```

[Federal Register Volume 89, Number 229 (Wednesday, November 27, 2024)]
[Rules and Regulations]
[Pages 93484-93498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27410]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 121

RIN 0937-AA13

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

AGENCY: Office of the Assistant Secretary for Health (OASH) and Health 
Resources and Services Administration (HRSA), Department of Health and 
Human Services (HHS).

ACTION: Final rule.

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SUMMARY: 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

[[Page 93485]]

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.

DATES: This rule is effective November 27, 2024.

FOR FURTHER INFORMATION CONTACT: Frank Holloman, Director, Division of 
Transplantation, Health Systems Bureau, HRSA, 5600 Fishers Lane, Room 
08W63, Rockville, MD 20857; by email at [email protected]; or by 
telephone (301) 443-7577.

SUPPLEMENTARY INFORMATION:

I. Public Participation

    On September 12, 2024, HHS published a notice of proposed 
rulemaking (NPRM) in the Federal Register (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.

II. Background

A. HHS Oversight of Organ Allocation and Transplantation

    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).

B. HOPE Act Requirements and Implementation

    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.\1\ The 2015 rule amended 42 CFR 121.6 to permit 
transplants of organs from donors with HIV in accordance with the HOPE 
Act requirements.
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    \1\ Federal Register. Organ Procurement and Transplantation: 
Implementation of the HIV Organ Policy Equity (HOPE) Act. 80 FR 
26464 (May 8, 2015). https://www.federalregister.gov/documents/2015/05/08/2015-11048/organ-procurement-and-transplantation-implementation-of-the-hiv-organ-policy-equity-act.
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    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 Final Human Immunodeficiency 
Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research 
Criteria for Transplantation of Organs Infected With HIV, on November 
25, 2015. 80 FR 73785.\2\
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    \2\ Federal Register. 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). https://www.federalregister.gov/documents/2015/11/25/2015-30172/final-human-immunodeficiency-virus-hiv-organ-policy-equity-hope-act-safeguards-and-research-criteria.
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    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

[[Page 93486]]

methods of improving organ allocation) providing standards for 
transplant hospitals conducting HOPE Act transplants.\3\ The OPTN 
expanded the variance in 2019 to include all solid organs,\4\ and 
extended the variance through January 2026, to provide for the 
gathering of data and subsequent evaluation of the outcomes of HOPE Act 
transplants.\5\
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    \3\ 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: 
https://optn.transplant.hrsa.gov/media/1872/dtac_policynotice_hope_201606.pdf.
    \4\ Organ Procurement and Transplantation Network. Policy 
Notice: Modify HOPE Act Variance to Include Other Organs. 2019 Jun 
10: https://optn.transplant.hrsa.gov/media/3000/dtac_policynotice_201906.pdf.
    \5\ Organ Procurement and Transplantation Network. Policy 
Notice: Extend HIV Organ Policy Equity (HOPE) Act Variance. 2021 Dec 
6: https://optn.transplant.hrsa.gov/media/t1sdej22/policy-notice_dtac_hope_variance.pdf.
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C. Review of Research Results

    The Secretary, in conjunction with the OPTN, reviewed the results 
of scientific research to determine whether the results warrant 
revision to the OPTN standards of quality with respect to organs from 
donors with HIV and the safety of transplanting an organ from a donor 
with a particular strain of HIV into a recipient with a different 
strain of HIV. 42 U.S.C. 274f-5(c)(1). This review allowed the 
Secretary to determine if the safety and efficacy of HOPE Act 
transplants are comparable to non-HOPE Act transplants and, if 
warranted, to further determine whether such transplants should be 
conducted outside of a research setting.
1. OPTN Review and Recommendations
    In 2018, the OPTN initiated a review of research results and data 
relevant to HOPE Act transplants, forming a working group for this 
purpose.\6\ The OPTN's assessment as to whether revision is warranted 
for the OPTN standards of quality applicable to HOPE Act transplants 
was based primarily on (1) the review of studies demonstrating the 
safety and outcomes of organ transplantation in recipients with HIV and 
(2) a recognition that the removal of the general research and IRB 
requirements for HOPE Act transplants could expand access to organ 
transplantation for all patients regardless of their HIV status. In 
this context, safety is measured by accidental or inadvertent 
transmission of HIV in the performance of HOPE Act transplants. (Of 
note, there were no recorded accidental or inadvertent transmission 
events in the data reviewed by the OPTN.) Outcomes are determined 
primarily by transplant recipient or graft survival, compared to non-
HOPE Act transplants or transplant recipients without HIV. Measures 
(e.g., CD4+ T-cell counts, ART resistance, and detectable HIV viral 
loads) or variables such as opportunistic infections, HIV 
superinfection, malignancy, rejection, or graft failure may also factor 
into comparative outcomes in the short and long term.
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    \6\ Organ Procurement and Transplantation Network. Public 
Comment Proposal: Modify the HOPE Act Variance to Include Other 
Organs. 2019 Jan 22: https://optn.transplant.hrsa.gov/media/2800/dtac_publiccomment_20190122.pdf.
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    The OPTN used three primary sources of data to assess HOPE Act 
transplants, each of which contributed to the recommendation the OPTN 
provided to the Secretary: (1) the research results of two pilot 
studies evaluating HOPE Act kidney transplants and liver transplants, 
and the progress of two ongoing NIH-funded clinical trials evaluating 
HOPE Act kidney transplants and liver transplants, (2) the research 
results of an older clinical trial analyzing safety and efficacy of 
kidney transplants in a small cohort of transplant recipients with HIV, 
and (3) OPTN data on the outcomes of all HOPE Act transplants.
Pilot Studies
    A multicenter pilot study was launched in 2016 to determine safety 
and efficacy of HOPE Act kidney transplants. The HOPE In Action 
Consortium of 14 transplant centers conducting HOPE Act kidney 
transplants found no major differences between HOPE Act transplants of 
a kidney from a donor with HIV to a recipient with HIV and non-HOPE Act 
kidney transplants from a donor without HIV to a recipient with HIV.\7\ 
Rates of opportunistic infections and infections requiring 
hospitalization post-transplant did not differ significantly across the 
study arms. Rejection was common for the study participants in the 
first year after transplant, occurring in 50 percent of recipients who 
received a kidney from a donor with HIV and 29 percent of recipients 
who received a kidney from a donor without HIV, but this result was not 
statistically significant. The insignificance of the result is due, in 
part, to the relatively small sample size. This finding is consistent 
with the earlier clinical trial of kidney transplantation in recipients 
with HIV, discussed in the next subsection of this preamble, which also 
found higher rejection rates in HIV allografts. The pilot study 
investigators noted that despite rejection rates, 1-year renal function 
was excellent for both study populations. Limitations of the pilot 
study include study size (75 transplants), which investigators 
attributed to the lower number of HOPE Act transplants conducted than 
the projected potential. In general, the study authors concluded that 
there is a survival benefit of transplantation for kidneys from donors 
with HIV to recipients with HIV, and that the availability of HOPE Act 
kidney transplants has the potential to mitigate disparities for a 
vulnerable population that faces lower access to transplant and higher 
waitlist mortality. The investigators further concluded that the 
observed trend toward higher rejection, albeit not statistically 
significant, for transplanted organs from donors with HIV merited 
further investigation.
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    \7\ Durand CM, Zhang W, Brown DM, Yu S, Desai N, Redd AD, 
Bagnasco SM, Naqvi FF, Seaman S, Doby BL, Ostrander D, Bowring MG, 
Eby Y, Fernandez RE, Friedman-Moraco R, Turgeon N, Stock P, Chin-
Hong P, Mehta S, Stosor V, Small CB, Gupta G, Mehta SA, Wolfe CR, 
Husson J, Gilbert A, Cooper M, Adebiyi O, Agarwal A, Muller E, Quinn 
TC, Odim J, Huprikar S, Florman S, Massie AB, Tobian AAR, Segev DL; 
HOPE in Action Investigators. A prospective multicenter pilot study 
of HIV-positive deceased donor to HIV-positive recipient kidney 
transplantation: HOPE in action. Am J Transplant. 2021 
May;21(5):1754-1764.
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    A separate pilot study conducted by HOPE In Action Consortium 
participants compared HOPE Act transplants of a liver from a donor with 
HIV to a recipient with HIV and non-HOPE Act liver transplants from a 
donor without HIV to a recipient with HIV, and found that there were no 
differences in one-year graft survival, rejections, HIV breakthrough or 
severe adverse events. While the recipients of HOPE Act liver 
transplants presented with more opportunistic infections, infectious 
hospitalizations, and cancer, compared to non-HOPE Act liver 
transplants, the investigators determined that these findings warrant 
further investigation and perhaps consideration of additional donor and 
recipient infection and malignancy monitoring. In general, the 
investigators concluded that the transplant outcomes were more 
favorable compared to historical data on liver transplantation in 
recipients with HIV, who are known to experience higher rates of 
opportunistic infections and other complications. In addition, it was 
noted that co-infections are more common among both donors and 
recipients with HIV and confound the results. (Results of non-HOPE Act 
transplants have confirmed that recipients with both HIV and a co-
infection have lower survival rates. Therefore, the presence of co-
infections could independently impact survival and other variables 
measured by studies on HOPE Act transplants.)

[[Page 93487]]

This pilot study was the first multicenter prospective study reporting 
results of U.S. transplants of livers from donors with HIV to 
recipients with HIV and comparing outcomes according to donor HIV 
status in order to assess attributable risk. The investigators 
recognized as a limitation that the pilot study was relatively small 
(45 transplants), and noted that increases among HOPE Act liver 
transplant recipients in mortality, cytomegalovirus (CMV) viremia, 
infectious hospitalizations, and cancer, were observed. However, they 
note that these results should be considered in light of the relatively 
high rate of mortality for recipients awaiting liver transplant. For 
these patients, the benefit of undergoing a HOPE Act liver transplant 
may outweigh the risks of living with HIV and end stage liver 
disease.\8\
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    \8\ Durand CM, Florman S, Motter JD, Brown D, Ostrander D, Yu S, 
Liang T, Werbel WA, Cameron A, Ottmann S, Hamilton JP, Redd AD, 
Bowring MG, Eby Y, Fernandez RE, Doby B, Labo N, Whitby D, Miley W, 
Friedman-Moraco R, Turgeon N, Price JC, Chin-Hong P, Stock P, Stosor 
V, Kirchner VA, Pruett T, Wojciechowski D, Elias N, Wolfe C, Quinn 
TC, Odim J, Morsheimer M, Mehta SA, Rana MM, Huprikar S, Massie A, 
Tobian AAR, Segev DL; HOPE in Action Investigators. HOPE in action: 
A prospective multicenter pilot study of liver transplantation from 
donors with HIV to recipients with HIV. Am J Transplant. 2022 
Mar;22(3):853-864.
