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Outlook 2026: New Guidance Raises the Bar for Medicaid 1115 Demonstration

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As part of its ongoing effort to reshape Medicaid policy and oversight, the Centers for Medicare & Medicaid Services (CMS) over the past few months has released a series of guidance documents in 2026 that collectively signal a more structured, fiscally rigorous approach to federal Medicaid funding. These changes will have a considerable impact on state innovation within the program.

In the most recent of these consequential directives, CMS outlines its plan to implement updated budget neutrality requirements for Medicaid Section 1115 demonstrations beginning in 2027.

To understand what this guidance means for states, health plans, and providers, ϱ (ϱ) senior principal Andrea Maresca caught up with Sara Singleton, Principal at Leavitt Partners, an ϱ Company, and Rob Buchanan, Senior Principal at ϱ. Of particular interest was the need for significantly more robust modeling and financing strategies to provide the new prospective actuarial analyses required for approval.

A Shift in Federal Policy Direction

Q: CMS has issued several guidance documents this year, but why and how does the one on Section 1115 budget neutrality stand out?

Sara Singleton: This guidance reflects a broader shift toward increased federal oversight and a more standardized interpretation of budget neutrality. While Section 1115 demonstrations have always been required to be budget neutral in concept, CMS and states have historically relied on methodologies that allowed for flexibility and, in some cases, greater federal spending over time.

What’s different now is that Congress recently added a requirement that the CMS Chief Actuary certify that demonstrations will not increase federal expenditures relative to what Medicaid would otherwise spend. That requirement, combined with CMS’s implementing guidance, is driving a more prospective, and in theory, data-driven approach to evaluating demonstrations.

Q: How is the change from reviewing retrospective to prospective spending expected to affect Medicaid programs?

Sara Singleton: Historically, CMS often reviewed budget neutrality retrospectively against what’s called “without waiver” spending limits, which means the agency reviewed what spending would have been in the absence of the waiver program. Going forward, CMS is emphasizing prospective certification and signals an expectation that states will provide more rigorous actuarial analysis and activity-level financial modeling.

The implication is that states will need to demonstrate upfront and in much greater detail how each component of their demonstrations affect federal spending. This is a substantive change in expectations for documentation, analytics, and accountability.

Implications for Innovation, Including HRSN Initiatives

Q: Sara, you’ve written previously about the opportunities to address health-related social needs (HRSN) through Medicaid. How does this new guidance intersect with those efforts?

Sara Singleton: The timing is important. Over the past several years, the number of states utilizing 1115 waivers to address HRSNs, such as housing instability, nutrition, and transportation, has significantly increased. Many of these waivers and additional research have proven what we have long known to be true—that addressing HRSNs has a clear impact on health outcomes and costs.

The new budget neutrality framework raises the bar for states to demonstrate that new innovations in an 1115 waiver will reduce costs before the waiver can be approved. States will need to show not just that these services are beneficial, but that they also are financially sustainable within the federal budget neutrality test. That’s a higher evidentiary standard, particularly for newer or more complex interventions.

Q: Does that mean HRSN initiatives are at risk?

Sara Singleton: Not necessarily; however, it does mean states may need to rethink how they structure and justify them.

One key element in the guidance is the distinction between services that are already Medicaid-authorizable and those that are unique to Section 1115 demonstrations. CMS is signaling a preference for using existing authorities where possible. CMS’s preference and negotiations with states could lead states to shift some HRSN activities into managed care programs, including using in lieu of services, or state plan options.

For services that remain in 1115 demonstrations, the burden will be on states to build a more robust financial and policy case. That expectation could shape which interventions move forward.

Q: Rob, what are you hearing from states as they process this guidance?

Rob Buchanan: States recognize that Section 1115 demonstrations are critical tools—they allow flexibility to test new delivery models and address complex population needs. In fact, every state has an 1115 demonstration, each with tailored initiatives that span coverage, benefits and services, workforce investments, and other programs. The pathway to approval and iteration of these programs is becoming more complex.

From a planning perspective, states will need to rethink how they approach the entire life cycle of a demonstration—from concept development to modeling, implementation, and evaluation.

Q: Where are the biggest pressure points?

Rob Buchanan: ϱ consultants have identified three key areas.

First is analytics and actuarial capacity. The guidance calls for more rigorous financial projections and certification prior to approval, which means states need stronger data infrastructure and modeling capabilities earlier in the process.

Second is program design and prioritization. Because demonstrations that increase federal spending will not be approved, states may need to narrow their focus, phase in initiatives, or identify offsetting savings within the demonstration.

Third is timing and alignment. CMS has indicated it will begin applying this framework in 2027, even as rulemaking continues. States with renewals or amendments coming up in that window will need to move quickly to align with the new expectations.

Q: How should states begin adapting their strategies?

Rob Buchanan: We’re advising states to start with a few practical steps.

One is to reassess their current demonstration portfolios. Which components are most essential? Which are most likely to meet the new budget neutrality standard? That prioritization will be critical.

Another is to integrate policy, finance, and operations early. Under this framework, you can’t develop policy concepts in isolation. You need to understand the financial implications from the outset.

Finally, states should think about implementation pathways. For example, if certain services can be authorized through managed care or state plan options, that may provide more flexibility than relying solely on Section 1115 authority.

Q: Does this change how states should think about partnerships?

Rob Buchanan: Yes, the level of coordination required across Medicaid agencies, actuaries, managed care plans, providers, and community organizations is increasing.

States will need strong partnerships to both design workable demonstrations and execute them effectively. That includes building connections with community-based organizations, particularly for initiatives that address HRSNs, where implementation relies heavily on local networks.

Q: As we look toward 2027 implementation, what should states and other Medicaid-focused organizations be focused on now?

Rob Buchanan: The most important thing is to recognize that this is not a distant policy change. It’s an immediate planning issue and states should already be assessing how the new framework applies to their program.

Compliance with this guidance requires state Medicaid programs to have detailed data  – specifically actuarial analyses that have a clear methodology and assumptions and documentation demonstrating the federal fiscal impact of each demonstration component. States must provide sufficient information for CMS’s Chief Actuary to evaluate and certify budget neutrality. Plans and providers should also be engaged because these changes will influence program design, reimbursement approaches, and operational expectations.

Sara Singleton: At a broader level, stakeholders should expect additional guidance from CMS. This is one piece of a larger policy agenda, and CMS plans to provide additional clarification through the federal rulemaking process as well as technical assistance to states.

ϱ, including ϱ companies Wakely and Leavitt Partners,is actively helping states, health plans, providers, and other stakeholders assess the implications of CMS’s proposed budget neutrality framework and prepare for upcoming section 1115 renewals and amendments, as well as other changes due to recent guidance on community engagement requirements, state directed payments, and program integrity. ϱ can support strategic assessments, renewal planning, demonstration redesign, financial modeling, actuarial coordination, federal negotiations, and implementation planning. Connect with ϱ to learn how we can support your organization in navigating the next phase of Medicaid Section 1115 demonstration and policy.

You can find more insights on the impact of federal Medicaid policy changes in, CMS Proposes New Budget Neutrality Framework for Medicaid Section 1115 Demonstrations and register for the next edition of ϱ’s Summer Webinar Series: Understanding Work and Community Engagement Requirements and New Section 1115 Guidance

New Funding Approaches Prompt Maryland Healthcare Leaders to Reassess Strategies for Affordable Coverage

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Strategies to improve healthcare delivery, sustain coverage, and manage growing cost pressures resulting from federal policy changes and state budget dynamics were key topics of discussion at this year’s , May 21, 2026, in Baltimore, MD. Hosted by (SOR), an ϱ Company, the program convened state policymakers and leaders of health plans, provider groups, and community-based organizations to examine the most pressing healthcare issues in Maryland.

