Covered Entity Responsibilities

340B Drug Pricing Program
Annual Recertification for
LCDR Joshua E. Hardin MBA, RN/BSN, MLT
340B Recertification Program Manager
U.S. Department of Health and Human Services
Health Resources and Services Administration
Healthcare Systems Bureau
Office of Pharmacy Affairs
Purpose of recertification
Covered entity - program responsibilities
Recertification timeline
Recertification walk through
Purpose of 340B Recertification
- Ensure program integrity, compliance, and
accountability within HRSA/OPA 340B Drug Program.
- Operate the most cost efficient database possible
while further enhancing the quality and
appropriateness of services delivered.
- Require and support efforts where our covered entity
and manufacturers are able to identify and resolve
issues themselves.
Covered Entity Responsibilities
The covered entity is responsible for ensuring:
• (1) all information listed on the 340B Program database for that
covered entity is complete, accurate, and correct;
• (2) all 340B Program eligibility requirements since being listed as
eligible on the 340B database have been met;
• (3) compliance with all requirements and restrictions of Section
340B of the Public Health Service Act and any accompanying
regulations or guidelines including, but not limited to, the prohibition
against diversion and duplicate discounts;
Covered Entity Responsibilities cont.
• (4) maintenance of auditable records demonstrating
• (5) systems/mechanisms are in place to reasonably
ensure ongoing compliance with program requirements;
• (6) OPA is contacted as soon as possible if there is any
material breach by the covered of any of the foregoing.
Recertification Timeline
• Began phased implementation of annual
recertification starting 2011
• Ryan White Programs completed Q4 FY 2011
• STD/TB-completed Q1 FY2012
• Family Planning –Currently Ongoing Q2 FY 2012
• Hospitals- Scheduled Q3 FY 2012 (Beginning in
• Continue with other entities as online systems
are developed
Q3 FY 2012 Covered Entities
• Disproportionate Share Hospitals = 3282
• Critical Access Hospitals = 1085 Parent/Child
• Rural Referral Centers = 76
• Sole Community Hospitals = 236
• Children’s Hospitals = 159
• Free Standing Cancer Hospitals = 5
340B Recertification Steps
• Ensure all information in 340B Database is accurate and prepared for recertification via change request form
for any changes by 3/1/2012 deadline
• Only Entities that have been in the system at least 12 months will be required to recertify
• Email with user name and Password will be mailed to the Authorizing Official listed for the parent hospital
• Authorizing Official for Parent will be required to recertify for Parent and all Children (Outpatient Facilities
associated with the parent hospital) sites
340B Recertification Steps
• Authorizing Official will be required to certify and update any information that is not complete for any
Parent/Child site. As the database has progressed throughout time, more requirements have been
added and additional information may be required to be entered by Authorizing Official
• Once Authorizing Official has completed any additional program updates they will “Certify” that their
information is true, accurate, and that the Hospital is in compliance with all program requirements.
• HRSA/OPA will review certifications and verify/request any additional information to support changes
made to the database on behalf of the Authorizing Official
• HRSA/OPA will Recertify or Decertify the Covered Entity
• 340B Recertification is integral to OPA program integrity
• It is Imperative that Covered Entities ensure change
requests forms are submitted ASAP for updating the
database and submitted by the Authorizing Official.
• All requests received after March 1, 2012 are not
guaranteed to be entered prior to recertification beginning
in April.
• Covered Entities with inaccurate information in the
database run a high risk of being removed from the
Contact Information
Office of Pharmacy Affairs (OPA)
Phone: 301-594-4353 or 1-800-628-6297
Web: and
Pharmacy Services Support Center (PSSC)
Phone: 1-800-628-6297
Specific Recertification questions can be emailed to:
[email protected]
Change Request Form:

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