340B Program for American HealthCare I a POV from GHIT Digital

340B Program for American HealthCare I a POV from GHIT Digital

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.

Who qualifies as a 340B patient?

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.

What is not covered by 340B?

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

• Disproportionate Share Hospitals (DSH): DSH hospitals are facilities that serve a high proportion of low-income and uninsured patients. These hospitals receive additional federal funding to help offset the cost of caring for these patients. DSH hospitals are eligible for the 340B program.
• Federally Qualified Health Centers (FQHCs): FQHCs are community-based health centers that provide primary care and other health services to underserved populations. FQHCs must meet certain requirements, such as providing care on a sliding fee scale, to be eligible for the 340B program.
• Ryan White HIV/AIDS Program (RWHAP): RWHAP is a federal program that provides funding for HIV-related care and treatment for people living with HIV/AIDS who are uninsured or underinsured. RWHAP grantees, which include community-based organizations and clinics, are eligible to participate in the 340B program.
• Sexually Transmitted Disease Clinics (STDC): STD clinics provide testing, treatment, and counseling for sexually transmitted infections. These clinics are also eligible for the 340B program.

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