Health Policy Volatility, Regulatory Shifts Shape Outlook Ahead of 2026 Midterms

Ongoing regulatory changes, legal challenges, and policy shifts are reshaping the health care landscape ahead of the 2026 midterm elections, experts explained during a Tuesday afternoon session at the Academy of Managed Care Pharmacy (AMCP) 2026 meeting in Nashville, Tennessee.¹

Current State of the Union

Adam Colborn, JD, vice president of government affairs at AMCP, opened the session with an overview of the policy landscape 1 year post inauguration, describing it as a mix of “business as usual” and atypical turbulence. On the more stable end, statutory changes are being implemented, as traditional Republican policy priorities and issues with broad public appeal, or 80/20 issues, remain stable. He added that efforts to align stakeholders across all levels of government remain ongoing.

“That's true in all administrations and all of Congress, but it's an even higher priority right now, given the massive changes we've seen among agency staffing,” he said.

As he mentioned, the need for alignment is complicated by elevated turnover across federal agencies, including HHS, the CDC, and the FDA. Although some level of transition is expected, Colborn noted that the current scale and timing are atypical, particularly this far into an administration, complicating continuity of policy.

He also highlighted the large amount of litigation surrounding managed care, with courts across jurisdictions taking different approaches to the same health policy issues. These circuit court splits are creating a more fragmented legal landscape for health plans, manufacturers, and providers, adding complexity on top of existing legislative and regulatory processes.

Trump added to this complexity during the early months of his second term with a rapid surge in executive orders and a high-volume “flood zone” messaging strategy. Compared with earlier administrations, including his first, Colborn explained that this approach places less emphasis on detailed policy development and consistent messaging, instead aiming to keep health and economic issues top of mind for voters.

He added that this is not unique to Republicans, as Democrats have also begun adopting this communication style. As a result, policy priorities are harder to anticipate for plans, manufacturers, and providers, making long-term planning riskier.

“There is business as usual that's going on, but there's also a lot of turbulence that is atypical, especially this far into an administration,” he summarized.

He and Geni Tunstall, JD, associate vice president of regulatory affairs of AMCP, discussed various areas of federal developments throughout the session, including the following: vaccine reform and restructuring of the Advisory Committee on Immunization Practices (ACIP), ongoing shifts in tariff regulations, and pharmacy benefit manager (PBM) changes in the Consolidated Appropriations Act (CAA) of 2026.

ACIP Restructuring and Court Rulings Disrupt Vaccine Policy and Coverage Alignment

Tunstall followed Colborn’s overview by discussing recent changes to vaccine policy at HHS. She explained that HHS Secretary Robert F. Kennedy Jr removed the previous 17 ACIP members and appointed 12 new ones, some of whom have antivaccine political leanings. As a result, public trust in federal vaccine recommendations has declined.

Tunstall added that internal staffing changes at the CDC, the FDA, and HHS have further disrupted the continuity of vaccine policy development. She emphasized that vaccine recommendations are not just clinical guidance. Under the Affordable Care Act (ACA), ACIP recommendations generally trigger mandatory coverage with no cost-sharing for many plans. As a result, instability at ACIP creates uncertainty for payers, providers, and patients, making it more difficult for plans to determine when and how to implement new vaccine recommendations.

However, a federal district court ruling has significantly disrupted ACIP’s work.² The court found issues with HHS actions related to revising the CDC childhood immunization schedule and restructuring ACIP, as well as the votes taken since those changes. Its primary concern centered on procedural and governance issues, particularly whether ACIP complies with federal advisory committee requirements. Consequently, those actions and votes have been stayed.¹

Tunstall explained that the Trump administration has appealed the district court ruling, but until a decision is made, there is no clear path forward for how ACIP will operate or how its recommendations will be treated. As a result, recent ACIP recommendations are not currently operative. She added that the March ACIP meeting was postponed indefinitely, with no new date announced. She acknowledged that this creates ongoing ambiguity for plans and payers around implementing new vaccine recommendations.

“There's potential misalignment between FDA-approved indications, ACIP recommendations, and coverage mandates, so there's a lot for you all to be juggling, and we understand that, so [AMCP] will definitely be keeping a close eye on all of that,” Tunstall concluded.

