Sneak Preview: HHS To Revoke Two ‘Ill-Advised’ Procedural Rules
(The following was excerpted from a recent Thompson Grants Compliance Expert article.) The Department of Health and Human Service (HHS) is repealing two procedural rules implemented during the Trump administration that affected overall agency guidance, particularly noting that one of the rules created confusion over the differences between financial assistance (i.e., grants and cooperative agreements) and contracts.
In a July 25 final rule, which becomes effective Aug. 24, the agency discussed its reasons for repealing and no longer enforcing its “Good Guidance Practices” final rule (i.e., the Guidance rule), which it issued on Dec. 7, 2020, and its “Transparency and Fairness in Civil Administrative Enforcement Actions” final rule (i.e., the Enforcement rule), which was implemented on Jan. 14, 2021.
The two previous final rules, codified at 45 C.F.R. Part 1, were issued to implement two executive orders (E.O.) under the Trump administration. E.O. 13891 required agencies, among other things, to: treat guidance documents as nonbinding both in law and in practice, except as incorporated into a contract; take into account public input on certain guidance documents; and make all guidance documents available on a single website. E.O. 13892 imposed a number of what the agency called “procedural hurdles” on agencies engaged in civil administrative enforcement or adjudication.
When President Biden took office in Jan. 20, 2021, he revoked both E.O.s. and instructed agencies to rescind, as appropriate, any rules that were based on them. HHS is now repealing these “ill-advised” rules, as deemed by the agency, accordingly, and will remove and reserve 45 C.F.R. Part 1 in the C.F.R.
“We now conclude that they create unnecessary hurdles that hinder the HHS’ ability to issue guidance, bring enforcement actions and take other appropriate actions that advance HHS’ mission,” the agency said, adding that it “continues to abide by its longstanding commitment to follow applicable principles of due process and administrative law; however, upon further reflection, we now conclude that the final rules establish procedures well beyond anything required by applicable law. Moreover, in significantly burdening HHS, these procedures are inconsistent with the policies and goals of the current administration to ensure that HHS can appropriately leverage administrative tools to protect and advance the public health and welfare.”
On Oct. 19, 2021, HHS proposed to revoke the two final rules in their entirety, and received 30 public comments, most of which favored repealing them. For example, commenters noted that the Guidance rule’s notice-and-comment requirements were especially onerous and time-consuming and needlessly hinder HHS’s ability to timely issue critical information on public health and HHS programs, adding that this burden not only hampers HHS, but its program beneficiaries.
(The full version of this story has now been made available to all for a limited time here.)
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