Request for Information; Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities
| Published date | 03 December 2021 |
| Citation | 86 FR 68594 |
| Record Number | 2021-26146 |
| Section | Proposed rules |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 86 Issue 230 (Friday, December 3, 2021)
[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Proposed Rules]
[Pages 68594-68608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26146]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Chapter IV
[CMS-3409-NC]
RIN 0938-AU55
Request for Information; Health and Safety Requirements for
Transplant Programs, Organ Procurement Organizations, and End-Stage
Renal Disease Facilities
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Request for information.
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SUMMARY: This request for information solicits public comments on
potential changes to the requirements that transplant programs, organ
procurement organizations, and end-stage renal disease facilities must
meet in order to participate in the Medicare and Medicaid programs.
These providers and suppliers are integral to the transplant ecosystem
in the United States and to the health of patients across the Nation.
We are seeking public comment that will help to inform potential
changes that would create system-wide improvements, which would further
lead to improved organ donation, organ transplantation, quality of care
in dialysis facilities, and improved access to dialysis services.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on February 1, 2022.
ADDRESSES: In commenting, refer to file code CMS-3409-NC.
[[Page 68595]]
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3409-NC, P.O. Box 8010,
Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3409-NC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Diane Corning, (410) 786-8486; James
Cowher, (410) 786-1948; Jeannine Cramer, (410) 786-5664; Lauren Oviatt,
(410) 786-4683; or Alpha-Banu Wilson, (410) 786-8687.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
I. Background
The organ donation and transplantation system (known and referred
to herein as the transplant ecosystem) in the United States comprises a
vast network of institutions dedicated to ensuring that patients are
evaluated and, if appropriate, placed onto the organ transplant
waitlist, and that those on the organ transplant waitlists receive
lifesaving organ transplants. These entities include organ procurement
organizations (OPOs), charged with identifying eligible donors and
procuring organs from deceased donors; transplant programs, located
within transplant hospitals, that perform transplantation procedures
from living and deceased donors; and donor hospitals that notify OPOs
of the imminent death of potential donors and assist the OPO in the
management of the donor and the procurement of the donor's organs.
OPOs, donor hospitals, and transplant programs rely on a close
collaborative relationship to ensure that organs are successfully
procured and appropriately placed with transplant programs. Further,
OPOs rely on families or next-of-kin, or the deceased donor themselves
(if they made the decision to donate prior to death), who voluntarily
make the choice to save lives and become donors. OPOs also have the
role of compassionately discussing donation issues with donor families
and educating the public on organ donation. In calendar year 2020,
there were a total of 39,034 transplants.\1\ These transplants resulted
from 12,587 deceased donors and 5,725 living donors. For deceased
donors, this represents about a 6 percent increase over 2019.\2\
However, there continues to be a chronic substantial unmet need for
transplantable organs as the number of people who need an organ
transplant increases in the United States. As of November 2, 2021,
there are 106,712 patients waiting for organ transplants.
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\1\ U.S. Health Resources and Services Administration. Organ
Procurement and Transplantation Network--DATA. https://optn.transplant.hrsa.gov/data/. Accessed January 13, 2021. https://optn.transplant.hrsa.gov/data/. Accessed January 13, 2021.
\2\ U.S. Health Resources and Services Administration. Annual
record trend continues for deceased organ donation, deceased donor
transplants. https://optn.transplant.hrsa.gov/news/annual-record-trend-continues-for-deceased-organ-donation-deceased-donor-transplants/. Published January 11, 2021. Accessed January 13, 2021.
https://optn.transplant.hrsa.gov/news/annual-record-trend-continues-for-deceased-organ-donation-deceased-donor-transplants/. Published
January 11, 2021. Accessed January 13, 2021.
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On the other side of the care spectrum and prior to
transplantation, end-stage renal disease (ESRD) facilities, also known
as dialysis facilities, are charged with delivering safe, adequate
dialysis to patients with ESRD. ESRD facilities also educate patients
on their treatment options, including kidney transplantation, and
ultimately refer patients to transplant programs for evaluation and
potential kidney transplantation. ESRD is complete kidney impairment
that is irreversible, permanent and requires either a regular course of
dialysis or kidney transplantation to maintain life. In the United
States, approximately 37 million patients suffer from chronic kidney
disease (CKD) \3\ and more than 785,000 have ESRD.\4\
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\3\ Chronic Kidney Disease Initiative. https://www.cdc.gov/
kidneydisease/
basics.html#:~:text=About%2037%20million%20US%20adults,dialysis%20tre
atment%20for%20kidney%20failure. Accessed November 4, 2021.
\4\ Kidney Disease: The Basics. National Kidney Foundation.
https://www.kidney.org/news/newsroom/fsindex.
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We have made changes to the existing CMS regulations with the goal
of making impactful changes to the transplantation ecosystem and
improving patient health, safety, and outcomes in transplant programs,
OPOs, and ESRD facilities. On September 30, 2019, we published the
final rule, ``Regulatory Provisions To Promote Program Efficiency,
Transparency, and Burden Reduction; Fire Safety Requirements for
Certain Dialysis Facilities; Hospital and Critical Access Hospital
(CAH) Changes To Promote Innovation, Flexibility, and Improvement in
Patient Care'' (84 FR 51732) and finalized changes to the transplant
program regulations by eliminating the data, clinical experience, and
outcome requirements for re-approval of transplant programs. This
action removed disincentives to transplantation by encouraging the use
of organs that may be perceived as being less than ideal, but could
still be used for transplantation with improved outcomes over
traditional therapies such as dialysis. On December 2, 2020, in
response to Executive Order 13879, which aimed to increase the
utilization of available organs, we published a final rule entitled,
``Organ Procurement Organizations Conditions for Coverage: Revisions to
the Outcome Measure Requirements for Organ Procurement Organizations
(85 FR 77898),'' which revised the OPO conditions for coverage (CfCs)
by replacing the previous outcome measures with new transparent,
reliable, and objective outcome measures. While these regulatory
changes recently went into effect with the goal of creating
improvements in the performance of these entities and the delivery of
care to patients additional system-wide improvements may be necessary
to further improve patient health and safety and outcomes in transplant
programs, OPOs, and ESRD facilities. In
[[Page 68596]]
addition, CMS is actively working to identify and address disparities
and inequities across these programs. We discuss the inequities that
exist in organ donation, transplantation, and dialysis and ask
questions regarding how the CoPs/CfCs can address and improve these
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issues later in this RFI. We are soliciting comments on ways to:
1. Continue to improve systems of care for all patients in need
of a transplant;
2. Increase the number of organs available for transplant for
all solid organ types;
3. Encourage the use of dialysis in alternate settings or
modalities over in-center hemodialysis where clinically appropriate
and advantageous;
4. Ensure that the Centers for Medicare & Medicaid Services
(CMS) and the Department of Health and Human Services (HHS) policies
appropriately incentivize the creation and use of future new
treatments and technologies; and
5. Harmonize requirements across government agencies to
facilitate these objectives and improve quality across the organ
donation and transplantation ecosystem.
In addition, we are soliciting information related to
opportunities, inefficiencies, and inequities in the transplant
ecosystem and what can be done to ensure all segments of our healthcare
systems are invested and accountable in ensuring improvements to organ
donation and transplantation rates.
II. Solicitation of Public Comments
A. Transplant Programs
1. Background
Transplant programs, located within a hospital that has a Medicare
provider agreement, provide transplantation services for one or more
specific organs. Transplant programs must comply with the Medicare
transplant program conditions of participation (CoPs) regulations at 42
CFR 482.68 through 482.104, and with the hospital CoPs at Sec. Sec.
482.1 through 482.58. There are several types of CMS-approved
transplant programs including heart, lung, liver, kidney, intestine,
pancreas, and multi-organ. The transplant program CoPs were finalized
and effective in 2007 and updated again in 2019 (84 FR 51732).
