# 340B ACCESS Act Summary
The 340B ACCESS Act reforms the 340B drug pricing program, which allows certain healthcare providers to purchase drugs at discounted prices from manufacturers. The bill tightens eligibility requirements, strengthens oversight, and adds new patient affordability protections.
**Key Changes to Program Eligibility and Operations**
The bill narrows who can participate in the 340B program and how they can use it. It redefines "patient" to require that individuals actually receive healthcare services from covered entities—not just get drugs dispensed. Participating hospitals must now register off-campus facilities (called "child sites") and meet strict requirements, including serving areas with health shortages and maintaining charity care levels comparable to their main locations. Large nonprofit healthcare systems and those affiliated with hospitals face new restrictions on using the program.
**Pharmacy and Contract Requirements**
Covered entities can use contract pharmacies to dispense 340B drugs, but with limits—hospitals can contract with no more than five pharmacies. The bill requires written agreements between covered entities and contract pharmacies, with compliance procedures to prevent improper drug resale or duplicate discounts. Contract pharmacies face escalating penalties for violations, from liability payments for first offenses to removal from the program for repeated violations.
**Patient Affordability Protections**
Hospitals must establish sliding fee scales capping patient out-of-pocket costs: free drugs for those below the poverty line, and maximum costs of $35-50 per prescription (adjusted for inflation) for low-income patients. These protections apply whether patients receive drugs directly from hospitals or contract pharmacies.
**Data Reporting and Oversight**
The bill requires covered entities to submit detailed claims data to a new clearinghouse within 45 days of dispensing drugs. This clearinghouse will identify duplicate discounts, prevent Medicaid rebate violations, and track which drugs qualify for Medicare inflation rebates. Hospitals must also annually report to the government on patient demographics, charity care costs, and profits made from 340B drugs. Hospitals in urban areas must demonstrate they serve low-income and uninsured patients more than average hospitals in their states to remain eligible.
**Enforcement and Penalties**
Civil monetary penalties of $2,500 per violation apply for various infractions, with amounts adjusted annually for inflation. Violations can include failure to report data, improper charity care practices, or
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