Local AIDS Pharmaceutical Assistance (LPAP)

LPAP Service Standard print version

Health Resources and Services Administration (HRSA) Description

Local Pharmaceutical Assistance Program (LPAP) is operated by a HRSA Ryan White HIV/AIDS Program (RWHAP) Part B (non-ADAP) recipient or subrecipient as a supplemental means of providing ongoing medication assistance when a HRSA RWHAP AIDS Drug Assistance Program (ADAP) has a restricted formulary, waiting list, and/or restricted financial eligibility criteria.

Program Guidance

An LPAP is a program to ensure that clients receive medications when other means to procure medications are unavailable or insufficient. As such, LPAPs are meant to serve as an ongoing means of providing medications. RWHAP Part B Base award or Part A grant funds may be used to support an LPAP. ADAP funds may not be used for LPAP support. LPAP funds are not to be used for emergency or short-term financial assistance. The Emergency Financial Assistance service category may assist with short-term medication assistance not covered by the LPAP.

Limitations

State AIDS Drug Assistance Program (ADAP) funds may not be used for LPAP support. LPAP funds are not emergency financial assistance for medications.

• Local pharmacy assistance programs are not funded with ADAP earmark funding.
• LPAPs are not to take the place of the ADAP program.
• Clients cannot be enrolled in another medication assistance program for the same medication, excluding co-payment discounts.
• Funds may not be used to make direct payments of cash/vouchers to a client.
• No charges may be imposed on clients with incomes below 100% of the Federal Poverty Level (FPL).
• For the following services, Emergency Financial Assistance (EFA) should be used rather than LPAP:
  • A result or component of a primary medical visit
  • A single occurrence of short duration (an emergency)
  • Vouchers to clients on an emergency basis

Services

RWHAP recipients using the LPAP service category must establish the following:

• Uniform benefits for all enrolled clients throughout the service area
• A recordkeeping system for distributed medications
• A LPAP advisory board
• A drug formulary that:
  • Has been approved by the local advisory committee/board
  • Consists of HIV-related medications not otherwise available to the clients due to the elements mentioned above
• A drug distribution system
• A client enrollment and eligibility determination process that includes screening for HRSA RWHAP ADAP and LPAP eligibility with rescreening at a minimum of every 6 months
• Coordination with the State’s RWHAP Part B ADAP (a statement of need should specify restrictions of the state ADAP and the need for the LPAP)
• Implementation in accordance with requirements of the HRSA 340B Drug Pricing Program and the Prime Vendor Program

Statement of Need

The Texas ADAP (Texas HIV Medication Program or THMP) has a limited formulary and currently limits income eligibility to 200% of the Federal Poverty Limit (FPL), with a spend-down adjustment to account for the cost of HIV medications. The LPAP is needed to assist clients that have incomes above 200% of FPL, after spend-down adjustment. Providers must first use client and/or Pharmaceutical Assistance Programs (PAPs) before using LPAP. However, these programs may not fully meet the needs of clients whose complete regimen of HIV-related medications are not affordable or available through PAPs. LPAP can assist clients requiring long-term HIV and HIV-related medications that cannot be obtained through the THMP or PAPs.

The TX ADAP must be accessed by eligible clients prior to using the LPAP.

• THMP must be accessed by eligible clients before using LPAP.
• LPAP may not duplicate services available through THMP.
• Clients needing long-term assistance with prescription medications must be assisted with completing a THMP application and, when applicable, PAP applications.
• If the medication is not on the THMP formulary and is not available through other assistance programs, the client may be served with LPAP funds if the medication is on the LPAP formulary.
• If short-term medication assistance is required and the client is eligible, this need may be met with Emergency Financial Assistance (EFA) funds.
• Clients with insurance and other third-party payer sources are not eligible for LPAP assistance unless there is documentation on file that the medication is not covered by their prescription benefits.

LPAP shall, to the extent allocations permit, provide eligible clients with medications on the local area’s LPAP formulary that have been prescribed by a qualified, prescribing medical provider. Medications must be consistent with the most current HHS HIV/AIDS Treatment Guidelines.

LPAP medications must be purchased at the lowest possible cost, such as 340B Program pricing. Clients must obtain their medications through a 340B covered entity or pharmacy or a comparable medication discount program. Contracts/Memoranda of Understanding (MOU) must be set up to purchase medications at wholesale or another below-retail price.

All LPAP programs will use the statement of need and available standards of care to inform their services and will operate in accordance with legal and ethical standards. The importance of maintaining confidentiality is critical and all programs must comply with the Health Insurance Portability and Accountability Act (HIPAA) standards.

Prescribed over-the-counter (OTC) medications may be purchased with LPAP funds if the medication is listed on the LPAP formulary and the provider has deemed that the medication is needed for the prevention and treatment of opportunistic infections or to prevent the serious deterioration of health. All OTC medications purchased with LPAP funds must be FDA-approved.

Medications not included in the LPAP formulary cannot be purchased. All medications purchased with LPAP funds must be FDA-approved. The provider wishing to prescribe a medication, not on the formulary shall make a request to the LPAP Board for approval to add the medication to the formulary. The medication may only be purchased after being added to the formulary.

Universal Standards

Services providers for Local Pharmaceutical Assistance Program Services must follow HRSA/DSHS Universal Standards 1-46 and 55-64.

Service Standards and Measures:

The following standards and measures are guides to improving healthcare outcomes for people living with HIV throughout the State of Texas within the Ryan White Part B and State Services Program.

References

Division of Metropolitan HIV/AIDS Programs, HIV/AIDS Bureau (HAB). Ryan White HIV/AIDS Program (RWHAP) National Monitoring Standards for RWHAP Part A Recipients. Health Resources and Services Administration, June 2022.

Division of State HIV/AIDS Programs, HIV/AIDS Bureau (HAB). Ryan White HIV/AIDS Program (RWHAP) National Monitoring Standards for RWHAP Part B Recipients. Health Resources and Services Administration, June 2022.

Ryan White HIV/AIDS Program. Policy Notice 16-02: Eligible Individuals & Allowable Uses of Funds. Health Resources and Services Administration, October 2018.

Ryan White HIV/AIDS Program. Local Pharmaceutical Assistance Program (LPAP) FAQs · LPAP Policy Clarification Memo (8/29/13).

Texas Administrative Code: TAC 22, Chapter 15, 291.6.

Texas Department of State Health Services HIV/STD Program Policies. Payer of Last Resort (Policy 590.001).

Texas Department of State Health Services HIV/STD Program Policies. Purchasing Prescription or Over-The-Counter Medications and Vitamins Not Covered by a Third-Party Payer. (Policy 220.101).

Texas Department of State Health Services HIV/STD Program Policies. HIV/STD Medication Program Pharmacy Eligibility Criteria. (Policy 700.003).