Law360 Publishes Akin Gump Article on HHS Proposal for Regulated Entity Guidance

Law360 has published the article “HHS Proposal May Simplify Guidance For Regulated Entities,” written by Akin Gump health partners John Jacob and Kelly Cleary and counsel Daniel Graver. Originating as an Akin Gump client alert, the article discusses a Department of Health and Human Services (HHS) notice of proposed rulemaking that would “establish clarity regarding how the department and its agencies, except for the U.S. Food and Drug Administration, will issue subregulatory guidance documents and how the public can engage with the department in this process.”

Subregulatory guidance, the authors write, “has been dubbed regulatory dark matter” that exists “in seemingly boundless quantities alongside statutory law and formally promulgated rules under the dictates of the Administrative Procedure Act.” The way in which it affects the world, they say, “remains a matter of extensive debate and often spurs uncertainty — and litigation.”

The authors examine the impact of HHS’s decision on heavily regulated industries, such as health care, noting there is a challenge process to determine “whether a guidance document actually creates new obligations or is being used by HHS (or one of its components) to create new obligations.” A stakeholder, the authors add, could also petition HHS to review its improper exemption of a document from the procedures set forth in the rulemaking.

The article concludes by noting that the proposed rule, if finalized, would seem to be “a positive development for entities regulated by HHS.” The authors advise that one should expect a final rule “with relatively few significant changes to be published before the end of the year.”

To read the article in its entirety, please click here.