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

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°Õ³ó±ðÌýÌýrepresents the next major step in the Centers for Medicare & Medicaid Services (CMS)ÌýÌýstrategy and reinforces a federal commitment to value-based participation in Traditional Medicare. Announced as the successor toÌý, 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 byÌýsetting 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 basedÌýfullyÌýon 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.ÌýACOs 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.ÌýMonthly 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.ÌýBy 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.ÌýNew 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.ÌýPlanned 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.

Connect with Us

ºÚÁÏÍø (HMA), supports organizations across the LEAD decision continuum, including those pursuing immediate application and those preparing for future cohorts. HMA 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, â€™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:ÌýIndiana and Montana
  • Funding system enhancements and improvements:ÌýAlaska and New Jersey
  • Hiring outreach and engagement contractors:ÌýArizona 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.ÌýPre-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.ÌýSystems 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.ÌýPre-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.ÌýMost 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.ÌýAwareness 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.
Connect with Us

ºÚÁÏÍø (HMA) 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

HMA 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 HMA 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.

Saving Lives with Compassion: Overdose Response Training with RiVive®

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This webinar will present findings from the 2025 RiVive Community Engagement Report and best practices in compassionate overdose response™, with a focus on the community use of RiVive naloxone nasal spray 3 mg. A panel of expert speakers will present their protocols for effective overdose intervention, guidance on the training of others, and strategies for integrating trauma-informed approaches into post-overdose care.

The webinar will cover why compassionate dosing is important, how to integrate this concept into trainings for community members, and communication strategies for teaching titration, rescue breathing, and overdose prevention.

Designed for program teams, medical professionals, and harm reduction leaders, anyone who attends will leave with research and experience-backed methods for improving outcomes in opioid overdose emergencies. A recording of this webinar will be available after this session, with a link to the 2025 report.

Learning Objectives:

  • Learn how to describe why compassionate dosing is important.
  • Apply evidence-based strategies for compassionate, trauma-informed intervention during overdose emergencies.
  • Integrate stigma-reducing practices into community response frameworks to enhance support for individuals affected by opioid use.

Speakers:

  • Dr. Michael Hufford, Co-Founder, CEO, Harm Reduction Therapeutics
  • Van Asher, Harm Reduction Consultant, Harm Reduction Therapeutics

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. 

ºÚÁÏÍø (HMA) 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 improveÌýÌýrequirements.ÌýThese commitmentsÌýmayÌýsignalÌýfuture regulatoryÌýmandatesÌýand shifts in the marketplace.Ìý
  • °Õ³ó±ðÌýÌýprovidesÌýthe foundation for quality initiatives.Ìý°Õ³ó±ðÌýCMSÌýAdministratorÌýhighlightedÌýthe 600-plus organizations that have committed to the goals ofÌýtheÌýCMS Health Tech Ecosystem,Ìýincluding companiesÌýthatÌýsupport conversationalÌýartificial intelligence (AI)ÌýassistantsÌýthatÌýwould makeÌýingestionÌýand sharing of data with healthcare providers easier through the “Kill the Clipboard†efforts, andÌýhave pledgedÌýto support interoperability.Ìý
  • CMSÌýis usingÌýlistening sessionsÌýandÌýRFIsÌýtoÌýshapeÌýthe directionÌýand drive qualityÌýpolicy.ÌýThe agencyÌýleaders invitedÌýnew ideasÌýand reinforced the value of feedback receivedÌýthroughÌýRFIs, citing examples such as theÌý, Medicare Advantage improvements, and the RFIÌýonÌý. 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.Ìý

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 HMA 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 andÌýHealth Tech Ecosystem initiatives intoÌýlastingÌýpolicy expectationsÌýfor transforming qualityÌý
  • The pace at which digital quality measurement shifts from pilot to standard practiceÌý
  • How AI governance frameworks evolve alongsideÌýadditionalÌýreal-worldÌýuse cases in quality and safetyÌý

Connect with Us 

HMA, 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. 

ForÌýdetails, contactÌýour 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 ºÚÁÏÍø, Inc. (HMA), and Leavitt Partners, an HMA 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)Ìý
  • Natural history studiesÌý
  • Registries and longitudinal dataÌý
  • Biomarkers and intermediate endpointsÌý

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 studiesÌý
  • Codifying successful regulatory pathways to ensure durability acrossÌýpresidentialÌýadministrationsÌý
  • Clarifying expectations for post‑market evidence generationÌý
  • Improving transparency and consistency in agency adviceÌý

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 HMA’s recent podcast on how evolving regulatory frameworks are shaping innovation, commercialization, and access across healthcare. The discussion features insights from Ben Shand of HMA 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. 

HMA 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.

April 1, 2026

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

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HIMSS26: Building the Foundation for Interoperable, AI-Ready HealthcareÌý

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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 , information blocking enforcement,  (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. 

°Õ³ó±ð  (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 ºÚÁÏÍø (HMA), companies actively engaged in the program: the  moderated sessions in the preconference forums and Interop Experience Pavilion, and , 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. 

What We Learned at HIMSS 

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. 

What It Means: Five Insights 

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 ,  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 (), 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:  

  • CMS confirmed Medicare.gov is now live with CLEAR, ID.me, and Login.gov, meaning consumers can choose which credential they use and relying parties can leverage that same credential to authenticate consumers into their own systems.  
  • Participants agreed on a common IAL2 token payload.  
  • UnitedHealth Group announced United Health Group’s pursuit of Kantara certification and unification of all their portals to a single identity based on IAL2. 

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. 

What Remains Unresolved 

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. 

What We’re Watching 

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. 

We Can Help 

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

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