340B Drug Pricing Program Annual Recertification for Hospitals

1. 340B Drug Pricing Program Annual Recertification forHospitals 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

2. Agenda • Purpose of recertification • Covered entity - program responsibilities • Recertification timeline • Recertification walk through

3. 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.

4. 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;

5. Covered Entity Responsibilities cont. • (4) maintenance of auditable records demonstrating compliance; • (5) systems/mechanisms are in place to reasonably ensure ongoing compliance with program requirements; and • (6) OPA is contacted as soon as possible if there is any material breach by the covered of any of the foregoing.

6. 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 April) • Continue with other entities as online systems are developed

7. Q3 FY 2012 Covered Entities Recertifying • Disproportionate Share Hospitals = 3282 Parent/Child • Critical Access Hospitals = 1085 Parent/Child • Rural Referral Centers = 76 • Sole Community Hospitals = 236 • Children’s Hospitals = 159 • Free Standing Cancer Hospitals = 5

8. 340B Recertification Steps

9. 340B Recertification Steps

10. Summary • 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 program

11. Contact Information Office of Pharmacy Affairs (OPA) Phone: 301-594-4353 or 1-800-628-6297 Web: http://www.hrsa.gov/opa and www.hrsa.gov/patientsafety Pharmacy Services Support Center (PSSC) Phone: 1-800-628-6297 Web http://pssc.aphanet.org/ Specific Recertification questions can be emailed to: 340b.recertification@hrsa.gov Change Request Form: http://opanet.hrsa.gov/OPA/HardcopyForms.aspx