What do I need to know about the 340B Program?
The 340B Program enables covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. Manufacturers participating in Medicaid agree to provide outpatient drugs to covered entities at significantly reduced prices. The program allows 340B hospitals to stretch limited federal resources to reduce the price of outpatient pharmaceuticals for patients and expand health services to the patients and communities they serve. Hospitals use 340B savings to provide free care for uninsured patients, offer free vaccines, provide services in mental health clinics, and implement medication management and community health programs. According to the Health Resources and Services Administration (HRSA), which is responsible for administering the 340B program, enrolled hospitals and other covered entities can achieve average savings of 25 to 50% in pharmaceutical purchases. Tax-exempt hospitals are required to publicly report on the ways in which they improve the health of the communities they serve yearly through the IRS Form 990 Schedule H, which is publicly available. In 2017, the most recent year for which this information is available, tax-exempt hospitals participating in the 340B drug savings program provided $64.3B in total benefits to their communities.
Is my healthcare organization eligible?
Eligible health care organizations/covered entities include HRSA-supported health centers and look-alikes, Ryan White clinics and State AIDS Drug Assistance programs, Medicare/Medicaid Disproportionate Share Hospitals, children’s hospitals, and other safety net providers. See the full list of eligible organizations/covered entities. To participate in the 340B Program, eligible organizations/covered entities must register and be enrolled with the 340B program and comply with all program requirements. Once enrolled, covered entities are assigned a 340B identification number that vendors verify before allowing an organization to purchase 340B discounted drugs.
What if my organization’s eligibility changed over the past year?
Covered entities must recertify their eligibility every year and notify the Office of Pharmacy Affairs whenever there is a change in their eligibility. If there is a change in a covered entity’s eligibility status, the covered entity has a responsibility to immediately notify OPA and should stop purchasing drugs through the 340B Program. Learn more about the process here: Recertification.
How does COVID-19 impact my organization’s eligibility?
Many 340B stakeholders are concerned about the evolving impact of the COVID-19 pandemic. The circumstances surrounding this public health emergency may warrant additional flexibilities, especially to affected 340B covered entities. To the extent a 340B stakeholder has a specific circumstance where they believe their COVID-19 response may affect their compliance or eligibility in the 340B Program, the stakeholder should contact the 340B Prime Vendor at 1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. ET) or email apexusanswers@340bpvp.com. Additionally, plan on contacting this resource if your organization is currently seeing a surge in patients and need to expand services to another site, to learn if any special exemptions be made for covered entities or any changes will be made to the registration process. The 340B Prime Vendor will coordinate with HRSA technical assistance and evaluate each issue on a case-by-case basis.