Across sessions, participants explored key policy priorities, including Maryland’s implementation of the Rural Health Transformation Program (RHTP), efforts to stabilize and expand health insurance coverage, and early lessons from implementing the AHEAD (Achieving Healthcare Efficiency through Accountable Design) total cost of care (TCOC) model. 

Sustaining Medicaid and Marketplace Accessibility Amid Federal Policy Changes 

Throughout the conference speakers and attendees engaged on myriad issues and concerns resulting from the 2025 budget reconciliation act, now referred to as the Working Families Tax Cuts (WFTC) Act, and its potential impact on state Medicaid programs and coverage stability. Maryland Deputy Secretary for Healthcare Financing and Medicaid Director Perrie Briskin joined Johanna Fabian-Marks, Deputy Executive Director of the Maryland Health Benefit Exchange (MHBE), and Melissa Horn, Director of State Legislative Affairs at the Arthritis Foundation, to examine strategies for mitigating coverage loss and maintaining affordability. 

Speakers emphasized the need for improved coordination between Medicaid and the MHBE, including clear and consistent consumer communications and targeted outreach in counties most affected by federal policy changes. 

For example, Maryland leaders described several innovative approaches the MHBE is using to help people in the state maintain Marketplace coverage, including state-funded subsidies to offset the expiration of enhanced premium tax credits, streamlined auto-renewals, and simplified enrollment pathways for individuals identified as uninsured based on their tax and employment records. The state reported an 8 percent decline in enrollment in April 2026, noting that without these mitigation strategies, enrollment could have dropped by as much as one-third. 

The MHBE is using artificial intelligence (AI) to support document verification and is deploying a chatbot to help consumers navigate common questions. 

On the Medicaid side, the state is consulting multiple data sources—including CRISP (Chesapeake Regional Information System for our Patients), labor, and education data—to verify eligibility and, compliance with community engagement requirements to reduce administrative burdens.

Rural Health Transformation Program Implementation and Early Priorities 

Maryland’s RHTP, supported by nearly $168.2 million in first-year funding from the Centers for Medicare & Medicaid Services (CMS), was a hot topic at the conference. State leaders and implementation partners emphasized the program’s role in addressing rural health disparities, strengthening care delivery infrastructure, and improving chronic disease outcomes.

Elizabeth Kromm, PhD, Assistant Secretary, Maryland Department of Health, outlined the three pillars of the state’s RHTP plan: 

  • Expand the rural healthcare workforce
  • Increase access to integrated primary, specialty, and behavioral health services
  • Address the underlying drivers of chronic disease through nutrition and food system interventions

Together, these initiatives highlight Maryland’s focus on both clinical care delivery and broader population health strategies. 

State officials also discussed the funding opportunities  in April 2026, one of which seeks to support care delivery innovation, improve chronic condition management, and advance value-based care models. Speakers emphasized that connection is central to the program’s success—both the strength of community relationships, the connections enabled through technology, and the integration of clinical and nonclinical services. 

AHEAD Model: Advancing Total Cost of Care and Population Health 

Maryland’s participation in CMS’s AHEAD Model represents a significant shift toward healthcare cost containment and system transformation. As one of the first states to implement the framework, Maryland is testing a statewide approach to managing TCOC while improving quality and population health outcomes. 

A panel discussion including leaders from the MedChi, Johns Hopkins, CareFirst Blue Shield, and Kaiser Permanente, addressed implementation considerations, open policy implications, and how providers and payers were approaching these changes in payment for healthcare services. Reimbursement strategies for primary care services were still uncertain and may differ significantly from those used under the Maryland TCOC model. Panelists also discussed what this model means in the broader healthcare environment of reductions in Medicaid payments resulting from the reconciliation legislation and additional funding coming from the Rural Health Transformation Fund. They also described how Maryland could serve as an example for other states working to implement AHEAD in the coming years. 

Speakers noted that successful implementation will require strong coordination among providers, payers, and state agencies, and more details are necessary to fulfill the requirements. The model’s 10-year timeline positions Maryland as a leading test case for future federal and state efforts to scale TCOC approaches. 

AI in Healthcare: From Innovation to Real-World Impact 

AI’s role in healthcare delivery and policy continues to evolve, with growing attention on its practical applications and regulatory implications. A session led by ϱ (ϱ) Principal Brandon Greife, JD, and speakers from Microsoft AI, the Pair Team, the Center for Virtual Care, and b.well Connected Health explored how healthcare organizations conceptualize AI use cases to deploy solutions that demonstrate measurable impact. 

AI holds promise for improving care delivery, but realizing that potential requires navigating ethical, regulatory, and operational challenges. Mr. Greife led a panel discussion on how the healthcare industry is transitioning from abstract use cases for AI toward evaluating the real-world impact of deployed solutions. 

Session speakers also explored how healthcare is advancing from AI tools that support clinicians and payers to patient-facing AI that supports care navigation, chronic disease management, and community outreach. They rounded out the session with a focus on fundamentals of healthcare—concepts like data quality, clinical trust, patient safety, and demonstrated value at the point of care. 

Looking Ahead 

If you are looking for strategies and solutions to address urgent healthcare policy and operational challenges, ϱ experts are available to help you navigate these complex changes and identify practical paths forward. 

Through the ,  partnership events, and other ϱ convenings across the country, we connect state leaders, providers, health plans, and community stakeholders to share insights, elevate lessons, and advance solutions. Join us at an upcoming event—including our next ϱ National Conference in New Orleans, LA on October 5-7, 2026—or explore additional opportunities to engage with ϱ and access the full schedule of conferences and resources. 

State of Reform develops its conference agendas through collaboration with ϱ subject matter experts/market leads and stakeholders across the public and private sectors, including state officials, community-based organizations, providers, payers, and more. 

Medicaid Community Engagement Interim Final Rule:Key Implications for States, Payers, and Providers

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ϱ’s issue brief on the Medicaid Community Engagement Interim Final Rule provides a clear, actionable summary of new Medicaid work requirements and community engagement requirements for states, Medicaid health plans, providers, community-based organizations, and technology vendors. The report explains key policy changes issued by CMS on June 1, 2026, including exemptions such as medical frailty, verification and reporting expectations, enrollee notification requirements, and the state systems changes needed to prepare for the January 1, 2027 implementation deadline. If you are searching for a summary of Medicaid work requirements, a summary of Medicaid community engagement requirements, the medical frailty definition, or guidance on Medicaid work requirements state systems changes, this brief helps translate complex federal regulation into practical next steps to support compliance, reduce coverage loss risk, and inform implementation strategy.

Please fill out this form to receive a copy of the issue brief.

Join us at ϱ’s 2026 National Conference: Signals, Signs & Flashing Lights

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Registration is now open for the ϱ (ϱ) 2026 National Conference, , October 5–7 in New Orleans, LA. 

 is intentionally structured to bring together leaders who are shaping decisions across sectors—those setting policy, managing risk, leading clinical operations, and innovating approaches to improve outcomes—to engage in candid conversations about what is working, what is not, and what is changing in  and adjacent programs. In an environment defined by new challenges and “flashing lights,” even the most seasoned healthcare leaders will find value in stepping out of their day‑to‑day roles to compare strategies, test assumptions, and learn from peers facing similar pressures. 

