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Blog

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

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罢丑别听听represents the next major step in the Centers for Medicare & Medicaid Services (CMS)听听strategy and reinforces a federal commitment to value-based participation in Traditional Medicare. Announced as the successor to听, LEAD is a voluntary, nationwide, 10鈥憏ear 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鈥檚 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鈥憈erm 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鈥憈erm participation in accountable care鈥攎ost notably through revised benchmarking, updated beneficiary alignment, and expanded flexibility for engaging specialists and high鈥憂eeds populations.

1. Revising Benchmarking Policies to Support Predictability and Success

  • LEAD provides a major win for ACOs seeking long-term predictability by听setting a long-term benchmark that will not rebase for the entirety of the 10-year model. In MSSP, many ACOs eventually face the 鈥渞atchet effect鈥� in which benchmarks erode after rebasing to reflect the ACO鈥檚 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鈥檚 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 based听fully听on 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.听ACOs will be eligible to receive a boost to their benchmarks with either a regional efficiency adjustment for ACOs with lower spending or a prior savings adjustment for ACOs with a demonstrated history of achieving savings. LEAD also introduces an administratively set component to benchmarking鈥攖he Accountable Care Prospective Trend鈥攚hich already is used in the MSSP, though LEAD adds a new guardrail policy to promote predictability.

2. Improving Accuracy in Beneficiary Alignment

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

3. Adding Support for High-Needs Beneficiaries

  • LEAD expands support for beneficiaries with complex needs through a universal High Needs category and recalibrated risk adjustment.听By moving away from ACO REACH鈥檚 population鈥慹xclusive model, LEAD lowers barriers for organizations that serve a disproportionate share of high鈥憂eeds and dually eligible populations. In addition, CMS will test Medicare鈥慚edicaid 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鈥慴ased arrangements.听New Non鈥慞rimary Care Capitation options and episode-based risk arrangements (CMS鈥慉dministered 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.听Planned Artificial Intelligence (AI)鈥慽nferred 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鈥攑articularly for smaller or resource鈥慶onstrained 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鈥憈erm application readiness, but also longer鈥憈erm strategic alignment with the model鈥檚 10鈥憏ear commitment, risk structure, and operational requirements. Key considerations include benchmarking predictability, readiness to manage regional benchmarks, capacity to engage specialists and high鈥憂eeds beneficiaries, technology capabilities, and alignment with broader value鈥慴ased care strategies across Medicare and Medicaid.

Connect with Us

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

  • Interpret LEAD鈥檚 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鈥憁aking will be critical for organizations seeking to align participation with their long鈥憈erm value鈥慴ased care strategies.

For questions contact Amy Bassano and Rebecca Nielsen.

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HIMSS26: Building the Foundation for Interoperable, AI-Ready Healthcare听

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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. 

罢丑别鈥� (HIMSS26),鈥疢arch 9鈥�12, in Las Vegas, NV, marked a marked a turning point in which the industry began translating that message into tangible organizational decisions. Two 黑料不打烊 (黑料不打烊), 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鈥攖he 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鈥攁n 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鈥� 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鈥檚 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鈥攁 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鈥攊ngesting EHR data daily, normalizing it against common models, making it computable across 34 hospitals鈥攂ecause 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鈥慳ssurance digital identity, privacy鈥憄reserving design, and consistent credentialing. Progress in this area reduces friction for patient鈥慸irected 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鈥檚 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 鈥� critical to medication management, managed care, and complete longitudinal records鈥攁re 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 鈥� 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鈥攖he Oral Health Interoperability Alliance and the Pharmacy Interoperability and Clinical Services Alliance (PICSA)鈥攁re 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 鈥� 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庐 FHIR庐 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 鈥� HL7庐 FHIR庐 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鈥檚 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. 黑料不打烊 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鈥攄ata, identity, standards, governance鈥攚ill be positioned to move faster and more responsibly as AI capabilities continue to advance. 

We Can Help 

黑料不打烊 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 黑料不打烊 Companies, and does not constitute legal or regulatory advice

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PBM Reform Accelerates: New Rules, Broader Oversight, and What鈥檚 Ahead

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The first quarter of 2026 marked a turning point in federal oversight of pharmacy benefit managers (PBMs), the intermediaries that manage prescription drug benefits for most health plans across the commercial insurance market, Medicare Part D, and other programs. New legislation, agency rulemaking, and enforcement activity collectively signal a new phase of oversight that could materially reshape PBM contracting, compensation, and transparency requirements. 

Most notably, the following developments stand out: 

  • 罢丑别听US Department of Labor (DOL)听听new disclosure requirements for PBMs听that听serve听self-insured听Employee Retirement Income Security Act听(ERISA)听plans.听
  • 罢丑别听Consolidated Appropriations Act听of听2026 (CAA 26),听听February 3,听2026, establishes听comprehensive PBM听transparency and contracting听requirements听in the听commercial insurance market and Medicare Part D.听
  • 罢丑别听Federal Trade Commission (FTC)听听a settlement听with Express Scripts, Inc.听(ESI),听requiring significant听changes to听ESI鈥檚听business practices.听

Together, these actions signal a trend toward greater PBM accountability, with implications for plans, pharmacies, manufacturers,听and听consumers.听This article provides a high-level overview of the major听recent听developments听in the PBM reform policy landscape, along with key considerations for听stakeholders.听

Medicare Part D: Key Statutory Changes 

Beginning in plan year 2028, CAA 26 makes significant changes for PBMs operating in Medicare Part D. Key provisions include: 

  • Requiring听PBMs to听provide听annual reports to听plan sponsor clients听detailing aggregate and drug-specific costs听
  • Restricting听PBMs compensation听structures, prohibiting payments tied to drug prices, rebates, or price-based benchmarks听and听limiting PBMs to only receive听bona fide service fees that reflect听fair market value听
  • Stipulating听additional听parameters related to rebate guarantees, contract terminology, and audit rights听

Additional provisions that will take effect in beginning with plan year 2029 include: 

  • A requirement that听plan听sponsors and PBMs听comply with听forthcoming听standards for 鈥渞easonable and relevant鈥澨齪harmacy听contracting terms and conditions听
  • Expansion of听the听enforcement infrastructure听to avert听potential violations of听the program鈥檚听pharmacy contracting听requirements听

Key considerations: The Centers for Medicare & Medicaid Services (CMS) has broad discretion in implementing these provisions, including setting pharmacy contracting standards, determining which PBM affiliates are subject to new requirements, and defining 鈥渇air market value.鈥� PBMs will face expanded reporting and compliance obligations, while plans and other stakeholders will have opportunities to shape implementation through the regulatory process. 

Commercial Health Insurance Market: Key Statutory Changes 

For the commercial market, CAA 26 establishes similar transparency requirements for PBMs that serve fully insured and self-insured plans, with reporting required up to four times per year. Unlike Medicare Part D, the statute does not prohibit pricelinked compensation in the commercial market, but it does require detailed disclosure of PBM fees and revenue streams. For contracts with selfinsured plans, PBMs must remit 100 percent of rebates and fees tied to drug utilization, subject to specified limitations. 

