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340B Drug Pricing Program

HRSA Refers Six Pharmaceutical Manufacturers to the Office of the Inspector General for Refusal to Comply with 340B Statute

On May 17, 2021, Acting Health Resources and Services Administration (HRSA) Administrator Diana Espinosa sent letters to six pharmaceutical manufacturers outlining each manufacturer’s violation of statutory 340B Program requirements by refusing to sell, without restriction, covered outpatient drugs at 340B prices to covered entities that dispense medications through contract pharmacy arrangements. The letters directed each manufacturer to submit a plan to come into compliance with the law. In their responses, the manufacturers refused to comply and did not provide such plans.

On September 22, 2021, HRSA sent letters to each manufacturer alerting them that, in light of their refusal to comply, the matter has been referred to the HHS Office of the Inspector General (OIG) in accordance with the 340B Ceiling Price and Civil Monetary Penalties Final Rule (PDF - 405 KB).

The full text of the letters can be found on the Program Integrity page.

COVID-19 Resources

HRSA is working to keep 340B Program participants and stakeholders updated on the latest information regarding the coronavirus disease 2019 (COVID-19). All COVID-19 information related to the 340B Program will appear on the COVID-19 Resources page, and we will update resources as they become available.

In response to the COVID-19 pandemic, HRSA is allowing some entities, upon request and review, to immediately enroll into the 340B Program. HRSA will post a supplemental Medicaid Exclusion File (MEF) (XLSX - 135 KB) every Friday, beginning April 10, 2020 that includes a list of entities who have been approved for immediate enrollment. This list is in addition to the quarterly MEF posted on the 340B Office of Pharmacy Affairs Information System.

Guidance to 340B providers in Louisiana, Mississippi, New Jersey, and New York

Public Health Emergency Declaration by the Secretary

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

Therefore, eligible entities in Louisiana, Mississippi, New Jersey, and New York 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.

Contact: 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.

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.

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.

Accessibility*

If you use assistive technology, you may not be able to fully access information in this file. For assistance, please email 340B-Communication@hrsa.gov.

Date Last Reviewed:  September 2021