340B Hospitals Push Back Against New Manufacturer Restrictions

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Hospitals Fight Back as Drugmakers Tighten 340B Pricing Rules

The battle over 340B drug pricing is heating up as hospitals push back against new manufacturer restrictions that limit their access to crucial discounts. In 2025, pharmaceutical companies have imposed even stricter rules on how hospitals can access 340B savings, leaving many healthcare providers scrambling to find solutions.

Hospitals and advocacy groups argue these restrictions threaten patient care, increase costs, and undermine the intent of the 340B program, which helps safety-net providers serve low-income and uninsured patients. As legal challenges mount and policymakers take notice, the fight to preserve 340B savings is more intense than ever.

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What’s Changing? The New Manufacturer Restrictions

Drug manufacturers have steadily increased their contract pharmacy restrictions, making it harder for hospitals to benefit from 340B pricing. Here’s what’s happening now:

• Fewer contract pharmacies allowed – Some manufacturers are limiting hospitals to just one or two contract pharmacy locations, significantly reducing access to discounted medications.
• Mandatory ESP data submission – Hospitals must submit detailed patient prescription data through the ESP to qualify for 340B pricing, raising privacy and compliance concerns.
• Exclusion of high-cost specialty drugs – Several manufacturers are cutting specialty medications from 340B eligibility, making life-saving treatments more expensive.
• Shifting to rebate models – Instead of upfront discounts, some manufacturers now require hospitals to pay full price for medications and apply for rebates later, creating financial strain.

For many hospitals, these changes mean higher drug costs, reduced access to medications, and increased administrative burdens.

Hospitals Raise Concerns

Financial Strain on Healthcare Providers

For hospitals that rely on contract pharmacy savings, these new restrictions threaten their financial stability. The loss of 340B pricing means hospitals must pay more for medications, cutting into budgets meant for uncompensated care, community health programs, and essential services.

“Pharmaceutical companies are deliberately restricting our access to contract pharmacies, and it’s hurting the very patients 340B was designed to help. Hospitals are being forced to pay more for life-saving medications, and it’s putting critical services at risk.”

— Maureen Testoni, President & CEO of 340B Health (Source: 340B Report, March 2025)

Patients Caught in the Middle

Patients who depend on contract pharmacies for affordable medication may now face longer wait times, higher costs, or even the inability to access their prescriptions at all.

“Rural hospitals and health centers rely on contract pharmacies to provide affordable medications to patients in their communities. Manufacturer restrictions are making it harder for these facilities to stay afloat and continue serving low-income and uninsured patients.”

— Maureen Testoni, President & CEO of 340B Health (340B Health Statement, March 2025)

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How Hospitals Are Fighting Back

1. Legal Challenges and Advocacy Efforts

Hospitals and healthcare organizations are challenging these restrictions in court and urging federal regulators to take action. 340B Health and the American Hospital Association have filed complaints with HRSA, arguing that manufacturers are violating the intent of the 340B program.

At the same time, hospital leaders are pressuring Congress to introduce stronger protections for 340B covered entities.

2. Pushing for New Legislation

Lawmakers are responding to the pushback with bipartisan bills aimed at stopping manufacturers from imposing unilateral restrictions on 340B pricing. Proposed measures include:

• Ensuring manufacturers provide 340B pricing at all contract pharmacies 
• Increasing transparency in manufacturer pricing policies 
• Expanding HRSA’s authority to enforce penalties against non-compliant drugmakers

3. State Governments Take Action

Some state legislatures are stepping in to protect 340B hospitals. States like California, Texas, and New York have introduced bills to prevent drug manufacturers from restricting contract pharmacy access. However, the legal battle over whether states can enforce these protections is still unfolding.

4. Adjusting Strategies to Maintain Access

Many hospitals are looking for alternative ways to secure 340B savings, including:

• Expanding in-house pharmacies to bypass contract pharmacy restrictions 
• Strengthening ESP compliance to meet manufacturer reporting requirements and avoid disqualifications
• Working with TPAs to automate data submission and minimize reporting errors

What’s Next for the 340B Program?

The fight over 340B pricing is far from over. With lawsuits, legislative battles, and HRSA investigations in progress, the next few months could be critical in determining the future of the program.

Hospitals are urging healthcare leaders, policymakers, and patients to speak out and push for changes that protect 340B discounts. The more pressure placed on Congress and HRSA, the higher the chance of meaningful reforms that secure 340B savings for the hospitals and communities that need them most.

Stay Informed and Take Action

The 340B program remains one of the most critical tools for hospitals serving underserved populations. If your hospital is struggling with ESP compliance, contract pharmacy restrictions, or navigating new manufacturer policies, RxTrail Consulting is here to help.

Contact us today to learn how we can support your 340B strategy and protect your savings amid these industry changes. 

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