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  • Washington Highlights

    AAMC Comments on Proposed Rule to Review Existing Regulations


    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel
    Ivy Baer, Senior Director and Regulatory Counsel
    Daria Grayer, Director, Regulation and Policy

    The AAMC submitted comments to the Department of Health and Human Services (HHS) on Dec. 4 in response to a Nov. 4 notice of proposed rulemaking (NPRM), Securing Updated and Necessary Statutory Evaluations Timely (“SUNSET”).

    Under the proposal, HHS would be required to assess each regulation within 10 years of its implementation and, if subject to the Regulatory Flexibility Act (5 U.S. Code section 604), review the regulation to assess its impact and necessity. Regulations more than 10 years old would need to be reviewed within two years of finalization  of the NPRM, and certain regulations that are not timely assessed and reviewed by HHS will automatically expire or “sunset.”

    The AAMC has long supported enhancing regulatory accountability and performance [see Washington Highlights, Feb. 8, 2018]. However, the association strongly urged the department to withdraw the proposed rule given the “serious concerns about the use of agency resources, the lack of content-based prioritization of rules for review, and the need for the regulated community to keep track of which rules are coming up for review, or which may be sunset without warning.”

    Instead of the department’s proposed approach, the AAMC suggested HHS develop a more targeted and thoughtful evidence-based process to identify which regulations require the highest priority for assessment and review instead of setting a rigid and arbitrary timeline for the review of each regulation and allowing those not timely reviewed to expire. As one example of the potential impact of deregulation without stakeholder input, the AAMC pointed to rules issued by the Centers for Medicare and Medicaid Services (CMS), noting that “expiration of critical regulations under CMS stand to impact not only stakeholders, but also patients who rely on Medicare and Medicaid for their care, including the elderly, the disabled, and indigent.” The AAMC also recommended that HHS:

    • Reference existing models of rigorous retrospective review such as the AAMC Conflict of Interest Metrics Project, which was designed to measure the cost and impact of revisions to the regulations on financial conflicts of interest in research funded by the Public Health Service.
    • Ask stakeholders for input; look to efforts by external groups such as the National Academies of Sciences, Engineering, and Medicine; and address the requirements of the 21st Century Cures Act to prioritize the retrospective review of rules that have already been identified as burdensome and in need of thoughtful review.
    • Adopt a commitment to embed systematic evaluation criteria into the rulemaking process on a prospective basis as a department policy.
    • Engage a diverse cross section of stakeholders to assist the department in identifying and prioritizing other regulations that warrant review using a request for information or other mechanisms (as has been done successfully by CMS and the Food and Drug Administration).