The Centers for Medicare & Medicaid Services (CMS) announced today that it has decided to make no change to the clinical trial policy (CTP) national coverage determination (NCD) issued on July 9, 2007, at this time, and is not imposing additional conditions for coverage.

The decision to make no change is based on a thorough review and consideration of comments from the public, and the enactment of the Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85 of September 27, 2007 (2007 FDA AA).  

In a July 19, 2007, proposed decision, CMS proposed to impose additional standards, require an approval process to determine if a study met those standards, and clarify the items and services that would be covered in approved trials.

Making no change to the July 9, 2007, clinical trial policy national coverage determination enables Medicare beneficiaries to continue, as before, participation in clinical research studies with the support of Medicare,” Acting CMS Administrator Kerry Weems said. “The CMS will continue to work to further refine the policy, as appropriate, in order to ensure the quality and appropriateness of trials that enroll Medicare beneficiaries.”

Details of the current coverage for clinical trials are available at the CMS coverage website at http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=210.

For more information of today's release, click on theCMS Press Release issued today at : http://www.cms.hhs.gov/apps/media/press_releases.asp