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Ongoing Clinical Trials
    The OPTN further considered the progress of an NIH-funded study on 
HOPE Act kidney transplants that was ongoing at the time of the OPTN's 
analysis. The NIH-funded U01 HOPE Act kidney transplant clinical trial 
was designed to analyze rejection and long-term outcomes of kidney 
transplantation for recipients with HIV. While the study was 
subsequently expanded, at the time of the OPTN's consideration the 
study was designed to compare outcomes of 100 HOPE Act kidney 
transplant recipients to 100 kidney transplant recipients with HIV who 
received an HIV-negative organ at 15 transplant centers, adding to the 
cohort accrued from the pilot studies discussed in the immediately 
preceding section of this preamble.\9\ The results from this clinical 
trial were published in October 2024 and are described in section 3, 
``Additional Research Results Published Subsequent to Issuance of the 
NPRM,'' below. Of note, these investigators were awarded an expansion 
grant to evaluate longer-term outcomes in HOPE Act kidney transplants.
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    \9\ National Institutes of Health RePORT. Kidney Transplantation 
from Donors with HIV: Impact on Rejection and Long-term Outcomes. 
Project No. 5U01AI177211-02. Accessed 21 May 2024. https://reporter.nih.gov/search/kcWJ0GeT8kigjO2_LU8R2g/project-details/10848468.
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    Similarly, the OPTN considered the progress of an ongoing U01 HOPE 
Act liver transplant clinical trial designed to compare outcomes 
between HOPE Act transplants and non-HOPE Act transplants of livers 
from donors without HIV. The study has enrolled 40 individuals in each 
group over 3 years at 16 transplant centers,\10\ reaching target 
enrollment, and now is in the phase of patient follow-up. The final 
results are not yet published.
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    \10\ National Institutes of Health RePORT. Hope In Action: A 
Clinical Trial of HIV-to-HIV Liver Transplantation. Project No. 
5U01AI138897-05. Accessed 21 May 2024. https://reporter.nih.gov/project-details/10459319.
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Other Research Results
    Prior to the initiation of the pilot studies and clinical trials 
discussed previously, a clinical trial examined outcomes of 150 kidney 
transplants in recipients with HIV conducted between November 2003 and 
June 2009. The investigators found both recipient and graft survival 
rates were high with no important increases in complications associated 
with HIV.\11\ As noted in the description of the findings of the HOPE 
Act kidney transplant pilot study described in the immediately 
preceding subsection of this preamble, the investigators observed what 
they described as ``unexpectedly higher'' rejection rates in the 
transplant recipients with HIV participating in the study, compared 
with kidney transplant recipients who are not living with HIV. This 
higher rejection rate was blunted in transplant recipients that 
received anti-T-cell antibody medication at the time of 
transplantation. Studies of non-HOPE Act transplants have confirmed 
that such immunosuppressive regimens can reduce the risk of rejection 
for kidney transplant recipients with HIV.\12\
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    \11\ Stock PG, Barin B, Murphy B, Hanto D, Diego JM, Light J, 
Davis C, Blumberg E, Simon D, Subramanian A, Millis JM, Lyon GM, 
Brayman K, Slakey D, Shapiro R, Melancon J, Jacobson JM, Stosor V, 
Olson JL, Stablein DM, Roland ME. Outcomes of kidney transplantation 
in HIV-infected recipients. N Engl J Med. 2010 Nov 18;363(21):2004-
14.
    \12\ Locke JE, James NT, Mannon RB, Mehta SG, Pappas PG, Baddley 
JW, Desai NM, Montgomery RA, Segev DL. Immunosuppression Regimen and 
the Risk of Acute Rejection in HIV-Infected Kidney Transplant 
Recipients. Transplantation. 2014 Feb 27;97(4):p 446-450.
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OPTN Data--HOPE Act Transplant Outcomes
    Data from HOPE Act transplants is compiled by the OPTN on a 
quarterly basis, including waitlist registrations and counts of HOPE 
Act transplants, and is routinely reviewed. Prior to issuing its 
recommendation to the Secretary, the OPTN reviewed data on over 300 
patients included in the HOPE Act research variance for which no case 
was halted, paused, or substantially amended to address safety 
concerns.
OPTN Recommendations
    Based on the assessment of the above-described research results and 
data, in 2021 the OPTN recommended to the Secretary that the research 
and IRB requirements of the HOPE Act be removed for all organs.\13\ The 
OPTN specifically noted that in its review of the data safety 
monitoring review board (DSMB) reports from five years of HOPE Act 
transplants, with over 300 persons with HIV receiving HOPE Act 
transplants, no DSMB identified patient safety concerns in HOPE Act 
research. Further, there have been no reports made to the OPTN of 
safety issues regarding HOPE Act transplants among OPO, hospital, or 
transplant center personnel or in patients, in donor hospitals, or 
transplant hospitals. The OPTN noted that it was the opinion of the 
OPTN Safety Review Group that the research and IRB requirements for 
HOPE Act transplants present a barrier to fully realizing the potential 
of organ transplantation from donors with HIV to recipients with HIV, 
as the research and IRB requirements limit access to such 
transplants.14 15
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    \13\ Cooper M. ``OPTN Letter to Secretary Becerra on the HOPE 
Act.'' 2021 Oct 29. https://optn.transplant.hrsa.gov/media/ueyjdfnd/hope-act-letter.pdf.
    \14\ McCauley J. ``Fifty Sixth ACBTSA Meeting, Written Public 
Comment--November 17, 2022 Meeting.'' 2022 Nov 8. https://optn.transplant.hrsa.gov/media/hwgncda2/optn-executive-committee_acbtsa-letter.pdf.
    \15\ Chandran S, Stock PG, Roll GR. Expanding Access to Organ 
Transplant for People Living With HIV: Can Policy Catch Up to 
Outcomes Data? Transplantation. 2024 Apr 1;108(4):874-883.
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2. Additional Research Results Published Subsequent to the OPTN 
Assessment
    Prior to publication of the NPRM, the Secretary further considered 
additional research published providing more evidence for the safety of 
organ transplantation from donors with HIV to recipients with HIV. In 
general, this research demonstrates 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.
    One prospective study published in 2022, examined 92 HOPE Act 
donors contributing 177 organs, which included 131 kidneys and 46 
livers, to understand the characteristics of donors with HIV in terms 
of clinical,

[[Page 93488]]

immunologic, and virologic profiles to ensure the safety of 
transplantation. Of these donors, 58 were donors with HIV and 34 were 
donors without HIV. For those donors with known HIV infection, 90 
percent received ART treatment. The study concluded that although drug 
resistant mutations (DRMs) were common, DRMs that could compromise the 
effectiveness of certain ART were rare, reassuring the safety of using 
organs from donors with HIV in recipients with HIV. Further, the study 
also found that there were no major differences in comorbidities 
between recipient groups that received an organ from a donor with HIV 
compared to those that received an organ from a donor without HIV.\16\
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    \16\ Werbel WA, Brown DM, Kusemiju OT, Doby BL, Seaman SM, Redd 
AD, Eby Y, Fernandez RE, Desai NM, Miller J, Bismut GA, Kirby CS, 
Schmidt HA, Clarke WA, Seisa M, Petropoulos CJ, Quinn TC, Florman 
SS, Huprikar S, Rana MM, Friedman-Moraco RJ, Mehta AK, Stock PG, 
Price JC, Stosor V, Mehta SG, Gilbert AJ, Elias N, Morris MI, Mehta 
SA, Small CB, Haidar G, Malinis M, Husson JS, Pereira MR, Gupta G, 
Hand J, Kirchner VA, Agarwal A, Aslam S, Blumberg EA, Wolfe CR, Myer 
K, Wood RP, Neidlinger N, Strell S, Shuck M, Wilkins H, Wadsworth M, 
Motter JD, Odim J, Segev DL, Durand CM, Tobian AAR; HOPE in Action 
Investigators. National Landscape of Human Immunodeficiency Virus-
Positive Deceased Organ Donors in the United States. Clin Infect 
Dis. 2022 Jun 10;74(11):2010-2019.
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    In a March 2024 analysis of the impact of the HOPE Act on access to 
kidney transplantation for recipients with HIV, the authors found 70 
percent of HOPE Act recipients received a kidney transplant during the 
4.5 year study period versus 43 percent of non-HOPE Act transplant 
candidates at the same center.\17\ Furthermore, those who received 
transplants in HOPE Act trials had shorter estimated wait times (median 
10.3 months versus 60.8 months), and after adjusting for relevant 
allocation factors including time on dialysis, kidney transplantation 
was 3.3-fold higher for those who received an organ from a donor with 
HIV.\18\ These findings suggest that the availability of kidneys from 
donors with HIV increases access to transplantation among people with 
HIV. Given that people with HIV who are living with end stage renal 
disease (ESRD) have higher mortality than people with ESRD who are not 
also living with HIV,\19\ in HHS's view, this data illustrates the 
benefit of HOPE Act kidney transplants for this vulnerable population.
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    \17\ Motter JD, Hussain S, Brown DM, Florman S, Rana MM, 
Friedman-Moraco R, Gilbert AJ, Stock P, Mehta S, Mehta SA, Stosor V, 
Elias N, Pereira MR, Haidar G, Malinis M, Morris MI, Hand J, Aslam 
S, Schaenman JM, Baddley J, Small CB, Wojciechowski D, Santos CAQ, 
Blumberg EA, Odim J, Apewokin SK, Giorgakis E, Bowring MG, Werbel 
WA, Desai NM, Tobian AAR, Segev DL, Massie AB, Durand CM; HOPE in 
Action Investigators. Wait Time Advantage for Transplant Candidates 
With HIV Who Accept Kidneys From Donors With HIV Under the HOPE Act. 
