Proposed HHS Rule Would Remove Barriers to Kidney, Liver Transplants for HIV-Positive Patients

The Department of Health and Human Services (HHS) has announced a proposed rule to remove clinical research and institutional review board (IRB) requirements for the transplantation of kidneys and livers from HIV-positive donors to recipients with HIV. The goal is to eliminate barriers and increase access to transplantation in the HIV community.

The proposed rule would only apply to liver and kidney transplants performed under the HIV Organ Policy Equity (HOPE) Act. In conjunction with the proposed rule, the National Institutes of Health plans to convene a working group to revisit its research criteria for other organs for HOPE Act transplants.

Signed into law in 2013, the HOPE Act allows organs from donors with HIV to be transplanted into candidates with HIV under research protocols designed to evaluate the feasibility, effectiveness, and safety of such transplants. Participating hospitals conduct transplants under IRB-approved research protocols.

“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.”