Health Center Regulatory Issues

OPA 340B Recertification of FQHCs to Begin in February

HRSA’s Office of Pharmacy Affairs (“OPA”) has announced that recertification of FQHCs that participate in the 340B drug discount program will begin FEBRUARY 5, 2013.  FQHCs will have three weeks from that date to complete the recertification process. Recertification must be done on-line through the web portal that OPA has established for that purpose.

FQHC recertification is part of an OPA initiative to recertify the eligibility of all 340B covered entities required under the ACA. OPA already has completed the recertification of DSH hospitals and other HRSA-grantee covered entities. It is expected that recertification will be required annually for all 340B covered entities.

Here are some important points for FQHCs recertifying their 340B covered entity status.

  1. OPA will initiate the recertification process through an email that will be sent to all currently registered FQHC covered entities on February 1, 2013.  The e-mail will be sent only to the FQHC’s 340B Authorized Official (“AO”) and the 340B Contact Person that the FQHC identified on the OPA FQHC database.  Therefore, it is essential that FQHCs confirm the name and, importantly, the email address of their AO and Contact Person listed on the database before February 1.  It is advisable to do that as soon as possible to avoid potential access problems due to “last minute” overloading of the OPA electronic systems.
  2. FQHCs will be provided with a password to access the recertification website.  The password will be sent only to the FQHCs AO.  Therefore, it is critical that the FQHC’s AO be alerted to the importance of the incoming recertification email and keep a record of the recertification password.
  3. FQHCs must register each delivery site in their approved scope of project at which patients are prescribed and/or receive 340B drugs (OPA refers to these as “child” sites for 340B registration purposes).  OPA requires the “site number” for the site as assigned on HRSA’s Electronic Handbook (“EHB”).  FQHC’s should have that information available when they update their information on the recertification website.
  4. The recertification process is intended to assure that entities registered on the OPA covered entity data base continue to be eligible to purchase at the 340B discount and to update the information on the database regarding registered covered entities.  FQHCs (whether grantees or “look-alikes”) are eligible for the program, so covered entity eligibility is a simple matter of providing information regarding FQHC status, which OPA will confirm with BPHC.  However, FQHCs should pay particular attention to assuring that all other information requested is accurate.
  5. FQHCs should pay particular attention to indicating whether or not they dispense 340B drugs to Medicaid fee-for-service beneficiaries.  State Medicaid agencies use that information to determine whether or not to seek a rebate from manufacturers on drugs dispensed to Medicaid fee-for-service beneficiaries, but manufacturers are not required to pay a rebate when a drug is purchased under 340B.  An FQHC that fails to appropriately indicate that it dispenses 340B drugs to Medicaid fee-for-service beneficiaries could be responsible for a Medicaid agency claiming a rebate to which it is not entitled and incur liability as a result.
  6. The information in the recertification must be “signed off” by the FQHC’s AO when he/she electronically submits the recertification.  This process requires the AO to personally certify to the FQHC’s compliance with numerous 340B program requirements. The AO and key personnel involved in administering the FQHC’s 340B program should review these certifications carefully before submitting.
  7. According to OPA, FQHCs that do not recertify within the three week window will be deemed ineligible and dropped from the FQHC database.  OPA is not likely to give individual extensions.  Therefore, a timely response to the recertification is very important since the FQHC may have to wait until the next general registration period that begins April 1, 2013, to re-register.

Additional information about the recertification process and sample electronic forms can be found in the Database Guide to Recertification posted on the OPA website:

FQHCs may submit specific questions about recertification via e-mail to:

For additional information contact: Roger Schwartz— ; 202-296-0158