Transplantation. 2024 Mar 1;108(3):759-767.
    \18\ Motter JD, et al, on behalf of the HOPE in Action 
Investigators. Wait Time Advantage for Transplant Candidates With 
HIV Who Accept Kidneys From Donors With HIV Under the HOPE Act. 
Transplantation. 2024 Mar 1;108(3):759-767.
    \19\ Motter JD, et al., on behalf of the HOPE in Action 
Investigators. Wait Time Advantage for Transplant Candidates With 
HIV Who Accept Kidneys From Donors With HIV Under the HOPE Act. 
Transplantation. 2024 Mar 1;108(3):759-767.
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    The HOPE in Action Consortium also has published information on the 
positive outcomes of living HOPE Act kidney donors. In a case series of 
three transplants, investigators reported that two of the three donors 
developed adverse events, but findings suggested these were medically 
managed and that HIV RNA copies and CD4+ T-cell counts were stable at 
two to four years post-transplant.\20\
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    \20\ Durand CM, et al., on behalf of the HOPE in Action 
Investigators. Living Kidney Donors with HIV: Experience and 
Outcomes from a Case Series by the HOPE in Action Consortium. The 
Lancet Regional Health Americas. 2023 Jul;24:100553.
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    There is significantly less data on non-kidney and non-liver HOPE 
Act transplants. Since 2019, when the OPTN's HOPE Act policy was 
expanded to include all solid organs, only three heart transplant 
programs have received approval to perform HOPE Act transplants. To 
date, just three heart transplants have been conducted, including one 
heart-kidney transplant.21 22 No HOPE Act transplants have 
been recorded among recipients in need of other organs. The lack of 
data makes it difficult to assess the safety and outcomes of HOPE Act 
transplants other than kidney and liver HOPE Act transplants.
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    \21\ Montefiore News Releases. World's First HIV-Positive to 
HIV-Positive Heart Transplant Performed at Montefiore Health System. 
2022 Jul 22. https://www.montefiore.org/body.cfm?id=1738&action=detail&ref=2194.
    \22\ Hemmige V, Saeed O, Puius YA, Azzi Y, Colovai A, Borgi J, 
Goldstein DJ, Rahmanian M, Carlese A, Jorde UP, Patel S. HIV D+/R+ 
heart/kidney transplantation: First case report. J Heart Lung 
Transplant. 2023 Mar;42(3):406-408.
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3. Additional Research Results Published Subsequent to Issuance of the 
NPRM
    Since publication of the NPRM, results from a new, groundbreaking 
study were published in October 2024.\23\ In the largest prospective, 
observational, multicenter study to date, researchers compared 
transplantation of kidneys at 26 U.S. centers from deceased donors with 
HIV and donors without HIV to recipients with HIV. The study enrolled 
408 transplantation candidates, of whom 198 received a kidney from a 
deceased donor; 99 received a kidney from a donor with HIV and 99 from 
a donor without HIV. This study was larger than the HOPE Act pilot 
study, described above, and was designed to assess whether kidney 
transplantation from donors with HIV to recipients with HIV would be 
noninferior to transplantation from donors without HIV. The study 
further assessed safety and post-transplantation complications.
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    \23\ C.M. Durand, A. Massie, S. Florman, T. Liang, M.M. Rana, R. 
Friedman-Moraco, A. Gilbert, P. Stock, S.A. Mehta, S. Mehta, V. 
Stosor, M.R. Pereira, M.I. Morris, J. Hand, S. Aslam, M. Malinis, G. 
Haidar, C.B. Small, C.A.Q. Santos, J. Schaenman, J. Baddley, D. 
Wojciechowski, E.A. Blumberg, K. Ranganna, O. Adebiyi, N. Elias, 
J.A. Castillo-Lugo, E. Giorgakis, S. Apewokin, D. Brown, D. 
Ostrander, Y. Eby, N. Desai, F. Naqvi, S. Bagnasco, N. Watson, E. 
Brittain, J. Odim, A.D. Redd, A.A.R. Tobian, and D.L. Segev, for the 
HOPE in Action Investigators. Safety of Kidney Transplantation from 
Donors with HIV. New England Journal of Medicine. 2024 Oct 17; 
391(15): 1390-1401.
---------------------------------------------------------------------------

    The primary outcome assessed was a safety outcome (a composite of 
death from any cause, graft loss, serious adverse event, HIV 
breakthrough infection, persistent failure of HIV treatment, or 
opportunistic infection) for noninferiority (margin for the upper bound 
of the 95% confidence interval, 3.00). Researchers found an adjusted 
hazard ratio of 1.00 for the primary composite outcome, demonstrating 
noninferiority of kidney transplantation from donors with HIV as 
compared to kidney transplantation from donors without HIV.
    Secondary outcomes included overall survival, survival without 
graft loss, rejection, infection, cancer, and HIV superinfection. The 
following secondary outcomes were similar whether the donor had HIV or 
not: overall survival at 1 year (94% vs. 95%) and 3 years (85% vs. 
87%), survival without graft loss at 1 year (93% vs. 90%) and 3 years 
(84% vs. 81%), and rejection at 1 year (13% vs. 21%) and 3 years (21% 
vs. 24%).
    The incidence of serious adverse events, infections, and cancer was 
similar in all groups studied. Of note, the incidence of HIV 
breakthrough infection was approximately three times higher among HOPE 
Act transplants (incidence rate ratio, 3.14; 95% CI, 1.02 to 9.63), 
which the researchers attributed to non-adherence to antiretroviral 
therapy. In all participants with HIV breakthrough infection, viral 
suppression was regained. A single case of potential HIV superinfection 
or dual infection occurred among the 58 recipients in this group, 
without HIV breakthrough infection or clinical consequences.

[[Page 93489]]

    Among the acknowledged limitations of this study are the lack of 
true randomization, which the authors note was not possible due to the 
U.S. national organ allocation process. The authors further note that 
study participants were equally eligible for a kidney from a donor with 
or a donor without HIV, and that study group assignment was determined 
according to whichever organ was available first. The study group whose 
donors did not have HIV served as a control group and included 27 
donors who were treated as having HIV during allocation but did not; in 
the authors' estimation, recipients of kidneys from these donors 
represent an ideal counterfactual control group. Immunosuppression and 
prophylaxis were heterogeneous; however, these factors were balanced 
between the two groups and reflect real-world practice, which the 
authors assert increases the generalizability of the study results.
    This study is an important addition to the evidence base for HOPE 
Act kidney transplants in that the finding that kidney transplantation 
from donors with HIV was noninferior to kidney transplantation from 
donors without HIV with respect to the primary safety outcome, and that 
the incidence of serious adverse events, infections, surgical or 
vascular complications, and cancer was similar in the two groups, 
supporting the safety of HOPE Act kidney transplants.
4. HHS Advisory Committee on Blood and Tissue Safety and Availability 
Recommendations
    The Secretary also considered the HHS Advisory Committee on Blood 
and Tissue Safety and Availability (ACBTSA) recommendation that the 
Secretary eliminate research and IRB requirements for all HOPE Act 
transplants. The ACBTSA working group developing this recommendation 
considered the OPTN recommendation and the results of relevant 
scientific research. While the ACBTSA working group proposed that the 
full committee recommend that the Secretary eliminate research and IRB 
requirements for all HOPE Act transplants, the working group expressed 
concern about the elimination of research and IRB requirements for non-
kidney and non-liver HOPE Act transplants,\24\ and whether there was 
sufficient data collected on other organs to justify a full adoption of 
the OPTN's recommendation.
---------------------------------------------------------------------------

    \24\ HHS Advisory Committee on Blood and Tissue Safety and 
Availability. 2022. Fifty-Sixth ACBTSA Meeting November 17, 2022--
Meeting Summary. https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meeting-summary/2022-11-17/index.html.
---------------------------------------------------------------------------

    The ACBTSA subsequently recommended that the Secretary act to lift 
the statutory research and IRB requirements for all HOPE Act 
transplants and at the same time recommended that the Secretary direct 
the OPTN to adopt, for HOPE Act transplants of organs other than 
kidneys and livers, organ-specific policies imposing additional 
requirements for the conduct of these transplants, including collecting 
safety and outcomes data for transplant candidates and recipients of 
such transplants through an IRB-approved research protocol.
    These recommendations were later approved by the HHS Blood, Organ, 
and Tissue Senior Executive Council (BOTSEC), an advisory forum for 
senior leadership from HHS entities involved in blood, organ, and 
tissue safety and availability.
    Upon review of the OPTN, ACBTSA and BOTSEC recommendations, and in 
consideration of the results of relevant scientific research, the 
Secretary proposed to determine that the research and IRB requirements 
for kidney and liver HOPE Act transplants are no longer warranted. The 
NPRM incorporated this approach, publishing the Secretary's proposed 
determination for comment, and proposing regulatory changes to exempt 
HOPE Act kidney and liver transplants from research and IRB 
requirements. In an effort to avoid the use of stigmatizing language, 
the NPRM further proposed wording changes to references to persons, 
donors, and recipients with HIV, and organs from individuals with HIV.

III. Discussion of Public Comment

    HHS received 56 comments from individuals and organizations 
involved in healthcare, organ transplantation, HIV advocacy, health 
equity, LGTBQIA+ health, and HOPE Act clinical research. The comments 
received expressed overwhelming support for the finalization of this 
rule. A total of 55 of the 56 commenters expressed support for the 
proposed rule. One commenter did not support the proposed rule. 
Additional consideration was given to comments that were expressed by 
multiple individuals and entities. HHS has considered all of the 
comments, and, in response to comments regarding the use of non-
stigmatizing language, made changes to the final rule as suggested by 
commenters.
    Themes identified in many comments include that the proposed rule, 
if finalized, could reduce morbidity and mortality for people with HIV, 
reduce barriers to organ transplantation, increase organ utilization, 
reduce wait times for people on organ transplant wait lists, and reduce 
stigma and discrimination associated with HIV. One commenter indicated 
that, given that only 31 of the 250 transplant centers in the U.S. 
currently participate in HOPE Act clinical trials, access to these 
vital transplants is geographically limited: the proposed rule would 
encourage more transplant centers to offer HOPE Act transplants, 
enabling more equitable access to life-saving care for people with HIV 
across the country and helping to generate additional clinical data to 
enhance understanding and inform best practices in transplant care for 
people with HIV. In addition, numerous commenters noted that research 
has sufficiently demonstrated that HOPE Act kidney and liver 
transplants are both safe and effective.
