On October 19, the U.S. Department of Health and Human Services (HHS) issued a proposed rule that would withdraw two regulations issued during the past administration that were directed at HHS’s issuance of guidance documents and processes around enforcement actions: the Good Guidance Practices rule (GGP Rule) (discussed further here) and the Transparency and Fairness in Civil Administrative Enforcement Actions rule (Fairness in Enforcement Rule).
HHS stated that its action was prompted by concerns relating to the rules’ adverse effect on HHS’s “ability to efficiently interpret and enforce regulations.” In proposing to withdraw these rules, HHS did acknowledge the constraints it still faces under the Administrative Procedure Act (APA) and the Medicare Act, as interpreted by Azar v. Allina Health Servs., 139 S. Ct. 1804 (2019), in using guidance documents to impose new requirements on regulated entities. Comments are due by November 19, 2021.
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