Notice2025-12195
Medicare Program; Implementation of Prior Authorization for Select Services for the Wasteful and Inappropriate Services Reduction (WISeR) Model
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 1, 2025
Effective
January 1, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This notice announces a 6-year model focused on reducing fraud, waste (including low-value care), and abuse in Medicare fee-for- service (FFS) via the implementation of technology-enabled prior authorization processes for select services.
Full Text
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<title>Federal Register, Volume 90 Issue 124 (Tuesday, July 1, 2025)</title>
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[Federal Register Volume 90, Number 124 (Tuesday, July 1, 2025)]
[Notices]
[Pages 28749-28753]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12195]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-5056-N]
Medicare Program; Implementation of Prior Authorization for
Select Services for the Wasteful and Inappropriate Services Reduction
(WISeR) Model
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: This notice announces a 6-year model focused on reducing
fraud, waste (including low-value care), and abuse in Medicare fee-for-
service (FFS) via the implementation of technology-enabled prior
authorization processes for select services.
DATES: This notice is effective on January 1, 2026.
FOR FURTHER INFORMATION CONTACT: Kate Blackwell (844) 711-2664, Option
8 or <a href="/cdn-cgi/l/email-protection#cd9a849ea89f8daea0bee3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="34637d675166745759471a5c5c471a535b42">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Wasteful medical care spending, broadly defined as spending that
could be reduced or eliminated without adversely affecting quality of
care or health outcomes, accounts for an estimated 25 percent of total
health care spending in the United States (U.S.).<SUP>1 2</SUP>
Medicare accounts for nearly one quarter of U.S. health care spending
($1 trillion in 2023) making it an important target for identifying and
reducing waste.\3\ The Medicare program is particularly vulnerable to
wasteful spending due to the age and complexity of the Medicare
population and their disproportionately high share of health care
spending compared to younger segments of the U.S. population.\4\
Additionally, the Medicare fee-for-service (FFS) payment structure may
further drive waste given there is an inherent incentive in some cases
for fraudulent actors to bill higher volumes of services, including
those that are unnecessary or inappropriate.\5\
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\1\ Speer M, McCullough JM, Fielding JE et al. Excess Medical
Care Spending: The Categories, Magnitude, and Opportunity Costs of
Wasteful Spending in the United States. Am J Public Health. 2020
Dec;110(12):1743-1748.
\2\ Shrank WH, Rogstad TL & Parekh N. Waste in the US Health
Care System: Estimated Costs and Potential for Savings. JAMA.
2019;322(15):1501-1509.
\3\ Martin AB, Hartman M, Washington B, Catlin A. National
Health Expenditures in 2023: Faster growth as insurance coverage and
utilization increased. Health Affairs. 2024;44(1):12-22.
doi:10.1377/hlthaff.2024.01375.
\4\ McGough M, Claxton G, Amin K, Cox C. How do health
expenditures vary across the population? Peterson-KFF: Health System
Tracker. 2024 Jan; retrieved from: <a href="https://www.healthsystemtracker.org/chart-collection/health-expenditures-vary-across-population/#Share%20of%20total%20population%20and%20total%20health%20spending,%20by%20age%20group,%202021">https://www.healthsystemtracker.org/chart-collection/health-expenditures-vary-across-population/#Share%20of%20total%20population%20and%20total%20health%20spending,%20by%20age%20group,%202021</a>.
\5\ Knickman JR. Marchica J, and Radley DC. ``Health Care
Financing, Costs, and Value.'' Jonas and Kovner's Health Care
Delivery in the United States (2023): 257.
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Key areas contributing to wasteful spending include fraudulent or
abusive billing practices, as well as the delivery of services that
have little or no clinical benefit, or services in which the risk of
harm from the service outweighs its potential benefit.\6\ Additionally,
these practices can inflict significant physical, financial, and
emotional harm on beneficiaries. A 2019 study of Medicare claims data
estimated that treatment by health care providers who were subsequently
prosecuted for fraud and/or abuse contributed to as many as 6,700
premature deaths among Medicare FFS beneficiaries.\7\ Such findings
indicate there is a significant opportunity to better address and
prevent fraud, waste, and abuse (FWA) and its negative impact on the
health and well-being of beneficiaries and the fiscal sustainability of
the Medicare FFS program.