Key considerations: These provisions significantly expand federal oversight in the commercial market. PBMs will need to scale compliance infrastructure, while employers and other plan sponsors may seek enhanced analytical and actuarial support to interpret disclosures and assess PBM performance. 

Medicaid Left Out, For Now. 

Unlike prior , CAA 26 does not include Medicaid-specific PBM reforms, such as  on spread pricing (i.e., a PBM charges a payer more than the amount it pays the dispensing pharmacy for a prescription) and expanded National Average Drug Acquisition Cost () reporting. 

Key considerations:听These policies听continue to have听听and听could听reemerge in legislation.听States,听PBMs,听and managed care plans听should continue听monitoring听for听renewed federal action听on these policies.听

DOL鈥檚 Proposed PBM Fee Disclosure Rule 

DOL鈥檚 proposed , 鈥淚mproving Transparency Into Pharmacy Benefit Manager Fee Disclosure,鈥� would require PBMs serving self-insured ERISA plans to  information about rebates, manufacturer fees, pharmacy payments, and spread pricing. In late February, DOL  the public comment period to April 15 to allow stakeholders to address how the proposed rule should align with the newly enacted CAA 26 provisions. 

Key considerations: DOL could withdraw the proposal in favor of the statutory framework or could finalize the rule to take effect before the CAA 26 requirements begin. Either path would further increase near-term compliance for PBMs and plan sponsors, and stakeholders should monitor this space closely. 

FTC Settlement with ESI 

罢丑别&苍产蝉辫;贵罢颁鈥檚&苍产蝉辫; with ESI resolves insulin-focused  against the PBM and imposes extensive requirements related to transparency, compensation, rebates and fees, and benefit design. The settlement also includes less common provisions, such as a commitment to reshore and increase disclosures related to ESI鈥檚 rebate group purchasing organization (GPO) functions. 

Key considerations: If similar settlements are reached with other PBMs, the FTC could play an expanded role in shaping PBM market behavior, supplementing legislative and regulatory reforms with enforcement-driven standards. 

State Efforts to Regulate PBMs 

States continue to pursue PBM reforms, with  of laws enacted in recent years addressing licensure, reporting, pharmacy reimbursement, and contracting standards. Although the Supreme Court鈥檚 2020  in Rutledge v. PCMA opened the door to certain state-level reforms,  have narrowed the scope of permissible state regulation, particularly when ERISA preemption or Medicare Part D conflicts arise. 

Key considerations: Stakeholders operating across multiple markets and states will continue to face a complex and evolving patchwork of requirements, underscoring the importance of ongoing policy tracking and compliance coordination. 

Connect with Us 

Recent federal and state actions suggest that PBM reform is entering a more operational phase defined by transparency听and听enforceable standards governing compensation, contracting, and market听behavior. As implementation unfolds, stakeholders across the prescription drug supply chain will need to engage closely with regulators, assess new data flows, and adapt听their听business practices to a more prescriptive oversight environment.听

For more information about the policies described鈥痠n this article and the PBM policy landscape more broadly, please contact our experts  or Stephen Palmer. 

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

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The Centers for Medicare & Medicaid Services (CMS) proposed  marks a notable shift in Marketplace policy, expanding lower premium plan options, relaxing certain federal standards, and moving more implementation and oversight responsibility to states and Marketplaces. It also introduces eligibility and verification policies that could significantly affect enrollment, operations, and market stability. 

To unpack what this could mean for plan year 2027 and beyond, Andrea Maresca spoke with Zach Sherman, Managing Director for Coverage Policy and Program Design at 黑料不打烊 (黑料不打烊); Lina Rashid, Principal at 黑料不打烊; and , PhD, Principal at Wakely, an 黑料不打烊 company, who, alongside colleagues, published a Policy Brief on state-level and consumer impacts, as well as a Wakely  on the proposed rule. 

 Q: When you zoom out from the technical details, what are the big takeaways from the proposed 2027 NBPP for states, consumers, and issuers? 

Lina Rashid: At a high level, the proposal reallocates risk and responsibility across the system. Consumers may see more lower premium options through expanded catastrophic plan eligibility and more flexible bronze plan design, but often with more cost-sharing, higher deductibles, or greater complexity. For consumers, affordability is about more than just premiums; it鈥檚 about how much healthcare costs for individuals and their families overall and the cost of care when they need it. 

States are being given options to take on more oversight and operational responsibility but without additional federal funding. And issuers are being given more flexibility, but it comes with uncertainty regarding enrollment and risk mix. 

Zach Sherman: The rule鈥檚 cumulative effect matters more than any one policy. Expanded catastrophic eligibility, higher out-of-pocket exposure, relaxed network standards, and tighter verification requirements all interact. Together, they raise questions about access, affordability, and whether Marketplaces are equipped to manage administrative and enrollment disruption. 

Q: The paper highlights potentially significant enrollment effects. What鈥檚 driving that dynamic? 

Michael: Two things stand out. First, the proposal implements statutory changes that remove advance premium tax credit (APTC) eligibility for certain lawfully present immigrants beginning in 2027. CMS estimates more than a million people could lose eligibility, and it鈥檚 reasonable to expect most of them will exit the individual market. 

Second, the proposed income verification changes could generate millions of data matching issues (DMIs) that temporarily or permanently cut off access to advance premium tax credits. While CMS projects a relatively modest disenrollment effect, our analysis suggests losses could be meaningfully higher depending on how quickly issues are resolved. We estimate that approximately 4.7 million enrollees could receive DMIs under the proposal, and upward of 80 percent of them could temporarily or permanently lose access to APTCs, putting coverage at risk. 

Zach: If consumers can鈥檛 afford the full premiums while resolving a data issue, many will drop coverage. That creates churn and administrative strain that Marketplaces must manage. 

Q: How do these policies affect state Marketplaces and regulators specifically? 

Zach: States are being asked to do more across multiple fronts. Network adequacy oversight is shifting toward states that conduct effective rate review. States may also choose or feel pressure to take on Essential Community Provider (ECP) review authority, including for new non-network plans. Accepting that responsibility requires legal authority, staff capacity, and technical infrastructure. 

At the same time, states may need to stand up the State Exchange Improper Payment Measurement (SEIPM) program, which CMS acknowledges will increase administrative burden. 

The proposed State Exchange Enhanced Direct Enrollment (SBE-EDE) option is also a significant shift. Rather than operating a centralized consumer enrollment platform, Marketplaces would focus on certifying, overseeing, and monitoring multiple third-party entities. As a former director of a state-based Marketplace program, I know this is a fundamentally different operational posture that comes with oversight and compliance costs. 

Q: The proposal also introduces non-network plans. What should stakeholders be watching here? 

Michael:  may offer lower premiums, but they change how access works. Provider participation depends on the willingness to accept the plan鈥檚 payment as payment in full. On paper a plan may meet access standards, but in practice consumers could face difficulty finding care. That places additional oversight responsibility on states to determine whether access is sufficient in practice. If aggressively priced non-network plans disproportionately attract healthier enrollees, it can create financial risk for issuers and for the broader market. 

Q: What does this mean for market stability going forward? 

Zach: Stability will vary by state. States that invest in oversight, consumer assistance, and operational readiness鈥攐ften a state-based Marketplace鈥攎ay be better positioned to manage these changes. Others may see sharper enrollment declines or access issues. That divergence across states is an important signal from this proposal. 

