The Centers for Medicare and Medicaid Services (CMS) revised the national coverage determination (NCD) regarding Medicare coverage and reimbursement of routine costs incurred in connection with beneficiary participation in qualifying clinical research studies effective July 9, 2007. CMS clarified that Medicare will cover items or services for participating beneficiaries if those services would otherwise be covered outside of the trial. In addition, CMS announced it will adopt the proposed addition of Coverage Evidence Development (CED) to the NCD, also currently known as the “Clinical Trial Policy” (CTP).
