340 B and Hepatitis C 340 B basics

340 B and Hepatitis C 340 B basics & 340 B value to HCV treatment June 2018; Hepatitis C Task Force Meeting Jasmine Muniz-Cadorette

Objectives 340 B Program Overview • History and Intent • Eligibility and Use Settings • Compliance Requirements 340 B Savings Support Your Programs • What are 340 B savings and how can they be used? • 340 B savings in HCV treatment Advocating with 340 B Savings • Market Valuable Savings to Leadership • Design Lean and Effective Programs • Tying it all Together 2 340 B and HCV, June 2018

What is the 340 B Program? • Drug Pricing Program started by U. S. federal government in 1992 (Veterans Health Care Act) • Requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices. 3 340 B and HCV, June 2018

Intent of 340 B Program The 340 B Program enables covered entities to “stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. ” H. R. Rep. No. 102 -384(II), at 12 (1992) 4 340 B and HCV, June 2018

340 B Program Eligibility Requirements • Include: • Health Centers • Ryan HIV/AIDS Program Grantees • Hospitals • Specialized Clinics • Only if: Eligible Organization Eligible Patients 5 340 B and HCV, June 2018 • Relationship and medical records • Served by our providers • Service provided is within scope of services covered by grant • Outpatient drugs: • FDA-approved prescription drugs • OTC drugs written on a prescription • Biological products dispensed by prescription (excludes vaccines) • FDA-approved insulin Eligible Drugs

340 B Program Use Settings • Covered entities can purchase their physician administered drugs at 340 B pricing • Entity owned pharmacies can purchase 340 B drugs to stock their pharmacies • Pharmacies can be open door or closed door • Covered entities can partner with pharmacies in their communities to provide 340 B medications to patients on the entity’s behalf • Virtual replenishment or physical inventory Eligible Organization In-House Pharmacies Contract Pharmacies 6 340 B and HCV, June 2018

340 B Program Compliance 1. Keep 340 B database information accurate 7 340 B and HCV, June 2018 2. Recertify eligibility yearly 3. Prevent duplicate discounts 4. Prevent diversion to ineligible patients 5. Prepare for program audits

Objectives 340 B Program Overview • History and Intent • Eligibility and Use Settings • Compliance Requirements 340 B Savings Support Your Programs • What are 340 B savings and how can they be used? • 340 B savings in HCV treatment Advocating with 340 B Savings • Market Valuable Savings to Leadership • Design Lean and Effective Programs • Tying it all Together 8 340 B and HCV, June 2018

Defining 340 B savings Multiple ways to calculate 340 B savings Wholesale acquisition cost (WAC) 340 B Cost Savings OR Reimbursement 9 340 B and HCV, June 2018 340 B Cost Savings

Defining appropriate use of 340 B savings Patient readiness programs Care Coordination Ideas for programs funded by 340 B savings Transportation Patient assistance funds 10 340 B and HCV, June 2018 Treatment counselors Support groups

340 B and HCV Treatment How does 340 B relate to HCV treatment? 11 340 B and HCV, June 2018

340 B and HCV Treatment 1. Avenue for funding comprehensive treatment 12 340 B and HCV, June 2018

340 B Savings in HCV Treatment costs between ~$26, 000 -$90, 000 at WAC cost 340 B pricing is typically 20 -50% lower than WAC costs 13 340 B and HCV, June 2018

340 B and HCV Treatment 2. Promotes Innovation and Service Expansion 14 340 B and HCV, June 2018

340 B and HCV Treatment Valuable savings to participating organization: Substantial savings* generated from prescriptions filled at inhouse or partner pharmacies Promotes development of comprehensive treatment programs: Provides avenue for expanding services: Patient readiness programs Patient assistance funds Transportation services Treatment counselors Therapy *Savings vary based on contracted pricing and reimbursement terms 15 340 B and HCV, June 2018 Support groups Expanded care team

