“On November 4, 2020, the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking (NPRM) titled, “Securing Updated and Necessary Statutory Evaluations Timely” (85 Fed. Reg. 70096). Subject to certain exceptions, the NPRM would add expiration dates to regulations promulgated under Titles 21 (Food and Drugs), 42 (Public Health Service, Centers for Medicare and Medicaid Services, Office of Inspector General) and 45 (Public Welfare, including Health Information Technology) of the Code of Federal Regulations (CFR) (collectively, the Regulations). These Regulations would expire between two to ten years after the NPRM becomes effective, depending on the applicable calculation set forth in the NPRM. The Regulations would expire unless:
- HHS timely assesses them to determine if they have a significant economic impact on a substantial number of small entities;
- If so, then the Regulations are subject to review under Section 3(a) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 610);
- HHS then would need to determine whether the Regulations should be continued without change, amended, or rescinded.”
“HHS explained that the purpose of sunsetting these Regulations is to effectuate the periodic retrospective reviews mandated by the RFA, and by various executive orders, which historically have not been completed.”
“Key Takeaways
- HHS proposes to set expiration dates for thousands of Regulations and put them at risk for inadvertent termination, including for key Regulations…
- The NPRM offers a fairly vague Review standard for amending or rescinding Regulations that may result in uncertainty for stakeholders…
- The NPRM includes exceptions to the expiration dates for certain types of regulations…
- The NPRM does not specify the statutory authority to “entirely eliminate” regulations…
- Congress or the Biden Administration may undo the proposed changes…” Read the full article here.
Source: HHS NPRM Could Invalidate Thousands of Regulations – December 7, 2020. Crowell & Moring LLP.
