US health policy dynamics heading into 2026 midterms

Market impact: Renewed emphasis on individual choice is shifting risk pools, financial calculations, and leverage in contract negotiations. The expiration of enhanced advance premium tax credits (eAPTCs), declining Medicaid enrollment due to the OBBBA, and continued economic challenges are driving down the number of patients covered by traditional health insurance products and driving up enrollment churn. Increasingly, patients are expected to seek alternative, non-traditional coverage options or risk being un- or underinsured.

Market impact: Direct-to-consumer (DTC) portals are changing the patient journey and approach to care coordination. The emergence of TrumpRx and other DTC/telehealth platforms is expanding patients’ choice of channel, enabling more direct pharma–patient interaction, reduced reliance on physicians and PBMs, and new opportunities for care coordination. Recent clarity from HHS on the Anti-Kickback Statute may broaden market entry opportunities and expand direct-pay structures, which will necessitate associated patient education and navigation support.

Market Impact: Federal funding reductions from OBBBA will necessitate tradeoffs in healthcare delivery. Roughly $1 trillion in funding reductions over the next decade may force payers and providers to make tradeoffs across competing priorities, potentially driving changes to service offerings, consolidation and M&A. Uncompensated care is expected to increase as patients move to alternative coverage or become uninsured.

Market Impact: Drug pricing controls will create sustained margin pressure. Layers of policy are coming to fruition (i.e. TrumpRx, Medicare Drug Price Negotiation, CMMI models, MFN, and PBM reform) with federal programs increasingly setting the reference point for broader market pricing and DTC portals creating public benchmarks. Manufacturers- and other stakeholders- should expect sustained margin pressure, higher pricing volatility, and greater policy-driven complexity in contracting and access strategy.

Market Impact: Financial and regulatory incentives aligned with MAHA objectives are amplifying the need for organizations to consider national priorities. Resources are being reallocated to reflect MAHA-focused objectives such as increasing funding to rural health through the Rural Health Transformation Program (RHTP) funding and prioritizing whole person health through the CMMI’s MAHA ELEVATE Model. The industry should consider how overarching business strategies may intersect or collide with the federal government’s most impactful levers: funding, regulation, reimbursement and enforcement.

Market Impact: The $50B RHTP represents a significant federal reinvestment into rural healthcare, signaling a shift from short-term stabilization to structural system redesign. This capital infusion is intended to modernize infrastructure, expand access, and accelerate digital, workforce, and community-based care transformation. Health systems that align enterprise strategy with these federal funding priorities, rather than treating them as temporary relief, may strengthen long-term resilience, competitive positioning, and value-based performance.

Market Impact: Price transparency spanning pharmaceutical manufacturer pricing & rebates, vertically integrated PBM rebate & fee models, hospital billing, and employer costs has become a core policy lever reshaping healthcare economics rather than a narrow compliance exercise. In an effort to enable consumer purchasing choices through comparison and accountability, federal and state transparency requirements are continuing to garner attention. As data becomes more visible, organizations that treat transparency as a strategic capability will be better positioned to manage margin pressure and strengthen trust.

Market Impact: FDA oversight is recalibrating to signal a lighter touch approach to consumer wearables, alongside a rethinking of evidence generation expectations for pharmaceuticals. Reduced premarket oversight of consumer wearables will enable developers to accelerate product launches and rapidly innovate but require greater post-market controls. At the same time, FDA signals around evidence generation for drugs are enhancing the need for integrated development plans and early cross functional collaboration. This includes the announcement around single pivotal trials, interest in continuous trials, and emphasis on post market data alongside PBM reform and potential shift away from rebate driven formulary designs.

Market Impact: AI innovation is accelerating amid a federally deregulated environment in the US. As oversight tightens in the EU and remains divided across US state and federal authorities, organizations are rapidly adopting AI to reduce cost and drive effectiveness, with consideration for AI governance structures to manage risk, compliance, and maintain trust at scale.

Looking ahead, providers should examine their care delivery footprints, leverage automation and technology to reimagine the workforce and operations in order to mitigate economic strain. This should include identifying opportunities to diversify revenue sources, partnerships or M&A with other stakeholders, and prioritizing investment in new technology to reduce impacts of the increase in uncompensated care and workforce constraints.