This year’s conference is designed to reflect the environment healthcare leaders are navigating today—one defined less by policy certainty and more by shifting expectations and competing pressures on cost, access, and performance. Our experts are crafting discussions to address how organizations are approaching policy engagement in this environment, including new strategies for interpreting signals from federal and state policymakers and negotiating policy frameworks that directly shape market dynamics. 

Across plenary sessions, breakout discussions, and ϱ’s signature coffee conversations, the conference will focus on how organizations are interpreting these signals and translating them into practical strategies. 

Programming will center on four cross-cutting themes shaping healthcare decision-making: 

  • Managingrisk and cost amid continued financial pressure. Discussions will examinethe drivers ofutilizationand affordability trends across Medicare, Medicaid, and commercial markets and whichstrategies aredemonstratingmeasurable impact.
  • Sustaining access and system stability. The agenda also will focus on how providers, health systems, and state programs are maintaining access amid workforce challenges, coverage transitions, and ongoing financial strain.
  • Turning innovation into impact.Sessions will explore where artificial intelligence(AI)and digital health tools are delivering measurable operational or clinical impactandwhat it takes to implement them effectively.
  • Building partnershipsthat last.Conversationwill highlight how stakeholders arealigning incentives,funding,and strategy to move from short-termresponses to long-term, sustainablesolutions.

As in prior years, the ϱ National Conference is structured to support candid dialogue, actionable takeaways, and meaningful connections. Attendees consistently highlight the opportunity to move beyond high-level trends and engage in practical discussions that inform decision-making in their organizations. 

 is now available for a limited time. The  includes new opportunities for your organization. Additional agenda details, featured speakers, and interactive programming announcements will be released in the coming weeks. 

Webinar Replay – ACA Enrollment Declines: Implications and Options for State and Federal Policymakers

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This webinar was held May 21, 2026.

Recent and future policy changes are reshaping the ACA market. A recent Wakely report finds that only 86% of ACA enrollees nationwide paid their first premium at the start of the year, raising important questions about affordability, access, and market stability. Additionally, the 2027 Notice of Benefits and Payment Parameters (NBPP) is expected to be finalized this Spring which will have additional implications for consumers, issuers, and other stakeholders. As policymakers and state leaders consider how to respond to the shifting market composition and future policy changes, this discussion will focus on the policy implications of these shifts and the options to address affordability and coverage options to improve market stability.

During this webinar, ϱ’s ACA team had a policy-focused conversation on what these projected changes mean for marketplace dynamics, including impacts to risk pools, premiums, and issuer participation. The session explored emerging federal and state policy responses and offered insight into how today’s decisions may shape 2027 rates, plan offerings, and long-term market sustainability.

Learning Objectives:

  • Analyze policy drivers: Examine how changes to federal subsidy policy are influencing ACA marketplace enrollment, affordability, and coverage continuity.
  • Evaluate policy tradeoffs: Assess how enrollment declines impact market stability, including risk pools, premiums, and issuer participation.
  • Inform policy strategy: Identify state and federal policy options to mitigate coverage losses and support a stable, competitive marketplace heading into 2027.

CMS Proposes Modest Hospital Payment Updates and Signals Expanded Use of Mandatory Value-Based Models

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On April 10, 2026, the Centers for Medicare & Medicaid Services (CMS) released the proposed rule for the . The proposal combines a modest net increase in hospital payments with policy signals around quality reporting and mandatory episode-based payment models—most notably a proposed nationwide expansion of the Comprehensive Care for Joint Replacement (CJR) model. 

These proposed updates underscore CMS’s continued emphasis on value-based purchasing, episode accountability, and alignment across quality programs. In addition, CMS resurfaces ongoing debates with hospital stakeholders about the adequacy of Medicare payment updates amid rising costs and coverage disruptions. 

This article reviews several key provisions in the FY 2027 proposed rule. 

Hospital Payment Updates: Headline Increase Masks Net Impact 

Under the proposed rule, CMS would increase base IPPS and LTCH PPS payment rates by 2.4 percent in FY 2027. However, after accounting for proposed reductions to uncompensated care payments for disproportionate share hospitals (DSH) and changes in outlier payments for extraordinarily high-cost cases, CMS estimates the effective payment increase would be closer to 1.2 percent. 

In aggregate, CMS projects the proposed update would translate to approximately $1.4 billion in additional payments to acute care hospitals next year. Hospital industry groups—including the American Hospital Association (AHA) and the Federation of American Hospitals (FAH)—have pushed back, arguing that the proposed update does not sufficiently reflect medical inflation, workforce pressures, or anticipated growth in the uninsured population. 

These concerns reflect a long-standing dynamic in annual hospital payment rules: CMS seeking to balance statutory updates and budget neutrality constraints against the hospital industry’s concern that Medicare payments are lagging behind underlying costs. 

Quality Reporting and Program Alignment 

The proposed rule would also make notable updates to the Hospital Inpatient Quality Reporting (IQR) Program. CMS proposes adding three new quality measures to be phased in during 2029 and 2030, while modifying eight existing measures to include Medicare Advantage patients. CMS also proposes shortening the performance period for certain measures from three years to two—a change designed to accelerate feedback and better align measures across programs. 

These changes continue CMS’s broader effort to harmonize quality measurement across Medicare payment and value-based programs, reduce reporting lag, and incorporate a more comprehensive view of patient populations. 

Updates to Mandatory TEAM Model 

CMS also proposes several updates to the Transforming Episode Accountability Model (TEAM), the mandatory episode-based payment model finalized last year. Key proposals include: 

  • Expanding the list ofMS-DRGsincluded in the spinal fusion episode
  • Aligning TEAM quality measurement performance periods with the IQR Program
  • Making targeted technical refinements to paymentmethodology

In addition, CMS is seeking stakeholder feedback on whether ambulatory surgery centers (ASCs) should participate in TEAM and whether participation should be voluntary for physician-owned hospitals, signaling potential future expansion or recalibration of the model. 

Proposed Expansion of Joint Replacement Bundles 

CMS proposes to expand the existing Comprehensive Care for Joint Replacement Expanded (CJR-X) Model nationwide beginning October 1, 2027. The agency also plans to make participation mandatory for most IPPS hospitals. 

CMS tested the original CJR model in 34 metropolitan areas between 2016 and 2024, generating improved patient outcomes and net Medicare savings, according to agency evaluations. CJR-X would become the fifth Center for Medicare and Medicaid Innovation model to meet the statutory criteria for nationwide expansion. 

Under CJR-X, hospitals performing lower extremity joint replacements would be accountable for the cost and quality of care for the initial procedure and most related spending during the subsequent 90 days. Although the overall structure mirrors the original CJR model, CMS proposes several important updates: 

  • Expansion of episodes to include ankle replacements, in addition to hip and knee procedures
  • Adoption of a more robust risk adjustmentmethodologywith significantly more variables, aligning closely with the TEAM model
  • Introduction of a 5 percent stop-loss policy for hospitalsthatservehigher proportions of dually eligible beneficiaries and certain smaller hospitals

Participation would be mandatory for most IPPS hospitals, with exceptions for hospitals already participating in TEAM, which includes a lower extremity joint replacement episode; Maryland hospitals operating under global budgets; and hospitals not paid under both IPPS and the Outpatient Prospective Payment System, such as Critical Access Hospitals. 

