CMS proposes revised clinical research policy

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The U.S. Centers for Medicare and Medicaid Services (CMS) said that it has reopened its clinical trial policy (CTP) national coverage determination (NCD) and is releasing a proposed decision memorandum for public comment. The public comment period will last for 30 days and a final decision will be released 60 days after that.

CMS published its final CTP decision memorandum on July 9 this year, with two changes to its prior policy -- the addition of coverage with evidence development and clarification that the item under investigation is considered a routine cost and therefore coverable by Medicare if it would have been covered outside the trial.

In this second reconsideration, the proposed determination builds upon the input received while the agency was developing its July 9 policy. It clarifies the standards that CMS believes are important to patient safety and good outcomes. It also allows study sponsors or principal investigators to certify that their study has met these standards.

The comment period for this proposed policy closes on August 18 this year. Details of the proposed coverage policy are available at the CMS coverage website at