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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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FDA and Office for Human Research Protections Issue Companion Regulations Requiring IRB Registration


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

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On January 15, 2009, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) issued companion regulations mandating new or expanded registration of institutional review boards (IRBs). These regulations respond to criticism that federal oversight of IRBs should be strengthened and are intended to enable FDA and OHRP to compile a comprehensive list of IRBs, send educational and other information to IRBs, and enhance monitoring and inspection of IRBs.

Under the new rule, FDA now requires an IRB to register prior to review of clinical investigations: (1) regulated by the FDA under its Investigational New Drug or Investigational Device Exemption regulations; or (2) intended to support a research or marketing permit application for FDA-regulated products. OHRP expands existing registration requirements for IRBs used by institutions to oversee research funded by the Department of Health and Human Services.

FDA and OHRP have coordinated their IRB registration rules to be substantially consistent with each other, and a joint IRB registration Web site will be used by both agencies. When registering, IRBs must provide the following information:

  • contact information for the organization operating the IRB, the senior officer of the organization responsible for overseeing IRB activities, and the IRB chairperson;
  • an approximate number of the IRB’s active protocols;
  • for IRBs subject to FDA oversight, a generic description of the types of FDA-regulated products involved in the protocols that they review (e.g., “human drugs,” “medical devices”); and
  • for IRBs subject to OHRP oversight, an approximate number of full-time equivalent positions allocated to IRB administrative activities.

Initial registration with all required information must be submitted by September 14, 2009. IRBs currently registered with OHRP must register prior to expiration of their registration. Registrations must be renewed periodically and updated to reflect information changes.

If you have any questions concerning the new regulations, please contact your usual Ropes & Gray advisor.

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