Why It Matters 

The 2027 IPPS and LTCH PPS proposed rule reinforces several clear policy signals: 

  • Pressure on hospital margins is likely to persist, as payment updates continue to trail hospital-reported cost growth.
  • Mandatory episode-based modelsremaincentral to CMS’svalue-based strategy, with CJR-Xrepresentinga significant escalation in scope and scale.
  • Program alignment and MA inclusion are accelerating, with implications for hospital data systems, care coordination strategies, and reporting infrastructure.

Hospitals and health systems will need to assess not only the near-term financial impact of the proposed payment updates, but also their readiness to accept expanded episode accountability and meet evolving quality measurement requirements. 

Comments on the proposed rule will shape final decisions regarding payment levels, quality program changes, and the scope of mandatory participation in CJR-X. Stakeholders will be watching closely to see whether CMS moderates its approach to mandatory models or doubles down on episode-based accountability as a cornerstone of Medicare payment reform. 

In parallel, CMS has released several other proposed payment rules this month, including those that would affect skilled nursing facilities, hospice providers, inpatient rehabilitation facilities, and inpatient psychiatric facilities. For these entities, CMS generally proposes payment updates of approximately 2.4 percent and 2.3 percent for inpatient psychiatric facilities. As part of its broader program integrity focus, CMS also has proposed new transparency measures for hospice providers; this follows recent enforcement actions related to fraudulent enrollment. 

Connect with Us 

ϱ, Inc. (ϱ), monitors federal regulatory and legislative developments in the inpatient setting and assesses the impact on hospitals, life science companies, and other stakeholders. Our experts interpret and model hospital payment policies and assist clients in developing CMS comment letters and long-term strategic plans. Our team replicates CMS payment methodologies and model alternative policies using the most recent Medicare fee-for-service and Medicare Advantage (100%) claims data. We also support clients with DRG reassignment requests, New Technology Add-on Payment (NTAP) applications, and analyses of Innovation Center alternative payment models. 

For more information about the proposed policies, contact one of our Medicare experts

Medicaid Managed Care Enrollment: Q4 2025 Trends and Early Signals Ahead of New Eligibility Policies

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This week ϱ (ϱ), draws on its database of monthly Medicaid managed care enrollment to present its latest quarterly analysis, offering a snapshot of enrollment trends across 37 states. 

The analysis comes at a critical time. As states prepare for Medicaid eligibility policy changes that take effect in 2027—including more frequent eligibility determinations and expanded work and community engagement requirements—current enrollment trends provide an early signal of how policy decisions and administrative practices are already influencing coverage levels. 

The ϱ Information Services (ϱIS) analysis shows that Medicaid managed care accounted for 85.6 percent of total Medicaid enrollment in December 2025. This analysis, available to ϱIS subscribers, uses data from nearly 300 health plans in 41 states. The report provides by-plan enrollment plus corporate ownership, program inclusion, and for-profit versus not-for-profit status, with breakout tabs for publicly traded plans. 

Key Insights from Q4 2025 Data 

The 37 states included in this review have released monthly Medicaid managed care enrollment data through public websites or in response to a public records request from ϱ. The report includes the most recent data obtained and illustrates the effect of state-level choices around eligibility and administration. Key findings include: 

  • As ofDecember2025,Medicaid managed care enrollment across the 37 states declined by2.2 million membersyear over year, falling to 62.5 million—a3.4 percent decrease.
  • Of the 37 states,eight—Colorado, Delaware, Mississippi, Missouri, New Jersey, North Carolina, North Dakota, and Oregon—didnotexperience year-over-yearmanaged care enrollmentdeclines,andinstead showedflat enrollment or modest gains.With the exception of Mississippi, theseareallMedicaid expansion states.
  • Arizonaand Indianaexperienceddouble-digitpercentagedeclines. Notably,Indiana began requiringenrolleesto actively respond to renewal mailers,which aligns withenrollment declines that began in March 2025.
  • Among theexpansion states in the analysis,enrollmentdeclinedby1.7million (-3.3%) to50.8million.ճseven non-expansion statesexperiencedasimilardecline (-3.6%),bringingenrollment to11.7million enrollees.

Data Considerations. The data have some important limitations. States report enrollment figures at different points during the month, with some data reflecting beginning of the month totals and others capturing end of the month enrollment. In addition, some state datasets encompass all Medicaid programs offering managed care plans, whereas others reflect only a subset of the managed Medicaid population. As a result, the findings should be viewed as indicative of broader trends rather than a comprehensive state-by-state comparison. &Բ;

Market Share and Plan Dynamics 

Using our data repository for 300 health plans across 41 states, ϱIS analyzes corporate ownership, program participation, and tax status among Medicaid managed care plans. As of December 2025, Centene maintained the largest share of the national Medicaid managed care market at 17.8 percent, followed by Elevance (10.4%), United (8.5%), and Molina (6.0%) (see Figure 1). These figures highlight continued concentration among large national plans, even as overall enrollment declines. 

Figure 1. National Medicaid Managed Care Market Share by Number of Beneficiaries for a Sample of Publicly Traded Plans, December 2025 

What to Watch  

Enrollment trends observed in the fourth quarter (Q4) of 2025 and continuing into 2026 indicate increasing state attention to eligibility policy and program integrity. State legislative activity, budget pressures, and federal regulatory developments are prompting many states to assess and strengthen certain aspects of their programs related to eligibility, particularly as they prepare to implement redetermination and work and community engagement requirements. 

Several states are already moving toward implementation. Nebraska is scheduled to launch Medicaid work requirements on May 1,2026,while Montana plans to begin implementation on July 1, 2026. Withadditionalfederal guidance stillemerging, most other states are working toward compliance ahead of January 2027 deadlines.Inexpansionstates,policymakersretainauthority to tighten administrative processes, alter optional benefits, or adjust provider payment levels—actions thatmaymaterially affect enrollment.

These developments underscore why Medicaid managed care enrollment trends deserve close attention. Declines in enrollment are often an early indicator of broader system impacts, including rising uncompensated care for providers, shifts in payer mix, and increased financial pressure on safety‑net systems. For managed care organizations, even modest enrollment changes can mask more significant shifts in risk profiles, geographic concentration, or service needs. 

Connect with Us  

ϱ is home to experts who know the Medicaid managed care landscapeand how it is evolving. ϱIS’sMedicaidenrollment data, financials,procurementtracking, and a robust library of public documents equips stakeholders withtimely, actionable intelligence.

For more information about the ϱIS subscription, contact Andrea Maresca aԻ Alona Nenko. &Բ;

ϱ Resource Provides Key Insights about the Evolving Medicare-Medicaid Integration Landscape

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People who are dually eligible for Medicare and Medicaid remain a central focus for policymakers and healthcare organizations, given their complex care needs, disproportionate share of spending, and the long-standing challenge of coordinating coverage across two programs. One of the primary vehicles for advancing integration has been Dual Eligible Special Needs Plans (D-SNPs), which continue to play an increasingly prominent role as federal and state policymakers encourage tighter Medicare-Medicaid alignment.

As states play a more active role in shaping enrollment rules, Medicaid contracting, and procurement strategies, the duals market is becoming more structured and more explicitly guided by state policy decisions. ϱ (ϱ’s) 2026 Duals Integration Environmental Inventory, examines how this shift shapes the integration landscape in 2026. This comprehensive inventory is based on a review of the 2026 market, insights from states, and other publicly available resources.

This article examines key trends from Ѵ’s&Բ;2026 inventory and addresses federal policy changes scheduled to take effect for 2027, which contribute to this dynamic environment.

