HHS Finalizes Good Guidance Practices Rule

The Department of Health and Human Services (HHS) announced in a Thursday news release that it finalized a rule pursuant to an Oct. 9, 2019 executive order that will ensure notice of “new guidance documents” and that the documents “do not impose obligations on regulated parties that are not already reflected in statutes or regulations.”

“For too long, federal agencies have succumbed to the temptation to create law without notice and comment or public participation,” HHS Chief of Staff Brian Harrison said in the release. “Our Good Guidance Practices regulation empowers and protects those we regulate by requiring increased transparency and raising the standards for issuing significant guidance.”

The new regulation seeks to broadly improve the process of issuing and maintaining guidance documents through self-identification of each guidance document released after the rule’s effective date; indication through disclaimers that the documents “generally” cannot force binding obligations exceeding the scope of other requirements/statutes/regulations; and ensuring transparency and consistency across documents through citing statutory/regulatory provisions being applied and keeping all of HHS’s guidance documents in a “single, searchable guidance repository.”

“These regulations will help to ensure that the public receives appropriate notice of new guidance and that the Department’s guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them,” according to HHS.

Also offered is a petition process that parties can use to “correct unlawful guidance”; the HHS announced Wednesday that it would be withdrawing a certain guidance document that was “unlawfully purporting to impose binding obligations,” concurrently encouraging the use of the petition process and demonstrating its impacts.