U.S. GOVERNMENT ACCOUNTABILITY OFFICE OPINION LETTER

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Record: Senate Floor
Section type: Floor speeches
Chamber: Senate
Date: May 14, 2026
Congress: 119th Congress
Why this source matters: This section came from the Senate floor portion of the record.

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People mentioned: Wyden, Ron

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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

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 1996 to strengthen congressional oversight

of agency rulemaking, requires federal agencies to submit a

report on each new rule to both houses of Congress and the

Comptroller General for review before the rule can take

effect. The report must contain a copy of the rule, “a

concise general statement relating to the rule,” and the

rule's proposed effective date. CRA allows Congress to review

and disapprove rules issued by federal agencies for a period

of 60 days using special procedures. If a resolution of

disapproval is enacted, then the new rule has no force or

effect.

CRA adopts the definition of a rule under the

Administrative Procedure Act (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 organization, procedure, or practice

requirements of an agency.” However, CRA excludes three

categories of APA rules from coverage: (1) rules of

particular applicability; (2) rules relating to agency

management or personnel; and (3) rules of agency

organization, procedure, or practice that do not

substantially affect the rights or obligations of non-agency

parties.

HHS did not submit a CRA report to Congress or the

Comptroller General on the WISeR Model Notice. In its

response to us, HHS stated that, in its view, the WISeR Model

Notice is a guidance document and the CRA does not apply to

guidance documents.

DISCUSSION

At issue here is whether the WISeR Model Notice meets CRA's

definition of a rule, which adopts APA's definition of a rule

with three exceptions. As explained below, we conclude that

the Notice meets the APA definition, and no exceptions apply.

Therefore, the Notice is a rule subject to CRA's submission

requirements.

The WISeR Model Notice is a Rule under APA

Applying APA's definition of a rule, the WISeR Model Notice

meets all of the required elements. First, the Notice is an

agency statement as it is an official document approved by

the CMS Administrator and published by CMS in the Federal

An agency action of future effect is one “concerned with

policy considerations for the future rather than the

evaluation of past or present conduct.” The Notice was

published on July 1, 2025, and announced the future

implementation of the WISeR Model beginning on January 1,

Finally, the WISeR Model Notice implements and prescribes

law or policy and describes agency procedure and practice

requirements. An agency statement implements, interprets, or

prescribes law or policy when the action creates new

regulations, changes regulatory requirements or official

policy, or alters how the agency will exercise its

discretion, among other things. The WISeR Model Notice

prescribes and implements new requirements for Original

Medicare providers in selected states by mandating prior

authorization or pre-payment medical review of claims for

certain services. The Notice also prescribes and implements a

new policy of having such claims reviewed by model

participants—companies using enhanced technology, like AI or

machine learning—and prescribes a new payment approach for

those participants based on averted Medicare expenditures. In

addition, the Notice implements section 1115A of the Social

Security Act by establishing the WISeR Model pursuant to that

section and using its authority to waive certain statutory

and regulatory provisions.

An agency statement describes agency organization,

procedure, or practice requirements when the statement

discusses the internal operations of an agency, including

statements that govern the conduct of agency proceedings. The

WISeR Model Notice describes new procedures for the

submission and processing of Original Medicare claims for

certain services in selected states. In addition, the Notice

outlines the method by which companies participating in the

model will be compensated by CMS. Therefore, the Notice also

describes agency organization, procedure, or practice

requirements.

Having satisfied all the required elements, the WISeR Model

Notice meets the APA definition of a rule.

HHS stated in its response that it did not submit the WISeR

Model Notice because it is a guidance document and CRA does

not apply to guidance documents. We have addressed in

previous decisions HHS's position that guidance documents are

not rules under CRA and rejected that interpretation. For

example, we previously examined an HHS Information Memorandum

informing states that HHS would use its statutory authority

to waive certain requirements of the Temporary Assistance for

Needy Families (TANF) program to allow states to test various

strategies, policies, and procedures designed to improve

employment outcomes for needy families. The Information

Memorandum also set forth requirements that had to be met for

a waiver request to be considered by HHS. HHS stated that the

Information Memorandum was a non-binding guidance document

and that guidance documents do not need to be submitted as

rules under CRA. We rejected this position, noting that the

APA definition of a rule “is expansive and specifically

includes documents that implement or interpret law or

policy.” We also cited previous GAO decisions in which we

concluded that “agency guidance, including guidance

characterized as non-binding, constitutes a rule under the

CRA.” Finally, we pointed to relevant CRA legislative

history listing guidance documents as an example of APA

rules.

Like the Information Memorandum at issue in B-323772, Sept.

4, 2012, the WISeR Model Notice implements a new policy and

prescribes new procedures for non-agency parties.

As discussed above, the Notice satisfies all the elements

of the APA rule definition and is a rule under APA,

regardless of whether it is a guidance document.

CRA Exceptions

We must next determine whether any of CRA's three

exceptions apply. CRA provides for three types of rules that

are not subject to its requirements: (1) rules of particular

applicability; (2) rules relating to agency management or

personnel; and (3) rules of agency organization, procedure,

or practice that do not substantially affect the rights or

obligations of non-agency parties.

