The Centers for Medicare and Medicaid Services (CMS) announced July 10 its revised clinical trial policy national coverage determination (NCD), which addresses Medicare coverage when beneficiaries participate in clinical research trials. The decision became effective July 9.
In this revised policy, CMS may determine that an item or service is reasonable and necessary only 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 memorandum will build on the extensive public comments already received.
