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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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HHS Grants 30-Day Extension on Comment Period for Common Rule Revisions

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

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Today, the Department of Health and Human Services (“HHS”) published a Federal Register notice that extends the comment period for the Federal Policy for the Protection of Human Subjects (“Common Rule”) notice of proposed rulemaking (“NPRM”) by 30 days to January 6, 2016. As we noted on September 8, 2015, the NPRM would extensively revise the Common Rule (Title 45 of the Code of Federal Regulations, Part 46), and would mark the first systematic attempt to overhaul the set of regulations that govern research conducted, funded or otherwise subject to regulation by the federal government since its promulgation in 1991. The NPRM has implications for a wide range of stakeholders across the life sciences and health care industries, including drug and device manufacturers, hospitals, academic medical centers, universities and medical schools, institutional review boards (“IRBs”), contract research organizations, laboratories, and tissue banks. 

Of considerable importance to the life sciences and health care industries, the NPRM contains substantive proposals that would (i) significantly alter the regulatory framework for biospecimen research to require informed consent, even for de-identified biospecimen research, and limit the applicability of the waiver of consent mechanism; (ii) impose IRB and data security protection requirements on private entities that receive biospecimens collected during federally funded research; (iii) mandate single IRB review and approval of cooperative research; (iv) require posting of consent forms; (v) grandfather existing biospecimen collections when the research use of the biospecimens occurs after removal of any individually identifiable information associated with the biospecimens; and (vi) require that institutions, researchers, and life sciences companies implement detailed infrastructures to track broad consent and biospecimens. 

To assist life sciences companies in understanding the complexities and implications of the NPRM, please refer to our in-depth Bloomberg BNA article

The NPRM seeks active public engagement on the proposed codified text, on the numerous questions identified for public comment, and on the alternative schemes discussed in the preamble. As the NPRM accurately acknowledges, public trust in the research enterprise is imperative to the success and effectiveness of any changes to the Common Rule. The proposed rule will now be open for public comment until January 6, 2016. If you have any questions about the proposed revisions or how the NPRM may affect your organization, please contact any member of Ropes & Gray’s health care or life sciences practices or your usual Ropes & Gray advisor. 

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