Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act, 74174-74184 [2024-20643]
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Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules
sentence of Rule 3D .0535(f),5 and in
Rule 3D .0535(c) and (g), is proposing to
incorporate only the statements that
each paragraph ‘‘is not included in
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ddrumheller on DSK120RN23PROD with PROPOSALS1
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Under the CAA, the Administrator is
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42 U.S.C. 7410(k); 40 CFR 52.02(a).
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Executive Orders 12866 (58 FR 51735,
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21879, April 11, 2023);
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5 The July 14, 2022, local effective version of the
last sentence of Rule 3D .0535(f) contains a change
that incorporates a reference to regulations not
approved into the SIP. If EPA takes final action to
approve the November 28, 2022, SIP revision, the
Agency will update the SIP table at 40 CFR
52.1770(c) to reflect the retention of the September
14, 1998, version of the aforementioned sentence.
6 If EPA takes final action to approve the
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version of Rule 3D .0535(c) will read, ‘‘(Paragraph
(c) is not included in Forsyth County’s portion of
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(g) is not included in Forsyth County’s portion of
the State Implementation Plan.).’’ The Agency
would update the SIP table at 40 CFR 52.1770(c) to
reflect this fact.
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• Is not subject to Executive Order
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because it approves a State program;
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• Is not subject to requirements of
section 12(d) of the National
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Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA.
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where EPA or an
Indian Tribe has demonstrated that a
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substantial direct costs on Tribal
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specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
Executive Order 12898 (Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal
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Consideration of EJ is not required as
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is no information in the record
inconsistent with the stated goal of E.O.
12898 of achieving environmental
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justice for communities with EJ
concerns.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Lead,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: September 6, 2024.
Jeaneanne Gettle,
Acting Regional Administrator, Region 4.
[FR Doc. 2024–20666 Filed 9–11–24; 8:45 am]
BILLING CODE 6560–50–P
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
Office of the Assistant
Secretary for Health (OASH) and Health
Resources and Services Administration
(HRSA), Department of Health and
Human Services (HHS).
ACTION: Notice of proposed rulemaking.
AGENCY:
The Department of Health and
Human Services (HHS) proposes to
amend 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
kidney 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 proposes to
determine that participation in such
clinical research should no longer be a
requirement for transplantation of HIV
positive kidneys and livers from donors
with HIV to recipients with HIV. This
proposed rule serves as publication of
the Secretary’s proposed determination
and proposes to amend the regulations
to reflect this determination. Consistent
with NOTA and current regulatory
requirements, the Secretary’s proposed
determination and the proposed
corresponding regulatory revision, if
finalized, will necessitate that the Organ
Procurement and Transplantation
Network (OPTN) adopt and use
standards of quality concerning kidneys
and livers from donors with HIV, as
SUMMARY:
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ddrumheller on DSK120RN23PROD with PROPOSALS1
directed by the Secretary, 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: Comments on this notice of
proposed rulemaking should be
received no later than October 15, 2024.
ADDRESSES: You may send comments,
identified by Document ID HRSA–2024–
0001, to the Federal eRulemaking Portal:
https://www.regulations.gov. For
detailed instructions on sending
comments and additional information
on the rulemaking process, see the
‘‘Public Participation’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
In accordance with 5 U.S.C. 553(b)(4),
a summary of this rulemaking may be
found in the docket for this rulemaking
at www.regulations.gov [Document ID
HRSA–2024–0001].
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 donation@hrsa.gov; or by
telephone (301) 443–7577.
SUPPLEMENTARY INFORMATION:
I. Public Participation
All interested parties are invited to
participate in this rulemaking by
submitting written comments and
supportive data that should be
considered. HHS also invites comments
that relate to the economic, legal,
environmental, or federalism effects that
might result from this proposed rule.
Comments that will provide the most
assistance to HHS in finalizing the rule
will reference a specific portion of the
proposed rule, explain the reason for
any recommended change, and include
data, information, or authority that
supports such recommended change.
Instructions: If you submit a
comment, you must include the agency
name and the Document ID HRSA–
2024–0001 for this rulemaking.
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at https://www.regulations.gov,
and will include any personal
information you provide. Therefore,
submitting this information makes it
public. You may wish to consider
limiting the amount of personal
information that you provide in any
voluntary public comment submission
you make to HHS. HHS may withhold
information provided in comments from
public viewing that it determines may
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impact the privacy of an individual or
is offensive. For additional information,
please read the Privacy Act notice that
is available via the link in the footer of
https://www.regulations.gov.
Docket: For access to the docket and
to read background documents or
comments received, go to https://
regulations.gov, referencing Document
ID HRSA–2024–0001. You may also sign
up for email alerts on the online docket
to be notified when comments are
posted or a final rule is published.
II. Background and Purpose
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 Code of
Federal Regulations (CFR) part 121. The
OPTN is also charged with developing
policies on many subjects related to
organ donation and transplantation,
which include establishing standards of
quality pertaining to organs procured for
use in transplantation. 42 U.S.C.
274(b)(2)(E). In addition to ensuring the
efficient and effective allocation of
donor organs through the OPTN, HHS
supports efforts to increase the number
of transplants performed in the United
States.
B. HOPE Act Requirements and
Implementation
In 1988, NOTA was amended to
prohibit the transplantation of organs
from donors with HIV, referring to HIV
as the etiologic agent for acquired
immunodeficiency virus or AIDS. Until
1997, a total of 32 kidney transplants
were performed in recipients with HIV,
all with organs from donors without
HIV.1 Advances in antiretroviral
therapies (ART) have now made it
possible for individuals with HIV to live
longer and with fewer complications
from the virus. Following the success of
pioneering transplants occurring outside
the United States of organs from donors
with HIV to recipients with HIV,2
1 Werbel WA, Durand CM. Solid Organ
Transplantation in HIV-Infected Recipients:
History, Progress, and Frontiers. Curr HIV/AIDS
Rep. 2019 Jun;16(3):191–203.
2 Muller E, Barday Z, Mendelson M, Kahn D. HIVPositive to HIV-Positive Kidney Transplantation—
Results at 3 to 5 Years. New England Journal of
Medicine. 2015 Feb 12;372(7):613–620.
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interest in developing specialized HIV
transplant programs grew domestically.3
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 clinical 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 26464.4 The 2015 rule
amended 42 CFR 121.6 to permit
transplants of organs from donors with
HIV in accordance with the HOPE Act
requirements.
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
3 Botha J, Fabian J, Etheredge H, Conradie F,
Tiemessen CT. HIV and Solid Organ
Transplantation: Where Are we Now. Curr HIV/
AIDS Rep. 2019 Oct;16(5):404–413.
4 Federal Register. Organ Procurement and
Transplantation: Implementation of the HIV Organ
Policy Equity (HOPE) Act. 2015 May:80 FR 26464.
https://www.federalregister.gov/documents/2015/
05/08/2015-11048/organ-procurement-andtransplantation-implementation-of-the-hiv-organpolicy-equity-act.
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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, 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
73785.5 The NIH Research Criteria were
developed by an HHS working group of
entities involved in organ
transplantation, with input from
multiple stakeholders.
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+ Tcell count and established HIV
suppression and control on effective
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.6 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
5 Federal
Register. Final Human
Immunodeficiency Virus (HIV) Organ Policy Equity
(HOPE) Act Safeguards and Research Criteria for
Transplantation of Organs Infected With HIV. 2015
Nov:80 FR 73785. https://www.federalregister.gov/
documents/2015/11/25/2015-30172/final-humanimmunodeficiency-virus-hiv-organ-policy-equityhope-act-safeguards-and-research-criteria.
6 HIV.gov. Opportunistic Infections: HIV
Treatment Overview. https://www.hiv.gov/hivbasics/staying-in-hiv-care/other-related-healthissues/opportunistic-infections. Accessed Apr 2024.
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transplants and coordinate related
OPTN policies. On November 21, 2015,
the OPTN published an open variance
(an experimental policy that tests
methods of improving organ allocation)
providing standards for transplant
hospitals conducting HOPE Act
transplants.7 The OPTN expanded the
variance in 2019 to include all solid
organs,8 and extended the variance
through January 2026, to provide for the
gathering of data and subsequent
evaluation of the outcomes of HOPE Act
transplants.9
C. Review of Research Results
As stated above, the HOPE Act
requires that the Secretary, in
conjunction with the OPTN,
periodically review 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
allows the Secretary to determine if the
safety and efficacy of HOPE Act
transplants are comparable to nonHOPE 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.10 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
7 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.
8 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.
9 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/policynotice_dtac_hope_variance.pdf.
10 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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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.
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 NIH-funded 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 funded by
NIH 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 which participated in the
pilot study found that there were 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.11 While donors with HIV were
more likely to have co-infections, the
study found that these were manageable
in the larger clinical context. Rejection
11 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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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
found to be statistically significant. The
insignificance of the result is due, in
part, to the relatively small sample size.
In addition, the investigators indicated
that this result could be due to chance.
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 that
rejection of such transplants is common.
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 raises concerns that merited further
investigation.
A separate pilot study funded by NIH
and 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
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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 coinfections could independently impact
survival and other variables measured
by studies on HOPE Act transplants.)
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 the
observed increases among HOPE Act
liver transplant recipients in mortality,
cytomegalovirus (CMV) viremia,
infectious hospitalizations, and cancer.