Q: What should states and stakeholders be doing right now? 

Zach: States should be doing scenario planning, assessing which flexibilities to adopt, where to maintain higher standards, and whether they have the capacity to take on expanded responsibilities. These decisions will shape how the rule plays out on the ground. 

Michael: Issuers should be , risk adjustment exposure, and operational readiness. All stakeholders should remember that comments on the proposed rule are due March 13, 2026. 

Lina:听Notably, CMS听is not done with听regulatory reforms.听罢丑别听agency solicited听comment听on听medical听loss听ratio (MLR)听policies听and听paused听Essential Health Benefit听benchmark updates,听as well as issues not covered in this proposed rule, such as revisions to the Section 1332 waiver and听Section听1333 interstate compacts.听States and issuers should be tracking what may come next, not just what鈥檚 in this proposal.

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The Value Shift in Medicare Advantage: What 2026 Benefits Tell Us 黑料不打烊 the Market鈥檚 Next Chapter

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The Medicare Advantage (MA) program continues to evolve as plans respond to shifting policy signals, market pressures, and beneficiary expectations. A new paper from Wakely, an 黑料不打烊 Company鈥斺�攑rovides a data-driven examination of how MA benefit designs are changing and what those changes signal about the future direction of the program. 

This paper refreshes Wakely鈥檚 ongoing MA , updating  with the latest 2026 plan enrollment data. It builds on Wakely鈥檚 established work examining benefit design, supplemental offerings, and the relationship between bids, rebates, and plan value, including . 

This article highlights findings from the proprietary value-add metric that Wakely developed to provide a comprehensive assessment of MA plan value. Although it can be used as a comparative metric to evaluate relative changes year over year, it is not intended to represent pricing. 

From Benefit Expansion to Optimization 

Over the past decade, MA plans have steadily expanded benefit offerings, supported by strong enrollment growth and favorable rebate dynamics. The 2026 benefit landscape suggests that plans have been taking a more measured approach (see Figure 1). Wakely鈥檚 analysis finds that plans are becoming more strategic in how benefits are designed and deployed, maintaining or enhancing benefits that are best aligned with quality performance, affordability, and target populations while pulling back in other areas. 

Plans appear to be optimizing benefits to better align with member needs, quality performance, and financial parameters. Examples include refining supplemental benefits, adjusting cost-sharing structures, and rethinking how benefits support care management and health outcomes. 

Figure 1. Change in Plan Value-Add from 2025 to 2026

 The shift reflects an MA market in which differentiation and long-term sustainability are increasingly important. 

Supplemental Benefits: More Targeted, More Strategic 

Supplemental benefits remain a defining feature of Medicare Advantage, but their role is evolving. Wakely鈥檚 paper highlights a move away from expanding the number of benefits toward targeted benefit offerings that are more clearly connected to member engagement and outcomes. 

Plans are homing their focus on benefits that support daily living, chronic condition management, and access to care, particularly for populations with higher needs. This targeted approach suggests plans are thinking about value, operational complexity, and how benefits contribute to overall value propositions. 

Between 2025 and 2026, the percentage of members with access to common supplemental benefits has, on average, stayed consistent or slightly decreased among the general enrollment population (Figure 2). The percentage of members who are enrolled in plans that offer over-the-counter (OTC) drug, transportation, and Flex Card benefits has decreased by 11 percent, 6 percent, and 4 percent, respectively. Conversely, the Dual Eligible Special Needs Plan (D-SNP) population saw an increase in member access to all supplemental benefit categories except transportation (an 8% decrease). 

Figure 2. Percent of Enrollment in Common Supplemental Benefits 

For stakeholders across the healthcare ecosystem, this trend underscores the importance of understanding not just what benefits are offered, but why. 

Shifts in Cost Sharing and the Enrollee Experience 

Wakely鈥檚 analysis also points to notable shifts in cost sharing and premium structures. There is continued attention to balancing affordability for members with the need to manage plan liability amid changing benchmarks and utilization patterns. 

These decisions directly affect the member experience. Small shifts in copays, deductibles, or benefit limits can influence enrollment, retention, and satisfaction, particularly in competitive markets. As plans fine tune these levers, data-driven insights become critical to understanding how benefit changes may resonate with different member segments. 

2026 Signals for Future Bid Cycles 

The benefit trends identified in 鈥�The Value Shift鈥� series suggest several broader signals for the MA market: 

  • Value over volume: Plans are prioritizing benefits that support quality, outcomes, and sustainable growth.听
  • Greater segmentation: Benefit designs are increasingly tailored to specific populations and market dynamics.听
  • Data-informed decision-making: As margins tighten, plans are relying more heavily on analytics to guide benefit strategy.听
  • Special needs plans continue to drive growth.听Enrollment in Chronic Condition Special Needs Plans (C-SNPs)听is听the fastest-growing segment听in MA.听

These dynamics have implications for MA organizations and for providers, policymakers, and partners seeking to understand how MA continues to shape care delivery and costs. 

Value-Add Metric and Benefit Design Insights 

In this paper, Wakely paired its actuarial and analytic expertise with tools that enable detailed benefit and market analysis. One of those tools, Wakely鈥檚  (WMACAT), calculates a comprehensive value-add metric that integrates five core components into a consistent framework that allows for apples-to-apples comparisons across plans, markets, and years. In addition, Wakely鈥檚  (SMART) supports broader competitive assessments by layering enrollment weighting, geographic variation, and plan positioning into the analysis. 

As an 黑料不打烊 company, Wakely鈥檚 work is complemented by broader policy, market, and strategy expertise, helping organizations connect benefit decisions to regulatory developments, operational considerations, and long-term goals. 

For health plans and healthcare organizations navigating the next phase of Medicare Advantage, these combined capabilities can respond to questions such as: 

  • How competitive is our benefit design today,听and where are the risks?听
  • Which benefits are most aligned with our population and quality strategy?听
  • How might future policy or payment changes affect benefit sustainability?听

Looking Ahead 

MA benefit design remains an important signal of market direction by showing how plans are responding to policy change, market competition, and financial pressure. As plans shift from broad expansion to more targeted value strategies, the ability to measure, compare, and interpret benefit changes becomes essential as plans look ahead to the 2027 and 2028 bid cycles. 

Wakely will continue to build on this work with upcoming analyses, including deeper dives into Part D design changes and the implications of the sunset of the Value-Based Insurance Design (VBID) program. 

For information about this analysis and the Wakely tools, contact  and . 

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2027 NBPP Proposed Rule Signals Further Marketplace Changes

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The Centers for Medicare & Medicaid Services听(CMS)听听proposed rule,听published February 11, 2026,听arrived听at a pivotal moment for the听Affordable Care Act (ACA)听Marketplaces. The temporary enhanced premium tax credits (ePTCs), first expanded in 2021 and extended through 2025, expired at the end of last year, returning Marketplace subsidies to their original ACA structure in 2026.听As we discussed in earlier articles听(here听and听here), that shift is already affecting affordability, plan selection, and enrollment dynamics鈥攑articularly for consumers who听are ineligible听for听premium assistance.听

The proposed 2027 NBPP represents a significant reset for the Marketplace, reflecting CMS vision and policy priorities to strengthen program integrity while expanding plan design flexibility and consumer choice as a pathway to affordability, as well as policies to defer to state authority. Healthcare organizations and other interested stakeholders may submit comments on the proposed rule through March 13, 2026. 

