H.R. 4581: To ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act.

This bill, known as the 340B PATIENTS Act of 2025, aims to enhance the accessibility of medications provided through the 340B drug discount program, which benefits certain healthcare providers serving low-income patients. Here’s a breakdown of what the bill proposes:

Key Components of the Bill

• Drug Discount Requirements: The bill reaffirms that drug manufacturers must provide discounted pricing to covered entities (like hospitals and clinics) according to the provisions of section 340B of the Public Health Service Act, irrespective of how or where the drug is dispensed.
• Prohibitions Against Conditions: Manufacturers are prohibited from imposing any conditions that would limit how covered entities can purchase or obtain these discounted drugs. This means they cannot restrict the delivery methods or who can dispense the medications.
• Support for Contract Pharmacies: Covered entities are allowed to collaborate with pharmacies to dispense the drugs they purchase at discounted rates, which is essential for extending care to more patients. The rules and restrictions applicable to manufacturers also apply to these contract pharmacy arrangements.
• Clarification of Eligibility: The bill clarifies that savings gained from using contract pharmacies help covered entities stretch their resources and expand patient care services.

Compliance and Penalties

• Manufacturer Compliance: Manufacturers that fail to comply with the requirements will face strict penalties. This includes civil monetary penalties for violations, assessed daily until the errant behavior is corrected.
• Claims Process: The bill outlines a process for covered entities to assert claims against manufacturers for violations of these rules.

Intent and Rationale

The primary goal of this legislation is to ensure that the savings generated through the 340B program can continue to support healthcare providers in delivering essential services to their communities. The findings in the bill emphasize the importance of access to affordable medications, particularly specialty drugs that are often critical for treating serious illnesses.

Background

Section 340B of the Public Health Service Act allows certain healthcare providers to purchase outpatient drugs at discounted rates. This program is designed to help them maximize their limited resources and provide a wider range of services to underserved populations. The bill aims to reinforce the program’s intent by preventing manufacturers from imposing restrictions on how these drugs can be accessed, ensuring that patients continue to benefit from reduced medication costs.

Relevant Companies

None found