Specialty Pharmacy: “The Inside Story” John Aforismo, B.Sc. Pharm., R.Ph Chairman & Founder RJ Health Systems International, LLC 1. Current Reimbursement Trends 2. Payor Models 3. Managed Care Expectations Payor Issues Pharmacy Network Contracts Home Infusion Contracts Specialty Pharmacy Contracts Manufacturer Incentives What issues are Payors struggling with? Specialty Formularies Physician Contracts Specialty vs Buy & Bill Reimbursement: Trends AWP? Average Wholesale Price ASP? Average Sales Price HCPCS Drug Code vs NDC AMP Average Manufacture Price SWP Suggested Wholesale Price PAYORS Reimbursement Methodologies? AAC Average Acquisition Cost MAC? Maximum Allowable Cost WAC? Wholesale Acquisition Cost Reimbursement: Trends • Payors (commercial & federal government) are using variations of the following: 1. ASP (average sales price) 2. AWP (average wholesale price) 3. WAC (wholesale acquisition cost) 4. SWP (suggested wholesale price) 5. AMP (average manufacturer’s price) 6. AAC (average acquisition cost) 7. MAC (maximum allowable cost) • Pharmacy benefit • Medical benefit New Reimbursement Methodologies MAC (Maximum Allowable Cost) • “A list of prescription medications established by a health plan (PBM or Third Party) which will be covered at a generic product level price.” • Pharmacy Benefit: • Medical Benefit: • HCPCS Drug Code Level • NDC Level Acquisition costs used as reference New Reimbursement Methodologies Average Acquisition Cost (AAC) • Used for Medicaid • Surveys of Pharmacy Purchases • Reflects the final drug price paid by the pharmacy after subtracting discounts • Each state reimbursement would be different • NA DAC- National Average Drug Acquisition Cost Potential New Benchmark from CMS NADAC National Average Drug Acquisition Cost • Developed in response to FDB ceasing publication of AWP in September 2011 • More precise than AWP/MAC • For Medicaid Drug Reimbursement Is A New National Benchmark Needed? Reimbursement: Observations Reimbursement Observations Present Payor Contracts Retail Pharmacy • Brand name drugs: • Usually AWP discounts range from AWP−14% to AWP−16% (plus dispensing fee) ($1.40 – $1.50) • Generic drugs: • MAC plus dispensing fee (AWP-76 or MAC) ($1.40 – $1.50) Mail Order Pharmacy • Brand name drugs: • AWP discounts range from AWP−23% (plus a small or no dispensing fee) • Generic drugs: • AWP− (plus a small or no dispensing fee) Reimbursement Observations Specialty Pharmacy • AWP discount can vary by drug with maximum discounts seen of AWP–35% • Payors requiring NDC on claim when HCPCS Drug Codes is supplied. Specialty Pharmacy Managed Care Expectations Specialty Patient Workflow Benefits Verification Initial Prescription Received Compliance & Persistence Prior Authorization & Step Therapy Clinical Reassessment Member Outreach Billing Proactive Clinical Assessment Care Coordination Clinical Intervention Personalized Education Dispensing & Shipping Payor/Management: ICD 9 ICD 10 Office Supportive Code Reimbursement CMS 1500/UB04 Claim Form CPT Drug Code Admin Code 857 Electronic Transfer Min Max Dose Drug Units NDC Drug Name Strengths HCPCS Drug Code RJ Health Systems International, LLC 30 Cold Spring Road Rocky Hill, CT 06067 Phone: 860-563-1223 Fax: 860-563-1650 E-Mail: [email protected] Specialty Pharmacy: “The Inside Story” Stephen Lagano, Founding Principal, Altometrixs, LLC Today’s Objectives • Overview Specialty Pharmacy And Market • Identify Significant Impactful Trends • Identify Key Stakeholders And Their Expectations • Review The Specialty Pharmacy Business/Financial Model • Business/Patient Impact – Reimbursement & Care Perspective • Discussion Into The “Future” Discussion Guide Specialty Pharmacy Market Stakeholders SP Business/Financial Model Reimbursement Trends Into the “Future” Discussion Trends What is Specialty? Confusion: • “Specialty” is term used to describe products, markets, companies, programs, etc. Clarity: • For consistency the term “Specialty” will be utilized to describe products ,certain therapeutic areas and channels: Specialty Products • Injectable and infusion therapies (can be an oral drug) • High-cost ($5,000 and up per patient per year) therapies • Therapies that require