July 11, 2007—The Centers for Medicare and Medicaid Services (CMS) announced yesterday that it has revised its clinical trial policy national coverage determination (NCD) based on public comments received in April.

In the revised NCD, CMS may determine that an item or service is only reasonable and necessary in a clinical trial, an option the agency has previously defined as Coverage with Evidence Development. CMS also announced that it plans to post a new proposed decision memorandum for a 30-day public comment period, building upon the extensive public comments already received.

"This decision will expand access for Medicare beneficiaries to participate in clinical trials that seek to establish better evidence for the management of care and treatment of Medicare beneficiaries," said CMS Acting Administrator Leslie V. Norwalk, Esq.

—Cat Vasko