The Centers for Medicare and Medicaid Services (CMS) issued a Proposed Decision Memorandum on Clinical Trial Policy on April 10, 2007, triggering a 30-day public comment period for the proposed National Coverage Determination (NCD) regarding Medicare coverage of routine clinical services furnished in clinical trials.
In several respects, the proposal is a significant improvement over the current NCD, which has been in place since September 19, 2000. The proposed NCD clarifies several problematic aspects of the current policy. It expands the scope of coverage in some situations, although it eliminates one category of approved studies—Investigational New Drug (IND) exempt studies—and it imposes certain requirements for approved studies. It is clear that CMS has taken prior public comments into consideration in preparing the proposed NCD, and organizations involved in clinical research should carefully review it and take the opportunity to comment on the proposed policies. Remaining issues could possibly be addressed by CMS after receiving thoughtful comments from affected parties.
CMS’ Proposed Decision is available at http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186.