340B ACCESS Act

The 340B ACCESS Act amends the 340B Drug Pricing Program to strengthen oversight and ensure discounts reach vulnerable populations. It establishes new patient affordability requirements that limit out-of-pocket costs for eligible patients (e.g., $0 for those below the Federal poverty line, up to $35 for those between poverty line and 200% of poverty). The bill adds requirements for hospital child sites, contract pharmacies, and covered entities to prevent duplicate discounts, improve transparency, and creates a claims data clearinghouse to monitor program compliance. It imposes civil penalties for noncompliance, including fines up to $13,946 per violation for contract pharmacies that violate program requirements.