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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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Latest CMS Rule Impacts Wide Range of Health Care Stakeholders with Changes for COVID-19 Emergency and Beyond


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On May 8, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published an interim final rule with comment (“IFC”) in the Federal Register. The rule includes a wide range of modifications to CMS regulations governing payment rates, coverage of telehealth services, conditions of participation, scope of practice, calculation of medical education payments, and value-based payment programs – to name a few. 

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