U.S. GOVERNMENT ACCOUNTABILITY OFFICE OPINION LETTER

On 2026-05-14, Senator Ron Wyden (D-OR) delivered a floor speech titled "U.S. GOVERNMENT ACCOUNTABILITY OFFICE OPINION LETTER" in the Senate.

U.S. GOVERNMENT ACCOUNTABILITY OFFICE OPINION LETTER

Congressional Record, Volume 172 Issue 82 (Thursday, May 14, 2026) [Congressional Record Volume 172, Number 82 (Thursday, May 14, 2026)] [Senate] [Pages S2299-S2302] From the Congressional Record Online through the Government Publishing Office [ www.gpo.gov ] U.S. GOVERNMENT ACCOUNTABILITY OFFICE OPINION LETTER Mr. WYDEN. Mr. President, I ask unanimous consent that the following GAO opinion letter dated May 12, 2026, be printed in the Record. There being no objection, the material was ordered to be printed in the Record, as follows: Decision Matter of: U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services--Applicability of the Congressional Review Act to Notice Implementing the Wasteful and Inappropriate Services Reduction (WISeR) Model. File: B-337994. Date: May 12, 2026. DIGEST On July 1, 2025, the U.S. Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) issued a notice announcing the implementation of the Wasteful and Inappropriate Services Reduction (WISeR) Model, a new process to be used in six states to evaluate whether claims for certain medical items and services comply with Medicare requirements (WISeR Model Notice or Notice). The Congressional Review Act (CRA) requires that before a rule can take effect, an agency must submit the rule to both the House of Representatives and the Senate, as well as the Comptroller General. CRA adopts the definition of a rule under the Administrative Procedure Act (APA) but excludes certain categories of rules from coverage. We conclude that the WISeR Model Notice is a rule for purposes of CRA because it meets the APA definition of a rule, and no CRA exception applies. Among other things, the WISeR Model Notice prescribes new requirements for Original Medicare providers in selected states by mandating prior authorization or pre- payment medical review of claims for certain services. Given the nature of the changes and because they could potentially affect the determinations made on claims for the selected services, we conclude that the Notice substantially affects the rights and obligations of non-agency parties, specifically providers and beneficiaries of those services. Therefore, the Notice is a rule subject to CRA's submission requirements. DECISION On July 1, 2025, the U.S. Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) issued a notice announcing the implementation of the Wasteful and Inappropriate Services Reduction (WISeR) Model, a new process to be used in six states to evaluate whether claims for certain medical items and services comply with Medicare requirements. We 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). As discussed below, we conclude that the WISeR Model Notice is a rule subject to CRA's submission requirements. Our practice when rendering decisions is to contact the relevant agencies to obtain factual information and their legal views on the subject of the request. Accordingly, we reached out to HHS on January 13, 2026. We received HHS's response on February 20, 2026. BACKGROUND Original Medicare Medicare consists of four distinct parts: Parts A, B, C, and D. Original Medicare--sometimes called Medicare Fee-for- Service (FFS)--includes Part A and Part B. Part A (Hospital Insurance) ``helps cover inpatient care in hospitals, skilled nursing facility care, hospice care, and home health care.'' Part B (Medical Insurance) helps cover a range of medical services and supplies, including physician, outpatient, and some home health care, durable medical equipment, and many preventive services. Medical providers and suppliers submit Part A and Part B claims for services and items to Medicare Administrative Contractors (MACs)--private health insurers that have specific geographic jurisdictions--which process and pay the claims. CMS and MACs employ a variety of techniques to reduce fraud, waste, and abuse in Original Medicare. These include publishing ``National and Local Coverage Determinations (NCDs and LCDs, respectively) describing the evidence-based requirements and limitations for Medicare coverage for specific medical services, procedures, or devices.'' MACs also operate a medical review program that includes pre- payment clinical review of medical records and related information to ensure that payment is made only for services that meet all Medicare coverage, coding, billing, and medical necessity requirements. The MAC may use any relevant information they deem necessary to conduct the review, including documentation submitted with the claim and additional information they request from the provider. However, only a small percentage of claims are subject to such pre-payment review. CMS pays MACs for pre-payment reviews based on the MACs' costs to review the claims. Claims are generally submitted to the