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Blog

Federal Shifts and the Potential Impacts on Healthcare Quality Oversight

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This week, our In Focus section explores how recent federal shifts—particularly under the Trump Administration—are reshaping healthcare quality oversight. Health Management Associates (HMA) has published several analyses on the 2025 Budget Reconciliation Act (H.R. 1, formerly known as the One Big Beautiful Bill), Title IV of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA), and the 2025 Centers for Medicare & Medicaid Services (CMS) Quality Conference. Together, these federal changes and the policy priority shifts described at the Quality Conference, have implications for monitoring and oversight of healthcare quality for publicly insured, commercially insured, and uninsured individuals.

In this article, HMA experts highlight potential areas for state Medicaid programs, healthcare organizations, and other industry partners to watch for as the rollout of new policies and programs begins to affect programs that monitor quality and creates the imperative to develop new oversight mechanisms.

Overview of Key Federal Policy Shifts

2025 Budget Reconciliation Act/H.R. 1

In July 2025, President Trump signed H.R. 1, the sweeping budget reconciliation legislation that directly affects publicly financed health coverage. Notable policy changes with quality implications include:

  • Mandatory six-month redetermination and community engagement for select populations
  • Stricter rules on healthcare-related provider taxes and state-directed payment policies
  • Elimination of Affordable Care Act (ACA) subsidy eligibility for certain lawfully present immigrants
  • An end to conditional eligibility for ACA subsidies, as well as passive re-enrollment
  • Required compliance with community engagement and work policies

Personal Responsibility and Work Opportunity Reconciliation Act of 1996

On July 10, 2025, the US Department of Health and Human Services (HHS) and other agencies, redefined “federal public benefits” to exclude individuals with “unsatisfactory immigration status” from certain healthcare programs. Examples include Certified Community Behavioral Health Clinics (CCBHCs), Community Health Centers/Federally Qualified Health Centers (FQHCs), grant-funded programs administered by the Substance Abuse and Mental Health Services Administration (SAMHSA), and Title X Family Planning.

2025 CMS Quality Conference

During the 2025 CMS Quality Conference, Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz and senior CMS officials, emphasized CMS’s and HHS’s evolving priorities under the Trump Administration. Notable priorities include empowering patients with data, reducing waste and tackling fraud, focusing on prevention, and transitioning to digital quality measures.

Quality Oversight Impacts

Key impacts on quality monitoring programs resulting from these federal changes and evolving priorities include:

Budget constraints elevate monitoring and value-based care metrics. Reduced Medicaid funding and tighter payment rules heighten the need for real-time monitoring of value-based care metrics to ensure financial sustainability in the changing market, optimize reimbursement.

Enrollment changes challenge quality tracking. Tighter eligibility and enrollment policies are expected to decrease enrollment in Medicaid (particularly among the adult expansion population) and the Affordable Care Act Marketplace program. Frequent redeterminations may cause coverage gaps and churn, distorting quality measure denominators and complicating performance tracking – especially for preventive and chronic care metrics.

Specifically, as the population mix in publicly funded programs changes or as gaps in enrollment exceed the 30‒45-day continuous enrollment criteria for many quality measures, the eligible population/denominators of quality measures will likewise fluctuate. Populations that lose coverage or churn on and off eligibility rolls can result in differential impacts for various quality measures (e.g., healthier individuals losing coverage affects prevention measures more than measures of chronic disease care).

Although performance on value-based care quality measures will have increased importance, the ability to track and trend performance will be increasingly challenging. Healthcare organizations will benefit from forecasting potential changes to patient mix and volume and real-time monitoring and improvement opportunities.

Rise in uncompensated care requires new quality monitoring. H.R. 1 changes that reduce eligibility, paired with PRWORA changes that limit treatment for certain individuals who receive public benefits, are likely to lead to increases in the uninsured population and inhibit access to preventive care. These populations tend to use emergency departments more often for health issues that could have been treated earlier or more effectively in outpatient settings, yet quality oversight is limited for populations that receive care outside of publicly or commercially funded programs. New mechanisms for quality oversight—and funding of those mechanisms—will be needed to monitor the health of these populations.

New programs and priorities warrant updated monitoring. H.R. 1’s Rural Health Transformation Program and CMS’s dual-track quality measurement approach (“treating illness” versus “maintaining health”) necessitate a reevaluation of current metrics and monitoring systems.

Implementation of digital quality measures will support these efforts when fully implemented. The accelerated movement toward digital quality measurement and interoperability may create an imperative for healthcare organizations to make the shift. For example, the transition to digital quality measures will be necessary to ensure real-time oversight and improvement of quality measures, population health analytics, maximizing value-based care payments and efficiencies needed to effectively respond to federal changes. At the same time, healthcare organizations will need strategies to effectively deploy digital quality and interoperability within and across their organizations to not just comply, but to maximize their capabilities.

Connect with Us

HMA works with state agencies, payers, health systems, and providers to assess and implement quality systems, value-based care programs, performance improvement and digital health. To discuss how federal changes will affect your organization’s quality programs, contact our featured experts below.

Blog

Health Tech Ecosystem Leaders to Speak at HMA’s National Conference

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The Trump Administration’s new Health Tech Ecosystem initiative is reshaping how patients and providers access health data, with the bold Kill the Clipboard road map offering a federal blueprint for modernization. At its National Conference being held October 14–16 in New Orleans, Health Management Associates (HMA) is bringing together healthcare leaders to explore how federal policy and industry innovation are driving smarter, more connected care. 

About the Sessions  

  • Driving Digital Health Forward: Federal and Industry Enablers of Smarter, Connected Care 
  • The Digital Health “State of the Art”: Success Stories, Trends and Opportunities 
  • Seizing Disruption to Make a Lasting Impact in Healthcare 

These and other sessions reflect the federal government’s evolving priorities around digital transformation, interoperability, and patient empowerment. The Health Tech Ecosystem initiative and CMS’s Interoperability Framework are setting new expectations for how healthcare organizations manage data, engage patients, and collaborate across sectors 

Featured Digital Healthcare and Innovation Leaders Speaking at the HMA Conference  

Our speakers will unpack the far-reaching impact of these advancements, spotlighting opportunities for smarter data exchange and care coordination in a connected ecosystem. In addition, experts from across the healthcare industry will share practical strategies for advancing digital maturity and overcoming operational challenges, with a focus on improving patient care and organizational efficiency. 

