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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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House and Senate Health Reform Bills: A Side-by-Side Comparison

Time to Read: 1 minutes Practices: Health Care

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Senate Majority Leader Harry Reid (D-Nev.) unveiled the Senate’s much-anticipated healthcare reform bill, the “Patient Protection and Affordable Care Act,” on November 18. Under the legislation, 94 percent of legal residents would be covered, or an additional 31 million of the 45 million currently uninsured. The bill includes a public plan option but permits individual states to opt-out. According to the Congressional Budget Office (CBO), the total cost of the bill is $848 billion over 10 years, comfortably under the $900 billion limit set by President Barack Obama. After offsets, the bill is projected to reduce federal budget deficits by $130 billion over the 10-year period, 2010-2019.

Several procedural hurdles remain before debate on the bill can proceed on the Senate floor, and it remains unclear whether the Democratic leadership will have the 60 Senate votes necessary to proceed. A key vote is scheduled for Saturday evening. If the requisite votes are obtained, debate may begin as early as this Sunday, prior to the Thanksgiving recess. With significant areas of controversy remaining, debate on the Senate bill will likely last several weeks, and numerous amendments are expected.

Sharp differences remain between the Senate proposal and the House-passed bill released in late October. Ropes & Gray has prepared a side-by-side comparison of these bills, available by clicking here or by visiting our Health Reform Resource Center, where you can also find copies of both bills and the CBO estimate, as well as other documents and materials relevant to this historic debate. For more information on the Senate bill or on health reform generally, contact your regular Ropes & Gray attorney or any of the attorneys listed above.

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