While we have made refinements to the transplant program CoPs over
the years, more work is still necessary to improve the transplantation
ecosystem. As evidenced through several studies and Organ Procurement
and Transplantation Network (OPTN) data, the number of organs discarded
continues to be high and we believe that this number could be
significantly reduced. For example, in 2018, there were 37,852 organs
recovered from deceased donors. Of these, 5,085 organs were discarded,
with 3,755 of those organs being kidneys, 278 being pancreata, 707
livers, 3 intestines, 23 hearts, and 319 lungs.\5\ Transplant programs
must play an important role in reducing the organ discard rate and can
do so by accepting and utilizing more organs that are deemed
``marginal'', thus ensuring that more patients on the waitlist receive
lifesaving transplants. Research indicates that many of the organs
deemed as ``marginal'' that are denied are later transplanted
successfully into patients at other transplant centers or they are
discarded despite having similar or better quality characteristics to
organs that are successfully transplanted elsewhere (see discussion in
section II.C.5).6 7 We are requesting the public's input on
issues pertaining to potential changes to the transplant program CoPs,
transplant recipient patient's rights, and equity in organ
transplantation, in order to achieve these goals.
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\5\ OPTN/SRTR 2018 Annual Data Report: Deceased Organ Donation.
\6\ Husain SA, King KL, Pastan S, Patzer RE, Cohen DJ,
Radhakrishnan J, Mohan S. Association Between Declined Offers of
Deceased Donor Kidney Allograft and Outcomes in Kidney Transplant
Candidates. JAMA Network Open. 2019 Aug 2;2(8):e1910312. doi:
10.1001/jamanetworkopen.2019.10312. Erratum in: JAMA Network Open.
2019 Oct 2;2(10):e1914599. PMID: 31469394; PMCID: PMC6724162.
\7\ Husain SA, King KL, Pastan S, Patzer RE, Cohen DJ,
Radhakrishnan J, Mohan S. Association Between Declined Offers of
Deceased Donor Kidney Allograft and Outcomes in Kidney Transplant
Candidates. JAMA Network Open. 2019 Aug 2;2(8):e1910312. doi:
10.1001/jamanetworkopen.2019.10312. Erratum in: JAMA Network Open.
2019 Oct 2;2(10):e1914599. PMID: 31469394; PMCID: PMC6724162.
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2. Transplant Program CoPs
We are seeking public comments on the following questions:
1. For patients and their families: Are transplant programs meeting
your specific needs and are you satisfied with the care that you have
received? Specifically, what type of information are you receiving from
your transplant program or transplant surgeon?
2. Do transplant programs adequately protect the health and safety
of living donors and transplant patients? Please provide data,
research, studies, or firsthand accounts that would be illustrative of
how transplant programs are performing with regards to adequately
protecting patient health and safety.
3. How can the current transplant program CoPs be improved in order
to incentivize and ensure performance quality in organ transplantation?
4. Do the initial approval requirements at Sec. 482.80 create
barriers to the establishment of new transplant programs? Do they
require an excessive amount of hospital resources at program launch,
resulting in hospitals retaining lower performing transplant programs?
What alternatives for ensuring quality and oversight should be
considered?
5. We are seeking ways to harmonize policies across the primary HHS
agencies (CMS, the Health Resources and Services Administration (HRSA),
and the Food and Drug Administration (FDA)) that are involved in
regulating stakeholders in the transplant ecosystem so that our
requirements are not duplicative, conflicting, or overly burdensome.
Are there any current requirements for transplant programs, ESRD
facilities, or OPOs that are unnecessarily duplicative of or in
conflict with OPTN policies or policies that are covered by other
government agencies? \8\ What are the impacts of these duplicative
requirements on organ utilization and transplant program/ESRD facility/
OPO quality and efficiency?
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\8\ Organ Procurement and Transplantation Network website.
https://optn.transplant.hrsa.gov/governance/
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6. Are there additional requirements that CMS could implement that
would improve the manner, effectiveness and timeliness of communication
between OPOs, donor hospitals, and transplant programs?
7. Are there additional data, studies, and detailed information on
why the current number of organ discards remains high, despite CMS'
decision to eliminate the requirements for data submission, clinical
experience, and outcome requirements for re-approval?
8. The industry as a whole has acknowledged that changes cannot be
made solely to one part of the transplantation system. Similar to the
outcome requirements that OPOs must meet, should CMS again consider
additional metrics of performance in relation to the organ
transplantation rate, considering that the number of organs discarded
remains high? What should these metrics be? Are there additional
quality measures that CMS should consider to measure a transplant
program's performance? For a meaningful evaluation of transplant
program outcomes from the recipient point of view, please comment on
meaningful outcome measures that should be included in the transplant
outcomes evaluations.
9. In the context of organ shortage and expanded use of marginal,
suboptimal quality organs, and transplantation into
[[Page 68597]]
standard and high-risk recipients, we are seeking public comments from
the recipient perspective and expectations on meaningful measures
including but not limited to graft survival benefit, shorter waiting
list time, frailty improvement and quality of life after transplant,
and other transplant benefits.
10. How can CMS meaningfully measure transplant outcomes without
dis-incentivizing transplantation of marginal organs or dis-
incentivizing performing transplants on higher risk patients?
3. Transplant Recipient Patient Rights
Section 482.102 ``Patient and living donor rights'' provides
specific rights for the patients on the waiting lists and transplant
recipients. However, these enumerated rights do not address
transparency regarding organ offers made for the patient on a
transplant program's waiting list. There is no requirement for the
transplant center or surgeon to notify a patient on the waiting list
that there has been an organ offered for them.
Research has shown that less than 16 percent of deceased donor
kidneys are accepted without being declined at least once.\9\ In
addition, as discussed later in this RFI, there are concerns that
kidneys may be declined for reasons other than organ quality. We
believe that there should be some degree of transparency between the
transplant program or surgeon and the patient on the waiting list.
Although we believe there should be some degree of transparency and
accountability, we want to avoid causing the patient undue anxiety.
Therefore, we are seeking comments on the degree of transparency that
we should require of programs to ensure that transplant patients on the
wait list receive the information they need to make decisions about
their care and ensure that transplant programs and surgeons are
accountable and transparent in their decisions to decline organs.
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\9\ Mohan S, ``Kidney Transplantation: Good intentions and
missed opportunities leave patients behind.'' Centers for Medicare &
Medicaid Grand Rounds. June 13, 2019.
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Specifically, we are seeking public comments on the following
question:
1. How can transplant programs facilitate greater communication
and transparency with patients on their waiting list regarding organ
selection while limiting undue delays or undue anxiety to their
patients?
We are also requesting feedback from individuals who are on a
waiting list or who have received a transplant, their families,
advocates, and caregivers regarding patient education, support, and
information on transplantation. We are interested in understanding how
the CoPs/CfCs, in particular the patient and transplant recipient
rights requirements, could be revised to ensure that transplant
programs, ESRD facilities, and OPOs are providing appropriate education
and information to patients and their families on organ
transplantation. This would ensure that patients, particularly those in
underserved communities, are aware of their ability to access a
lifesaving organ transplant, which will lead to better long-term health
outcomes. While we use the term ``transplant program,'' please include
any communication or information that you have received from other
health care providers such as physicians or hospitals in your
responses.
Specifically, we are seeking public comments on the following
questions:
1. Did the transplant program provide you with information
specific to your unique needs, medical situation, and potential
transplant outcomes?
2. Did the transplant program provide you with any information
about waiting times specific to your type of organ transplant? If
so, what was the waiting time estimate that the transplant program
gave you?
3. Did the transplant program or transplant surgeon provide you
with any information on organ offers that were made for you and were
declined by the transplant program or surgeon? If so, was the reason
for a decline explained to you?
4. What is/was the most helpful information about organ
transplantation you received? From which source did you receive this
information? Did you receive other helpful information from other
sources? If so, what were those sources?
5. Are you satisfied with the communication and support you have
received from your transplant program? What information from your
transplant program did you find helpful in making your decision?
6. For patients who are or were on dialysis, what information
did you receive on organ transplantation from your dialysis center?
Do you believe the dialysis center supported organ transplantation?
Why or why not?
4. Equity in Organ Transplantation and Organ Donation
On January 20 through January 21, 2021, President Biden issued
three executive orders addressing issues of health equity:
Executive Order On Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government (E.O. 13985, 86
FR 7009, January 20, 2021);
Executive Order on Preventing and Combating Discrimination
on the Basis of Gender Identity or Sexual Orientation (E.O. 13988, 86
FR 7023, January 25, 2021); and
Executive Order or Ensuring an Equitable Pandemic Response
and Recovery (E.O. 13995, 86 FR 7193, January 26, 2021).
