
April 1, 2026
Outlook 2026: Regulatory Uncertainty, Evidence Evolution, and the Future of Healthcare Innovation
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Outlook 2026: Regulatory Uncertainty, Evidence Evolution, and the Future of Healthcare Innovation

Key Insights from the 2026 HIMSS Global Health Conference and What They Mean for Your Organization
American healthcare is confronting two urgent realities. First, the administrative burden on clinicians and patients remains very high. Prior authorization delays, manual intake forms, fragmented records, and identity challenges continue to drive cost and erode the trust that is the foundation of the provider-patient relationship. At the same time, artificial intelligence (AI) capabilities are advancing rapidly, outpacing governance frameworks, regulatory structures, and data infrastructure. Together, these dynamics are the defining operational challenge of 2026.
Federal policy is responding less through sweeping new regulation than through coordinated execution levers. The Centers for Medicare & Medicaid Services (CMS) initiatives, including the Health Technology Ecosystem, information blocking enforcement, Health Data, Technology, and Interoperability (HTI-5) Proposed Rule , and the prior authorization (PA) final rule, reflect a shift toward making interoperability operational in production environments. What distinguishes this moment from prior efforts is the explicit linkage between interoperability and AI. Federal leaders are saying openly that reliable, trustworthy, and deflationary AI depends on disciplined data exchange, identify, and governance.
The 2026 HIMSS Global Health Conference & Exhibition (HIMSS26), March 9–12, in Las Vegas, NV, marked a marked a turning point in which the industry began translating that message into tangible organizational decisions. Two Health Management Associates (HMA), companies actively engaged in the program: the Leavitt Partners digital health team moderated sessions in the preconference forums and Interop Experience Pavilion, and Wakely Consulting Group, lent their expertise in Medicare Advantage (MA), Medicaid managed care, risk adjustment, and quality measurement—the areas in which FHIR-based infrastructure will directly reshape performance and risk management.
This article reflects what these teams learned and what it means for the industry.
Several themes surfaced throughout the conference, not as isolated ideas but as shared assumptions of the field shaping near-term strategy:
Successful AI deployments rely on interoperability and quality data. Across sessions and conversations, speakers emphasized that success will require not just access, but data that are standardized, governed, and semantically consistent. The promise of AI is advancing quickly, but many organizations are still working to build the data foundation needed to support it.
CMS-aligned networks are paving the way for federal transformation. Concrete pledge deadlines, and a Centers for Medicare & Medicaid Services (CMS) Administrator willing to say publicly that healthcare is the only sector where technology has failed to be deflationary, sent a signal that the industry took seriously. Voluntary frameworks are being seen as previews of future requirements.
Information blocking enforcement is no longer theoretical. Officials from ASTP/ONC confirmed that notices of potential nonconformity have already gone out to health IT firms under the certification program, and more are on the way. With Department of Health and Human Services Office of the Inspector General penalties of up to $1 million per active violation and more than 1,500 complaints filed since the federal portal launched, the compliance calculus has shifted. Dr. Thomas Keane, National Coordinator for Health Information Technology, was direct: Developers that block information risk losing their certification, and their clients risk losing access to CMS payment incentives. The long implementation runway is over, enforcement is now active, and the consequences are real.
The federal vision for AI is patient-first. CMS Administrator Dr. Mehmet Oz said to slow the inflationary effects of the growth in healthcare technology, he wants to put agentic AI tools in the hands of every Medicare beneficiary before the end of this administration—an ambitious goal. He cautioned, however, that none of it works without building the necessary data infrastructure now. AI is the destination; interoperability is the road.
CMS is ready to pivot to digital quality measures and put investment behind it. CMS and ASTP/ONC leadership announced that all quality measures will now be modeled on HL7 FHIR. MultiCare Connected Care showed it working in production. Early adopters will shape the pathway and gain strategic advantage as the transition accelerates. Successful transformation will require simplified workflows, established lines of accountability, and a product-oriented mindset geared toward data and interoperability.
Identity is a known gap, but the solution is taking shape. Patient matching, provider directories, and consumer-facing credentialing came up in nearly every policy and technical session. The $6 billion CMS cited for annual provider directory validation waste alone captured attendees’ attention. But HIMSS26 brought concrete, live progress on the credential side and a Leavitt Partners-moderated preconference session focused on moving the industry from alignment in principle to alignment in production.
