MEDICARE ANNOUNCES NEW PROPOSED CLINICAL RESEARCH POLICY
The Centers for Medicare & Medicaid Services (CMS) announced today the reopening of 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 Clinical Trial Policy Decision Memorandum on July 9, 2007, with two changes to its prior policy -- the addition of Coverage with Evidence Development (CED) 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 the July 9, 2007, 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.
“This proposed decision will address ambiguities about Medicare coverage in research studies and what items and services are reasonable and necessary for beneficiaries participating in clinical research studies,” said CMS Acting Administrator Leslie V. Norwalk. “We look forward to comments from the public on all aspects of this proposed policy, which will expand access for Medicare beneficiaries while providing important patient protections.”
The comment period for this proposed policy closes on August 18, 2007. To further solicit public comments CMS will have an Open Door Forum on August 07, 2007 from 2:00pm to 4:00pm. After consideration of public comments, CMS will make a final determination and issue a final decision memorandum by October 19, 2007. Details of the proposed coverage policy are available at the CMS coverage website at http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=210.
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