The Centers for Medicare & Medicaid Service (CMS) on July 10, 2007, posted its revised national coverage determination (NCD) that addresses Medicare coverage when beneficiaries participate in clinical research trials (CAG-00071R).

In this revised policy, CMS may determine that an item or service is only reasonable and necessary in a clinical trial – an option that CMS has previously defined as Coverage with Evidence Development. The decision became effective on July 9, 2007.

Details of the full coverage policy are available at the CMS coverage Web site at: https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=186.