News & Resources

Publications & Media

“Key Dates Approaching for Title X Family Planning Grantees in the 340B Program”

To Be Or Not To 340B By Alyce C. Katayama and Elizabeth R. Gebarski

Mark your calendars! Calling all Title X Family Planning clinics that participate in the 340B Program—recertification opens May 13, 2015 and that means 340B Participant Change Forms must be submitted before that date.

Online 340B Participant Change Forms take between five and ten days to process. These forms will not be processed during recertification. However, change requests for Authorizing Officials (AOs) will be processed during recertification—a change to last year’s recertification procedures.

Recertification for Title X Family Planning clinics that participate in the 340B Program opens on May 13, 2015 and closes four weeks later on June 10, 2015. AOs and Primary Contacts can expect to receive a reminder email from the Office of Pharmacy Affairs (OPA) on May 11, 2015. On May 13, 2015, the AO will receive an email with the covered entity’s unique username and password from the OPA, which will instruct the AO to recertify the entity.

On April 15, 2015, LCDR Samuel Cardarella of the OPA conducted a 340B Recertification webinar for Title X Family Planning Grantees. He walked through the entire recertification gambit, although he indicated that there was no major change from last year.

All Title X Family Planning grantees with an active 340B ID and without a future termination date must recertify. Recertification must be completed regardless of when the facility initially registered. The responsibility for completing recertification, and doing so accurately, lies with the covered entity. The recertification process is the primary mechanism for annually capturing a covered entity’s updated information. LCDR Cardarella indicated that entities may still submit 340B Participant Change Forms online, but he stressed that filing these forms is not a substitute for recertification.

LCDR Cardarella devoted some time to the responsibilities of an AO, as this was an issue in previous years. The AO must be someone who can represent and confirm that s/he is 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 site.

The AO is the person the Federal Government contacts for requests of compliance, integrity evaluations, and audits. Therefore, the AO must be chosen with care. Because of the importance of this position, LCDR Cardarella recommended that the AO and Primary Contact be two separate individuals, to ensure that important communications and notifications from the OPA do not get lost if an entity’s AO leaves his or her position.

Finally, LCDR Cardarella urged covered entities to utilize the “OPA Database Guide for Public Users – Recertification.” The most recent version has not been updated since August 2013; however, LCDR Cardarella warned that it may be updated immediately preceding issuance of the recertification notification emails.

Remember: if your facility does not file for recertification within the four-week window (May 13, 2015 – June 10, 2015), it will be removed from the 340B Program!