Medicare clinical research policy
Executive Summary
CMS issues a 1proposed decision memorandum on its clinical trial policy national coverage determination July 19 with a request for public comment. The agency earlier announced it would reopen its consideration of changes to the policy to allow for additional public input (2"The Pink Sheet" July 16, 2007, p. 22). Originally issued in 2000, the policy sets parameters for coverage of routine medical costs under Medicare Part B for patients participating in clinical trials that meet certain criteria. The new proposal aims to clarify those standards and allows study sponsors or principal investigators to certify that their study has met them. Comments are requested by Aug. 18, and CMS plans to issue a final decision by Oct. 19...