By Brian Craig, J.D.
The rule requires all guidance documents to self-identify as "guidance," and also requires that all significant guidance documents be issued only following a public notice and comment period.
To help ensure that the public receives appropriate notice and to increase accountability, HHS has issued its final Good Guidance Practice rule governing the agency’s release and maintenance of guidance documents. The final rule, which takes effect January 6, 2021, requires all guidance documents to self-identify as "guidance," carry a disclaimer indicating that the contents of the document generally cannot impose binding new obligations that exceed requirements set forth in statutes or regulations, and include certain information designed to ensure transparency and uniformity across guidance documents. In response to a recent U.S. Supreme Court decision, the new rule requires that all guidance documents that qualify as "significant guidance documents" be issued only following a public notice and comment period (Final rule, 85 FR 78770, December 7, 2020).
Purpose of rule. HHS adopted the rule to increase accountability, improve the fairness of guidance issued by the Department, guard against unlawful regulation through guidance, and safeguard the important principles underlying the administrative law system. HHS withdrew its the previous guidance document in response to the U.S. Supreme Court’s decision Azar v. Allina Health Services, 139 S. Ct. 1804 (2019) where the Court held that HHS must use notice-and-comment rulemaking in certain circumstances, even where the Administrative Procedure Act does not require it. The Good Guidance Practices regulation clarifies HHS’s obligations under the Administrative Procedure Act and enhances how HHS issues and maintains guidance documents.
Response to comments. After publication of the proposed rule on August 20, 2020, HHS received 88 comments from industry trade organizations, patient advocacy groups, providers, health insurers, manufacturers, a law firm, and members of the public. HHS responded to the comments in adopting the final rule.
Good Guidance Practices. The rule requires all guidance documents issued after the rule’s effective date to self-identify as "guidance," carry a disclaimer indicating that the contents of the document generally cannot impose binding new obligations that exceed requirements set forth in statutes or regulations, and include certain information designed to ensure transparency and uniformity across guidance documents, including citations to any statutory or regulatory provisions that the guidance document is interpreting or applying. HHS must include all of its guidance documents in a single, searchable guidance repository, which is located at HHS.gov/Guidance. Any historical guidance document not posted to the guidance repository by January 6, 2021 will be considered rescinded.
Significant guidance documents. To follow the mandate in Azar v. Allina Health Services, the rule requires that guidance documents that qualify as "significant guidance documents" can only be issued after a public notice-and-comment period. A "significant guidance document" generally means a guidance document that may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights or obligations of recipients thereof; or raise novel legal or policy issues arising out of legal mandates, or the President’s priorities.
Petition process. The regulation additionally creates a petition process, which gives interested parties an opportunity to petition HHS to correct an unlawful guidance. HHS must provide a written response to petitions within 90 business days and state whether HHS agrees or disagrees with the petition. HHS must remedy the substance or use of any guidance documents that it determines in a petition response to be inconsistent with this part or otherwise unlawful. HHS will post all responses to petitions on the guidance repository website.
FederalRegisterIssuances: FinalRules AgencyNews NewsFeed
Interested in submitting an article?
Submit your information to us today!Learn More
Health Reform WK-EDGE: Breaking legal news at your fingertips
Sign up today for your free trial to this daily reporting service created by attorneys, for attorneys. Stay up to date on health reform legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.