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.12
Ongoing Clinical Trials
Two NIH-funded studies on kidney
and liver HOPE Act transplants are
ongoing. The NIH-funded U01 HOPE
Act kidney transplant clinical trial is
designed to analyze rejection and longterm outcomes of kidney transplantation
for recipients with HIV. The study will
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.13 Similarly, the
U01 HOPE Act liver transplant clinical
12 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.
13 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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trial is designed to compare outcomes
between HOPE Act transplants and nonHOPE Act transplants of livers from
donors without HIV. The study has
enrolled 40 individuals in each group
over 3 years at 16 transplant centers.14
Both U01 clinical trials have reached
their target enrollments and now in
phases of final data analysis (kidney)
and patient follow-up (liver). The final
results are not yet published.
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.15 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 antiT-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.16
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
14 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.
15 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.
16 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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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 abovedescribed 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.17 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.18 19
2. Additional Research Results
Published Subsequent to the OPTN
Assessment
Following the OPTN’s review of
research results and data relevant to
HOPE Act transplants and its
recommendation to the Secretary,
additional research has since been
published providing more evidence for
the safety of organ transplantation from
donors with HIV to recipients with HIV.
In general, safety and outcomes of
kidney and liver HOPE Act transplants
is well established with over 468 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,
immunologic, and virologic profiles to
ddrumheller on DSK120RN23PROD with PROPOSALS1
17 Cooper
M. ‘‘OPTN Letter to Secretary Becerra
on the HOPE Act.’’ 2021 Oct 29. https://
optn.transplant.hrsa.gov/media/ueyjdfnd/hope-actletter.pdf.
18 McCauley J. ‘‘Fifty Sixth ACBTSA Meeting,
Written Public Comment—November 17, 2022
Meeting.’’ 2022 Nov 8. https://
optn.transplant.hrsa.gov/media/hwgncda2/optnexecutive-committee_acbtsa-letter.pdf.
19 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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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 donor
organs with HIV in recipients with HIV.
Further, the study also found that there
were no major differences 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.20
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 nonHOPE Act transplant candidates at the
same center.21 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 3.3fold higher for those who received an
organ from a donor with HIV.22 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 ESRD have higher
20 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, FriedmanMoraco 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.
21 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.
22 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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mortality than people with ESRD who
are not also living with HIV,23 in HHS’s
view, this data illustrates the benefit of
HOPE Act kidneys transplants for this
vulnerable population.
In addition to providing important
evidence for the survival benefit of
organ transplantation for recipients with
HIV, the HOPE in Action Consortium
has also published 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 posttransplant.24
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 one heart
transplant has been conducted (dual
organ: heart-kidney).25 26 No HOPE Act
transplants have been recorded among
recipients in need of organs such as a
lung, pancreas, islet, or intestine. 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.
3. HHS Advisory Committee on Blood
and Tissue Safety and Availability
Recommendations
Following the OPTN recommendation
to the Secretary in 2021, the HHS
Advisory Committee on Blood and
Tissue Safety and Availability
(ACBTSA) formed a Working Group to
evaluate the recommendation from the
OPTN. After analyzing the OPTN
recommendation, and receiving
presentations on data on HOPE Act
kidney and liver transplants, and
relevant research results on heart
transplants and lung transplants in
recipients with HIV, the ACBTSA HOPE
Act working group recommended to the
full committee that the Secretary
23 Ibid.
24 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.
25 Montefiore News Releases. World’s First HIVPositive 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
26 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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eliminate research and IRB
requirements for all HOPE Act
transplants. However, the working
group expressed concern about the
elimination of research and IRB
requirements for non-kidney and nonliver HOPE Act transplants,27 and
whether there was sufficient data
collected on other organs to justify a full
adoption the OPTN’s recommendation.
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.
4. HHS Secretary: Review
ddrumheller on DSK120RN23PROD with PROPOSALS1
Upon review of the OPTN, ACBTSA
and BOTSEC recommendations, and in
consideration of the results of relevant
scientific research, the Secretary
believes that the research and IRB
requirements for kidney and liver HOPE
Act transplants are no longer warranted.
The Secretary has been informed by
the research results described in this
preamble from pilot studies, clinical
trials, and case reports, as well as OPTN
outcomes data on all HOPE Act
transplants and additional data. Studies
of kidney and liver HOPE Act
transplants have demonstrated survival
benefit for transplant recipients with
HIV, compared to non-HOPE Act
transplants, with few adverse
consequences.28 29 30 Additionally, the
27 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/.
28 Durand CM, et al; 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.
29 Durand CM, et al; 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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OPTN’s letter to the Secretary noted that
in five years of HOPE Act transplants
with over 300 HOPE Act transplant
recipients with HIV, no patient safety
concerns were identified, and no HOPE
Act research has been halted, paused, or
substantially amended to address
recipient safety concerns.31
The outcomes of HOPE Act
transplants are considered in light of the
limitations of organ transplantation
generally: that too few organs are
available for the thousands of patients
awaiting transplants. The pretransplant
mortality rate for adults awaiting a
kidney transplant varies substantially
across the country. The average is 5.4
deaths per 100 person years, but it is
reported to be as high as 7.5 deaths per
100 person years as of the most recent
OPTN/SRTR Annual Data Report.32
This results in most transplant
candidates waiting years for a kidney
transplant, often requiring dialysis or
other interventions.
It is well established that
pretransplant kidney mortality rates
among candidates with HIV are higher
than those without HIV. In one study
analyzing survival benefit of HIVpositive kidney transplantation (i.e.,
non-HOPE Act transplants), mortality
rates among transplant candidates with
HIV after one year were 8.7 deaths per
100 person years compared to just 3.1
deaths per 100 person years among
those that received a kidney
transplant.33 Therefore, it is
hypothesized that reduction in waitlist
times may indeed result in lower
mortality for transplant candidates with
HIV and end-stage diseases.
Research has demonstrated that
recipients with HIV may reduce the
time on the kidney waitlist significantly
if they are willing to accept a HOPE Act
transplant. As previously mentioned,
one 2023 study found that median wait
time for a HOPE Act transplant was 10.8
months compared to 60.8 months—a
30 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.
31 Cooper M. ‘‘OPTN Letter to Secretary Becerra
on the HOPE Act.’’ 2021 Oct 29. https://
optn.transplant.hrsa.gov/media/ueyjdfnd/hope-actletter.pdf.
32 Organ Procurement and Transplantation
Network (OPTN)/Scientific Registry of Transplant
Recipients (SRTR). 2022. ‘‘Annual Data Report:
Kidney.’’ Accessed May 2024. https://
srtr.transplant.hrsa.gov/annual_reports/2022/
Kidney.aspx.
33 Locke JE, Gustafson S, Mehta S, Reed RD,
Shelton B, MacLennan PA, Durand C, Snyder J,
Salkowski N, Massie A, Sawinski D, Segev DL.
Survival Benefit of Kidney Transplantation in HIVinfected Patients. Ann Surg. 2017 Mar;265(3):604–
608.
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3.3-fold higher rate of kidney transplant
compared to non-HOPE Act
transplants.34
Significant progress has been made in
the reduction of pretransplant mortality
for liver transplant candidates over the
past decade. Rates have declined from a
high of 17.9 deaths per 100 person years
in 2014 to 12.3 deaths per 100 person
years in 2022.35 Like kidney transplant,
research has also demonstrated the
survival benefit of organ transplantation
for those with HIV and end-stage liver
disease when compared to transplant
candidates without HIV.36
It is also hypothesized that the
expansion of kidney and liver HOPE Act
transplantation will also help to reduce
stigma and health disparities associated
with HIV. Stigma and physician
reluctance to counsel potential
transplant candidates with HIV on the
benefits of organ transplantation may
contribute to the lower than projected
counts of HOPE Act transplants to
date.37
The Secretary also believes that the
current research and IRB requirements
should be maintained for HOPE Act
transplants of all other organs, in light
of the lack of data on outcomes for
HOPE Act organ transplants other than
kidney or liver transplants. At the time
the ACBTSA developed its
recommendations, no HOPE Act
transplants outside of kidneys, livers,
and one dual heart-kidney transplant
had been performed, and data on heart,
lung, pancreas, islet, intestine, or other
organ transplants from donors with HIV
to recipients with HIV that were
conducted outside the U.S. is limited.
The HOPE Act requires that, for the
statutory research and IRB requirements
to be lifted for HOPE Act transplants,
the Secretary must determine that
participation in such clinical research,
as a requirement for these transplants, is
no longer warranted. 42 U.S.C. 274
(b)(3)(B)(ii). In the absence of research
results and robust outcomes data
34 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.
35 Organ Procurement and Transplantation
Network (OPTN)/Scientific Registry of Transplant
Recipients (SRTR). 2022. ‘‘Annual Data Report:
Liver.’’ Accessed May 2024. https://
srtr.transplant.hrsa.gov/annual_reports/2022/
Liver.aspx.
36 Ragni MV, Eghtesad B, Schlesinger KW,
Dvorchik I, Fung JJ. Pretransplant survival is shorter
in HIV-positive than HIV-negative subjects with
end-stage liver disease. Liver Transpl. 2005
Nov;11(11):1425–30.
37 Klitenic SB, Levan ML, Van Pilsum Rasmussen
SE, Durand CM. Science Over Stigma: Lessons and
Future Direction of HIV-to-HIV Transplantation.
Curr Transplant Rep. 2021;8(4):314–323.
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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.
