Washington, DC - Senate Finance Committee Chairman Max Baucus (D-Mont.) said today he plans to introduce a resolution to nullify a decision by the Centers for Medicare and Medicaid Services (CMS) to limit Medicare coverage of certain anti-anemia drugs.
The National Coverage Decision (NCD) issued by CMS on July 30 affects coverage of erythropoiesis-stimulating agents (ESAs) for Medicare beneficiaries with cancer. ESA therapy can be used to raise patients’ hemoglobin levels to avoid the safety risks of blood transfusions and prevent unnecessary utilization of the nation’s blood supply. The CMS decision limits the use of ESA therapy to levels below the amount approved by the Food and Drug Administration (FDA). Doctors and clinicians who treat cancer patients have widely criticized the decision as lacking any scientific basis.
“CMS’s decision will prevent vulnerable cancer patients from getting the care they need," Baucus said. “Esteemed clinicians state, and no one has refuted, that the cap set by CMS will require thousands of patients to seek blood transfusions that could have been avoided. This resolution simply requires CMS to go back and work with the medical community on a policy supported by science. The safety of patients must be the guiding principle for Medicare rules regarding these anti-anemia drugs,
and some parts of this decision reflect that principle. But unless there is scientific evidence to the contrary, Medicare patients should have access to treatments based on the clinical judgment of their physician."
This week, the FDA stated that CMS’s limitation is “generally consistent" with available data and published literature. However, no existing data or literature has ever demonstrated that using ESAs to avoid transfusions in a manner consistent with the FDA label presents a risk to patients.
Once passed, the resolution nullifying the NCD would be binding on the agency upon signature by the President. Baucus’s resolution would compel CMS to review the facts and issue new coverage rules.
Prior to CMS’s final July 30 decision on ESA coverage, 52 Senators and 235 Members of the House of Representatives sent bipartisan letters to CMS expressing serious concerns regarding the ESA policy. On September 4, the U.S. Senate passed a unanimous resolution instructing CMS to immediately reconsider its decision. Baucus said he intends to introduce the legislation on Monday, October 22.
Source: Ranking Member’s News