Volatile Tariff Landscape Contributes to Drug Pricing Uncertainty

Tunstall also discussed the tariff landscape, describing the past year as “very volatile.” She explained that Trump has repeatedly imposed and then rolled back tariffs, making it difficult for stakeholders to predict drug acquisition costs.

One major focus has been on pharmaceutical tariffs and Most Favored Nation (MFN) deals. Drug manufacturers with voluntary MFN agreements are shielded from some tariffs, while those without such agreements face significantly higher rates.

Specifically, the Trump administration imposed a 20% tariff on patented pharmaceuticals and ingredients for companies with onshoring agreements in place, while those without such agreements face a 100% tariff. Tunstall noted, however, that the 20% tariffs for companies with MFN agreements are not set to take effect until 2029.

She also explained that tariffs impact the affordability of prescription drugs because they affect drug acquisition costs and manufacturer pricing strategies, which are tied to international benchmarks.

“We really need to get a handle on it,” she said. “…it’s one of those things where it's very difficult to wrap your head around. [AMCP is] constantly monitoring it, and we'll put out information to all of you as new information becomes available, but it's definitely something to keep an eye on.”

CAA Redefines PBM Payment, Transparency Rules

Colborn later outlined significant PBM reforms included in the CAA. For example, he noted that it delinks PBM revenue from drug prices in Medicare Part C, also known as Medicare Advantage. Instead, compensation must now be paid as flat-dollar bona fide service fees.

He noted that this effectively pushes PBMs toward fee-based revenue models and away from spread- or pricing-linked income in these lines of business. Colborn added that this change could significantly alter PBM contracting structures in Medicare Advantage and increase scrutiny of how service fees are defined and justified.

For commercial plans governed by the Employee Retirement Income Security Act (ERISA), PBMs must pass 100% of rebates and discounts to the health plan. Colborn highlighted, however, that there is no requirement that the plan then pass those rebates on to employers or members.

The law also requires greater PBM transparency, as they face new annual and biannual reporting duties on drug costs and fees for Medicare and ERISA-governed commercial plans, respectively, along with stronger audit rights for plans. However, he emphasized that key definitions, particularly what qualifies as a permissible service fee, remain open to interpretation and will likely be shaped through regulatory guidance.

By contrast, Colborn noted that the widely anticipated federal ban on spread pricing in Medicaid did not make it into the final CAA. He reported that this was largely due to updated budget scoring that turned spread-pricing reform into a net cost, not a saver. Previously paired with the spread pricing ban, a mandatory national drug acquisition cost survey also fell out.

Health Care Policy Impact on the Midterm Elections

These recent developments are expected to heavily influence voter decision-making in the midterm elections on November 3, 2026. Colborn noted that 44% of voters report that health care costs have a major influence on their preferences.

As a result, he explained that Republican campaigns are likely to emphasize direct-to-consumer drug sales and MFN pricing models. Meanwhile, Democratic campaigns are expected to focus on the expiration of enhanced premium tax credits under the Affordable Care Act and ongoing drug price negotiations under the Inflation Reduction Act.

Republicans currently hold a narrow majority in the House, 217 to 214, although all 435 seats are up for reelection. In the Senate, Republicans also maintain control with a 53 to 45 majority, with 35 seats up for reelection this November.

Given these slim margins, Colborn predicted that Democrats could regain the House majority, while the Republicans are likely to retain their narrow hold on the Senate. However, he cautioned that redistricting may cause significant and unpredictable shifts.

“In a lot of these districts, what the parties have done is take a +10 district and convert it right in the middle; I think they basically cancel each other out,” he said. “But when you convert a bunch of +10 districts into +5 districts, that makes you extremely susceptible to wave elections, so [there’s] lots of speculation that these various maneuvers will end up costing 1 or both parties in ways they didn't expect.”

References

1. Colborn A, Tunstall G, Thorne T. Federal legislative and regulatory update. Presented at: AMCP 2026; April 13-16, 2026; Nashville, TN.
2. Jeremias S. Federal judge puts brakes on RFK Jr's vaccine agenda. AJMC^®. March 17, 2026. Accessed April 15, 2026. https://www.ajmc.com/view/federal-judge-puts-brakes-on-rfk-jr-s-vaccine-agenda