The Secretary acknowledges that the
OPTN has argued that any research and
IRB requirements serve as a barrier to
access for HOPE Act transplant
candidates and may perpetuate
inequities in HOPE Act transplant
programs.38 We believe, however, that
the proposed rule balances the need to
ensure the safety of HOPE Act
transplants while removing research
and IRB requirements for HOPE Act
kidney and liver transplants in
transplant programs that are well
established and have demonstrated both
efficacy and safety.
ddrumheller on DSK120RN23PROD with PROPOSALS1
D. Diversity, Equity, Inclusion: Effects
on Individuals in Need of Transplant
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 as a
barrier to participation in HOPE Act
transplant programs, which may impact
equity and access to organ
transplantation throughout the United
States.39 By eliminating the requirement
that HOPE Act kidney and liver
transplants are conducted in the
research context, it is anticipated that a
larger number of transplant centers will
be able to conduct such transplants.
This proposal 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
38 McCauley J. ‘‘Fifty Sixth ACBTSA Meeting,
Written Public Comment—November 17, 2022
Meeting.’’ 2022 Nov 8. https://
optn.transplant.hrsa.gov/media/hwgncda2/optnexecutive-committee_acbtsa-letter.pdf.
39 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.
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opportunities for people with HIV and
end-stage diseases.
Other factors, such as systemic
racism, perpetuate long-standing
inequalities and inequities in health
care access including organ
transplantation. People who identify as
Black or African American are four
times more likely to develop ESRD
compared to non-Hispanic White people
but are less likely to receive a kidney
transplant.40 41 These outcomes are not
explained by individual characteristics
alone, suggesting that other factors, such
as lower socioeconomic status and poor
clinical communication, contribute to
this inequity.42 43
Separate from organ transplantation,
HIV disproportionately affects people of
some racial and ethnic groups in the
United States, such as Black or African
American and Hispanic or Latino
populations. Prevalence rates suggest
these communities have higher rates of
HIV compared to White populations.
For example, according to the Centers
for Disease Control and Prevention’s
(CDC) HIV Surveillance Supplemental
Report, 2023, people who identified as
Black or African American represented
12.4 percent of the population but 40.2
percent of those with diagnosed HIV in
2021.44 In addition, people identified as
Hispanic or Latino represent 17.6
percent of the population but make up
23.8 percent of people with diagnosed
HIV.45 Incidence rates also confirm that
new infections disproportionately affect
Black or African Americans (40 percent
of new infections), and Hispanic or
Latinos (29 percent of new infections),
suggesting that prevention efforts are
not adequately reaching these
populations.46 Higher prevalence and
40 National Institute of Diabetes and Digestive and
Kidney Diseases. n.d. Kidney Disease Statistics for
the United States. Accessed February 2024. https://
www.niddk.nih.gov/health-information/healthstatistics/kidney-disease.
41 U.S. Department of Health and Human
Services. Office of Minority Health: Organ Donation
and African Americans. https://
minorityhealth.hhs.gov/organ-donation-andafrican-americans. Accessed 2/27/2024.
42 El-Khoury B, Yang TC. Reviewing Racial
Disparities in Living Donor Kidney Transplantation:
a Socioecological Approach. J Racial Ethn Health
Disparities. 2023 Mar 29:1–10.
43 Siminoff LA, Burant CJ, Ibrahim SA. Racial
disparities in preferences and perceptions regarding
organ donation. J Gen Intern Med. 2006
Sep;21(9):995–1000.
44 Centers for Disease Control and Prevention.
Estimated HIV incidence and prevalence in the
United States, 2017–2021. HIV Surveillance
Supplemental Report, 2023; 28 (No.3). https://
www.cdc.gov/hiv/library/reports/hivsurveillance.html. Published May 2023.
45 Ibid.
46 Centers for Disease Control and Prevention.
Estimated HIV incidence and prevalence in the
United States, 2017–2021. HIV Surveillance
Supplemental Report, 2023; 28 (No.3). https://
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incidence rates among communities
over-represented in the HIV epidemic
suggest that these communities would
also benefit from expanded access to
HOPE Act transplants. In fact, in one
2019 study of HOPE Act deceased-donor
characteristics, investigators found a
higher proportion of people who
identify as Black or African American
(72 percent) among HOPE Act kidney
transplant recipients than the percent of
Black or African Americans in the
general population. Among recipient
characteristics of HOPE Act liver
transplant recipients in the same study,
23 percent identified as Black or African
American.47
In addition to racial and ethnic
diversity, gay, bisexual, and other men
who have sex with men (MSM) are the
most affected group of people with HIV,
accounting for 66 percent of new
infections in 2021 even though they
only compose 2 percent of the
population.48 49 Lastly, people who
identify as transgender represent 2
percent of all new HIV diagnoses,
exceeding the proportion of people who
identify as transgender in the general
population.50
In light of all of these considerations,
HHS expects that this proposed rule, if
finalized, will assist in improving access
to kidney and liver transplants for
recipients with HIV. This anticipated
positive result is consistent with the
Department’s commitment to diversity,
equity, and inclusion.
Further, this proposed rule to remove
research and IRB requirements for
kidney and liver HOPE Act transplants
would, if finalized, expand access to
organ transplantation for all patients,
regardless of their HIV status. When
eligible for transplant, a 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
www.cdc.gov/hiv/library/reports/hivsurveillance.html. Published May 2023.
47 Wilk AR, Hunter RA, McBride MA, Klassen
DK. National landscape of HIV+ to HIV+ kidney
and liver transplantation in the United States.
American Journal of Transplantation
2019;19(9):2594–2605.
48 Centers for Disease Control and Prevention.
Surveillance Supplemental Report, 2023, 2003
May;28(No.3). https://www.cdc.gov/hiv/library/
reports/hiv-surveillance.html.
49 Purcell DW, Johnson CH, Lansky A, et al.
Estimating the population size of men who have sex
with men in the United States to obtain HIV and
syphilis rates. Open AIDS J 2012; 6:98–107.
50 Centers for Disease Control and Prevention.
HIV Surveillance Report, 2021; vol. 34. https://
www.cdc.gov/hiv/library/reports/hivsurveillance.html. Published May 2023.
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ddrumheller on DSK120RN23PROD with PROPOSALS1
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.51 Every 10 minutes another
person is added to the waiting list, and
nearly 20 people die every day while
waiting for a transplant.52 The current
approach to acquiring organs for
transplantation relies on the altruism of
donors and their families.
According to the National Institute of
Diabetes and Digestive and Kidney
Diseases (NIDDK), more than 1 in 7
adults in the U.S. are affected by kidney
disease.53 Of those, more than 800,000
Americans are living with end-stage
renal disease (ESRD), a condition that
often requires renal dialysis or kidney
transplant.54 Kidney transplants in 2023
set a new record, offering 27,332 ESRD
patients and their families a lifechanging organ.55 Despite upward
trends in the number of kidney
transplants conducted year over year,
tens of thousands of Americans remain
on the waiting list, which currently
exceeds 88,700 candidates.56 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.57 Furthermore, at
51 Organ Procurement and Transplantation
Network. 2024. Dashboard and metrics. Accessed
February 2024. https://insights.unos.org/OPTNmetrics/.
52 Health Resources and Services Administration.
Organ Donation Statistics. Accessed February 2024.
https://www.organdonor.gov/learn/organ-donationstatistics.
53 National Institute of Diabetes and Digestive and
Kidney Diseases. n.d. Kidney Disease Statistics for
the United States. Accessed February 2024. https://
www.niddk.nih.gov/health-information/healthstatistics/kidney-disease.
54 National Institute of Diabetes and Digestive and
Kidney Diseases. n.d. Kidney Disease Statistics for
the United States. Accessed Feb 2024. https://
www.niddk.nih.gov/health-information/healthstatistics/kidney-disease.
55 Ibid.
56 Organ Procurement and Transplantation
Network. Dashboard and metrics. https://
insights.unos.org/OPTN-metrics/. Accessed Feb
2024.
57 Organ Procurement and Transplantation
Network (OPTN)/Scientific Registry of Transplant
Recipients (SRTR). 2021. ‘‘Annual Data Report.’’
Accessed Feb 2024. https://srtr.transplant.hrsa.gov/
annual_reports/2021_ADR_Preview.aspx.
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least 562,000 Americans endure renal
dialysis each year, often while awaiting
a kidney transplant.58
In addition, thousands of Americans
suffer from conditions requiring liver
transplant. In 2023, more than 10,660
liver transplants were carried out with
organs from both living and deceased
donors, setting an all-time record.59 As
of February 16, 2024, 9,882 candidates
remain on the waiting list, but
additional registrations are expected
throughout the year.60 In 2021, more
than 1,100 liver patients died while
awaiting transplant, according to the
OPTN/SRTR Annual Data Report.61
As such, HHS believes regulatory
changes designed to increase the
number of organs available for donation,
such as those proposed in this rule,
could mitigate these outcomes. HHS is
committed to reducing the number of
persons on the organ transplant waiting
list by increasing the number of organs
made available for transplantation.
E. Implementation Considerations
1. 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). If
this proposed rule is finalized, HHS
anticipates that NIH will, in
consultation with HRSA and the OPTN,
and including the input of other
relevant Federal stakeholders, revise
and publish updated Research Criteria
in the Federal Register for public
comment later this year. The 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 the current Research Criteria will no
longer be applicable to HOPE Act
kidney and liver transplants once the
Secretary’s determination is
implemented, much of the current
criteria will no longer be relevant.
