Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>42 CFR Part 121</CFR> <RIN>RIN 0937-AA13</RIN> <SUBJECT>Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Office of the Assistant Secretary for Health (OASH) and Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Department of Health and Human Services (HHS) amends the regulations implementing the National Organ Transplant Act of 1984, as amended (NOTA), to remove clinical research and institutional review board (IRB) requirements (“research and IRB requirements”) for transplantation of kidneys and livers from donors with human immunodeficiency virus (HIV) to recipients with HIV. As allowed by the HIV Organ Policy Equity (HOPE) Act, the Secretary of HHS determines that participation in such clinical research should no longer be a requirement for transplantation of kidneys and livers from donors with HIV to recipients with HIV. This final rule serves as publication of the Secretary's determination and amends the regulations to reflect this determination. This final rule also serves as publication of the Secretary's direction to the Organ Procurement and Transplantation Network (OPTN) to adopt and use standards of quality with respect to kidneys and livers from donors with HIV to ensure that HOPE Act kidney and liver transplants are subject to OPTN policies that are consistent with NOTA, and in a way that ensures the revised requirements for transplantation of such organs will not reduce the safety of organ transplantation. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective November 27, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Frank Holloman, Director, Division of Transplantation, Health Systems Bureau, HRSA, 5600 Fishers Lane, Room 08W63, Rockville, MD 20857; by email at <E T="03">donation@hrsa.gov;</E> or by telephone (301) 443-7577. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Public Participation</HD> On September 12, 2024, HHS published a notice of proposed rulemaking (NPRM) in the <E T="04">Federal Register</E> (89 FR 74174) proposing both that the Secretary of HHS determine that participation in clinical research should no longer be required for transplantation of kidneys and livers from donors with HIV to recipients with HIV, and that the HHS regulations at 42 CFR part 121 implementing the HOPE Act be amended consistent with this proposed determination. The NPRM provided for a 30-day comment period, and HHS received 56 comments raising a variety of issues. HHS has carefully considered all comments in developing this rule, as outlined in section III, below, and presents a summary of all significant comments and Departmental responses. <HD SOURCE="HD1">II. Background</HD> <HD SOURCE="HD2">A. HHS Oversight of Organ Allocation and Transplantation</HD> Within HHS, HRSA is responsible for overseeing the operation of the Nation's OPTN, including assisting in the equitable allocation of donor organs for transplantation. 42 U.S.C. 274(b)(2)(D). The allocation of organs is guided by the OPTN in accordance with NOTA and with the HHS regulations governing the operation of the OPTN in 42 CFR part 121. The OPTN is also charged with developing policies on many subjects related to organ donation, procurement, and transplantation, which include establishing standards of quality pertaining to organs procured for use in transplantation. 42 U.S.C. 274(b)(2)(E). <HD SOURCE="HD2">B. HOPE Act Requirements and Implementation</HD> The enactment of the HOPE Act in 2013, Public Law 113-51, amended NOTA to eliminate the prohibition in the United States on transplantation of organs from persons with HIV, allowing transplantation of these organs if certain requirements are satisfied. Under the HOPE Act, organs from donors with HIV may be transplanted only in recipients living with HIV prior to receiving such an organ. 42 U.S.C. 274(b)(3)(A). Further, the HOPE Act requires that transplants of HIV-positive organs occur only in recipients with HIV who are participating in IRB-approved research protocols that adhere to certain criteria, standards, and regulations. 42 U.S.C. 274(b)(3)(B)(i). However, the Secretary may lift the research and IRB requirements if the Secretary has determined that participation in such clinical research, as a requirement for such transplants, is no longer warranted. 42 U.S.C. 274(b)(3)(B)(ii). The HOPE Act outlines the process by which the Secretary may make such a determination under 42 U.S.C. 274(b)(3)(B)(ii). Specifically, the Secretary must routinely review the results of scientific research, in conjunction with the OPTN, to determine whether the results warrant revision of the OPTN standards of quality regarding organs from donors with HIV. If the Secretary determines that those standards of quality should be revised, the Secretary must direct the OPTN to revise the standards. 