November 5, 2007

CMS issues second reconsideration of clinical trial policy

The federal Center for Medicare and Medicaid Services has posted its Proposed Decision Memorandum for Second Reconsideration of the Clinical Trial Policy. An initial proposal was issued in April but never finalized. The current proposals stipulate that a clinical research study must meet 13 specific criteria to qualify for Medicare coverage. Federally funded studies--previously considered to have "deemed" status, through which projects are assumed to meet criteria for Medicare or Medicaid reimbursement--will now receive the same treatment as studies funded by other sources. Comments must be submitted electronically on the CMS Web site by Aug. 18. The CMS will be holding an Open Door Forum to solicit public comments on Aug. 7 from 2 p.m. to 4 p.m. The agency has not yet provided call-in information for the forum. The AAMC will be reviewing this proposal and discussing it with members in preparation for our comment submission. For more information, please visit http://www.cms.hhs.gov/mcd/viewnca.asp.

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