The Biden-Harris Administration has issued a proposed rule to expand access to life-saving organs for people with HIV. The Department of Health and Human Services (HHS), through the Office of the Assistant Secretary for Health (OASH) and the Health Resources and Services Administration (HRSA), announced a Notice of Proposed Rulemaking (NPRM) aimed at amending regulations under the National Organ Transplant Act of 1984.

"All across this country there are HIV-positive Americans who need an organ transplant and HIV-positive Americans who are ready and willing to donate. Unfortunately, the process of approving those transplants is too slow and too few transplant centers participate due to burdensome requirements, resulting in unnecessary suffering for all involved," said HHS Secretary Xavier Becerra. "Our new policy removes these requirements for HIV-positive kidney and liver transplants and will expand access to organ transplantation for people with HIV and increase overall transplant volumes for all Americans irrespective of their HIV status. This is another important step by the Biden-Harris Administration to reduce stigma and health disparities around organ transplantation, and lower health care costs for Americans."

If finalized, the proposed rule would eliminate clinical research and institutional review board (IRB) requirements for kidney and liver transplants from donors with human immunodeficiency virus (HIV) to recipients with HIV. The rule, titled "Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act," is based on a rigorous analysis of clinical data.

The HOPE Act, signed into law on November 21, 2013, allows organs from donors with HIV to be transplanted into candidates with HIV under research protocols designed to evaluate feasibility, effectiveness, and safety. Participating hospitals conduct these transplants under IRB-approved research protocols conforming to National Institutes of Health (NIH) standards.

This proposed rule specifically addresses HOPE Act liver and kidney transplants due to limited data on other organs' safety and outcomes. In conjunction with this proposed rule, NIH plans to convene a working group to reassess its research criteria for other HOPE Act organ transplants.

Should the rule be finalized, HHS anticipates that more transplant centers will conduct HOPE Act kidney and liver transplants, thereby reducing stigma and health disparities associated with HIV.

Public comments on the NPRM are due 30 days after its publication in the Federal Register on October 15, 2024, at 11:59 PM ET. The NPRM can be viewed or downloaded at: Federal Register :: Public Inspection: Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act.

The proposed rule marks another step by HHS toward improving access to care for people with HIV while addressing systemic issues such as inequities in transplant access.