340B Drug Pricing Program

Update: November 30, 2018

HRSA is notifying all stakeholders that the secure pricing component of the 340B Office of Pharmacy Affairs Information System (340B OPAIS) will be open for the submission of manufacturer pricing data in the first quarter of 2019. The system is designed to capture pricing data from manufacturers and then calculate and verify 340B ceiling prices through a quarterly process. It also will increase the integrity and effectiveness of 340B information related to participating manufacturers. Authorized covered entity users would then be able to access the pricing component of the OPAIS in a secure manner to view 340B ceiling prices once the quarterly validation process has occurred. HRSA expects to publish 340B ceiling prices on April 1, 2019 and encourages all stakeholders to regularly check our website for announcements and further information in the coming weeks.

Guidance to 340B providers in Alaska/California/Florida/Georgia/Commonwealth of the North Mariana Islands: Public Health Emergency Declaration by the Secretary

HRSA recognizes that circumstances surrounding disaster relief efforts warrant flexibility for entities eligible for participation in the 340B Program.

Therefore, eligible entities in Alaska/California/Florida/Georgia/Commonwealth of the North Mariana Islands may immediately enroll for the 340B Program during the Public Health Emergency Declaration by the Secretary, rather than having to wait for the normal quarterly registration period.

We believe this will enable these entities to meet the needs of the residents affected by this disaster. If you are in the listed states/territories and would like to enroll, email the 340B Prime Vendor Program or call 1-888-340-2787.

HRSA/OPA conducted a 340B Recertification webinar for hospitals exit disclaimer. Recertification began August 15, 2018 and ended September 12, 2018.

pictures of prescription drugsThe 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.

Eligible health care organizations/covered entities are defined in statute and 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 340B Program requirements. Once enrolled, covered entities are assigned a 340B identification number that vendors verify before allowing an organization to purchase 340B discounted drugs.

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Date Last Reviewed:  January 2019