  • Secretary Bruce Greenstein, Louisiana Department of Health  
  • Jaime Bland, DNP, RN, Chief Executive Officer, CyncHealth 
  • Ryan Howells, Principal, Leavitt Partners (an HMA Company) and co-author of Kill the Clipboard 
  • Thomas Keane, MD, MBA, Assistant Secretary for Technology Policy and National Coordinator for Health IT, US Department of Health and Human Services  
  • Martin Lupinetti, President & Chief Executive Officer, HealthShare Exchange 
  • Juan Montanez, MBA, Managing Director, IT Advisory Services, HMA 
  • Curt Schatz, Vice President, Enterprise Clinical Enablement, Optum 
  • Chris Walker, Associate Vice President of Enterprise Transformation-Interoperability, Humana 

Healthcare organizations need to prepare for a future regulatory environment that is significantly more digital, interoperable, and chronic disease–focused. From health plan executives and state Medicaid directors and policy teams, to provider organizations and health IT and digital health innovators, our speakers will discuss what changes are coming  in the digital health space and how you can get your organization ready. Register for the conference today with the code HOTTOPIC25 to receive 20% off the standard conference rate through August. 

Blog

Streamlining Healthcare with AI: The Administration’s Plan and What Comes Next

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On July 23, 2025, the Trump Administration released Winning the Race: America’s AI Action Plan, a comprehensive federal strategy designed to position the United States as the global leader in artificial intelligence (AI). The plan, developed in accordance with Executive Order 14179, outlines over 90 policy initiatives across three strategic pillars: Accelerating Innovation, Building AI Infrastructure, and Leading International AI Diplomacy.

Healthcare and Medicaid Impacts

CMS AI-Enabled Prior Authorization Pilot
The AI Action Plan explains the Centers for Medicare & Medicaid Services (CMS) plan to launch a six-year pilot to improve, streamline, and where possible, automate prior authorizations using AI. Consistent with the AI Action Plan, CMS on June 27, 2025, announced a new Innovation Center model, the Wasteful and Inappropriate Service Reduction (WISeR) Model. WISeR will test ways to improve the prior authorization process relative to Original Medicare’s existing processes. This initiative is expected to dramatically reduce approval times—from days to, potentially, minutes in some cases — while easing administrative burdens for providers and improving access to timely care for beneficiaries. CMS will evaluate the pilot using metrics such as efficiency gains, cost savings, satisfaction levels, and decision accuracy.

Enhanced Fraud Detection and Program Integrity
CMS will also expand its use of AI to detect and prevent fraud, waste, and abuse (FWA) in Medicaid and Medicare. By leveraging predictive analytics and real-time data, the agency aims to identify anomalies and improper payments before they occur—enhancing program integrity and public trust.  CMS is also encouraging state Medicaid agencies to bolster its investments in FWA systems, and enhanced federal funding continues to be available for such investments.

Regulatory Streamlining and Innovation Incentives
The plan calls for removing outdated regulatory barriers to AI adoption in healthcare. Proposed measures include revising compliance requirements and offering financial incentives or preferential funding access to states that foster innovation-friendly environments. While specifics are pending, states are encouraged to modernize regulations to support AI adoption.

Key Differences from Prior Administration’s AI Policy

The following table outlines key differences between the Biden and Trump administrations’ approaches to AI policy:

Considerations for Healthcare Organizations and Partners

Medicaid agencies, healthcare providers, and industry stakeholders should track the next wave of federal actions to implement the AI Action Plan and the healthcare sector’s response. Data from pilot initiatives will inform future federal policy decisions on broader AI deployments within Medicaid administration. In addition, healthcare organizations will need to remain nimble as variability may emerge in how states pursue regulatory changes to align with federal incentives under the Action Plan.

Sector specific considerations include:

Health Plans:  Plans should proactively pursue initiatives such as AI-driven prior authorization, claims adjudication, fraud detection, and member engagement to improve their operations, their position in the markets in which they operate, and ideally, their performance. This effort will require significant investments in information technology, new workflows, and continuous quality improvement initiatives, staff training, enhanced compliance protocols, and a culture that embraces AI. In addition, plans must implement robust AI oversight mechanisms that incorporate the necessary level of transparency, avoid bias, and are appropriate across all functions that use AI, including population health analytics, member engagement, care management, prior authorization management, claims processing, and fraud detection.

State Government: States will face pressure to modernize health and human services regulatory frameworks to align with federal requirements and access federal incentives. Moreover, states should proactively pursue initiatives that improve the operations of health and human services agencies with a particular focus on improving program design, oversight, and evaluation functions. In addition, agencies should assess current rules regarding AI and consider how to support AI adoption while safeguarding desired outcomes and accountability.

Health Systems and Providers: Providers can benefit from reduced administrative overhead, improved care delivery, and the use of AI to augment the ability of providers to diagnose and treat patients. Providers will have to adapt to new workflows that incorporate use of AI, ensure data quality, and monitor data for unintended consequences such as unintended bias. In addition, providers must incorporate AI literacy training to align with federal expectations and remain competitive in a deregulated, innovation-driven landscape. Providers will also have to implement robust compliance protocols.

Looking Ahead

The AI Action Plan signals a substantial shift toward streamlined regulatory approaches and expanded AI deployment in Medicaid and broader healthcare administration. Stakeholders should anticipate federal guidance updates, pilot program evaluations, and further clarifications regarding state incentives in the months ahead.

To discuss the implications of the AI Action Plan or for further policy analysis, contact Health Management Associates experts below.

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CMS and Tech Leaders Unite to Build a Patient-Centric Digital Health Ecosystem

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The White House and Centers for Medicare & Medicaid Services (CMS), on July 30, 2025, announced new commitments from leading technology firms—including Amazon, Apple, Google, OpenAI, and Anthropic—to create a smarter, more secure, and patient-centered digital health ecosystem. At the Make Health Tech Great Again event, CMS unveiled voluntary criteria for trusted data exchange across networks, electronic health records (EHR), and tech platforms, emphasizing interoperability, personalized tools, and reduced provider burden.

This announcement echoes many of the priorities laid out in Leavitt Partners’ Kill the Clipboard road map—a federal policy and industry blueprint for modernizing patient and provider access to health data. The priorities outlined at today’s White House event and the administration’s recent regulatory announcements closely reflect the multisector road map’s recommendations. A recent webinar hosted by Leavitt Partners, an HMA Company, explored how the recommendations are shaping federal policy and creating strategic opportunities for early adopters.

What’s Next

Health Management Associates (HMA) experts, including those with Leavitt Partners, will delve further into the new initiative and considerations for the healthcare industry in an upcoming Weekly Roundup.

Blog

HHS Issues Immediate Policy Shift on Federal Benefit Eligibility Under PRWORA

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On July 10, 2025, the US Department of Health and Human Services (HHS), Department of Labor, Department of Justice, Department of Education, and US Department of Agriculture (USDA) issued notices that significantly reinterpret the definition of “federal public benefit” used in Title IV of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA). These changes are effective immediately upon publication in the Federal Register, though agencies have opened 30-day public comment periods to solicit feedback.

In this article, Health Management Associates (HMA) experts explain two of these notices—those from HHS and USDA—based on what we know and outstanding issues that organizations should expect to arise in the coming months.

