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CMS Seeks To Revise Clinical Trial Coverage Rules

Tuesday, April 24, 2007

The Centers for Medicare and Medicaid Services (CMS) has proposed new coverage rules for payments to Medicare recipients involved in clinical trials. The rules would revise the agency’s Clinical Trial Policy’s national coverage determination (NCD) system and push additional transparency requirements on trial sponsors.

Some of the new rules would include adding post approval study coverage,requiring all studies to be registered with the NIH’s clinicaltrials.gov web site prior to enrollment, requiring all studies to publish results and paying for additional clinical services outside of the trial. The proposal also seeks to rename the coverage policy, the Clinical Research Policy. The new rules will be open for comment for a 30-day period after which the CMS will review these suggestions and draft a final NCD within 60 days.

“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 Leslie Norwalk, acting administrator for CMS.

The full draft of the proposed policy changes and the current rules for the NCD system can be found on the CMS website.

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