Update and Clarifications Regarding Local Pharmaceutical Assistance Programs

1. Update and Clarifications Regarding Local Pharmaceutical Assistance Programs Susan Robilotto, D.O. Clinical Consultant/ Medical Officer Department of Health and Human Services Health Resources and Services Administration HIV/AIDS Bureau Division of Metropolitan HIV/AIDS Programs Division of State HIV/AIDS Programs

2. Objectives • Understand the current context and purpose of local pharmaceutical assistance programs (LPAPs) • Explain the revised National Monitoring Standards for LPAPs • Know the key components of an LPAP • Understand how LPAPs work in conjunction with other resources essential for people living with HIV/AIDS (PLWH) to achieve retention in care and viral suppression

3. Most Recent Data on LPAP Allocations

4. Ryan White HIV/AIDS Program • An LPAP is an allowable Ryan White HIV/AIDS Program (RWHAP) core medical service • The purpose of an LPAP is “…to provide therapeutics to treat HIV/AIDS or to prevent the serious deterioration of health arising from HIV/AIDS in eligible individuals, including measures for prevention and treatment of opportunistic infections”

5. LPAP Purpose • Supplement to AIDS Drug Assistance Program (ADAP) when an ADAP has cost containments • Provide for HIV medications that are not included in the ADAP formulary • Provide medications when the ADAP financial eligibility is restrictive • Provide for medications if there is a protracted State ADAP eligibility process and/or other means of accessing medications are not available (i.e., pharmaceutical company assistance programs)

6. An LPAP Is Not… • An LPAP is not a substitute for ADAP • An LPAP is not emergency financial assistance for medications

7. Key Components of LPAPs • Statement of Need • Specifies ADAP restrictions • Submitted in the yearly application for RWHAP funding

8. Key Components of LPAPs • Coordination with the ADAP • Compliance with RWHAP requirement of Payer of Last Resort

9. Key Components of LPAPs 4. Enrollment and Eligibility Process • Screening for LPAP eligibility • Screening for ADAP eligibility • Screening for other potential pharmacy benefits including: • Medicaid • Medicare Part D • Other Public or Private Insurance • Local and State Pharmacy Assistance Programs • Pharmaceutical Company Assistance Programs (PAPs)- while waiting

10. Key Components of LPAPs • Advisory Board • Purpose • Structure • Financing • Eligibility Criteria • Formulary • Quality Assurance • Quality Management

11. Key Components of LPAPs • Compliance with the most current HHS HIV/AIDS Treatment Guidelines • http://www.aidsinfo.nih.gov

12. Key Components of LPAPs • Implementation in accordance with 340B Pricing Program, Direct Purchase, Prime Vendor Program and/or Alternative Methods Project • http://www.hrsa.gov/opa

13. 340B Program • LPAPs are not directly eligible 340B entities • LPAPs can be structured in a way that they do receive 340B pricing

14. 340B Program • The RWHAP Part A or Part B role in coordinating 340B and LPAP: • Must certify to the HRSA Office of Pharmacy Affairs (OPA) that the sub-grantee is receiving funds to provide patient care as defined by OPA • Establish requirements for sub-grantees who are not currently participating in 340B to submit application to OPA for 340B eligibility determination • Have sub-grantees set up contracts with pharmacies to purchase medications for clients at 340B prices

15. Summary • LPAPs help to ensure that PLWH have access to vital medications when other resources are insufficient • LPAPs must function under the guidance of an advisory board which ensures that all Ryan White HIV/AIDS Program requirements are met

16. Contact Information Susan Robilotto, D.O. Clinical Consultant/Medical Officer (301) 443-6554 srobilotto@hrsa.gov http://hab.hrsa.gov