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\6\ Medicare Payment Advisory Commission. Health Care Spending
and the Medicare Program: A Data Book. 2024. Retrieved from:
<a href="http://www.medpac.gov/wp-content/uploads/2024/07/July2024_MedPAC_DataBook_SEC.pdf">www.medpac.gov/wp-content/uploads/2024/07/July2024_MedPAC_DataBook_SEC.pdf</a>.
\7\ Nicholas LH, Hanson C, Segal JB et al. Association Between
Treatment by Fraud and Abuse Perpetrators and Health Outcomes Among
Medicare Beneficiaries. JAMA Intern Med. 2020;180(1):62-69.
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The Centers for Medicare & Medicaid Services (CMS) and the Medicare
Administrative Contractors (MACs) employ a variety of techniques to
reduce FWA in Medicare FFS. These include publication of 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. Generally, prior
authorization is a utilization management tool in which a health care
provider requests provisional affirmation of coverage from a health
care payer before medical
[[Page 28750]]
service is furnished to a beneficiary and before a claim is submitted
for payment.
Under Medicare FFS, providers and suppliers submit a request for
prior authorization (also known as pre-claim review, depending on the
service type and the timing of the submission) for a limited set of
specific services \8\ to their MAC. The MAC then reviews the prior
authorization request based on the associated Medicare requirements
such as those found in NCDs and LCDs and provides a decision, which can
be either a provisional affirmation or non-affirmation. CMS has
implemented prior authorization in Medicare FFS under specific and
limited initiatives, and evidence suggests doing so for these services
has contributed to significant reductions in the amounts paid by CMS
for these targeted services.\9\ In an effort to reduce provider burden,
these initiatives do not change any medical necessity or documentation
requirements. Additionally, evidence demonstrates that under the
Medicare Prior Authorization Model for Repetitive, Scheduled Non-
Emergent Ambulance Transport (RSNAT), there was no adverse effect on
quality of care or access to care--as demonstrated by increased
emergency service use, hospitalizations (including hospitalizations for
complications of end stage renal disease (ESRD)), or deaths--
notwithstanding that some beneficiaries had been non-affirmed for
RSNAT.\10\
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\8\ CMS. Prior Authorization and Pre-Claim Review Initiatives.
<a href="http://CMS.gov">CMS.gov</a>. <a href="https://www.cms.gov/data-research/monitoring-programs/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives">https://www.cms.gov/data-research/monitoring-programs/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives</a>.
\9\ CMS. Prior Authorization and Pre-Claim Review Program Stats
for Fiscal Year 2023. 2025. Retrieved from: <a href="https://www.cms.gov/files/document/pre-claim-review-program-statistics-document-fy-23.pdf">https://www.cms.gov/files/document/pre-claim-review-program-statistics-document-fy-23.pdf</a>.
\10\ Asher A, Contreary K, Haile G, and Coopersmith J.
Evaluation of the Medicare Prior Authorization Model for Repetitive
Scheduled Non-Emergent Ambulance Transport: Final Report. 2021.
Retrieved from: <a href="https://www.cms.gov/priorities/innovation/data-and-reports/2021/rsnat-finalevalrpt">https://www.cms.gov/priorities/innovation/data-and-reports/2021/rsnat-finalevalrpt</a>.
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Other payers, including Medicare Advantage (MA) plans, often employ
more utilization management approaches to reduce FWA, including
requiring prior authorization for a more expansive set of services.
Additionally, some MA plans have prior experience working with third
parties to leverage enhanced technologies, like artificial intelligence
(AI), machine learning (ML) or algorithmic decision logic, to
streamline and improve detection of FWA. This work is done with certain
guardrails in place. For example, 42 CFR 422.566(d) requires that an
adverse medical necessity decision related to a prior authorization
request must be reviewed by a physician or other health care
professional with appropriate expertise before the MA plan issues the
decision.
CMS conducted market research from various different MA
organizations that had experience with enhanced technology-enabled
prior authorization processes. The research indicated significant
reductions in the decision time to prior authorization determination,
particularly for affirmed prior authorization requests. Some MA plans
reported decision time to prior authorization approval being almost
instantaneous for services with very clear clinical coverage criteria.
As a result, CMS is exploring findings from MA plans regarding enhanced
technologies to examine how to efficiently, accurately, and
appropriately ensure select services are provided and paid for based on
clinical and evidence-based guidelines.