Programs Affected by HHS’s Revised Interpretation

The notice changes HHS’s 1998 interpretation of PRWORA and will have sweeping implications for service delivery across the country. It does this by reversing the classification of many long-standing programs to be “Federal public benefits;” until now, these programs had been specifically excluded from that definition. People with Unsatisfactory Immigration Status are not permitted to access these benefits. People classified as such include those who are undocumented, but also several categories of people lawfully in the United States, such as holders of H1B and J-1 visas, as well as some lawful permanent residents (green card holders — only for the purposes of eligibility for certain programs).

Programs newly subject to these restrictions include:

  • Head Start
  • Certified Community Behavioral Health Clinics (CCBHCs)
  • Community Mental Health Services Block Grant
  • Community Services Block Grant (CSBG)
  • Health Center Program (Community Health Centers/FQHCs)
  • Health Workforce Programs (including grants, loans, scholarships, and loan repayments)
  • Services administered by the Substance Abuse and Mental Health Services Administration (SAMHSA)
  • Title IV-E programs (Educational and Training Voucher Program, Kinship Guardianship Assistance Program and Prevention Services Program)
  • Title X Family Planning

Organizations that receive federal or pass-through federal funding may now be required to assess immigration status as a condition of service delivery—something many have never done before. This shift raises significant operational, ethical, and mission-aligned challenges for hospitals, community health centers, behavioral health providers, and human services organizations. PRWORA does include language exempting 501(c)(3) charitable organizations from being required to verify immigration status, but as the administration notes in its announcement, they are not barred from doing so. This will be an area to watch.

USDA Interpretation

The USDA’s notice similarly identifies all 16 programs the Food and Nutrition Services (FNS) administers as meeting the definition of “Federal public benefit” used in Title IV of PRWORA. These programs include:

  • Supplemental Nutrition Assistance Program (SNAP)
  • Nutrition Assistance Program for Territories
  • Food Distribution Program on Indian Reservations (FDPIR)
  • Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
  • National School Lunch Program, School Breakfast Program, and Summer Food Service Program
  • Child and Adult Care Food Program

The notice, however, states that there is a difference between defining a program as a federal public benefit and applying other provisions of PRWORA to those programs. The USDA’s notice clarifies that providers of non-exempt benefits must verify that applicants have a qualified immigration status for purposes of PRWORA but does not address how verification should be implemented or how exceptions should be applied.

What We Know—and Don’t Know

Though the list of affected programs is extensive, many critical implementation details remain uncertain. Both agencies acknowledge that further guidance will be needed to clarify how these changes will be operationalized.

Organizations should expect additional updates and further clarifications from federal agencies in the coming months. Legal challenges to these changes are almost certainly forthcoming.

Looking Ahead

These policy changes are both significant and still evolving. They will affect how and where services are delivered, as well as whether people choose to access the services at all.

During this period of uncertainty, frequent and transparent communication is essential. Deploy information and updates in multiple formats —written, verbal, visual—to reach diverse audiences, including your organization’s staff and other stakeholders in your community. When policy is fluid and changing rapidly, authentic messaging about what is known and what remains unclear will position your organization as an honest broker and trusted partner.

HMA experts are tracking these and related developments. For questions and to discuss the impact of these policies on your organization, contact our featured experts below.

Blog

H.R. 1 Signed Into Law—What It Means for Medicaid and Public Coverage

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Just one week after we reviewed the Senate’s version of the budget reconciliation bill, H.R. 1, President Trump has now signed the legislation into law. The final iteration of H.R. 1 includes sweeping changes to Medicaid, the Affordable Care Act (ACA) Marketplaces, and Medicare—several of which diverge significantly from the version that the House passed May 22, 2025.

This update outlines many of the most consequential healthcare provisions, with a focus on Medicaid financing, eligibility, and operational impacts. It also highlights how stakeholders can act now to prepare for what happens next.

From Proposal to Policy: What Changed

The Senate’s amended version of H.R. 1, approved on July 1 and passed by the House on July 3, 2025, reshaped several key provisions in the earlier version of the House bill. Although the bill retains its core focus on tax policy and entitlement reforms, it further constrains state Medicaid financing and eligibility and scales back Marketplace subsidies for certain populations.

According to preliminary analysis from the Congressional Budget Office, the final bill will reduce federal healthcare spending by approximately $1.15 trillion over the next decade but also will increase the number of uninsured individuals by 11.8 million by 2034 because of changes to both Medicaid and Marketplace programs.

Medicaid Eligibility: A New Era of Policy and Operational Complexity

Mandatory Community Engagement Requirements

By December 31, 2026, states must implement community engagement (work) requirements for certain Medicaid enrollees. These requirements cannot be waived under Section 1115, though states may request “good faith” exemptions through 2028.

States must notify enrollees through multiple channels and develop the infrastructure needed to track compliance. Managed care organizations and other entities that have financial relationships with Medicaid services are prohibited from determining compliance.

Tighter Eligibility and Redetermination Requirements

States must now conduct Medicaid eligibility redeterminations every six months for expansion populations. The bill also delays implementation of previously finalized rules that would have streamlined enrollment and imposes new verification requirements, including address checks. For immigrants, H.R. 1 narrows the definition of “qualified” individuals who are eligible for Medicaid and CHIP, removing coverage for refugees, asylees, and other humanitarian categories.

Cost Sharing for Expansion Adults

Starting in 2028, states must apply cost-sharing requirements to Medicaid expansion adults with incomes greater than 100 percent of the federal poverty level. Though primary care, mental health, and certain other services are exempt, the policy introduces new administrative burdens for states and many providers.

Medicaid Financing: A Structural Shift

Provider Tax Restrictions

H.R. 1 freezes existing provider tax programs and bars any new taxes. Also, Medicaid expansion states must phase down the maximum allowable tax rate from 6 percent to 3.5 percent by 2032. This change will significantly constrain states’ ability to use provider taxes to finance Medicaid and draw down federal matching funds.

Limits on State-Directed Payments

The bill caps state-directed payments at either 100 percent or 110 percent of Medicare rates, depending on the state’s expansion status. Grandfathered payment arrangements will be phased down by 10 percent annually beginning in 2028. These provisions will require states to reassess supplemental payment strategies and may affect provider participation and access to care.

Other Key Provisions

The Rural Health Transformation Program provides $50 billion over five years to support financially distressed rural providers. H.R. 1 requires that each state submit a plan, and the Centers for Medicare & Medicaid Services (CMS) administrator must approve or deny the plan by December 31, 2025, giving CMS and the US Department of Health and Human Services significant authority to shape the approval/denial processes, as well as critical details of the program and funding decisions.

For the Marketplace, the law eliminates ACA subsidy eligibility for certain lawfully present immigrants, ends conditional eligibility for ACA subsidies as well as passive re-enrollment, and eliminates the cap on ACA subsidy repayment at tax time. It also prohibits individuals who are not enrolled in Medicaid because of a failure to satisfy community engagement requirements from receiving any subsidies.

In addition, a new 1915(c) waiver option allows states to offer home and community-based services (HCBS) without requiring that they provide institutional level of care but only if waiting lists for existing services are not extended. Another provision excludes family planning and abortion service providers from receiving Medicaid funding if they received at least $800,000 in Medicaid reimbursements in 2023.

Finally, the law includes a one-year, 2.5 percent increase to the Medicare physician fee schedule conversion factor, which will be in effect for calendar year 2026 and expire thereafter.

What Stakeholders Should Do Now

States can begin planning for eligibility system changes, redetermination volume, and community engagement implementation, all of which require an understanding of the potential interactions of the federal Medicaid, Medicare, and ACA Marketplace policy changes. In addition, state officials should consider reassessing provider tax structures and supplemental payment strategies, where applicable. They need to engage early on rural health transformation funding opportunities and other provider supports.

Health plans can forecast enrollment and risk mix changes. They have opportunities to support states in compliance efforts to avoid federal funding recoupments. In addition, plans must prepare for new administrative requirements related to cost sharing and work requirements, among other policy changes on the horizon. Consumer communications should also be a focus area.

Providers and community-based organizations will need to prepare for greater uncompensated care needs and costs, which can lead to potential revenue loss, as well as new reporting and program integrity expectations. They also will play an integral role in assisting patients in maintaining coverage and navigating new requirements.

Vendors and health information exchanges have several opportunities to support the implementation of new requirements in H.R. 1 alongside the changing regulatory priorities. Examples include reviewing system capabilities to support new eligibility, verification, and reporting requirements and coordinating with states to ensure smooth implementation and program integrity.

Looking Ahead

The passage of H.R. 1 marks a turning point in federal health policy. Although the law’s fiscal goals are clear, its operational impacts will unfold over the coming months and years. States, plans, providers, and community organizations must now pivot from policy analysis to implementation readiness.

HMA will continue to monitor federal guidance, state responses, and stakeholder strategies. For more detailed analysis or support with scenario planning, contact our experts below.

Blog

What the Senate’s Budget Approval Means for the Future

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On July 1, 2025, the US Senate voted 51–50, to advance its version of H.R. 1, continuing the budget reconciliation process. Like the bill that the House passed in May, the Senate language calls for making significant changes to the Medicare, Medicaid, Affordable Care Act (ACA) Marketplace programs, as well as health savings accounts (HSAs) and publicly funded programs such as the Supplemental Nutrition Assistance Program.

Relative to the House bill, however, the Senate differs substantially in approach and scope. Thus, the bill has been sent back to the House for consideration. Speaker of the House Mike Johnson (R-LA) intends to accelerate voting with the goal of clearing the legislation in the House by July 4, 2025.

Key Differences Between House and Senate Bills

Notable differences between the House and Senate packages pertain to the following:

  • Medicaid Provider Payments: The Senate version includes more restrictive changes to federal Medicaid provider taxes and state-directed payment policies. These changes are expected to affect hospitals that rely on Medicaid supplemental payments. The Senate bill also would create a $50 billion Rural Health Transformation Program to mitigate financial strain on healthcare providers in rural communities. The provision includes several stipulations regarding distributions, allocations, eligibility standards, and permissible uses of the funds, which will likely prompt considerable ongoing engagement from stakeholders if signed into law, particularly among hospitals and clinics that will face substantial headwinds under other components of the legislation.
  • ACA Marketplaces: Like the House bill, the Senate version includes provisions to recapture full ACA subsidy amounts, restrict subsidy eligibility for certain immigrant populations, and require verification of ACA subsidy eligibility. The Senate bill neither appropriates funding for cost sharing reduction subsidies nor includes provisions regarding the Marketplace Integrity and Affordability rule, which the Centers for Medicare & Medicaid Services (CMS) finalized on June 20, 2025. In addition, the Senate bill offers several smaller flexibilities intended to increase usage of HSAs but does not include the full suite of HSA changes included in the House bill. The Senate language also does not call for expanding individual coverage health reimbursement arrangements (ICHRAs).
  • More Limited Medicare Package: Although the Senate language restores the ORPHAN Cures Act and adds a modest one-year payment increase under the Medicare Physician Fee Schedule (PFS), the bill omits a number of significant Medicare policies included in the House version, including a much broader PFS investment tied to the Medicare Economic Index, as well as multiple pharmacy benefit manager (PBM) reforms under Medicare Part D. The Senate legislation also excludes two Medicaid PBM provisions that the House had included.

Estimates from the Congressional Budget Office

The Congressional Budget Office (CBO) has provided several estimates of the cost and coverage impacts of the healthcare and tax provisions in multiple versions of the reconciliation legislation. CBO has provided cost estimates for the House-passed bill, as well as the Senate substitute amendment, but has yet to release information on the final Senate version. Of note, CBO estimated the following:

  • The Medicaid, Medicare, and ACA related provisions in the Senate substitute amendment would reduce healthcare spending by approximately $1.15 trillion over the next 10 years.
  • The House bill would, by 2034, add 10.9 million people to the number of uninsured individuals in the United States.

What to Watch

Stakeholders should plan for the financial, policy, and operational impacts of the many provisions that could be enacted, including:

  • New administrative requirements for enrollment that will place additional obligations on individuals seeking coverage and which will require more state resources to implement and manage. Community engagement and work requirements are scheduled to take effect December 31, 2026.
  • Downward Medicaid financial pressures due to fewer federal funds, which will stress state budgets and states’ ability to maintain existing programs. This situation could lead some states to scale back eligibility for Medicaid, limitenrollment for optional programs, or some combination of these. Additionally, states could be expected to address increases in uncompensated care among their providers.
  • A pause on implementation of previously finalized regulations that streamlined the Medicaid enrollment process for individuals.

The combination of the House and Senate reconciliation bills and the recently finalized Marketplace Program Integrity and Affordability rule indicate an uncertain future for cost sharing subsides and enhanced premium tax credits in Marketplace programs. Healthcare stakeholders should prepare for the impact of the expiration of the enhanced premium tax credits would have on benefit packages, enrollee risk profiles, uncompensated care, and other key issues affecting access, cost, and outcomes.

Connect with Us

To learn more about the these policy changes and the impact on your organization, contact our featured experts below.

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CSR Funding, Budget Debates, and the Future of Marketplace Affordability

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In May 2025, the US House of Representatives passed a budget bill that includes funding for cost-sharing reduction (CSR) payments, marking a potential end to the “silver loading” practice that has shaped pricing in the Affordable Care Act (ACA) Marketplace pricing since 2017. The US Senate is now considering this legislation as part of a broader budget reconciliation package that includes major Medicaid reforms, such as new work requirements and changes to eligibility and financing rules.

This evolving policy landscape has significant implications for states, payers, providers, and consumers. Wakely, an HMA Company, recently published Implications of Ending Silver-Loading on the Individual Market, which outlines how reinstating CSR payments could reshape ACA marketplace plan pricing, enrollment patterns, and federal subsidy flows. It also highlights the operational and financial risks stakeholders must prepare for in 2026.