    The NPRM specifically invited public comment on the future 
Secretarial direction to the OPTN to revise the standards of quality 
concerning kidneys and livers from donors with HIV. Some commenters 
provided specific suggestions for the Secretary's direction, and other 
comments received appear relevant to HHS's consideration as to the 
content of the direction to the OPTN. These comments are noted below in 
both the subheading discussing the comments specifically provided on 
the content of the direction to the OPTN, and the subheadings relating 
to the subject matter of the comment. HHS has considered these comments 
in the development of the Secretary's direction to the OPTN, which is 
provided in section V, ``Implementation Considerations,'' below.
    Multiple commenters also provided specific suggestions for the 
content of the revised NIH Research Criteria, and other comments 
received appear relevant to the content of the Research Criteria. These 
comments are noted below in both the subheading discussing the comments 
specifically provided on the Research Criteria, as well as in the 
subheadings relating to the subject matter of the comment when the 
commenter did not specifically reference the Research Criteria. All 
comments relating to the content of the revised Research Criteria were 
provided to NIH for consideration in the development of the revised 
Research Criteria.
    Detailed descriptions of comments on specific aspects of the NPRM 
preamble and the proposed regulation, and HHS's responses to these 
comments, are provided below.

[[Page 93490]]

Removal of Research and IRB Requirements for All Organs
    Several commenters suggested that the Secretary should consider in 
this rule, or in a future rulemaking, the removal of research and IRB 
requirements for all HOPE Act organ transplants instead of removing 
research and IRB requirements only for kidney and liver transplants. 
Some of these commenters referenced the October 2021 letter from the 
OPTN to the Secretary providing that the OPTN had not identified any 
patient safety concerns involving HOPE Act transplants and that no 
research protocols applicable to HOPE Act transplants had been stopped, 
paused, or substantially altered due to patient safety concerns.\25\ 
Many of these comments suggested that the available data was sufficient 
to prove the safety and efficacy of HOPE Act transplantation for all 
organ transplants, not only kidney and liver transplants. Others 
suggested that HHS should continue supporting research on HOPE Act 
transplants with the goal of generating sufficient evidence to make the 
case for a future Secretarial determination and rulemaking process that 
would remove the research and IRB requirements for all HOPE Act 
transplants.
---------------------------------------------------------------------------

    \25\ Cooper M. ``OPTN Letter to Secretary Becerra on the HOPE 
Act.'' 2021 Oct 29. https://optn.transplant.hrsa.gov/media/ueyjdfnd/hope-act-letter.pdf.
---------------------------------------------------------------------------

    HHS response: In the process leading up to the development of the 
NPRM, the Secretary considered whether to eliminate research and IRB 
requirements for all HOPE Act transplants. As a part of this process, 
the Secretary considered the October 2021 communication from the OPTN 
referenced by commenters, recommendations of advisory bodies, and 
research results and outcomes data on HOPE Act transplants. The vast 
majority of this data was generated from kidney and liver transplants, 
and, as discussed in the NPRM preamble, the Secretary notes the limited 
evidence demonstrating safety and efficacy of non-kidney and non-liver 
HOPE Act transplants. In order to lift the research and IRB 
requirements for HOPE Act transplants, the HOPE Act requires that the 
Secretary must determine that participation in clinical research is no 
longer warranted. 42 U.S.C. 274(b)(3)(B)(ii). In the absence of 
research results and robust outcomes data relevant to HOPE Act 
transplants of organs other than kidneys and livers, the Secretary does 
not have sufficient information about transplants of organs other than 
kidneys and livers on which to base the statutorily required 
determination. For this reason, the NPRM proposal to lift the research 
and IRB requirements only for HOPE Act kidney and liver transplants is 
incorporated in this final rule. As required by the HOPE Act, the 
Secretary will periodically review the results of additional scientific 
research relevant to transplants of organs other than kidneys and 
livers, and will reevaluate in the future whether the evidence is 
robust enough to demonstrate that other types of HOPE Act transplants 
need not be conducted in the research context. HHS makes no changes to 
the regulatory proposal in response to these comments.
Language Regarding HIV
    Many commenters expressed support for the proposed revisions to the 
regulatory language used when referencing people, donors, and 
recipients with HIV. In general, commenters suggested that the proposed 
changes are more respectful, reflect a person-centered approach, and 
help to combat stigma associated with HIV. Others noted that these 
wording changes help to create a more inclusive healthcare environment.
    One commenter requested that the proposed modification to 42 CFR 
121.6 regarding references to donor organs be changed from ``donor 
organ(s) with HIV'' to ``organ(s) from donors with HIV.'' The commenter 
stated that, in their view, the term ``organs from donors with HIV'' is 
accurate and precise, stigma-reducing, and reflects a person-first 
approach in describing these donated organs.
    HHS response: HHS appreciates this feedback, and includes the 
regulatory revisions in this final rule as proposed with regard to 
references to people, donors, and recipients with HIV. Further, HHS 
concurs with the suggested revision provided by the commenter with 
respect to the references to donor organs, and has incorporated this 
suggested revision and other similar revisions in the final rule at 42 
CFR 121.6(b)(1)(ii)(B) introductory text, (b)(1)(ii)(B)(1) and (2), and 
(b)(2).
Ongoing Data Monitoring
    Multiple commenters expressed support for efforts to monitor 
outcomes of HOPE Act transplants, both for patient safety and to 
develop evidence for the safety and efficacy of HOPE Act transplants.
    Commenters addressing patient safety indicated that while the 
proposed rule may streamline the transplant process and increase the 
availability of organs, patient safety must be the top priority and 
rigorous safety standards must continue to apply. Several commenters 
noted that areas needing further attention, such as monitoring for 
rejection, malignancy, and infection, do not overshadow the overall 
favorable outcomes for HOPE Act kidney and liver transplants. 
Commenters emphasized the importance of continued monitoring of 
outcomes for these transplants by the OPTN, and that transparency and 
public communication of these outcomes are critical to maintaining 
trust and ensuring the ongoing success of HOPE Act transplant programs. 
Commenters indicated that application of the NIH Research Criteria has 
provided essential protections with regard to outcomes monitoring for 
HOPE Act kidney and liver transplants, and urged continued monitoring 
of HOPE Act transplants to ensure these protections are maintained.
    Other commenters expressed that data monitoring could help HOPE Act 
transplant recipients and HOPE Act living donors who may need to be 
monitored for the development of chronic or end-stage conditions. For 
example, one commenter noted that living kidney donors ``are already at 
higher risk of kidney disease and will now only have one kidney.''
    Commenters addressing evidence development noted that monitoring 
and evaluation of HOPE Act transplants may help develop evidence that 
will inform future policy, including a potential future implementation 
of the HOPE Act to remove research and IRB requirements for all HOPE 
Act organ transplants.
    Several commenters indicated that current data monitoring 
requirements applicable to all organ transplants are sufficient. One 
commenter indicated that there is no reason to continue monitoring HOPE 
Act kidney and liver transplant outcomes above and beyond the baseline 
safety and outcomes monitoring for all organ transplants in the United 
States. One commenter indicated that the OPTN structure and outcome 
data collected are sufficient in their current state to provide 
oversight for all organs. Another commenter indicated comfort with 
appropriate oversight and data management by the organizations 
designated to oversee transplant services on a national level, which 
could include comprehensive reporting systems to track outcomes and 
address any issues promptly. The commenter further expressed an 
expectation that this information be made available to the public is a 
transparent manner.
    HHS response: HHS notes that the final rule does not affect 
existing data

[[Page 93491]]

monitoring or evaluation requirements for HOPE Act transplants, as 
these are determined by OPTN policy and the NIH Research Criteria. HHS 
agrees that patient safety remains a paramount concern and that 
appropriate safety standards apply to protect organ donors and 
transplant recipients. Further, HHS expects to utilize data on HOPE Act 
transplant outcomes in its ongoing evaluation of the HOPE Act. These 
comments were provided to the NIH working group for consideration in 
the development of revisions to the Research Criteria. Further, HHS 
considered these comments in developing the Secretary's direction to 
the OPTN to revise the OPTN standards of quality embodied in OPTN 
policy regarding organs from donors with HIV. HHS makes no changes to 
the regulatory proposal in response to these comments.
Standards for Transplant Centers Performing HOPE Act Transplants
    Several commenters provided suggestions for transplant centers that 
are seeking to participate in HOPE Act transplants. One commenter 
requested that HHS evaluate all outstanding requests by transplant 
centers to participate in HOPE Act transplants, and approve qualifying 
transplant centers as soon as possible to both expand access to care 
and to generate additional data on the HOPE Act transplants they 
perform. The commenter further requested that HHS explore providing 
grants designed to build the capacity at transplant centers such that 
more transplant centers will be able to meet the minimum requirements 
necessary to become HOPE Act transplant centers.
    HHS response: Thank you for these suggestions. While no changes 
have been made to the regulatory proposal in response to these 
comments, HHS will consider these suggestions in the Department's 
ongoing approach to implementation of the HOPE Act.
Informed Consent and Autonomy of Transplant Recipients
    Some commenters expressed the desire that, if HHS finalizes the 
proposed rule, that HHS take steps to prioritize ethical considerations 
relevant to the autonomy of donors and recipients. In particular, 
commenters asked that transplant centers maintain meaningful processes 
to provide patients with the opportunity to provide informed consent, 
and that transplant candidates with HIV retain the option to elect a 
non-HOPE Act transplant instead of a HOPE Act transplant.
    HHS response: This rule does not affect existing OPTN policies that 
require that informed consent is obtained from all transplant 
candidates, including HOPE Act transplant candidates,\26\ or the 
informed consent policies or practices at hospitals providing clinical 
care to potential organ donors, OPOs, or individual transplant centers. 
HHS supports retaining the existing approach in OPTN policy that 
requires informed consent.
