (CMS), Joseph S. Bailes, MD, chair of ASCO's Government Relations Council, asked that CMS withdraw its proposed decision memorandum regarding coverage of erythropoiesis-stimulating agents (ESAs) in nonrenal disease indications

ARLINGTON, Virginia—In a recent letter to Steve Phurrough, MD, of the Centers for Medicare & Medicaid Services (CMS), Joseph S. Bailes, MD, chair of ASCO's Government Relations Council, asked that CMS withdraw its proposed decision memorandum regarding coverage of erythropoiesis-stimulating agents (ESAs) in nonrenal disease indications (see ONI, June 2007, page 43).

"In our view, the proposal is premature and should be withdrawn pending future decisions by the FDA," Dr. Bailes wrote. "We do not believe that the lawful decision of FDA concerning recommendations for usage should be preempted by CMS's coverage decision, which is not only inconsistent with the Medicare statute but also unsupported by the available medical evidence . . ."