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The 340B Drug Pricing Program: The Basics

The 340B Drug Pricing Program: The Basics. Office of Pharmacy Affairs. Promoting Integrity, Access, & Value. to deliver clinically and cost-effective pharmacy services. Learning Objectives. Intent of the program. 340B Pricing determination. Entity eligibility. 1. 2. 3.

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The 340B Drug Pricing Program: The Basics

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  1. The 340B Drug Pricing Program: The Basics Office of Pharmacy Affairs Promoting Integrity, Access, & Value to deliver clinically and cost-effective pharmacy services.

  2. Learning Objectives Intent of the program 340B Pricing determination Entity eligibility 1 2 3 Entity enrollment procedure Program requirements and prohibitions Program guidance and policy 4 5 6 Patient eligibility determination Drug delivery options Available resources 7 8 9

  3. 340B DRUG PRICING PROGRAM $ Outpatient Drugs Drug Manufacturers Creation of the 340B Program

  4. Safety net providers 340B Eligible Entities Patients Intent of the 340B Program SAVINGS Improve financial stability Stretch dollars to serve vulnerable patients

  5. The 340B Price 340B The 340B price is actually a “ceiling” price DRUG PRICING PROGRAM Drug Manufacturers 25-50% of the average wholesale price Can offer sub-ceiling prices

  6. The 340B Price 340B OFFICE OFPHARMACY AFFAIRS The 340B price is actually a “ceiling” price DRUG PRICING PROGRAM Centers for Medicare and Medicaid Services Drug Manufacturers 25-50% of the average wholesale price

  7. 340B Entity Eligibility The eligibility to purchase at the 340B price belongs only to the entities

  8. Consolidated Health Centers FQHC look-alikes Family planning projects (Title X) Ryan White Care Act (Parts A, B, C, D) grantees Black lung clinics Comprehensive hemophilia diagnostic treatment centers Native Hawaiian health centers Urban Indian organizations Certified tuberculosis clinics Certain disproportionate share hospitals Certified sexually transmitted disease clinics 340B Entity Eligibility

  9. 340B Enrollment Procedure Click on “Legal Resources” http://www.hrsa.gov/opa Submit completed form to OPA OPA verifies eligibility Participation begins next quarterly database update ELIGIBLE ENTITIES MUST ENROLL FORMS AND ENROLLMENT INFORMATION ADMISSION PROCESS

  10. 340B Enrollment Procedure http://www.hrsa.gov/opa/legalresources.htm Click on “Introduction to 340B” FIND THE FORM COMPLETE THE FORM DEADLINES participation begins 1 month after the enrollment deadline

  11. Program Components Price Formula Eligible Entities Requirements & Prohibitions 340B Statute Requirements and Prohibitions 340B Legislation

  12. Audit Resell/Transfer Prohibition Duplicate Discount Prohibition Disproportionate Share Hospital GPO Exclusion Prime Vendor 340B Statute Requirements and Prohibitions

  13. Federal Register Notice publication OFFICE OFPHARMACY AFFAIRS 340B Regulation and Policy Interpreting the legislation and implementing the 340B Program may at times be a challenge www.hrsa.gov/opa

  14. Federal Register Notice publication OFFICE OFPHARMACY AFFAIRS entity has established relationship & maintains records of care 1 patient receives health care services from health care professional employed/contracted with entity 2 Definition of a Patient patient receives health care consistent with range of services from the covered entity 3 340B Regulation and Policy www.hrsa.gov/opa/federalregister.htm

  15. Federal Register Notice publication OFFICE OFPHARMACY AFFAIRS Definition of a Patient 340B Regulation and Policy If three requirements are not met, the person is not eligible for 340B drugs www.hrsa.gov/opa/federalregister.htm

  16. 340B Implementation Options 340B Eligible Entities Entities expressed interest in new ways to increase access to 340B drugs

  17. 340B Implementation Options OFFICE OFPHARMACY AFFAIRS Alternative Methods Demonstration Projects www.hrsa.gov/opa/alternativemethods.htm 340B Eligible Entities

  18. 340B Program Resources: Integrity Access Value

  19. Integrity Importance of Comprehensive Pharmacy Services Integrity Resource: Office of Pharmacy Affairs (OPA) Develops innovative pharmacy service models and supports technical assistance Serves as Federal resource for pharmacy practice Administers 340B program • Access to affordable drugs • Application of “best practices” • Efficient pharmacy management • Systems to improve patient outcome

  20. Operates Access Resource: Pharmacy Services Support Center (PSSC) Helps eligible entities, implement and optimize the 340B program • Provides • information resources, • policy analysis & • education Access • Call Center • Web Site • Outreach Program • Pharmacy Technical Assistance Program

  21. Value Resource: Prime Vendor Program (PVP) Negotiates sub-ceiling prices Helps with access to drug distribution solutions Offers value added products and services Offered at no cost to entity Value

  22. www.hrsa.gov/opa 1-800-628-6297 OFFICE OFPHARMACY AFFAIRS pssc@aphanet.org pssc.aphanet.org 1-888-340-2787 340B_primevendor@340bpvp.com www.340bpvp.com How to Access Resources:

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