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HHS Proposed Regulatory Reform Rule Will Require Vigilant Monitoring

Written by: Angela Tompkins, MSHA, RN, Esq.

Earlier this month, The Department of Health and Human Services (HHS) issued a notice of proposed rulemaking requiring the Department to assess its regulations every ten years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA), which requires regular review of certain significant regulations.

The “purpose of the review shall be to determine whether such rules should be continued without change or should be amended or rescinded . . . to minimize any significant economic impact of the rules upon a substantial number of small entities.” 5 U.S.C. 610(a).  In conducting this retrospective review, agencies must consider a variety of factors, including the continued need for the rule, legal issues, public input, overlap and duplication with other federal or State and local governmental rules, and technological, economic, or other changes. 5 U.S.C. 610(b).

Under the proposed rule, any regulation issued by HHS (with certain exceptions) will cease to be effective ten years after it is issued, unless HHS performs a complete assessment of the regulation and a more detailed review of those regulations that have a significant economic impact upon a substantial number of small entities.

In order to ensure evidence-based regulation that does not become outdated as conditions change, HHS proposes that, subject to certain exceptions, all regulations issued by the Secretary or his delegates or sub-delegates in Titles 21, 42, and 45 of the CFR shall expire at the end of (1) two calendar years after the year that this proposed rule first becomes effective, (2) ten calendar years after the year of the regulation’s promulgation, or (3) ten calendar years after the last year in which the Department Assessed and, if required, Reviewed the regulation, whichever is latest.

In its Nov.4, 2020 Press Release, HHS pointed out that during the pandemic, it has suspended numerous regulations based on the judgment that they impose unnecessary costs impeding the response saying these rules would have to be regularly reviewed to determine whether they make sense in ordinary times, too. Examples of these regulations given included the types of communications technologies that are HIPAA-compliant and available for use in telemedicine; restrictions around the practice of medicine across state lines; and regulations on benefits and support hospitals can provide to their medical staffs, such as meals, laundry service for personal clothing, or childcare, while staff are at the hospital and engaging in activities that benefit the hospital and its patients.

If HHS is unable to meet the proposed rule’s review deadlines, automatic sunset of HHS regulations can occur. HHS says it plans to mitigate this risk by setting up a website where, if by the deadline for publishing an Assessment or Review is nearing and the Department has not yet announced that it has commenced either, the public can submit a comment requesting that it do so.

The proposed rule will require healthcare entities to devote significant resources to vigilant monitoring and even prompting the Department to timely Review and Assess regulations in danger of expiration in order to be in compliance.