The Department of Health and Human Services (“HHS”) proposed a rule that would require HHS components to inform the public when issuing a “guidance document” and to clarify the document’s legal impact. The new procedures also create a process for “any interested party” to petition HHS to review guidance documents that go too far in creating new legal obligations. Because it is already subject to regulations on good guidance practices, only the FDA is exempt from the rule. The posted rule will be published in the Federal Register on August 20, 2020 with comments due September 13, 2020.
Highlights
New Definition of “Guidance Document”
The proposed rule applies to a defined range of “guidance documents” that include “any Department statement of general applicability which is intended to have a future effect on the behavior of regulated parties and which sets forth a policy on a statutory, regulatory or technical or scientific issue, or an interpretation of a statute or regulation,” as determined by the content of the communication rather than the format. In other words, even “video, audio, and Web-based” materials could be “guidance documents” subject to the new procedures.
Excepted from the definition are statements that apply only to specific factual circumstances, such as advisory opinions issued by the Centers for Medicare & Medicaid Services (“CMS”) or the Office of Inspector General, and documents that are intended only to regulate HHS and its components or their employees. There are other exceptions as well.
Procedural Requirements
HHS components will have to clearly identify which documents are “guidance” and use specific language informing the public that the guidance is not binding and serves only to clarify existing legal requirements. When a guidance document directs a party outside the federal government to do something, HHS components will have to include citations to statutes, regulations or binding judicial precedent that support the directive. HHS components will also have to identify the persons and activities that are subject to the guidance document. A statement constituting a “significant guidance document” must be labeled as such and will be subject to additional rules, including a notice-and-comment process. HHS will also presume that any significant guidance document is actually a legislative rule that has to go through the traditional rulemaking process.
Online Guidance Repository
All HHS guidance documents will be uploaded to an online, text-searchable repository located here. If an existing guidance document is not in the repository by November 2, 2020, it will be considered rescinded. New guidance documents will have to be uploaded within 3 business days of the date that they are issued.
Petitions for Review
The proposed rule will also create a process for the public to petition HHS to withdraw or modify any particular guidance document, including where the guidance document creates binding obligations that go beyond what is required under applicable statutes or regulations. Clear instructions on how to petition for review would be posted in the guidance repository, as well as all responses to such petitions.
Practical Takeaways
- The federal government relies heavily on nonbinding, subregulatory guidance when regulating health care entities. Providers often comply with this guidance as a matter of best practice, but the legal authority of these documents is often uncertain. The proposed rule will clarify these important questions and afford providers greater flexibility in structuring their operations in a way that complies with all actual legal requirements.
- While the proposed rule could have a significant impact on a wide array of health care providers, the practical effect could be muted when it comes to CMS’s direct regulation of the Medicare program. Many health care entities sign a provider agreement when enrolling in the Medicare program, and the proposed rule does not directly address the status of these existing agreements, CMS manuals and other subregulatory guidance.
- Comments on the proposed rule are due September 13, 2020. Readers interested in submitting a comment are invited to reach out to Hall Render.
If you have any questions, please contact:
- James Junger at (414) 721-0922 or jjunger@wp.hallrender.com;
- Heather Mogden at (414) 721-0457 or hmogden@wp.hallrender.com; or
- Your regular Hall Render attorney.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