Governance is now an operational discipline. Health system chief information officers and chief medical information officers described governance structures already in place and under active revision. The shift from “we need governance” to “our governance needs to evolve” was palpable.
Consumer technology has entered the clinical conversation. Emory Hillandale Hospital’s announcement of the first all-Apple facility signaled that the boundary between consumer devices and clinical infrastructure is evolving.
Autonomous AI systems were everywhere. Vendors demonstrated how AI agents are handling administrative workflows, such call centers, revenue cycle, scheduling, and PA. Health system leaders acknowledged real deployments alongside real uncertainty about governance, security, and identity management for non-human actors in clinical environments. The technology is moving faster than the frameworks designed to oversee it.
The CMS Health Technology Ecosystem is redefining what “interoperable” means for federal programs; TEFCA will scale what it proves
For years, interoperability has been a certification checkbox rather than a functional description. The CMS ecosystem is changing that by tying the definition to observable behaviors: HL7 FHIR APIs that respond, encounter notifications that fire, identity verification that works at the front door. More than 700 organizations have pledged; CMS has set hard deadlines (March 31 for initial results, July 4 for advanced capabilities), and the agency is tracking outcomes, not just attestations.
In the fireside chat moderated by Leavitt Partners Principal Ryan Howells, Dr. Thomas Keane was direct: The regulatory cycle is slow, and what the ecosystem can produce in nine months is what the regulations will eventually codify. Organizations that shape this work now will have less catching up to do when it becomes mandatory.
The Trusted Exchange Framework and Common Agreement (TEFCA), which now exchanges 600 million health records across 75,000+ organizations (up from 10 million in January 2025), is the rising tide that scales what the speedboat networks prove. And state-level health information exchanges (HIEs) remain strategically important given their governance structures, trust relationships, and operational capabilities.
Provider directory is the sleeper issue
Patient matching and digital identity got considerable attention, but a provider directory may be the highest-yield near-term opportunity. CMS estimates $6 billion is wasted annually simply validating where providers practice, what licenses they hold, and what insurance they accept—a problem that compounds every time a payer, health system, or patient tries to connect with the right clinician through the right channel.
A real-time, standardized provider directory is foundational to PA, network adequacy, and care navigation. It is also one of the three heavy lifts that the CMS Health Technology Ecosystem is actively working to address. Organizations that invest now in clean, FHIR-based provider data will be ahead of an upcoming requirement.
Semantic Consistency Determines AI Outcomes
The distinction between syntactic interoperability (data move between systems) and semantic interoperability (data means the same thing in every system) was a running thread through the Interoperability and HIE Forum. Dan Liljenquist, chief strategy officer at Intermountain Healthcare, put the operational reality plainly during his keynote address: Intermountain is building a unified semantic data layer in the cloud—ingesting EHR data daily, normalizing it against common models, making it computable across 34 hospitals—because without that layer, AI produces unreliable outputs at scale.
Graphite Foundry, the mechanism Graphite Health is developing as a nonprofit collaborative, represents a model where health systems build shared semantic infrastructure rather than solving the same problem independently behind proprietary walls. The broader implication: AI strategy and data infrastructure strategy are the same, and organizations that treat them separately will find that their AI investments underperform.
Digital Identity and Privacy Architecture are Converging
Policy and industry discussions reflected growing alignment around higher‑assurance digital identity, privacy‑preserving design, and consistent credentialing. Progress in this area reduces friction for patient‑directed access while supporting trust and security across ecosystems.
Mr. Howells moderated the preconference session, Bridging Digital Worlds: Identity Federation Strategies Across B2B and B2C Ecosystems, which brought together CMS Chief Health Technology Officer Alberto Colon Viera, David Bardan (CLEAR), Wes Turbeville (ID.me), and Renee Edwards, Applied AI at UnitedHealth Group. The session produced three concrete outcomes:
Identity has long been a blocker to scalable patient access. Aligning on a common IAL2 model removes another friction point and moves the industry closer to a future in which patients can securely access their medical records through the apps they choose.
Interoperability is Expanding Beyond Traditional Boundaries
For years, FHIR-based infrastructure has been built primarily around clinical and claims data. But two sessions in signaled meaningful progress on two long-neglected fronts: pharmacy and oral health. Pharmacy data — critical to medication management, managed care, and complete longitudinal records—are increasingly being drawn into the standards-based exchange ecosystem, including the recognition of pharmacists as clinicians whose data and clinical contributions belong in the longitudinal record.
