The WISeR Model: What Medical Device Manufacturers Need to Know Right Now

CMS's Prior Authorization Demonstration Could Dramatically Reshape Medicare Reimbursement Strategies for Medical Device Manufacturers and Innovators 

At a Glance: WISeR Model Key Facts 

What: Medicare's new Wasteful and Inappropriate Service Reduction (WISeR) Model introduces AI-powered prior authorization to traditional Fee-for-Service Medicare 

When: January 1, 2026, to December 31, 2031 

Where: Six states: New Jersey, Ohio, Oklahoma, Texas, Arizona, and Washington 

Who: Affects medical device manufacturers, healthcare providers, and Medicare FFS beneficiaries 

Services Impacted: 17 categories including neurostimulation devices, spinal procedures, knee arthroscopy, skin substitutes 

Why It Matters: First-ever use of AI technology vendors and routine use of prior authorization in FFS Medicare 

Keywords: WISeR Model, Medicare prior authorization, CMS demonstration, medical device reimbursement, AI prior auth, Medicare FFS, neurostimulation reimbursement, spine device coverage, Traditional Medicare 

Executive Summary 

The Centers for Medicaid and Medicare Services (CMS) proposed Wasteful and Inappropriate Service Reduction (WISeR) Model, running from January 1, 2026, to December 31,2031, in six states¹, represents a major shift in how Medicare approaches utilization management for Fee-for-Service beneficiaries (traditional Medicare). While initially limited in scope, broader adoption of the program would impact manufacturers and beneficiaries. WISeR warrants attention for manufacturers who have built commercial access, adoption and reimbursement strategies around Medicare's traditional approaches towards coverage and claims processing. 

What is WISeR? 

The WISeR Model is a demonstration project launching in six specific geographies for Fee-for-Service (FFS or “traditional”) Medicare beneficiaries: New Jersey, Ohio, Oklahoma, Texas, Arizona, and Washington. CMS will contract with third-party technology vendors who must have demonstrated experience using tools such as artificial intelligence, machine learning, and automated decision logic to manage prior authorization processes³.   

The model targets services and associated devices or technologies CMS identifies as high-risk for inappropriate use, including neurostimulation devices, spinal procedures, knee arthroscopy for osteoarthritis, and skin substitutes. According to CMS, these services "when delivered inappropriately, may result in harm to people with Medicare: financial (out-of-pocket costs), physical (i.e., complications like the risk of infection), or psychological (i.e., anxiety over tests and procedures).”   

Associating Prior Authorization with reduced anxiety seems counter to what many advocacy groups argue is a significant downside of expanded use of the tool.  Medicare Rights Center President Fred Riccardi says, “Coverage denials can be extremely stressful and disruptive. They can force beneficiaries to choose between seeking other care, paying out of pocket, going without or getting embroiled in a daunting appeals system. Too often these denials are inappropriate and even successful appeals come at a cost, including care delays and negative health outcomes.”8 

Selected vendors will share in savings generated from denied requests or procedures deemed not “reasonable or necessary,” CMS’s historically vague bar for coverage. They will be compensated by CMS based on a percentage of demonstrated savings from avoided payments for selected services. While much of the controversy related to WISeR questions why Traditional Medicare is integrating a generally unpopular private play utilization management tool at all, there are also questions about whether these changes will improve the lives of beneficiaries. Former CMS Administrator Donald Berwick equated vendor incentives as "bounties for companies that decrease costs by denying care" in a July 25, 2025, STAT News op-ed. Berwick’s editorial continues with a blunt warning: "WISeR, a Medicare demonstration program from the CMS Innovation Center, will not cut waste — but it will hurt seniors."10 

Broad Adoption of WISeR Could Be Transformational 

The End of Predictable Medicare Pathways 

Traditionally, FFS Medicare's minimal use of prior authorization has created addressable strategic timetables for achieving optimal coding, coverage, and payment for novel procedures. These milestones (Category III and Category I CPT designations, transitional programs for enhanced outpatient or inpatient payments) have been anchors for successful medical device commercialization strategies. Once manufacturers secured appropriate CPT codes, payment pathways, and/or Medicare Coverage Determinations, they could rely on routinely processed claims within coverage criteria.  Providers are then reasonably assured that investments they make in newer or innovative technologies will enable them to practice reimbursable procedures without a burdensome claims submission process. 