58 National Institute of Diabetes and Digestive and
Kidney Diseases. n.d. Kidney Disease Statistics for
the United States. Accessed Feb 2024. https://
www.niddk.nih.gov/health-information/healthstatistics/kidney-disease.
59 United Network for Organ Sharing (UNOS).
February 14, 2024. A decade of record increases in
liver transplant. Accessed Feb 2024. https://
unos.org/news/in-focus/a-decade-of-recordincreases-in-liver-transplant/.
60 Organ Procurement and Transplantation
Network. Dashboard and metrics. https://
insights.unos.org/OPTN-metrics/. Accessed Feb
2024.
61 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.
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74181
Further, HHS recognizes it will be
appropriate to update the NIH Research
Criteria to reflect advances in research
in the time since HOPE Act transplants
began. The research criteria should
reflect the current needs of various
entities involved in 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.
2. Secretarial Direction To Revise OPTN
Policies
Should this proposed rule be
finalized, 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). Through this NPRM,
HHS specifically seeks 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 welcomes
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.
HHS expects that the OPTN would
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 a final rule.
F. Secretarial Determination
The Secretary has reviewed the
recommendations of the OPTN, the
ACBTSA, and the BOTSEC on
implementation of the HOPE Act, and
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. 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 proposes to determine that
participation in clinical research, and
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Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules
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 this rulemaking, the
Secretary proposes to lift the statutory
research and IRB requirements for such
transplants.
Through this NPRM, HHS specifically
seeks public comment on the Secretary’s
proposed determination that
participation in clinical research, and
application of the statutory research and
IRB requirements, as a requirement for
transplants of kidneys and livers from
persons with HIV, is no longer
warranted.
HIV.’’ Further, HHS proposes to revise
the current reference in § 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.62
HHS is proposing these new
regulatory references to ‘‘donors with
HIV’’ and ‘‘living with HIV’’ with the
intent to be respectful, and not to
change the group of people referenced
in the current § 121.6.
III. Discussion of the Proposed Rule
V. Explanation of the 30-Day Public
Comment Period
HHS is publishing this proposed rule
with a 30-day public comment period,
as multiple opportunities for public
input on the matters addressed through
this rulemaking already have been
provided. HHS has been collecting
public commentary on the HOPE Act
since the OPTN provided its HOPE Act
recommendations to Secretary Becerra
in October 2021. ACBTSA heard a
summary of the OPTN’s consideration
of the HOPE Act soon after its December
1, 2021 public meeting. Following this
presentation, ACBTSA formed a
working group to develop a
recommendation regarding the HOPE
Act. During the ACBTSA’s November
17, 2022 public meeting, ACBTSA
received written public comment on its
proposed recommendations to the
Secretary regarding removing the
research and IRB requirements for
kidney and liver HOPE Act
transplantations.63
HHS has actively engaged transplant
surgeons, researchers, advocates,
donors, and recipients involved in organ
transplantation in the course of drafting
a recommendation to the Secretary. The
Department has reviewed dozens of
comments received in response to
discussions held by the ACBTSA, the
BOTSEC and the Presidential Advisory
Council on HIV/AIDS (PACHA).64 65 The
A. Removal of Research and IRB
Requirements for HOPE Act Kidney and
Liver Transplants
Consistent with the Secretary’s
proposed determination under the
HOPE Act, this proposed rule, if
finalized, will revise § 121.6 of the HHS
regulations governing the OPTN to
reflect the removal of the statutory
research and IRB requirements for
kidney and liver HOPE Act transplants.
HHS proposes to revise
§ 121.6(b)(1)(ii)(B) to reflect the
Secretary’s proposed determination that
participation in clinical research is no
longer warranted for the following
categories of transplants:
(1) Transplant of a donor kidney with
HIV; and
(2) Transplant of a donor liver with
HIV.
In implementation, this proposal, if
approved, would mean that HOPE Act
kidney and liver transplants will no
longer be conducted as research, and
instead will be conducted in accordance
with newly adopted OPTN policies
regarding kidneys and livers from
donors with HIV.
ddrumheller on DSK120RN23PROD with PROPOSALS1
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 proposes to revise all current
references in § 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, ‘‘donor organs with
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62 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.
63 HHS Advisory Committee on Blood and Tissue
Safety and Availability. 2022. Fifty-Sixth ACBTSA
Meeting November 17, 2022—Meeting Summary.
64 79th Presidential Advisory Council on HIV/
AIDS (PACHA) Full Council Meeting |12.06.23 | Part
4. Uploaded by U.S. Department of Health and
Human Services. 2023 Dec 14. https://
www.youtube.com/watch?v=oHM3ygWpMek.
65 HHS Presidential Advisory Council on HIV/
AIDS (PACHA). Seventy-Ninth PACHA Meeting
December 6, 2023—Meeting Summary. 2023 Dec 6.
https://files.hiv.gov/s3fs-public/2024-03/PACHADec-2023-meeting-summary-final.pdf.
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Department understands that there is
widespread support for the proposed
recommendation including the
endorsement of at least 35 nongovernmental organizations involved in
HIV advocacy, organizations
representing entities involved in organ
transplantation, associations
representing transplant surgeons,
nephrologists, HIV clinicians,
epidemiologists, and many more
individuals.
Given the multiple committees and
policy mechanisms employed for
discussion of potential changes to
requirements for HOPE Act transplants,
previous efforts to gather public
commentary and the considerable
public health impact this proposed
policy may have on those in need of
organ transplantation, HHS believes the
30-day public comment period is
sufficient and most expedient.
VI. Paperwork Reduction Act of 1995
This proposed rule, if finalized,
would 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. The current
data collection requirements in the
OPTN final rule approved by the 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).
VII. Preliminary Economic Analysis of
Impacts
We have examined the impacts of the
proposed 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
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Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules
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.
This analysis indicates that this
proposed rule is a significant regulatory
action under Executive Order 12866
section 3(f)(1).
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
Because the impacts are small relative to
the number of organ transplants
performed annually, and because the
costs are small relative to the average
payroll of firms in the smallest
enterprise size category, we propose to
certify that the proposed 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 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, or by the private sector.
Each agency must also seek input from
State, local, and Tribal governments.66
The current threshold after adjustment
for inflation using the Implicit Price
Deflator for the Gross Domestic Product
is $183 million, reported in 2023
dollars. This proposed rule, if finalized,
would not result in an unfunded
mandate in any year that meets or
exceeds this amount.
This proposed rule would, if
finalized, remove the current research
and institutional review board (IRB)
requirements for transplants of human
immunodeficiency virus (HIV)-positive
kidneys and livers. This would result in
impacts related to changes in the
number of kidney and liver transplants
performed annually. We monetize
benefits associated with increases in life
74183
expectancy for organ transplant
recipients and, for kidney transplant
recipients, benefits associated with
improved quality of life and time
savings from fewer kidney dialysis
visits. We monetize costs from medical
expenditures associated with organ
transplantation; for kidney transplants,
we report impacts that are net of
medical expenditures associated with
kidney dialysis. We also monetize costs
associated with organ transplant centers
reading and understanding the rule,
reviewing policies and procedures, and
training staff. We report the shift in
expenditures associated with kidney
dialysis to expenditures associated with
kidney transplantation separately as
transfers. We estimate that the
annualized benefits over a 10-year time
horizon covering 2025 through 2034
would range from $561 million to $1.26
billion at a 2 percent discount rate, with
a primary estimate of $900 million. The
annualized costs would range from $134
million to $174 million, with a primary
estimate of $154 million. The
annualized transfers would range from
$24 million to $39 million, with a
primary estimate of $31 million.
TABLE 1—SUMMARY OF IMPACTS OF THE PROPOSED RULE
[Millions of constant 2023 dollars
Primary
estimate
Category
BENEFITS:
Annualized monetized benefits.
Annualized quantified, but nonmonetized, benefits.
Unquantified benefits.
COSTS:
Annualized monetized costs.
TRANSFERS:
Annualized monetized transfers.
NET BENEFITS:
Annualized monetized net benefits.
Low
estimate
High
estimate
Dollar year
or unit
Discount
rate
(%)
Time
horizon
Notes
$900
$561
$1,261
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.
Improved quality of life for liver transplant recipients.
147
129
166
People affected ....
2
2025–2034
................
................
................
...............................
................
2025–2034
Time savings for caregivers; cost savings related to removing the research and institutional review board requirements.
$154
$134
$174
2023 .....................
2
2025–2034
Net costs associated with organ transplants; costs associated with organ transplant centers reading and
understanding the rule, reviewing policies and procedures, and training staff.
$31
$24
$39
2023 .....................
2
2025–2034
Shift in expenditures associated with kidney dialysis to
expenditures associated with kidney transplantation.
$746
$412
$1,101
2023 .....................
2
2025–2034
ddrumheller on DSK120RN23PROD with PROPOSALS1
Note: primary, low, and high estimates correspond to the mean, 5th percentile, and 95th percentile of the outcomes of a Monte Carlo simulation.
We have developed a comprehensive
preliminary economic analysis of
impacts that assesses the impacts of the
proposed rule, which is available in the
docket for this proposed rule Document
ID HRSA–2024–0001.
List of Subjects in 42 CFR Part 121
66 U.S. Office of Management and Budget, Office
of Information and Regulatory Affairs. ‘‘2018, 2019,
and 2020 Report to Congress on the Benefits and
Costs of Federal Regulations and Agency
Compliance with the Unfunded Mandates Reform
Act.’’ https://www.whitehouse.gov/wp-content/
uploads/2021/01/2018_2019_2020-OMB-CostBenefit-Report.pdf.