340 B and HCV Treatment Designing and implementing programs: 1. 2. 3. 4. 5. 6. 7. 16 Assess need and potential return on investment Secure leadership buy-in Hire staff Map and design program workflows, roles, and targets Build pharmacy relationships Coordinate with and promote to various departments Reassess and make changes as necessary 340 B and HCV, June 2018

340 B and HCV Treatment Designing and implementing programs: 1. 2. 3. 4. 5. 6. 7. 17 Assess need and potential return on investment Secure leadership buy-in Hire staff Map and design program workflows, roles, and targets Build pharmacy relationships Coordinate with and promote to various departments Reassess and make changes as necessary 340 B and HCV, June 2018

Assessing Need and ROI potential # HCV Positive Patients 27 EMR Query, reporting period of 12 months 3 68 56 Brooklyn Primary Care Clinic Church Avenue Primary Care 37 HUB Primary Care Health Center Inwood Primary Care PSI Citiwide 50 21 Queens Primary Care Staten Island Primary Care Westchester Square Primary Care 159 18 340 B and HCV, June 2018 1. Pull patients that had positive HCV PCR test during reporting period

Assessing Need and ROI potential Treatment status of HCV + Patients EMR Query, reporting period of 12 months # tx completed 15% # never started tx 37% # lost to care 48% 19 340 B and HCV, June 2018 2. Stratify population

Assessing Need and ROI potential Treatment status of HCV + Patients EMR Query, reporting period of 12 months # tx completed 15% # never started tx 37% # lost to care 48% 20 340 B and HCV, June 2018 3. Review patient files 4. Design targeted interventions

340 B and HCV Treatment How does 340 B relate to HCV treatment? 21 340 B and HCV, June 2018

ROI potential and senior leadership buy-in Potential ROI= ((# patients to be treated) x (Average 340 B Savings* per patient x Average Utilization)) Example: Potential ROI for 50 patients treated= (50 x ($1, 400* x 2. 3 fills)) = $161, 000** * Average 340 B savings is inclusive of all expenses related to 340 B administration and HCV program expenses (Avg savings listed do not represent BPH/HRHCare contracted prices, are estimates based on average savings reported for 340 B) ** This is assuming 100% engagement and capture rate. 22 340 B and HCV, June 2018

340 B and HCV Treatment Designing and implementing programs: 1. 2. 3. 4. 5. 6. 7. 23 Assess need and potential return on investment Secure leadership buy-in Hire staff Map and design program workflows, roles, and targets Build pharmacy relationships Coordinate with and promote to various departments Reassess and make changes as necessary 340 B and HCV, June 2018

Securing Leadership Buy-In 1. Present needs assessment Treatment status of HCV + Patients # tx completed 15% 2. Big picture: • Quality improvement project • Leaders in treatment # never started tx 37% 3. Present ROI # lost to care 48% 24 340 B and HCV, June 2018

340 B and HCV Treatment Designing and implementing programs: 1. 2. 3. 4. 5. 6. 7. 25 Assess need and potential return on investment Secure leadership buy-in Hire staff Map and design program workflows, roles, and targets Build pharmacy relationships Coordinate with and promote to various departments Reassess and make changes as necessary 340 B and HCV, June 2018

Hiring Staff Develop Job Description - LPN - 3 yrs of experience with chronic disease management - Familiarity with HCV - Bronx based job 26 340 B and HCV, June 2018 Recruiting Interviewing Hire

340 B and HCV Treatment Designing and implementing programs: 1. 2. 3. 4. 5. 6. 7. 27 Assess need and potential return on investment Secure leadership buy-in Hire staff Map and design program workflows, roles, and targets Build pharmacy relationships Coordinate with and promote to various departments Reassess and make changes as necessary 340 B and HCV, June 2018

Designing your Program Developed Unique Brightpoint Health HCV Care Coordination Program GOALS: • HCV Coordinator will identify clients eligible for Brightpoint Health’s HCV/HIV Program • Providers will refer clients to HCV Coordinator • HCV Coordinator will facilitate treatment of more patients through intervention, education, and support • HCV Coordinator will oversee PA process and promote Brightpoint Health contract pharmacies 28 340 B and HCV, June 2018