Patients are also gaining real-time visibility into their own pharmacy benefits: the Consumer Real-Time Pharmacy Benefit Check, an open FHIR-based standard, puts cost and coverage information directly in patients’ hands at the point of prescribing — a meaningful step toward the same patient empowerment that the “kill the clipboard” and digital identity work is driving elsewhere in the ecosystem.
Oral health data, long absent from the medical record despite its correlation with diabetes, cardiovascular disease, and maternal health, is now the subject of active federal interoperability investment across CMS, the Veterans Health Administration, and the Indian Health Service. Leavitt Partners’ alliances in both domains—the Oral Health Interoperability Alliance and the Pharmacy Interoperability and Clinical Services Alliance (PICSA)—are helping shape the technical and policy frameworks that will bring these data streams into the broader ecosystem. Whole-person care requires whole-person data, and the field is finally building the infrastructure to support it.
Despite momentum, several issues remain unresolved:
The Role of Payers in TEFCA and National Exchange is Still Evolving
There is growing interest in extending TEFCA beyond provider-to-provider exchange to support payer use cases such as quality measurement, care management, and prior authorization. However, questions remain around participation models, data rights, governance, and value alignment. Until these are resolved, payer engagement will likely remain uneven, limiting the full potential of nationwide exchange.
The Business Case for Interoperability is Not Yet Consistently Realized
While the policy direction is clear, the economic incentives are still misaligned. Providers often bear the operational burden of data exchange, while financial benefits may accrue elsewhere. Similarly, investments in interoperability infrastructure do not always translate into immediate or measurable returns. Advancing adoption will require clearer ROI pathways, shared incentives, and models that distribute value more equitably across stakeholders.
Governance and Operating Models are Still Catching Up to the Technology.
There is increasing recognition that interoperability at scale is not just a technical challenge — it is a governance challenge. Questions around enforcement, delegation of authority, participant accountability, and operational oversight remain active areas of development. As exchange expands, these governance structures will need to mature rapidly to sustain trust and ensure consistent implementation.
Near-term signals, such as CMS responses to pledged-network deadlines, finalization of HTI5 and related rules, continued prior authorization modernization, and digital quality measure implementation, will shape the next phase of execution.
Extending Open Standards to Rural and Underserved Providers
The Rural Health Transformation Program offers a unique opportunity to expand the open standards ecosystem being built. Leavitt Partners and Wakely are engaged in both the policy conversations and implementations that will determine how to ensure this opportunity can transform healthcare.
March 31 and July 4 deadlines
CMS set these dates publicly and specifically. How the agency responds to organizations that miss them will signal how serious the voluntary framework really is and how quickly it becomes a program condition.
HTI-5 Finalization and HTI-6 Proposed Rule
ONC’s proposed rule to focus certification on HL7 FHIR APIs, algorithm transparency, and interoperability is still in proposed form. Finalization, as proposed, would transform the vendor landscape and remove the safe harbor that legacy proprietary interfaces have relied on.
Prior Authorization is Moving
The federal regulations and last summer’s voluntary commitment by more than 60 health insurers covering 257 million Americans across commercial, Medicare Advantage, and Medicaid markets has created a moment of regulatory and industry alignment. Payers committed to reducing the volume of services requiring PA, standardizing electronic PA using HL7® FHIR® APIs, and answering at least 80 percent of electronic requests in real time by 2027. The direction is clear, the commitments are specific, and the infrastructure to support them — HL7® FHIR® APIs being built for patient access and the ecosystem is the same infrastructure PA modernization requires. Leavitt Partners and Wakely are watching closely as implementation moves from pledge to production.
The Digital Quality Measure (dQM) Enters the Implantation Phase
CMS has made clear where the market is headed: digital quality measurement built on HL7 FHIR. The challenge now is execution. FHIR infrastructure developed for prior authorization or patient access can be leveraged for quality reporting as well, creating the potential for reusable investment across use cases. But the transition to dQM is not simply a technology upgrade; it is a broader business transformation that will require changes in workflows, governance, and organizational readiness.
Digital Identity Momentum
The IAL2 token payload agreement, Medicare rollout of digital identity, and United Health Group’s Kantara pursuit signal that the industry is aligning on a shared credential infrastructure. Leavitt Partners will continue to support the development and adoption of the open identity standards that make patient-directed access real across payers, providers, and health technology platforms.