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Health care, Hospitals, Transplant
centers, Organ transplantation,
Reporting and recordkeeping
requirements.
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Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Proposed Rules
Dated: September 6, 2024.
Xavier Becerra,
Secretary.
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 proposed to be amended as follows:
PART 121—ORGAN PROCUREMENT
AND TRANSPLANTATION NETWORK
1. The authority citation for part 121
continues to read as follows:
requirement for transplants of donor
organs with HIV, the OPTN shall adopt
and use standards of quality with
respect to donor organs 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.
*
*
*
*
*
[FR Doc. 2024–20643 Filed 9–11–24; 8:45 am]
BILLING CODE 4150–28–P
■
Authority: Sections 215, 371–77, 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.
47 CFR Parts 1 and 64
[GN Docket No. 24–213; MD Docket No. 10–
234; FCC 24–85; FR ID 240720]
2. In § 121.6, revise paragraph (b) to
read as follows:
Improving the Effectiveness of the
Robocall Mitigation Database;
Amendment of CORES Registration
System
§ 121.6
AGENCY:
■
Organ procurement.
*
ddrumheller on DSK120RN23PROD with PROPOSALS1
FEDERAL COMMUNICATIONS
COMMISSION
*
*
*
*
(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
transplants of donor organs 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 donor kidney with
HIV; and
(2) Transplant of a donor liver 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 donor organs 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.
(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
VerDate Sep<11>2014
16:43 Sep 11, 2024
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Federal Communications
Commission.
ACTION: Proposed rule.
In this document, the Federal
Communications Commission
(Commission) proposes and seeks
comment on procedural measures that
would require Robocall Mitigation
Database filers to take additional steps
to ensure the accuracy of submitted
information, potential technical
solutions for validating data,
accountability measures to ensure and
improve the overall quality of
submissions in the Robocall Mitigation
Database, and generally invites
comment on any other procedural steps
the Commission could require to
increase the effectiveness of the
Robocall Mitigation Database as a
compliance and consumer protection
tool.
SUMMARY:
Comments are due on or before
October 15, 2024, and reply comments
are due on or before November 12, 2024.
ADDRESSES: Pursuant to §§ 1.415 and
1.419 of the Commission’s rules, 47 CFR
1.415, 1.419, interested parties may file
comments and reply comments on or
before the dates indicated above.
Comments may be filed using the
Commission’s Electronic Comment
Filing System (ECFS). See Electronic
Filing of Documents in Rulemaking
Proceedings, 63 FR 24121 (1998).
• Electronic Filers: Comments may be
filed electronically using the internet by
accessing ECFS: https://www.fcc.gov/
ecfs/.
• Paper Filers: Parties who choose to
file by paper must file an original and
one copy of each filing.
DATES:
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• Filings can be sent by commercial
overnight courier, or by first-class or
overnight U.S. Postal Service mail. All
filings must be addressed to the
Commission’s Secretary, Office of the
Secretary, Federal Communications
Commission.
• Hand-delivered or messengerdelivered paper filings for the
Commission’s Secretary are accepted
between 8 a.m. and 4 p.m. by the FCC’s
mailing contractor at 9050 Junction
Drive, Annapolis Junction, MD 20701.
All hand deliveries must be held
together with rubber bands or fasteners.
Any envelopes and boxes must be
disposed of before entering the building.
• Commercial courier deliveries (any
deliveries not by the U.S. Postal Service)
must be sent to 9050 Junction Drive,
Annapolis Junction, MD 20701.
• Filings sent by U.S. Postal Service
First-Class Mail, Priority Mail, and
Priority Mail Express must be sent to 45
L Street NE, Washington, DC 20554.
Accessible Formats. To request
materials in accessible formats for
people with disabilities (Braille, large
print, electronic files, audio format),
send an email to fcc504@fcc.gov or call
the Consumer & Governmental Affairs
Bureau at 202–418–0530 (voice).
FOR FURTHER INFORMATION CONTACT: For
further information about the Notice of
Proposed Rulemaking (NPRM), contact
Erik Beith, Attorney Advisor,
Competition Policy Division, Wireline
Competition Bureau, at Erik.Beith@
fcc.gov. For additional information
concerning the Paperwork Reduction
Act proposed information collection
requirements contained in this
document, send an email to PRA@
fcc.gov or contact Nicole Ongele at (202)
418–2991.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s NPRM in
GN Docket No. 24–213, MD Docket No.
10–234, released on August 8, 2024. The
complete text of this document is
available for download at https://
docs.fcc.gov/public/attachments/FCC24-85A1.pdf.
Paperwork Reduction Act: The NPRM
may contain proposed new and revised
information collection requirements.
The Commission, as part of its
continuing effort to reduce paperwork
burdens, invites the general public and
the Office of Management and Budget
(OMB) to comment on the information
collection requirements contained in
this document, as required by the
Paperwork Reduction Act of 1995,
Public Law 104–13. In addition,
pursuant to the Small Business
Paperwork Relief Act of 2002, Public
Law 107–198, see 44 U.S.C. 3506(c)(4),
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]]>Agencies
[Federal Register Volume 89, Number 177 (Thursday, September 12, 2024)]
[Proposed Rules]
[Pages 74174-74184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20643]
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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: Notice of proposed rulemaking.
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SUMMARY: The Department of Health and Human Services (HHS) proposes to
amend 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 kidney 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 proposes to
determine that participation in such clinical research should no longer
be a requirement for transplantation of HIV positive kidneys and livers
from donors with HIV to recipients with HIV. This proposed rule serves
as publication of the Secretary's proposed determination and proposes
to amend the regulations to reflect this determination. Consistent with
NOTA and current regulatory requirements, the Secretary's proposed
determination and the proposed corresponding regulatory revision, if
finalized, will necessitate that the Organ Procurement and
Transplantation Network (OPTN) adopt and use standards of quality
concerning kidneys and livers from donors with HIV, as
[[Page 74175]]
directed by the Secretary, 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: Comments on this notice of proposed rulemaking should be
received no later than October 15, 2024.
ADDRESSES: You may send comments, identified by Document ID HRSA-2024-
0001, to the Federal eRulemaking Portal: https://www.regulations.gov.
For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document.
In accordance with 5 U.S.C. 553(b)(4), a summary of this rulemaking
may be found in the docket for this rulemaking at www.regulations.gov
[Document ID HRSA-2024-0001].
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
All interested parties are invited to participate in this
rulemaking by submitting written comments and supportive data that
should be considered. HHS also invites comments that relate to the
economic, legal, environmental, or federalism effects that might result
from this proposed rule. Comments that will provide the most assistance
to HHS in finalizing the rule will reference a specific portion of the
proposed rule, explain the reason for any recommended change, and
include data, information, or authority that supports such recommended
change.
Instructions: If you submit a comment, you must include the agency
name and the Document ID HRSA-2024-0001 for this rulemaking. Regardless
of the method used for submitting comments or material, all submissions
will be posted, without change, to the Federal eRulemaking Portal at
https://www.regulations.gov, and will include any personal information
you provide. Therefore, submitting this information makes it public.
You may wish to consider limiting the amount of personal information
that you provide in any voluntary public comment submission you make to
HHS. HHS may withhold information provided in comments from public
viewing that it determines may impact the privacy of an individual or
is offensive. For additional information, please read the Privacy Act
notice that is available via the link in the footer of https://www.regulations.gov.
Docket: For access to the docket and to read background documents
or comments received, go to https://regulations.gov, referencing
Document ID HRSA-2024-0001. You may also sign up for email alerts on
the online docket to be notified when comments are posted or a final
rule is published.
II. Background and Purpose
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 Code of Federal
Regulations (CFR) part 121. The OPTN is also charged with developing
policies on many subjects related to organ donation and
transplantation, which include establishing standards of quality
pertaining to organs procured for use in transplantation. 42 U.S.C.
274(b)(2)(E). In addition to ensuring the efficient and effective
allocation of donor organs through the OPTN, HHS supports efforts to
increase the number of transplants performed in the United States.
B. HOPE Act Requirements and Implementation
In 1988, NOTA was amended to prohibit the transplantation of organs
from donors with HIV, referring to HIV as the etiologic agent for
acquired immunodeficiency virus or AIDS. Until 1997, a total of 32
kidney transplants were performed in recipients with HIV, all with
organs from donors without HIV.\1\ Advances in antiretroviral therapies
(ART) have now made it possible for individuals with HIV to live longer
and with fewer complications from the virus. Following the success of
pioneering transplants occurring outside the United States of organs
from donors with HIV to recipients with HIV,\2\ interest in developing
specialized HIV transplant programs grew domestically.\3\
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\1\ Werbel WA, Durand CM. Solid Organ Transplantation in HIV-
Infected Recipients: History, Progress, and Frontiers. Curr HIV/AIDS
Rep. 2019 Jun;16(3):191-203.
\2\ Muller E, Barday Z, Mendelson M, Kahn D. HIV-Positive to
HIV-Positive Kidney Transplantation--Results at 3 to 5 Years. New
England Journal of Medicine. 2015 Feb 12;372(7):613-620.
\3\ Botha J, Fabian J, Etheredge H, Conradie F, Tiemessen CT.
HIV and Solid Organ Transplantation: Where Are we Now. Curr HIV/AIDS
Rep. 2019 Oct;16(5):404-413.
