340B Recertification: Annual Opportunity to Ensure 340B Program Compliance

The 340B Drug Pricing Program requires covered entities to ensure program integrity through several processes.¹

One important requirement for covered entities is recertification. Recertification is an annual process (see Table) to attest that the covered entity has maintained eligibility and program compliance as described in Section 340B of the Public Health Services Act.¹ Failure to recertify results in termination from the 340B Drug Pricing Program.

Recertification ensures database accuracy for all stakeholders and promotes the integrity of the program. During recertification, covered entities ensure that all information is accurate and up-to-date and all registered sites are eligible for 340B under the eligibility criteria. All covered entities are required to perform these steps for their parent and child sites (for hospitals) or associated sites (for grantees).

What is included when attesting to program compliance? When recertifying, the authorizing official (AO) testifies to program compliance. This covers many elements of the covered entity’s 340B program. The language within the recertification steps is included below.²

The undersigned further acknowledges the 340B covered entity’s responsibility to abide by the following:

As an AO, I certify on behalf of the covered entity that:

• All information listed on the 340B program database for the covered entity is complete, accurate, and correct;
• The covered entity meets 340B program eligibility requirements;
• The covered entity will comply with all requirements of Section 340B of the Public Health Service Act and any accompanying regulations, including, but not limited to, the prohibition against duplicate discounts and diversion (section 340B[a][5][A] and [B] of the Public Health Service Act);
• The covered entity maintains auditable records pertaining to compliance with the requirements described in paragraph 3, above, pursuant to section 340B(a)(5)(C) of the Public Health Service Act;
• If the covered entity uses contract pharmacy services, that the contract pharmacy arrangement will be performed in accordance with Office of Pharmacy Affairs (OPA) requirements and guidelines;
• The covered entity acknowledges its responsibility to contact OPA as soon as possible if there is any change in 340B eligibility and/or breach by the covered entity of any of the foregoing; and
• The covered entity acknowledges that if there is a breach of the requirements described in paragraph 3, above, that the covered entity may be liable to the manufacturer of the covered outpatient drug that is the subject of the violation and, depending upon the circumstances, may be subject to removal from the list of eligible 340B entities.

Necessary Activities and Materials

The first step in the recertification process is an email with advance notification. The AO and primary contact (PC) receive advance notification prior to the recertification window specific to the type of covered entity. Covered entities have their own unique recertification deadlines based on covered entity type. This notification includes the date recertification must be completed.² On day 1 of the recertification period, both the AO and the PC will receive notification with instructions and log in information for each unique 340B ID under the purview of the AO. The PC can go through the recertification steps outlined within the instructions and make any necessary changes to the database. Any changes made by the PC are then submitted to the AO for approval. In addition to approving any changes made by the PC, only the AO can perform the final recertification attestation and submission to the Health Resources and Services’ Administration.

The dates of the recertification periods fluctuate each year. Although each covered entity type is scheduled to recertify during a specific quarter, the actual dates do not typically occur during the same time period. For example, all HRSA and Indian Health Service grantees, excluding family planning, sexually transmitted diseases, and tuberculosis, recertify during the first quarter of each year, but the actual dates of the period differ. Covered entities can expect to recertify during the same quarter as the previous year. HRSA announces the official start and end dates for recertification about 4 to 6 weeks prior to the recertification period start date. For more information related to the quarter in which an entity should expect to recertify, entities should contact Apexus Answers.³

Recertification is an important process for HRSA and OPA to ensure an accurate database for all 340B stakeholders. With adequate preparation, the covered entity can promptly complete the process. High-level support will ensure the covered entities’ ability to provide the necessary information and attest to complete accuracy. Overall, recertification is an essential component of 340B program management and integrity.

Quick Tips:

• Collect all necessary documents and pieces of information before starting the recertification process.
• Ensure that AO and PC information is correct in the HRSA database before the recertification period. As of August 2018, hospitals have the ability to upload the Medicare cost report documents directly to the OPA Information System for automatic submission when completing recertification.
• Use the HRSA user guide, available at 340bopais.hrsa.gov/help/Resources/PDFUserGuides/PublicUserGuide.pdf

Ashley Mains Espinosa, PharmD, MS, CPHIMS, is the director of system pharmacy business services at SCL Health in Denver, Colorado.Christopher Loucks, PharmD, MS, is an assistant director of pharmacy at the University of Kansas Health System in Kansas City.Alexandra Williams, 340B ACE, is a 340B education and compliance specialist at Apexus in Durham, North Carolina.

References

• 340B drug pricing program requirements. HRSA website. hrsa.gov/opa/programrequirements/index.html. Updated December 2017. Accessed May 27, 2017.
• Recertification process. HRSA website. hrsa.gov/opa/updates/2015/july.html. Updated April 2017. Accessed October 16, 2018.
• 340B answers aligned with HRSA policy. Apexus website. 340bpvp.com/about/apexus-answers/. Accessed October 16, 2018.