(1) Rule of Particular Applicability

The WISeR Model Notice is not a rule of particular

applicability. Such rules are addressed to specific,

identified persons or entities and determine actions those

persons or entities may or may not take, considering the

facts and circumstances specific to those persons or

entities. In determining whether a rule is one of general or

particular applicability, we have noted that a rule need not

apply to the population as a whole to be considered a rule of

general applicability; rather, all that is required is that

the rule has general applicability within its intended range,

regardless of the magnitude of the range. In particular, we

have determined that a rule is one of general applicability

even if the rule is limited to a specific geographic area, so

long as the rule does not apply to specific, identified

persons or entities.

Although the WISeR Model Notice announces the

implementation of the model in six states, the Notice is not

addressed to specific, identified persons or entities.

Instead, the Notice applies to all providers of the specified

services in those states, as well as the model participants.

Therefore, the Notice is a rule of general applicability.

(2) Rule of Agency Management or Personnel

The WISeR Model Notice is not a rule of agency management

or personnel. This exception applies to rules relating to

“purely internal agency matters.” These include

rules related to controlling, directing, or supervising

internal management issues, as well as rules related to

personnel issues like pay, leave, or benefits. In contrast,

we have determined that rules affecting agency proceedings

with non-agency parties do not fall within this exception.

For example, in B-337397, Aug. 27, 2025, we concluded that an

HHS policy statement rescinding a prior policy generally

requiring APA notice-and-comment procedures for certain rules

did not fall within the exception because the policy

statement changed public participation in certain HHS

rulemakings and therefore did not relate primarily to agency

management or personnel.

The WISeR Model Notice involves neither internal management

nor personnel issues. Instead, the Notice establishes new

claims procedures for providers of the specified services in

specific states. The Notice also establishes a new process by

which such claims will be reviewed by model participants and

prescribes a new payment approach for those participants.

Therefore, the Notice does not meet this exception.

(3) Rule of Agency Organization, Procedure, or Practice

That Does Not Substantially Affect Non-Agency Parties

The WISeR Model Notice is not a rule of agency

organization, procedure, or practice that does not

substantially affect the rights or obligations of non-agency

parties.

We have previously explained that this exception was

modeled on the APA exception to notice-and-comment rulemaking

requirements for “rules of agency organization, procedure,

or practice,” which some courts have limited to rules that

do not have a substantial impact on non-agency parties. The

purpose of the APA exception is “to ensure that agencies

retain latitude in organizing their internal operations.”

Following this interpretation in the CRA context, we have

only applied CRA's third exception to rules that primarily

focus on an agency's internal operations.

Rules of agency organization, procedure, or practice

include rules addressing the submission of information to an

agency by non-agency parties, rules that affect how the

agency reviews that information, and rules that affect the

type or timing of actions the agency will take based on that

submission. The WISeR Model Notice qualifies as a rule of

agency organization, procedure, or practice because it

establishes new procedures for submitting and processing

Medicare claims for certain services in specific states.

However, the Notice substantially affects the rights or

obligations of non-agency parties. Rules that satisfy this

exception do not alter the rights or interests of non-agency

parties, though they may alter the manner in which parties

present themselves or their viewpoints to the agency.

In particular, we have determined that rules that could

affect the outcome of an agency proceeding substantially

affect non-agency parties and do not fall within the

exception. 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. For example, we reviewed an HHS Policy Statement

that rescinded a previous policy of generally requiring the

use of APA notice-and-comment procedures for otherwise exempt

rules relating to public property, loans, grants, benefits,

or contracts. We noted that the Policy Statement eliminated

the public's right to notice and an opportunity to submit

information that could affect HHS's rulemaking decisions.

Accordingly, we concluded that the Policy Statement

substantially affected the rights of non-agency parties.

Further, in B-281575, Jan. 20, 1999, we reviewed

Environmental Protection Agency (EPA) interim guidance for

investigating discrimination complaints related to EPA

permits. The guidance, in part, significantly departed from

existing EPA procedures by requiring EPA to make an initial

finding as to whether there were discriminatory effects

associated with the relevant permit, and, if so, to notify

the permit recipient and complainant and afford the recipient

an opportunity to rebut EPA's finding, propose a plan to

mitigate the disparate impact, or seek to demonstrate that

there was a legitimate interest that justified the decision

to proceed notwithstanding the discriminatory effect. We

concluded that by providing for an initial finding of

discriminatory effects and allowing permit recipients to

provide input at that stage—including justifications for the

discriminatory effects—the guidance gave permit “recipients

significant rights that they did not previously possess for

obtaining dismissal of [a] complaint,” and thereby affected

the rights and duties of recipients, complainants, and the

affected population.