Section 1115A of the Social Security Act (the Act) authorizes the
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. Section 1115A(d)(1) of the Act
authorizes the Secretary to waive such requirements of Titles XI and
XVIII and of sections 1902(a)(1), 1902(a)(13), and 1903(m)(2)(A)(iii)
of the Act as may be necessary solely for purposes of carrying out
section 1115A of the Act with respect to testing models described in
section 1115A(b) of the Act. For this model, consistent with this
standard, we will waive such provisions of sections 1834(a)(15) and
1869(h) of the Act that limit our ability to conduct prior
authorization. While these provisions are specific to durable medical
equipment and physician services, we will waive any portion of these
sections as well as any portion of 42 CFR 410.20(d), which implements
section 1869(h) of the Act, and 42 CFR 414.234, which implements
section 1834(a)(15) of the Act, that could be construed to limit our
ability to conduct prior authorization for other items or services or
that could be construed to restrict what entity performs said prior
authorization. We have determined that the implementation of this model
does not require the waiver of any fraud and abuse law, including
sections 1128A, 1128B, and 1877 of the Act. Thus, providers and
suppliers affected by this model must comply with all applicable fraud
and abuse laws.
II. Provisions of the Notice
A. Model Specifications
We plan to implement a 6-year model test (the Wasteful and
Inappropriate Services Reduction (WISeR) Model), in two 3-year
agreement periods, with companies that have experience implementing
technology-enhanced prior authorization with other payers, including MA
plans, as model participants. Under the model, participants will
implement and streamline prior authorizations to ensure that select
services that are provided and paid for are clinically appropriate,
evidence-based, and consistent with Medicare FFS requirements. We
envision that implementing the review process while leveraging enhanced
technologies would identify when such services are medically
unnecessary, that model participants will support providers and
suppliers in navigating beneficiaries towards more clinically
appropriate or higher value care when appropriate and will streamline
the prior authorization process for providers and suppliers.
This model will be tested in select states in select MAC
jurisdictions. The selected MAC jurisdictions for WISeR are JH, JL, JF,
and J15, and the selected states are New Jersey (JL), Ohio (J15),
Oklahoma and Texas (JH), and Arizona and Washington (JF).). These MAC
jurisdictions and states were selected based on various evaluability
and operational criteria. Evaluability criteria included: (1) MAC
jurisdictions that allow for within-MAC comparisons between test and
comparison states; (2) selected states with adequate volume to provide
sufficiently precise impact estimates; (3) MAC jurisdictions with skin
and tissue substitute LCDs to assess effectiveness, as well as one MAC
jurisdiction without existing skin and tissue substitute LCDs to
increase generalizability;\11\ and (4) geographic diversity.
Operational criteria used for geographic selection included: (1) MAC
jurisdictions that have existing skin and tissue substitute LCDs; and
(2) states that also meet the evaluation criteria and have the highest
volume of services by highest historical claim paid amount. The model
will begin on January 1, 2026, in the selected states.
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\11\ Not all MAC jurisdictions have an active skin and tissue
substitute LCD in place at this time. Skin and tissue substitutes
are a selected service in WISeR only in states and MAC jurisdictions
that have an active skin and tissue substitute LCD in place.
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The WISeR model will focus on testing the implementation of prior
authorization and pre-payment review for specific selected services
that will be
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performed by third party entities leveraging enhanced technologies,
that would be paid under a novel payment approach where the model
participants are compensated based on a share of averted expenditures.
Further, the WISeR model would test: the speed and accuracy of new
technology-assisted decision-making; WISeR participants' ability to
help patients navigate away from low-value or potentially unsafe
treatments and towards clinically appropriate higher-value care through
provider/supplier education; a novel payment approach that is based on
paying WISeR participants a share of averted expenses in lieu of the
traditional acquisition-based approach; and potential alignment with MA
in terms of standardization, predictability, and transparency. We plan
that model participants will use a technology-assisted prior
authorization process to help ensure that all relevant clinical and
medical documentation requirements are met before services are rendered
to beneficiaries and before claims are submitted for payment, and to
help navigate patients towards alternatives when appropriate. This
process will further help ensure that claims comply with existing
Medicare documentation, coverage, payment, and coding requirements.
