Epstein Becker Green’s Insight, titled “HHS Proposes to Repeal Rules on Guidance Documents,” co-authored by Jonah D. Retzinger and Robert E. Wanerman, attorneys in the firm’s Los Angeles and Washington, DC, offices, respectively, was featured in HealthPlanMarkets' October 2021 newsletter.

Following is an excerpt:

The Biden Administration is finally acting to pull back a Trump effort to block HHS from using “guidance documents” to change regulations instead of more formal rulemaking. On October 20, 2021, HHS published its “Department of Health and Human Services Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures.”

A new Epstein Becker Green Alert notes the ... Trump effort occurred just before Trump left office when virtually all “guidance documents” were blocked. The old HHS Guidance Rules contain “sweeping changes to HHS’s ability to issue and use guidance documents” even though there a real problem with how these documents are used.

“It remains to be seen if HHS will finalize the proposed rule and, if so, whether established administrative processes will be sufficient to address the improper use of guidance documents. However, the proposed rule makes it clear that HHS under the Biden administration believes that the current regulations are unworkable regardless of their original intent.”

The proposal says that Trump created “unnecessary hurdles that hinder HHS’s ability to issue guidance, bring enforcement actions, and take other appropriate actions that advance the Department’s mission …” Repeal “would not change the existing state of the law on the non-binding effect of guidance documents or whether they lack the force and effect of law.

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