The remainder of this article addresses the key policy proposals and considerations for issuers, states, and consumer groups. 

颁惭厂鈥檚&苍产蝉辫;笔谤辞辫辞蝉补濒蝉&苍产蝉辫;

The proposed NBPP for 2027 sets standards for the Exchanges and ACA-compliant individual and small group markets and updates payment parameters for risk adjustment and risk adjustment data validation (RADV). The rule also implements changes approved under the , (P.L. 119-21, OBBBA) and includes a range of policies spanning plan certification, eligibility and verification, and Exchange oversight. 

Expanded Plan Design Flexibility 

CMS proposes to discontinue standardized plan options in the Federally-facilitated Marketplace (FFM) and remove limits on the number of non-standardized plans offered by issuers on the FFM and state-based Marketplaces on the federal platform (SBE-FPs). Issuers would be permitted to decide whether to discontinue existing standardized or chronic condition plans or continue them with modified cost sharing. 

Considerations: This change is designed to allow greater innovation in plan design. It also raises questions about the potential return of a more complex Marketplace shopping experience for consumers who will have to shift through more plans. 

Certification of Non-Network QHPs 

One of the most consequential proposals would allow 鈥渘on-network鈥� plans to be certified as qualified health plans beginning in 2027. These plans would not rely on contracted provider networks. Instead, they would set benefit payment amounts and require issuers to demonstrate that sufficient providers鈥攊ncluding Essential Community Providers (ECPs) and mental health and substance use disorder providers鈥攁re willing to accept those amounts as payment in full. 

Considerations: CMS positions non-network plans as a way to create lower premium options. For states and issuers, this proposal introduces new oversight and operational considerations related to access standards, consumer protections, the risk of balance billing or access gaps for consumers, and potential market instability. 

Changes in Catastrophic and Bronze Cost Sharing 

The proposed rule would further expand access to catastrophic plans by codifying hardship exemptions for individuals ineligible for advance premium tax credits (APTCs) or cost-sharing reductions (CSRs) because of projected income. CMS also proposes to allow multiyear catastrophic plans with contract terms of up to 10 consecutive years. In addition, CMS proposes new flexibility for certain bronze plan designs in the individual market. In both cases, CMS proposes to allow catastrophic and bronze plans to exceed the annual maximum out-of-pocket limit. 

Consideration: These policies reflect CMS鈥檚 emphasis on affordability through lower premiums and expanded consumer choice, while shifting more financial risk to enrollees through higher cost sharing. 

Network Adequacy and Essential Community Providers 

CMS proposes to give states greater discretion in provider access for network adequacy and ECP certification reviews, including allowing federally funded exchange (FFE) states to conduct their own reviews if CMS determines they have sufficient authority and technical capacity. CMS also proposes to reduce the minimum percentage of ECPs that issuers must include in their networks from 35 percent to 20 percent. 

Considerations: These changes reduce federal prescriptiveness and could lower issuer compliance costs but also place more responsibility on states to monitor access and ensure that vulnerable populations are not adversely affected. 

Essential Health Benefits and State Mandates 

The proposed rule would prohibit issuers from including routine non-pediatric (adult) dental services as an Essential Health Benefit (EHB). More significantly for states, CMS proposes changes to cost defrayal requirements for state-mandated benefits, requiring states to cover the cost of benefits considered 鈥渋n addition to EHB鈥� under specified criteria, even if those benefits are embedded in the state鈥檚 EHB benchmark plan. 

Consideration: These changes could have direct budgetary implications for states, pricing implications for issuers, and could stunt or potentially decrease benefits for consumers. 

Program Integrity and Increased Eligibility Verification 

CMS includes a robust set of program integrity provisions, including: 

  • Strengthened听standards for agent, broker, and web听broker marketing practices听
  • Required use of a听US听Department of Health and Human Services (HHS)-approved consumer consent and application review form听
  • Codification of听听policies听and reintroduction of听听provisions听not听previously听implemented,听including听expanded special enrollment period (SEP) verification听and听increased eligibility standards for enrollees applying for APTCs听(see听Navigating CMS鈥檚 2025 Marketplace Rule: What It Means for ACA Marketplaces, Insurers, and Consumers)听
  • Implementation of the State Exchange Improper Payment Measurement (SEIPM) program for state-based Marketplaces听

Consideration: These policies continue CMS鈥檚 heightened scrutiny of enrollment activity and subsidy eligibility. CMS鈥檚 policies are likely to increase data matching issues (DMIs), which could increase burden on Marketplaces and enrollees, resulting in reduced enrollment. 

Preparing for Policy Driven Changes in ACA Marketplaces 

The 2027 NBPP underscores a clear policy shift away from extending federal subsidies toward advancing a Marketplace framework that emphasizes program integrity, state flexibility, and expanded plan design options as mechanisms to promote affordability and consumer choice. 

The proposed rule sets the stage for significant strategic and operational decisions for issuers and states ahead of the 2027 plan year. 黑料不打烊 (黑料不打烊), including Wakely, an 黑料不打烊 company, works with issuers modeling enrollment and risk shifts and to assist in pricing decisions. States also should consider the need for new strategies and approaches to adapt to federal policy changes that are expected for ACA Marketplace programs. 

For more information about the policies described鈥痠n this article, support with scenario-based modeling of enrollment and data-informed strategy development for 2027 and beyond, please contact鈥痮ur experts , Lina Rashid, or Zach Sherman. 

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Outlook 2026: Medicare Advantage Advance Notice鈥擶hat It Means for the 2027 Market

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In this conversation, Andrea Maresca, Senior Principal at 黑料不打烊 (黑料不打烊), caught up with , Director, Wakely, and , Co-Founder & Managing Partner at Health Transformation Strategies, LLC, to unpack the biggest questions emerging from the Calendar Year (CY) 2027 Medicare Advantage (MA) and Part D Advance Notice. Of particular interest was the Centers for Medicare & Medicaid Services鈥檚 (CMS鈥檚) proposed risk adjustment and diagnosis source changes, which are drawing significant attention across the industry. 

Q: The headline is 鈥渇lat鈥� payments. How should the market interpret CMS鈥檚 projected rate change? 

Tim Courtney: CMS  a net average payment change of just +0.09 percent for CY 2027鈥攁bout $700 million (M). The effective growth rate is about 4.97 percent, but it鈥檚 largely offset by risk model and normalization changes and the proposed diagnosis source policy. 

Jon Blum: Exactly. It鈥檚 important to note that CMS鈥檚 impact projections are based on the change in its average payments. Its proposed policies will have much more far-reaching distributional impacts, depending on the diagnoses of their enrolled members. At the same time CMS recently proposed changes to its Star Ratings methodologies. Over time, we could see quite significant changes to the balance of Medicare Advantage payments distributed across the country that could significantly affect benefit offerings and premium amounts. 

