November 5, 2007

CMS issues Clinical Trial Policy decision memo

The Centers for Medicare and Medicaid Services has issued its decision memo on the agency's Clinical Trial Policy. At this time, the CMS is making only two changes to the CTP:  A clarification stating that Medicare will cover items or services covered outside of the clinical research trial, and adding a Coverage with Evidence Development clause that will allow Medicare payment for items and services in clinical research trials for which there is insufficient evidence to support a "reasonable and necessary" determination. The CMS is also reopening a reconsideration of the CTP and says it will "shortly" propose changes to the regulations that pertain to clinical trials and Medicare payments. The AAMC will continue to work with the CMS on all CTP actions. For more information, please visit  https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=186.

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