Update and Clarifications Regarding Local Pharmaceutical

Assistance ProgramsSusan Robilotto, D.O.

Clinical Consultant/ Medical OfficerDepartment of Health and Human Services

Health Resources and Services Administration

HIV/AIDS BureauDivision of Metropolitan HIV/AIDS Programs

Division of State HIV/AIDS Programs

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

Most Recent Data on LPAP Allocations

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”

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)

An LPAP Is Not…

• An LPAP is not a substitute for ADAP

• An LPAP is not emergency financial assistance for medications

Key Components of LPAPs

1. Statement of Need

•Specifies ADAP restrictions

•Submitted in the yearly application for RWHAP funding

Key Components of LPAPs

2. Coordination with the ADAP

3. Compliance with RWHAP requirement of Payer of Last Resort

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

Key Components of LPAPs

5. Advisory Board• Purpose

• Structure

• Financing

• Eligibility Criteria

• Formulary

• Quality Assurance

• Quality Management

Key Components of LPAPs

6. Compliance with the most current HHS HIV/AIDS Treatment Guidelines

• http://www.aidsinfo.nih.gov

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

340B Program

• LPAPs are not directly eligible 340B entities

• LPAPs can be structured in a way that they

do receive 340B pricing

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

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

Contact Information

Susan Robilotto, D.O.Clinical Consultant/Medical

Officer(301) 443-6554

srobilotto@hrsa.govhttp://hab.hrsa.gov