The COVID-19 public health emergency ends May 11, 2023
The COVID-19 public health emergency (PHE) will end on May 11, 2023. As such, the specific COVID-19 PHE flexibilities allowed under the 340B Program will expire on May 11, 2023.
Updated 5/11/23: In light of the end of the COVID-19 PHE, the 340B COVID-19 Resources Page has been removed. Covered entities should continue to comply with the 340B Program statute and all applicable regulations, guidance and policies. For audit purposes, entities should continue to maintain accurate records (including their policies and procedures) documenting their compliance with the 340B Program statute and all applicable regulations, guidance, and policies.
HRSA understands that the end of the PHE may raise questions regarding 340B Program administration and compliance. To the extent a 340B stakeholder has a specific circumstance where they believe the end of the PHE may affect their enrollment and compliance 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 apexusanswers@340bpvp.com. The 340B Prime Vendor will coordinate with HRSA, and each issue will be evaluated on a case-by-case basis.
Supplemental Medicaid Exclusion File for immediate registrations
HRSA's supplemental Medicaid Exclusion File (MEF) (XLSX - 218 KB) includes a list of entities that have been approved for immediate enrollment and will be posted through June 9, 2023. This list is in addition to the quarterly MEF posted on the 340B Office of Pharmacy Affairs Information System.
Implementation of Section 121 of the Consolidated Appropriations Act of 2022
The Consolidated Appropriations Act of 2022 was signed into law on March 15, 2022. Section 121 of the law permits certain hospitals to be reinstated into the 340B Drug Pricing Program if they meet the following conditions:
- The hospital must be classified as a:
- Disproportionate share hospital,
- Sole community hospital,
- Rural referral center,
- Children's hospital, or
- Free standing cancer hospital.
- The hospital must have been terminated from the 340B Program due to an inability to meet the statutorily-required disproportionate share adjustment (DSH percentage) during Medicare cost reporting periods beginning October 1, 2019 and ending no later than December 31, 2022.
- The hospital's termination must have been as a result of actions taken by or other impact on the hospital in response to, or as a result of, the COVID-19 Public Health Emergency (PHE).
- The hospital must have been a covered entity on January 26, 2020 (i.e., the day before the first day of the COVID-19 PHE).
If you believe that your hospital may be eligible for this exception and have not yet been contacted by HRSA, please contact the 340B Prime Vendor at 1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. ET) or apexusanswers@340bpvp.com. Requests will be evaluated on a case-by-case basis.
Guidance to 340B providers in Guam and Mississippi
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 Guam and Mississippi 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.