• Core Dynamics
  • Escalating uncompensated care pressure: With OBBBA and the ending of the eAPTCs estimated to reduce coverage by ~14M lives, uncompensated care is projected to rise by approximately $278 billion by 2034.³ This is likely going to place disproportionate strain on safety-net providers and have a ripple effect on service lines and patient flow throughout large health systems.
  • $50B RHTP as a catalytic lever: The $50 billion federal investment flowing through the RHTP represents a once-in-a-generation capital infusion into rural healthcare infrastructure.⁴ This funding creates a near-term opportunity for rural and regional health systems to modernize core infrastructure, redesign care delivery models, and innovate beyond traditional operating boundaries.
  • Intensifying workforce disruption and capacity constraints: OBBBA’s elimination of Grad PLUS loans and new lifetime borrowing caps, combined with the reclassification of nursing degrees as non-advanced degrees, are expected to constrain the healthcare workforce pipeline by increasing financial barriers to clinical training. At the same time, heightened restrictions on immigrant visas may further strain staffing for hospitals and other providers, with disproportionate impacts on rural and underserved communities. These pressures compound existing shortages.
  • MAHA-driven shift in uptake of preventive care: The MAHA campaign may continue to reshape the government’s role in healthcare, with downstream effects on patient acuity and population health management. Preventive services, including routine vaccination and cancer screenings, become subject to reduced federal oversight, signaling a shift away from centralized guidance and placing greater emphasis on individual decision‑making. Over time, this shift may contribute to higher acuity presentations and increased variability in preventive care uptake.
• No regret actions
  • Assess opportunities to diversify patient growth and mix by expanding into higher commercial geographies, prioritizing sustainable service lines, extending care beyond the hospital (e.g., ASCs), and strengthening access, scheduling, and patient engagement.
  • Activate a disciplined rural transformation strategy to capture and deploy the $50B investment: Establish a centralized governance structure to proactively secure and strategically allocate Rural Health Transformation Program funds toward long-term infrastructure modernization with clear ROI metrics, compliance oversight, and measurable impact on outcomes.
  • Embed AI-driven automation and predictive monitoring into back-office operations and administrative workflows in a deliberate, well-governed manner. Organizations that do this while embedding AI observability, model risk management, and clear accountability from the outset can alleviate manual burden and create capacity at scale while managing risk.
  • Strengthen care delivery through robust ecosystem partnerships, including digital patient engagement platforms, post-acute providers (SNFs/rehab), and transportation services, to improve care throughput and patient outcomes.
  • Strengthen patient engagement by partnering with community-based organizations, post-acute providers (SNFs/rehab), digital patient engagement (access and scheduling solutions), and transportation services to improve access, manage care throughput, and both retain existing patients and attract new ones.

In the future, payers will likely need to strengthen care management capabilities as they expand their holistic support to members. This will include, in the future, leveraging sophisticated data models and interactive real-time communications to understand and influence member behavior patterns, accelerate paths to appropriate cost-effective care, and drive financial savings for members and plans. In the interim, payers should consider offering alternative coverage plans that can meet member needs and support consumer education. Payers should also consider leveraging automation to manage changing administrative requirements, take cost out of operations, and continue to emphasize mitigating fraud, waste, and abuse.

• Core Dynamics
  • A wave of PBM reform is reshaping the traditional drug insurance business model: At the federal level, new requirements mandating the delinking of PBM compensation from drug prices, coupled with enhanced transparency obligations, are placing sustained pressure on legacy revenue streams.⁵ An FTC settlement further heightens regulatory scrutiny of pricing and contracting practices. Meanwhile, accelerating state-level reforms, led by California’s SB 41, are adding financial, operational, and compliance strain, particularly for vertically integrated PBM structures.⁶
  • Health coverage affordability pressures reshape consumer choice: The expiration of eAPTCs and rising healthcare premiums in commercial plans is making ACA-compliant coverage increasingly unaffordable for many Americans. As upfront prices increase, beneficiary product selection is expected to shift, accelerating a structural reallocation of financial responsibility for healthcare.
  • Rising administrative complexity in public coverage programs: As OBBBA-driven requirements for Medicaid and Marketplace beneficiaries (e.g., semiannual redeterminations and work requirements) take effect, regulatory complexity is expected to increase, placing added operational and financial strain on payers.
  • Intensified federal focus on program integrity: As the administration advances efforts to “crush” fraud, waste, and abuse through stricter rules, a new fraud war room, and expanded oversight, payers may face more frequent audits and faster investigations.^{7, 8} As a result, payers will be expected to manage and demonstrate effective fraud controls not only internally, but across vendors, providers, and member interactions.
• No regret actions
  • Invest in automation and modernize the PBM operating model to meet heightened regulatory and operational demands in a landscape defined by reduced rebate leverage and tighter transparency requirements.
  • Recapture lost member lives and engage new market entrants through alternative coverage products and targeted consumer engagement, positioning private insurers to fill the gap as government programs tighten eligibility and reduce coverage.⁹
  • Reduce the cost of payer operations by building integrated, AI-enabled compliance tools and real-time monitoring to embed regulatory requirements into daily operations, improving accuracy, reducing rework, and enhancing member trust while managing complexity and creating capacity.
  • Modernize FWA operating models by integrating medical policy, clinical operations, payment integrity, and SIU functions through advanced analytics, automation, and shared governance to systematically prevent and detect improper payment.