In general, this model will require the same information and
clinical documentation that is already required to support Medicare FFS
payment but earlier in the process, namely, prior to the service being
furnished. Prior authorization allows providers and suppliers to
address potential issues with claims prior to rendering services,
including potentially navigating beneficiaries to more effective or
appropriate alternative care, and reduces the likelihood that a
furnished service is not covered. Implementing a process that leverages
enhanced technology will streamline the claim review and adjudication
process. The model will not change payment or coverage for the selected
services in the model.
Beginning January 1, 2026, the prior authorization process under
this model will be implemented in the selected states on the following
items and services with affiliated NCDs or LCDs:
<bullet> Electrical Nerve Stimulators (NCD 160.7)
<bullet> Sacral Nerve Stimulation for Urinary Incontinence (NCD 230.18)
<bullet> Phrenic Nerve Stimulator (NCD 160.19)
<bullet> Deep Brain Stimulation for Essential Tremor and Parkinson's
Disease (NCD 160.24)
<bullet> Vagus Nerve Stimulation (NCD 160.18)
<bullet> Induced Lesions of Nerve Tracts (NCD 160.1)
<bullet> Epidural Steroid Injections for Pain Management excluding
facet joint injections (L39015, L33906, L39036, L39240, L39242, L36920,
L38994, L39054)
<bullet> Percutaneous Vertebral Augmentation (PVA) for Vertebral
Compression Fracture (VCF) (L33569, L34106, L34228, L38201, L34976,
L35130, L38737, L38213)
<bullet> Cervical Fusion (L39741, L39799, L39770, L39758, L39762,
L39793, L39773, L39788)
<bullet> Arthroscopic Lavage and Arthroscopic Debridement for the
Osteoarthritic Knee (NCD 150.9)
<bullet> Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
(L38276, L38307, L38398, L38387, L38310, L38312, L38385, L38528)
<bullet> Incontinence Control Devices (NCD 230.10)
<bullet> Diagnosis and Treatment of Impotence (NCD 230.4)
<bullet> Percutaneous Image-Guided Lumbar Decompression for Spinal
Stenosis (NCD 150.13)
<bullet> Skin and Tissue Substitutes (LCDs below)--only applicable to
MAC jurisdictions and states that have an active LCD in place
++ Application of Bioengineered Skin Substitutes to Lower Extremity
Chronic Non-Healing Wounds (L35041)
++ Wound Application of Cellular and/or Tissue Based Products (CTPs),
Lower Extremities (L36690)
We selected these services based on several factors. We considered
for inclusion services for which there is existing evidence of
potential FWA, including alignment with definitions and evidence around
services defined as low-value by Schwartz et al.; \12\ concerns around
and prior reports <SUP>13 14</SUP> of fraud, waste, and abuse from the
Department of Health and Human Services' (HHS) Office of Inspector
General (OIG), Department of Justice (DOJ), the Medicare Comprehensive
Error Rate Testing (CERT) program, and other sources; and services
already subject to prior authorization in MA at the time. We considered
patient safety concerns, including both excluding services that are
inpatient only, or pose a substantial risk to patients if services are
delayed. We also considered for inclusion services where opportunity
exists to support the model test, including services with publicly
available NCDs or LCDs, and cost savings opportunity. CMS may add
additional services in future years.
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\12\ Schwartz, A.L., Landon, B.E., and Elshaug, A.G. (2014).
Measuring Low-Value Care in Medicare. JAMA Intern Med. 174(7):1067-
1076. doi:10.1001/jamainternmed.2014.1541.
\13\ HHS Office of the Inspector General. ``Medicare Part B
Payments for Skin Substitutes.'' HHS OIG Work Plan. Available at:
<a href="https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000894.asp">https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000894.asp</a>.
\14\ HHS Office of the Inspector General. ``Audits of Medicare
Payments for Spinal Pain Management Services.'' HHS OIG Work Plan.
Available at: <a href="https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000583.asp">https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000583.asp</a>.
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Prior to the start of the model and throughout the duration of the
model, we will conduct outreach and education to Medicare-enrolled
providers and suppliers, beneficiaries, and the model participants
through such methods as open-door forums, frequently asked questions
(FAQs) on our website, other website postings, and educational
materials issued by the MACs. Traditionally, utilization management
tools such as technology-enabled prior authorization are widely used in
the MA and commercial payer space but applied in limited cases in the
Medicare FFS program. For this reason, the WISeR model would ensure
that there is rigorous communication and education between the MACs and
the model participants to seamlessly interface with one another, reduce
health care provider burden, and avoid Medicare beneficiary harm.
