340B Covered Entity Recertification
An essential element to a covered entity’s ability to participate in the 340B Drug Pricing Program is the process of covered entity recertification. Having accurate information from the covered entities in the OPA database from the initial registrations and the annual recertification is important for 340B Program compliance. This update provides some reminders and tips for covered entities to help facilitate the recertification process.
HRSA is required by statute to recertify eligibility for all covered entity types on an annual basis. This enables HRSA to verify that all covered entities continue to meet the 340B statutory requirements. Recertification ensures program integrity, compliance, transparency and accountability. Recertification is the primary mechanism for annually capturing covered entities updated information in the 340B database.
Keys to the Recertification Process
- All entities with an active 340B ID, currently listed in the 340B database, that do not have a future, pending termination date are required to recertify regardless of the length of time participating in the 340B Program. Failure to recertify may be grounds for removal from the 340B Program.
- The listed Authorizing Official (AO) for the parent site (e.g., hospital) performs the recertification for the parent and all child sites (outpatient facilities, satellite sites, sub-grantees, sub-contractors), as well as all contract pharmacies associated with the covered entity. The AO is someone who represents and confirms that they are fully authorized to legally bind the covered entity into a relationship with the Federal Government and has knowledge of the practices and eligible programs at that entity site. The AO is also responsible for requests regarding compliance, integrity evaluations and audits. For hospitals, it is required that someone at the CEO/CFO/COO/President/Vice President level perform this role.
- To start the recertification process, HRSA sends an email message with the necessary user name and password to the AO listed for the parent covered entity. The AO is the only one who receives the email containing the user name and password required to access the online recertification form, and it is the Authorizing Official who is required to update and certify information pertaining to the parent entity and any associated child sites (i.e., outpatient clinics associated with a parent hospital).
- If any information needs to be corrected or modified, a 340B Program Change Request must be submitted online to update covered entity information prior to recertification. Change Request forms must be submitted by the Authorizing Official.
- Once the AO has completed any updates, they (a) “certify” the information is true and accurate, and (b) submit the recertification information for review by “attesting to 340B compliance”.
- HRSA/OPA reviews the recertification information and makes a determination to Accept All, Accept Partial or Reject All proposed changes in the database (i.e. recertify or decertify the covered entity).
- A completion notification is sent to the AO who will then have the ability to review the 340B database record for approved updates.
Recertification Helpful Hints and Best Practices
- Recertify early! Once the recertification period begins, do not wait to recertify. Waiting until the last days allotted for the recertification period typically does not allow sufficient time to receive any necessary technical assistance, and therefore increases the potential for recertification to fail.
- Carefully verify the accuracy of all entity information in the 340B database prior to starting the recertification process. Run a report first to ensure that the AO and Primary Contact Person information is correct, and that these roles have different names listed (i.e., not performed by the same individual).
- Be sure to have and follow documented policies and procedures for your recertification practices outlining who is responsible to complete both the registration and recertification processes.
- Schedule time with the AO and the Primary Contact Person to review each of the tabs in the recertification process. It is important that the AO clearly understands what is expected in recertification.
- Have the AO and all other appropriate staff review the Recertification Users Guide, which is updated prior to the initiation of the recertification process, at http://opanet.hrsa.gov/OPA/UserGuides.aspx
- Review the OPA database guide found at http://opanet.hrsa.gov/OPA_MOD/MANUALS/PUBLIC/CERecertify.pdf to become familiar with the process.
- Have all necessary information (e.g., grant #) and other documents available before starting the recertification process.
- Carefully read and follow the instructions.
Annual recertification is an important mechanism for 340B Program integrity. If you have any questions, or need further clarification, the team at ApexusAnswers-a service of the 340B contracted Prime Vendor Program-stands ready to assist by email (ApexusAnswers@340bpvp.com) or by phone (888-340-2787).