Coverage of Routine Costs of Clinical Trials Involving Investigational Device Exemption (IDE) Category A Devices
Guidance for Section 731 (b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) that authorizes Medicare to cover the routine costs of clinical trials involving IDE category A devices effective for routine costs incurred on or after January 1, 2005. This extension of coverage only refers to the routine services performed for such a trial. The Category A device itself remains non-covered.
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: December 17, 2004
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