What to Expect in 2026

As the landscape for duals integration evolves, the central question has shifted from whether D-SNPs operate in a state to the more consequential question of how states are using Medicaid policy levers (i.e., enrollment rules, procurement, contracting, and managed care structures) to drive tighter alignment between Medicare and Medicaid. 

At the federal level, recent Medicare Advantage and Part D rulemaking is reinforcing that movement. The  finalized the second phase-down of the D-SNP look-alike threshold to 60 percent for 2026 and established 2027 rules that limit enrollment in certain D-SNPs to members of an affiliated Medicaid managed care organization. The rule also limits the number of D-SNP benefit packages that can be offered alongside an affiliated Medicaid managed care organization. More recently, the  requires certain D-SNPs to use integrated member ID cards and integrated health risk assessments beginning in 2027. 

Together these rules signal a continued federal emphasis on linking D-SNP enrollment and operations more closely to Medicaid coverage and delivery systems, with states playing a greater role in determining how alignment is achieved. 

What the 2026 Inventory Shows

ϱ’s 2026 Duals Integration Environmental Inventory shows how these policy signals are translating into state action. More specifically: 

  • Statewide exclusively aligned enrollment appears in 16 states in the 2026 inventory, up fromninein 2025.
  • Applicable Integrated Plans (AIPs) are present in 22 states, up from 14, and default enrollment is in place in 21 states, up from 16.
  • The inventory also captures 6,084,997 total D-SNP enrollees, including 1,975,250 inHighly IntegratedSNPs(HIDE)and 743,683 inFully Integrated SNPs (FIDE-SNPs).

Those changes are already visible in state markets: 

  • Illinois, Massachusetts, Ohio, and Rhode Island entered2026 with a greater FIDE-SNP presence tied to legacy Medicare-Medicaid Plan transitions.
  • MichiganlaunchedMI Coordinated Health as a HIDE-SNP in selected regions in 2026, with statewide expansion planned for 2027.
  • Delaware also stands out:Although it already had AIPs in the 2025 inventory, it adds statewide exclusively aligned enrollment in 2026 and shows both HIDE-SNPs and coordination-only D-SNPs.

A Resource to Track State Market Direction

Ѵ’s&Բ;, available to ϱ Information Services (ϱIS) subscribers, includes a state-by-state view of the Medicaid policy, contracting, and program structures shaping duals integration and D-SNP markets. In addition to enrollment trends, the inventory documents the integration model each state is pursuing, whether long-term services and supports or behavioral health are included in managed care, and how procurement and contract decisions may inform future market activity. 

ϱ experts work with clients to apply this information and deepen their understanding of state integration approaches, inform assessments of their market readiness and alignment opportunities, and develop strategies that support more effective Medicare-Medicaid integration. 

Looking Ahead

Notably, ϱ’s inventory reflects a point in time understanding of where an individual state is today and what is known at this time about their next steps and plans. However, we expect changes in many states as they seek guidance from the Centers for Medicare & Medicaid Services and the D-SNP community to implement required changes and adopt new regulatory provisions that support state goals and priorities. 

The 2026 inventory suggests that more states are using formal alignment tools, that more enrollment is concentrated in integrated products, and that more markets are being shaped by the interaction between Medicaid structure, procurement, and D-SNP strategy. 

Connect with Us 

For organizations seeking to understand where the market is headed, the Duals Integration Inventory offers a clear view of how state policy and market structure are evolving and where tighter Medicare-Medicaid alignment is taking hold. 

Contact Holly Michaels Fisher and Julie Faulhaber to discuss your organization’s questions and needs regarding an integration strategy and market analysis. For information about the ϱIS subscription, access to the Duals Environmental Inventory contact Andrea Maresca and Gabby Palmieri

CMS’s LEAD Model: A New Phase for Accountable Care and Application Considerations

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ճrepresents the next major step in the Centers for Medicare & Medicaid Services (CMS)strategy and reinforces a federal commitment to value-based participation in Traditional Medicare. Announced as the successor to, LEAD is a voluntary, nationwide, 10‑year model that will operate from 2027 to 2036, making it the longest-running accountable care organization (ACO) model the Center for Medicare and Medicaid Innovation has tested.

Momentum around the LEAD ACO model has accelerated since CMS’s recent release of the  (RFA), which formally moves LEAD from policy design to implementation. The RFA requires prospective participants to evaluate program design choices, financial implications, and operational readiness on a compressed timeline. Notably, CMS has indicated that additional opportunities to express interest will follow for organizations that are not prepared to apply for participation in the initial cohort.

This article explains key design elements of the LEAD model and identifies considerations for organizations assessing whether and when to pursue participation in LEAD.

Core Design Evolutions of the LEAD Model

While LEAD builds on many of the elements from ACO REACH, its design reflects how the Innovation Center intends to address challenges with previous ACO models, such as the Medicare Shared Savings Program (MSSP). At its core, LEAD seeks to establish a pathway to long‑term engagement in value-based care that creates an attractive option for all types of providers, including ACOs with a history of engaging in value-based care and providers that have yet to meaningfully participate.

LEAD introduces a set of targeted design changes intended to improve predictability, alignment accuracy, and long‑term participation in accountable care—most notably through revised benchmarking, updated beneficiary alignment, and expanded flexibility for engaging specialists and high‑needs populations.

1. Revising Benchmarking Policies to Support Predictability and Success

  • LEAD provides a major win for ACOs seeking long-term predictability bysetting a long-term benchmark that will not rebase for the entirety of the 10-year model. In MSSP, many ACOs eventually face the “ratchet effect” in which benchmarks erode after rebasing to reflect the ACO’s more recent spending patterns. It can create a significant hurdle for ACOs that have already successfully reduced spending, as their own prior success lowers their benchmark. By not rebasing for the entirety of the model period, LEAD provides an attractive alternative to the MSSP, which rebases every five years.
  • LEAD will also support historically successful ACOs by transitioning to a fully regional rate book by the end of the model period. As a result, benchmarks will be set based on overall spending in the region where an ACO operates rather than an ACO’s historical spending. While ACO REACH also used a regional rate book to inform some ACO benchmarks, LEAD goes further by seeking to transition all ACOs to a benchmark basedfullyon a regional rate book while also adding protections for higher-spending ACOs by transitioning regions at different timelines to ensure that newer ACOs have the opportunity to implement the kinds of care delivery changes that lead to lower spending before they are subject to penalties.
  • Other notable changes to benchmarking include a variety of ACO-specific adjustments and the addition of an administrative component to benchmarking.ACOs will be eligible to receive a boost to their benchmarks with either a regional efficiency adjustment for ACOs with lower spending or a prior savings adjustment for ACOs with a demonstrated history of achieving savings. LEAD also introduces an administratively set component to benchmarking—the Accountable Care Prospective Trend—which already is used in the MSSP, though LEAD adds a new guardrail policy to promote predictability.

2. Improving Accuracy in Beneficiary Alignment

  • LEAD’s new “hybrid” alignment option increases accuracy and responsiveness.Monthly additions of voluntarily aligned beneficiaries and mid-year recognition of new participant taxpayer identification numbers (TINs) adopted after the start of the performance year (PY) allow alignment to better reflect real-time care relationships, averting lag and operational friction.

3. Adding Support for High-Needs Beneficiaries

  • LEAD expands support for beneficiaries with complex needs through a universal High Needs category and recalibrated risk adjustment.By moving away from ACO REACH’s population‑exclusive model, LEAD lowers barriers for organizations that serve a disproportionate share of high‑needs and dually eligible populations. In addition, CMS will test Medicare‑Medicaid alignment in two states, and help states develop arrangements supporting the provision of value-based care between ACOs and state Medicaid agencies or managed care organizations.

