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14th Annual NPPA Conference
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
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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
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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.)
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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
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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
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Health Care Reform Affordable Care Act - P.L (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 P.L (signed into law on March 30, 2010) Exclusion of Orphan Drugs for certain Covered Entities (Sec 2302)
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New Eligible Program Types
Covered Entity Type Code Statutory Definition Critical Access Hospitals CAH 1820 (c)(2) of SSA Rural Referral Centers RRC 1886(d)(5)(C)(i) of SSA Sole Community Hospitals SCH 1886(d)(5)(C)(iii) of SSA Free Standing Cancer Hospitals CAN 1886 (d)(1)(B)(v) of SSA Children's Hospitals PED 1886 (d)(1)(B)(iii) of SSA OPA website:
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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
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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
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Summary of Criteria for Hospitals
Covered Entity Type Non profit/ Gvt. Contract DSH % GPO Exclusion Orphan Drug Rule Critical Access Hospitals Yes No Rural Referral Centers ≥ 8% Sole Community Hospitals Free Standing Cancer Hosp. ≥ 11.75% Children's Hospitals Disproportionate Share Hospitals
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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
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Program Prohibitions Diversion Duplicate Discounts
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
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Program Requirements Auditable Records Ongoing Eligibility
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.
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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.
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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)
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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 Through CE networking, contracting, and other arrangements questions about definition of CE patient have arisen. HRSA believes current definition of patient provides sufficient guidance for many situations. It is possible that some CE may havition too broadly with resat includes several examples that provide CE further guidance regarding the relationship of the CE and an individual that makes that individual a patient of the CE. HRSA sought comments on elements of contrac
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Apexus – Strategic Initiatives
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
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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
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Key PVP Contracts 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 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
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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)
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2010 Apexus PVP Bids Bid (IFB) Number IFB Description Products IFB3010
Bronchodilators for COPD Indication Advair Diskus; Brovana; Foradil; Perforomist; Serevent Diskus; Spiriva HandiHaler; Symbicort IFB3011 Immunomodulators for Multiple Sclerosis Indication Tysabri; Rebif; Avonex; Extavia; Copaxone; IFB3012 Bisphosphonates for Postmenopausal Indication Actonel; Boniva; Fosamax; Reclast IFB3013 Hematopoietic Agents – Erythropoiesis-stimulating Agents Aranesp; Epogen; Procrit; Leukine IFB3014 Hematopoietic Agents – Colony Stimulating Factors Pegfilgrastim; Filgrastim IFB3015 Hepatitis B (CMV) End-Organ Disease Valcyte; Cytovene; Foscarnet; Vistide IFB3016 Hepatitis C Tyzeka; Baraclude; Hepsera; Viread; Epivir HBV; Pegasys; Intron-A; Peg-Intron IFB3017 Oral Contraceptives Monophasic; Monophasic Low; Monophasic Ultra Low; Biphasic; Multiphasic; Extended Cycle; Progestin Only; Injectable DMPA; Transdermal; Emergency IFB3018 Heparin and Saline Flush Syringes Heparin vials and syringes; Saline vials and syringes IFB3019 Glucagon-like Peptide Receptors Victoza; Byetta IFB3020 Phosphodiestearase Type 5 inhibitors Cialis; Lavitra; Viagra IFB3021 Antibiotics – Fluoroquinolones Moxifloxacin (Avelox); Ciprofloxacin (Cipro); Levofloxacin (Levaquin); Ofloxacin 2010 Apexus PVP Bids
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PVP Savings by Entity Type
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Market Segment Secure Website
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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
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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
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340B Related Information Resources
Affordable Care Act Medicaid Exclusion Children’s/Free Standing Cancer Hospitals Orphan Drug listing Contract Pharmacy
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Contact Information Office of Pharmacy Affairs Phone: or Web: HRSA Pharmacy Services Support Center (APhA) Phone: Web: Prime Vendor Program (Apexus) Phone: Web:
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