42 U.S.C. 274f-5(c)(2). The Secretary is also required to revise the regulatory provision implementing the HOPE Act, 42 CFR 121.6, upon determining that revisions to the OPTN standards of quality are warranted. 42 U.S.C. 274f-5(c)(3). HRSA published a final rule implementing the HOPE Act on May 8, 2015. 80 FR 26464. <SU>1</SU> <FTREF/> The 2015 rule amended 42 CFR 121.6 to permit transplants of organs from donors with HIV in accordance with the HOPE Act requirements. <FTNT> <SU>1</SU>   <E T="04">Federal Register</E> . Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act. 80 FR 26464 (May 8, 2015). <E T="03">https://www.federalregister.gov/documents/2015/05/08/2015-11048/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-act.</E> </FTNT> The HOPE Act also directs the Secretary to develop and publish criteria for the conduct of research relating to transplantation of organs from donors with HIV into persons who are living with HIV before receiving an HIV-positive organ. 42 U.S.C. 274f-5(a). Subsequent to publication of the 2015 rule implementing the HOPE Act, the National Institutes of Health (NIH) published the <E T="03">Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV,</E> on November 25, 2015. 80 FR 73785. <SU>2</SU> <FTREF/> <FTNT> <SU>2</SU>   <E T="04">Federal Register</E> . Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. 80 FR 73785 (Nov. 25, 2015). <E T="03">https://www.federalregister.gov/documents/2015/11/25/2015-30172/final-human-immunodeficiency-virus-hiv-organ-policy-equity-hope-act-safeguards-and-research-criteria.</E> </FTNT> In general, the NIH Research Criteria include safeguards designed to protect both donors and recipients, as well as healthcare providers at Organ Procurement Organizations (OPOs) and transplant centers. Specifically, and in addition to the requirements in established OPTN transplant policies, 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 (ART). The study team must describe the anticipated effective HIV treatment plan and ART regimen for patients receiving an organ with a potentially different HIV strain. Antiretroviral drugs suppress viral replication; however, HIV may develop resistance to a specific drug necessitating a different medication regimen to maintain effectiveness. Transplant hospitals conducting HOPE Act operations are required to have expertise in transplants provided to recipients with HIV. OPOs are required to have procedures in place to address working with families of deceased donors who lived with HIV and a biohazard plan to address viral exposure and potential transmission. Finally, the Research Criteria establish uniform outcome measures that must be incorporated in the research design so that data on HOPE Act transplants can be analyzed consistently and data collection is harmonized to inform future implementation of the HOPE Act. Publication of both the final rule implementing the HOPE Act and the NIH Research Criteria necessitated that the OPTN update its standards of quality for HIV-positive organ transplants and coordinate related OPTN policies. On November 21, 2015, the OPTN published an open variance (an experimental policy that tests methods of improving organ allocation) providing standards for transplant hospitals conducting HOPE Act transplants. <SU>3</SU> <FTREF/> The OPTN expanded the variance in 2019 to include all solid organs, <SU>4</SU> <FTREF/> and extended the variance through January 2026, to provide for the gathering of data and subsequent evaluation of the outcomes of HOPE Act transplants. <SU>5</SU> <FTREF/> <FTNT> <SU>3</SU>  Organ Procurement and Transplantation Network. Policy Notice: Modifications to the Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors. 2016 Sep 1: <E T="03">https://optn.transplant.hrsa.gov/media/1872/dtac_policynotice_hope_201606.pdf.</E> </FTNT> <FTNT> <SU>4</SU>  Organ Procurement and Transplantation Network. Policy Notice: Modify HOPE Act Variance to Include Other Organs. 2019 Jun 10: <E T="03">https://optn.transplant.hrsa.gov/media/3000/dtac_policynotice_201906.pdf.</E> </FTNT> <FTNT> <SU>5</SU>  Organ Procurement and Transplantation Network. Policy Notice: Extend HIV Organ Policy Equity (HOPE) Act Variance. 2021 Dec 6: <E T="03">https://op ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 101k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━