On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a requirement'known as the Richardson Waiver'that agencies under HHS engage in "notice-and-comment" rulemaking for matters otherwise exempted from this process under the Administrative Procedure Act (APA).
- While the APA generally requires agencies to engage in notice-and-comment rulemaking before issuing regulations, there are exceptions for matters related to "agency management or personnel or to public property, loans, grants, benefits, or contracts," or if an agency "for good cause" determines "that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest."
- Since 1971, however, HHS has taken the position that matters within the agency's jurisdiction that are excused from notice-and-comment rulemaking under the APA are nevertheless subject to public comment. This policy, articulated by then-Secretary Elliot Richardson, is colloquially referred to as the "Richardson Waiver." On February 28, 2025, HHS issued a policy announcement to rescind the Richardson Waiver.
- Even absent the Richardson Waiver, CMS must comply with other statutory requirements for notice-and-comment rulemaking, even for APA-exempt matters; specifically, ' 1871 of the Social Security Act requires notice-and-comment rulemaking for any proposed policy affecting the Medicare program that establishes or changes a substantive legal standard governing Medicare benefits payment, or eligibility.
- Because ' 1871 does not apply to the Medicaid program, the revocation of the Richardson Waiver may have implications for that program.
- Rescinding the Richardson Waiver may have implications for other agencies under HHS, including the FDA, NIH, HRSA, and SAMHSA though it remains to be seen how, and in what capacity, agencies will be affected.
Overview on Rulemaking and the Richardson Waiver
The Administrative Procedure Act (APA) establishes federal agency rulemaking procedures governing the issuance of proposed rules. Among other requirements, the APA generally requires federal agencies to seek public comment on proposed rules (known as "notice-and-comment" rulemaking) before finalizing rules and regulations (5 U.S.C. ' 553). Under ' 553(a)(2) of the APA, however, matters related to "agency management or personnel or to public property, loans, grants, benefits, or contracts" do not require notice-and-comment rulemaking.
Additionally, ' 553(b) provides an exception for notice-and-comment rulemaking (unless otherwise required by statute) if the agency "for good cause" determines "that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest." While the APA sets the procedural requirements generally applicable to all federal agencies, Congress may also create agency- or program-specific requirements to engage in notice-and-comment rulemaking.
In 1971, HHS adopted the Richardson Waiver, which requires HHS to engage in notice-and-comment rulemaking for the matters otherwise exempted under ' 553 of the APA (36 Fed. Reg. 2532 (Feb. 5, 1971)). According to the Richardson Waiver, "[t]he public benefit from such participation should outweigh...
