On July 19, the Centers for Medicare and Medicaid Services (CMS) issued a proposed decision memo that would dramatically alter Medicare coverage for participation in clinical trials. CMS is expected to release its final decision by October 17^th.  Senators Benjamin Cardin (D-MD) and Sam Brownback (R-KS) are asking their colleagues to sign a letter to CMS in opposition to the proposed policy change. ASCO applauds Senators Cardin and Brownback for their leadership on this important issue.  It is critical that you contact your Senators today to urge them to sign on to the Cardin-Brownback letter.

The CMS Proposal

• Since 2000, Medicare has provided automatic coverage for participation in trials that are funded by the federal government, such as the National Cancer Institute, or reviewed by the Food and Drug Administration (FDA). The proposed policy would rescind this “deemed” coverage.
• Instead, this new policy would require that investigators seeking Medicare coverage certify to CMS that the study meets thirteen scientific and technical standards. CMS would then determine whether those research studies that have certified compliance.
  

Action Needed

Please call your Senators and ask them to sign on the Cardin-Brownback letter to CMS because:

• The certification process proposed in the policy is burdensome, duplicative, and impractical. In large part, the certification process duplicates what research institutions already must provide to other Federal agencies and institutional review boards (IRBs).
• The certification process will discourage provider participation in clinical research and greatly add to its cost, while providing no tangible benefit. 
• The proposed policy will likely result in fewer Medicare beneficiaries participating in clinical trials – compromising the overarching goals of the clinical research policy that CMS reaffirmed in its July 2006 reconsideration announcement.
• Thank them for their attention to this important matter.
  

ASCO filed comments in strong opposition to this proposed policy change on August 8.  In addition, ASCO sent a second letter with the Association of American Cancer Institutes and 46 cancer centers on August 18. 

ASCO will keep members informed of this issue as it develops.   If you have questions, please contact the Cancer Policy and Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.