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A new rule applies to liver and kidney transplants and will increase access to these organs, according to the U.S. Department of Health and Human Services.
The U.S. Department of Health and Human Services has eased the regulations on kidney and liver donations between HIV-positive donors and HIV-positive recipients, something that HHS says will increase access to these organs.
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A rule on interpretation of the HIV Organ Policy Equity Act removes requirements for clinical research and institutional review board approval for such donations, “based on research demonstrating the safety and effectiveness of kidney and liver transplants between donors and recipients with HIV,” says an HHS press release. The rule became final Wednesday.
“We continue to do everything in our power to increase access to life-saving organs while addressing health inequities faced by people with HIV,” HHS Secretary Xavier Becerra said in the release. “This rule removes unnecessary barriers to kidney and liver transplants, expanding the organ donor pool and improving outcomes for transplant recipients with HIV. This evidence-based policy update demonstrates our commitment to ensuring all Americans have access to the care they need.”
“Research shows that kidney and liver transplants between donors and recipients with HIV can be performed safely and effectively,” added Adm. Rachel Levine, assistant secretary for health. “This policy change reflects our commitment to following the evidence and updating our approaches as we learn more. By removing research requirements where they are no longer needed, we can help more people with HIV access life-saving transplants."
The HOPE Act, passed in 2013, allows for organ donation by people with HIV only to those who are already living with the virus. Under the act, “donors with HIV must not have evidence of opportunistic infections and recipients must have a stable CD4+ T-cell count and established HIV suppression and control on effective antiretroviral therapy,” the new rule explains.
Research has demonstrated “that the safety and outcomes of kidney and liver HOPE Act transplants are well established, with over 517 HOPE Act kidney and liver transplants conducted to date,” the new rule notes. The requirements for these transplants that were revoked by the new rule created an unnecessary barrier, according to HHS.
HHS published the proposed rule in the Federal Register in September and received 56 public comments on it before it became final.
Also Wednesday, the National Institutes of Health, part of HHS, published a notice seeking public comment on a proposed revision to its research criteria for HOPE Act transplants of other organs, such as heart, lung, and pancreas. “This effort aims to streamline the HOPE Act research requirements and continue to build an evidence base of outcomes data on HOPE Act transplants of organs other than livers and kidneys,” the press release says. Comments are due by December 12.
