CMS Issues Final Decision Memorandum on Proposed Revisions to Medicare Clinical Research Policy; ASH Recommendations Incorporated and Concerns Addressed

October 17, 2007 – The Centers for Medicare and Medicaid Services (CMS) issued a final policy on proposed revisions to rules governing Medicare coverage of services provided to beneficiaries enrolled in clinical research studies that incorporates a number of recommendations and concerns ASH voiced throughout the reconsideration process. The final policy maintains the proposed revisions contained in CMS’s July 9 final Decision Memorandum on the policy and negates all of the proposals contained in its reconsideration of proposed revisions to the Medicare National Clinical Trial Policy.

Since the September 2000 issuance of the original National Coverage Decision (NCD) on this issue, Medicare has paid for the routine costs of beneficiaries enrolled in qualifying clinical trials. In April, CMS issued proposed revisions to this policy, and ASH submitted comments expressing concern with a number of the proposed revisions. ASH's original comments to CMS in May focused on concerns about proposed new requirements for public release of research study information, the generalization of studies to the Medicare population, and self-certification and deeming.

As a result of the comments submitted by ASH and other organizations during the agency’s first reconsideration of the policy, CMS announced in its July 9 Decision Memorandum that it was backing away from the proposed changes and indicated the agency was "issuing this national coverage determination in order to preserve the status quo with the exception of two changes." The Memorandum clarifies that items or services under investigation will be covered by Medicare if they would be otherwise covered outside of a clinical trial and language has been added that indicates that Medicare could cover routine costs in connection with clinical trials required as a result of a National Coverage Decision (NCD) based on a Coverage with Evidence Development (CED) determination.

However, after issuing the July 9 Decision Memorandum, CMS reopened the Clinical Trial Policy for a second reconsideration. ASH's comments on the most recent proposed revisions focused on concerns about proposed new requirements for public release of research study information and self-certification requirements.

A copy of the final Decision Memorandum can be found on the CMS Web site, along with a Q&A on the Final Decision for Clinical Research Policy.