We are committed to supporting the President's Executive Orders by
``advancing equity for all, including people of color and others who
have been historically underserved, marginalized, and adversely
affected by persistent poverty and inequality''.\10\ Such efforts
extend to ensuring equity within the organ transplantation and donation
system for all populations, including racial and ethnic minorities and
people with disabilities. Organ transplantation and donation in the
United States remains highly inequitable amongst racial and ethnic
minorities as compared to White Americans. As one study notes regarding
kidney transplants, ``racial disparities were observed in access to
referral, transplant evaluation, waitlisting and organ receipt'' and
``SES [socioeconomic status] explained almost one-third of the lower
rate of transplant among black versus white patients, but even after
adjustment for demographic, clinical and SES factors, blacks had a 59
percent lower rate of transplant than whites''.\11\ In addition, Black/
African Americans, Hispanics/Latinos, Asian Americans, and other
minorities are at a higher risk of illnesses that may eventually lead
to kidney failure, such as diabetes and high blood pressure.\12\
``Black/African Americans are almost 4 times more likely and Hispanics
or Latinos are 1.3 times more likely to have kidney failure as compared
to White Americans.'' \13\ Yet those Black/African American and
Hispanic/Latinos patients on dialysis are less likely to be placed on
the transplant waitlist and also have a lower likelihood of
transplantation.\14\ In particular, Black/African Americans make up the
largest group of minorities in need of an organ transplant and yet the
number of organ transplants performed on Black/African Americans
[[Page 68598]]
in 2020 was 28.5 percent of the number of Black/African Americans
currently waiting for a transplant. The number of transplants performed
on White Americans, however, was 40.4 percent of the number currently
waiting.\15\
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\10\ Executive Order on Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government, January 20,
2021.
\11\ Patzer, RE, Perryman, JP et. al. The Role of Race and
Poverty on Steps to Kidney Transplantation in the Southeastern
United States. American Journal Tranplant. https://pubmed.ncbi.nlm.nih.gov/22233181/.
\12\ https://www.kidney.org/atoz/content/minorities-KD, Race,
Ethnicity, & Kidney Disease.
\13\ https://www.kidney.org/atoz/content/minorities-KD. Race,
Ethnicity, & Kidney Disease.
\14\ Social Determinants of Health: Going Beyond the Basics to
Explore Racial Disparities in Kidney Transplantation. https://journals.lww.com/transplantjournal/Fulltext/2020/07000/Social_Determinants_of_Health__Going_Beyond_the.9.aspx. Access.
\15\ Organ Donation and African Americans--The Office of
Minority Health (hhs.gov). Accessed June 10, 2021.
U.S. Transplant Waiting List--Candidates by Race/Ethnicity
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Number of Black percent Number of White percent
Organ All candidates Black of all White of all
candidates candidates candidates candidates
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All Organs...................... 106,666 30,421 28.5 43,054 40.4
Kidney.......................... 90,235 28,365 31.4 32,377 35.9
Liver........................... 11,704 836 7.1 7,865 67.2
Heart........................... 3,531 990 28.0 2,004 56.8
Lung............................ 922 118 11.9 661 66.6
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Transplants Performed in the U.S. by Recipient Ethnicity, 2020
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Percentage of
Number total 2020
transplants
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Black................................... 8,414 21.6
White................................... 20,997 53.8
Total Transplants....................... 39,036 100
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Source: HRSA. U.S. Organ Procurement and Transplantation Network (OPTN).
Based on OPTN data as of August 23, 2021. https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/. Tables
from https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=27.
There are many theories that have been posited as to why these
racial and ethnic inequities in transplantation exist. A person's
social determinants of health (those additional social and economic
factors that are driven by systemic racism and social policies) affect
a wide range of health and quality of life risks and outcomes.\16\
These can therefore be contributing factors that lead to inequities in
transplantation and impact a patient's access to dialysis and placement
on the waitlist. In addition, low health literacy, lack of healthcare
coverage, and lack of economic, environmental, and other social
opportunities can contribute to poorer health outcomes in general.
However, studies have also shown that medical practices can contribute
to inequities in transplantation. Delays in referrals to kidney
transplantation, in particular, may be due ``. . . in part, to
clinicians' implicit or explicit biases, including physician
misperceptions about the benefits of transplants for Black individuals
or discordant and inaccurate beliefs regarding causes or prevalence of
these disparities''.\17\ Another contributing factor to inequities in
transplantation could also be due to the widespread use of the Chronic
Kidney Disease Epidemiology (CKD-EPI) equation used by kidney
transplant programs, which measures kidney function and includes an
adjustment for race (Black/African American) that often under-
identifies chronic kidney disease in Black/African Americans and denies
them equitable appropriate intervention, which in turn could have an
impact on the time a patient waits for a kidney transplant. The use of
race in the calculation of the estimated glomerular filtration rate
(eGFR) has been questioned recently and the OPTN has solicited public
feedback on reassessing the inclusion of race in eGFR equations.\18\
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\16\ https://www.cdc.gov/socialdeterminants/index.htm.
\17\ Systemic Kidney Transplant Inequities for Black
Individuals: Examining the Contribution of Racialized Kidney
Function Estimating Equations [bond] Health Disparities [bond] JAMA
Network Open [bond] JAMA Network. January 14, 2021.
\18\ Reassess Inclusion of Race in Estimated Blomerular
Filtration Rate (eGFR) Equation. https://optn.transplant.hrsa.gov/governance/public-comment/reassess-inclusion-of-race-in-estimated-glomerular-filtration-rate-egfr-equation/.
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In addition, inequity exists for people with disabilities who
similarly need access to organ transplantation. A 2019 National Council
on Disability report found that people with disabilities are frequently
denied equal access to receive organ transplants based solely on their
disability status.\19\ Providers and transplant centers also often
assume that people with disabilities, especially those with
intellectual disabilities, will have worse outcomes after
transplantation. A survey conducted in 2008 of pediatric transplant
centers determined that ``43 percent always or usually consider
intellectual disabilities an absolute or relative contraindication to
transplant due to assumptions about quality of life, concerns regarding
`compliance or long-term self-care' `financial concerns', and `the
functional prognosis of the delay itself' ''.\20\ However, individuals
with disabilities can have equally positive outcomes, and the
disability should have very limited impact on the individual's ability
to adhere to post-transplant care, if they receive adequate
support.\21\ These individuals must be afforded equal access to
transplantation services in accordance with federal civil rights laws,
and the value of their lives are no less than those individuals who are
without disabilities. This inequity exists despite numerous federal and
state prohibitions on discrimination on the basis of race, color,
national origin, and disability.
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\19\ Organ Transplant Discrimination Against People with
Disabilities: Part of the Bioethics and Disability Series, National
Council on Disability, September 25, 2019. https://ncd.gov/publications/2019/bioethics-report-series.
\20\ Organ Transplant Discrimination Against People with
Disabilities: Part of the Bioethics and Disability Series, National
Council on Disability, September 25, 2019. https://ncd.gov/publications/2019/bioethics-report-series.
\21\ Organ Transplant Discrimination Against People with
Disabilities: Part of the Bioethics and Disability Series, National
Council on Disability, September 25, 2019. https://ncd.gov/publications/2019/bioethics-report-series.
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As the discussion on inequity for racial and ethnic minorities and
people with disabilities demonstrates, there remain outstanding issues,
including those that lead to inequities in transplantation. It is
imperative that racial and ethnic minorities as well as those with
disabilities are afforded the same opportunities to receive a life-
[[Page 68599]]
saving organ transplant as their non-disabled, white counterparts.
Further, addressing these issues in transplantation will have
intersectional impacts for individuals that belong to more than one
group.
We acknowledge that this and other critical improvements cannot,
and will not, be achieved only through revisions to the transplant
CoPs, OPO CfCs alone, or the ESRD facility CfCs. Thus, we are asking
the public for specific ideas on advancing equity within the organ
transplantation ecosystem, as they pertain to changes to the health and
safety standards for transplant programs and OPOs. Specifically, we are
seeking public comments on the following questions:
1. Are there revisions that can be made to the transplant
program CoPs or the OPO CfCs to reduce disparities in organ
transplantation?
2. Further, are there ways that transplant programs or OPOs
could or should consider social determinants of health in their
policies, such as those relating to requesting consent for donation,
patient and living donor selection, or patient and living donor
rights? Social determinants of health are those conditions in the
places where people live, learn, work, and play that affect a wide
range of health and quality-of life-risks and outcomes.\22\
Obtaining consent for donation is vital to increasing the number of
organs available for transplantation. However, studies have
demonstrated that African Americans are half as likely as Whites to
agree to donate a loved one's organs.\23\ In addition, studies have
shown a ``lower donation rate among racial/ethnic minorities,
specifically including Blacks, Hispanics, and Asians''.\24\ There
are many factors that contribute to these differences, including
medical mistrust and differing opinions on organ donation and
transplantation. OPOs have a key role in educating the public on
organ donation and reaching out to those in underserved populations
to address concerns or misconceptions regarding organ donation. They
must also obtain consent from families in underserved communities
with cultural sensitivity, awareness, and empathy. In order to
ensure that more organs are available for transplant to those in
underserved populations that need them the most, we are therefore
asking what role CMS can play to ensure that OPOs can better build
trust and awareness in historically underserved populations and
communities (including racial and ethnic minorities).
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\22\ Social Determinants of Health. Know What Affects Health.
https://www.cdc.gov/socialdeterminants/index.htm.
\23\ Goldberg, David, et al. Rejecting Bias: The case against
race adjustment for OPO performance in communities of Color. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1831604/. March 17, 2020.
\24\ Siminoff, Laura, et al. Racial Disparities in Preferences
and Perceptions Regarding Organ Donation. https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.15865. September 21,
2006.
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3. How can those in the transplant ecosystem better educate and
connect with these communities about organ donation, so as to
address the role that institutional mistrust plays in consenting to
organ donation? This would include ways that CMS can hold OPOs
accountable for their outreach and communication to those
underrepresented communities while maintaining cultural competency,
such as awareness of various religious beliefs surrounding organ
donation. Comments should include considerations of how to address
issues pertaining to medical mistrust, disadvantageous social and
economic factors, and the effects of systemic racism and
discrimination on underserved populations.
4. How can the CoPs/CfCs ensure that transplant programs, ESRD
dialysis facilities, and OPOs distribute appropriate information and
educate individuals in underserved communities on organ
transplantation and organ donation?
5. What changes can be made to the current requirements to
ensure that transplant programs ensure equal access to transplants
for individuals with disabilities?
6. What changes can be made to the current requirements to
address implicit or explicit discrimination, such as decisions made
based on faulty assumptions about quality of life and the ability to
perform post-operative care?
B. Kidney Health and End-Stage Renal Disease Facilities
1. Background
On September 29, 2020, we published a final rule entitled,
``Medicare Program; Specialty Care Models To Improve Quality of Care
and Reduce Expenditures'' (85 FR 61114), hereinafter referred to as the
Specialty Care Models final rule. Among other things, the Specialty
Care Models final rule finalized the End-Stage Renal Disease (ESRD)
Treatment Choices (ETC) Model, which is designed to encourage greater
use of home dialysis and kidney transplants for Medicare beneficiaries
with ESRD, while reducing Medicare expenditures and preserving or
enhancing the quality of care furnished to beneficiaries with ESRD. As
described in the Specialty Care Models final rule, both of these
modalities have support among health care providers and patients as
preferable alternatives to in-center hemodialysis, but utilization has
been less than in other developed nations (85 FR 61263).
Interventions that can slow progression of CKD include early
identification of the disease, controlling blood pressure, controlling
blood glucose, reducing albuminuria, eating a healthy diet, and
maintaining a healthy lifestyle. We would like to learn what patient,
clinician and system factors would help patients maintain or improve
their health. We are also interested in knowing various approaches to
identifying those at risk of developing CKD and ways to improve CKD
detection rates. Additionally, we are interested in actions that aim to
close health equity gaps in CKD detection, education and care and would
like to learn about these and other health equity concerns among this
patient population. Feedback on ways to increase interventions and
awareness of health inequities may further improve patient centered
ESRD health and safety CfCs, or may impact future CfCs for health
equity. To that end, we request the public's help in answering the
following questions:
1. How can CMS increase the use of nutritional, lifestyle, and
medical management interventions to improve health care and decrease
the progression of CKD?
2. What are the barriers to access for routine and preventive
health care? To what extent does low health literacy and cultural
and attitudinal beliefs impact access to care?
3. How can we better educate patients about behaviors (such as
diet and exercise) that may affect CKD progression? What is working?
What is not working? How can pre-dialysis education and prevention
programs be improved?
4. How can we increase awareness of known racial, ethnic,
gender, sexual orientation, and economic disparities in care for
CKD?
5. How can primary care providers (PCPs) better support their
patients in prevention and slowing progression of CKD? What can be
done to increase screening of at-risk individuals and how can we
ensure that PCPs provide timely referrals to nephrologists for
individuals with poor or declining kidney function?
6. How can we improve health literacy among the general
population, and individuals at higher risk about the prevention of
CKD?
7. How can individuals facing complete kidney failure be
informed and empowered to make choices about their care?
Transition to dialysis is too often a surprise, with as many as
half of all new dialysis patients having never previously seen a
nephrologist. We are interested in learning about how patients with CKD
receive appropriate information on kidney health and modality options,
including transplantation. Transitional care units are specialized
programs offered by dialysis facilities that provide medical and
psychosocial support during the peridialysis initiation period. The
goal of these units is to improve awareness of all aspects of renal
replacement therapy, including modalities, access, transplantation
options, and nutritional and psychosocial aspects of the disease
enabling patients to make informed decisions regarding their care. In
addition, we would like more information on transitional units.
[[Page 68600]]
1. To improve long-term outcomes and quality of life, how can we
support and promote transplantation prior to the need for dialysis
(preemptive transplantation)?
2. For people beginning dialysis, how can CMS support a safe
transition?
3. Are there concerns regarding the location or quality of care
of the transitional care units?
4. How can these care transitions be equitably provided?
2. Home Dialysis
Under the current CfCs at 42 CFR 494.70(a)(7) the patient has the
right to be informed about all treatment modalities and settings,
including but not limited to, transplantation, home dialysis modalities
(home hemodialysis, intermittent peritoneal dialysis, continuous
ambulatory peritoneal dialysis, continuous cycling peritoneal
dialysis), and in-facility hemodialysis. Once they are stable on a
specific modality, patients are infrequently aware that they are able
to change modalities. In 2018, 72 percent of Black or African-American
patients with ERSD received in-center hemodialysis versus only 57
percent of White patients. This data point may indicate that more White
ESRD patients receive home dialysis than Black or African-American
patients.\25\ We would like information on the following questions:
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\25\ National Kidney Foundation. https://www.kidney.org/news/newsroom/fsindex. Accessed 11/15/2021.
1. What are patient barriers to dialysis modality choice? How
can we overcome barriers to ensure patients understand their options
and have the freedom to choose their treatment modality?
2. What are reasons for differing rates of home dialysis by
race/ethnicity? How can we address any barriers in access to home
dialysis to improve equity in access to home dialysis?
3. With regard to home dialysis, how can CMS ensure adequate
safety standards such as appropriate infection control behaviors and
techniques are enforced?
4. What can CMS do to increase availability and use of home
support resources with regard to home dialysis as described in 42
CFR 494.100(a)((3)(iv)? Given the increase in home dialysis
patients, is there a need to revise the current standards Sec.
494.100, including but not limited to updating and revising training
and care delivery requirements?
5. If more patients choose home dialysis, would there be systems
and infrastructure in place to support this? Were more patients to
choose home dialysis, what other supports, systems or infrastructure
might be necessary?
6. To what degree does telehealth and remote monitoring
technology impact decisions of home dialysis use? Would allowing
physicians to leverage evolving telehealth and remote monitoring
technology for their patients increase the selection of and uptake
of home dialysis as a modality? What are best practices in this area
that would facilitate the delivery of safe and quality care?
3. Dialysis in Alternative Settings
a. Dialysis in Nursing Homes
There are several means by which dialysis services are currently
provided to nursing home residents, including transporting a resident
to a local dialysis facility, dialysis facilities located on the campus
of a nursing home, qualified dialysis facility staff that comes to the
nursing home, or trained nursing home staff that provides dialysis
services. The population of dialysis patients who receive home dialysis
care in nursing homes is small, but it is an especially high-risk
population. Our internal analysis shows that the percentage of dialysis
patients in a nursing home was approximately 17 percent (89,568) in
2018. Most dialysis facilities (93 percent) had at least one patient in
a nursing home. Only a small fraction of these dialysis patients (https://khn.org/news/how-lifesaving-organs-for-transplant-go-missing-in-transit/.
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Recovered organs that are ready for transplant must first be
preserved, packed, stored, and transported to the transplant hospital.
The OPTN has specific policies for the transport of organs including
requirements for packaging, labeling, shipping and storage of organs
and vessels.\27\ Such processes are extremely important in reducing
errors and help ensure that donated organs are matched correctly and
efficiently with the identified recipient. However, there are currently
no specific requirements, such as real-time tracking, for OPOs that
utilize organ transport via common or commercial carriers. An OPO may
choose a transport and tracking method that it believes is most
appropriate based on the particular circumstances; however, these
choices sometimes have resulted in lost opportunities for
transplantation. Therefore, we are asking the public the following
questions:
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\27\ UNOS. https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf.
1. Are there best practices regarding the arrangement of organ
transportation between an OPO and a transplant program?
2. How can the tracking of organs during transport be improved?
Should specific requirements be implemented to facilitate real-time
tracking of organs? What additional factors should be considered to
ensure organs undergoing real-time tracking arrive at their intended
destination timely?
3. Can the OPO CfCs address the issue of organs that are lost
during transport to a transplant program?
4. Are there other ways HHS can incentivize creation or use of
additional mechanisms to reduce the likelihood organs will be lost
or damaged after procurement but before transplantation?
3. Donor Referral Process
Under the OPO CfCs, OPOs are required to have agreements with 95
percent of the Medicare and Medicaid participating hospitals and
critical access hospitals in its DSA that have both a ventilator and an
operating room and have not been granted a waiver by CMS to work with
another OPO. The agreement must describe the responsibilities of both
the OPO and hospital or critical access hospital in regards to organ
donation. Hence, the first step in the organ donation process is for
the donor hospital to timely notify the appropriate OPO of all deaths
and imminent deaths in the hospital (42 CFR 482.45(a)(1)).
The notification and timing of referrals to OPOs is critical to
ensure the identification of potential donors and availability of
organs for transplantation. The failure to make this referral is a
significant reason a potential donor who is medically suitable for
organ donation does not become a donor.\28\ This should be done as soon
as possible to give the OPO time to evaluate the person to determine if
he or she is a potential donor and, if so, obtain consent and begin
managing the potential donor's care to maximize the chances of organ
recovery. CMS does not define ``imminent death'' or ``timely referral''
but requires that these terms be defined in the agreement between the
OPO and the hospital (42 CFR 486.322(a)).
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\28\ Dominguez-Gil, B, et al. The critical pathway for deceased
donation: Reportable uniformity in the approach to deceased
donation. Transplant International. 24 (2011): 373-378.
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Some members of the OPO community have advocated for invasive
mechanical ventilation to be a clinical trigger that would require a
referral to the OPO. Most of the potential donors will be on invasive
mechanical ventilation. A person being assessed for brain death
criteria will be on invasive mechanical ventilation due to their
inability to breathe. In addition, potential donation after cardiac
death (DCD) donors will most likely be on invasive mechanical
ventilation prior to any decision to discontinue life support due to
devastating injuries. If the decision has been made to withdraw life
support, it is critical that the OPO know of these individuals before
invasive mechanical ventilation is withdrawn to give the OPO time to
evaluate the potential donor and obtain consent for donation.
Since CMS does not specifically define ``imminent death'' or
``timely referral,'' it has been suggested that this may result in
variable performance in this requirement due to lack of any national
standards. Some have indicated that reporting timelines vary from
hospital to hospital and the demands of patient care can cause
unintended delays in this process. One recommendation to reduce the
variation in timeliness of reporting is automating real time donor
referral thereby removing the subjective element of identifying
potential organ donors and reducing the variation in timeliness of
reporting.\29\
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\29\ https://unos.org/news/media-resources/5-ways/automate-real-time-donor-referral/.
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CMS is interested in learning more about the capabilities hospitals
and OPOs may currently have for transmitting and receiving automated
referrals. We are particularly interested in the experience of OPOs and
donor hospitals that have successfully piloted or implemented the use
of automated donor referral systems.
1. What specific patient events, clinical triggers, or subsets
of clinical information are used to send notifications to OPOs?
2. Should a patient being placed on invasive mechanical
ventilation, except for a planned medical or surgical procedure, be
one of the triggers for a referral to the OPO? Should these triggers
exclude certain patient populations (for example, should the reason
for placement on invasive mechanical ventilation be considered for a
potential exclusion from the trigger or should the trigger be
automatic for all patients)?
3. Could the referral to the OPO be made by someone other than a
doctor or nurse, such as a respiratory therapist?
4. What is the minimum information necessary to facilitate
notification to the OPO and what additional clinical information, if
any, may also be beneficial?
5. Do donor hospitals that are making electronic referrals
leverage the existing admission, discharge, and transfer elements in
electronic medical record systems to transfer information to OPOs,
and if so, how is this information utilized? We are interested to
learn if there is any standardization in the industry for
transmitting and receiving this information as well as any common
data sets that are currently collected.
6. Are there aspects to donor referral processes or how
referrals are made that help to engender trust or potentially worsen
mistrust among underserved populations, including racial, ethnic,
and religious minorities?
7. Are there clinical decision support protocols or algorithms
that can reduce the cognitive burden and thereby assist clinicians
in identifying potential donor candidates? If so, are there concerns
regarding potential bias in clinical decision support protocols or
algorithms that can introduce or exacerbate inequities, and how can
those biases be addressed?
8. Are there opportunities for OPOs to use electronic health
record (EHR) application program interfaces (APIs) to facilitate key
information transfer between the hospital and OPO?
We welcome comments from staff in the electronic medical record
(EMR) and EHR industries on ways to automate reporting requirements in
a cost-effective manner, as well as how such an approach may be
implemented on a national scale. We would like to better understand
what technical requirements are necessary and how any changes can be
duplicated across hospital EHR systems nationally with minimal burden
to the industry.
Finally, we are also interested in challenges OPOs may have in
gaining access to donor hospital EHRs for organ procurement activities
once referrals are received. Since OPOs have agreements with a large
number of hospitals within its DSA, and timely access to potential
[[Page 68603]]
donor information facilitates donation, we are interested to learn of
any potential barriers to accessing information via EMRs and how CMS
may facilitate better access to information through its requirements.
4. Organ Recovery Facilities
Organs from deceased donors are nearly always recovered in donor
hospitals. However, OPOs have pointed out that there can be numerous
challenges in recovering organs in this setting, and the overall
process of organ procurement is often time consuming and logistically
challenging. Unless an organ(s) is going to be recovered and
transplanted in the same hospital, transplant surgeons must often
travel to the donor hospital to surgically recover the organ(s). This
procedure is complex and time-sensitive, especially for extra-renal
organs. Depending upon the organs intended to be procured from the
donor, multiple teams of recovery surgeons may need to travel to the
donor hospital. Due to competing priorities in a donor hospital, donors
often receive lower priority for operating room time and may experience
delays in special tests, such as echocardiograms, biopsies, or cardiac
catheterizations. These delays may result in increased costs for
procurement of the organ(s) or in not being able to procure organs from
a donor due to medical complications during a protracted timeframe
while on mechanical ventilation. Additionally, OPOs are responsible for
all costs for donor evaluation and medical management once declaration
of death and consent for donation occurs. These costs are reimbursed by
transplant hospitals, other OPOs and Medicare for Medicare
beneficiaries. Donor evaluation and management tasks can include a
range of laboratory, imaging, and diagnostic procedures that OPOs
report they may complete at a fraction of the cost they pay for these
services at donor hospitals.
CMS is aware of at least 10 OPOs that have developed dedicated
facilities to recover organs from donors. These facilities are
independent of the donor hospital location from which the donor was
referred. These facilities do not provide routine medical care but they
may provide a range of services to facilitate donor evaluation and
management and organ recovery. In addition, the only potential donors
who would be transferred to these facilities would have been declared
dead by brain death criteria and the OPO would have already received
appropriate consent for organ donation.
There are few published studies evaluating the effectiveness of
organ recovery facilities.30 31 While these studies
highlight the potential benefits, the practice has not been universally
adopted by OPOs and growth of these facilities is relatively slow.
Federal oversight of tissue collection is provided under the Public
Health Service Act (PHS Act) and FDA regulations on human cells,
tissue, and cellular and tissue-based products, or HCT/Ps (21 CFR part
1271). However, organ recovery facilities are not specifically
addressed in the OPO CfCs and Medicare does not currently compensate
OPOs for some activities associated with operation of these facilities,
such as transportation of the donor to the OPO's facility.
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\30\ Doyle, M., et al. Organ Donor Recovery Performed at an OPO-
Based Facility Is an Effective Way to Minimize Organ Recovery Costs
and Increase Organ Yield.'' Journal of the American College of
Surgeons, April 2016 (Vol. 222, Issue 44, pp. 591-600).
\31\ Marslais, P., et al. The First 2 Years of Activity of a
Specialized Organ Procurement Center: Report of an Innovative
Approach to Improve Organ Donation. American Journal of
Transplantation 2017; 17: 1613-1619.
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CMS is interested in learning about the potential benefits and
concerns for the use of organ recovery facilities in greater detail and
determining whether it would be appropriate or beneficial to establish
specific health and safety requirements that would apply to these
facilities. Specifically, CMS would like to explore aspects related to
the effectiveness, operations, donor families, and impacts to other
stakeholders. Since this is an emerging model of practice, there is
limited information currently available. We are requesting public
comments that provide evidence-based conclusions, such as additional
peer-reviewed literature, that we should consider to inform any future
rulemaking. Additionally, we are requesting that commenters share any
experiences in operating or interacting with staff from OPOs with organ
recovery facilities. Finally, we are particularly interested in the
experience of donor families and patient advocates and seek comments
from these individuals and any organizations representing donor
families. While much of the information reviewed by CMS highlights the
benefits of organ recovery facilities, we are also interested in
learning of specific risks or adverse outcomes associated with these
facilities.
Effectiveness:
1. What benefits and risks may OPOs experience in regards to cost-
effectiveness, organ yield, and organ quality from operating an organ
recovery facility?
2. Are there particular benefits to securing organs from marginal
or extended criteria donors while at an organ recovery facility?
3. Are OPOs able to achieve better placement of these organs
relative to organs recovered at donor hospitals?
Operations:
1. What medical evaluation diagnostic procedures are commonly
performed in these organ recovery facilities?
2. What special equipment needs, such as laboratory and imaging,
are necessary?
3. What supplies, such as pharmaceuticals, should be considered?
4. Which professional staff are needed and what are their
qualifications for operating an organ recovery facility?
5. What specific risks may be associated with operating a facility
for the recovery of organs outside a donor hospital?
6. What state or local requirements apply to the currently existing
facilities, including health and safety and fire?
Impacts on other stakeholders:
1. Are there any negative impacts or disincentives to donor
hospitals or transplant centers?
2. How does having an organ recovery facility impact tissue
recovery and the relationships with tissue banks in the DSA? \32\
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\32\ Establishments that manufacture human cells, tissues, and
cellular and tissue-based products (HCT/Ps) regulated solely under
section 361 of the PHS Act are commonly referred to as ``tissue
establishments'' within FDA terminology but are commonly referred to
as ``tissue banks'' within the CMS regulations.
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Impacts on Donor Families:
1. Were you satisfied with the request for donation discussion by
the OPO representative and how did this affection your decision for
donation?
2. How does organ donation at organ recovery facilities impact
donor families?
3. Does the process for transfer to organ recovery facility make
the process more difficult for the donor family if the facility is
remote from the donor hospital? How are distance challenges addressed
to ensure family involvement in the donation process?
4. What are the reasons why donor families reject transfer from the
donor hospital to an organ recovery facility? If you have personal
experience with this issue, what reasons led you and your family to the
decision to reject transfer?
5. Have there been any studies specifically focused on evaluating
donor family satisfaction when utilizing an OPO operated organ recovery
facility versus traditional organ recovery in donor hospitals?
[[Page 68604]]
6. What aspects do donor families find particularly beneficial and
which are challenging for them?
5. ``Zero Organ Donors'' and Discarded Organs
In response to our recent rulemaking (85 FR 77898), some commenters
raised concerns about the new definition of ``donor,'' which excludes
``zero organ donors.'' While there is no commonly accepted definition
of a ``zero organ donor,'' it is generally interpreted to mean a
situation where the donation process was initiated but no organ was
transplanted. Our internal analysis during this rulemaking indicated
that in 2018, there were 1,255 organs procured from 593 ``zero organ
donors,'' but never transplanted. Commenters claimed that excluding
``zero organ donors'' from the donation rate may discourage OPOs from
pursuing extended criteria or marginal and complex donors, which is
inconsistent with our goal of increasing organ donation.
More recent data indicates that the number of ``zero organ donors''
is increasing significantly. A recent internal analysis indicates that
``zero organ donors'' increased by 31 percent between 2019 and 2020
(746 to 977) and 76 percent from 2017 through 2020 (555 to 977). In
2017, these donors represented 5 percent (555) of all deceased donors
and 25 percent (1,215) of all discarded organs. In 2020, ``zero organ
donors'' increased to 8 percent (977) of all deceased donors and 31
percent (2,051) of all discarded organs. During the past decade, the
rate of ``zero organ donors'' ranged from a low of 5.3 percent to a
high of 8.5 percent in 2020 with an average annual rate of 6.0 percent.
In addition to ``zero organ donors'' where no organs from a donor
are transplanted, there are many donors that have organs recovered and
transplanted while other organs from the same donor are discarded. The
number of all organ discards (including organs from zero organ donors)
has increased steadily over the past 15 years. There were 3,553
discarded organs (including kidney, liver, heart, pancreas, lung, and
intestine) in 2005, 3,878 discarded organs in 2010 (increase of 9.1
percent), 4,439 discarded organs in 2015 (increase of 14.5 percent),
and 6,512 discarded organs in 2020 (increase of 31.8 percent). Overall,
there were a total of 71,335 discarded organs in the 16-year period
inclusive of the years 2005 to 2020. The rate of organ discards
increased from 10.5 percent to 13.4 percent during this same period
highlighting the increased frequency of discarding organs.
Historically, kidney discards represent the largest number of discarded
organs accounting for 77.6 percent (5,051) of all organ discards in
2020 despite over 91,000 candidates registered on the waitlist for a
kidney transplant.\33\ The Scientific Registry of Transplant Recipients
(SRTR) data indicate that many organs that are not recovered or are
discarded are a result of failure to locate a recipient for the organs.
Additionally, many of these organs have a disposition reason code of
``other'' despite a range of options for categorizing the organs.\34\
While there may be many medically appropriate reasons for organ
discards or non-recovery, such as infection, organ trauma, poor organ
function and anatomical abnormalities, we are concerned with the
increasing number of organs that go unused and are subsequently
discarded. We are interested in ways to better understand and identify
these issues and incentivize a reduction in these numbers through
policy options.
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\33\ OPTN National Data. Accessed 2/18/2021.
\34\ SRTR/OPTN 2018 Annual Data Report; Deceased Organ Donors:
https://srtr.transplant.hrsa.gov/annual_reports/2018/DOD.aspx.
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The elimination of outcome measures for recertification of
transplant programs was intended to eliminate provider disincentives
for performing transplantations, improve organ procurement for
transplantation, and increase organ utilization through increased
acceptance of organs that previously may have been declined. Since the
change in the transplant program outcome measures was only implemented
in 2019, we only have 1 year of data to assess at this time. However,
data from 2020 demonstrates a continued increase in the number of
``zero organ donors'' and discarded organs suggesting the policy change
may not be achieving the desired outcome indicating other factors may
be impacting placement of organs. While we acknowledge the complexity
that is involved in the placement of organs, we are seeking information
on additional factors to consider and methods that may facilitate
improvements in this area through OPO and transplant center
collaboration.
Recent research indicates that factors beyond organ quality impact
acceptance behavior by transplant centers. These factors may include
donor characteristics, geographic area, characteristics of the organ
donation-transplantation environment within a DSA, and timing such as
interruptions caused by weekends and holidays.\35\ This often results
in missed opportunities for many patients on the waitlist and
frequently leads to organ discards. Some of these organs are initially
rejected only to later be accepted at other centers and successfully
transplanted in patients lower on the waitlist. Recent studies have
found that many kidneys that were discarded had similar or better
quality characteristics to those that had been successfully
transplanted.36 37 Additionally, candidates for
transplantation are frequently not aware of organs being declined on
their behalf and may not be informed of the reason for the decline.
Center-level organ acceptance practices eliminate a patient-centered
approach to involvement in decision making on the advantages and
disadvantages to organ acceptance versus continuation of existing care
while remaining on a waitlist.\38\ This may result in significant
negative quality of life impacts for potential organ recipients, and
even death, while waiting for a better organ after many potentially
acceptable offers were declined on behalf of the patient. The net
effect is the discard of lifesaving organs, frequently without
potential recipient involvement in the decision-making process, while
there is a shortage of organs for over 106,000 individuals.\39\
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\35\ Mohan S, Foley K, Chiles MC, Dube GK, Patzer RE, Pastan SO,
Crew RJ, Cohen DJ, Ratner LE. The weekend effect alters the
procurement and discard rates of deceased donor kidneys in the
United States. Kidney Int. 2016 Jul; 90(1):157-63. doi: 10.1016/
j.kint.2016.03.007. Epub 2016 May 12. PMID: 27182001; PMCID:
PMC4912390.
\36\ Aubert O, Reese PP, Audry B, Bouatou Y, Raynaud M,
Viglietti D, Legendre C, Glotz D, Empana JP, Jouven X, Lefaucheur C,
Jacqueline C. Loupy A. Disparities in Acceptance of Deceased Donor
Kidneys Between the United States and France and Estimated Effects
of Increased US Acceptance. JAMA Intern Med. 2019 Aug
26;179(10):1365-74. doi: 10.1001/jamainternmed.2019.2322. Epub ahead
of print. PMID: 31449299; PMCID: PMC6714020.
\37\ Mohan S, Chiles MC, Patzer RE, Pastan SO, Husain SA,
Carpenter DJ, Dube GK, Crew RJ, Ratner LE, Cohen DJ. Factors leading
to the discard of deceased donor kidneys in the United States.
Kidney Int. 2018 Jul;94(1):187-198. doi: 10.1016/j.kint.2018.02.016.
Epub 2018 May 5. PMID: 29735310; PMCID: PMC6015528.
\38\ Husain SA, King KL, Pastan S, Patzer RE, Cohen DJ,
Radhakrishnan J, Mohan S. Association Between Declined Offers of
Deceased Donor Kidney Allograft and Outcomes in Kidney Transplant
Candidates. JAMA Network Open. 2019 Aug 2;2(8):e1910312. doi:
10.1001/jamanetworkopen.2019.10312. Erratum in: JAMA Netw Open. 2019
Oct 2;2(10):e1914599. PMID: 31469394; PMCID: PMC6724162.
\39\ Organ Procurement and Transplantation Network (OPTN)
website. Accessed 10/27/2021.
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Given the impact from reducing the number of organ discards, CMS is
interested in exploring policy options that may assist in this effort.
We are seeking information that we can act upon to strengthen
requirements as well
[[Page 68605]]
as information where additional burden reduction may facilitate
improvement. We are seeking input on areas where our policies may
create additional burdens or conflict with policies of the OPTN. We are
particularly interested in ways to facilitate better communication and
collaboration between OPOs and transplant centers and how this
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information can be incorporated into our requirements.
1. How has the sharing of information on organ offer and
acceptance data impacted practice, including information on root
causes for failure to place organs as well as organs that were
declined but later successfully transplanted at another center?
2. What is the impact to these types of information sharing in
practice, and if they have been productive, how can CMS build
requirements around OPO--transplant center collaboration to support
best practices in reducing the number of organ discards?
3. Should this type of collaboration between OPOs and transplant
programs be incorporated into quality assurance performance
improvement (QAPI) requirements for OPOs and transplant centers?
There are many quality improvement tools and initiatives available
to OPOs and transplant centers through the OPTN, and potentially within
the industry itself that may foster improvements in reducing the number
of ``zero organ donors'' and organ discards. OPOs and transplant
programs that do not take full advantage of the resources available to
improve performance may continue to unnecessarily waste these
lifesaving organs.
Patient rights and patient-centered care are a vitally important
aspect of organ donation and transplantation. Ensuring individuals have
the information needed to make informed decisions about their care is
essential and transparency is an important component of this process.
We believe that patients and their families should have increased
awareness of practices at OPOs and transplant centers. OPOs that have a
high discard rate and transplant centers that have a high rate of
declining organs are a concern in that many potentially life-savings
organs are wasted and patients are at greater risk for dying while
waiting for a transplant.
1. We are interested in ways information on organ discard rates
and organ acceptance practices can become more available and whether
CMS should track and evaluate this information more closely and
consider it for recertification purposes.
2. We are also interested in ways in which it may be possible to
determine an ``acceptable'' baseline rate of organ discards based on
medically disqualifying factors and how this should be assessed.
6. Donation After Cardiac Death (DCD)
In the May 31, 2006 final rule entitled, ``Conditions for Coverage
for Organ Procurement Organizations (OPOs)'' (71 FR 30982), we noted
that commenters expressed concern that we did not include specific
requirements related to Donation after Cardiac Death (DCD) (71 FR
30985). In this rulemaking, our intention was not to avoid addressing
the issue of DCD, nor did we specifically encourage OPOs to recover
organs from cardiac death donors. Rather, we stated that we believed
DCD donation was addressed in three separate sections of the CFCs,
specifically 42 CFR 486.322, Relationships with hospitals, critical
access hospitals, and tissue banks; Sec. 486.324, Administration and
governing body; and Sec. 486.344, Evaluation and management of
potential donors and organ replacement and recovery. Therefore, we
finalized the requirements to facilitate our oversight of donation
after cardiac death and not disadvantage OPOs that did not pursue these
donors. We indicated that we understood donation after cardiac death
was an evolving practice and was not yet accepted in every area of the
country. Some donor hospitals were reluctant to permit donation after
cardiac death in their facilities and some transplant surgeons were
unwilling to transplant organs from such donors into their patients.
Thus, some OPOs were hesitant to advocate donation after cardiac death
in their service areas.
CMS is interested in better understanding both the successes and
the challenges that OPOs face in implementing DCD organ donation. We
are interested in learning whether and to what extent the clinical,
scientific, and general environment for DCD donation has changed in
recent years and if commenters have specific recommendations in regards
to policy options related to DCD donation that may be beneficial.
1. What has contributed to the recent rapid increase in DCD
organ donation?
2. What challenges do OPOs face from stakeholders regarding DCD
donation and how have some OPOs overcome these challenges?
3. How are OPOs sharing information related to best practices in
DCD donation and what barriers limit progress in this area?
4. Are there ways to better align the CfCs with the current
environment for DCD donation?
5. How well do the CfCs complement requirements from the OPTN
related to DCD donation?
6. Are there requirements that CMS should establish that may
facilitate greater acceptance of DCD donation while ensuring patient
rights and protections?
7. OPO Tissue Banking Activity and Relationships With Other Tissue
Banking Organizations
CMS is interested in exploring the relationship between hospitals,
OPOs, and tissue banks and how these relationships may have evolved
over time, particularly since publication of the OPO final rule in
2006. Currently, hospitals are required to have an agreement with at
least one tissue bank and at least one eye bank to cooperate in the
retrieval, processing, preservation, storage and distribution of
tissues and eyes, to assure that all usable tissues and eyes are
obtained from potential donors provided these activities do not
interfere with organ donation.
Additionally, regulations at Sec. 486.322(c) require that OPOs
have arrangements to cooperate with tissue banks that have agreements
with hospitals and critical access hospitals with which the OPO has
agreements. These regulations include cooperating on a range of
potential activities to ensure that all usable tissues are obtained
from potential donors. These activities may include screening and
referrals; obtaining informed consent; managing tissue retrieval,
processing, preservation, storage, and distribution; and providing
designated requestor training. CMS does not regulate tissue banks, also
known as tissue establishments. Instead, oversight over such
establishments is primarily provided by FDA.
In drafting requirements for OPOs with respect to such agreements
with tissue banks, in 2006, CMS considered three factors including (1)
an OPO's role as the agency that receives most referrals of deaths and
imminent deaths from the hospitals in its service area (unless
referrals are screened by a third-party designated by the OPO); (2) the
need to show sensitivity toward the circumstances of potential organ
and tissue donor families (such as ensuring that potential donor
families are not approached by more than one agency unnecessarily); and
(3) the statutory requirement that an OPO have arrangements to
cooperate with tissue banks to assure that all useable tissues are
obtained. The CfCs were intended to ensure OPOs maintain a
collaborative relationship with tissue banks in their area but OPOs are
only required to have agreements with those tissue banks that have
agreements with hospitals in their DSA.
We noted in our 2006 final rule ``Medicare and Medicaid Programs;
[[Page 68606]]
Conditions for Coverage for Organ Procurement Organizations (OPOs)''
(71 FR 31007), that many OPOs were beginning to establish tissue
banking services. We seek input on the changes that have occurred since
then to better understand how this service has evolved and if changes
to the existing requirements are necessary.
1. To what level have OPOs developed their own tissue banks and
is this currently standard practice across OPOs?
2. How has the increase in OPOs participating in tissue banking
impacted the collection of useable tissues from donors?
3. Are there areas for improvement in the relationship between
OPOs, hospitals, and tissue banks that would facilitate increasing
the collection of useable tissue?
4. For OPOs that do have active tissue banks, how does this
service impact or intersect with the OPOs primary mission of
recovering and distributing organs?
8. Organs for Research
While the primary mission of an OPO is to maximize the number of
viable organs it recovers for transplantation, OPOs also serve a role
in providing organs to the research community. Currently, OPOs are
assessed on both these aspects of organ donation as a requirement of
the outcome measures at Sec. 486.318. During recent rulemaking
revising these measures (85 FR 77898), CMS eliminated the assessment of
organs for research focusing the measures on the primary mission of
OPOs in providing organs for transplantation. This change is scheduled
to be implemented during the next OPO certification period beginning in
2022. The one exception to this change was the inclusion of pancreata
procured for islet cell transplantation or research that was included
in the outcome measures in order to comply with the Pancreatic Islet
Cell Transplantation Act of 2004. While this recent rulemaking
accomplished our goal of developing more transparent, reliable, and
objective outcome measures that will drive higher performance, it also
leaves some areas that CMS may consider in future rulemaking.
Specifically, CMS is interested in exploring the need for continued
support for obtaining organs for research as well as possible
alternative approaches to address the requirements of the Pancreatic
Islet Cell Transplantation Act. Additionally, we are seeking
information on approaches that align with our efforts to have
transparent, reliable, and easily verifiable information while
minimizing burdens associated with any potential future changes.
Providing organs for research is an important aspect for assisting
researchers in discovering new treatments for debilitating and fatal
diseases. The Department of Health & Human Services defines research at
45 CFR 46.102(l). For our purpose of assessing OPO performance, we
consider three categories of organs including: organs transplanted into
patients with no research interventions (conventional transplants);
organs that have had a research intervention that are transplanted into
patients; and organs used exclusively for research purposes. In recent
rulemaking (85 FR 77902), we indicated the transplant and research
communities commonly described the transplantation of organs into
humans using research protocols (for example, deceased donor
intervention research) as both transplants and research. Generally,
such research involves the transplantation of organs into transplant
candidates that is generally considered clinical care while
simultaneously qualifying as human subject research. Therefore, in
establishing the new OPO performance measures, we consider organs used
for research as applying to organs procured and used only for research
purposes whereas organs transplanted into human subjects are counted as
part of clinical care and included in the outcome measures. For
example, in regards to assessing OPO performance in providing organs
for research purposes as relating to organs that have been manipulated
for research purposes but are not transplanted into a human recipient.
This interpretation, used only for assessing OPOs on performance
outcome measures, provides a level of demarcation for counting organs
transplanted into human subjects (including those as part of a research
protocol) versus those that are utilized strictly for research
purposes, and aligns with our assessment of an OPO's primary mission
with data that is independently verifiable. As previously noted,
pancreata procured for research are also counted in the performance
measures based on statutory requirement.
Given the importance of research to continued innovation in
transplant medicine, CMS is interested in exploring the issue of
incentivizing the placement of organs with researchers without
detracting from the OPOs primary mission of providing organs for
transplantation.
1. We are interested to know if there are currently sufficient
incentives to provide organs for research absent a metric or process
measure for this purpose. If an incentive is needed in this area,
how should OPOs be assessed on this aspect of its operations?
2. Data on organs submitted for research is self-reported by
OPOs and there is currently no method to independently verify this
information on a regular basis limiting utility in annual
performance measures. Are there other methods CMS should consider
that would be effective?
3. How can CMS implement an approach that both incentivizes OPOs
and is not excessively burdensome through enforcement?
4. Given the decline in islet transplantation research, are
there other methods CMS should consider to assess pancreata procured
for islet transplantation and research that can be used for
certification and recertification purposes?
9. Vascular Composite Allografts
The use of vascular composite allografts (VCAs) is an evolving area
of practice that involves the transplantation of multiple tissue types
that may include skin, bone, muscles, blood vessels, nerves, and
connective tissue. It includes body structures such as a face, limb
(for example, arms, hands, fingers, legs, toes), bone, soft tissue (for
example, larynges and abdominal wall), and/or reproductive organs.
According to data from the OPTN, there have been approximately 110 VCA
transplantations in the United States. While VCA transplantations are
relatively infrequent and the goals of surgery are restorative and
life-enhancing, versus lifesaving, they can provide profound quality of
life benefits for the recipient. FDA regulates human cells, tissues,
and cellular and tissue-based products (HCT/Ps) under 21 CFR part 1271.
Prior to 2014, VCAs were not explicitly excluded from the definition of
HCT/Ps under FDA's regulations and therefore were subject to FDA
oversight, while HRSA regulated vascularized human organs through the
OPTN, which sets policies related to the procurement, transplantation,
and allocation of human organs, at regulations under 42 CFR part 121
(the ``OPTN final rule''). In enacting the National Organ Transplant
Act (NOTA) in 1984, the Congress gave the Secretary the authority to
expand the definition of organ in regulation. Prior to 2013, VCAs were
not included in the definition of organ and the classification of VCAs
as HCT/Ps previously excluded them from regulation by HRSA. However, in
2013 the Secretary changed the definition of ``organ'' in the OPTN
final rule to include VCAs shifting oversight responsibilities to HRSA
(78 FR 40033, July 3, 2013). By including VCAs within the OPTN final
rule's definition of ``organs'', transplants involving VCA are subject
to the requirements of the OPTN final rule and explicitly excluded from
the definition of HCT/Ps under FDA
[[Page 68607]]
regulations. This change became effective on July 3, 2014. The rule
established specific criteria for body parts to qualify as VCAs.
In establishing the regulatory requirements for the oversight of
VCAs through the OPTN, HRSA requires the body part to have specific
characteristics to be considered a VCA. The characteristics include a
body part that is: (1) Vascularized and requires blood flow by surgical
connection of blood vessels to function after transplantation; (2)
containing multiple tissue types; (3) recovered from a human donor as
an anatomical/structural unit; (4) transplanted into a human recipient
as an anatomical/structural unit; (5) minimally manipulated (that is,
processing that does not alter the original relevant characteristics of
the organ relating to the organ's utility for reconstruction, repair,
or replacement; (6) for homologous use (the replacement or
supplementation of a recipient's organ with an organ that performs the
same basic function or functions in the recipient as in the donor; (7)
not combined with another article such as a device; (8) susceptible to
ischemia and, therefore, only stored temporarily and not cryopreserved;
and (9) susceptible to allograft rejection, generally requiring
immunosuppression that may increase infectious disease risk to the
recipient.
Despite the change in the definition of organ by HRSA, CMS has not
made changes to its definition of ``organ'' in oversight of solid organ
transplantation through the CoPs at 42 CFR part 482 subpart E. However,
we are seeking comment on whether or not we should revise its
definition of organ to correspond to that of HRSA. We seek comment on
ways to support this evolving area of practice while providing
necessary health and safety oversight for transplant recipients.
1. CMS would like to determine if it is equitable to count VCAs
as organs for OPO performance measures. Would certain OPOs be
disproportionately advantaged or disadvantaged from such a change?
2. Given the low volume of VCA transplantation, should CMS
establish specific survey and certification requirements for centers
that transplant VCAs? If so, what health and safety aspects specific
to VCA transplantation should be considered?
D. Nephrology Joint Ventures
The Medicare Payment Advisory Commission (MedPAC) has stated that
many dialysis facilities are operated as a joint venture between a
dialysis organization and physicians. Joint ventures allow
participating partners to share in the management, profits, and losses
of an entity.\40\ MedPAC has noted concerns raised in the literature
that joint ventures between dialysis organizations and physicians
create financial incentives for participating physicians that could
inappropriately influence decisions about patient.\41\
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\40\ March 2021 Report to the Congress: Medicare Payment Policy
https://www.medpac.gov/document/http-www-medpac-gov-docs-default-source-reports-mar18_medpac_entirereport_sec_rev_0518-pdf/ (cut and
paste into browser, page 205).
\41\ MedPAC 2021 report citing Berns, J.S., A. