October 19,2007

Baucus Resolution Would Help Cancer Patients Get Sufficient Coverage for Anti-Anemia Treatment

CMS decision to limit coverage widely criticized for lacking scientific basis

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.

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