Pharmacy Access: The 340B Program June 24, 2008

1. Health Resources and Services Administration2008 Primary Health Care All-Grantee Meeting Pharmacy Access: The 340B ProgramJune 24, 2008 Ann Ferrero & Bhavani Pattabiraman Public Health Analysts U.S. Department of Health and Human Services Health Resources and Services Administration Healthcare Systems Bureau Office of Pharmacy Affairs

2. Office of Pharmacy Affairs Mission • Mission: Promote access to clinically and cost effective pharmacy services • Maximize the value of participation in 340B • Develop innovative pharmacy services • Serve as a Federal resource for pharmacy practice

3. Program Administration • Three Legs of the 340B Program • Federal Team (OPA) • Pharmacy Services Support Center (PSSC) • 340B Prime Vendor Program (PVP) OPA/340B Program FEDS PVP PSSC

4. Pharmacy Services Support Center (PSSC) • American Pharmacists Association (APhA) • Services to OPA and 340B covered entities • Information and analysis • Relationships and networking • Program development/Free Technical Assistance • Partner with schools of pharmacy to encourage students to develop projects in 340B Safety-net organizations that promote access to clinically and cost effective pharmacy services.

5. Prime Vendor Program (PVP) • No cost to participate/voluntary • Drug price negotiation services • > 3000 drug items average 10% below 340B ceiling price • > $2 billion in purchase volume • Multiple wholesale distributor agreements • All national and most regional wholesalers • Favorable distribution costs • Other value added products/services

6. What is the 340B Drug Pricing Program? • Section 340B of the Public Health Service Act • Provides discounts on outpatient drugs to certain safety-net covered entities • Covered drugs are only for covered entity patients • Manufacturers that participate in Medicaid must also participate in the 340B program

7. 340B Eligible Entities • Federally Qualified Health Centers (FQHC) • Comprehensive Hemophilia Treatment Centers • Ryan White Programs (Parts A, B, C, D) • Sexually Transmitted Disease/Tuberculosis Programs (STD/TB) • Title X Family Planning Clinics • Urban / 638 Tribal Programs • Federally Qualified Health Center Look-Alikes (FQHC-LA) • Disproportionate Share Hospitals (DSH) • Children’s Hospitals (Pending)

8. HRSA Grant Award and Participation in 340B Drug Pricing Program • “…If your organization is eligible to be a covered entity under Section 340B of the PHSA and the assessment shows that participating in the 340B Drug Pricing Program and its Prime Vendor Program is the most economical and reasonable manner of purchasing or reimbursing for covered outpatient drugs (as defined in section 340B), failure to participate may result in a negative audit finding, cost disallowance or grant funding offset.”

9. Program Benefits • Average savings of 25-50% on outpatient drug purchases for 340B covered entities • Savings may be used to: • Reduce price of pharmaceuticals for patients • Expand drug formularies • Expand services offered to patients

10. Program Prohibitions • Diversion • Drug provided to a non-patient • Drug dispensed in an area of a larger facility that is not included in the defined covered entity • Non-covered services • Duplicate Discounts • 340B Discount + Medicaid Rebate on same drug • Covered Entities must report Medicaid billing status • For more information: http://www.hrsa.gov/opa/medicaidexclusion.htm

11. OPA Website: http://www.hrsa.gov/opa

12. OPA Website: http://www.hrsa.gov/opa/legalresources.htm

13. OPA Database: http://opanet.hrsa.gov/opa/Login/MainMenu.aspx

14. OPA Database: http://opanet.hrsa.gov/opa/CE/CEExtract.aspx

15. OPA Database: http://opanet.hrsa.gov/opa/CP/CPExtract.aspx

16. Growth of 340B Drug Pricing Program

17. Growth of 340B Program by Covered Entity Type

18. Growth of HRSA Grantee and FQHC Look-alike 340B Covered Entity Sites

19. Growth in 340B Contract Pharmacy Arrangements

20. Participation in 340B Prime Vendor Program

21. Alternative Methods Demonstration Projects (AMDP) – December 2001-May 2008

22. Proposed Guidance • Definition of Patient (72 FR 1543) • Clarifies previous FR Notice of October 1996 • Provides specific guidance and examples • A clear and enforceable definition to help ensure against diversion and support 340B program integrity • Status • Comment Period 1/12/07 – 03/13/07 • Comments being reviewed and final publication being developed

23. Proposed Guidance • Contract Pharmacy (72 FR 1540) • Updates previous FR Notice of August 1996 • Builds upon experience with Demonstration Projects • Incorporates Multiple Pharmacies as standard option • Status • Comment Period 1/12/07 – 03/13/07 • Comments being reviewed and final publication being developed

24. Proposed Guidance • Children’s Hospitals • Clarifies children’s hospitals responsibilities as 340B covered entities • Describes application procedures • Reaffirms drug manufacturers’ responsibility to furnish 340B discounts under Pharmaceutical Pricing Agreement (PPA) • Status • Comment period 7/9/07 – 9/7/07 • Comments being reviewed and final publication being developed

25. Grants to Establish or Expand Comprehensive Pharmacy Services • Purpose: To increase access to pharmacy services for CHC by establishing or expanding pharmacy services • Approximately 40 awards up to $150,000 per year, for two years • Anticipated Award Date: Sept 1, 2008

26. Grants Concepts to Establish or Expand Pharmacy Services • Onsite or contract pharmacy services • 340B and the Prime Vendor Participation • Effective risk management practices • Clinical pharmacy services including MTM • Partnership with school or college of pharmacy • Pharmacy “best practices” • Patient Safety & Clinical Pharmacy Collaborative

27. Patient Safety Clinical Pharmacy Services Collaborative (PSPC) • Patient Safety Problem: • IOM reports medication errors injure 1.5 Million people and cost billions annually. • Pharmacy services in HRSA programs & safety-net partners growing rapidly. HRSA desires these programs to be the best and safest in the United States. • Solution: • Work with internal and external stakeholders • Identify safety-net best practice models of patient safety/ clinical pharmacy services. • Use technical assistance and “collaborative care model” to transfer best practices to other safety-net providers

28. PSPC Performance Goals • More High Quality, Cost-Effective Clinical Pharmacy Services • Enhanced Patient Safety • Effective Health Outcomes

29. PSPC Timelines • 34 Site Visits completed = Leading Practices • Expert Panel = Change Package + Faculty • Enroll teams – May and June 2008. Enrollment deadline July 1, 2008. • First Learning Session - August 13 - 15, 2008 • Fourth and Final Learning Session in Fall 2009

30. Patient Safety Clinical Pharmacy Services Collaborative • For more information: • http://www.hrsa.gov/patientsafety • http://www.healthdisparities.net • Contact: Phone: 1-800-628-6297 Email: patientsafety@hrsa.gov

31. Questions?

32. Contact Information Office of Pharmacy Affairs (OPA) Phone: 301-594-4353 or 1-800-628-6297 Web: http://www.hrsa.gov/opa Pharmacy Services Support Center(PSSC) Phone: 1-800-628-6297 Web: http://pssc.aphanet.org Prime Vendor Program (PVP) Phone: 1-888-340-2787 Web: http://www.340bpvp.com