340B Registration Reviews and Additional Program Integrity Analysis

The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau (HSB), Office of Pharmacy Affairs (OPA) is committed to maintaining the integrity of the 340B Drug Pricing Program (340B Program). HRSA continuously reviews and updates processes to improve program integrity, and would like to update stakeholders on our continued efforts as it relates to the registration process. In addition to the standard registration reviews conducted by HRSA to ensure covered entities meet statutory requirements, HRSA may request additional information from covered entities during the registration process. These additional program integrity requests are specific to hospital eligibility documentation and contract pharmacy agreements of all covered entities registering for the 340B Program. During the registration process, a randomly generated list of hospital and contract pharmacy registrations are chosen for additional program integrity analysis and HRSA will request additional supporting documentation as outlined below. HRSA will continue to enhance this process and will keep stakeholders informed. Because the documentation requested is related to statutory eligibility requirements, covered entities are required to provide the documentation and should have all the information with them at the time of registration.

Program Integrity Analysis for Hospital Eligibility

Hospitals must first register for the 340B Program in order for HRSA to verify the hospital meets all statutory requirements prior to participation. For more information about documentation and the standard registration process for hospitals, please visit the 340B Program Registration webpage.

Section 340B(L)(i) of the Public Health Service Act defines the hospital classifications that are eligible for the 340B Program. New hospitals registering for the 340B Program must choose one of the following statutory classifications:

1. Owned or operated by a State or local government;
2. Private, non-profit with contract with a State or local government; or
3. Public or private non-profit corporation which is formally granted governmental powers by a unit of State or local government.

As part of HRSA’s additional program integrity requests, hospitals must be able to provide documentation, if asked, to support the chosen hospital classification upon registration. In addition, HRSA may also request the hospital’s latest filed Medicare cost report worksheets A and C and the hospital’s trial balance. These documents should always be maintained as part of the hospital’s auditable records. HRSA reserves the right to request additional documentation if needed to verify eligibility of the hospital and any off-site, outpatient facilities.

Program Integrity Analysis for Contract Pharmacy Registrations

Covered entities must register their contract pharmacies and be listed on the 340B OPAIS prior to dispensing 340B drugs on a covered entity’s behalf. Covered entities must have a written, signed contract pharmacy agreement in place with the contract pharmacy prior to registering that pharmacy with the 340B Program. For more information about the documentation and the standard contract pharmacy registration process, please visit the the 340B Program Contract Pharmacy Services webpage.

HRSA’s additional program integrity analysis includes requests to covered entities to provide the written contract upon registration. HRSA reviews the contracts to ensure that they:

1. are dated prior to the registration period;
2. list all covered entity locations and all pharmacies with addresses, which should be an identical match to those within the registration; and
3. include signatures of officials from both the entity and the pharmacy.

Complying with requests for documentation

If HRSA requests additional documentation during the registration process, the Authorizing Official (AO) will be notified through the 340B OPAIS. Therefore, AOs should regularly check their 340B OPAIS dashboards and monitor email for communications from the 340B Program. The registration will be rejected if the entity fails to produce the requested documentation, and the covered entity would have to re-register itself or its contract pharmacies during the next quarterly registration period.

For technical assistance, or if you need further information, the 340B Prime Vendor Program is available at ApexusAnswers@340bpvp.com or by phone at 888-340-2787.