MACs after the services are rendered, though certain services require prior authorization before the service is provided to the beneficiary. For those services, providers submit a request for prior authorization to the MAC, and the MAC reviews the request based on the associated Medicare requirements, such as those found in NCDs and LCDs, and provides a decision, which can be either provisional affirmation or non- affirmation. WISeR Model Notice On July 1, 2025, CMS issued the Notice announcing the implementation of the WISeR Model, a new process to evaluate claims for certain medical services under Original Medicare. The Notice explains that the WISeR Model will be tested for a six-year period beginning on January 1, 2026, in six states. According to CMS, the model ``will focus on testing the implementation of prior authorization and pre-payment review for specific selected services that will be performed by third party entities leveraging enhanced technologies''-- referred to as ``model participants.'' The model participants will implement an optional prior authorization process for the selected services to ensure they ``are clinically appropriate, evidence-based, and consistent with Medicare . . . requirements.'' CMS stated that it envisions that the model's use of enhanced technology will streamline the process and identify when services are medically unnecessary, thereby supporting providers in navigating beneficiaries towards more clinically appropriate or higher value care. The Notice states that for the selected services, providers will have the option to: (1) submit a request for prior authorization with supporting documentation to the relevant model participant; (2) submit a request for prior authorization with supporting documentation to the MAC (which will send the request to the model participant); or (3) perform the service without requesting prior authorization and then submit a claim, which [[Page S2300]] will be subject to pre-payment medical review by the model participant and may involve requests for supporting documentation. Under options 1 or 2 described above, if the provider opts to seek prior authorization from either the model participant directly or via the MAC, the model participant will review the request and issue a provisional affirmation or non- affirmation. If the model participant provisionally affirms the request, the associated claim will generally be paid by the MAC. On the other hand, claims associated with a non- affirmed request will be denied by the MAC, and the denial would be subject to the existing administrative appeals process. Under option 3, if the provider opts to furnish the service without requesting prior authorization and then submits a claim to the MAC, the MAC will flag the claim for pre-payment medical review, to be performed by the model participant. The model participant will request documentation from the provider to support the medical necessity of the claim, conduct a medical review, and then communicate its decision to the MAC, which will approve or deny the claim based on the model participant's decision. If the MAC denies the claim, the denial would be subject to the existing appeals process. The Notice states that the WISeR Model does ``not change any medical necessity or documentation requirements'' and ``will require the same information and clinical documentation that is already required to support Medicare . . . payment but earlier in the process, namely, prior to the service being furnished.'' The Notice further states that the WISeR Model ``will not change payment or coverage for the selected services.'' Regarding the model participants themselves, the Notice states that CMS will implement two three-year agreement periods with participants, which will be companies that have experience using technology-enhanced prior authorization with other payers, including Part C Medicare Advantage plans. The participants will be paid under a ``novel payment approach,'' where they will be compensated based on a share of averted expenses from reducing unnecessary or non-covered services in lieu of the traditional acquisition-based approach. The Notice states that the WISeR Model is being implemented under section 1115A of the Social Security Act, 42 U.S.C. Sec. 1315a, which, according to the Notice, ``authorizes the [HHS] Secretary to test innovative payment and service delivery models to reduce program expenditures, while preserving or enhancing the quality of care furnished to Medicare, Medicaid, and Children's Health Insurance Program beneficiaries'' and allows the Secretary to waive certain statutory requirements as may be necessary to test the models. The Notice states that pursuant to this authority, the agency is waiving specific statutory and regulatory provisions that could be construed as limiting its ability to conduct prior authorization or that could be construed to restrict what entity performs such prior authorization. Congressional Review Act (CRA) CRA, enacted in