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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 CMS Quality Conference 2026 (QualCon) 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. 

Health Management Associates (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 improve prior authorization requirements. These commitments may signal future regulatory mandates and shifts in the marketplace. 
  • The CMS Health Tech Ecosystem provides the foundation for quality initiatives. The CMS Administrator highlighted the 600-plus organizations that have committed to the goals of the CMS Health Tech Ecosystem, including companies that support conversational artificial intelligence (AI) assistants that would make ingestion and sharing of data with healthcare providers easier through the “Kill the Clipboard” efforts, and have pledged to support interoperability. 
  • CMS is using listening sessions and RFIs to shape the direction and drive quality policy. The agency leaders invited new ideas and reinforced the value of feedback received through RFIs, citing examples such as the 2025 RFI on the Health Technology Ecosystem, Medicare Advantage improvements, and the RFI on Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH). CMS leaders also convened sessions pertaining to patient safety, dialysis care, and best practices for medication for treatment of opioid use disorder, signaling these are areas under consideration for policy development. 

Health and Wellness Positioned as a Core Component of Quality Efforts 

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

CMS officials highlighted new Center for Medicare and Medicaid Innovation (Innovation Center) models, such as ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) and Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-based Approaches Through Evidence (MAHA ELEVATE), 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 one 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 and Health Tech Ecosystem initiatives into lasting policy expectations for transforming quality 
  • The pace at which digital quality measurement shifts from pilot to standard practice 
  • How AI governance frameworks evolve alongside additional real-world use cases in quality and safety 

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 dQM Playbook

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 Leavitt Partners white paper. In addition, Leavitt Partners convenes the Digital Quality Implementers Community, which is working to solve both technical and policy issues in digital quality measurement. 

For details, contact our 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 Health Management Associates, 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) 
  • Natural history studies 
  • Registries and longitudinal data 
  • Biomarkers and intermediate endpoints 

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

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

Regulatory Approval Is a Midpoint for the Innovator Product Journey 

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

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

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

Predictability and Durability Are Emerging Policy Priorities 

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

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

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

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

Why It Matters 

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

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

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

Connect with Us 

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

For further exploration of these issues, listen to 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 Healthcare 

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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 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. 

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 Leavitt Partners Principal Ryan HowellsDr. 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:  

  • 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

How Do Life Sciences Companies Keep Innovating When the Rules Keep Changing?

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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.

Webinar Replay – Achieving Success with New Technology Add-on Payment (NTAP): What Life Sciences Companies Need to Know

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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:

  • Understand NTAP eligibility requirements and the end-to-end application process
  • Learn how CMS evaluates applications and what drives approval decisions
  • Explore key updates and policy changes impacting NTAP in 2026 and 2027

Speakers:

  • Clare Mamerow, Principal, Health Management Associates
  • Ross Margulies, Partner, Manatt Health

Fiscal 2027 State Budget Proposals: Provider Taxes, Medicaid Financing, and OBBBA Effects

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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: 

  • Arizona estimates it will receive $5.3 billion less in federal support between FY 2029 and 2033 as a result of policy changes. 
  • California projects that state expenditures for Medi-Cal will grow $2.4 billion in FY 2027, largely because the Medical Provider Interim Payment expires in FY 2026 and a decrease in managed care organization (MCO) tax revenue available to support the Medi-Cal program. Gov. Gavin Newsom’s proposed FY 2027 budget assumes a transition period for the decreased MCO tax through December 31, 2026. 
  • Connecticut Gov. Ned Lamont’s proposed supplemental budget for the 2025–27 fiscal biennium calls for reducing hospital provider taxes by $275 million. Connecticut increased supplemental payments and provider taxes during the 2025 legislative session, but the governor’s proposal would reduce the inpatient hospital provider tax rate from 6 percent to 4.1 percent. 
  • Illinois projects that most of the budgetary impacts will begin in FY 2028, with federal Medicaid support reduced by approximately $2.8 billion annually by FY 2031. 
  • New York Gov. Kathy Hochul’s budget proposal updates the managed care tax spending plan and estimates the state will collect $1.5 billion fewer receipts than anticipated in fiscal 2027. 

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:

  • Michigan’s proposed budget, for example, includes $186.6 million from the state general fund to fully implement OBBBA, including $80.3 million in all funds to hire additional full-time employees who can meet the increased workload. 
  • Missouri proposes $294.6 million and dedicated staff members to comply with OBBBA. 
  • Arizona proposes a $14.4 million one-time investment and dedicated OBBBA implementation staff. 

Several governors also propose investments to help beneficiaries remain enrolled amid more frequent eligibility checks and new requirements. For example: 

  • Kentucky proposes $35.6 million in FY 2027 and $11 million in FY 2028 to modify the Medicaid information technology systems and other administrative systems to cover increased costs for the more frequent six-month eligibility redeterminations and to implement the new community engagement and work requirements. 
  • Rhode Island proposes $32.7 million for technology modifications to the RIBridges software to maintain compliance for various health and human services programs to align with OBBBA. 

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

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

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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: 

  • Apply community engagement requirements to expansion adults, unless they qualify for an exemption 
  • Conduct eligibility redeterminations at least every six months for these enrollees 
  • Reduce retroactive coverage eligibility from 90 to 30 days 
  • Verify community engagement or exemptions using available data sources 
  • Enforce consequences for noncompliance beginning in 2027 

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: 

  • Who is in scope and who is exempt and how are exemptions verified without creating new burdens on enrollees and the people and systems that support them? 
  • What counts as a “qualifying activity” for compliance with the community engagement requirement (e.g., education/training and caregiving)? 
  • Which data sources can be deemed as “authoritative” for verifying compliance? 
  • How and when will beneficiaries be notified, supported, and given opportunities to supply missing information? 
  • How do they track compliance with the community engagement requirement and address its intended and unintended impacts? 
  • How do the verify eligibility for new applicants and what process do they use to monitor ongoing compliance for existing enrollees? 

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: 

  • Eligibility and enrollment systems and renewal workflows 
  • Data sources (wage databases, SNAP/TANF interfaces, workforce systems, education/training records) 
  • Managed care member services and, potentially, capitated payments 
  • All engagement with contact centers (e.g., phone, chat, text messaging, email, beneficiary portal, etc.) 
  • Document processing 
  • Notices, appeals, fair hearing processes, and case management 
  • Reporting, audit trails, and quality assurance 

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: 

  • Timely actionable information regarding which members are subject to the requirement 
  • Visibility into exemption status and pending verification 
  • Clear rules and data feeds that support proactive outreach 
  • Alignment on plan member communications 

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: 

  • Streamlined, clinically grounded exemption processes 
  • Clear guidance on documentation standards 
  • Fast, predictable exemption determinations 
  • Feedback loops when exemption requests are denied or incomplete 

Community engagement requirements will require coordination with nontraditional partners, such as: 

  • Departments of Labor/Workforce Development 
  • Community colleges, adult education, and training programs 
  • SNAP/TANF agencies (and their employment and training programs) 
  • Community-based and faith-based organizations, organizations that offer volunteer and community service opportunities, and local workforce boards 
  • Employers, chambers, and sector-based workforce intermediaries 

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: 

  • 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 contributors to this article include Erin DorrienKaitlyn FeiockAndrea 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.  

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