The infrastructure for an interoperable, AI-ready healthcare system is being built under real policy pressure in real-world environments. HMA companies bring health IT policy and open standards expertise to help organizations shape and navigate that landscape as well as actuarial and implementation depth to translate it into financial and operational decisions. Organizations that invest in the foundation—data, identity, standards, governance—will be positioned to move faster and more responsibly as AI capabilities continue to advance.
HMA companies are uniquely positioned to help organizations move from interoperability strategy to real-world execution. We provide end-to-end support across digital quality measurement transformation, policy-to-operations execution, pharmacy interoperability, oral health interoperability, digital insurance cards, and the actuarial and financial modeling needed to assess performance impact, revenue implications, and reporting risk. Leavitt Partners and Wakely professionals were active participants in HIMSS26 conversations and bring the policy, operational, measurement, and financial expertise needed to help clients prepare for what comes next.
This blog reflects policy signals and public session content from the 2026 HIMSS Global Health Conference. It represents the perspective of Leavitt Partners and Wakely Consulting Group, both HMA Companies, and does not constitute legal or regulatory advice

This episode of Vital Viewpoints on Healthcare unpacks the rapidly evolving regulatory landscape for pharmaceuticals. The discussion covers the challenges to innovation, such as the growing unpredictability in FDA policy, the challenges with reimbursement, and the increasing role of real-world evidence in bringing therapies to market. Julie Tierney, principal at Leavitt Partners (an HMA Company) shares her expert perspectives on rare disease innovation and upcoming user fee negotiations; while Ben Shand, vice president at Health Management Associates, talks about why organizations must actively engage to navigate risk, identify opportunity, and ultimately improve patient access to care.

This webinar was held on April 22, 2026 at 12pm ET.
This webinar was designed for life sciences companies seeking to navigate the New Technology Add-on Payment (NTAP) program. This session equipped drug, device, and diagnostic manufacturers with a clear understanding of eligibility requirements, the application process, and how to strategically position products for approval. Experts from HMA and Manatt Health also broke down CMS evaluation criteria and highlighted key updates shaping the NTAP program in 2026 and 2027.
Learning Objectives:
Speakers:

As of March 15, 2026, most governors had released proposed budgets for state fiscal year (FY) 2027. In addition, several governors in states that enacted biennial budgets in 2025 have released supplemental proposals. These FY 2027 state budget proposals signal how governors are responding to Medicaid financing changes, provider tax phase downs, and new implementation costs created in the 2025 Budget Reconciliation Act (P.L. 119-21, OBBBA).
Given the requirement enacted in OBBBA, this year’s state budgets are more than spending plans. They are critical policy tools governors will use to navigate changes in federal funding, new program requirements, and increasing pressures across Medicaid and broader healthcare markets.
The FY 2027 budgets indicate how governors are attempting to balance competing imperatives: maintaining healthcare coverage and access, stabilizing provider networks, financing Medicaid obligations, and aligning state healthcare and health-related programs with new federal rules. Healthcare provider taxes, revised funding priorities, and targeted funding proposals are key levers in the process of balancing budgets.
Health Management Associates Information Services (HMAIS) has published its final iteration of the FY 2027 Proposed State Budget Overview Report (subscriber access required), which examines proposed FY 2027 state budgets (January 22, 2026, A Look at Proposed State Fiscal Budgets). Our March 2026 issuance covers all proposed FY 2027 budgets for non-biennial budget states and some supplemental budget proposals for states that enacted biennial budgets in 2026. Following is a look at key trends in Medicaid proposals and some of the substantial budget proposals that are discussed within the report.
Provider Taxes and Medicaid Financing Under OBBBA
One notable fiscal federal policy change under OBBBA is the phase down of the Medicaid provider tax programs, a financing mechanism many states rely on to draw down federal matching funds and support provider payments. The federal law freezes existing provider tax programs, prohibits new ones, and requires Medicaid expansion states to phase down the minimum allowable tax rate from 6 to 3.5 percent by 2032.
In addition, OBBBA places new limits on state-directed payments, capping them at 100 percent of Medicare rates for expansion states and 110 percent for non-expansion states. Grandfathered payment arrangements will be phased down by 10 percent annually beginning in 2028.
FY 2027 state budget proposals highlight how these changes will have substantial and long-term fiscal impacts, even if some effects are delayed. Examples include:
Implementation Costs: Staffing, Systems, and Administrative Burden
Along with the decreased federal funding, implementing OBBBA carries significant administrative and operational costs, compounding pressure on state budgets.
