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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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Senator Chuck Grassley Presses Comptroller General to Investigate Foreign Threats to Taxpayer-Funded Research


Time to Read: 1 minutes Practices: Health Care

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On Tuesday, Senate Finance Committee Chairman Chuck Grassley of Iowa sent a letter to the General Accountability Office asking it to examine “how federal agencies implement and oversee conflict-of-interest policies and requirements related to federally funded research,” with special attention to diversity across federal agency and nonfederal institutional research policies, including monitoring and enforcement, and requirements for disclosing foreign affiliations. The letter follows from a June Finance Committee hearing and multiple oversight letters from Senator Grassley in the last year, all focused on foreign threats and perceived threats to research funded by federal agencies like the National Institutes of Health, the National Science Foundation, and the Department of Defense, among others. Of note, and as is common in these types of GAO request letters, there is a specific request for GAO to consult stakeholders, including research institutions and principal investigators, to learn their views about “options to strengthen federal agencies’ and nonfederal institutions’ ability to identify and address foreign threats to federally funded research.” For example, the letter asks about the possibility of making “changes to grant forms that place more responsibility for financial disclosures on principal investigators.”

While GAO is not legally bound to begin this inquiry, it may be expected to do so given the source of the request and the timeliness of the topic. Notwithstanding this uncertainty, and the fact the GAO reviews can often take years to complete, universities, academic medical centers, and others receiving federal research dollars should be aware of the request and attend to its terms and progress, and to the Senate’s interest in the topic. For example, the reference to changing grant forms to place more responsibility on PIs signals current thinking on actions that Congress might take to address its concerns about undue foreign influence in taxpayer-funded research.

The letter and press release describing it can be found here.

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