Understanding the 340B Program: Integrity, Access & Value

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. Purpose of Activity 340B 101: The Basics The purpose of this module is to illustrate the history, intent and statutory principles of the 340B Drug Pricing Program.

3. Topic Guide Intent of the program 340B pricing determination Entity eligibility Entity enrollment procedure Program guidance and policy Program requirements and prohibitions Patient eligibility determination Drug-delivery options Available resources

4. Creation of the 340B Program

5. Intent of the 340B Program • 1. HR Rep No. 102–384, pt 2, at 12 (1992).

6. 340B Program Evolution

7. The 340B price is actually considered a “ceiling” price 340B Drug Pricing Program Drug Manufacturers 340B Price 25%–50% of the average wholesale price Can offer sub-ceiling prices

8. 340B Covered Drugs 11

9. Federal Grantees Hospital Types 340B Eligible Entities • Disproportionate share hospitals • Children’s hospitals* • Critical access hospitals* • Free-standing cancer hospitals* • Rural referral centers* • Sole community hospitals* *340B eligible through Section 7101 of the Affordable Care Act (ACA) 11 • Comprehensive hemophilia treatment centers • Federally qualified health centers/lookalikes • Urban/638 health center • Ryan White programs • Sexually transmitted disease/tuberculosis • Title X family planning

10. Hospital Eligibility Criteria *340B eligible through Section 7101 of the Affordable Care Act (ACA)

11. Hospital Outpatient Facilities 11 • In order for outpatient facilities to become eligible for the 340B Program: • The outpatient facility must be an integral part of the hospital • The outpatient facility must be included as reimbursable on the covered entity’s most recently filed Medicare Cost Report • To register additional outpatient facilities, complete the online Register an Outpatient Facility registration at: http://opanet.hrsa.gov/OPA/CERegister.aspx

12. 340B Enrollment Procedure http://opanet.hrsa.gov/OPA/CERegister.aspx

13. 340B Implementation • Ensure entity is listed correctly in the OPA 340B database • Set up an account with wholesaler using 340B ID for purchasing • Wholesalers will not ship discounted drugs unless 340B ID is an exact match to the 340B database • Prepare operational and logistical monitoring, auditing, and compliance processes and procedures • Utilize available resources • Prime Vendor Program for sub-ceiling 340B pricing, value-added services and for technical assistance

14. 340B Prohibitions and Requirements

15. Duplicate Discount Prohibition • Duplicate Discount • Accessing the 340B discount AND Medicaid Rebate on the same drug • Medicaid Exclusion File at: http://opanet.hrsa.gov/opa/CEMedicaidExtract.aspx • Medicaid Exclusion Tutorial at: http://www.hrsa.gov/opa/medicaidexclusion.htm • State policies • Entities should contact their state Medicaid offices for state-specific requirements for using 340B with Medicaid patients. Fed Regist. 2000;65(51):13983–4.

16. Diversion Prohibition • Diversion occurs when: • A drug is provided to an individual who is not a patient of that entity • Required to follow patient definition guidelines1 • A drug is dispensed in an area of a larger facility that is not eligible (e.g., an inpatient service, a non-covered clinic) • Entities should enroll all eligible outpatient or satellite sites 1. Fed Regist.1996;61(207):55156–8.

17. GPO Prohibition DSHs GPO Prohibition Only Applies to PEDs CANs Hospitals can continue to purchase all products for inpatient operations through a GPO, even if their outpatient departments participate in 340B. GPO prohibition prohibits certain entities from purchasing any covered outpatient drugs through a GPO or other group-purchasing arrangement, even if items are available at a lower price through the GPO.

18. The Orphan Drug Exclusion CAHs Orphan Drug Exclusion Only Applies to SCHs RRCs CANs The Orphan Drug Product Designation Database can be found at: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm The orphan drug exclusion prohibits certain entities from purchasing orphan drugs at 340B discount prices.

19. 340B Guidance and Policy http://www.hrsa.gov/opa/federalregister.htm

20. 340B Proposed Regulations

21. Patient Definition For eligibility, three components must always be considered regarding the individual and his/her associated prescription: Fed Regist. 1996;61(207):55156–8.

22. Drug Delivery Contract Pharmacies Fed Regist. 2010;75(43):10272–9. • 340B Program allows entities to have multiple contract pharmacies for increased patient access to cost-effective pharmaceuticals • Covered entity purchases the drug, but “ship to/bill to” procedure may be used • Covered entity retains legal title to all drugs purchased under 340B and must pay for all 340B drugs

23. 340B Usage Considerations 11

24. 340B Program Resources 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

25. Office of Pharmacy Affairs (OPA) Integrity • Administrates over the 340B Drug-Pricing Program • Develops innovative pharmacy service models and provides technical assistance to help entitiesimplement effective pharmacy programs • Serves as a federal resource about pharmacy • Emphasizes the importance of comprehensive pharmacy services functioning as integral part of primary health care 

26. Prime Vendor Program(PVP) Access • Relationships and networking • Policy analysis • Education • 340B University • Technical assistance • Apexus Answers Call center • 340B tools and resources • www.340bpvp.com

27. Prime Vendor Program (PVP) Value • Negotiation of • 340B sub-ceiling pricing • Discounts on value-added products, services, and supplies • Overcharge recovery • Pricing transparency • Reports and tools • Technical assistance

28. 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/

29. 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/