Q: What鈥檚 most surprising in the Advance Notice for 2027? 

Blum: The diagnosis source tightening is the big one. CMS proposes excluding diagnoses from 鈥渦nlinked Chart Review Records鈥� from risk score calculation starting in CY 2027. That signals a continued progression by the agency toward encounter-anchored data integrity. Assuming this policy is finalized, Medicare Advantage plans must continue to invest in systems to respond to CMS鈥檚 program integrity focus. 

Courtney: And it鈥檚 not only chart review. CMS also proposes excluding diagnoses from audio-only services for Part C and similarly for Part D. Operationally, that鈥檚 a big deal. Plans need to understand where diagnoses originate, how they鈥檙e supported, and what the downstream risk adjustment factor (RAF) impact looks like by segment and provider channel. 

Q: The Wakely team estimates a different 鈥渇eel鈥� than CMS鈥檚 topline. What does Wakely鈥檚 analysis add? 

Courtney:  helps translate CMS components into both benchmark and plan payment change. 

Blum: This point is really key. Wakely鈥檚 analysis flags that rebasing/repricing impacts aren鈥檛 fully reflected yet, which means county-level outcomes can diverge materially once the final Rate Announcement is released. The rebasing could be particularly volatile this year as CMS adjusts for rural emergency hospital payments and the removal of anomalous and suspect DME claims. Both adjustments vary by geographic area. 

Q: How should plans think about bid strategy and benefit pressure for 2027? 

Courtney:听The tighter risk adjustment environment could squeeze rebates and supplemental benefit richness鈥攅specially if bids听don鈥檛听adjust quickly. Wakely estimates risk-adjusted bid and rebate revenue is down roughly听0.35听percent听under a set of simplifying assumptions, underscoring the margin sensitivity.听

Practically this means plans should run a few scenarios: 1) RAF compression from diagnosis source changes, 2) normalization updates, and 3) Star-related shifts鈥攅ven if the Star change is estimated to be small nationally. 

Blum: I鈥檇 add provider contracting and clinical program return on investment (ROI) will likely be an even greater focus for Medicare Advantage plans. When risk score lift is constrained, the value of medical cost management and quality performance becomes more important. We have seen tremendous pushback by healthcare providers over the greater use of prior authorization, with some major health systems dropping their contracts with Medicare Advantage plans altogether. Medicare Advantage plans will have to carefully balance the need to reduce medical expenditures and maintain their provider networks to attract enrollment. Establishing strong partnerships with provider systems will be more important than ever. 

Q: What do plans need most right now? 

Courtney: This is where integrated strategy and actuarial and policy expertise really matter. 黑料不打烊 is supporting stakeholders with payment impact modeling, scenario analysis, and advisory services tied to benchmark rebasing, risk adjustment, Star Ratings, product strategy, and Part D payment policy, so clients can translate the Notice into concrete bid and operating decisions. 

From Wakely鈥檚 side, the detailed benchmarking and methodology interpretation helps clients quantify what CMS鈥檚 technical updates mean in dollar terms and across geographies. 

The CY 2027 Advance Notice is also a reminder that average impacts hide portfolio impacts. The plans that model 鈥渨here the change hits鈥� (diagnosis sources, provider channels, county mix, Stars trajectory) will be best positioned heading into April鈥檚 final Rate Announcement. 

Blum: And from a policy lens, plans need to connect the dots. CMS鈥檚 proposed rate notice is both an articulation of its current priorities and continued progression toward more payment accuracy, encounter-linked data, and program integrity. Medicare Advantage plans should be both prepared to operationalize these policies and to work with the agency to ensure its policies better serve Medicare beneficiaries. 

Medicare Advantage plan leaders will be those organizations that operationalize these policy directions early, constructively engage in the policy process, and form far stronger partnerships with health care providers. 

You can find more insights on the important proposed changes in plan payments, risk adjustment, and other financial and regulatory requirements for 2027 in Wakely鈥檚 summary analysis, . 

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CBO鈥檚 New Baseline Signals Shifting Cost and Risk Dynamics in Medicaid and Medicare

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On February 11, 2026, the Congressional Budget Office (CBO) released  report. The publication, which represents the first time CBO has released Medicare and Medicaid spending baseline projections since , reflects the impact of the 2025 Budget Reconciliation Act (P.L. 119-21, OBBBA), recent changes to Medicare reimbursement for skin substitute products, and the latest Medicare Part D and Medicare Advantage bids.

CBO鈥檚 baseline serves many functions, including serving as the official 鈥渟corekeeping鈥� benchmark used for cost estimates of proposed legislation under consideration in Congress.

Changes to CBO鈥檚 Medicaid Baseline

CBO decreased its projections of 2026鈥�2035  by approximately $514 million from its January 2025 baseline update. The main driver of that reduction is the impact of the Medicaid provisions in the 2025 Budget Reconciliation Act, which CBO expects will reduce total Medicaid enrollment by 13.1 million people in 2035. The drop in Medicaid spending from the OBBBA-related enrollment reductions was partially offset by technical changes CBO made to the Medicaid baseline.

Medicaid costs per enrollee grew by 16 percent in 2025, which was more than CBO had anticipated. The agency attributes the cost per enrollee growth to a reported decrease in the average health status of Medicaid enrollees following the end of the COVID-era continuous eligibility policy.

CBO anticipates that payment rates for Medicaid managed care plans will begin to rise in 2026 because of this decrease in the average health status of enrollees, and the agency has updated the Medicaid baseline accordingly (see Figure 1).

Source: 黑料不打烊 analysis of CBO鈥檚  and F reports.

Changes to CBO鈥檚 Medicare Baseline

Compared with its January 2025 baseline, CBO increased its projections of  by about $1 trillion (roughly $942 billion, by 黑料不打烊 (黑料不打烊) calculations). The main driver of that increase came from CBO鈥檚 updates to its Medicare Part D spending projections, which were increased to reflect higher than expected 2026 bids from private insurance plans that administer the Part D benefit. According to their 2026 bids, Part D plans anticipate a 35 percent increase in their annual per enrollee costs in 2026鈥攁 trend that CBO was not expecting and . Part D spending per beneficiary in 2035 is now projected to exceed $4,000, up from less than $3,000 in the January 2025 baseline (See Figure 2).

The agency鈥檚 Medicare Part A fee-for-service (FFS) spending projection increase was the result of larger than expected increases in 2025 enrollment and per enrollee spending. Those trends were also seen in Medicare Part B FFS but were partially offset by the Centers for Medicare & Medicaid Services鈥檚 (CMS) recent reimbursement changes to skin substitute products. Overall, CBO estimates that the skin substitute reform issued in CMS鈥檚  and  final rules will save $245 billion over the 2026鈥�2035 period, including the effects on the Medicare Advantage (MA) program (see Figure 3).

Finally, CBO reduced its spending projections for MA compared to the January 2025 baseline. This change was made to reflect lower-than-expected Medicare Advantage enrollment in 2025, although the spending implications of lower enrollment were partially offset by higher-than-expected bids in 2026 by providers of MA plans (see Figure 4).

