The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) allowed Medicare payment of the routine costs of care furnished to Medicare beneficiaries in certain categories of investigational device exemption (IDE) studies. Covering the costs in these IDE studies removes a financial barrier that could otherwise discourage beneficiaries from participating.
Change request 8921 announces changes effective on and after January 1, 2015, to Medicare coverage requirements and review procedures related to items and services in Food and Drug Administration (FDA) approved Category A and B IDE studies. In addition, CR 8921 updates impacted Medicare manuals.
For more information please visit http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM8921.pdf