Broad Loading and Silver Loading

Because CSR loading increases premium costs on silver plans that determine subsidies, they also increase federal payments for premium tax credit (PTC) subsidies. Guidance from the US Department of Health and Human Services on silver plan pricing has evolved over time. Three types of CSR loading are occurring in ACA markets, specifically:

  • Broad loading: Increasing premiums for all metal level qualified health plans (QHPs) in the individual market to collect enough revenue to offset the CSR costs of the silver plan variants enrollees
  • Two means of silver loading:
    • Increasing premiums for only silver QHPs in the individual market to collect enough revenue to offset the CSR costs of the silver plan variant enrollees
    • Raising premiums, functionally, for only on-exchange silver QHPs

As discussed in the Wakely paper, the impact of silver loading is that the federal government is likely paying out more in additional PTC subsidies than would be paid if CSR payments were fully funded. On Friday, May 2, 2025, the Centers for Medicare & Medicaid Services (CMS) released guidance related to silver loading and CSR payments for 2026 rate filings. This action was urgently needed, especially for states with May filing deadlines.

What’s at Stake

If Congress does appropriate funding for CSR payments, some issuers will be reimbursed for the difference in cost sharing between standard and CSR-enhanced silver plans. Issuers that cover nonemergency pregnancy termination services, would be ineligible for CSR payments; however, as the Wakely paper indicates, these payments would not cover the additional utilization driven by richer benefits. For example, it is anticipated that a member in a 94 percent actuarial value CSR plan will use more services (i.e., four primary care visits versus three in a standard plan), but reimbursement would only reflect the cost-sharing difference—not the increased volume of care.

States like Georgia and New Mexico, which mandate silver loading, could see significant shifts in premium relativities and enrollment behavior. Wakely’s modeling suggests that changes in CSR policy—especially if paired with the expiration of enhanced premium subsidies at the end of 2025—could lead to higher net premiums, reduced enrollment, and a deterioration in risk pool morbidity.

What to Watch

The Senate’s deliberations will determine whether CSR funding is restored and could have significant implications on whether enhanced premium subsidies are extended beyond 2025. These decisions will directly affect the following:

  • 2026 rate filings and benefit designs
  • Marketplace affordability and enrollment stability
  • State reinsurance funding and 1332 waiver dynamics
  • Consumer costs and plan switching behavior

Wakely’s analysis also cautions that if CSR funding is restored without accounting for induced utilization, issuers may still need to price for higher service use—potentially leading to premium volatility. In addition, if broad loading is mandated instead of silver loading, it could raise premiums across all metal tiers and reduce the value of premium tax credits for many enrollees.

Key Considerations for Stakeholders

  • States should assess how CSR policy changes affect reinsurance programs, waiver funding, and Medicaid redeterminations.
  • Payers must prepare for multiple pricing scenarios and evaluate how changes in subsidy structures influence enrollment and risk adjustment, 1332 reinsurance programs, and overall market risk.
  • Providers should anticipate shifts in patient mix and utilization (i.e., more uncompensated care with more uninsured patients).
  • Advocates need to monitor how policy changes affect access and affordability for low-income and underserved populations.

These developments also create more opportunities for movement between Medicaid, Marketplace, and uninsured populations, underscoring renewed opportunity for integrated eligibility systems and coordinated outreach.

Connect with Us

Health Management Associates (HMA), experts are actively advising stakeholders on how to navigate these complex changes. Whether you’re a state policymaker, health plan executive, provider leader, or advocate, we can help you assess the impact and plan strategically.

These issues will also be explored in depth at the HMA Conference in October 2025. To discuss how these developments will affect your organization, contact our featured expert below.

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Evolving Medicaid Work Requirement Policies: Essential State Actions to Prepare

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On May 22, 2025, the US House of Representatives advanced a comprehensive legislative package that includes expansive changes to healthcare spending and tax policies. The One Big Beautiful Bill Act, H.R. 1, will be subject to further revision in the Senate – and potentially again in the House – before it can be sent to the president for his signature. If enacted, the legislation would have significant implications for the Medicaid program, including a nationwide work and community engagement requirement. The House-passed bill establishes a deadline of December 31, 2026, for implementation, but individual states could move earlier.

As state legislatures pass work requirement bills, governors consider executive actions, and Congress contemplates revisions to the Medicaid work mandate, vetting key implementation issues may significantly affect the direction of related policies. Even before implementation, states must test operations, enable systems, and establish connections to beneficiaries to reduce potential implementation missteps, inappropriate disenrollments, and litigation risks.

If the goal of Medicaid work requirement policies is to stimulate connections between health benefits and employment/workforce, building state and federal capacities to support these approaches is critical to effectuating that change. In the remainder of this article, Health Management Associates (HMA), experts focus on the operational dynamics that need to be discussed, tested, and built as states begin introducing work and community engagement initiatives.

Federal Policies and Early State Actions on Work Requirements

The House bill would require all states to implement work and community engagement requirements for adults without dependents for at least 80 hours per month.[1] Employment, work programs, education, or community service (or a combination of those activities) would satisfy the requirement.

The work requirements in the House-passed legislation would apply only to individuals between the ages of 19 and 64 without dependents, and the following groups are exempted:

  • Women who are pregnant or entitled to postpartum medical assistance
  • Members of Tribes
  • Individuals who are medically frail (i.e., people who are blind, disabled, with chronic substance use disorder, has serious or complex medical conditions, or others as approved by the Secretary of the US Department of Health and Human Services)
  • Parents of dependent children or family caregivers to individuals with disabilities
  • Veterans
  • People who are participating in a drug or alcoholic treatment and rehabilitation program
  • Individuals who are incarcerated or have been released from incarceration in the past 90 days

In addition, individuals who already meet work requirements through other programs, such as Temporary Assistance for Needy Families (TANF) or the Supplemental Nutrition Assistance Program (SNAP), would be exempt. However, the House-passed version would make the eligibility verification and work requirements for SNAP more stringent and shift program costs to these states, which would affect cross-functional eligibility. The legislation also includes temporary hardship waivers for natural disasters and areas with an unemployment rate greater than 8 percent (150 percent of the national average).

Though the federal budget package has received a great deal of attention, at least 14 states already have moved forward (see Table 1) in advance of the current federal debate by passing laws and submitting work requirement demonstration requests to the Centers for Medicare & Medicaid Services (CMS).

