Proposed Rules Seek to Repeal Multiple Trump Era Regulations That Received Prior Industry Scrutiny
The United States Department of Health and Human Services
(HHS) – still within its first full year under the direction and leadership of a new administration in the White House – has recently taken steps to repeal several final regulations promulgated by the Trump administration, in an effort to keep the agency nimble, address inequities, and allow for greater flexibility to respond to the ongoing COVID public health crisis.
On October 20, 2021, HHS published a proposed rule (the October 20 Proposed Rule) that would repeal two HHS final rules issued within the past year: the “Department of Health and Human Services Good Guidance Practices,” published in the Federal Register on December 7, 2020; and the ”Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions,” published in the Federal Register on January 14, 2021.
In the commentary to the October 20 Proposed Rule, HHS stated that “the Department has reconsidered these rules and now believes that they create unnecessary hurdles that hinder the Department’s ability to issue guidance, bring enforcement actions, and take other appropriate actions that advance the Department’s mission” and that “these rules significantly burden the Department and are inconsistent with the policies and goals of the current Administration. Both rules created a single set of procedures for guidance documents and civil enforcement for the entire Department, which we believe is contrary to the efficient and effective administration of the wide array of programs by the Department, given the diversity of those programs.” Public comments on the October 20 Proposed Rule are being accepted until November 19, 2021.
In another significant move, HHS published another proposed rule on October 29, 2021 to repeal a Trump era regulation that would have mandated certain health care regulations to automatically expire if they were not reviewed every ten years (the October 29 Proposed Rule).
At issue is the final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET Final Rule) and published in the Federal Register of January 19, 2021. The SUNSET Final Rule would have required that all regulations issued by HHS, subject to certain exceptions, expire at the end of:
- 5 calendar years after the year that the SUNSET Final Rule first becomes effective,
- 10 calendar years after the year of the applicable regulation’s promulgation, or
- 10 calendar years after the last year in which HHS “assessed” and, if required, “Reviewed” the applicable regulation, whichever is latest.
HHS now seeks to withdraw and repeal the SUNSET Final Rule in its entirety.
Addressing its decision to repeal the SUNSET Final Rule, HHS stated that “[t]he SUNSET final rule, if implemented, would significantly alter the operations of HHS with considerable repercussions for a diverse array of stakeholders. We note that the process to promulgate the rule was extremely unusual, if not unprecedented. The rule is expansive in scope and impact, faced considerable opposition from stakeholders (and very little support), and lacked a public health or welfare rationale for expediting rulemaking.” Comments on the October 29 Proposed Rule may be submitted until December 28, 2021.
Stakeholders should take the opportunity to comment on these proposed rules.
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