Health Law Daily Wrap Up, ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—GAO REPORTS: CRA applies to WISeR Model Notice, (May 15, 2026)

By Sherri M. Schroeder, J.D.

Because the Notice substantially affects the rights and obligations of non-agency parties and meets the APA definition of a “rule,” the Notice is a rule subject to the CRA.

On July 1, 2025, CMS issued a Notice announcing the implementation of the Wasteful and Inappropriate Services Reduction (WISeR) Model, which is a new process to be used in six states to evaluate whether claims for certain services and items comply with Medicare requirements. In HHS’s view, the Notice was a guidance document to which the CRA did not apply, so it did not submit it for review. After the U.S. Government Accountability Office (GAO) received a request for a decision as to whether the implementation of the WISeR Model is a “rule” for purposes of the Congressional Review Act (CRA), the GAO concluded that the Notice is a rule subject to the CRA’s submission requirements. The GAO determined that the Notice meets the definition of a rule under the Administrative Procedure Act (APA) and that no exception applied. The Notice prescribes new requirements for Medicare providers in selected states by requiring prior authorization or pre-payment medical review of claims for certain services. Because the GAO determined the nature of these changes and their potential effect on claim determination substantially affected the rights and obligations of non-agency parties like providers and beneficiaries, the GAO concluded the Notice was subject to CRA’s submission requirements, meaning the Notice must be submitted to the House, Senate, and Comptroller General before it can take effect (GAO Report, B-337994, May 12, 2026).

WISeR. The WISeR Model is a proposed new process to evaluate claims for certain medical services under Medicare. It would be tested for a six-year period in six states beginning January 1, 2026. Model participants will implement a prior authorization process for the selected services to ensure the services are clinically appropriate, evidence-based, and consistent with Medicare requirements. Providers may submit prior authorization requests to either the relevant model participant; to their Medicare administrative contractor (MACs), which will then send the request to the model participant; or perform the service without requesting prior authorization and then submit a claim, which will be subject to pre-payment medical review by the model participant. HHS envisions that the model’s use of enhanced technology (e.g., artificial intelligence or machine learning) will streamline the process and identify when services are medically unnecessary.

Definition. The CRA adopts the definition of a “rule” under the APA, which states that a rule is “the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organizatin, procedure, or practice requirements of an agency.” Three categories of rules are excluded from coverage under the CRA: rules of particular applicability, rules relating to agency management or personnel, and rules of agency organization, procedure, or practices that do not substantially affect he rights or obligations on non-agency parties.

The GAO noted that the Notice meets all the required elements of a rule under the APA’s definition, as follows. It is an agency statement because it is an official document approved and published by CMS. It is of future effect because the Notice was published July 1, 2025, with future implementation beginning on January 1, 2026. It implements and prescribes law or policy and describes agency procedure and practice requirements because it prescribes and implements new requirements for Medicare provides in selected states by mandating prior authorization or pre-payment medical review of claims for certain services, among other things.

In addition, the GAO concluded the Notice was also an “agency statement” because it describes new claim submission and processing procedures for certain claims in selected states and outlines the method by which participating companies will be compensated by CMS. Therefore, the Notice also describes agency organization, procedure, or practice requirements.

The GAO rejected CMS’s argument that it did not submit the Notice for review because it is a guidance document and the CRA does not apply to guidance documents. The GAO noted that it had already addressed this argument in previous decisions and found that the APA’s definition “is expansive and specifically includes documents that implement or interpret law or policy” and that “agency guidance, including guidance characterized as non-binding, constitutes a rule under the CRA.”

Exceptions. The GAO also concluded that none of the exceptions to the definition of a rule under the CRA applied to the Notice. It was not a rule of particular applicability because it is not addressed to specific, identified persons or entities; instead, it applies to all providers of the specified services in the six selected states, as well as model participants. It was not a rule of agency management or personnel because it involves neither internal management nor personnel issues; instead, it establishes new claims procedures, new review processes, and new payment approaches for providers of the specified services in specific states. Finally, it was not a rule of agency organization, procedure, or practice that did not substantially affect non-agency parties. Although the Notice established new procedures for submitting and processing Medicare claims for certain services in certain states, which qualifies for the first part of the third exception, the Notice substantially affects the rights or obligation of non-agency parties. “[R]ules that could affect the outcome of an agency proceeding substantially affect non-agency parties and do not fall within the exception,” stated the GAO. “This includes changes to important procedural rights that could affect the outcome, even if they do not alter the substantive criteria used by the agency to make a decision.” Per the GAO, the Notice transfers decision-making authority over certain Medicare claims to different entities that will use new technology-assisted processes to evaluate claims that will be paid based on whether they reduce Medicare expenditures. This substantially affects the rights and obligations of non-agency parties.

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