Table 1. A Review of 2025 States’ Approaches to Work Requirements in Medicaid

StatusStatePopulation CriteriaRequirementsExemptions/ NotesPublic Comment
Work Requirement Request SubmittedArizonaAges 19−5580 hours/monthMultiple exemptions; 5-year lifetime limitClosed
Work Requirement Request SubmittedArkansasAges 19−64; covered by a qualified health plan (QHP)Data matching to assess whether on track/not on trackNo exemptionsClosed
Work Requirement Amendment Request SubmittedGeorgiaAges 19−64; 0-100% FPL80 hours/monthAlready has approval but is requesting reporting be changed from monthly to annually and adding more qualifying activitiesFederal comment period open through June 1, 2025
Work Requirement Request SubmittedOhioAges 19−54; expansion adultsUnspecified hoursLimited list of exemptionsClosed
Legislation PassedIdahoAges 19−6420 hours/week requiredLimited list of exemptions
Legislation PassedIndianaAges 19−64; expansion adults20 hours/week requiredLimited list of exemptions
Legislation PassedMontanaAges 19−5580 hours/month requiredMultiple exemptions
Ballot Initiative PassedSouth DakotaExpansion adults2024 ballot initiative asking voters for approval for state to impose work requirements for expansion adults passed
Legislation PendingNorth CarolinaPursue requirements that are CMS approvable
Work Requirement Request DraftIowaAges 19−64; expansion adults100 hours/month requiredLimited list of exemptions Separate bill would end expansion if work requirements are withdrawn/ prohibited (80 hr./mo.)Closed
Work Requirement Request DraftKentuckyAges 19−60; no dependents; enrolled more than 12 monthsConnected to employment resourcesMultiple exemptionsState comment period open through June 12, 2025
Work Requirement Request DraftSouth CarolinaAges 19−64; 67%−100% FPLSpecified activities (work specific is 80 hours/month)Limiting participation to 11,400 individuals based upon available state fundingState comment period open through May 31, 2025
Work Requirement Request DraftUtahExpansion adults ages 19−59Register for work, complete an employment training assessment and assigned job training, and apply to jobs with at least 48 employers within 3 months of enrollmentSeveral exemptions, largely aligned with federal SNAP exemptionsState comment period open through May 22, 2025
Anticipated Waiver RequestAlabamaNon-expansion populationPotential to resubmit previous work requirement demonstration request

Key Questions to Guide State Policy Decisions

Considerable research and findings from previous Medicaid work requirement initiatives can help prepare policymakers to implement a potential new phase of Medicaid work requirement policies. Some previous findings include the high cost of administration relative to potential savings, the importance of systems that support foundational items like logging an enrollee’s compliance activities and exemptions, as well as developing an efficient appeals process. The Medicaid and CHIP Payment and Access Commission (MACPAC), General Accounting Office, National Institutes for Health, and multiple researchers have published assessments regarding previous experiences that could prove useful in policy making.

HMA experts have experience identifying key issues and considerations, analyzing options, and implementing critical issues and for state leaders and stakeholders who will be responsible for implementing work requirements. Several of these issues are described below and in more detail in the HMA blog, Building State Capacities for Medicaid Work and Community Engagement Requirements.

  • Exemptions, particularly medical frailty definitions and assessments. The federal government and states will need to identify individuals classified as “medically frail” and make them exempt from the mandates. Medically frail individuals include those with chronic, serious, or complex medical conditions. Various methods can be employed to identify these people.
  • Developing and streamlining systems and processes to promote continued coverage for eligible individuals. The Medicaid unwinding from the COVID public health emergency taught policymakers lessons about the complexities of Medicaid systems, patient engagement, and reliable methods of member outreach. State Workforce Commissions and Departments of Labor are clear partners, as they manage integrated eligibility systems and data-sharing agreements across programs like SNAP and TANF, which also serve many Medicaid participants. These and other partnerships will need further exploration.
  • Clinical and utilization data that promote eligibility assessment. Many, but not all, individuals with chronic diseases may be exempt from the requirements. Knowing the health status and chronic conditions of the populations affected and the conditions that qualify people for exemption are variables as implementation questions, like the definition of medically frail, are addressed.
  • Anticipated need for effective Medicaid managed care engagement in work requirements/community engagement initiatives. Approximately 80 percent of Medicaid expansion enrollees are members of comprehensive managed care organizations (MCOs). States will need to review the scope of existing vendor contracts as well as determine the need for new services, roles, third-party reporting, oversight, and potential exemptions for emergencies. Work requirements can disrupt MCO risk pool stability and care coordination. MCOs have a financial incentive to drive down inappropriate disenrollments and are uniquely positioned to support state responsibilities, including maintenance of up-to-date contact information.
  • Measuring impact and adapting policies as needed. Dynamic metrics that provide actionable information to federal and state policy makers will support effective oversight and monitoring.

Connect with Us

HMA helps stakeholders—including state agencies and their partners—manage the challenges of implementing new Medicaid or CHIP initiatives, with a focus on ensuring efficient integration and improvements in outcomes. Our teams are adept at developing materials for and supporting stakeholder engagement from design to implementation, which is a critical aspect for work and community engagement initiatives and other potential new eligibility and renewal requirements.

For support tracking federal and state level developments and enhancing your organization’s strategy and preparations for new Medicaid requirements, contact our featured experts below.

[1] U.S. Congress. House. One Big Beautiful Bill Act. H.R.1. 119th Cong., 1st sess. Introduced May 20, 2025.

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CMS Seeks Input on the Future of Digital Health: What the Health Technology Ecosystem RFI Means for Stakeholders

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This week, in our In Focus section, health IT experts at Leavitt Partners, an HMA Company, review the recently released Request for Information (RFI) from the Centers for Medicare & Medicaid Services (CMS) and the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health (ASTP/ONC), titled Health Technology Ecosystem (CMS-0042-NC). The RFI, published May 16, 2025, signals a renewed federal focus on advancing digital health tools, improving data interoperability, and supporting patient-centered innovation.

Notably, this RFI aligns with the vision laid out in Leavitt Partners’ Kill the Clipboard policy blueprint, developed in collaboration with a broad coalition of healthcare stakeholders. The paper outlines a future in which patients and providers benefit from seamless digital experiences, real-time data exchange, and reduced administrative burden. The RFI reflects many of the same priorities—such as expanding FHIR® Application Programming Interfaces (APIs), improving provider directories, and promoting digital identity solutions—that were highlighted in the paper as essential to modernizing the healthcare system.

Why This RFI Matters

The RFI invites public input on how CMS and ASTP/ONC can strengthen the digital health ecosystem for Medicare beneficiaries. It builds on years of federal investment in interoperability. The agencies are now seeking feedback on how to reduce barriers to data access, promote innovation in digital health products, and align technology with value-based care goals.

This is a pivotal opportunity for stakeholders to shape the future of digital health policy—especially as CMS continues to explore how APIs, digital identity, and patient-facing tools can improve care delivery and outcomes.