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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 clinical 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.\4\ 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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\4\ Federal Register. Organ Procurement and Transplantation:
Implementation of the HIV Organ Policy Equity (HOPE) Act. 2015
May:80 FR 26464. 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
[[Page 74176]]
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, 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.\5\ The NIH Research Criteria were developed by an HHS working
group of entities involved in organ transplantation, with input from
multiple stakeholders.
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\5\ Federal Register. Final Human Immunodeficiency Virus (HIV)
Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for
Transplantation of Organs Infected With HIV. 2015 Nov:80 FR 73785.
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 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.\6\ 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.
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\6\ HIV.gov. Opportunistic Infections: HIV Treatment Overview.
https://www.hiv.gov/hiv-basics/staying-in-hiv-care/other-related-health-issues/opportunistic-infections. Accessed Apr 2024.
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Publication of both the final rule implementing the HOPE Act and
the NIH Research Criteria necessitated that the OPTN update its
standards of quality for HIV-positive organ transplants and coordinate
related OPTN policies. On November 21, 2015, the OPTN published an open
variance (an experimental policy that tests methods of improving organ
allocation) providing standards for transplant hospitals conducting
HOPE Act transplants.\7\ The OPTN expanded the variance in 2019 to
include all solid organs,\8\ and extended the variance through January
2026, to provide for the gathering of data and subsequent evaluation of
the outcomes of HOPE Act transplants.\9\
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\7\ 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.
\8\ 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.
\9\ 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
As stated above, the HOPE Act requires that the Secretary, in
conjunction with the OPTN, periodically review 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 allows 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.\10\ 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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\10\ 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 NIH-funded
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 funded by NIH 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 which participated in the pilot study found that
there were 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.\11\ While donors with HIV were more likely to have co-infections,
the study found that these were manageable in the larger clinical
context. Rejection
[[Page 74177]]
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 found to be
statistically significant. The insignificance of the result is due, in
part, to the relatively small sample size. In addition, the
investigators indicated that this result could be due to chance. 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 that rejection of such
transplants is common. 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 raises concerns that merited further
investigation.
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\11\ 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 funded by NIH and 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.) 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
the observed increases among HOPE Act liver transplant recipients in
mortality, cytomegalovirus (CMV) viremia, infectious hospitalizations,
and cancer. 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.\12\
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\12\ 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
Two NIH-funded studies on kidney and liver HOPE Act transplants are
ongoing. The NIH-funded U01 HOPE Act kidney transplant clinical trial
is designed to analyze rejection and long-term outcomes of kidney
transplantation for recipients with HIV. The study will 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.\13\
Similarly, the U01 HOPE Act liver transplant clinical trial is 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.\14\
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\13\ 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.
\14\ 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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Both U01 clinical trials have reached their target enrollments and
now in phases of final data analysis (kidney) and patient follow-up
(liver). The final results are not yet published.
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.\15\ 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.\16\
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\15\ 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.
\16\ 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
[[Page 74178]]
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.\17\ 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.18 19
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\17\ 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.
\18\ 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.
\19\ 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
Following the OPTN's review of research results and data relevant
to HOPE Act transplants and its recommendation to the Secretary,
additional research has since been published providing more evidence
for the safety of organ transplantation from donors with HIV to
recipients with HIV. In general, safety and outcomes of kidney and
liver HOPE Act transplants is well established with over 468 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, 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
donor organs with HIV in recipients with HIV. Further, the study also
found that there were no major differences 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.\20\
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\20\ 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.\21\ 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.\22\ 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 ESRD have higher
mortality than people with ESRD who are not also living with HIV,\23\
in HHS's view, this data illustrates the benefit of HOPE Act kidneys
transplants for this vulnerable population.
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\21\ 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.
\22\ 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.
\23\ Ibid.
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In addition to providing important evidence for the survival
benefit of organ transplantation for recipients with HIV, the HOPE in
Action Consortium has also published 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.\24\
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\24\ 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 one heart transplant has been conducted (dual organ: heart-
kidney).25 26 No HOPE Act transplants have been recorded
among recipients in need of organs such as a lung, pancreas, islet, or
intestine. 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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\25\ 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
\26\ 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. HHS Advisory Committee on Blood and Tissue Safety and Availability
Recommendations
Following the OPTN recommendation to the Secretary in 2021, the HHS
Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA)
formed a Working Group to evaluate the recommendation from the OPTN.
After analyzing the OPTN recommendation, and receiving presentations on
data on HOPE Act kidney and liver transplants, and relevant research
results on heart transplants and lung transplants in recipients with
HIV, the ACBTSA HOPE Act working group recommended to the full
committee that the Secretary
[[Page 74179]]
eliminate research and IRB requirements for all HOPE Act transplants.
However, the working group expressed concern about the elimination of
research and IRB requirements for non-kidney and non-liver HOPE Act
transplants,\27\ and whether there was sufficient data collected on
other organs to justify a full adoption the OPTN's recommendation.
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\27\ 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/.
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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.
4. HHS Secretary: Review
Upon review of the OPTN, ACBTSA and BOTSEC recommendations, and in
consideration of the results of relevant scientific research, the
Secretary believes that the research and IRB requirements for kidney
and liver HOPE Act transplants are no longer warranted.
The Secretary has been informed by the research results described
in this preamble from pilot studies, clinical trials, and case reports,
as well as OPTN outcomes data on all HOPE Act transplants and
additional data. Studies of kidney and liver HOPE Act transplants have
demonstrated survival benefit for transplant recipients with HIV,
compared to non-HOPE Act transplants, with few adverse
consequences.28 29 30 Additionally, the OPTN's letter to the
Secretary noted that in five years of HOPE Act transplants with over
300 HOPE Act transplant recipients with HIV, no patient safety concerns
were identified, and no HOPE Act research has been halted, paused, or
substantially amended to address recipient safety concerns.\31\
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\28\ Durand CM, et al; 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.
\29\ Durand CM, et al; 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.
\30\ 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.
\31\ 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.
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The outcomes of HOPE Act transplants are considered in light of the
limitations of organ transplantation generally: that too few organs are
available for the thousands of patients awaiting transplants. The
pretransplant mortality rate for adults awaiting a kidney transplant
varies substantially across the country. The average is 5.4 deaths per
100 person years, but it is reported to be as high as 7.5 deaths per
100 person years as of the most recent OPTN/SRTR Annual Data
Report.\32\ This results in most transplant candidates waiting years
for a kidney transplant, often requiring dialysis or other
interventions.
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\32\ Organ Procurement and Transplantation Network (OPTN)/
Scientific Registry of Transplant Recipients (SRTR). 2022. ``Annual
Data Report: Kidney.'' Accessed May 2024. https://srtr.transplant.hrsa.gov/annual_reports/2022/Kidney.aspx.
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It is well established that pretransplant kidney mortality rates
among candidates with HIV are higher than those without HIV. In one
study analyzing survival benefit of HIV-positive kidney transplantation
(i.e., non-HOPE Act transplants), mortality rates among transplant
candidates with HIV after one year were 8.7 deaths per 100 person years
compared to just 3.1 deaths per 100 person years among those that
received a kidney transplant.\33\ Therefore, it is hypothesized that
reduction in waitlist times may indeed result in lower mortality for
transplant candidates with HIV and end-stage diseases.
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\33\ Locke JE, Gustafson S, Mehta S, Reed RD, Shelton B,
MacLennan PA, Durand C, Snyder J, Salkowski N, Massie A, Sawinski D,
Segev DL. Survival Benefit of Kidney Transplantation in HIV-infected
Patients. Ann Surg. 2017 Mar;265(3):604-608.
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Research has demonstrated that recipients with HIV may reduce the
time on the kidney waitlist significantly if they are willing to accept
a HOPE Act transplant. As previously mentioned, one 2023 study found
that median wait time for a HOPE Act transplant was 10.8 months
compared to 60.8 months--a 3.3-fold higher rate of kidney transplant
compared to non-HOPE Act transplants.\34\
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\34\ 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.
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Significant progress has been made in the reduction of
pretransplant mortality for liver transplant candidates over the past
decade. Rates have declined from a high of 17.9 deaths per 100 person
years in 2014 to 12.3 deaths per 100 person years in 2022.\35\ Like
kidney transplant, research has also demonstrated the survival benefit
of organ transplantation for those with HIV and end-stage liver disease
when compared to transplant candidates without HIV.\36\
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\35\ Organ Procurement and Transplantation Network (OPTN)/
Scientific Registry of Transplant Recipients (SRTR). 2022. ``Annual
Data Report: Liver.'' Accessed May 2024. https://srtr.transplant.hrsa.gov/annual_reports/2022/Liver.aspx.
\36\ Ragni MV, Eghtesad B, Schlesinger KW, Dvorchik I, Fung JJ.
Pretransplant survival is shorter in HIV-positive than HIV-negative
subjects with end-stage liver disease. Liver Transpl. 2005
Nov;11(11):1425-30.
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It is also hypothesized that the expansion of kidney and liver HOPE
Act transplantation will also help to reduce stigma and health
disparities associated with HIV. Stigma and physician reluctance to
counsel potential transplant candidates with HIV on the benefits of
organ transplantation may contribute to the lower than projected counts
of HOPE Act transplants to date.\37\
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\37\ Klitenic SB, Levan ML, Van Pilsum Rasmussen SE, Durand CM.
Science Over Stigma: Lessons and Future Direction of HIV-to-HIV
Transplantation. Curr Transplant Rep. 2021;8(4):314-323.