Source: 黑料不打烊 analysis of CBO鈥檚  and  reports.
Source: 黑料不打烊 analysis of CBO鈥檚  and  reports.
Source: 黑料不打烊 analysis of CBO鈥檚  and  reports

Contact an 黑料不打烊 Expert Today

Interested in understanding how CBO鈥檚 latest baseline update affects the federal budgetary implications of certain Medicare or Medicaid policy topics or proposals? Contact our experts, Mark Desmaris and Rachel Matthews, to learn more about 黑料不打烊鈥檚 鈥淐BO-style鈥� federal budgetary scoring work, which relies on The Moran Company鈥檚 long-standing methodology. [1]

Beyond federal budget scoring, 黑料不打烊 is working with states, health plans, and providers to assess how changes in enrollee health status are affecting utilization, costs, and payment rates鈥攁nd what those trends may mean for Medicaid and MA organizations and providers. Our teams support states in evaluating managed care rate setting and program design, help Medicaid and MA plans anticipate risk and bid implications, and assist providers in understanding how changes in patient acuity could affect care delivery, contracting, and financial performance.

[1]Specifically, we apply our understanding of CBO precedents to predict how CBO will likely evaluate the budgetary impact of the legislation in question. We use our best judgment to adopt the assumptions CBO would tend to use, with the understanding that any variance in the assumptions CBO ultimately adopts could cause our estimate to differ from theirs.

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Tending the Embers: Staying Ready for Medicare Advantage RADV Audits

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The Centers for Medicare & Medicaid Services (CMS)鈥痠ssued a memo January 27, 2026, with updates on the agency鈥檚 approach to checking whether Medicare Advantage (MA) plans are being paid correctly. These reviews are conducted through which help CMS confirm that the diagnoses MA plans report are supported by medical records. 

The January 2026 memo signals that CMS intends to honor its commitment to strengthen oversight of MA payments, including accelerating and expanding the use of RADV audits and using AI (artificial intelligence) to streamline human coding reviews. MA organizations must now prepare to respond to the RADV audit notice within the required five-month window, while balancing their other risk-adjustment programs. 

In this article, we explain the rapidly evolving landscape affecting RADV audits. Wakely, an 黑料不打烊 company, addresses what these changes mean for MA organizations and key considerations to ensure they are prepared for the upcoming enhancements to federal program integrity initiatives. 

Overview of CMS鈥� RADV Refresh 

CMS  a major shift in May 2025: All MA plans will undergo RADV audits鈥攏ot just a small sample as before. These audits look for cases in which diagnosis information submitted by a plan does not match the documentation in the patient鈥檚 medical record. When this happens, CMS may decide the plan was overpaid and require repayment. Historically, CMS audits have identified widespread diagnosis-code documentation errors, resulting in significant revenue recoupment from MA plans. 

The 2025 announcement creates a framework for additional risk for MA plans, which could shift to risk-bearing provider groups. As we explained in an , key components of that announcement include: 

  • All MA plans will be audited starting听with听Payment Year听(PY)听2018.听
  • CMS committed to accelerating audits by听adding more staff and using听new听technology.听
  • CMS听planned to听use 鈥渆xtrapolation鈥濃�攎eaning听if errors were found in a small sample of records, the error rate could be applied to the full population, which could lead to much larger repayment amounts.听
  • CMS also planned to听eliminate听the fee-for-service听(FFS)听adjuster鈥攁听policy that previously helped reduce the amount a plan would have to repay. This听proposal听would increase financial risk for plans.听

Both the use of extrapolation and the removal of the FFS adjuster were later challenged in court. 

Legal Challenge 

In September 2023, Humana  CMS in federal court, arguing that the 2023 RADV final rule, which allowed extrapolation and removed the FFS adjuster, was put into place without following proper federal rulemaking procedures. On September 25, 2025, the court agreed with Humana and vacated certain parts of this final rule, meaning certain parts of the rule are no longer in effect. 

CMS appealed the ruling on November 1, 2025, which has created uncertainty about how RADV audits will work in future years. 

Navigating the Legal and Regulatory Changes in Early 2026 

The court did not say that extrapolation or elimination of the FFS adjuster is illegal鈥攐nly that CMS did not follow the required process for changing the rules. Hence, the 2023 RADV final rule cannot take effect unless CMS wins its appeal or reissues the policy using the proper steps. 

In its January 2026 Health Plan Management System (HPMS) memo, CMS stated that it will comply with the order while it is in effect. 

The pending litigation does not diminish CMS鈥檚 broader commitment to increased audit activity and heightened scrutiny of MA risk-adjustment practices. 

Effect of the Ruling. During RADV audits, CMS selects a sample of enrollees and requests corresponding medical records from the MA plan. These records are reviewed to confirm that the documented diagnoses meet CMS requirements. If unsupported diagnoses are found, CMS may recalculate payments and recover overpayments from the health plan. This audit process maintains program integrity and ensures accurate payments. 

Plans that submit incomplete records could owe significant repayments to CMS. 

CMS鈥檚 January 2026 memo clarifies how the agency plans to roll out additional RADV audits starting with PY 2020. CMS also addresses the agency鈥檚 plans to:  

  • Reduce burden on plans and providers,听for example by extending the submission window听听
  • Balance the volume of medical record submissions needing review听by using smaller sample sizes听where appropriate听
  • Use AI听to further accelerate the review process听

Preparing for What鈥檚 Next 

Given CMS鈥檚 stated direction and the still unsettled litigation environment, MA plans should remain vigilant and audit ready.

Key steps include: 

  • Prioritizing听timely听and complete chart submission processes听
  • Strengthening internal criteria to听identify听and听prioritize听charts most likely to support diagnoses听
  • Improving documentation and coding accuracy through provider engagement听
  • Conducting proactive self鈥慳udits to听identify听potential vulnerabilities听
  • Partnering with expert RADV consultants to navigate audit strategy, documentation, and submission readiness听

Connect with Us 

Wakely assists plans with their RADV initiatives and development of robust RADV playbooks. For more information about Wakely鈥檚 RADV playbooks, contact . 

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Congress Advances FY 2026 HHS Appropriations Bill with Health Extenders and PBM Reforms

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On February 3, 2026, Congress finalized federal funding for fiscal year (FY) 2026, with the House passing the Consolidated Appropriations Act (CAA), 2026, with a vote of 217-214, following Senate approval last week. The president signed the CAA () shortly thereafter. The law provides full-year appropriations for the Departments of Health and Human Services (HHS), Housing and Urban Development, Labor, and several other departments. 

This year鈥檚 HHS funding bill is notable not only for what it includes, but also for what it omits. It restores or maintains funding for key public health and research agencies previously proposed for elimination in the president鈥檚 FY 2026 , extends several healthcare programs, and contains a significant package of pharmacy benefit manager (PBM) reforms. All of this activity comes as the Administration  new grant programs and policy efforts related to its signature priorities. 

In this article, we review the major funding and policies approved in the HHS spending bill. We also address key considerations for healthcare organizations as they anticipate downstream funding and policy developments and develop advocacy initiatives for federal FY 2027 bills. 