4. Promoting Deeper Engagement with Specialists

  • LEAD increases flexibility for engaging specialists in value‑based arrangements.New Non‑Primary Care Capitation options and episode-based risk arrangements (CMS‑Administered Risk Arrangements (CARAs)), allow ACOs to share risk with specialists without Total Care Capitation, reducing operational complexity while expanding accountability beyond primary care.

5. Advancing Technology Adoption and Innovation

  • LEAD introduces structured pathways to promote technology adoption.Planned Artificial Intelligence (AI)‑inferred risk adjustment will be phased in following successful testing and validation, while the Tech Enabler Initiative and Rapid Cycle Innovation Program seek to reduce administrative burden and accelerate evidence generation—particularly for smaller or resource‑constrained ACOs.
Next Steps

The Innovation Center is operating on an accelerated timeline for the initial LEAD cohort. Prospective ACOs have fewer than 50 days to digest a detailed  and model potential performance. Applications are due May 17, 2026. ACOs that participated in ACO REACH in PY 2026 will be well-positioned, as many of the provisions in LEAD will be familiar, and the agency is permitting this group of ACOs to submit an abbreviated application for participation.

For organizations not ready to apply for the first cohort, CMS will release a standardized Letter of Interest form by April 17, 2026, to gauge interest in future application rounds. In this context, organizations considering LEAD participation should be assessing not only near‑term application readiness, but also longer‑term strategic alignment with the model’s 10‑year commitment, risk structure, and operational requirements. Key considerations include benchmarking predictability, readiness to manage regional benchmarks, capacity to engage specialists and high‑needs beneficiaries, technology capabilities, and alignment with broader value‑based care strategies across Medicare and Medicaid.

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ϱ (ϱ), supports organizations across the LEAD decision continuum, including those pursuing immediate application and those preparing for future cohorts. ϱ can help organizations:

  • Interpret LEAD’s policy and financial design relative to existing ACO and MSSP participation
  • Model performance scenarios under alternative benchmark, alignment, and risk configurations
  • Assess operational readiness across care management, contracting, analytics, and compliance
  • Develop application strategies and supporting materials, including responses to the LEAD RFA
  • Choose to defer application on steps that preserve future optionality

As CMS advances LEAD under an ambitious timeline, early analysis and disciplined decision‑making will be critical for organizations seeking to align participation with their long‑term value‑based care strategies.

For questions contact Amy Bassano and Rebecca Nielsen.

Connecting the Dots: Medicaid Community Engagement Requirements and State Readiness for 2027

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Our March 19, 2026, Connecting the Dots analysis described the federal requirements and the operational questions states and partners will need to answer to effectively implement Medicaid work and community engagement requirements. Since then, federal officials have advanced their forthcoming regulation to the final stage of review and intend to meet the statutory requirement to release interim final guidance by June 2026. In addition, many states have taken early steps to communicate upcoming changes and begin planning for system, policy, and partner readiness.

While state sessions are clearly grabbing a lot of energy, timing of pulling together many of the moving parts is becoming a concern as states undergo one of the most fundamental operational challenges to the Medicaid program since its inception. This article synthesizes emerging approaches and identifies practical opportunities to refine strategies and strengthen readiness while minimizing burden for enrollees and state Medicaid agencies.

Early Actions in States Preparing to Implement Work and Community Engagement Requirements

1. States Are Launching Websites that Highlight Coming Changes

As of April 2026, more than half of US states that are subject to the Medicaid work and community engagement requirement had posted web page content describing forthcoming changes associated with the 2025 budget reconciliation act (P.L. 119-12, OBBBA). Some websites provide high-level descriptions of key provisions (e.g., qualifying beneficiary ages, qualifying activities, and exemptions), while others include more detailed information reflecting state-specific policy decisions, educational messages, and suggested steps that beneficiaries, providers, managed care plans (MCPs), and community-based stakeholders can take now (see Figure 1).

Figure 1. States with a Community Engagement Web Page

For example, ’s website describes the requirements for, and provides examples of, acceptable documentation Medicaid members may use to demonstrate compliance or eligibility for an exemption. Ohio also offers a  that contains frequently asked questions (FAQs) and draft outreach materials to support stakeholder communications and increase awareness. The communications tools include a one-page flyer, a rack card, and potential social media posts to raise awareness of the changes, with some use of QR codes to enhance quick access to key websites like the beneficiary self-service portal.

2. States are Beginning to Make and Communicate Preliminary Policy Decisions

States must make a range of policy decisions, including the penalty start date, the number of required months of compliance for both the initial application and subsequent renewals, the potential adoption of short-term hardship exceptions, and how exceptions are defined and operationalized. While most states anticipate compliance beginning January 1, 2027, in alignment with OBBBA, Nebraska and Montana have announced plans to begin implementation in 2026, and their websites reflect additional policy details to support accelerated timelines.

A handful of states, including Arkansas and Ohio, also are communicating ahead of OBBBA’s timeline to promote awareness and engagement before the work and community engagement requirement becomes effective. Table 1 summarizes examples of the current state planning[1] around the number of required months of compliance for the initial application and renewals.

Table 1. Sample Number of Months in Compliance

States also are taking different approaches to exemptions and short-term exceptions. Although many exemptions and exceptions are defined in statute, the interpretation of “medically frail” remains an area in which states have significant flexibility, with implications for how many individuals are exempt. Many states have experiences with establishing definitions of medically frail. For example, states that offer an adult benefit package that differs from the state plan benefit package must allow medically frail adults to opt in to the state plan. At least 12 states already make medically frail determinations, and these existing policies and processes may inform approaches for work and community engagement requirements.

One of those states—Nevada—has posted a  with a request for public comment, including a sample list of qualifying medical conditions. Although such lists can provide clarity, they also underscore the importance of a clear and straightforward exemption request process to support appropriate determinations, including for individuals with conditions that are omitted from a specified list.

3. States Are Securing Additional Support to Address Administrative Challenges

The new eligibility criteria, coupled with more frequent eligibility checks, are placing substantial new demands on Medicaid agencies, eligibility systems, and personnel. In response, states are considering or actively pursuing a range of approaches to strengthen administrative capacity. Examples include:

  • Hiring new state eligibility and enrollment workers:Indiana and Montana
  • Funding system enhancements and improvements:Alaska and New Jersey
  • Hiring outreach and engagement contractors:Arizona and Arkansas

States are also proposing to take a more coordinated, cross-agency approach that uses other state agencies and programs as data sources and referral pathways to help beneficiaries meet their work and community engagement requirements. A variety of states are looking to leverage data from their Supplemental Nutrition Assistance Program (SNAP) program to facilitate compliance checks, and Kentucky has  receiving data from a variety of sources (e.g., Department of Revenue, Department of Corrections, Unemployment Insurance, Vital Statistics, and others) to more automatically identify eligibility and exemption changes.

States like Hawaii, Montana, and Nebraska have highlighted their labor departments to connect people to job and community service resources. Virginia’s work and community engagement website directs the public to a series of different programs based on whether they are interested in employment, volunteer, or education resources. Minnesota also has introduced legislation proposing collaboration between the commissioner and county agencies to link beneficiaries to other critical services like job training, childcare, and transportation.

Shrinking federal contributions and constraints on Medicaid revenue strategies—such as limits on provider taxes—are prompting states to rethink how Medicaid agencies operate within existing budgets. Limited federal funding to support administrative needs elevates the importance of efficiency, coordination, and automation.