According to an Associated Press analysis of 25 state budget protections, states will need to spend up to $1 billion in federal and state funds on technology upgrades and additional staff to fully implement the Medicaid work and community engagement requirements. Many FY 2027 budgets reflect this reality, with new investments focused on expanding staffing capacity and modernizing eligibility and data systems. For example:
Several governors also propose investments to help beneficiaries remain enrolled amid more frequent eligibility checks and new requirements. For example:
What to Watch: FY 2027 Budget Decisions and Medicaid Financing Risks
Upcoming provider tax phase downs and caps on state-directed payments constrain core funding tools just as implementation costs for staffing and systems are rising, forcing difficult decisions about coverage, provider support, and administrative capacity. Providers face growing uncertainty as tax supported supplemental payments are reduced or restructured, with potential implications for cash flow, service availability, and network participation.
Managed care plans, meanwhile, must navigate shifting rate development assumptions, changes in provider payment arrangements, and increased enrollment churn tied to eligibility and redetermination changes.
While the timing and magnitude of effects vary, these proposals underscore that provider tax and supplemental payment changes are more than abstract future concerns. They already are shaping FY 2027 budget decisions and long-term Medicaid financing strategies.
Most state legislatures are still debating their spending plans, making it critical to track which proposals are included in FY 2027 budgets, which are scaled back, and which are eliminated. These budget decisions will play a central role in determining market stability, access to care, and program sustainability in the years ahead.
HMAIS will publish additional reports in the coming months summarizing each state’s enacted budget. The first iteration is expected in May 2026.
Connect with Us
As the policy and funding landscapes continue to evolve, states and other stakeholders need to remain flexible. HMA brings the expertise, tools, and insights needed for stakeholders to stay on top of the rapidly changing environment. For questions or to connect with an HMA expert, contact Andrea Maresca and Kathleen Nolan.
The full report is available to HMAIS subscribers. Questions can be directed to Maddie McCarthy.

New federal Medicaid community engagement requirements, along with more frequent redetermination and a reduced retroactive eligibility timeframe, take effect January 1, 2027. These changes are reshaping state Medicaid policy agendas, budget decisions, and eligibility system design as states prepare to implement federally mandated work and community engagement requirements for the Affordable Care Act (ACA) expansion population. This blog addresses the forthcoming policy changes, key issues related to eligibility and information systems, and timely actions for state partners preparing to meet the new requirements.
Community engagement requirements often are discussed in broad terms: whether they encourage self-sufficiency or create barriers. For state Medicaid agencies, managed care plans (MCPs), and providers, however, the more immediate and consequential question is operational: Is the Medicaid program—across eligibility systems, data flows, partner roles, and communications—ready to administer these requirements without losing eligible people?
Based on our work with states, Medicaid programs, and community partners, the answer is dependent on the approach to execution. Specifically, it hinges on how states prepare their systems and partners for compliance with community engagement requirements without placing undue burden or expectations on beneficiaries, government agencies, MCPs, and community partners.
Federal Context: Medicaid Community Engagement Requirements Beginning in 2027
Under federal law, states that extended Medicaid to able‑bodied adults in the ACA Medicaid expansion population (up to 138 percent of the federal poverty level) must:
Forthcoming federal guidance and regulations will clarify key implementation details. In the interim, states are using the statutory framework to design the necessary policy changes. For example, many states will move beyond a simple “requirement” model toward support-oriented programs that make compliance achievable for enrollees, minimizes administrative churn, and leverages available data and information systems functionality to reduce compliance burden. In so doing, states need to use existing federal guidance to answer the following questions:
Analyis and planning for community engagement is underway now, state by state, and will determine whether the mandates will increase employment, education, and volunteerism and yield the expected health and economic benefits or drive avoidable coverage loss.
From Policy Requirement to Workable Medicaid Community Engagement Implementation
The community engagement, redetermination, and reduced retroactive coverage requirements touch multiple components of a Medicaid enterprise, including:
In other words, the backend systems that support compliance with the community engagement requirement must be designed and built for real-world administration and meet oversight requirements. Backend system readiness is among the most important operational issues for expansion states, as it will dictate the overall timeline and success in meeting Medicaid leaders’ goals.
How Medicaid MCPs and Providers Will Support Enrollees
The Centers for Medicare & Medicaid Services (CMS) collaborated with Medicaid technology companies to meet the compressed community engagement implementation timeline, the scale of system changes required across eligibility and verification workflows, and long-standing cost and capacity constraints. States are being asked to implement these complex new expectation largely within existing eligibility platforms, which were designed for purposes other than continuous activity tracking or cross-agency data exchange.