HHS Funding Levels and Direction 

The bill provides $116.8 billion for HHS, an increase of $210 million over FY 2025, and rejects large-scale structural reorganizations proposed in the president鈥檚 FY 2026 budget. This provision preserves funding for the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Health Resources & Services Administration (HRSA), and the Substance Abuse and Mental Health Services Administration (SAMHSA) 

Table 1. HHS Agency Funding Highlights, FY 2026 

Agency  FY 2026 Funding  (+/-) Compared with FY 2025 
Administration for Strategic Preparedness and Response (ASPR) $3.7 billion +$58 million  
CDC $9.2 billion level funding 
Centers for Medicare & Medicaid Services (CMS), administrative expenses only  $3.7 billion level funding  
 HRSA $8.9 billion +$415 million  
National Institutes of Health (NIH) $48.7 billion  +$929 million  
SAMHSA $7.4 billion  +$65 million  

The bill also extends mandatory funding for community health centers, special diabetes programs, the National Health Service Corps, and Teaching Health Center Graduate Medical Education. 

PBM Reforms in the Package 

In one closely watched area of federal policymaking, the FY 2026 package includes a substantial set of PBM-related reforms that largely mirror the bipartisan package negotiated but not enacted in December 2024. These reforms have implications across Medicare Part D, commercial insurance, and employer-sponsored plans. 

The legislation contains the following PBM reforms: 

  • Prohibits PBMs from deriving听remuneration听linked to drug prices for听Medicare-covered Part D drugs听
  • Restricts spread pricing in Medicaid,听eliminating听a major driver of PBM revenue听
  • Requires contractual transparency, mandating that PBMs clearly define pricing terms in agreements with Part D plan sponsors听
  • Adds new PBM reporting obligations, including drug price reporting and rebate disclosures听
  • Requires 100听percent听passthrough of rebates in ERISA-regulated plans for new, renewed, or extended contracts beginning听30 months听after enactment听
  • Expands audit rights for plan sponsors听
  • Codifies the 鈥渁ny willing pharmacy鈥� requirement for Medicare plan sponsors听

These provisions position 2026 as a consequential year for PBM regulation, increasing transparency, strengthening plan leverage, and heightening HHS oversight. 

Healthcare Extenders and Program Reauthorizations 

The bill includes a broad set of Medicaid, Medicare, and public health program extenders, affecting providers, patients, states, and managed care plans. 

Medicaid 

  • Postpones reductions听in the听Disproportionate Share Hospital (DSH)听allotments听until FY 2028听
  • Changes听the听DSH cap calculation听to听broaden which patient costs count toward Medicaid shortfall听
  • Requires states to听develop and implement a process to听allow certain out-of-state pediatric providers to deliver services without听additional听screening for three years听
  • Removes age limits on Medicaid鈥檚 Ticket to Work program, allowing adults older than age听65 to听participate听and requires state compliance by January 1, 2028听
  • Establishes new maternity care reporting requirements听for rural hospitals, with dedicated federal funding听for hospitals听and states to听comply with听the reporting听

Medicare 

Congress extends several key programs and payment provisions, including: 

  • Telehealth flexibilities through December 31, 2027听
  • Incentive payments for participation in eligible alternative payment models through payment year 2028 (for performance year 2026) and applies an adjustment amount of 3.1 percent for 2028听
  • Acute Hospital Care at Home waivers through 2030听
  • Low-volume and Medicare-dependent hospital payment adjustments听
  • 罢丑别听1.0 work geographic practice cost index floor used in the calculation of payments under the Medicare physician fee schedule through December 31, 2026听
  • Add-on payments for ambulance services听
  • Continuation of Part D coverage for certain antivirals and modifications to hospice payment caps听

Behavioral Health Policy 

The appropriations bill听was听finalized听as the听administration听听new funding and policy initiatives听to听support behavioral health, crisis services, workforce expansion, and youth mental health鈥攅fforts mirrored in SAMHSA鈥檚 increased appropriations.听

SAMHSA鈥檚 $7.4 billion budget includes: 

  • $1.6 billion听for State Opioid Response grants听
  • $1.01 billion听for the Mental Health Block Grant听
  • $535 million for the 988 Suicide and Crisis Lifeline听

Considerations for Stakeholders 

Federal funding and policy developments affect state budget dynamics as many states are now releasing 2026鈥�2027 budget proposals as well as the operational and growth plans of healthcare organizations and partners. 

A few key takeaways from the FY 2026 funding bill include: 

  • Federal appropriations signal听congressional and听administration priorities and have听downstream听impact on upcoming rounds of grant cycles, including听SAMSHA and HRSA听awards.听
  • The approved funding and certain policy extensions provide operational stability and reduce near-term fiscal pressure, such as the further delay of Medicaid DSH cuts. The extra time will allow healthcare entities to prepare for future reductions and plan for financial sustainability.听
  • Agency and program funding emphasize oversight, program integrity, and听compliance. In addition,听fraud and program integrity听priorities are听woven into听certain听new听policies听and program听extensions,听including听PBM reforms, flexibility for pediatric care across state borders,听and rural maternity cost reporting requirements,听among others.听

Connect with Us 

If you would like deeper analysis or state and stakeholder-specific effects, 黑料不打烊鈥檚 policy experts are available to assist. 

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2026 Marketplace Open Enrollment: Where the Numbers Currently Stand

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On January 28, 2026, the Centers for Medicaid & Medicare Services (CMS) posted a detailing 2026 Open Enrollment (OE) results. Although this report is neither a complete nor final picture of 2026 Marketplace enrollment activity, it is likely to be the last OE data CMS publishes for some time. A comparison of 2026 and 2025 Open Enrollment results can be found in Table 1.

Table 1. Comparison of 2026 and 2025 Open Enrollment

20262025Net Change
Total22,973,21924,166,491(1,193,272)
New Consumers3,382,1893,938,907(556,718)
Returning Consumers19,591,03020,227,584(636,554)

A summary of our analysis on these 2026 OE results and how they compare with 2025 data can be found below. This analysis builds on the findings in Wakely鈥檚 from January 2026.

  • Overall, topline plan selections are down from last year. Total enrollment decreased by 5%, with new enrollment down 14% and renewals down 3%.
  • State-based marketplace (SBM) enrollment declined modestly, but the data are as of January 10, and many SBMs are continuing to enroll people through the end of January.
    • New Mexico plan selections increased by 14% over last year, the largest increase of any state, driven by state-funded subsidies mirroring the expired enhanced premium tax credits (ePTCs).
    • Georgia plan selections decreased by 14%, the largest SBM year-over-year decline.
  • The federally facilitated marketplace (FFM) experienced an overall decrease of 5%. FFM data are as of January 15 and therefore measures plan selections after the OE period has ended. Within the FFM, state-by-state results varied significantly.
    • Texas led all FFM states with a 5% increase, whereas Ohio and North Carolina experienced 20% and 22% decreases in enrollment, respectively.
    • Some of this variation is surprising and not readily explainable from the available data and will be a focus of future 黑料不打烊 and Wakely analyses.
  • The data include neither effectuated enrollment nor paid enrollment鈥攄ata which will be key to fully understanding 2026 enrollment trends and the impact of changing federal policies, including the ePTC expiration and changing eligibility standards introduced in 2026 as the result of P.L. 119-21 (OBBBA).
    • from SBMs suggest significantly higher rates of cancellations and disenrollments than in previous years.
    • SBMs are also sharing that they expect high rates of affordability-driven voluntary and non-payment terminations throughout the first half of 2026.
    • Monitoring paid enrollments, attrition, and grace period dynamics, including retro-terminations, will be key to understanding market dynamics and 2027 pricing.

