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Apexus’ 340B Update 14th Annual NPPA Conference Thursday, August 12, 2010 The MGM Grand, Las Vegas

Apexus’ 340B Update 14th Annual NPPA Conference Thursday, August 12, 2010 The MGM Grand, Las Vegas. John Barnes, C.P.M. Director, National Contracts 340B Prime Vendor Program Apexus Inc. Irving, Texas. Objectives. Verbalize an overview (basic rules) of the 340B Drug Pricing Program  

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Apexus’ 340B Update 14th Annual NPPA Conference Thursday, August 12, 2010 The MGM Grand, Las Vegas

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  1. Apexus’ 340B Update 14th Annual NPPA Conference Thursday,August 12, 2010 The MGM Grand, Las Vegas John Barnes, C.P.M. Director, National Contracts 340B Prime Vendor Program Apexus Inc. Irving, Texas

  2. Objectives • Verbalize an overview (basic rules) of the 340B Drug Pricing Program   • Define 340B expansion cited in health reform (PPACA) • Explain the new 340B integrity provisions • Describe the Prime Vendor Program’s strategic initiatives and interaction to health reform provisions

  3. 340B Program Administration • The 340B Program Team: • HRSA’s Office of Pharmacy Affairs • Pharmacy Services Support Center (PSSC/PharmTA) • 340B PVP Prime Vendor Program (Apexus Inc.)

  4. 340B Drug Program Overview • Section 340B of the Public Health Service Act • Provides discounts on outpatient drugs to certain safety-net covered entities • Estimated six billion dollars in 340B drug purchases last year • Manufacturers that participate in Medicaid must also participate in the 340B Program

  5. Program Benefits • The 340B Drug Program average savings of 25-50% on outpatient drug purchases for 340B covered entities on >20,000 NDC’s • The 340B Prime Vendor offers additional savings of 15% on over 3,500 NDC’s • Savings may be used to: • Reduce price of pharmaceuticals for patients • Expand services offered to patients • Provide services to more patient

  6. Health Care Reform • Affordable Care Act - P.L. 111-148 (signed into law on March 23, 2010) • The expansion of and increase in access to the 340B Program (sec 7101) • Health Care and Education Reconciliation Act of 2010 - P.L. 111-152 (signed into law on March 30, 2010) • Exclusion of Orphan Drugs for certain Covered Entities (Sec 2302)

  7. New Eligible Program Types OPA website: www.HRSA.gov/OPA

  8. Eligibility Requirements • Verifiable designation/ Valid Medicare provider number • A hospital must meet one of the following criteria: • is a private non-profit hospital under contract with state or local government; OR • is owned or operated by a unit of state or local government; OR • is a public or private non-profit corporation which is formally granted governmental powers by a unit of state or local government

  9. Eligibility Criteria • Eligible Disproportionate Share (DSH) adjustment percentage • Must meet the proposed levels outlined in the legislation for the most recent cost reporting period • Does NOT apply to Critical Access Hospitals • Group Purchasing Organization (GPO) Exclusion: (applicable to) • Free Standing Cancer Hospitals • Children’s Hospitals and all DSH

  10. Summary of Criteria for Hospitals

  11. New Entity Enrollment • Enrollment start date: August 2, 2010 • Rolling admission starting on August 2, 2010 • Please remember this will only be in effect for the first quarter of eligibility. Entities would then be eligible for participation on January 1, 2011. DEADLINES- Completed application must be received 1 month before the start of the quarter

  12. Program Prohibitions • Diversion • Drug provided to individuals who are not patients • Drug dispensed in an area of a larger facility that is an integral part of the eligible and participating entity (e.g. an inpatient service, a non-covered clinic) • Duplicate Discounts • Accessing the 340B Discount + Medicaid Rebate on same drug • Covered Entities must report Medicaid billing status • www.hrsa.gov/opa/medicaidexclusion.htm

  13. Program Requirements • Auditable Records • Covered entities must maintain auditable records that demonstrate compliance with all Program requirements • Subject to audit by the government or manufacturers • Ongoing Eligibility • Covered entities must immediately notify OPA in the event of any change in eligibility, location, operating status, and authorizing official/contacts.

  14. Contract Pharmacy Services • The Covered Entity purchases the drug, but “ship to bill to” procedure may be used. • The Covered Entity retains legal title to all drugs purchased under 340B. The Covered Entity MUST pay for all 340B drugs. • The contract pharmacy is subject to audits to identify and prevent diversion and/or duplicate discount.

