Pharmacy leaders are facing high-stakes challenges that could threaten the stability of drug access and affordability across the U.S. Amid this uncertainty, health systems are responding with urgency, with many exploring new ways to gain control over drug pricing, efforts to increased transparency and options for protecting vulnerable populations.

Here are some of the top policy issues facing pharmacy leaders in the coming year:

Preserving the 340B Drug Pricing Program

As shifts continue with the 340B program, pharmacy leaders have emphasized maintaining the original intent of the program, which is to expand access to care for safety-net hospitals.

Jennifer Bair, PharmD, chief pharmacy officer of Greenville, S.C.-based Prisma Health, which has locations in Tennessee and South Carolina, told Becker’s 340B savings have allowed the health system to expand pharmacy access in rural communities where commercial pharmacies have closed. The savings also allowed the system to implement a 24-hour pharmacy.

However, in recent years major drugmakers have sought to limit the use of contract pharmacies to test rebate-based alternatives to traditional discounts. Drugmakers including Johnson & Johnson, Eli Lilly and Sanofi argued the measures will help improve oversight and curb abuse, while hospital groups and the Health Resources and Services Administration have pushed back, saying the rebate models threaten the financial support safety-net hospitals rely on to serve vulnerable populations.

As a result, certain states have stepped in an attempt to protect contract pharmacies from drugmaker restrictions. For example, a Colorado Senate bill aims to prevent drug companies from limiting how covered entities use the contract pharmacies. Arkansas, Maine, Utah and Nebraska are pursuing similar protections.

In April, President Donald Trump signed an executive order that reintroduces and reinforces a policy from his first term that adjusts Medicare outpatient hospital drug payments to reflect 340B drug discounts. The order came amid a Senate investigation led by Sen. Bill Cassidy, MD, into how covered entities are using 340B funding.

Additionally, in June, HHS proposed transferring oversight of the 340B program from the HRSA to CMS. The move would allow the agency to use its in-house drug pricing expertise and streamline oversight, according to HHS. The funding for 340B oversight would be capped at $12 million under the proposal.

One of the most recent concerns for hospitals and hospital groups is the introduction of the 340B pilot, set to be imposed by the HRSA. The program allows drugmakers to submit alternative rebate plans to the agency by Sept. 15 and, if accepted, the plans would go into effect for one year starting Jan. 1.

In response, hospital groups including the American Hospital Association, America’s Essential Hospitals and the American Society of Health-System Pharmacists issued an Aug. 8 letter outlining concerns about the speed and scope of the rollout, urging the agency to extend the deadlines.

The American Medical Group Association also opposed the rebate pilot program, saying the move would undermine the program’s original purpose and threaten access for underserved communities.

PBM transparency

Pharmacy benefit managers also remain a top concern for policymakers and health systems, as mounting criticism continues on opaque pricing practices and their role in inflating drug costs.

PBMs such as CVS Caremark, Express Scripts and Optum Rx control nearly 79% of U.S. prescriptions and are integrated across insurance and pharmacy networks.

In July 2024, a House Committee on Oversight and Accountability investigation found that PBMs steered patients toward higher-cost drugs and affiliated mail-order pharmacies. A 2024 investigation by the Federal Trade Commission also revealed PBM favoritism toward their own pharmacies and vast market control, affecting both medication access and affordability.

In November, Good Rx and PBMs CVS Caremark, Express Scripts, MedImpact and Navitus Health Solutions faced class-action lawsuits accusing them of suppressing reimbursements to independent pharmacies for generic drug prescriptions.

In 2025, states across the U.S. have stepped in to regulate PBMs amid concerns of their pricing practices and impact on independent pharmacy operations. In Iowa, Gov. Kim Reynolds signed Senate Bill 383, preventing PBM practices such as cost sharing that favor large pharmacy chains and mandating reimbursement based on average state or national drug prices.

Alabama Gov. Kay Ivey, meanwhile, signed the Community Pharmacy Relief Act into law April 15. The measure bans PBM steering to affiliate pharmacies and spread pricing practices.

In May, Illinois approved a bill banning PBMs from steering patients to affiliate pharmacies, with the measure requiring the full rebate to be passed down to insurers. The legislation also imposed a per-member fee on PBMs, with up to $25 million annually.

The North Carolina House and Senate passed separate bills, with the House bill aiming to ban spread pricing and requiring minimum reimbursements for pharmacies, and the Senate bill focusing more on transparency and supply chain oversight.

California is advancing a PBM oversight plan in its 2025-2026 budget. It would allow the state Department of Managed Health Care to manage PBMs through the authority to review their contracts and conduct financial audits. In June, the California Senate passed a PBM bill that would prevent spread pricing practices and the steering of patients toward their own pharmacies.

Another model, billionaire entrepreneur Mark Cuban’s Cost Plus Drugs, launched in January 2022, sparking debate in the pharmaceutical space. The company prices 100 medications by a manufacturing fee, a 15% markup along with a shipping and handling fee. The company has rapidly expanded, with more than 2,500 medications available to its customers as of 2024.

Other players, including UnitedHealth, Elevance Health, Express Scripts and CVS, also introduced pharmacy services and models focused on transparency and competitive pricing to meet growing demand.

An emerging strategy for health systems amid ongoing criticisms of PBMs has been to bring PBMs in house. Salt Lake City-based Intermountain Health, through its insurance arm Select Health, rebranded its PBM to Scripius to gain greater control over prescription costs, enhance transparency and eliminate inefficiencies.

Chapel Hill, N.C.-based UNC Health also launched its own pharmacy benefit management platform, offering a transparent model for drug cost management, claiming up to 32% of savings on annual prescription drug costs.

The aim for the in-house PBMs is to allow health systems to design tailored drug management solutions for their patients.

Health systems bracing for tariffs

Tariffs have also emerged as a potential threat for pharmacy leaders, with potential implications for drug costs and shortages.

In April, President Trump imposed a 10% baseline tariff on all foreign imports, along with higher levies for certain countries. The administration also said it was exploring a Section 232 investigation into pharmaceutical imports, which could lead to new tariffs under the Trade Expansion Act.

Renton, Wash.-based Providence estimated costs to increase by around $10 million to $25 million annually after assessing the impact to essential medical equipment.

A May report from the American Society for Health-System Pharmacists flagged tariffs as the top policy concern that could raise drug prices in 2025. This is because injectable generics and other other low-margin drugs, already prone to drug shortages, are at a heightened risk.

Michael Gaino, PharmD, senior director of pharmacy practice and quality at the ASHP, told Becker’s tariff impacts on drug shortages may be difficult to trace because a drug manufacturer could choose not to disclose the reasoning behind a product shortage.

“A lot of these products have very slim profit margins. We’re talking older drugs that are 20 to 30 years old. Especially for injectable medications, there’s a lot of overhead expense and by the time you factor all that in, in a lot of cases these drugs are making very little as far as revenue or margin,” he said. “Now you add on a tariff, and if the price is not allowed to rise — which there are penalties for some of these drugs — if the price rises faster than the rate of inflation, the manufacturer may choose just to stop making the drug, but they may never disclose the reason for discontinuing.”

In September, President Trump signed an executive order modifying the scope of tariffs for certain imports, including certain generic pharmaceuticals and their ingredients. The changes are dependent on the U.S. reaching broader trade agreements, however.

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