340B Drug Pricing Program

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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, or is at risk of losing eligibility for 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, or risk of losing eligibility 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 [email protected]. A request to continue participation should only be submitted once the hospital has filed its next Medicare Cost Report that indicates the hospital did not meet the 340B statutorily required DSH percentage for the reporting period. Requests will be evaluated on a case-by-case basis.

Statement from the Health Resources and Services Administration Regarding Recent Court Rulings Involving the 340B Program

We are pleased that two of three recent U.S. District Court opinions involving the 340B Program agree with HRSA that three pharmaceutical manufacturers have unlawfully restricted access to 340B discounted drugs by covered entities that dispense medications through contract pharmacy arrangements – the core finding of HRSA's May 17, 2021, Violation Letters. HRSA respectfully disagrees with the recent District Court opinion finding that two other manufacturers had not violated the statute, and continues to evaluate its options.

Guidance to 340B Providers in New Mexico

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 New Mexico 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.