On February 28, 2025, under the direction of the Secretary, the US Department of Health and Human Services (HHS) announced that the process for interaction with public stakeholders, including physicians, health care organizations, and patients will change significantly. Specifically, this would apply to opportunities for non-lawmakers to comment on proposed or current public programs such as Medicaid. On May 3, 2025, the Secretary rescinded the so-called “Richardson waiver.”1

This course of action is completely and diametrically opposed to the secretary’s previous promise of “radical transparency."1,2 How did this come to pass?

The Administrative Procedure Act (ATA) specifies processes for administrative agencies for enacting rules. A key presumption in the formulation of these processes has always involved public input. The most common procedure to offer or encourage public input is known as “informal” rulemaking, by which HHS provides public notice of particular legislation or rules, typically posting the notice in the Federal Register.3

This was not a blanket opportunity for comment. Input could be tempered by the “good cause exception” whereby the process of posting would not be followed, if this were contrary to public interest. In 1971, the Secretary of Health, Education, and Welfare, Elliott Richardson decided that the “good cause exception” should be used infrequently (hence, the term “Richardson Waiver”). This survived an attempt at revocation 11 years later by members of Congress.4 It would now appear that the current Secretary has succeeded where 1982 Congress failed.

How significant has public and professional input and modifying or altering policy been?

Shachar and Huberfield5 noted, that in 2017, public and professional input on coverage determination of genetic sequencing for patients with advanced cancer, proposed by the Centers for Medicare and Medicaid Services (CMS), was directly influenced by the Richardson Waiver. Public and professional comments resulted in significant changes to the coverage policy. These included broader coverage of patients with many different types of cancer, and allowed increased discretion of the Medicare Administrators in coverage decisions. Unfortunately, given the radical opacity (as opposed to the radical transparency promised) inherent in the current sea change1, programs such as Medicaid will likely be impacted.

Recently (2018–2020) HHS endorsed many state proposals for work requirements for Medicaid eligibility.6 Initially, this was done without “informal” input. Had these programs been instituted as proposed, thousands of patients with Medicaid coverage would have lost that coverage. This should not be taken as approval or condemnation of the work requirement. It simply illustrates the effect of an accepted process to provide a forum for input on program changes that could have been devastating for many people.

Most recently it would appear that the National Institutes of Health (NIH) have also “moved the goal posts.” In February, the NIH recommended capping indirect costs on existing and future grants.7 This would have affected at least 20 states, and many universities. I do think this is a topic which deserves frank and thorough discussion. Having been, in various stages my career, affiliated with universities where indirect causes have on occasion approached 100%, I have experienced the “indirect impact” personally. However, given the tighter financial margins on which many institutions of higher learning operate, any change, at least on existing grants, could have devastating consequences, perhaps even jeopardizing the continued existence of the institution. I would certainly support this initiative considering future grants, but only after proper dialogue with the institutions affected.

Unbelievably, curtailment of the Richardson Waiver may also affect practitioner reimbursement. In the 1982 congressional challenge, the Washington Circuit Court of Appeals decided that Medicare practitioner reimbursements fell under the APA specifically for benefit carve-outs. The implications of this are regrettably clear.

Revocation of the Richardson Waiver is certainly legal. How this would fill the Secretary’s purported commitment to accountability and transparency is frankly incomprehensible.