This stands in stark contrast to Medicare Advantage and commercial plans, most enrollees face prior authorization requirements that create less predictable utilization patterns. The FFS Medicare pathway has historically offered manufacturers a clear sequence: FDA approval → coding → coverage determination → predictable market adoption. Companies could model revenue projections, secure investor funding, and scale manufacturing based on these reliable timelines. 

Justice in Aging captured why this is of significant concern in their July 11, 2025, analysis: "Prior authorization is currently rare in Traditional Medicare. Prior authorization in Medicare Advantage has been tied to delays in care." They note that WISeR contractors will "receive a percentage of the savings from denials," fundamentally disrupting the established commercialization framework that has enabled medical innovation for decades.9 

Now, innovators and manufacturers face a new reality where existing codes and coverage determinations are less reliable indicators of market access. Even for companies whose innovative technologies have successfully navigated the existing coding system, this represents a particular threat. WISeR essentially changes the rules mid-game, forcing manufacturers to justify not just clinical efficacy and coverage criteria, but also "appropriateness" to AI systems programmed to generate savings through denials. 

The Administrative Burden Reality 

Prior authorization is widely considered cumbersome for physician practices and consistently frustrates both private health plan members and Medicare Advantage beneficiaries. The traditional trade-off from a practice management perspective was accepting generally lower than private insurer rates for FFS Medicare in exchange for significantly reduced practice administration hassle with aggressive forms of utilization management.  

 However, WISeR creates a fundamentally different operational challenge than Medicare Advantage prior authorization. While providers can choose whether to contract with specific MA plans and manage their requirements, they cannot selectively opt out of WISeR without abandoning FFS Medicare entirely. More critically, FFS Medicare's historic operational advantage has been its uniformity.  WISeR shatters this simplicity, forcing providers to track patient location, procedure-specific rules (which of the 17 services require authorization?), and maintain dual workflows within what was once a single, predictable system. As the Center for Medicare Advocacy warns, this "places tremendous additional pressure on an already over-burdened health care delivery system,"11 transforming FFS Medicare from the simplest payer to potentially the most complex for affected services.

Critical Implications of WISeR for Medical Device Innovators & Manufacturers 

Upstream Strategic Assumptions May Need Recalibration 

Medical device companies should consider adjusting their upstream strategic assumptions about the impact of existing codes and Medicare Coverage Determinations. Having appropriate CPT codes and positive coverage determinations may no longer ensure practices and hospitals that claims processing will run smoothly. 

Consider how your strategic planning must evolve: 

• R&D investments must account for AI-reviewable clinical evidence and trial inclusion/exclusion protocol 

• Market sizing requires factoring in prior authorization barriers withing the Traditional Medicare population 

• Revenue projections need adjustment for potential denial rates  

• Customer Support Investments similar to those implemented in private plan and Medicare Advantage (Market Access hotlines, case management, patient/provider hubs) will need to be expanded to Fee-for-Service Medicare in effected specialties and geographies 

CMS states that WISeR does not change Medicare Coverage Determination or payment policy¹, but enforcement through AI fundamentally changes market access dynamics. 

Customer Support Requirements Will Intensify 

Your customers (practices, hospitals, and Medicare beneficiaries) will require support understanding requirements and criteria for coverage of procedures (and associated technologies or devices) that are currently routinely reimbursed. 

Healthcare providers need: 

• Documentation templates optimized for AI review, 

• Prior authorization specialists or outsourced support services, 

• Appeals process guidance when AI systems deny coverage, and 

• Patient communication tools explaining new access barriers 
  
  

Partner with Veranex’ CSMA Practice 

At Veranex CSMA, we help medical device manufacturers navigate complex reimbursement transformations through integrated evidence planning, market access strategy, and health economics modeling⁷. Our team combines deep Medicare policy expertise with practical implementation experience, helping you build the infrastructure needed to thrive under WISeR and similar emerging models. 

The companies that act now (adjusting strategies, building support systems, and generating appropriate-use evidence) will maintain market leadership. Those that wait risk being blindsided as demonstration projects become permanent policy. 

Contact our CSMA team today to assess your WISeR readiness or exposure and develop your comprehensive response strategy