SECURE 340B Act

The SECURE 340B Act strengthens oversight of the drug discount program for safety-net health care providers by establishing clearer definitions for patients and prescribing providers, requiring detailed record-keeping to prove a legitimate patient relationship. The bill introduces strict rules for contract pharmacies, mandating that manufacturers cannot restrict discounts based on their use and requiring full transparency on where these drugs are dispensed. It also expands eligibility for child sites of covered entities while imposing a new community need standard based on geographic vulnerability scores to prevent abuse. To improve program integrity, the legislation creates a centralized data clearinghouse to track claims and prevent duplicate discounts, while simultaneously prohibiting discriminatory practices by insurance companies and pharmacy benefit managers against covered entities. Finally, the Act authorizes new user fees and additional funding for the Health Resources and Services Administration to support expanded audits and enforcement activities.