The 340B Program is a federal program in the United States that requires drug manufacturers to provide outpatient drugs to eligible healthcare organizations at significantly discounted prices. The federal 340B Drug Pricing Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a discount of 25 percent to 50 percent. The program was created as part of the Veterans Health Care Act of 1992, which was designed to expand access to affordable medications for certain eligible entities. Eligible healthcare organizations include certain federally qualified health centers, Ryan White HIV/AIDS Program grantees (RW), and disproportionate share hospitals that serve a high number of low-income and uninsured patients. These organizations can purchase drugs at discounted prices and use the savings to provide additional healthcare services to their patients.
Regulations specific to the 340B program include requirements for covered entities to maintain auditable records of drug purchases and use, limitations on the use of 340B drugs, and restrictions on the diversion or resale of discounted drugs. Covered entities are also required to meet certain patient eligibility and provider eligibility criteria to participate in the program. In addition, the Health Resources and Services Administration (HRSA) oversees the 340B program and is responsible for providing guidance and enforcing program requirements. HRSA audits covered entities to ensure compliance with program regulations, and manufacturers may also audit covered entities to verify compliance with program requirements.
The 340B Program is limited to patients of the covered entity and has never been a general employee pharmacy benefit or self-insured organization pharmacy benefit. Evidence of an employer relationship or insurer relationship alone is insufficient to determine 340B patient eligibility.
There are a few exceptions, which include vaccines and Orphan Drugs (which are, by definition, medications specifically developed to treat rare diseases or conditions — and drugs that have only recently been granted New Drug Status by the FDA).
Types of 340B approved program includes but not limited to DSH, FQHC, & RWHAP, STDC
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