What States Might Do to Chart a Better Path Forward

A robust pre-implementation plan is critical to successful work and community engagement implementation. A well-documented plan helps states fully document the variety of moving parts across policy, systems, and partners, clarify milestones and decision points, and define what readiness looks like in practice.

Key components of a pre-implementation plan may include:

  • Signing agreements and contracts to support infrastructure.Pre-implementation planning should ensure that appropriate support from third-party vendors and sister agencies is secured to optimize flexibilities and manage the requirements. Examples may include maintenance of effort (MOE) agreements, memoranda of understanding (MOU), contract updates, and requests for proposals (RFP) as appropriate. States may need to use expedited contracting vehicles when available and maximize existing vendor arrangements. Agreements should address data governance, privacy, and cost allocation issues to support smooth operational integration and reduce downstream friction.
  • Quantifying and automating exemptions.Systems and reporting should be updated to identify, notify, and manage cases for expansion adults who are likely exempt. Leveraging additional resources and data matching may help states identify common exempt populations, such as caretakers with dependents under age 14, disabled veterans, and pregnant women without requiring additional verification. Understanding the demographics of the remaining nonexempt population may also be useful in outreach, education, and links to supports.
  • Preparing for readiness review, including system readiness, coverage transition, and churn management.Pre-implementation plans should prioritize robust system testing, staff training, and timely updates to required documentation (e.g., state plan amendments, policy and member manuals, notices, and reviewing and approving MCP communications). Building in clear transition supports for individuals who may lose coverage or transition to other coverage options can improve continuity of coverage, reduce uninsurance and uncompensated care, and limit administrative burden following implementation.
  • MCP contracts.Most enrollees subject to work and community engagement requirements are enrolled in Medicaid MCPs. States will need to describe enhanced roles and responsibilities in both the MCP contracts as well as the rates. Clear contract expectations can support transparency and mutual accountability across partners.
  • Test communications with the target audiences to ensure understanding and appropriate action.Awareness of the new work and community engagement requirement was one of the biggest challenges Arkansas faced when it launched its program in 2018. Beneficiaries also struggled to understand whether the requirement applied to them and what they needed to do to comply. States must build communications plans and messaging to clearly address these issues to reduce the number of beneficiaries losing coverage simply because they did not understand the new requirements.
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ϱ (ϱ) Medicaid experts assist Medicaid and state policymakers with the following:

  • Strategic positioning
  • Policy-to-operations design
  • Cross-agency governance and partner alignment
  • Information systems impact assessment, change planning, testing strategies and readiness metrics
  • Scenario planning and beneficiary impact analysis
  • Communications and operational playbooks
  • Program integrity, reporting, and audit support

ϱ Medicaid experts can also assist MCPs, providers, and community-based organizations with:

  • Risk assessments (e.g., enrollment, utilization, and spending impacts)
  • State-specific policy and operational insights and trends
  • Communications, outreach, and engagement strategies and content
  • Member retention strategies
  • Grassroots workforce development and community engagement strategies

For questions, contact ϱ contributors to this article Lora SaundersMatt PowersAndrea Maresca, and Amber Swartzell.

[1] Some of these policies are in pending legislation and, therefore, are subject to change.

CMS Quality Conference 2026: CMS Signals a Faster Path from Policy to Practice in Quality

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The Centers for Medicare & Medicaid Services (CMS) convened the  at a moment when healthcare quality policy is increasingly being shaped through formal rulemaking as well as informal policy signals and implementation vehicles. The discussions reflected CMS’s core priorities—wellness and prevention, digital infrastructure, patient safety, and program integrity—and reinforced a broader theme that CMS intends to continue to move faster to advance these priorities than traditional regulatory timelines allow. 

ϱ (ϱ) experts attended QualCon and are working with healthcare organizations as they interpret these signals and prepare to implement the policy priorities highlighted during the conference. This article describes these cross-cutting issues and highlights strategies and actions healthcare entities can take now. 

Moving Faster Requires Different Approaches to Policy and Implementation 

CMS Administrator Dr. Mehmet Oz emphasized CMS’s increasing use of voluntary commitments, public-private collaboration, Requests for Information (RFIs), and other informal policy tools as alternatives or precursors to formal requirements, creating an imperative for early stakeholder engagement. 

  • CMS leaders highlighted stakeholder convenings as a key vehicle to drive change outside of regulatory processes, including the pledge by health plans to streamline and improverequirements.These commitmentsmaysignalfuture regulatorymandatesand shifts in the marketplace.
  • ճprovidesthe foundation for quality initiatives.ճCMSAdministratorhighlightedthe 600-plus organizations that have committed to the goals oftheCMS Health Tech Ecosystem,including companiesthatsupport conversationalartificial intelligence (AI)assistantsthatwould makeingestionand sharing of data with healthcare providers easier through the “Kill the Clipboard” efforts, andhave pledgedto support interoperability.
  • CMSis usinglistening sessionsandRFIstoshapethe directionand drive qualitypolicy.The agencyleaders invitednew ideasand reinforced the value of feedback receivedthroughRFIs, citing examples such as the, Medicare Advantage improvements, and the RFIon. CMS leaders also convened sessions pertaining to patient safety, dialysis care, and best practices for medication for treatment of opioid use disorder, signaling these are areas under consideration for policy development.

Health and Wellness Positioned as a Core Component of Quality Efforts 

QualCon prominently featured CMS’s commitment to promoting health and wellness. Dr. Oz discussed underutilization of existing benefits, such as annual wellness visits, and CMS Deputy Administrator and Director of the Center for Medicare, Chris Klomp, focused on community-based approaches to prevention. Mr. Klomp also spoke of ongoing interest in moving physician payment toward primary care and away from specialty procedures. 

CMS officials highlighted new Center for Medicare and Medicaid Innovation (Innovation Center) models, such as  and , which are aligned with the Administrator’s policy priority of empowering patients. CMS officials also acknowledged challenges to behavioral change and the levers CMS is employing in new models, including technology and incentives for beneficiaries, partnerships, and community health workers. 

Digital Infrastructure Framed as Necessary for Quality Reforms 

QualCon also emphasized making quality measurement fully digital, specifically using FHIR® (Fast Healthcare Interoperability Resources) specifications. Agency officials reported having FHIR specifications for 70+ measures and characterized FHIR as the standard for new measures. Use of FHIR aligns with broader interoperability rules, including  requiring state Medicaid programs and payers participating in public programs to use FHIR for electronic prior authorization by January 2027. 

Quality measurement leaders spoke about the value of integrating quality data in real time and the move from “lagged scorecards” to “continuous intelligence.” Notably, attendees expressed enthusiasm about the potential for AI to support measurement and personalization of quality, measures addressing trajectories of care over time, and new approaches to risk adjustment. 

Application of AI to Patient Safety Is on the Horizon 

Patient safety discussions focused on the potential for AI‑enabled tools to identify risk earlier and prevent harm, particularly with regard to medication safety and error prevention. CMS speakers emphasized that realizing these gains depends on intentional governance, standardized workflows, and patient involvement in AI development and deployment. Rather than positioning AI as a substitute for clinical judgment, sessions framed it as an augmentation tool requiring clear safeguards and accountability. 

Avoiding Fraud, Waste, and Abuse 

CMS leaders noted the potential to avoid fraud, waste, and abuse through a cross-functional fraud detection center that can analyze claims in real time. CMS also discussed collaboration with states and private insurers and encouraged external input. 