  15. New Integrity Provisions • Covered entities to have access to verified list of 340B ceiling prices via OPA website (OPA/PVP) • OPA to develop system to determine accurate pricing by auditing sales transactions and ensuring corrective action (OPA/PVP) • Covered entities required to update contact information annually (OPA/PSSC) • OPA to develop guidance on billing Medicaid (OPA/PSSC) • OPA granted additional authorities to fine CE’s for intentional violations (OPA) • OPA to develop procedure for manufactures to return overcharges to entities (OPA/PVP)

  16. Health Center Expansion • Three areas of focus - $11B over 5 years • Expands number of sites and locations • Supports expanded health-care services • Oral/dental & mental health • Supports construction & renovation projects • 19 million patients/year • 1,100 grantees (FQHC) – 7,900 actual sites

  17. Mission: Apexus leverages its unique purchasing power and expertise to deliver value which helps eligible health care and public service organizations to access unmatched savings and optimize performance Strategic Initiatives 2010: Increase Value to PVP Participants Increase Participant Loyalty Meet the Evolving Needs of HRSA Continuously Improve Wholesaler, Supplier, and Partnering Organization Relationships Apexus – Strategic Initiatives

  18. Summary of 2009 Accomplishments • Re-awarded HRSA’s Prime Vendor Agreement • 23% increase in participants • Overall customer satisfaction improved to 85% • Over $30 million in participant savings • Lost savings/recovery = $1.3 million • $3 million shareback in 2009; $4.5 million announced for 2010 (Over 1700 entities) • Sub-ceiling priced pharmaceuticals covering 204 AHFS Therapeutic Classes (61%) • Improved technical assistance via new tutorial and webinar offerings • New on-line enrollment

  19. Key PVP Contracts • HDI – Diabetic supplies • Lilly – Zyprexa, Cymbalta, Symbyax • Merck – Vaccines and women’s health • Pfizer - Protonix, Xyntha • Sandoz – Injectables • Sanofi– vaccines • Teva– Injectables • Sanofi – Vaccines • Watson – multisource orals • Abbott – Ultane, Simcor, Humira, Diabetic meters/strips • Astellas – Lexiscan • AstraZeneca – Crestor, Seroquel XR, Symbicort • Bayer – Mirena, diabetic supplies • Bedford – Injectables • CSL Behring – Hemophilia Products • Eisai – Aloxi, Dacogen • GSK – vaccines, respiratory products, and Epzicom

  20. Other Outpatient Rx Products and Services • Vaccines – Hep A, Hep B, Flu (multiple sources) • Split billing solutions • Patient assistance program Software • Auditing and overcharge recovery services • Prescription vials/labels/printer cartridges • Diabetic supplies – meters, strips and syringes • Outpatient Rx technology and automation – ScriptPro, Automed, Innovation, VoiceTech, others • Contract pharmacy solutions – SunRx • Spend optimization/revenue recovery – Esi Inc. • Apothecary supplies • Reverse distribution (pharmacy returns)

  21. 2010 Apexus PVP Bids

  22. PVP Savings by Entity Type

  23. Market Segment Secure Website

  24. Optimize 340B Savings • Drug price forecasts and other budgeting tools • Best Buy by Therapeutic Class Report • Best Buy by Chemical Compound • Best Buy for Over-the-Counter Medication

  25. Feedback Leading to New Reports and Service Offerings • New reports on secure website (Q4, 2010) • Expanded PVP portfolio on non-340B drugs • Expanded PVP generics portfolio for DSH • Reviewing solutions for Medicaid Carve-out

  26. 340B Related Information Resources • Affordable Care Act http://www.healthreform.gov • Medicaid Exclusion http://www.hrsa.gov/opa/medicaidexclusion.htm • Children’s/Free Standing Cancer Hospitals http://www.hrsa.gov/opa/children.htm • Orphan Drug listing http://www.accessdata.fda.gov/scripts/opdlisting/oopd • Contract Pharmacy http://www.hrsa.gov/opa/contractpharmacy.htm

  27. Contact Information Office of Pharmacy Affairs Phone: 301-594-4353 or 1-800-628-6297 Email: opastaff@hrsa.gov Web: www.hrsa.gov/opa HRSA Pharmacy Services Support Center(APhA) Phone: 1-800-628-6297 Email: lscholz@aphanet.org Web: http://pssc.aphanet.org Prime Vendor Program (Apexus) Phone:1-888-340-2787 Email: chatwig@340bpvp.com Web: http://www.340bpvp.com

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