---------------------------------------------------------------------------

    \26\ Organ Procurement and Transplantation Network. OPTN 
Policies. Updated October 31, 2024. https://optn.transplant.hrsa.gov/media/eavh5bf3/optn_policies.pdf.
---------------------------------------------------------------------------

    Further, existing OPTN policies do not prohibit transplant 
candidates eligible for a HOPE Act transplant to choose a non-HOPE Act 
transplant.\27\ There are no revisions made in this rule that would 
force a transplant candidate to receive an organ from a donor with HIV. 
HHS supports retaining the existing approach in OPTN policy that 
permits transplant candidates eligible for a HOPE Act kidney or liver 
transplant to choose a non-HOPE Act kidney or liver transplant.
---------------------------------------------------------------------------

    \27\ Organ Procurement and Transplantation Network. OPTN 
Policies. Updated October 31, 2024. https://optn.transplant.hrsa.gov/media/eavh5bf3/optn_policies.pdf.
---------------------------------------------------------------------------

    HHS considered these comments in developing the Secretary's 
direction to the OPTN to revise the OPTN standards of quality embodied 
in OPTN policy regarding organs from donors with HIV, as provided below 
in this preamble in the discussion of implementation considerations. 
HHS makes no changes to the regulatory proposal in response to these 
comments.
Education
    Commenters expressed the desire for additional educational efforts 
regarding HOPE Act transplantation. Some commenters suggested that HRSA 
collaborate with the OPTN and work with OPOs to ensure that transplant 
centers are making compassionate efforts to seek authorization from 
potential kidney donors with HIV. Commenters further suggested that 
HRSA partner with the Centers for Medicare & Medicaid Services (CMS) to 
ensure that donor hospitals recognize every opportunity for organ 
donation for patients with an HIV-positive diagnosis and make referrals 
to the local OPO for an organ donation evaluation as mandated by the 
CMS Conditions of Participation. Other commenters asked for educational 
efforts aimed at people with HIV, healthcare professionals, students of 
health sciences, transplant centers, OPOs, and the public at large to 
increase awareness of the HOPE Act and opportunities to elect organ 
donation regardless of HIV status.
    HHS response: HHS is supportive of any and all efforts to increase 
awareness and education about HOPE Act transplants, opportunities for 
persons with HIV to participate as organ donors, and transplant 
candidates with HIV to receive a HOPE Act transplant. While HHS is not 
making any revisions to the regulatory proposal in response to these 
comments, HHS will consider additional educational efforts along the 
lines of those suggested by the commenters.
NIH Research Criteria
    Several commenters provided specific suggestions for the content 
and development of the revised NIH Research Criteria:
     Commenters requested the elimination of the current 
requirement that a transplant team perform at least five transplants 
within a four-year period between any donor and a recipient with HIV 
for all organs, as, in the commenters' estimation, this requirement is 
not necessary for organs from donors with HIV to be used safely.
     Commenters suggested that each transplant team should 
include infectious disease specialists with expertise in HIV care.
     One commenter requested the elimination of the biopsy 
requirement.
     One commenter noted that, in revising the Research 
Criteria, NIH should both maintain the strong patient safety record for 
HOPE Act transplants, while actively seeking to reduce burdens that may 
be slowing the establishment of non-kidney and non-liver HOPE Act 
transplant programs.
     One commenter requested that NIH include people with HIV, 
HIV researchers, physicians, and healthcare providers in the process of 
developing revised Research Criteria, and indicated that these 
individuals can provide invaluable insights that can only come from 
lived experience.
    HHS response: HHS appreciates these suggestions, and agrees that 
these comments are relevant to the content of the NIH Research 
Criteria. These comments were provided to the NIH working group for 
consideration in the development of revisions to the Research Criteria. 
HHS makes no changes to the regulatory proposal in response to these 
comments.
Secretarial Direction to the OPTN
    While multiple commenters provided suggestions that appear relevant 
to the Secretary's future direction to the OPTN to revise the standards 
of quality concerning kidneys and livers from donors with HIV, only a 
few commenters specifically referenced the

[[Page 93492]]

content of the Secretarial direction and provided recommendations. One 
commenter indicated that they defer to health care professionals as to 
the content of such direction, and further urged HHS to make sure that 
the final OPTN policies do not create additional barriers or lead to 
unintended consequences that make it more difficult for individuals to 
access these organs. One commenter requested that the direction to the 
OPTN require intensive and multi-disciplinary counseling and 
discussions to be conducted with the solid organ recipient, with 
ongoing care before, during, and after the transplant, to ensure that 
solid organ recipients understand the complexities of the transplant 
procedure while also receiving the emotional and physical care they 
need throughout the entirety of the process. The commenter further 
noted the opportunity for the OPTN to define transplant program 
collaboration on a more formal basis, recommending that the structure 
of the transplant team include nephrologists and/or hepatologists, 
infectious diseases experts, and transplant pharmacy members, and that 
requirements be instituted for providing counseling or any specific 
transplant training recommendations for infectious disease experts.
    The commenters who provided views and suggestions that are relevant 
to the Secretary's direction to the OPTN, while not specifically 
referencing the content of the Secretary's direction, generally 
indicated that the current requirements applicable to all organ 
transplants are sufficient to appropriately ensure the safety of HOPE 
Act kidney and liver transplants conducted outside of the research 
context. One commenter indicated that there is no reason to impose 
special monitoring requirements for HOPE Act kidney and liver 
transplant outcomes, as appropriately protective standards are already 
included in the baseline safety and outcomes monitoring for all organ 
transplants in the United States. One commenter indicated that the OPTN 
structure and outcome data collected are sufficient in their current 
state to provide appropriate oversight for all organ transplants, 
regardless of whether the transplant involves organs from donors with 
HIV to recipients with HIV. Another commenter indicated comfort with 
appropriate oversight and data management by the organizations 
designated to oversee transplant services on a national level, 
indicating that such oversight may include stringent medical protocols, 
regular follow-ups, and comprehensive reporting systems to track 
outcomes and address any issues promptly. The commenter further 
expressed an expectation that safety and outcomes information be made 
available to the public is a transparent manner.
    One commenter noted that HHS stated in the NPRM that scientific 
evidence demonstrates that transplants of kidneys and livers from 
donors with HIV to recipients with HIV are safe and effective. Given 
this view, the commenter opined that the current clinical standards of 
care for non-HOPE Act organ transplants are sufficient to apply to 
transplants of all kidneys and livers, of any HIV serostatus. The 
commenter further expressed that additional scrutiny of transplants of 
kidneys and livers from donors with HIV to recipients with HIV could be 
viewed as discrimination against recipients with HIV who are willing to 
accept offers of an organ from a donor with HIV, and infringes on 
patient autonomy. The commenter noted that the OPTN already is 
responsible for safety and outcomes monitoring for transplants that 
involve donors or recipients with viruses other than HIV, including 
cytomegalovirus, Epstein-Barr virus, hepatitis B and C viruses, and 
severe acute respiratory syndrome coronavirus 2.
    HHS response: HHS appreciates all of the comments and suggestions 
regarding the content of the Secretary's direction to the OPTN. HHS has 
carefully considered these comments in developing the Secretary's 
direction to the OPTN to revise the OPTN standards of quality embodied 
in OPTN policy regarding organs from donors with HIV. As discussed 
below in section V, ``Implementation Considerations,'' through 
publication of this final rule, the Secretary directs the 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, from the OPTN's expertise, will not 
reduce the safety of HOPE Act kidney and liver transplants, provide 
appropriate oversight for these transplants, and require sufficient 
data collection and outcomes monitoring.
Health Equity and Patient Experience
    Many comments positively noted the health equity component of the 
proposed rule and the potential impact to populations that are 
disproportionately impacted by HIV and end-stage chronic diseases. 
Several commenters requested that HHS consider the insights and 
experiences of HOPE Act patients in this and future rulemaking efforts.
    HHS response: We agree. HHS supports efforts to better address 
health equity in organ transplantation and believes this rule will help 
to increase access to care among populations that are disadvantaged. 
HHS also is supportive of efforts to incorporate patient experience 
into policy, and we have received, and considered, comments from HOPE 
Act patients during this rulemaking process, including a comment from a 
self-identified living donor of a kidney used in a HOPE Act transplant. 
HHS makes no changes to the regulatory proposal in response to these 
comments.
Approach to Patient Care
    Several commenters suggested changes to clinical care standards for 
HOPE Act transplant patients. One commenter requested that the 
Department encourage transplant centers to incorporate syndemic care 
approaches to address the complex needs of people with HIV. Syndemic 
care aims to provide more holistic service delivery to prevention and 
care, including by addressing the social determinants of health that 
allow for health conditions to cluster and interact. Several commenters 
requested that additional safety protocols be developed for transplant 
centers, such as post-operative care guidelines for HOPE Act transplant 
recipients.
    HHS response: HHS is supportive of efforts to incorporate syndemic 
care approaches within the organ transplantation domain. Regarding the 
establishment of additional safety protocols for transplant centers, 
currently safety protocols beyond those included in the NIH Research 
Criteria are determined by individual transplant centers. These 
comments were provided to the NIH working group for consideration in 
the development of revisions to the Research Criteria. Further, HHS 
considered these comments in developing the Secretary's direction to 
the OPTN to revise the OPTN standards of quality embodied in OPTN 
policy regarding organs from donors with HIV, as provided below in the 
discussion of implementation considerations. HHS makes no changes to 
the regulatory proposal in response to these comments.
Addressing Diverse Needs
    Several commenters requested that HHS consider the unique 
challenges of patients who are Black, Indigenous, and people of color 
and patients living in rural areas. A commenter indicated that post-
transplant care is essential for

[[Page 93493]]

positive patient outcomes and factors such as implicit bias in medical 
settings, socioeconomic disparities, and geographic limitations 
frequently hinder equitable access to post-transplant care, especially 
for people experiencing both geographic isolation and medical racism. 
Long travel distances to transplant centers and lacking local 
healthcare options can impede consistent follow-up care and medication 
compliance.
    HHS response: HHS is supportive of efforts to improve health equity 
in organ transplantation and believes this rule will contribute to 
improving access to care for patients who are Black, Indigenous, and 
people of color and patients living in rural areas by allowing HOPE Act 
kidney and liver transplants to be conducted at any transplant center 
in the United States. HHS makes no changes to the regulatory proposal 
in response to this comment.
