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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 Announces Delays and Extensions for Pay for Performance Value-Based Programs


Time to Read: 1 minutes Practices: Health Care

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On June 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced timeline changes for several CMS Innovation Center Models in response to the COVID-19 public health emergency, extending some models while delaying the start of others. The changes, first announced in a blog post authored by CMS leadership, are outlined in a flexibilities table made available by CMS. We have prepared a table below providing a brief description of each model and indicating the timeline changes. Links to related Ropes & Gray alerts are provided as well for additional information. If you have any questions, please don’t hesitate to contact one of the authors or your usual Ropes & Gray advisor.

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