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HHS Proposed Rule: HIV Organ Transplant Policy Equity Act Implementation

The Department of Health and Human Services (HHS) proposes to amend regulations implementing the National Organ Transplant Act (NOTA) to remove research and Institutional Review Board (IRB) requirements for the transplantation of kidneys and livers from HIV-positive donors to HIV-positive recipients. This proposed rule aligns with the HIV Organ Policy Equity (HOPE) Act.

HRSA Announces 340B Rebate Model Pilot Program Application Process

The HRSA announced the application process for a voluntary 340B Rebate Model Pilot Program for qualifying drug manufacturers. The agency is also requesting public comment on the program's structure and application process, with a deadline of September 8, 2025.

HRSA Lowers Out-of-Pocket Medication Costs at Health Centers

The Health Resources and Services Administration (HRSA) has issued updated award terms requiring HRSA-funded health centers to provide insulin and injectable epinephrine to low-income patients at or below the price paid by the center through the 340B Drug Pricing Program. This action aims to lower out-of-pocket costs for life-saving medications nationwide.

HRSA 340B Rebate Model Pilot Program Application and Comment Period

The Health Resources and Services Administration (HRSA) has announced a voluntary 340B Rebate Model Pilot Program for 2026 drugs. HRSA is seeking public comment on the application process for manufacturers and the pilot program itself, with a 30-day comment period.