Standards for Transplant Candidates
    One commenter noted his opposition to lengthy sobriety requirements 
for liver transplant candidates.
    HHS response: Currently, sobriety requirements for transplant 
candidates are determined by individual transplant centers. This 
comment was provided to the NIH working group for consideration in the 
development of revisions to the Research Criteria. Further, HHS 
considered this comment in developing the Secretary's direction to the 
OPTN to revise the OPTN standards of quality embodied in OPTN policy 
regarding organs from donors with HIV, as provided below in this 
preamble in the discussion of implementation considerations. HHS makes 
no changes to the regulatory proposal in response to this comment.
Future Research on HOPE Act Transplants
    Multiple commenters expressed support for additional research 
evaluating the safety and efficacy of HOPE Act transplants. One 
commenter suggested that the experience of HOPE Act transplant patients 
should help inform the direction of future research on HOPE Act 
transplants.
    HHS response: HHS is supportive of additional research evaluating 
the safety and efficacy of HOPE Act transplants, and considering 
patient experiences in informing the direction of future research. 
While no changes are made to the regulatory proposal in response to 
these comments, HHS will consider these comments in further efforts to 
implement the HOPE Act.
Beyond Scope
    Some commenters provided comments or made suggestions that are 
beyond the scope of the proposed rule.
    One commenter requested that HHS establish a program to provide 
technical assistance to state, local, and tribal health departments 
with the goal of adopting policies to prevent health information from 
being used in a criminal, civil, or immigration legal proceeding.
    One commenter noted that none of the other comments provided on the 
NPRM highlight that there will be a conflict between a majority of 
expressly prohibitive or potentially permissive State laws and 
expressly permissive Federal law when this proposed rule is finalized. 
The commenter indicated that State laws that are silent on or 
prohibitive of organ transplantation between people diagnosed with HIV 
can and do preclude performance of HOPE Act transplants within a given 
jurisdiction regardless of permissive Federal laws, and despite 
Congress and Federal regulators having the authority to preempt state 
and local health laws.
    Multiple commenters noted that State criminal laws that prohibit 
persons with HIV for donating or attempting to donate organs, blood, 
tissue, and other bodily fluids are a legal barrier to implementation 
of the HOPE Act.
    HHS response: As these comments are not within the scope of the 
proposed rule, these comments have not altered HHS's proposed approach 
to lifting the research and IRB requirements for HOPE Act kidney and 
liver transplants.
Opposition
    One commenter opposed the proposed rule, suggesting that organs 
from donors with HIV are not the same as organs from donors without 
HIV, and expressing concern regarding the transmission of HIV through 
organ transplantation to recipients without HIV.
    HHS response: HHS notes that there have been no reported cases of 
inadvertent HIV transmission resulting from HOPE Act transplants. 
Further, under the requirements of the HOPE Act, transplantation of 
organs from donors with HIV to recipients without HIV is prohibited. 
HHS makes no changes to the regulatory proposal in response to this 
comment.

IV. Secretarial Determination

    The Secretary has reviewed the recommendations of the OPTN, the 
ACBTSA, and the BOTSEC on implementation of the HOPE Act, the results 
of research on HOPE Act transplants conducted to date as well as 
results of other relevant research on organ transplants in recipients 
with HIV, and public comment received on the NPRM. Pursuant to his 
authority under the HOPE Act, 42 U.S.C. 274(b)(3)(B)(ii), and 
consistent with the implementing regulations at 42 CFR 121.6, the 
Secretary determines that participation in clinical research, and 
therefore adherence to research and IRB requirements, as a requirement 
for transplants of kidneys and livers from persons with HIV, is no 
longer warranted. Through publication of this final rule, the Secretary 
is lifting the statutory research and IRB requirements for such 
transplants.
    HHS anticipates that the Secretary's determination and publication 
of this final rule will increase access to kidney and liver transplants 
by allowing more transplant centers to perform HOPE Act kidney and 
liver transplants. Currently, only a limited number of centers can 
perform HOPE Act transplants, because there are specific requirements 
stipulated by the NIH Research Criteria for such transplant centers. 
These requirements include expertise in HIV infection management, 
minimum organ-specific transplant team experience of five transplants 
of organs from donors without HIV to recipients with HIV over four 
years and an independent advocate for both recipients with HIV and 
prospective living donors with HIV. The requirements for centers 
conducting HOPE Act transplants have been subject to critique and have 
been viewed by some as a barrier to participation in HOPE Act 
transplant programs, which may impact equity and access to organ 
transplantation throughout the United States.\28\ By eliminating the 
requirement that HOPE Act kidney and liver transplants are conducted in 
the research context, HHS expects that a larger number of transplant 
centers will be able to conduct such transplants. This rule will enable 
more transplant centers to transplant kidneys and livers donated by 
both living and deceased donors with HIV, in recipients with HIV, 
thereby expanding opportunities for people with HIV and end-stage 
diseases.
---------------------------------------------------------------------------

    \28\ Bowring, M.G., Ruck, J.M., Bryski, M.G., Werbel, W., 
Tobian, A.A.R., Massie, A.B., Segev, D.L., & Durand, C.M. (2023). 
Impact of expanding HOPE Act experience criteria on program 
eligibility for transplantation from donors with human 
immunodeficiency virus to recipients with human immunodeficiency 
virus. American Journal of Transplantation, 23(6), 860-864.
---------------------------------------------------------------------------

    Further, HHS expects this rule will expand access to organ 
transplantation for all patients, regardless of their HIV status. When 
eligible for transplant, a

[[Page 93494]]

person with HIV is added to the waiting list. That patient may elect to 
receive an organ from a donor with HIV, as a HOPE Act transplant, 
should it become available, or may choose to wait for an organ from a 
donor who did not have HIV. If the patient with HIV chooses the HOPE 
Act transplant, this will allow another patient on the waiting list to 
receive the next available organ from a donor who does not have HIV, 
which would reduce the time spent waiting for a transplant. Of note, 
patients who do not have HIV will not be offered an organ from a donor 
who has HIV, as such transplants are not allowed under Federal law.
    As of February 16, 2024, more than 103,000 men, women, and children 
were on the national organ transplant waiting list.\29\ Every 10 
minutes another person is added to the waiting list, and nearly 20 
people die every day while waiting for a transplant.\30\ HHS expects 
that the Secretary's determination and publication of this rule will 
improve access to kidney and liver transplants both by increasing the 
number of kidneys and livers available for transplant, and by allowing 
more transplant centers to perform HOPE Act kidney and liver 
transplants. This anticipated positive result is consistent with the 
Department's commitment to reducing the number of persons on the organ 
transplant waiting list.

V. Implementation Considerations

A. NIH Research Criteria

    The HOPE Act provides the Secretary with the discretion to 
determine what research criteria should apply to HOPE Act transplants. 
42 U.S.C. 274f-5(a). NIH, in consultation with HRSA and the OPTN, and 
including the input of other relevant Federal stakeholders, formed a 
working group to develop revised NIH Research Criteria. The NIH 
Research Criteria, as originally drafted, include a strong focus on 
HOPE Act kidney and liver transplants, as these are the most common 
types of HOPE Act transplants: as this rule removes HOPE Act kidney and 
liver transplants from the research context, it is necessary that the 
revised NIH Research Criteria appropriately address non-kidney and non-
liver HOPE Act transplantation.
    Further, HHS recognizes the revised NIH Research Criteria should 
reflect advances in research in the time since HOPE Act transplants 
began, including the current needs of various entities involved in non-
kidney and non-liver HOPE Act transplants in consideration of input 
from transplant centers, transplant surgeons, OPOs, HIV clinicians, 
donors, recipients, HIV advocates, the OPTN, and individuals affected 
by the HOPE Act.
    HHS has considered the comments submitted in response to the NPRM 
that are relevant to the revised NIH Research Criteria, as summarized 
in the discussion of public comment in section III, supra. These 
comments have been provided to NIH for consideration in developing the 
revised NIH Research Criteria. HHS will publish updated Research 
Criteria in the Federal Register for public comment.

B. Secretary's Direction To Revise OPTN Policies

    As part of the implementation of the Secretary's determination that 
participation in clinical research as a requirement for transplants of 
kidneys and livers from persons with HIV is no longer warranted, the 
Secretary must direct the OPTN to update its policies to clarify that 
HOPE Act kidney and liver transplants may be conducted in a way 
consistent with the statutory requirements at 42 U.S.C. 274, and that 
ensures the revisions to the policies will not reduce the safety of 
organ transplantation. 42 U.S.C. 274f-5(c)(2); 42 CFR 121.6(b)(3).
    In the NPRM preceding publication of this final rule, HHS 
specifically sought public comment on the nature and content of the 
Secretary's direction to the OPTN, including the level of specificity 
in the direction and the extent of the OPTN's discretion in developing 
the revised policies; what factors should be considered in assessing 
whether the revised policies are consistent with 42 U.S.C. 274; and 
what factors should be considered in assessing whether the revisions to 
the OPTN policies will not reduce the safety of organ transplantation. 
HHS further welcomed comment on any other aspects relating to the 
Secretary's direction to the OPTN to revise its standards of quality as 
required by the HOPE Act.
    As described in the discussion of public comment in section III, 
supra, HHS received multiple comments relating to HHS's consideration 
as to the direction to the OPTN. The vast majority of commenters agreed 
that scientific evidence clearly demonstrates that HOPE Act kidney and 
liver transplants are safe and effective. Many of those commenters 
indicated that the current requirements applicable to all organ 
transplants are sufficient to appropriately ensure the continued safety 
of HOPE Act kidney and liver transplants conducted outside of the 
research context. HHS has carefully considered all comments received in 
the development of the Secretary's direction to the OPTN.
    Through publication of this final rule, the Secretary directs the 
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 42 
U.S.C. 274, and from the OPTN's expertise, will not reduce the safety 
of HOPE Act kidney and liver transplants, provide appropriate oversight 
for these transplants, and require sufficient data collection and 
outcomes monitoring.
