HHS Comment Reversal Sets Stage for Quick Policy Changes

Healthcare attorney Julia Hesse, litigation attorney Lynn Calkins and healthcare policy advisor Miranda Franco were quoted in a Law360 article exploring the ramifications of a change to U.S. Department of Health and Human Services (HHS) rulemaking procedures. HHS Secretary Robert Kennedy Jr. announced the department would no longer follow the Administrative Procedure Act's (APA) notice and comment requirements before issuing rules on public property, loans, grants, contracts and benefits; known as the Richardson Waiver, the policy instructed HHS to seek public comment before adopting rules affecting these areas, which were otherwise exempt from the APA, along with limiting the use of the law's good cause exception.

Ms. Hesse commented on how widespread the effects of rescinding the 50-year-old policy will be.

"[This] constitutes a sea change in the way regulated entities – and individuals impacted by HHS policies – can expect to interact with the government," she said.

Ms. Calkins, who focuses on federal regulatory litigation, predicted legal challenges will follow as industry stakeholders parse out what HHS deems "contracts and benefits" to mean, as well as what constitutes "good cause" to forgo asking for public feedback. She added that without the notice and comment period, companies will have to move faster to engage legal counsel and respond to federal rulemaking.

"When regulatory changes are implemented under this new policy, entities may be forced to attempt to immediately implement the changes and simultaneously be assessing whether to challenge the rule," she explained.

Ms. Franco agreed that regulations will advance more quickly, and "as a result, stakeholders will need to be ready to act swiftly when new rules are released."

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