On August 20, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would impose requirements regarding the issuance and reliance on HHS guidance documents. This proposed rule results from the 2019 U.S. Supreme Court decision in Azar v. Allina Health Services (139 S. Ct. 1804). In this case the Supreme Court held that policy statements addressing “substantive legal standards” must undergo notice and comment rulemaking (HL Pulse article here). If finalized as proposed, the policies would formalize constraints on the ability of HHS to implement and apply substantive requirements without notice-and-comment rulemaking.

First, the proposed rule would apply to “guidance documents” issued by all HHS divisions except for the Food and Drug Administration (“FDA”). HHS proposes to define “guidance document” as:

“any Department statement of general applicability which is intended to have a future effect on the behavior of regulated parties and set a policy on a statutory, regulatory, or technical or scientific issue, or an interpretation of a statute or regulation.”

HHS explains that substance instead of format will determine whether it considers a document to be guidance, and a guidance document may include “letters, memoranda, circulars, bulletins, advisories, and preambles and may [also] include video, audio, and Web-based formats.”

The proposed rule would also implement additional procedural requirements for a “significant guidance document.” HHS proposes to define “significant guidance document” to mean:

“a guidance document that is likely 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, the President’s priorities, or the principles of Executive Order 12866, ‘Regulatory Planning and Review.’”

HHS also proposes to create a “guidance repository”, an internet-based, text searchable, collection of HHS guidance. HHS proposes to post “all guidance documents in effect that were issued by any component of [HHS]” by November 2, 2020 at www.hhs.gov/guidance. Reiterating the position that guidance documents are non-binding, HHS proposes that all repository web pages would include a disclaimer that the guidance documents: ‘‘lack the force and effect of law, except as authorized by law or as specifically incorporated into a contract’’ and ‘‘the Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.’’

Before issuing a “significant guidance document,” HHS also proposes that it must offer a notice and comment rulemaking period and publish the guidance in the Federal Register and in HHS’s proposed guidance repository.

HHS also proposes to require all of its guidance to state the following, unless the guidance is authorized by law to be binding:

“The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law.”

HHS explains that this phrase adequately explains that guidance documents cannot direct the public how to act or not to act without first restating and citing requirements that are included in a statute or regulation.

Finally, HHS proposes that each guidance document issued by the agency must contain the following information:

  • “(1) The activities to which and the persons to whom the guidance applies;
  • (2) the date HHS issued the guidance document;
  • (3) a unique agency identifier;
  • (4) a statement indicating whether the guidance document replaces or revises a previously issued guidance document and, if so, identifying the guidance document that it replaces or revises;
  • (5) a citation to the statutory provision(s) and/or regulation(s) (in Code of Federal Regulations format) that the guidance document is interpreting or applying; and
  • (6) a short summary of the subject matter covered in the guidance document.”

Public comments in response to the proposed rule must be electronically submitted by 11:59 p.m. on September 16, 2020 at www.regulations.gov.