At AMCP Nexus 2025, policy experts Geni Tunstall, JD, and Adam Colborn, JD, provided an in-depth look at the political, legal, and regulatory developments shaping health care over the past year. Their wide-ranging discussion covered executive orders, federal workforce changes, new drug pricing initiatives, and shifts in Medicaid and Medicare policy, illustrating how these evolving dynamics could reverberate across the managed care landscape.

Executive Orders, Tariffs, and Drug Pricing

Tunstall opened the session by reviewing the administration’s extraordinary output—more than 200 executive orders—many of which have touched health care. These actions have focused on themes such as price transparency, deregulation, domestic manufacturing, and supply chain stabilization. Among the more disruptive developments has been the imposition of tariffs as high as 100% on certain imported pharmaceuticals.

Colborn cautioned that these trade measures may not withstand legal scrutiny, as their justification under “national security” provisions stretches traditional boundaries of executive authority. He noted that ongoing lawsuits could have significant fiscal implications, with billions of dollars potentially at stake for manufacturers and importers.

“Most-Favored Nation” and Direct-to-Consumer Pricing

The speakers turned to drug pricing reforms under the “Most Favored Nation” concept, where manufacturers have been asked to align US prices with those offered internationally. Letters sent to 17 pharmaceutical firms requested pricing transparency and parity for Medicaid beneficiaries and direct-to-consumer sales.

Tunstall described a not-yet-live federal pricing portal, envisioned as a consumer-facing marketplace akin to Amazon. Colborn added that while the policy is being framed as a transparency initiative, its practical impact may be limited—prices are likely to resemble Medicaid “best price” rates rather than significantly reduced consumer options.

The Make American Healthy Again and CDC Shakeup

Tunstall also discussed the Make American Healthy Again (MAHA) Commission, established by Executive Order 14212. Its recent artificial intelligence (AI)-generated assessment and strategy report aimed to address drivers of chronic childhood illness—such as diet, environmental exposure, and overmedicalization—through deregulation and new public-private partnerships. However, questions have arisen about the report’s accuracy and implementation.

Meanwhile, major upheaval has gripped the Centers for Disease Control and Prevention (CDC), where leadership changes and workforce losses have reshaped agency priorities. The reconstitution of the Advisory Committee on Immunization Practices (ACIP) with members expressing vaccine skepticism has further fueled concern about the future of federal immunization guidance.

H.R. 1 and Medicaid Overhaul

A significant portion of the session focused on H.R. 1, described by Colborn as the most consequential health care legislation since the Affordable Care Act (ACA). The measure enacts $911 billion in Medicaid cuts over ten years, threatening coverage for an estimated 7.5 million Americans. Among its most controversial provisions are national work requirements and biannual eligibility verifications, which are expected to drive up administrative costs and reduce enrollment—even among eligible populations.

Tunstall noted that while the legislation slightly increases Medicare funding, it tightens eligibility for noncitizens and complicates ACA premium tax credit renewals, likely leading to coverage disruptions and increased uncompensated care.

Rural Health and Government Funding Stalemates

To offset the deep Medicaid reductions, H.R. 1 established a $50 billion Rural Health Transformation Fund, but the speakers emphasized that it represents only a fraction of what will be lost. Because much of the fund’s allocation lies at the discretion of the Department of Health and Human Services (HHS) Secretary, concerns remain that the program could be used to reward political allies rather than meet rural health needs.

The conversation also touched on the continuing federal government shutdown, which has stalled key health care funding and furloughed large portions of the HHS workforce. Both speakers predicted that resolution may come only after political pressure mounts during ACA open enrollment.

Inflation Reduction Act Negotiations

Tunstall reviewed the latest Centers for Medicare and Medicaid Services (CMS) guidance on drug price negotiations under the Inflation Reduction Act, which for the first time includes Part D drugs. Manufacturers must now ensure that all dispensing entities have access to the maximum fair price (MFP), either through direct reimbursement or a new Medicare Transaction Facilitator (MTF) process. CMS expects this data-driven system to bridge longstanding gaps between manufacturers and pharmacies. Additional rulemaking for the physician fee schedule and outpatient payments is anticipated in the coming months.

PBM Reform, 340B Oversight, and Medicare Advantage

Colborn highlighted several legislative efforts likely to resurface before year’s end. These include pharmacy benefit manager (PBM) reforms aimed at curbing spread pricing and limiting utilization management, as well as renewed bipartisan interest in overhauling the 340B program. A recent Senate hearing revealed growing skepticism toward 340B operations, signaling possible congressional action.

Medicare Advantage is also under new scrutiny. With more than one-half of seniors now enrolled, lawmakers are increasingly receptive to revisiting reimbursement practices and oversight mechanisms.

AI Policy and the Wasteful and Inappropriate Service Reduction (WISeR) Model

Both speakers closed by addressing the uncertain regulatory path for artificial intelligence in health care. While early drafts of H.R. 1 sought to preempt state regulation, that language was dropped in favor of maintaining local authority. Federal policymakers are instead emphasizing the need for human oversight in algorithm-supported decisions.

The new WISeR model—a Medicare initiative employing advanced analytics for faster service reviews—was cited as a potential step forward but also as a cautionary tale, given that participating administrators may be compensated based on cost savings, creating potential conflicts of interest.

Key Takeaways

The session underscored a rapidly shifting health care policy environment defined by executive-driven governance, regulatory uncertainty, and fiscal constraint. The Biden-Trump era transitions have blurred traditional policy lines, leaving stakeholders navigating a volatile mix of cost containment, deregulation, and political polarization.

Tunstall and Colborn emphasized that Medicaid and ACA subsidy changes could destabilize coverage for millions, while rural and safety-net providers brace for funding gaps. At the same time, Congress’s growing interest in PBM transparency, 340B reform, and AI oversight reflects an effort to modernize the health care system amid mounting economic pressures. For managed care leaders, the message was clear: vigilance and adaptability will be essential as federal policy continues to evolve in unpredictable ways.

Reference

Colborn A, Tunstall G. Federal Legislative and Regulatory Update. Presented at: AMCP Nexus 2025; October 27-30; National Harbor, MD.