Medicaid Discussions 

Medicaid received more limited attention at this conference. CMS Medicaid officials reiterated interest in having fewer quality measures and engaged in discussion with state leaders on how to focus quality efforts. They highlighted learnings about the Medicaid early, periodic, screening, diagnosis, and treatment (EPSDT) program and from CMS Innovation Center models centered on maternal health and substance use disorder care. 

What We’re Watching Next 

Following QualCon ϱ experts are continuing to follow several federal quality-related initiatives that affect plans, health systems, states, and other healthcare delivery organizations include: 

  • How CMS translates voluntary commitments andHealth Tech Ecosystem initiatives intolastingpolicy expectationsfor transforming quality
  • The pace at which digital quality measurement shifts from pilot to standard practice
  • How AI governance frameworks evolve alongsideadditionalreal-worlduse cases in quality and safety

Connect with Us 

ϱ, including Leavitt Partners and Wakely, work with healthcare organizations to navigate the transition to digital quality measurement and act upon digital quality data to improve healthcare delivery. 

Wakely uses analytics-driven operating design and return on investment (ROI) analysis, clinical data acquisition models and tools, and pilot-based validation of measure rates and processing performance to support scalable digital quality measurement (dQM) adoption, as outlined in the . 

Leavitt Partners is working with federal agencies on a number of activities related to the CMS Health Tech Ecosystem and interoperability, including the Kill the Clipboard initiative, which was informed by a seminal . In addition, Leavitt Partners convenes the , which is working to solve both technical and policy issues in digital quality measurement. 

Fordetails, contactour experts below.

Outlook 2026: Regulatory Uncertainty, Evidence Evolution, and the Future of Healthcare Innovation

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As healthcare innovation accelerates, regulatory and policy frameworks are evolving just as rapidly. Across drug development, medical devices, diagnostics, and emerging therapies, innovators are navigating a landscape shaped by shifting federal signals, changing evidentiary expectations, and growing pressure to align regulatory success with real‑world access and affordability. 

This article draws on insights from experts at ϱ, Inc. (ϱ), and Leavitt Partners, an ϱ company, who bring decades of experience working within the US Food and Drug Administration (FDA) and in collaboration with industry leaders to address complex regulatory, commercialization, and access challenges. Their perspectives reflect firsthand experience with translating policy intent into operational reality across the healthcare ecosystem. 

These insights underscore a central theme in early 2026: Innovation is advancing faster than the policy frameworks designed to support it. For developers, investors, payers, and policymakers alike, the challenge is no longer whether innovation is possible, but whether regulatory and coverage pathways can evolve quickly and coherently enough to support it. 

A More Fragmented Policy Signal Environment 

Historically, federal health policy followed relatively formal and predictable channels—rulemaking, guidance documents, and established notice and comment processes. Today, innovators increasingly receive policy signals through nontraditional and informal mechanisms, including agency websites, journal articles, speeches, podcasts, and pilot initiatives. 

This evolution in communication and how we ingest information has two implications. 

First, it creates greater uncertainty for market planning, as policy direction often emerges incrementally or indirectly. In addition, the higher stakes are higher for understanding the federal regulatory environment. Organizations that closely track agency behavior, precedent, and internal norms are better positioned to distinguish meaningful change from repackaged status quo. 

For innovators operating on 10‑to-15-year development timelines, even modest policy volatility can materially affect research and development (R&D) investment decisions, pipeline prioritization, and commercialization strategies. 

Innovation Is Outpacing Traditional Evidence Models 

Scientific progress, especially in rare disease therapies, advanced biologics, and precision medicine, can both strain and challenge traditional clinical trial paradigms. Small patient populations, heterogeneous disease pathways, and novel mechanisms of action are making large, randomized trials increasingly difficult or impractical. 

In response, federal regulators are signaling a broader openness to: 

  • Real‑world evidence (RWE)
  • Natural history studies
  • Registries and longitudinal data
  • Biomarkers and intermediate endpoints

These approaches are not new, but their expanding role reflects a recognition that traditional evidence hierarchies alone are no longer sufficient for evaluating next‑generation therapies. At the same time, regulators continue to emphasize that alternative evidence must meet rigorous scientific standards, particularly when used to support initial approval or expanded indications. 

The implication for innovators is that evidence strategy can no longer be an afterthought. Developers must design programs that support regulatory approval and downstream coverage, pricing, and post‑market evaluation. It is possible for evidence frameworks to overlap, but they must remain distinct. 

Regulatory Approval Is a Midpoint for the Innovator Product Journey 

A recurring challenge across healthcare sectors is the disconnect between regulatory approval and payer coverage decisions. While regulators focus on safety and efficacy, payers assess value, durability of response, and budget impact because they often struggle to justify large upfront payments within their annual budgeting structure. 

This misalignment is particularly acute for high-cost therapies with long-term benefits and products approved through accelerated or flexible pathways, where long-term value may misalign with short-term payer budgeting cycles. 

As policymakers explore ways to modernize regulatory frameworks, questions remain about whether coverage and payment systems will adapt in parallel. Without greater alignment, innovators may continue to face scenarios where regulatory success does not translate into timely or consistent patient access. 

Predictability and Durability Are Emerging Policy Priorities 

Looking further ahead in 2026 and beyond, predictability and durability—not just flexibility—are emerging as core priorities for industry and policymakers alike. Flexibility is essential to support innovation, but durable policy frameworks, particularly those derived from statute, offer greater confidence in long‑term investments. 

Several themes will likely shape the next phase for how federal health policy handles innovation: 

  • Streamlining early clinical development, including first‑in‑human studies
  • Codifying successful regulatory pathways to ensure durability acrosspresidentialadministrations
  • Clarifying expectations for post‑market evidence generation
  • Improving transparency and consistency in agency advice

These efforts reflect a broader recognition that innovation ecosystems depend not just on scientific breakthroughs, but also on stable rules of the road. 

Why It Matters 

For healthcare innovators, the policy environment in 2026 presents both opportunity and risk. They can leverage new evidence frameworks, engage earlier with regulators, and shape emerging policy conversations; however, they also face risks linked with unpredictability, misaligned incentives, and uncertainty around long‑term access and reimbursement. 

Successful innovation will increasingly depend on industry partners with integrated strategies that connect regulatory planning, evidence development, policy engagement, and market access from the earliest stages of innovation. 

For policymakers, the challenge is to modernize regulatory and coverage frameworks in ways that support innovation without sacrificing rigor, affordability, or public trust. 

Connect with Us 

As healthcare continues to evolve, one thing is clear: Innovation policy is no longer a niche concern. Rather, it is central to the future of access, outcomes, and system sustainability. 

For further exploration of these issues, listen to ϱ’s recent podcast on how evolving regulatory frameworks are shaping innovation, commercialization, and access across healthcare. The discussion features insights from Ben Shand of ϱ and Julie Tierney of Leavitt Partners, whose combined experience spans senior roles within FDA and extensive collaboration with industry on complex regulatory and policy challenges. The conversation expands on the themes highlighted here, including regulatory predictability, evidence evolution, and strategies for navigating uncertainty across the product life cycle. 

The takeaway is clear: Waiting until late in development to collaborate with regulators and policymakers is no longer a viable strategy. Organizations that engage earlier and more actively are better positioned to anticipate shifts, shape the conversation, and avoid costly misalignment between approval and coverage. 

ϱ can help you identify where the policy landscape is creating new opportunities and where risks may emerge. We work with organizations to develop proactive engagement strategies that align with today’s changing environment, especially when traditional approaches are no longer delivering results.

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