    In consideration of the public comments received, HHS notes that it 
may be appropriate for the OPTN to determine that current OPTN policies 
that are generally applicable to kidney and liver transplants provide 
appropriate safety and oversight standards for HOPE Act kidney and 
liver transplants. Alternatively, the OPTN may choose to revise OPTN 
policies to provide additional standards for HOPE Act kidney and liver 
transplants.
    This rule provides the Secretary's determination that that 
participation in clinical research as a requirement for transplants of 
kidneys and livers from persons with HIV is no longer warranted; 
revises 42 CFR 121.6 to reflect the removal of the statutory research 
and IRB requirements for HOPE Act kidney and liver transplants; and 
directs the OPTN to revise its standards of quality with respect to 
kidneys and livers from donors with HIV consistent with 42 U.S.C. 274 
and in a way that ensures the changes will not reduce the safety of 
organ transplantation policies as required by the HOPE Act. The final 
implementation step is for the OPTN to adopt and use standards of 
quality as directed by the Secretary to reflect that HOPE Act kidney 
and liver transplants no longer are subject to research and IRB 
requirements.
    As was stated in the NPRM, HHS expects that the OPTN will solicit 
public comment on a proposed revision to relevant OPTN policies, and 
update the OPTN policies containing standards of quality with respect 
to kidneys and livers from donors with HIV, within 15 months from the 
publication of this final rule. As publication of this final rule has 
obviated current OPTN policies requiring HOPE Act kidney and liver 
transplants to be conducted in accordance with research and IRB 
requirements, HHS encourages the OPTN to act expeditiously to revise 
these policies. This will allow transplant centers that had not

[[Page 93495]]

previously been performing HOPE Act kidney and liver transplants in the 
research context to begin performing HOPE Act kidney and liver 
transplants in accordance with the revised OPTN policies.

VI. Final Rule Requirements

A. Removal of Research and IRB Requirements for HOPE Act Kidney and 
Liver Transplants

    Consistent with the Secretary's determination under the HOPE Act, 
this rule revises 42 CFR 121.6 to reflect the removal of the statutory 
research and IRB requirements for kidney and liver HOPE Act 
transplants. Section 121.6(b)(1)(ii)(B) provides that participation in 
clinical research is no longer warranted for the following categories 
of transplants:
     Transplant of a kidney from a donor with HIV; and
     Transplant of a liver from a donor with HIV.
    In implementation, this means that HOPE Act kidney and liver 
transplants will no longer be required to be conducted as research, and 
instead will be conducted in accordance with OPTN policies applicable 
to HOPE Act kidney and liver transplants. As noted above, the OPTN may 
decide that OPTN policies that generally apply to kidney and liver 
transplants are appropriate to apply to HOPE Act kidney and liver 
transplants, or may create different policies for HOPE Act kidney and 
liver transplants.

B. Revised Terminology: Persons With HIV

    HHS is aware that previous language used in enacting and 
implementing the HOPE Act contained vocabulary and phrases that some 
people find stigmatizing--namely, references to ``infected with HIV'' 
when the regulatory language encompasses both living and deceased 
donors with HIV, or recipients with HIV. For the references to both 
living and deceased donors with HIV, HHS revises all current references 
in 42 CFR 121.6(b) from ``individuals infected with human 
immunodeficiency virus (HIV)'' and ``individuals infected with HIV'' to 
``donors with HIV'' or, when discussing organs donated, ``organs from 
donors with HIV'' and specifically ``kidneys from donors with HIV'' and 
``livers from donors with HIV.'' Further, HHS revises the current 
reference in 42 CFR 121.6(b)(1)(i) describing the allowable recipients 
of HOPE Act transplants from individuals who are ``infected with HIV 
before receiving such organ(s)'' to instead refer to individuals who 
are ``living with HIV before receiving such organ(s).'' This is 
consistent with the Centers for Disease Control and Prevention's (CDC) 
Stigma Language Guide.\31\ These changed regulatory references are to 
avoid stigmatizing language, and do not change the groups of people 
referenced in 42 CFR 121.6.
---------------------------------------------------------------------------

    \31\ Centers for Disease Control and Prevention. Let's Stop HIV 
Together: Stigma Language Guide. https://www.cdc.gov/stophivtogether/hiv-stigma/ways-to-stop.html. Accessed 2/23/2024.
---------------------------------------------------------------------------

VII. Effective Date

    HHS finds that there is good cause for this rule to be effective 
upon publication in accordance with 5 U.S.C. 553(d)(3) of the 
Administrative Procedure Act and 5 U.S.C. 808(2) of the Congressional 
Review Act.
    The waiting list for kidney transplant in the U.S. currently 
exceeds 88,700 candidates.\32\ The 2022 OPTN/U.S. Scientific Registry 
of Transplant Recipients (SRTR) Annual Data Report indicated that over 
the course of a year more than 4,400 adults died while waiting for a 
kidney transplant, and an additional 4,500 persons were removed from 
the waiting list because they became too sick to receive a 
transplant.\33\ Most transplant candidates wait years for a kidney 
transplant, often requiring dialysis or other interventions.
---------------------------------------------------------------------------

    \32\ Organ Procurement and Transplantation Network. Dashboard 
and metrics. https://insights.unos.org/OPTN-metrics/. Accessed Feb 
2024.
    \33\ Organ Procurement and Transplantation Network (OPTN)/
Scientific Registry of Transplant Recipients (SRTR). 2022. ``Annual 
Data Report.'' Accessed November 2024. https://srtr.transplant.hrsa.gov/ADR/Chapter?name=Liver&year=2022.
---------------------------------------------------------------------------

    In addition, thousands of Americans suffer from conditions 
requiring liver transplant. As of November 8, 2024, 13,170 candidates 
were added to the waiting list in 2024.\34\ In 2022, more than 1,031 
liver patients died while awaiting transplant, according to the OPTN/
SRTR Annual Data Report.\35\
---------------------------------------------------------------------------

    \34\ Organ Procurement and Transplantation Network. Dashboard 
and metrics. https://optn.transplant.hrsa.gov/data/dashboards-metrics/. Accessed November 2024.
    \35\ Organ Procurement and Transplantation Network (OPTN)/
Scientific Registry of Transplant Recipients (SRTR). 2021. ``Annual 
Data Report.'' Accessed February 2024. https://srtr.transplant.hrsa.gov/annual_reports/2021_ADR_Preview.aspx.
---------------------------------------------------------------------------

    HHS expects that this final rule will have the effect of decreasing 
the time all candidates for kidney and liver transplants spend on the 
waiting list, regardless of their HIV status. As described in section 
IV, above, a transplant candidate with HIV may choose to receive a HOPE 
Act kidney or liver transplant if an organ from a donor with HIV 
becomes available, or may choose to wait for an organ from a donor 
without HIV. Research has demonstrated that candidates with HIV who 
accept a HOPE Act kidney transplant spend significantly less time 
awaiting transplant than candidates on the waiting list for an kidney 
from a donor without HIV. A 2023 study found that median wait time for 
a HOPE Act kidney transplant was 10.8 months compared to 60.8 months--a 
3.3-fold higher rate of transplant compared to non-HOPE Act 
transplants.\36\ When candidates with HIV choose a HOPE Act transplant, 
this data suggests that this will decrease the time they spent on the 
waiting list. Additionally, this will have the effect of allowing a 
candidate further down the waiting list to receive the next available 
organ from a donor who does not have HIV, both reducing the time that 
candidate spends waiting for a transplant and decreasing the time all 
other candidates spend on the waiting list.
---------------------------------------------------------------------------

    \36\ Motter JD, et al; HOPE in Action Investigators. Wait Time 
Advantage for Transplant Candidates With HIV Who Accept Kidneys From 
Donors With HIV Under the HOPE Act. Transplantation. 2024 Mar 
1;108(3):759-767.
---------------------------------------------------------------------------

    Moreover, HHS expects that this final rule also will increase 
access to organ transplantation. Thirty-one transplant centers are 
qualified to perform HOPE Act kidney and liver transplants as research 
in conformance with the requirements of the NIH Research Criteria, 
while 250 transplant centers operate nationwide. As, pursuant to this 
rule, HOPE Act kidney and liver transplants no longer need to be 
conducted as research, it can be reasonably expected that more 
transplant centers than in the past will be able to offer HOPE Act 
kidney and liver transplants to appropriate candidates on the 
transplant center's waiting list. It also is reasonable to expect that 
if a greater number of transplant centers will be able to offer HOPE 
Act transplants, this will allow more candidates with HIV on the 
waiting list to receive HOPE Act kidney and liver transplants.
    Lastly, HHS believes that a delayed effective date is unnecessary 
to afford affected parties a reasonable time to adjust practices in 
accordance with this rule. From the economic analysis of impacts, 
provided below in section IX, this final rule will have a minimal 
direct impact on affected entities with regard to preparing for 
implementation. The direct effect of this final rule on transplant 
centers is considered to be limited to the time spent by transplant 
centers to read and understand the final rule, educate their staff on 
the content of this final rule, and review and update

[[Page 93496]]

internal policies. This rule does not impose obligations on transplant 
centers, and rather increases available flexibilities in that 
transplant centers are no longer required to conduct HOPE Act kidney 
and liver transplants in the research context. Further, as described 
above in section V(B), the final implementation step for HOPE Act 
kidney and liver transplants to begin occurring outside of the research 
context is for the OPTN to revise its policies to reflect that HOPE Act 
kidney and liver transplants no longer are subject to research and IRB 
requirements. HHS is encouraging the OPTN to act expeditiously to 
revise these policies, and it is likely that transplant centers will 
educate their staff and review and update internal policies relevant to 
the content of this final rule after the OPTN has published its revised 
policies for HOPE Act kidney and liver transplants. Transplant centers 
do not have any obligations stemming from this rule until the OPTN 
revises its policies. In light of this context, a delayed effective 
date for this rule is unnecessary for implementation purposes.
    Given that, and the expected positive effects on time candidates 
spend on the waiting list and the increase in access to HOPE Act 
transplants resulting from this rule, pursuant to 5 U.S.C. 553(d)(3) 
and 5 U.S.C. 808(2) HHS finds that there is good cause for this rule to 
be effective upon publication.

