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Medicare Expands Coverage of “Breakthrough” Medical Devices and Codifies “Reasonable and Necessary” Standard

On January 14, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published a final rule that significantly alters the Medicare reimbursement landscape for medical devices approved under the Food and Drug Administration’s (“FDA”) “Breakthrough Devices Program.” The rule, which represents the culmination of years of advocacy by the medical device industry and patient and provider interest groups, finalizes a September 1, 2020 proposed rule that aimed to address the substantial time lag between FDA authorization of medical devices and Medicare coverage of the same. Specifically, the rule establishes a Medicare Coverage of Innovative Technology (“MCIT”) pathway for Medicare coverage of Breakthrough Devices and related medical procedures during a four-year period that begins immediately upon FDA marketing authorization. The final rule also codifies the definition of the “reasonable and necessary” standard that is used to determine when other items and services (and MCIT devices after the four-year period) may be covered by the Medicare program. The new rule becomes effective March 15, 2021.

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CMS Aims to Clarify Medicare Policy on Clinical Trial Coverage


Time to Read: 1 minutes Practices: Health Care, Life Sciences

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The Centers for Medicare & Medicaid Services has recently launched a number of initiatives addressing Medicare coverage of clinical trial services, including an upcoming "Question & Answer" document on coverage of clinical trial services; proposed revisions to the national coverage decision on clinical trial services; and a revised guidance document for certain national coverage decisions. To learn more about these significant CMS initiatives, click "Download PDF."

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