Similarly, courts have determined that a change in decision

maker substantially affects the rights and interests of non-

agency parties. For example, in National Association of Home

Health Agencies v. Schweiker, the U.S. Court of Appeals for

the D.C. Circuit examined the HHS Secretary's administrative

instruction regarding Medicare reimbursement for certain home

health agencies. Prior to the instruction, those home health

agencies had the option of submitting claims for Medicare

reimbursement directly to the Secretary or to an intermediary

contracted by HHS. The administrative instruction directed

the relevant home health agencies to begin using

intermediaries for all Medicare reimbursement determinations

and payments, eliminating the option of seeking reimbursement

from the Secretary. The court determined that the instruction

substantially affected the rights and interests of the

affected home health agencies because it eliminated their

right to deal directly with the Secretary. In a more recent

opinion, the D.C. Circuit emphasized that “[t]he crucial

element of Home Health Agencies is . . . which staffers have

decision[-]making authority.”

Similar to the administrative instruction at issue in Home

Health Agencies, the WISeR Model Notice effectively transfers

decision-making authority for certain Medicare reimbursement

claims, in this case from the MACs to the model participants.

Although the MACs will continue to approve or deny claims,

they are bound by the determinations of the model

participants for claims related to the specified services.

With respect to claims that are submitted for prior

authorization, those that are provisionally affirmed by the

model participant “will be paid in full, so long as all of

the applicable Medicare coverage and clinical documentation

are met, and the claim was billed and submitted correctly.”

In contrast, if the model participant does not affirm the

prior authorization request, “the MAC will deny the

[subsequent] claim.” For claims not submitted for prior

authorization, the model participant will perform a pre-

payment medical review and communicate its decision to the

MAC, and “[t]he MAC will then process the claim in

accordance with the model participant's decision.”

Not only does the WISeR Model Notice effectively transfer

decision-making authority over certain claims from the MACs

to the model participants, that change could potentially

affect whether claims are approved or denied given the

participants' novel approach to reviewing claims and their

compensation structure. Specifically, the model participants

will use advanced technologies, like AI and machine learning,

to determine whether the relevant services are medically

necessary and providers should be reimbursed. In addition,

the participants will be compensated based on their ability

to reduce payments for unnecessary or non-covered services;

in other words, model payments will be “calculated from

requests that did not result in a paid claim.” This differs

from the payment structure for MACs, which are paid based on

the costs of reviewing claims.

Several medical organizations raised concerns to CMS that

the WISeR Model's use of advanced technologies to review

claims and the model participant compensation structure could

result in inappropriate denials. For example, the American

Medical Association (AMA) stated that “AI and other

automated tools raise significant risks if not governed

properly” and “[o]utdated, incomplete, or biased training

data can lead to false positives, inappropriate denials, or

unfair patterns of flagging services for certain patient

populations.” With respect to the compensation structure,

AMA stated that “[w]hen third-party entities are paid based

on the volume of denied services, there is a clear risk that

care that is medically necessary for certain patients will be

inappropriately denied in pursuit of savings.” AMA therefore

included a number of recommendations to mitigate these

concerns.

Part of the purpose of the WISeR Model is to test “the

speed and accuracy of new technology-assisted decision-

making,” and it is unclear what the ultimate effects of the

model will be on coverage determinations in practice. In

addition, we note that CMS has included measures to reduce

inaccuracy, such as requiring that final non-affirmation

decisions be made by licensed clinicians. However, because

the purpose of our CRA determinations is to identify whether

an action is a rule and should have been submitted to

Congress before it took effect, we must assess the potential

effects of the rule before they occur, not at some later time

when those effects become known.

In this case, the WISeR Model Notice transfers decision-

making authority over certain Medicare claims to different

entities that will use new technology-assisted processes to

evaluate claims and will be compensated based on reducing

Medicare expenditures. Given the nature of these 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 the selected services in the six states covered by the

model.

HHS states in its response that its voluntary models do not

alter or affect the rights of any party under any statute

absent a voluntary decision to participate in the model and

that the WISeR Model does not change substantive Medicare

eligibility, coding, coverage, or payment requirements.

However, despite HHS's characterization and the fact that a

third-party's participation as a model participant may be

voluntary, provider participation in the WISeR Model is

largely involuntary. Providers in the six states must use the

model procedures for claims related to the selected services,

including having those claims adjudicated by a model

participant. The only choice such providers appear to have is

the option to submit a prior authorization request for the

service—not required previously—or to have their claim

subject to pre-payment medical review by a model

participant—a process previously applied to only a small

number of claims. And as discussed above, the changes to the

claims procedures—including the transfer of decision-making

authority to the model participants, the processes they will

use to evaluate claims, and their compensation structure—

could potentially affect the outcome of claims decisions,

notwithstanding that the WISeR Model Notice does not purport

to change substantive Medicare eligibility, coding, coverage,

or payment requirements. Accordingly, we conclude that the

Notice substantially affects the rights and obligations of

non-agency parties and does not fall within the third CRA

exception.

CONCLUSION

The WISeR Model Notice is a rule for purposes of CRA

because it meets the definition of a rule under APA and no

CRA exception applies. Therefore, the Notice is subject to

CRA's requirement that it be submitted to Congress and the

Comptroller General before it can take effect.

Edda Emmanuelli Perez,

General Counsel.

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