黑料不打烊 and Wakley experts have considerable experience working with states, insurers, and federal policymakers with jurisdiction over the Marketplace. We work with these entities to inform, analyze, and influence federal policies and conduct impact analyses on pricing, enrollment, administration, and operations. 黑料不打烊 also provides strategic and project management support for the implementation of finalized policies.

Please contact Taylor Gehrke at [email protected], Michael Cohen at [email protected], or Zachary Sherman at [email protected] with questions, follow-up, or if you would like expert assistance exploring any of the issues discussed in this post.

Related Resources:

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CMS ACCESS Model: A New On-Ramp to Outcomes-Based, Tech-Enabled Care in Traditional Medicare

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The Centers for Medicare & Medicaid Services (CMS) Innovation Center recently published applications for its new  (Advancing Chronic Care with Effective, Scalable Solutions), a 10-year voluntary initiative beginning July 2026. The model is designed to advance outcomes-based, technology-enabled care delivery in Original Medicare and aligns with the Innovation Center鈥檚 priorities of strengthening prevention, empowering beneficiaries, and promoting performance-based competition. ACCESS is particularly suited to organizations with mature clinical operations and data infrastructure, offering a new pathway for tech-supported services. 

This article summarizes the model鈥檚 design, highlights key considerations for prospective applicants, and addresses common questions our Medicare and technology experts fielded during a recent Health Management Associates (黑料不打烊)/Leavitt Partners webinar. 

What the ACCESS Model Is Testing 

ACCESS evaluates whether Outcome-Aligned Payments (OAPs)鈥攔ecurring payments contingent on measurable clinical improvement鈥攃an reduce spending while maintaining or improving quality for beneficiaries with chronic conditions. The model tests whether incentivizing technology supported care can produce reliable clinical outcomes while complementing traditional care delivery. 

Who may participate? Organizations must be Medicare Part B鈥揺nrolled providers or suppliers (excluding DMEPOS [Durable Medical Equipment, Prosthetics, Orthotics, and Supplies] and labs). Participants may enroll beneficiaries directly, operate across multiple clinical tracks, and manage all qualifying conditions within each selected track. Beneficiary participation is voluntary, and individuals may switch ACCESS participants every 90 days. 

Clinical tracks. At launch, the four clinical tracks reflect high-prevalence chronic conditions with established care pathways and strong evidence for technology-supported interventions: 

  • Early Cardio-Kidney-Metabolic (eCKM)听
  • Cardio-Kidney-Metabolic (CKM)听
  • Musculoskeletal (MSK)听
  • Behavioral Health (BH)听

Payment. OAPs vary by track and performance period. CMS pays a portion prospectively each quarter and withholds 50 percent pending reconciliation based on: 

  • Clinical outcomes attainment: The percentage of aligned beneficiaries who complete the 12鈥憁onth performance period and achieve track鈥憇pecific clinical targets relative to their baseline.听
  • Substitute鈥憇pend test: Ensures beneficiaries do not receive duplicative听fee-for-service (FFS)听services for conditions managed under ACCESS.听

Technology and data exchange. ACCESS takes a tech-forward approach. Key expectations include use of Fast Healthcare Interoperability Resources (FHIR庐) based Application Programming Interfaces (APIs)鈥痜or eligibility, consent, claims sharing, and care coordination鈥攑art of the broader federal push to modernize the health data ecosystem. CMS also plans to publish a public directory that lists participants, tracks, cost-sharing policies, and risk-adjusted outcomes to enable consumer and clinician choice. 

Regulatory coordination. To complement ACCESS and expand the pipeline of technology-supported interventions, the US Food and Drug Administration鈥檚 (FDA)  (Technology-Enabled Meaningful Patient Outcomes)  allows selected US-based digital health device manufacturers to participate while generating real-world evidence. Up to 40 device manufacturers may participate across clinical areas. 

This coordinated CMSFDA effort is intended to reduce barriers to innovation and accelerate access to safe, effective digital tools that can support chronic disease management. 

Key Considerations for Applicants 

Program integrity and fraud/abuse. CMS has emphasized program integrity across Medicare and Medicaid, and ACCESS reflects that emphasis. Applicants and their parent organizations should expect rigorous screening. Participants must also operationalize controls to pass the substitute spend test and maintain auditable evidence of outcomes and beneficiary consent. 

Overlap with Accountable Care Organizations (ACOs) and other models. Patients may participate in ACCESS and be aligned with an ACO simultaneously; however, 鈥減articipant overlap鈥� raises important operational and financial issues. ACCESS includes an FFS exclusion policy that prohibits participants or affiliated entities from billing Medicare FFS for any services delivered to the same beneficiaries for the duration of their ACCESS episode. As a result, traditional providers, ACO-aligned clinicians, and integrated delivery systems must assess whether they can segment patient populations or if partnering is more feasible. 

Eligibility and clinical scope. ACCESS is focused on relatively stable, chronically ill beneficiaries and excludes those with more acute/severe conditions. Participants must accept responsibility for all qualifying conditions a beneficiary has within a track. 

Outcomes听performance.听罢丑别听ACCESS Model places substantial听emphasis on clinical听performance听and care coordination. Participants听are paid in full only if enough patients hit outcomes targets.听Early cohorts will听likely skew听toward organizations with mature clinical protocols, robust engagement models, and demonstrated outcomes.听Applicants should听be听financially听prepared听to听tolerate withholds, beneficiary switching, and听follow-on听period payment reductions after year one.听

Digital infrastructure and interoperability. ACCESS presumes API-driven data exchange, including consent capture, eligibility checks, claims/clinical data integration, and bidirectional information sharing with the patient鈥檚 broader care team. Applicants should ensure they have a FHIR API server and meet the requirements described in the CMS .

Go-to-market and referral strategy. Beneficiary alignment is voluntary and will be facilitated by CMS鈥檚 planned public directory with risk-adjusted outcomes. Access participants will benefit from strong referral relationships鈥攅specially with ACOs and primary care providers鈥攂oth to enroll eligible beneficiaries and to minimize substitute services. A field strategy grounded in evidence, patient engagement, and interoperability with local providers is critical to success. 

Connect with Us 

 for the first ACCESS Model performance period are due April 1, 2026, with model launch in July 2026; applications submitted later would start January 1, 2027. Because ACCESS is a rolling, decade-long model, some organizations may choose to stage entry. 

ACCESS is the most explicit Innovation Center opportunity to date on outcomes-based, tech-enabled chronic care in Traditional Medicare. It offers digital health and advanced care organizations a direct line to FFS beneficiaries with payment tied to results, not activities. Success will favor teams that combine clinical excellence, consumer-grade engagement, and API-level interoperability, as well as manage program integrity, ACO overlap, and beneficiary churn. 

For questions or support assessing readiness, developing an application, or operationalizing the model, contact Amy Bassano, , or Kate de Lisle. 

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