HHS Rescinds Richardson Waiver

April 9, 2025

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On Feb. 28, 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 its agencies 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.” 

The rescission of the Richardson Waiver means that these matters are thus exempt from notice and comment procedures, except as otherwise required by law. Of note, Medicare is separately subject to notice and comment rulemaking requirements and requirements imposed by other statutory provisions, but most programs within HHS do not have similar statutory requirements. The Social Security Act also imposes specific notice and comment requirements on Medicaid, and many ACA provisions are subject to the APA’s notice and comment requirement. HHS will need to demonstrate a good cause exemption to promulgate rulemakings without notice and comment or at least 30-days’ advance notice.

Cigna is working closely with legal counsel and trade associations to determine the impact on rulemaking processes for various agencies and programs.

Initiatives

Calls grow for Drug Patent reform

In a recent blog post, the Pharmaceutical Care Management Association (PCMA) highlighted increased attention to pharmaceutical companies’ abuse of drug patents. Last month, the Supreme Court unanimously ruled in favor of a generic drugmaker in a “skinny labeling” case, a victory for patients. Skinny labels allow generic and biosimilar competitors to launch products for non-patented indications, helping accelerate […]
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August 11, 2026

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perspectives

AHIP calls for Bipartisan reform to address health care cost drivers

On July 23, AHIP President and CEO Mike Tuffin wrote an opinion piece in The New York Times saying, “common-sense bipartisan reforms are needed to promote competition in care delivery and prescription drugs, protect consumers from providers and drugmakers’ anticompetitive practices and transition away from the perverse incentives of fee-for-service medicine.” Tuffin notes that health […]
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August 11, 2026

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Solutions

PCMA urges preserving patient access and flexibility in new fertility benefits rule

PCMA recently submitted comments to HHS, DOL, and the Treasury (the Departments) in response to the proposed rule establishing a new category of limited excepted benefits for fertility services. PCMA supports the Departments’ goal of expanding access to fertility care while encouraging employer innovation but urged several targeted refinements to ensure the framework is operationally […]
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August 11, 2026

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