Press Releases
MEDICARE ANNOUNCES NEW CLINICAL TRIAL POLICY
MEDICARE ANNOUNCES NEW CLINICAL TRIAL POLICY
The Centers for Medicare & Medicaid Services (CMS) announced today its revised clinical trial policy national coverage determination (NCD) which addresses Medicare coverage when beneficiaries participate in clinical research trials.
CMS published its proposed Clinical Trial Policy Decision Memorandum on April 10, 2007. Based on the public comments received regarding the proposed decision, CMS became aware of differing views regarding the existing and proposed clinical trial policy. Based on these comments, CMS has modified its proposed Clinical Trial Policy NCD.
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.
In addition to the final decision on the current reconsideration of the clinical trial policy, CMS is also announcing that it plans to reopen the Clinical Trial Policy NCD and post a new proposed decision memorandum for a 30 day public comment period. The proposed decision memorandum will build 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.
The decision became effective on July 9, 2007. Details of the full coverage policy are available at the CMS coverage website at https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=186