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The Secretary also believes that the current research and IRB
requirements should be maintained for HOPE Act transplants of all other
organs, in light of the lack of data on outcomes for HOPE Act organ
transplants other than kidney or liver transplants. At the time the
ACBTSA developed its recommendations, no HOPE Act transplants outside
of kidneys, livers, and one dual heart-kidney transplant had been
performed, and data on heart, lung, pancreas, islet, intestine, or
other organ transplants from donors with HIV to recipients with HIV
that were conducted outside the U.S. is limited.
The HOPE Act requires that, for the statutory research and IRB
requirements to be lifted for HOPE Act transplants, the Secretary must
determine that participation in such clinical research, as a
requirement for these transplants, is no longer warranted. 42 U.S.C.
274 (b)(3)(B)(ii). In the absence of research results and robust
outcomes data
[[Page 74180]]
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.
The Secretary acknowledges that the OPTN has argued that any
research and IRB requirements serve as a barrier to access for HOPE Act
transplant candidates and may perpetuate inequities in HOPE Act
transplant programs.\38\ We believe, however, that the proposed rule
balances the need to ensure the safety of HOPE Act transplants while
removing research and IRB requirements for HOPE Act kidney and liver
transplants in transplant programs that are well established and have
demonstrated both efficacy and safety.
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\38\ 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.
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D. Diversity, Equity, Inclusion: Effects on Individuals in Need of
Transplant
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 as a barrier to
participation in HOPE Act transplant programs, which may impact equity
and access to organ transplantation throughout the United States.\39\
By eliminating the requirement that HOPE Act kidney and liver
transplants are conducted in the research context, it is anticipated
that a larger number of transplant centers will be able to conduct such
transplants. This proposal 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.
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\39\ 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.
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Other factors, such as systemic racism, perpetuate long-standing
inequalities and inequities in health care access including organ
transplantation. People who identify as Black or African American are
four times more likely to develop ESRD compared to non-Hispanic White
people but are less likely to receive a kidney
transplant.40 41 These outcomes are not explained by
individual characteristics alone, suggesting that other factors, such
as lower socioeconomic status and poor clinical communication,
contribute to this inequity.42 43
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\40\ National Institute of Diabetes and Digestive and Kidney
Diseases. n.d. Kidney Disease Statistics for the United States.
Accessed February 2024. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease.
\41\ U.S. Department of Health and Human Services. Office of
Minority Health: Organ Donation and African Americans. https://minorityhealth.hhs.gov/organ-donation-and-african-americans.
Accessed 2/27/2024.
\42\ El-Khoury B, Yang TC. Reviewing Racial Disparities in
Living Donor Kidney Transplantation: a Socioecological Approach. J
Racial Ethn Health Disparities. 2023 Mar 29:1-10.
\43\ Siminoff LA, Burant CJ, Ibrahim SA. Racial disparities in
preferences and perceptions regarding organ donation. J Gen Intern
Med. 2006 Sep;21(9):995-1000.
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Separate from organ transplantation, HIV disproportionately affects
people of some racial and ethnic groups in the United States, such as
Black or African American and Hispanic or Latino populations.
Prevalence rates suggest these communities have higher rates of HIV
compared to White populations. For example, according to the Centers
for Disease Control and Prevention's (CDC) HIV Surveillance
Supplemental Report, 2023, people who identified as Black or African
American represented 12.4 percent of the population but 40.2 percent of
those with diagnosed HIV in 2021.\44\ In addition, people identified as
Hispanic or Latino represent 17.6 percent of the population but make up
23.8 percent of people with diagnosed HIV.\45\ Incidence rates also
confirm that new infections disproportionately affect Black or African
Americans (40 percent of new infections), and Hispanic or Latinos (29
percent of new infections), suggesting that prevention efforts are not
adequately reaching these populations.\46\ Higher prevalence and
incidence rates among communities over-represented in the HIV epidemic
suggest that these communities would also benefit from expanded access
to HOPE Act transplants. In fact, in one 2019 study of HOPE Act
deceased-donor characteristics, investigators found a higher proportion
of people who identify as Black or African American (72 percent) among
HOPE Act kidney transplant recipients than the percent of Black or
African Americans in the general population. Among recipient
characteristics of HOPE Act liver transplant recipients in the same
study, 23 percent identified as Black or African American.\47\
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\44\ Centers for Disease Control and Prevention. Estimated HIV
incidence and prevalence in the United States, 2017-2021. HIV
Surveillance Supplemental Report, 2023; 28 (No.3). https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published May
2023.
\45\ Ibid.
\46\ Centers for Disease Control and Prevention. Estimated HIV
incidence and prevalence in the United States, 2017-2021. HIV
Surveillance Supplemental Report, 2023; 28 (No.3). https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published May
2023.
\47\ Wilk AR, Hunter RA, McBride MA, Klassen DK. National
landscape of HIV+ to HIV+ kidney and liver transplantation in the
United States. American Journal of Transplantation 2019;19(9):2594-
2605.
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In addition to racial and ethnic diversity, gay, bisexual, and
other men who have sex with men (MSM) are the most affected group of
people with HIV, accounting for 66 percent of new infections in 2021
even though they only compose 2 percent of the
population.48 49 Lastly, people who identify as transgender
represent 2 percent of all new HIV diagnoses, exceeding the proportion
of people who identify as transgender in the general population.\50\
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\48\ Centers for Disease Control and Prevention. Surveillance
Supplemental Report, 2023, 2003 May;28(No.3). https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html.
\49\ Purcell DW, Johnson CH, Lansky A, et al. Estimating the
population size of men who have sex with men in the United States to
obtain HIV and syphilis rates. Open AIDS J 2012; 6:98-107.
\50\ Centers for Disease Control and Prevention. HIV
Surveillance Report, 2021; vol. 34. https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published May 2023.
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In light of all of these considerations, HHS expects that this
proposed rule, if finalized, will assist in improving access to kidney
and liver transplants for recipients with HIV. This anticipated
positive result is consistent with the Department's commitment to
diversity, equity, and inclusion.
Further, this proposed rule to remove research and IRB requirements
for kidney and liver HOPE Act transplants would, if finalized, expand
access to organ transplantation for all patients, regardless of their
HIV status. When eligible for transplant, a 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
[[Page 74181]]
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.\51\ Every 10
minutes another person is added to the waiting list, and nearly 20
people die every day while waiting for a transplant.\52\ The current
approach to acquiring organs for transplantation relies on the altruism
of donors and their families.
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\51\ Organ Procurement and Transplantation Network. 2024.
Dashboard and metrics. Accessed February 2024. https://insights.unos.org/OPTN-metrics/.
\52\ Health Resources and Services Administration. Organ
Donation Statistics. Accessed February 2024. https://www.organdonor.gov/learn/organ-donation-statistics.
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According to the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), more than 1 in 7 adults in the U.S. are
affected by kidney disease.\53\ Of those, more than 800,000 Americans
are living with end-stage renal disease (ESRD), a condition that often
requires renal dialysis or kidney transplant.\54\ Kidney transplants in
2023 set a new record, offering 27,332 ESRD patients and their families
a life-changing organ.\55\ Despite upward trends in the number of
kidney transplants conducted year over year, tens of thousands of
Americans remain on the waiting list, which currently exceeds 88,700
candidates.\56\ 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.\57\
Furthermore, at least 562,000 Americans endure renal dialysis each
year, often while awaiting a kidney transplant.\58\
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\53\ National Institute of Diabetes and Digestive and Kidney
Diseases. n.d. Kidney Disease Statistics for the United States.
Accessed February 2024. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease.
\54\ National Institute of Diabetes and Digestive and Kidney
Diseases. n.d. Kidney Disease Statistics for the United States.
Accessed Feb 2024. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease.
\55\ Ibid.
\56\ Organ Procurement and Transplantation Network. Dashboard
and metrics. https://insights.unos.org/OPTN-metrics/. Accessed Feb
2024.
\57\ Organ Procurement and Transplantation Network (OPTN)/
Scientific Registry of Transplant Recipients (SRTR). 2021. ``Annual
Data Report.'' Accessed Feb 2024. https://srtr.transplant.hrsa.gov/annual_reports/2021_ADR_Preview.aspx.
\58\ National Institute of Diabetes and Digestive and Kidney
Diseases. n.d. Kidney Disease Statistics for the United States.
Accessed Feb 2024. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease.
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In addition, thousands of Americans suffer from conditions
requiring liver transplant. In 2023, more than 10,660 liver transplants
were carried out with organs from both living and deceased donors,
setting an all-time record.\59\ As of February 16, 2024, 9,882
candidates remain on the waiting list, but additional registrations are
expected throughout the year.\60\ In 2021, more than 1,100 liver
patients died while awaiting transplant, according to the OPTN/SRTR
Annual Data Report.\61\
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\59\ United Network for Organ Sharing (UNOS). February 14, 2024.
A decade of record increases in liver transplant. Accessed Feb 2024.
https://unos.org/news/in-focus/a-decade-of-record-increases-in-liver-transplant/.
\60\ Organ Procurement and Transplantation Network. Dashboard
and metrics. https://insights.unos.org/OPTN-metrics/. Accessed Feb
2024.
\61\ 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.
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As such, HHS believes regulatory changes designed to increase the
number of organs available for donation, such as those proposed in this
rule, could mitigate these outcomes. HHS is committed to reducing the
number of persons on the organ transplant waiting list by increasing
the number of organs made available for transplantation.
