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 FY12 Part A $25,822,015 Part B $1,529,672

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 1.Statement of Need Specifies ADAP restrictions Submitted in the yearly application for RWHAP funding

8. Key Components of LPAPs 2.Coordination with the ADAP 3.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 5.Advisory Board Purpose Structure Financing Eligibility Criteria Formulary Quality Assurance Quality Management

11. Key Components of LPAPs 6.Compliance with the most current HHS HIV/AIDS Treatment Guidelines http://www.aidsinfo.nih.gov

12. Key Components of LPAPs 7.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