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Optimizing The 340B Program

Optimizing The 340B Program. Promoting Integrity, Access, & Value To deliver clinically and cost-effective pharmacy services. This educational product created by: Health Resources and Services Administration | Office of Pharmacy Affairs 340B Peer-to-Peer Program.

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Optimizing The 340B Program

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  1. Optimizing The 340B Program Promoting Integrity, Access, & Value To deliver clinically and cost-effective pharmacy services This educational product created by: Health Resources and Services Administration | Office of Pharmacy Affairs 340B Peer-to-Peer Program

  2. The Office of Pharmacy Affairs: The 340B Integrity Resource Purpose of Activity The purpose of this module is to explain the history and functions of the HRSA Office of Pharmacy Affairs.

  3. Topic Guide Explain the history of OPA Describe why OPA is the 340B Integrity Resource List the functions of OPA Outline how OPA helps stakeholders

  4. History of OPA Office of the Associate Administrator for the Healthcare Systems Bureau Countermeasures Injury Compensation Program Poison Control Centers Division of Transplantation Division of Health Facilities Office of Vaccine Injury Compensation Office of Pharmacy Affairs 

  5. History of Office of Pharmacy Affairs U. S. Department of Health and Human Services Health Resources and Services Administration Created in 1992 340B Drug Pricing Program 340B Program The Office of Pharmacy Affairs

  6. 340B Program Support Program integrity assures stakeholders that the 340B Program’s intent is being met and that rules are being followed. Access to services under the 340B Program is important because it ensures that entities and their patients have the means to fully utilize the program’s benefits. The value that program participation brings to entities is essential for stretching scarce entity resources. Integrity Access Value

  7. 340B Program Integrity Resource Various stakeholderswith differentinterests Clarificationof legalresources 340B Complexities Drug pricingtransparency OPA offers mechanisms to address and strengthen program integrity Frequentinformationupdates inOPAdatabase Practicalprogramimplementationguidance needed

  8. 340B Program Integrity Resource Integrity Audits Accurate &consistentinterpretationof law/policy FederalRegisterNotices Transparencyin drugpricing In all of its functions, OPA prioritizes program integrity OPAmaintains datafor each 340Bentity. Annualrecertification Website FAQ & PVP CallCenter

  9. Functions of OPA Administrator of 340B Program Program oversight to help maximize value of 340B Service as Federal resource on pharmacy

  10. Clinically and Cost-Effective Pharmacy Services

  11. Managing PHS Pharmaceutical Pricing Agreements with drug manufacturers  Maintaining the OPA database  Publishing guidelines/regulations  Implementing & overseeing 340B Prime Vendor Program  Coordinating 340B implementation activities of programs in HRSA, CDC, IHS, & Office of Population Affairs  Working with CMS and the U.S. Department of Veterans Affairs  Administration of 340B Program

  12. Maintains liaison with grantee associations, professional organizations, the pharmaceutical industry, & trade associations  Develops & maintains cooperative relationships with national pharmacy & governmental organizations  Federal Resource About Pharmacy

  13. Legal resources On-line program enrollment Federal Register Notices Policy Releases New information Program information How OPA Helps Stakeholders Comprehensive Website http://www.hrsa.gov/opa

  14. Enrolling in 340B Complete & submit online registration http://opanet.hrsa.gov/OPA/Default.aspx Once enrolled, entity is responsible for ensuring database is up-to-date 340B Program Enrollment Deadlines

  15. Enrollment Forms http://opanet.hrsa.gov/OPA/CERegister.aspx

  16. Contract Pharmacy Registration

  17. PPA Enrolling as Manufacturer Office of Pharmacy Affairs

  18. OPA Website Resources Links Legal Resources • Law creating the 340B Program • Federal Register Notices regarding the 340B Program • Official documents issued by other governmental agencies (ex. Office of the Inspector General)

  19. OPA Database

  20. Covered Entity Search

  21. Contract Pharmacy Search

  22. Manufacturer Search

  23. Reports

  24. 1-888-340-2787 ApexusAnswers@340bpvp.com 340B Resource Information Health Resources and Services Administration http://www.hrsa.gov/opa/ http://www.hrsa.gov/publichealth/clinical/patientsafety/index.html 340B Prime Vendor Program Managed by Apexus https://www.340bpvp.com/

  25. Thank you for viewing this 340B tutorial developed by : Health Resources and Services Administration Office of Pharmacy Affairs 340B Peer-to-Peer Program You can view additional 340B educational products and tools specifically developed to assist 340B-participating entities create and maintain processes to ensure 340B program integrity at: www.hrsa.gov/opa/peertopeer/

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