E. Implementation Considerations
1. 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). If this proposed rule is finalized, HHS
anticipates that NIH will, in consultation with HRSA and the OPTN, and
including the input of other relevant Federal stakeholders, revise and
publish updated Research Criteria in the Federal Register for public
comment later this year. The 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 the current
Research Criteria will no longer be applicable to HOPE Act kidney and
liver transplants once the Secretary's determination is implemented,
much of the current criteria will no longer be relevant.
Further, HHS recognizes it will be appropriate to update the NIH
Research Criteria to reflect advances in research in the time since
HOPE Act transplants began. The research criteria should reflect the
current needs of various entities involved in 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.
2. Secretarial Direction To Revise OPTN Policies
Should this proposed rule be finalized, 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). Through this NPRM, HHS
specifically seeks 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 welcomes 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.
HHS expects that the OPTN would 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 a
final rule.
F. Secretarial Determination
The Secretary has reviewed the recommendations of the OPTN, the
ACBTSA, and the BOTSEC on implementation of the HOPE Act, and 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. 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 proposes to determine that
participation in clinical research, and
[[Page 74182]]
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 this rulemaking, the Secretary proposes to
lift the statutory research and IRB requirements for such transplants.
Through this NPRM, HHS specifically seeks public comment on the
Secretary's proposed determination that participation in clinical
research, and application of the statutory research and IRB
requirements, as a requirement for transplants of kidneys and livers
from persons with HIV, is no longer warranted.
III. Discussion of the Proposed Rule
A. Removal of Research and IRB Requirements for HOPE Act Kidney and
Liver Transplants
Consistent with the Secretary's proposed determination under the
HOPE Act, this proposed rule, if finalized, will revise Sec. 121.6 of
the HHS regulations governing the OPTN to reflect the removal of the
statutory research and IRB requirements for kidney and liver HOPE Act
transplants.
HHS proposes to revise Sec. 121.6(b)(1)(ii)(B) to reflect the
Secretary's proposed determination that participation in clinical
research is no longer warranted for the following categories of
transplants:
(1) Transplant of a donor kidney with HIV; and
(2) Transplant of a donor liver with HIV.
In implementation, this proposal, if approved, would mean that HOPE
Act kidney and liver transplants will no longer be conducted as
research, and instead will be conducted in accordance with newly
adopted OPTN policies regarding kidneys and livers from donors with
HIV.
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 proposes to revise all current
references in Sec. 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, ``donor organs
with HIV.'' Further, HHS proposes to revise the current reference in
Sec. 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.\62\
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\62\ 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.
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HHS is proposing these new regulatory references to ``donors with
HIV'' and ``living with HIV'' with the intent to be respectful, and not
to change the group of people referenced in the current Sec. 121.6.
V. Explanation of the 30-Day Public Comment Period
HHS is publishing this proposed rule with a 30-day public comment
period, as multiple opportunities for public input on the matters
addressed through this rulemaking already have been provided. HHS has
been collecting public commentary on the HOPE Act since the OPTN
provided its HOPE Act recommendations to Secretary Becerra in October
2021. ACBTSA heard a summary of the OPTN's consideration of the HOPE
Act soon after its December 1, 2021 public meeting. Following this
presentation, ACBTSA formed a working group to develop a recommendation
regarding the HOPE Act. During the ACBTSA's November 17, 2022 public
meeting, ACBTSA received written public comment on its proposed
recommendations to the Secretary regarding removing the research and
IRB requirements for kidney and liver HOPE Act transplantations.\63\
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\63\ HHS Advisory Committee on Blood and Tissue Safety and
Availability. 2022. Fifty-Sixth ACBTSA Meeting November 17, 2022--
Meeting Summary.
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HHS has actively engaged transplant surgeons, researchers,
advocates, donors, and recipients involved in organ transplantation in
the course of drafting a recommendation to the Secretary. The
Department has reviewed dozens of comments received in response to
discussions held by the ACBTSA, the BOTSEC and the Presidential
Advisory Council on HIV/AIDS (PACHA).64 65 The Department
understands that there is widespread support for the proposed
recommendation including the endorsement of at least 35 non-
governmental organizations involved in HIV advocacy, organizations
representing entities involved in organ transplantation, associations
representing transplant surgeons, nephrologists, HIV clinicians,
epidemiologists, and many more individuals.
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\64\ 79th Presidential Advisory Council on HIV/AIDS (PACHA) Full
Council Meeting [verbar]12.06.23 [verbar] Part 4. Uploaded by U.S.
Department of Health and Human Services. 2023 Dec 14. https://www.youtube.com/watch?v=oHM3ygWpMek.
\65\ HHS Presidential Advisory Council on HIV/AIDS (PACHA).
Seventy-Ninth PACHA Meeting December 6, 2023--Meeting Summary. 2023
Dec 6. https://files.hiv.gov/s3fs-public/2024-03/PACHA-Dec-2023-meeting-summary-final.pdf.
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Given the multiple committees and policy mechanisms employed for
discussion of potential changes to requirements for HOPE Act
transplants, previous efforts to gather public commentary and the
considerable public health impact this proposed policy may have on
those in need of organ transplantation, HHS believes the 30-day public
comment period is sufficient and most expedient.
VI. Paperwork Reduction Act of 1995
This proposed rule, if finalized, would 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. The current data collection
requirements in the OPTN final rule approved by the 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).
VII. Preliminary Economic Analysis of Impacts
We have examined the impacts of the proposed 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
[[Page 74183]]
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. This analysis indicates that this proposed rule is a
significant regulatory action under Executive Order 12866 section
3(f)(1).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the impacts are small relative to the number of organ
transplants performed annually, and because the costs are small
relative to the average payroll of firms in the smallest enterprise
size category, we propose to certify that the proposed 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 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, or by the
private sector. Each agency must also seek input from State, local, and
Tribal governments.\66\ The current threshold after adjustment for
inflation using the Implicit Price Deflator for the Gross Domestic
Product is $183 million, reported in 2023 dollars. This proposed rule,
if finalized, would not result in an unfunded mandate in any year that
meets or exceeds this amount.
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\66\ U.S. Office of Management and Budget, Office of Information
and Regulatory Affairs. ``2018, 2019, and 2020 Report to Congress on
the Benefits and Costs of Federal Regulations and Agency Compliance
with the Unfunded Mandates Reform Act.'' https://www.whitehouse.gov/wp-content/uploads/2021/01/2018_2019_2020-OMB-Cost-Benefit-Report.pdf.
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This proposed rule would, if finalized, remove the current research
and institutional review board (IRB) requirements for transplants of
human immunodeficiency virus (HIV)-positive kidneys and livers. This
would result in impacts related to changes in the number of kidney and
liver transplants performed annually. We monetize benefits associated
with increases in life expectancy for organ transplant recipients and,
for kidney transplant recipients, benefits associated with improved
quality of life and time savings from fewer kidney dialysis visits. We
monetize costs from medical expenditures associated with organ
transplantation; for kidney transplants, we report impacts that are net
of medical expenditures associated with kidney dialysis. We also
monetize costs associated with organ transplant centers reading and
understanding the rule, reviewing policies and procedures, and training
staff. We report the shift in expenditures associated with kidney
dialysis to expenditures associated with kidney transplantation
separately as transfers. We estimate that the annualized benefits over
a 10-year time horizon covering 2025 through 2034 would range from $561
million to $1.26 billion at a 2 percent discount rate, with a primary
estimate of $900 million. The annualized costs would range from $134
million to $174 million, with a primary estimate of $154 million. The
annualized transfers would range from $24 million to $39 million, with
a primary estimate of $31 million.
Table 1--Summary of Impacts of the Proposed 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... $900 $561 $1,261 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- 147 129 166 People affected............. 2 2025-2034 Improved quality of life for
monetized, benefits. liver transplant
recipients.
Unquantified benefits........... ......... ......... ......... ............................ ......... 2025-2034 Time savings for caregivers;
cost savings related to
removing the research and
institutional review board
requirements.
COSTS:
Annualized monetized costs...... $154 $134 $174 2023........................ 2 2025-2034 Net costs associated with
organ transplants; costs
associated with organ
transplant centers reading
and understanding the rule,
reviewing policies and
procedures, and training
staff.
TRANSFERS:
Annualized monetized transfers.. $31 $24 $39 2023........................ 2 2025-2034 Shift in expenditures
associated with kidney
dialysis to expenditures
associated with kidney
transplantation.
NET BENEFITS:
Annualized monetized net $746 $412 $1,101 2023........................ 2 2025-2034 ............................
benefits.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: primary, low, and high estimates correspond to the mean, 5th percentile, and 95th percentile of the outcomes of a Monte Carlo simulation.
We have developed a comprehensive preliminary economic analysis of
impacts that assesses the impacts of the proposed rule, which is
available in the docket for this proposed rule Document ID HRSA-2024-
0001.
List of Subjects in 42 CFR Part 121
Health care, Hospitals, Transplant centers, Organ transplantation,
Reporting and recordkeeping requirements.
[[Page 74184]]
Dated: September 6, 2024.
Xavier Becerra,
Secretary.
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 proposed to be 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, 371-77, 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 transplants of donor organs 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 donor kidney with HIV; and
(2) Transplant of a donor liver 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 donor
organs 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.
(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 transplants of donor organs with HIV,
the OPTN shall adopt and use standards of quality with respect to donor
organs 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.
* * * * *
[FR Doc. 2024-20643 Filed 9-11-24; 8:45 am]
BILLING CODE 4150-28-P
