1. 340B basics & 340B value to HCV treatment
340B and Hepatitis C
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340B basics & 340B value to HCV treatment
June 2018; Hepatitis C Task Force Meeting
Jasmine Muniz-Cadorette

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

3. What is the 340B 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.
Section 340B of the Public Health Service Act(1992)
Administered by Office of Pharmacy Affairs (OPA)
340B and HCV, June 2018

4. Intent of 340B Program
The 340B 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 (II), at 12 (1992)
340B and HCV, June 2018

5. 340B Program Eligibility Requirements
Include:
Health Centers
Ryan HIV/AIDS Program Grantees
Hospitals
Specialized Clinics
Only if:
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 Organization
Eligible Patients
The most fundamental 340B requirements, those that must be met to be able to apply for the 340B Program, are as follows. In order for an organization to be considered eligible, it must fall under either health centers, ryan HIV/AIDS program grantees, hospitals, or specialized clinics. The next requirement is for the eligible organization, or “covered entity”, to serve what is called an “eligible patient”. Patients are considered eligible if, and only if, all of the following requirements are met (read requirements). Finally, the covered entity must distribute eligible drugs, which are either….(read slide).
Eligible Drugs
340B and HCV, June 2018

6. 340B Program Use Settings Eligible Organization In-House Pharmacies
Covered entities can purchase their physician administered drugs at 340B pricing
Entity owned pharmacies can purchase 340B drugs to stock their pharmacies
Pharmacies can be open door or closed door
Covered entities can partner with pharmacies in their communities to provide 340B medications to patients on the entity’s behalf
Virtual replenishment or physical inventory
Eligible Organization
In-House Pharmacies
The most fundamental 340B requirements, those that must be met to be able to apply for the 340B Program, are as follows. In order for an organization to be considered eligible, it must fall under either health centers, ryan HIV/AIDS program grantees, hospitals, or specialized clinics. The next requirement is for the eligible organization, or “covered entity”, to serve what is called an “eligible patient”. Patients are considered eligible if, and only if, all of the following requirements are met (read requirements). Finally, the covered entity must distribute eligible drugs, which are either….(read slide).
Contract Pharmacies
340B and HCV, June 2018

7. 340B Program Compliance 2. Recertify eligibility yearly
1. Keep 340B database information accurate
2. Recertify eligibility yearly
3. Prevent duplicate discounts
4. Prevent diversion to ineligible patients
5. Prepare for program audits
According to HRSA, these are the five most crucial compliance requirements. ..Read Slides..
340B and HCV, June 2018

8. Objectives 340B Program Overview 340B Savings Support Your Programs
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Right click on the illustration and choose Change Picture. Browse for a new illustration.
340B Program Overview
History and Intent
Eligibility and Use Settings
Compliance Requirements
340B Savings Support Your Programs
What are 340B savings and how can they be used?
340B savings in HCV treatment
Advocating with 340B Savings
Market Valuable Savings to Leadership
Design Lean and Effective Programs
Tying it all Together
340B and HCV, June 2018

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

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

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

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

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

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

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

16. Designing and implementing programs:
340B and HCV Treatment
Designing and implementing programs:
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
340B and HCV, June 2018

17. Designing and implementing programs:
340B and HCV Treatment
Designing and implementing programs:
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
340B and HCV, June 2018

18. Assessing Need and ROI potential
EMR Query, reporting period of 12 months
Pull patients that had positive HCV PCR test during reporting period
340B and HCV, June 2018

19. Assessing Need and ROI potential
EMR Query, reporting period of 12 months
2. Stratify population
340B and HCV, June 2018

20. Assessing Need and ROI potential
EMR Query, reporting period of 12 months
Review patient files
Design targeted interventions
340B and HCV, June 2018

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

22. ROI potential and senior leadership buy-in
Potential ROI=
((# patients to be treated) x (Average 340B Savings* per patient x Average Utilization))
Example:
Potential ROI for 50 patients treated= (50 x ($1,400* x 2.3 fills)) = $161,000**
* Average 340B savings is inclusive of all expenses related to 340B administration and HCV program expenses (Avg savings listed do not represent BPH/HRHCare contracted prices, are estimates based on average savings reported for 340B)
** This is assuming 100% engagement and capture rate.
340B and HCV, June 2018

23. Designing and implementing programs:
340B and HCV Treatment
Designing and implementing programs:
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
340B and HCV, June 2018

24. Securing Leadership Buy-In
Present needs assessment
2. Big picture:
Quality improvement project
Leaders in treatment
3. Present ROI
340B and HCV, June 2018

25. Designing and implementing programs:
340B and HCV Treatment
Designing and implementing programs:
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
340B and HCV, June 2018

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

27. Designing and implementing programs:
340B and HCV Treatment
Designing and implementing programs:
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
340B and HCV, June 2018

28. 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
340B and HCV, June 2018

29. Designing Co-Infected Patient Support
EHR Query to identify HIV/HCV Co-infected patients
340B and HCV, June 2018

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

31. 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
340B and HCV, June 2018

32. Designing and implementing programs:
340B and HCV Treatment
Designing and implementing programs:
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
340B and HCV, June 2018

33. Building Pharmacy Relationships
340B 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
340B and HCV, June 2018

34. Designing and implementing programs:
340B and HCV Treatment
Designing and implementing programs:
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
340B and HCV, June 2018

35. 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”
340B and HCV, June 2018

36. Designing and implementing programs:
340B and HCV Treatment
Designing and implementing programs:
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
340B and HCV, June 2018

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

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

39. Resources 340B Drug Pricing Program Veterans Health Care Act of 1992
Veterans Health Care Act of 1992
CDC Hepatitis FAQs
New York City Hep B and C Annual Report
340B and HCV, June 2018

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