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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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NIH Publishes Advance Notice of Proposed Rulemaking to Revise PHS Conflict of Interest in Research Regulations

Time to Read: 2 minutes Practices: Health Care

The National Institutes of Health (NIH) issued an Advance Notice of Proposed Rulemaking on Friday, May 8, 2009, announcing the first comprehensive re-examination of the Public Health Service (PHS) conflict of interest in research regulations since they were adopted in 1995.

In the notice, the NIH seeks comments from the public on a series of questions regarding possible areas in which the regulations might be changed. The six areas that the NIH plans to re-examine, and some of the key issues that the NIH raised, are:

  • Expanding Scope of the Regulations and Disclosure of Interests 
    • Should investigators be required to disclose all significant financial interests (SFIs) related to their responsibilities, regardless of dollar value and perceived conflict?
  • Revising Definition of “Significant Financial Interest”
    • Is the current list of interests that do not constitute SFIs (e.g., royalties received from an institution) too broad?
  • Adopting New Requirements for Identification and Management of Conflicts by Institutions
    • Should institutions be required to establish independent review committees, develop formal conflict management plans (possibly pursuant to prescribed standards), and file conflict management plans with the PHS?
    • Should all investigators involved in participant selection, the informed consent process, and clinical management be prohibited from having any SFI in any company whose interests could be affected by the research?
  • Enhancing Methods for Assuring Institutional Requirements
    • Should the PHS’s enforcement options be enhanced?
    • Should institutions’ compliance be subject to independent confirmation? If so, how? Should accreditation be required?
  • Requiring Institutions to Provide Additional Information to PHS
    • What information should institutions be required to submit to the PHS? Should it differ by kind of research? How would the PHS use the information?
  • Amending Regulations to Address Institutional Conflicts of Interest
    • Should the regulations address institutional conflicts of interest? If so, how?

The NIH notice comes at a time of continuing attention in this area. Indeed, on April 28, 2009 the Institute of Medicine (IOM) released a report, “Conflict of Interest in Medical Research, Education, and Practice,” in which it made a number of recommendations in areas where the NIH has suggested regulations may change. For example, the IOM recommended eliminating the $10,000 reporting threshold for SFIs; establishing a presumptive bar prohibiting all investigators with SFIs from having substantial responsibility for the design, conduct, or reporting of the findings of clinical studies; and extending the PHS regulations to cover institutional conflicts of interest and to require institutions to report such interests to the NIH. Please see our May 5 alert, IOM Releases Report Addressing Potential Conflicts of Interest Between Industry and the Medical Community, for more information.

Comments to the NIH are due on July 7, 2009. Following the public comment period, the NIH expects to undertake a comprehensive review, and is not expected to issue new proposed regulations for a year or more. Although many in the academic community already have adopted policies that go beyond the 1995 regulations, and likely will have further developed policies by the time any new regulations are adopted, the potential changes are extensive. Institutions should be aware of the evolving requirements, and may want to submit comments to the NIH to supplement those that the American Association of Medical Colleges is expected to file.

If you have any questions regarding the Advance Notice of Proposed Rulemaking or other conflict of interest matters, please contact the attorneys listed above or your regular Ropes & Gray attorney.

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