Additional information about the WISeR model is available on the CMS
website [<a href="https://www.cms.gov/priorities/innovation/innovation-models/wiser">https://www.cms.gov/priorities/innovation/innovation-models/wiser</a>].
B. Prior Authorization Process Under WISeR
Under the WISeR model, a Medicare-enrolled provider/supplier will
have the opportunity to submit a request for prior authorization to
either the MAC or the model participant,\15\ along with documentation
to support Medicare coverage of a selected service included in the
model as defined in the statute, regulation, NCD and/or LCD. After
receipt of this documentation, the model participant will be required
to make every effort to conduct a review and notify the provider/
supplier of their decision on a prior authorization request within the
timeframe specified by CMS for an initial submission. Submitting a
prior authorization request will be voluntary; however, if the
provider/supplier does not submit a request, their claim will be
subject to
[[Page 28752]]
pre-payment medical review by model participants that may involve
requests for documentation to support the medical necessity of the
targeted item or service (see Scenario 3 for further details).
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\15\ The model participant would be required to offer options
for providers and suppliers to submit prior authorization requests
that would be consistent with standardized submission approaches
recognized by CMS, including an electronic portal.
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To be provisionally affirmed, the request for prior authorization
must meet all applicable coverage, coding, and documentation
requirements found in statutes, rules, NCDs, and LCDs for the select
service. A provisional affirmation is a preliminary finding that a
future claim submitted to Medicare for the service likely meets
Medicare's coverage, coding, and payment requirements. Claims for which
there is an associated provisional affirmation decision 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.
A provider/supplier may request an expedited review when the
model's standard timeframe for making a prior authorization decision
could jeopardize the life or health of the beneficiary. Requests for
expedited review will need to include justification for why the
standard timeframe would not be appropriate. If the MAC or model
participant determines that the request does not substantiate the need
for an expedited review, they will provide notification that the
request will not be expedited and communicate a decision within the
regular timeframe. As we plan to initially target nonemergent services
only, we expect requests for expedited reviews to be extremely rare.
For a non-affirmed request where the service has yet to be provided
and a claim has yet to be submitted, the provider/supplier has
unlimited opportunities to resubmit a prior authorization request to
the model participant or MAC. When resubmitting the request to the
model participant or MAC, the provider or supplier would have the
opportunity to request a peer-to-peer review to inform the new
determination. A non-affirmed prior authorization decision does not
prevent the provider/supplier from submitting a claim. However,
submission of such a claim would be denied by the MAC and would
constitute an initial determination, which would be subject to the
administrative appeals process. The existing claims appeals process
would not change under the model. See 42 CFR part 405, subpart I. This
would be a further opportunity to challenge the coverage decision.
The following describes how WISeR will address three potential
scenarios under the model:
Scenario 1: A Medicare-enrolled provider/supplier submits a prior
authorization request to the model participant. The model participant
will make a decision of affirmation or non-affirmation based on its
review of the prior authorization request and relevant supporting
documentation. If the model participant determines provisional
affirmation, then the model participant will provide notification to
the provider/supplier and coordinate with the MAC to generate a unique
tracking number (UTN) to inform payment determination when the claim is
submitted. The provider/supplier will need to include the UTN on the
claim when billing for applicable services. If the model participant
determines a non-affirmative prior authorization, they will provide the
provider/supplier with a detailed reason for the non-affirmative
decision and work with the MAC to generate an UTN that is associated
with the non-affirmative decision. After reviewing the information
provided, the provider/supplier should consider if there is additional
documentation or other rationale that could address the non-affirmation
decision and can resubmit the prior authorization request an unlimited
number of times. If a claim with a non-affirmed prior authorization
request is submitted, the MAC will deny the claim. The provider/
supplier may then appeal the claim denial with the MAC under existing
appeals procedures.
Scenario 2: A Medicare-enrolled provider/supplier submits a prior
authorization request to the MAC. When the MAC receives the prior
authorization request and supporting documentation from the provider or
supplier, the MAC will route the prior authorization request to the
model participant to conduct the prior authorization. After that, the
same process as outlined in scenario 1 will be followed.
