The Centers for Medicare & Medicaid Services (CMS) announced today its proposed revisions to the Clinical Trial Policy national coverage determination (NCD).  Under the Clinical Trial Policy, first developed in September 2000, Medicare pays for certain items and services for Medicare beneficiaries involved in clinical trials.

“This new decision will signal our continued support to provide access to services for beneficiaries by facilitating participation in the full range of qualified, scientifically sound research projects,” said CMS Acting Administrator Leslie V. Norwalk, Esq. 

In developing the revised clinical trial policy, CMS convened the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) on December 13, 2006.  The MedCAC proposed several recommendations, subsequently reviewed by a federal panel led by the Agency for Healthcare Research and Quality (AHRQ).  In addition to AHRQ, the federal panel included representatives from CMS, FDA, CDC, HRSA and the NIH. 

Based on the recommendations from the MedCAC and the federal panel, CMS is proposing to revise its Clinical Trial Policy. Below are some highlights of the proposed changes. 

Renaming the policy as the Clinical Research Policy; 

• Adding FDA post-approval studies and coverage with evidence development (CED) to studies that would qualify under this policy;
• Requiring all studies to be registered on the NIH ClinicalTrials.gov website before enrollment begins;
• Requiring studies to publish their results;
• Paying for investigational clinical services if they are covered by Medicare outside the trial or required under an CED through the NCD process; and
• Expanding the “deeming” agencies to all DHHS Agencies, the Veterans Administration, or the Department of Defense.  Deeming agencies are agencies that can “deem” whether a trial has met the general standards outlined in the policy.

“This proposed Clinical Research Policy exemplifies the Agency’s commitment to providing access to services for beneficiaries by encouraging the conduct of research studies that add to the knowledge base about the efficient, appropriate, effective, and cost-effective use of products and technologies in the Medicare population, thus improving the quality of care that Medicare beneficiaries receive,” Norwalk said.

The proposed NCD opens a 30-day comment period.  CMS will review all the public comments and suggestions received and incorporate them into a final NCD. CMS will publish the final NCD no later than sixty days after the end of the comment period. The revised policy will be effective with the publication of the final NCD.

Details of the coverage policy are available at the CMS coverage website at:  www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186