Although these arrangements may improve affordability and speed, states must still assess whether vendor-offered solutions align with their specific policy choices, data sources, partner roles, and operational risk tolerance.
Medicaid MCPs and provider groups, including hospitals and federally qualified health centers (FQHCs), will be on the front lines of enrollee retention. These organizations should engage with states now to ensure systems and information flows support their work. MCPs should focus on access to:
Primary care providers, hospitals, FQHCs, and behavioral health providers play a critical role in identifying and supporting exemptions. If the exemption processes are slow, unclear, or burdensome, patients with legitimate medical or functional limitations may lose coverage and providers may incur increased uncompensated care costs. Providers should be engaging states to solidify:
Community engagement requirements will require coordination with nontraditional partners, such as:
These partners can become essential to making the policy workable for enrollees, but they often have timelines, data standards, funding streams, and performance incentives that differ from Medicaid’s. Partners should be in conversation with states now about investments in a cross-agency and cross-sector governance structure that answers practical questions about the definitions, systems and workflows, and beneficiary experience.
States Should Act Now
A real and preventable risk is embedded in the 2027 timeline: coverage loss among healthy, working adults who remain eligible but cannot navigate new processes. States must look across every part of their Medicaid system, decide what they need each partner to do, and ensure those partners have the information, tools, and authority to act. Plans and providers must be clear and advocate for what they need to prevent eligible individuals from losing coverage.
Handled well, this is an opportunity to modernize systems, strengthen cross-sector coordination, and may demonstrate whether community engagement can yield a net benefit to members—not just add steps to maintaining coverage.
Connect with Us
HMA Medicaid experts assist Medicaid and state policymakers with the following:
HMA contributors to this article include Erin Dorrien, Kaitlyn Feiock, Andrea Maresca, and Juan Montanez.
HMA Blog Series
The Health Management Associates (HMA) Connecting the Dots blog series brings our experts together to examine the major policy, program, and market forces shaping healthcare coverage, delivery systems, and financing in 2026. The posts look beyond individual changes to connect emerging developments across programs and markets to help leaders understand what’s changing, why it matters, and how their decisions shape the path ahead. This month our experts weigh in on preparations for Medicaid Work and Community Engagement Requirements.

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

The first quarter of 2026 marked a turning point in federal oversight of pharmacy benefit managers (PBMs), the intermediaries that manage prescription drug benefits for most health plans across the commercial insurance market, Medicare Part D, and other programs. New legislation, agency rulemaking, and enforcement activity collectively signal a new phase of oversight that could materially reshape PBM contracting, compensation, and transparency requirements.
Most notably, the following developments stand out:
Together, these actions signal a trend toward greater PBM accountability, with implications for plans, pharmacies, manufacturers, and consumers. This article provides a high-level overview of the major recent developments in the PBM reform policy landscape, along with key considerations for stakeholders.
Medicare Part D: Key Statutory Changes
Beginning in plan year 2028, CAA 26 makes significant changes for PBMs operating in Medicare Part D. Key provisions include:
Additional provisions that will take effect in beginning with plan year 2029 include:
Key considerations: The Centers for Medicare & Medicaid Services (CMS) has broad discretion in implementing these provisions, including setting pharmacy contracting standards, determining which PBM affiliates are subject to new requirements, and defining “fair market value.” PBMs will face expanded reporting and compliance obligations, while plans and other stakeholders will have opportunities to shape implementation through the regulatory process.
Commercial Health Insurance Market: Key Statutory Changes
For the commercial market, CAA 26 establishes similar transparency requirements for PBMs that serve fully insured and self-insured plans, with reporting required up to four times per year. Unlike Medicare Part D, the statute does not prohibit pricelinked compensation in the commercial market, but it does require detailed disclosure of PBM fees and revenue streams. For contracts with selfinsured plans, PBMs must remit 100 percent of rebates and fees tied to drug utilization, subject to specified limitations.
Key considerations: These provisions significantly expand federal oversight in the commercial market. PBMs will need to scale compliance infrastructure, while employers and other plan sponsors may seek enhanced analytical and actuarial support to interpret disclosures and assess PBM performance.
Medicaid Left Out, For Now.
