UPDATE: HRSA revises registration process. Read more
HRSA rules require that all offsite clinics and departments associated with a child site of a parent hospital must individually register as child sites of the covered entity if the covered entity purchases and/or provides 340B drugs to patients of those facilities. The registration requirement applies even when multiple clinics/departments share the same building and may have been registered previously as a single child site. For example, in a specialty hospital considered a child site of a larger IDN that serves as the parent, each department of the child site hospital (ED, oncology, etc.) must register with OPA as a separate child site.
Outpatient clinics and departments within the hospital’s four walls do not need to register separately for the 340B Program. However, as always, the covered entity must maintain auditable records for those clinics/departments to demonstrate that they are meeting all program integrity requirements.
You can register all new covered entities, add outpatient facilities, and register contract pharmacies now through April 15 for an effective start date of July 1. The OPA encourages you to register early to allow time to resubmit your registration if they determine that the information you’ve provided is incorrect or incomplete.
For all the latest details specific to this registration period, or to begin the registration process, visit http://opanet.hrsa.gov/opa/.
Here are a few additional reminders regarding registration:
- For hospital registrations: In addition to the complete on-line registration, any required supporting documentation must be submitted on the same day as on-line registration is completed. To learn more about what constitutes a complete registration package, click here. This documentation may be emailed or faxed to the location listed for your entity type, or delivered via overnight courier to:
Health Resources and Services Administration
Attn: Office of Pharmacy Affairs
5600 Fishers Lane, 10C-03
Rockville, MD 20857
- For contract pharmacy registrations: Signed contract certification forms are no longer required; covered entity authorizing officials will receive e-mailed requests to certify registrations (or terminations) online and will have 15 calendar days to respond. Requests will expire if not certified within 15 calendar days.
- For registration of other entity types: See specific instructions on the OPA website.
For personalized registration assistance, contact the 340B Prime Vendor Program at email@example.com or call 1.888.340.2787.