Scenario 3: A Medicare-enrolled provider or supplier performs a
selected service without requesting prior authorization. As noted
previously, submitting a prior authorization request is voluntary. In
this scenario, the provider or supplier submits the claim to the MAC
without seeking prior authorization. The MAC then flags the claim for
pre-payment medical review to be performed by the model participant;
the model participant would request documentation from the provider/
supplier to support medical necessity for the claim. After receipt of
all relevant documentation, the model participant will conduct a
medical review, which could include leveraging technology and clinician
review, and communicate the decision to the MAC. The MAC will then
process the claim in accordance with the model participant's decision.
If the claim is denied for payment, the provider/supplier and
beneficiary may request an appeal and will have full administrative
appeal rights. This appeal would follow the existing Medicare FFS claim
appeal process.
Under the model, we will work to avoid any adverse impact on
beneficiaries or providers/suppliers and to educate stakeholders about
the model. We will hold model participants accountable for the accuracy
and timeliness of prior authorization determinations through quality
adjustments to model payments and we will also monitor for downstream
impacts on quality and outcomes. If a prior authorization request is
not affirmed, and the claim is still submitted by the provider or
supplier, the claim will be denied and the providers/suppliers as well
as beneficiaries will retain their administrative appeal rights.
CMS is also exploring implementation of ``gold carding'' which is a
process to exempt compliant providers/suppliers from the prior
authorization process and expanded pre-payment review processes. Such
an exemption acknowledges providers'/suppliers' resource limitations
and reduces burden for compliant providers while enforcing prior
authorization for aberrant billers, meeting our fiduciary obligation to
protect the Medicare Trust Fund. We would likely leverage and align
with existing exemptions policies in place for the CMS' OPD prior
authorization program. A provider/supplier could be exempt from prior
authorization if they achieve a prior authorization provisional
affirmation threshold of 90 percent during a periodic assessment,
thereby demonstrating a sufficient understanding of the requirements
for submitting an accurate claim. Under such an approach, 100 percent
compliance may not be necessary as there could be unintentional or
sporadic errors that could occur that are not deliberate or a result of
issues out of the provider's/supplier's control. We could withdraw an
exemption if evidence became available, based on a review of claims,
that the provider/supplier had begun to submit claims that are not
payable based on FFS Medicare's billing, coding, or payment
requirements during a periodic assessment.
Given the model participants in WISeR will be third-party entities,
CMS privacy and security policies will govern data sharing under the
model.
[[Page 28753]]
Model participants will be required to comply with all applicable data
privacy and security laws, including relevant provisions of the Health
Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy,
Security, and Breach Notification Rules (45 CFR parts 160 and 164,
subparts A through E) (HIPAA Rules). By performing prior authorization
functions on behalf of the Medicare FFS health plan that involve
protected health information (PHI), the model participants will be
serving as business associates (see 45 CFR 160.103). A business
associate relationship will be established between CMS's Medicare FFS
health plan and the model participants which will be documented through
valid business associate agreements (BAA) that comply with the
requirements of the HIPAA Privacy Rule (see 45 CFR 164.502(e) and
164.504(e)). Currently, MACs also function as business associates to
CMS's Medicare FFS health plan. CMS will develop the WISeR model's data
sharing policies in compliance with the HIPAA Rules and all relevant
HIPAA guidance applicable to the use and disclosure of PHI, as well as
CMS's overarching privacy and security framework, and other applicable
federal laws and regulations.
Additional information is available on the WISeR website at <a href="https://www.cms.gov/priorities/innovation/innovation-models/wiser">https://www.cms.gov/priorities/innovation/innovation-models/wiser</a>.
III. Collection of Information Requirements
Section 1115A(d)(3) of the Act, as added by section 3021 of the
Affordable Care Act, states that chapter 35 of title 44, United States
Code (the Paperwork Reduction Act of 1995), shall not apply to the
testing and evaluation of models or expansion of such models under this
section. Consequently, this document need not be reviewed by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 35).
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Dr. Mehmet Oz, having reviewed and approved this document,
authorizes Chyana Woodyard who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Chyana Woodyard,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2025-12195 Filed 6-27-25; 4:15 pm]
BILLING CODE 4120-01-P
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