VIII. Paperwork Reduction Act of 1995

    This rule does not impose any additional information collection 
burden under the Paperwork Reduction Act and does not contain any 
information collection requirements beyond those already imposed by 
current regulations, which have been approved by the Office of 
Management and Budget (OMB). The current data collection requirements 
in the OPTN final rule approved by OMB under the Paperwork Reduction 
Act of 1995 are assigned control numbers OMB No. 0915-0157 (for organ 
donors, candidates, and recipients) and OMB No. 0915-0184 (for OPTN 
membership application data).

IX. Final Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review 
Act (5 U.S.C. 801, Pub. L. 104-121), and the Unfunded Mandates Reform 
Act of 1995 (Pub. L. 104-4).
    Executive Orders 12866, 13563, and 14094 direct us to assess all 
benefits, costs, and transfers of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). Rules are ``significant'' under Executive Order 12866, 
section 3(f)(1) (as amended by Executive Order 14094), if they have an 
annual effect on the economy of $200 million or more (adjusted every 3 
years by the Administrator of the Office of Information and Regulatory 
Affairs (OIRA) for changes in gross domestic product); or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, territorial, or tribal governments or 
communities. The regulatory impact analysis indicates, and OIRA has 
determined, that the final rule is a significant regulatory action 
under Executive Order 12866, section 3(f)(1), and that it meets the 
criteria set forth in 5 U.S.C. 804(2) under the Congressional Review 
Act.
    The Regulatory Flexibility Act (RFA) requires agencies to consider 
the impact of their regulatory proposals on small entities. Because the 
impacts on kidney and liver transplants are small relative to the 
number of transplants performed annually, and because the economic 
impacts on affected small entities are small relative to the average 
payroll of firms in the smallest enterprise size category, HHS 
certifies that the final rule will not have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (UMRA) generally requires 
that each agency conduct a cost-benefit analysis; identify and consider 
a reasonable number of regulatory alternatives; and select the least 
costly, most cost-effective, or least burdensome alternative that 
achieves the objectives of the final rule before promulgating any 
proposed or final rule that includes a Federal mandate that may result 
in expenditures of more than $100 million (adjusted for inflation) in 
at least one year by State, local, and tribal governments, in the 
aggregate, or by the private sector. Each agency issuing a final rule 
with relevant effects over that threshold must also seek input from 
State, local, and tribal governments. The current threshold after 
adjustment for inflation using the Implicit Price Deflator for the 
Gross Domestic Product is $183 million, reported in 2023 dollars. The 
final rule will not result in an unfunded mandate in any year that 
meets or exceeds this amount.
    The final rule removes the current research and IRB requirements 
for the transplantation of kidneys and livers from donors with HIV. We 
have assessed the likely impacts of the final rule, and report in the 
regulatory impact analysis (RIA) several sources of monetized, 
quantified, and unquantified benefits, costs, or transfers. Most of the 
monetized or quantified impacts relate to the incremental increases in 
the number of kidney and liver transplants that will be performed 
annually as a result of the final rule.
    We report monetized benefits from increases in life expectancy for 
both kidney and liver transplant recipients; and for kidney transplant 
recipients, we also report monetized benefits from quality-of-life 
improvements and time savings from fewer kidney dialysis visits. We 
also anticipate quality-of-life improvements for liver transplant 
recipients, and quantify the number of people affected who might 
experience those benefits. We also identify several sources of 
unquantified benefits, which could potentially be quantified through 
additional research or data, including time savings for caregivers, and 
cost savings for transplant centers from removing the research and 
institutional review board requirements. We also identify difficult-to-
quantify benefits associated with revising vocabulary and phrases that 
some people find stigmatizing through adoption of language that is 
intended be respectful of people living with HIV, and living and 
deceased donors with HIV. These changes may result in people living 
with HIV experiencing more inclusive interactions when accessing 
healthcare, generating additional benefits beyond the increases in life 
expectancy and improvements in quality of life from improved access to 
liver and kidney transplantation.
    We report monetized costs from increases in medical expenditures 
associated with organ transplantation; for kidney transplants, we 
report net costs that account for reductions in medical expenditures 
associated with kidney dialysis. We report this shift in expenditures 
from kidney dialysis to kidney transplantation as a monetized transfer. 
We also monetize the opportunity costs of the time spent by transplant 
centers reading and understanding the final rule, reviewing policies 
and procedures, and training staff.
    Table 1 summarizes our estimates of the benefits, costs, and 
transfers of the final rule, annualizing impacts over a 10-year 
analytic time horizon covering 2025 through 2034 using a 2 percent real 
discount rate, and reporting all

[[Page 93497]]

monetary estimates in constant 2023 dollars. Annualized benefits range 
from $381 million to $858 million, with a primary estimate of $612 
million; costs range from $73 million to $92 million, with a primary 
estimate of $83 million; and transfers range from $24 million to $37 
million, with a primary estimate of $30 million. Table 1 also reports 
our estimates of the annualized net benefits of the final rule, which 
range from $301 million to $772 million, with a primary estimate of 
$530 million. The RIA concludes that the monetized net benefits, 
combined with the quantified, but non-monetized, and unquantified 
impacts, indicate that the final rule is highly likely to generate net 
benefits to society. This finding is further supported through 
additional quantitative assessments of uncertainty and sensitivity 
analyses contained in the RIA. The full RIA is available in the docket 
for this final rule at https://www.regulations.gov/docket/HRSA-2024-0001/document.

                                                      Table 1--Summary of Impacts of the Final Rule
                                                           [Millions of constant 2023 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Primary        Low          High                                    Discount       Time
              Category                 estimate     estimate     estimate       Dollar year or unit        rate (%)     horizon            Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        BENEFITS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized monetized benefits......         $612         $381         $858  2023.......................            2    2025-2034  Increased life
                                                                                                                                    expectancy for organ
                                                                                                                                    transplant
                                                                                                                                    recipients; improved
                                                                                                                                    quality of life for
                                                                                                                                    kidney transplant
                                                                                                                                    recipients; time
                                                                                                                                    savings from fewer
                                                                                                                                    kidney dialysis
                                                                                                                                    visits.
Annualized quantified, but non-               72           64           81  People affected............            2    2025-2034  Improved quality of
 monetized, benefits.                                                                                                               life for liver
                                                                                                                                    transplant
                                                                                                                                    recipients.
Unquantified benefits..............  ...........  ...........  ...........  ...........................  ...........    2025-2034  Time savings for
                                                                                                                                    caregivers; cost
                                                                                                                                    savings for
                                                                                                                                    transplant centers
                                                                                                                                    from removing the
                                                                                                                                    research and
                                                                                                                                    institutional review
                                                                                                                                    board requirements;
                                                                                                                                    difficult-to-
                                                                                                                                    quantify benefits
                                                                                                                                    associated with
                                                                                                                                    stigma-reducing
                                                                                                                                    terminology.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          COSTS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized monetized costs.........           83           73           92  2023.......................            2    2025-2034  Medical expenditures
                                                                                                                                    associated with
                                                                                                                                    transplantation;
                                                                                                                                    time spent by
                                                                                                                                    transplant centers
                                                                                                                                    to read and
                                                                                                                                    understand the final
                                                                                                                                    rule, review
                                                                                                                                    policies and
                                                                                                                                    procedures, and
                                                                                                                                    train staff.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        TRANSFERS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized monetized transfers.....           30           24           37  2023.......................            2    2025-2034  Shift in expenditures
                                                                                                                                    from kidney dialysis
                                                                                                                                    to kidney
                                                                                                                                    transplantation.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      NET BENEFITS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized monetized net benefits..          530          301          772  2023.......................            2    2025-2034
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: primary, low, and high estimates correspond to the mean, 5th percentile, and 95th percentile of the outcomes of a Monte Carlo simulation.

List of Subjects in 42 CFR Part 121

    Health care, Hospitals, Organ transplantation, Reporting and 
recordkeeping requirements, Transplant centers.
    Accordingly, by the authority vested in me as the Secretary of 
Health and Human Services, and for the reasons set forth in the 
preamble, 42 CFR part 121 is amended as follows:

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

0
1. The authority citation for part 121 continues to read as follows:

    Authority:  Sections 215, 371-377, and 377E of the PHS Act (42 
U.S.C. 216, 273-274d, 274f-5); sections 1102, 1106, 1138 and 1871 of 
the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8, and 1395hh); 
section 301 of the National Organ Transplant Act, as amended (42 
U.S.C. 274e); and E.O. 13879, 84 FR 33817.

0
2. In Sec.  121.6, revise paragraph (b) to read as follows:

Sec.  121.6  Organ procurement.

* * * * *
    (b) HIV. (1) Organs from donors with human immunodeficiency virus 
(HIV) may be transplanted only into individuals who--
    (i) Are living with HIV before receiving such organ(s); and
    (ii)(A) Are participating in clinical research approved by an 
institutional review board, as defined in 45 CFR part 46, under the 
research criteria published by the Secretary under subsection (a) of 
section 377E of the Public Health Service Act, as amended; or
    (B) The Secretary has published, through appropriate procedures, a 
determination under section 377E(c) of the Public Health Service Act, 
as amended, that participation in such clinical research, as a 
requirement for transplantation of organs from donors with HIV, is no 
longer warranted. The Secretary has determined that participation in 
such clinical research is no longer warranted for the following 
categories of transplants:
    (1) Transplant of a kidney from a donor with HIV; and
    (2) Transplant of a liver from a donor with HIV.
    (2) Except as provided in paragraph (b)(3) of this section, the 
OPTN shall adopt and use standards of quality with respect to organs 
from donors with HIV to the extent the Secretary determines necessary 
to allow the conduct of research in accordance with the criteria 
described in paragraph (b)(1)(ii)(A) of this section.

[[Page 93498]]

    (3) If the Secretary has determined under paragraph (b)(1)(ii)(B) 
of this section that participation in clinical research is no longer 
warranted as a requirement for transplantation of organs from donors 
with HIV, the OPTN shall adopt and use standards of quality with 
respect to organs from donors with HIV as directed by the Secretary, 
consistent with 42 U.S.C. 274, and in a way that ensures the changes 
will not reduce the safety of organ transplantation.
* * * * *

    Dated: November 19, 2024.
Xavier Becerra,
Secretary.
[FR Doc. 2024-27410 Filed 11-26-24; 8:45 am]
BILLING CODE 4150-41-P
```