Unlike prior legislative packages, CAA 26 does not include Medicaid-specific PBM reforms, such as prohibitions on spread pricing (i.e., a PBM charges a payer more than the amount it pays the dispensing pharmacy for a prescription) and expanded National Average Drug Acquisition Cost (NADAC) reporting.
Key considerations: These policies continue to have bipartisan support and could reemerge in future legislation. States, PBMs, and managed care plans should continue monitoring for renewed federal action on these policies.
DOL’s Proposed PBM Fee Disclosure Rule
DOL’s proposed rule, “Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure,” would require PBMs serving self-insured ERISA plans to disclose information about rebates, manufacturer fees, pharmacy payments, and spread pricing. In late February, DOL extended the public comment period to April 15 to allow stakeholders to address how the proposed rule should align with the newly enacted CAA 26 provisions.
Key considerations: DOL could withdraw the proposal in favor of the statutory framework or could finalize the rule to take effect before the CAA 26 requirements begin. Either path would further increase near-term compliance for PBMs and plan sponsors, and stakeholders should monitor this space closely.
FTC Settlement with ESI
The FTC’s settlement with ESI resolves insulin-focused litigation against the PBM and imposes extensive requirements related to transparency, compensation, rebates and fees, and benefit design. The settlement also includes less common provisions, such as a commitment to reshore and increase disclosures related to ESI’s rebate group purchasing organization (GPO) functions.
Key considerations: If similar settlements are reached with other PBMs, the FTC could play an expanded role in shaping PBM market behavior, supplementing legislative and regulatory reforms with enforcement-driven standards.
State Efforts to Regulate PBMs
States continue to pursue PBM reforms, with dozens of laws enacted in recent years addressing licensure, reporting, pharmacy reimbursement, and contracting standards. Although the Supreme Court’s 2020 decision in Rutledge v. PCMA opened the door to certain state-level reforms, subsequent court decisions have narrowed the scope of permissible state regulation, particularly when ERISA preemption or Medicare Part D conflicts arise.
Key considerations: Stakeholders operating across multiple markets and states will continue to face a complex and evolving patchwork of requirements, underscoring the importance of ongoing policy tracking and compliance coordination.
Connect with Us
Recent federal and state actions suggest that PBM reform is entering a more operational phase defined by transparency and enforceable standards governing compensation, contracting, and market behavior. As implementation unfolds, stakeholders across the prescription drug supply chain will need to engage closely with regulators, assess new data flows, and adapt their business practices to a more prescriptive oversight environment.
For more information about the policies described in this article and the PBM policy landscape more broadly, please contact our experts Conor Sheehey or Stephen Palmer.

The Centers for Medicare & Medicaid Services (CMS) proposed 2027 Notice of Benefit and Payment Parameters (NBPP) marks a notable shift in Marketplace policy, expanding lower premium plan options, relaxing certain federal standards, and moving more implementation and oversight responsibility to states and Marketplaces. It also introduces eligibility and verification policies that could significantly affect enrollment, operations, and market stability.
To unpack what this could mean for plan year 2027 and beyond, Andrea Maresca spoke with Zach Sherman, Managing Director for Coverage Policy and Program Design at Health Management Associates (HMA); Lina Rashid, Principal at HMA; and Michael Cohen, PhD, Principal at Wakely, an HMA company, who, alongside colleagues, published a Policy Brief on state-level and consumer impacts, as well as a Wakely White Paper on the proposed rule.
Q: When you zoom out from the technical details, what are the big takeaways from the proposed 2027 NBPP for states, consumers, and issuers?
Lina Rashid: At a high level, the proposal reallocates risk and responsibility across the system. Consumers may see more lower premium options through expanded catastrophic plan eligibility and more flexible bronze plan design, but often with more cost-sharing, higher deductibles, or greater complexity. For consumers, affordability is about more than just premiums; it’s about how much healthcare costs for individuals and their families overall and the cost of care when they need it.
States are being given options to take on more oversight and operational responsibility but without additional federal funding. And issuers are being given more flexibility, but it comes with uncertainty regarding enrollment and risk mix.
Zach Sherman: The rule’s cumulative effect matters more than any one policy. Expanded catastrophic eligibility, higher out-of-pocket exposure, relaxed network standards, and tighter verification requirements all interact. Together, they raise questions about access, affordability, and whether Marketplaces are equipped to manage administrative and enrollment disruption.
Q: The paper highlights potentially significant enrollment effects. What’s driving that dynamic?
