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
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
FY12
Part A
Part B
$25,822,015
$1,529,672
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.gov
http://hab.hrsa.gov