Key Themes in the RFI

The RFI is broad in scope, but several themes stand out, including:

  • Addressing Patient and Caregiver Needs: The RFI asks patients which digital tools would be most helpful to them and their caregivers in managing their health needs, navigating care, and accessing all relevant health information in one place. It asks what features are most needed, what is missing from current apps, and how CMS can support adoption, especially for Medicare beneficiaries with limited digital experience. CMS is exploring how to make more data—beyond claims and clinical data—available through APIs. It also explores the role that CMS should play in reviewing and measuring the real-world impact of these tools on outcomes and costs. They also are considering how to promote the use of secure, standardized digital identity credentials (e.g., Login.gov, ID.me) to streamline patient access. Feedback also is sought on how TEFCA, FHIR APIs, and health information exchanges (HIEs) can better support seamless data exchange.
  • Provider Adoption of Digital Health Tools: CMS is exploring how to help providers, especially those in rural areas, adopt digital health tools by addressing barriers like workflow integration, data access, and interoperability. CMS is also looking to improve administrative functions like scheduling and intake through third-party apps. In addition, CMS is seeking to understand which FHIR APIs and capabilities are already being supported or utilized in provider systems. They are also interested in understanding how providers might accept standardized digital identity credentials from patients and any challenges that might inhibit its adoption. ASTP/ONC is also seeking information on revisions to the information blocking requirements.
  • Engaging Payers: The RFI invites payers to share how they can support interoperability and digital innovation, including through the use of APIs, digital identity credentials, and real-time access to clinical quality data. CMS is also interested in how payers can reduce provider burden, support value-based care (VBC), and contribute to a more connected digital health infrastructure. Feedback is requested on TEFCA participation, payer-to-payer data exchange, and the potential for a nationwide provider directory.
  • Advancing VBC Organizations: The RFI emphasizes the role of digital health in supporting alternative payment models (APMs) and accountable care organizations. CMS is seeking feedback on which digital capabilities are most essential for success in VBC—such as care coordination, quality measurement, and patient engagement—and how certification criteria and data standards can better align with these needs. The agencies are also exploring how to reduce complexity for APM participants while maintaining flexibility and data access.
  • Enabling Technology Vendors, Data Providers, and Networks: The RFI requests feedback from developers, data aggregators, and HIEs on how to unlock innovation through better access to CMS data, improved API standards, and streamlined certification processes. The RFI asks which technical and policy changes would enable more effective digital health products, recommendations to improve interoperability across networks, and means of supporting the viability of data exchange infrastructure.

Implications for Stakeholders

This RFI is more than a technical exercise; it is a strategic signal. The Trump Administration is maintaining momentum behind VBC and digital transformation. Stakeholders should consider:

  • Submitting comments to CMS by the June 16, 2025, deadline.
  • Assessing internal readiness to adopt or develop digital tools that align with CMS’s vision.
  • Engaging in policy discussions regarding digital identity, data standards, and patient access.
  • Monitoring related RFIs, including the Food and Drug Administration RFI exploring the potential use of HL7 FHIR standards to support the submission of study data derived from real-world data sources—such as electronic health records, claims, and registries—for regulatory purposes.

Next Steps

Health Management Associates, Inc. (HMA), encourages healthcare organizations to review the RFI and consider how their experiences, innovations, and challenges can inform CMS’s next steps. This is a rare opportunity to influence the infrastructure that will shape digital healthcare for years to come.

For support in drafting comments or understanding how this RFI intersects with your organization’s strategy, contact our Leavitt Partners health IT experts below.

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CMS Announces New Innovation Agenda: Here’s What You Need to Know

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On May 13, 2025, the Centers for Medicare & Medicaid Services (CMS) published its new strategic direction for the CMS Innovation Center. The strategy builds on the lessons of the first 15 years of the Innovation Center, while presenting a significant pivot in policy direction, which emphasizes evidence-based prevention, consumer engagement, and tech-enabled care, while prioritizing financial performance over broad participation.

The new strategy provides high-level direction on the Trump Administration’s vision for the next phase of value-based payment reform under the leadership of CMS Administrator Dr. Mehmet Oz and Innovation Center Director Abe Sutton. They intend to “double down on our commitment to value-based care and take the learnings from the[se] previous investments to build a health system that empowers people to drive and achieve their health goals and Make America Healthy Again.” Notably, the strategy also aligns with goals central to the Trump Administration’s Make America Healthy Again initiative.

This new direction affirms the administration’s commitment to continue advancing value-based care and opens additional opportunities for organizations seeking to enhance the delivery of services that drive positive outcomes. Health Management Associates (HMA), experts will be tracking the implementation of the Innovation Center’s new strategy, including expected forthcoming models, movement toward greater levels of downside risk, and changes to existing models to align with the administration’s priorities. In this article, our experts review the strategy and provide insights on key takeaways for stakeholders.

New Strategy Overview

CMS leaders view the Innovation Center agenda as a framework for accelerating healthy behaviors, leveraging the agency’s authority to test new approaches designed to incentivize and engage stakeholders. According to CMS officials, the Innovation Center “will work expeditiously toward the future of health—building a system in which people are empowered to achieve their health goals and providers are incentivized to compete to deliver high-quality, efficient care and improve the health outcomes of their patients.”

The strategy has three interrelated, foundational pillars:

  • Promoting evidence-based prevention
  • Empowering people to achieve their health goals
  • Driving choice and competition.

Table 1 provides more detail on each pillar.

In addition to the new agenda, CMS released a request for information (RFI) seeking industry input on strategies that can better leverage data and technology to empower consumers. The focus of the RFI aligns with the Innovation Center’s strategic pillars to use tools, information, and processes that better connect people to their health data and allow them to make informed health decisions alongside their providers.

Table 1. CMMI’s Interrelated Strategic Pillars

Takeaways and Considerations

Critical to CMS’s approach is the belief that empowering individuals to make their health decisions—through incentives, better data access, and more flexible options—can lead to better health outcomes and lower overall costs. This shift reflects an evolution in healthcare policy that places greater emphasis on personal accountability and private sector collaboration—a key theme that is emerging across the administration’s policy initiatives.

Consumer Engagement. One of the most notable aspects of the new Innovation Center strategy is the promotion of consumer engagement; it places more focus on direct consumer engagement through education and incentives compared with earlier initiatives. This is one area in which the Innovation Center plans to collaborate with the private sector to develop consumer-facing tools (e.g., mobile apps, nudges toward healthy behaviors, etc.).

The focus on consumer engagement also presents opportunities for organizations to enhance their customer experience. By understanding the needs and preferences of their patients, organizations can tailor their services and care models to better meet those demands. This personalized approach not only improves patient satisfaction, but also drives continuity of care, ultimately contributing to long-term improvements in health.

Data and Technology. The new strategy also emphasizes the importance of data, indicating intentions to better equip organizations that participate in the model with data that can inform decisions and optimize their processes. CMS officials are examining policies and collaborations that will empower private sector organizations, including model participants, researchers, and technology vendors, to develop innovative data-driven solutions to drive efficiencies and improved health.

To that end, the May 16, 2025, Request for Information (RFI) from CMS and the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health (ASTP/ONC), Health Technology Ecosystem (CMS-0042-NC), focuses on Medicare beneficiaries’ use of technology to improve health outcomes. The RFI, which HMA experts analyze here [insert bookmark or link to the other In Focus article] underscores the administration’s intentions of taking “bold steps to modernize the nation’s digital health ecosystem.”