complex care (“high touch” services) • Special handling Specialty Channels* • Specialty Distributors • Servicing physicians • Clinics, etc. • Specialty Pharmacies * - Specialty products can go through the retail channel Specialty Pharmacy Specialty Pharmacy: • Specialty pharmacy is a “closed door” pharmacy that is delivering high cost drugs for complex therapies that require patient case management and “high touch” services • Specialty pharmacies provide day-to-day patient management services to optimize the patient’s clinical outcomes, including: • Coordination of care across all providers • Patient counseling and support to assist with injection technique • medication side effects and disease complications • Recognizing and responding to suboptimal responses to therapy • Identifying insurance coverage and reimbursement support services to assist the patient with out-of-pocket expenses that may limit the patient’s access to the drug Specialty Markets Specialty Markets: • The specialty markets is an aggregate of specialty of specialty products under therapeutic categories • Common specialty markets therapeutic areas*: • • • • • • • • Rheumatoid Arthritis Multiple Sclerosis Oncology HIV/AIDS Human Growth Hormone Hepatitis C Infertility Auto-Immune * - Sample list not meant to be exhaustive The Specialty Markets Are About Growth Drug Spend - Prescriptions Drug Spend: 2006 - $270B, 2011 - $320B, 2016 - $404B Sources: HIRC & IMS Estimates Multiple Influences Affecting Specialty Complex “Picture” Health Care Reform New & Improved Specialty Biologics Patient Pool Increases Affordable Care Act “Actual Care Act” Innovation ????? Quality of Care Rising Health Care Costs Provider Pool Decreases Costs/drug Spend Increase Increasing Challenges = Increasing Opportunities Trends Impacting Specialty Patient Protection Act Health Care Reform Affordable Care Act Multiple Moving Parts – “Not All in the Same Direction” More Patients ACO/Health Exchanges Technology “Push” Comparative Effectiveness Research Trends Impacting Specialty Patient Health Care Costs/Drug Spend Provider Plan Employers Increasing costs/spend Cost Containment Utilization Management Pharmacy/Medical Benefit Management Outcomes Demonstrated Value Decision/Payment Criteria Trends Impacting Specialty Increasingly Orphan Drugs Drug Pipeline REMs Requirements Simple /Traditional Retail/ Specialty Channels Reimbursement Needs Complex/Specialty Limited/ Restricted Channels Therapeutic Expertise Critical Patient Needs Trends Impacting Specialty Generics Employment Situation Other Simple /Traditional Important “Stuff” Biosimiliars Complex/Specialty Copay Programs TBD TBD Multiple Stakeholders & Multiple Interests Payer Data, SP/Plan Performance Patient Physician Patient Info, care planning & mgt Patient, Program Support Services Reimbursement Data, SP/ patient performance Data, Data, Referrals HUB/ Patient Center Specialty Pharmacy Mfg Funds Data, Referrals Data Stakeholder – SP Value Propositions Stakeholder Service(s) Value Proposition Patient Benefits Investigation, Clinical/patient assessments, product fulfillment Product availability, financial support on OOP expenses, increased compliance and persistency, increase overall quality of life Physician Coordinated support for patient care, reimbursement support, Collaborative partner to extend, execute and report on patient care Payer Implement drug utilization requirements and report on patient and SP performance Cost savings through appropriate drug utilization, compliance data reporting to validate performance Manufacturer Patient delivered benefits support, compliance and disease management services, inventory management and data Provides valuable data that provides insight into patients and business performance, deliver services that increase compliance & persistency and supply chain efficiencies through inventory management and decreased returns HUB/Patient Support Center Interfacing with HUB for referrals, coordinate product fulfillment, benefits verification, services and data Coordinated care/data between SP, HUB and physician SPECIALTY PHARMACY BUSINESS MODEL AND REIMBURSEMENT TRENDS
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