The 340B Drug Pricing Program: The Basics INTEGRITY ACCESS VALUE 1

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1 The 340B Drug Pricing Program: The Basics INTEGRITY ACCESS VALUE 1

2 Learning Objectives Intent of the program 340B Pricing determination Entity eligibility Program requirements and prohibitions Entity enrollment procedure Program guidance and policy 7 Patient eligibility determination 8 Drug delivery options 9 Available resources INTEGRITY ACCESS VALUE 2

3 What is 340B? 340 entities? 340 drugs on the formulary? Year it was created? 340 pharmacies? 340 hospitals? 340 lawyers that got together 340 manufacturers INTEGRITY ACCESS VALUE 3

4 Creation of the 340B Program 340B DRUG PRICING PROGRAM $ Drug Manufacturers Outpatient Drugs INTEGRITY ACCESS VALUE 4

5 Intent of the 340B Program Safety net providers 340B Eligible Entities SAVINGS Improve financial stability Stretch dollars to serve vulnerable patients Patients INTEGRITY ACCESS VALUE 5

6 The 340B Price 25-50% of the average wholesale price The 340B price is actually a ceiling price 340B DRUG PRICING PROGRAM Can offer sub-ceiling prices Drug Manufacturers INTEGRITY ACCESS VALUE 6

7 The 340B Price 25-50% of the average wholesale price The 340B price is actually a ceiling price 340B DRUG PRICING PROGRAM OFFICE OF PHARMACY AFFAIRS Drug Manufacturers Centers for Medicare and Medicaid Services INTEGRITY ACCESS VALUE 7

8 340B Entity Eligibility The eligibility to purchase at the 340B price belongs only to the entities INTEGRITY ACCESS VALUE 8

9 340B Entity Eligibility Consolidated Health Centers Federally Qualified Health Center, or FQHC look-alikes Family planning (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 (>11.75%) Certified sexually transmitted disease clinics INTEGRITY ACCESS VALUE 9

10 340B Enrollment Procedure ELIGIBLE ENTITIES MUST ENROLL FORMS AND ENROLLMENT INFORMATION Click on Legal Resources ADMISSION PROCESS Submit completed form to OPA OPA verifies eligibility Participation begins next quarterly database update INTEGRITY ACCESS VALUE 10

11 340B Enrollment Procedure FIND THE FORM COMPLETE THE FORM Click on Introduction to 340B DEADLINES participation begins 1 month after the enrollment deadline INTEGRITY ACCESS VALUE 11

12 340B Statute Requirements and Prohibitions 340B Legislation Program Components Price Formula Eligible Entities Requirements & Prohibitions INTEGRITY ACCESS VALUE 12

13 340B Statute Requirements and Prohibitions Prime Vendor Audit Resell/ Transfer Prohibition Duplicate Discount Prohibition Disproportionate Share Hospital GPO Exclusion INTEGRITY ACCESS VALUE 13

14 340B Regulation and Policy Interpreting the legislation and implementing the 340B Program may at times be a challenge OFFICE OF PHARMACY AFFAIRS Federal Register Notice publication INTEGRITY ACCESS VALUE 14

15 340B Regulation and Policy 1 entity has established relationship & maintains records of care 2 patient receives health care services from health care professional employed/contracted with entity Definition of a Patient 3 patient receives health care consistent with range of services from the covered entity OFFICE OF PHARMACY AFFAIRS Federal Register Notice publication INTEGRITY ACCESS VALUE 15

16 340B Regulation and Policy Definition of a Patient If three requirements are not met, the person is not eligible for 340B drugs OFFICE OF PHARMACY AFFAIRS Federal Register Notice publication INTEGRITY ACCESS VALUE 16

17 340B Implementation Options 340B Eligible Entities Entities expressed interest in new ways to increase access to 340B drugs INTEGRITY ACCESS VALUE 17

18 340B Implementation Options 340B Eligible Entities OFFICE OF PHARMACY AFFAIRS Alternative Methods Demonstration Projects INTEGRITY ACCESS VALUE 18

19 340B Program Resources: Integrity Access Value INTEGRITY ACCESS VALUE 19

20 Integrity Resource: Office of Pharmacy Affairs (OPA) Administers 340B program Integrity Develops innovative pharmacy service models and supports technical assistance Serves as Federal resource for pharmacy practice Importance of Comprehensive Pharmacy Services Access to affordable drugs Application of best practices Efficient pharmacy management Systems to improve patient outcome INTEGRITY ACCESS VALUE 20

21 Access Resource: Pharmacy Services Support Center (PSSC) Helps eligible entities, implement and optimize the 340B program Provides information resources, policy analysis & education Access Operates Call Center Web Site Outreach Program Pharmacy Technical Assistance Program INTEGRITY ACCESS VALUE 21

22 Value Resource: Prime Vendor Program (PVP) Negotiates subceiling prices Helps with access to drug distribution solutions Offers value added products and services Offered at no cost to entity Value INTEGRITY ACCESS VALUE 22

23 Staying connected to the 340B World ASHP meetings June and December APHA meeting April 340B Coalition meetings January and July APhA Pharmacy Today Access For All Network at various entity specific meetings (NACHC, NAPH, Primary Care Associations,etc.) SNHPA HRSA PSSC Prime Vendor Program The Monitor List Serves Others INTEGRITY ACCESS VALUE 23

24 Contacts: OFFICE OF PHARMACY AFFAIRS Pharmacy Services Support Center pssc.aphanet.org Prime Vendor Program INTEGRITY ACCESS VALUE 24

25 Thank You! INTEGRITY ACCESS VALUE 25