Medicare Advantage. The Innovation Center’s new strategy indicates that stakeholders should expect more models that address Medicare Advantage (MA). The agency stated that “features of a model could include testing changes to payment for MA plans, such as testing the impact of inferred risk scores, regional benchmarks, or changes to quality measures that better align with promoting health.” Additionally, the strategy references a forthcoming specialty-focused longitudinal care model within MA and Medicaid, signaling intentions to drive multi-payer alignment.

Saving Federal Tax Dollars. Another major aspect of the strategy is “protecting federal taxpayers.” This goal reflects a continued emphasis on total cost of care accountability and indicates a more aggressive shift to downside risk. The Innovation Center says it will “require all models to have downside financial risk and require providers to assume some of the financial risk..” Additional provisions of protecting tax dollars include reducing role of state governments in rate setting, simplifying model benchmark methodology, and ensuring “proper and nondiscriminatory provision of funds for health care services.”

What to Watch

For healthcare organizations, the Innovation Center’s agenda signals a need to prioritize consumer-centric models. Hospitals, providers, and insurers should anticipate the following:

  • Increased focus on preventive care initiatives to align with new model designs
  • More robust data-sharing and technology requirements, meaning investments in patient-focused digital tools will become essential
  • New opportunities in MA, given potential payment model innovations affecting plan structures and risk-adjusted reimbursement

Healthcare stakeholders should monitor possible developments related to the strategy.

  • While details on specific strategies have yet to emerge, the Innovation Center indicated it plans to provide more information on new models, as well as changes to existing models, in the coming months.
  • The Innovation Center has not provided a goal akin to the previous administration’s effort to have 100 percent of Medicare beneficiaries in accountable care relationships by 2030. It is still unknown whether these goals are forthcoming or if this will remain vague.
  • Stakeholders are still awaiting clarity on changes to existing models, including key models set to conclude at the end of 2026 (i.e., ACO REACH and Kidney Care Choices).
  • Strategy language indicates that the agency may develop payment innovation in prescription drugs, medical devices, and technology.

Connect With Us

The Health Management Associates Annual Conference, Adapting for Success in a Changing Healthcare Landscape, October 14-16, 2025, in New Orleans, LA, will feature discussions on how the new strategy is reshaping the healthcare system and care delivery for patients, particularly the opportunities to revisit provider contracts with MA plans and to integrate technology to advance the prevention of chronic conditions and achieve population health goals.

For more information about the opportunities and considerations the Innovation Center agenda presents for your organization, contact HMA’s featured experts below.

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President Issues Executive Order Calling for Most Favored Nation Drug Pricing

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On May 12, 2025, the President signed an Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” The EO calls for or, in some cases, presumes a range of manufacturer, administrative and regulatory actions to reduce drug prices, but ultimate outcome remains unclear.

HMA experts, including Leavitt Partners, an HMA company, are closely following executive agency and stakeholder responses to the EO. In this article, our experts summarize the EO and identify key considerations for healthcare stakeholders.

Policy Overview

Since his first administration, President Trump has consistently criticized disparities in brand-name prescription drug prices between the United States and other developed countries. In 2018, the previous Trump Administration issued a preliminary proposal to institute an International Pricing Index (IPI) model targeting Medicare payments for a subset of clinician-administered drugs. The IPI model would have set a Medicare payment amount for select Part B drugs at a lower amount to align with international prices and allow for negotiation of prices, while still providing a drug add-on payment to providers consistent with historical drug costs.  In November 2020, the administration issued an interim final rule (IFR) instituting an escalated version of this concept, entitled the Most Favored Nation (MFN) Model. Both the IPI proposal and the MFN final rule, the latter of which was enjoined by the courts on largely procedural grounds and later rescinded by the Biden administration, would have been implemented under the Center for Medicare and Medicaid Innovation’s (CMMI) demonstration authority.

On May 12, 2025, the President signed an EO, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients, which reaffirms the Administration’s concerns regarding what it perceives to be American funding of pharmaceutical research and development “while foreign health systems get a free ride.” In an effort to address the Administration’s concerns, the EO notes that the Administration “will take immediate steps to end global freeloading” and that “should drug manufacturers fail to offer American consumers the most-favored-nation lowest price, my Administration will take additional aggressive action.”

The EO outlines efforts to implement this policy, including:

  • Trade Efforts. The US Department of Commerce and United States Trade Representative (USTR) are directed to ensure that foreign countries are not engaged in actions with the effect of forcing Americans to “pay for a disproportionate amount” of R&D costs.
  • Direct-to-Consumer (DTC) Sales at MFN Price. The US Department of Health and Human Services (HHS) is directed to facilitate DTC sales programs for manufacturers to offer MFN prices.
  • MFN Targets. The HHS Secretary is directed to provide MFN targets to manufacturers within 30 days with the expectation that manufacturers will “bring prices for American patients in line with comparably developed nations.”
  • If “significant progress” toward MFN pricing is not made, HHS will be directed to propose a rulemaking plan to impose it.
  • The order suggests that the HHS Secretary certify, on a case-by-case basis, that reimportation will pose no additional risk to public health and will result in savings, as well as to create standard mechanisms for importation. It is unclear how this direction aligns with the current statutory framework, which is focused on Canada.
  • Federal Trade Commission/Department of Justice Action. The EO calls for efforts “consistent with law” to undertake enforcement action against anticompetitive practices identified in the prior drug pricing EO, including use of the Sherman Antitrust Act.

Key Considerations

At this stage, the scope and practical effects of the EO remain uncertain, as the administration has not yet provided details regarding the regulatory and subregulatory actions envisioned under the document. With respect to trade policy, for instance, the EO does not outline explicitly what particular tools it expects USTR or the Commerce Department to leverage in combating “foreign freeloading.”

Similarly, the EO does not elaborate on the steps that the administration plans to take in “facilitat[ing]” voluntary MFN target pricing under DTC purchasing arrangements. Such efforts could theoretically bring waivers or other regulatory flexibilities to bear, or else they could take a more hands-off approach, simply encouraging drugmakers to take action on their own.

Without further clarifications around how the administration might define or assess “significant progress” towards MFN pricing targets on the part of manufacturers, nor the form, manner, or timeline that “aggressive action” in the absence of such progress might take, the EO serves principally as an illustration of the President’s posture, perspective, and priorities with respect to prescription drug affordability and access.

Even in the absence of immediate pricing or payment interventions, the EO could provide a preview of future executive actions aligned with the document’s focus. Such actions could include CMMI models building on the IPI or MFN initiatives from the first term, explicit trade negotiation priorities, regulatory measures related to DTC purchasing arrangements, FDA reimportation program flexibilities, or any number of other drug-related policies.

Our experts will continue to monitor these activities as they progress.

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For details regarding the EO and potential impact on the healthcare sector, contact our featured experts below at [email protected]

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