Designing Co-Infected Patient Support HIV Status in HCV Positive Patients EHR Query to identify HIV/HCV Co-infected patients HCV/HIV Co. Infected 39% HCV Monoinfected 61% 29 340 B and HCV, June 2018

Designing Co-Infected Patient Support Validated 100% of patients on report 30 340 B and HCV, June 2018

HCV Program Structure Materials Snapshots • Intake Assessment • Care Plan and Patient Agreement • Patient Knowledge Tests • HCV Education Powerpoint • Tracking Spreadsheet • Support Groups • Outreach Letters • Initiated access to HEPCURE DASHBOARD • Incentive Model: • $10 -15 gift card at milestones; total $75 • Metrocards • Snacks • Targets 31 340 B and HCV, June 2018

340 B and HCV Treatment Designing and implementing programs: 1. 2. 3. 4. 5. 6. 7. 32 Assess need and potential return on investment Secure leadership buy-in Hire staff Map and design program workflows, roles, and targets Build pharmacy relationships Coordinate with and promote to various departments Reassess and make changes as necessary 340 B and HCV, June 2018

Building Pharmacy Relationships 340 B Registered • Quarterly registration with quarter lag for go live Specialty Pharmacy • Adherence services • Success with prior authorization approvals Community based • Consider proximity to health center • Works with population well • Deliveries available 33 340 B and HCV, June 2018

340 B and HCV Treatment Designing and implementing programs: 1. 2. 3. 4. 5. 6. 7. 34 Assess need and potential return on investment Secure leadership buy-in Hire staff Map and design program workflows, roles, and targets Build pharmacy relationships Coordinate with and promote to various departments Reassess and make changes as necessary 340 B and HCV, June 2018

Coordinating and promoting program Most challenging part of program implementation Multiple meetings with clinical and leadership Organization wide memo Continued coordination, not “one and done” 35 340 B and HCV, June 2018

340 B and HCV Treatment Designing and implementing programs: 1. 2. 3. 4. 5. 6. 7. 36 Assess need and potential return on investment Secure leadership buy-in Hire staff Map and design program workflows, roles, and targets Build pharmacy relationships Coordinate with and promote to various departments Reassess and make changes as necessary 340 B and HCV, June 2018

Assessing and modifying program Questions for evaluation on quarterly basis: 1. Are clinical staff referring patients appropriately? 2. Are patients meeting with HCV Coordinator as intended? 3. How many clients are enrolled on a monthly basis? 4. How many clients are initiating treatment? 5. How many clients are completing treatment? 6. What percentage of client prescriptions are being filled by partner pharmacies? 7. What changes need to be made? 37 340 B and HCV, June 2018

Summary 340 B Program is Federal Drug Pricing Program • Qualifying entities can generate much needed savings • Needs dedicated FTE for program oversight HCV and 340 B • 340 B savings can be used to fund special programs Program Implementation • Assess need, ROI, secure buy-in, map workflows • Patience is key 38 340 B and HCV, June 2018

Resources 1. 340 B Drug Pricing Program – https: //www. hrsa. gov/opa/index. html 2. Veterans Health Care Act of 1992 – https: //www. hrsa. gov/opa/programrequirements/publiclaw 102585. html 3. CDC Hepatitis FAQs – https: //www. cdc. gov/hepatitis/hcvfaq. htm#a 4 4. New York City Hep B and C Annual Report – http: //www 1. nyc. gov/assets/doh/downloads/pdf/cd/hepatitis-b-and-c-annual-report-2015. pdf 39 340 B and HCV, June 2018

QUESTIONS? Jasmine Muniz-Cadorette 340 B Program Specialist Brightpoint Health jcadorette@brightpointhealth. org 40 340 B and HCV, June 2018