Michael: Two things stand out. First, the proposal implements statutory changes that remove advance premium tax credit (APTC) eligibility for certain lawfully present immigrants beginning in 2027. CMS estimates more than a million people could lose eligibility, and it’s reasonable to expect most of them will exit the individual market.
Second, the proposed income verification changes could generate millions of data matching issues (DMIs) that temporarily or permanently cut off access to advance premium tax credits. While CMS projects a relatively modest disenrollment effect, our analysis suggests losses could be meaningfully higher depending on how quickly issues are resolved. We estimate that approximately 4.7 million enrollees could receive DMIs under the proposal, and upward of 80 percent of them could temporarily or permanently lose access to APTCs, putting coverage at risk.
Zach: If consumers can’t afford the full premiums while resolving a data issue, many will drop coverage. That creates churn and administrative strain that Marketplaces must manage.
Q: How do these policies affect state Marketplaces and regulators specifically?
Zach: States are being asked to do more across multiple fronts. Network adequacy oversight is shifting toward states that conduct effective rate review. States may also choose or feel pressure to take on Essential Community Provider (ECP) review authority, including for new non-network plans. Accepting that responsibility requires legal authority, staff capacity, and technical infrastructure.
At the same time, states may need to stand up the State Exchange Improper Payment Measurement (SEIPM) program, which CMS acknowledges will increase administrative burden.
The proposed State Exchange Enhanced Direct Enrollment (SBE-EDE) option is also a significant shift. Rather than operating a centralized consumer enrollment platform, Marketplaces would focus on certifying, overseeing, and monitoring multiple third-party entities. As a former director of a state-based Marketplace program, I know this is a fundamentally different operational posture that comes with oversight and compliance costs.
Q: The proposal also introduces non-network plans. What should stakeholders be watching here?
Michael: Non-network plans may offer lower premiums, but they change how access works. Provider participation depends on the willingness to accept the plan’s payment as payment in full. On paper a plan may meet access standards, but in practice consumers could face difficulty finding care. That places additional oversight responsibility on states to determine whether access is sufficient in practice. If aggressively priced non-network plans disproportionately attract healthier enrollees, it can create financial risk for issuers and for the broader market.
Q: What does this mean for market stability going forward?
Zach: Stability will vary by state. States that invest in oversight, consumer assistance, and operational readiness—often a state-based Marketplace—may be better positioned to manage these changes. Others may see sharper enrollment declines or access issues. That divergence across states is an important signal from this proposal.
Q: What should states and stakeholders be doing right now?
Zach: States should be doing scenario planning, assessing which flexibilities to adopt, where to maintain higher standards, and whether they have the capacity to take on expanded responsibilities. These decisions will shape how the rule plays out on the ground.
Michael: Issuers should be stress testing pricing assumptions, risk adjustment exposure, and operational readiness. All stakeholders should remember that comments on the proposed rule are due March 13, 2026.
Lina: Notably, CMS is not done with regulatory reforms. The agency solicited comment on medical loss ratio (MLR) policies and paused Essential Health Benefit benchmark updates, as well as issues not covered in this proposed rule, such as revisions to the Section 1332 waiver and Section 1333 interstate compacts. States and issuers should be tracking what may come next, not just what’s in this proposal.

Outlook 2026: What CMS’s Proposed 2027 NBPP Signals for ACA Marketplaces, States, and Consumers

On February 9, 2026, the Department of Health and Human Services (HHS) released the proposed Notice of Benefit and Payment Parameters (NBPP) for 2027. The notice includes important proposed rules and parameters for the operation of the individual and small group health insurance markets in 2027 and beyond.
This paper summarizes key provisions in the proposed notice with a focus on the major changes to plan types, cost-sharing, network design and oversight, marketplace philosophy, and the shift of responsibilities from the federal government to states. It also evaluates any changes to returning policies from the Marketplace Affordability and Integrity rule from last year, which are currently being challenged in court, and codifies relevant statutory changes in the One Big Beautiful Bill Act.
The paper reviews the potential impact of these proposed policies on consumer affordability and access as well as the impact and associated level of effort on state regulators and marketplaces. Lastly, it touches on policies not included in this rule, including those highlighted as issues that may or will be addressed in future rulemaking as well as issues surprisingly not covered in this proposed rule, such as revisions to the Section 1332 waiver process as well as details on how a state could explore and pursue a 1333 interstate compact. Comments are due no later than March 13, 2026.