In the future, pharmaceutical manufacturers, propelled by accelerating science and shifting patient expectations, should expand from drug manufacturers to “lifespan partners,” requiring more agile operating models and greater collaboration across technology, and ecosystem players. In the interim, pharmaceutical manufacturers can embrace innovative approaches to access, affordability and evidence generation to meet the needs of today’s consumer and keep pace with pipeline and pricing pressures.

• Core Dynamics
  • New opportunities for care coordination arise as the patient journey shifts: As healthcare becomes increasingly consumer driven, PBM reform goes into effect and direct-to-patient portals are launched by a multitude of stakeholders, the traditional rebate-driven and physician centered commercialization model is evolving. Even at initially low volume, these developments shift negotiation leverage and create new opportunities for manufacturers to coordinate care.
  • Research and innovation realignment toward China: As scientific advancement accelerates and US federal investment in biomedical research faces new hurdles, early‑stage and higher‑risk development is now predominantly sourced from China, where ample early‑stage capital, supportive regulators, and maturing clinical‑trial infrastructure are accelerating first‑in‑human and proof‑of‑concept work.^{10, 11} Pharmaceutical manufacturers may need to balance partnerships with Chinese innovators against rising supply chain and security risks, while also absorbing a greater share of early-stage research and innovation costs to sustain global competitiveness. Expect increased attention and momentum for modernization of US regulatory frameworks around innovative clinical trials and more flexible approval pathways.
  • Global drug pricing pressures and market access dynamics: With TrumpRx, MFN, and other pricing dynamics intertwine US and global pricing and the EU’s joint clinical assessment reshapes payer expectations, major changes are coming for how companies develop, launch, and price products. US regulators are signaling an interest in continuous trial design and a single pivotal trial, alignment between regulatory and commercial teams may tighten to confirm that data packages meet both approval and reimbursement thresholds. These dynamics are driving a shift toward more integrated, lifecycle‑long market access strategies that anticipate stricter evidence baselines while navigating increasing price scrutiny.
  • Single pivotal trial reshapes evidence strategies and risk concentration: By formalizing single pivotal trials as the default standard, FDA is broadening how substantial evidence can be demonstrated and expanding the role of confirmatory and real-world data.¹² However, now one study should carry the evidentiary weight that two trials once shared, concentrating operational and financial risk in trial execution.
• No regret actions
  • Invest in patient‑centric engagement and care‑coordination capabilities to adapt to consumer‑driven health models and emerging direct‑to‑patient platforms.
  • Tighten regulatory–commercial alignment to navigate increasing drug‑pricing pressures and shifting market‑access dynamics.
  • Reassess global R&D and partnership strategies to leverage China’s fast‑moving innovation ecosystem while mitigating supply‑chain and security risks.
  • Enhance integrated development plans as decision‑centric and lifecycle-oriented to confirm coordination supports decisions related to both regulators and payers in the US and abroad.

In the future, medtech is expected to become a broader ecosystem player, building interoperable, intelligent systems that connect care across hospitals and the home. MedTech should strengthen capabilities for post market surveillance as FDA shifts oversight focus from a premarket review paradigm to an emphasis on performance and safety once on the market, particularly for low risk, consumer devices.

• Core Dynamics
  • Accelerated digital health premarket deregulation with enhanced post market monitoring: FDA is setting a new tone for the future of digital health by redefining regulatory boundaries for consumer products and clinical decision support software.^{13, 14} The agency is expected to continue to take deregulatory action throughout 2026, part of which may include an update to a majority of the existing 27 pieces of guidance. This expands market entry opportunities while placing greater responsibility on manufacturers to manage product performance and risk as FDA continues to invest in active post-market monitoring rather than passive adverse event reporting of the past.
  • Broadened use of real world evidence (RWE) in regulatory decision making: Sponsors could leverage de-identified registries, claims databases and electronic health record (EHR) networks for premarket approval, label changes and post-market studies.¹⁵ This expands the potential data available to support regulatory submissions making data strategy, governance, analytics, and automation capabilities increasingly central to regulatory success.
• No regret actions
  • Evaluate potential new data sources: Developers should consider what additional data may exist for FDA decision making and invest in data quality, governance, analytics, and automation to efficiently leverage datasets and expedite regulatory changes such as pre/post market approval, labeling, etc.
  • Strengthen capabilities for post-market surveillance: Developers should modernize regulatory and quality processes to meet evolving policy expectations, while embedding effective enterprise governance controls to continuously assess performance, safety, and security of digital and AI enabled products.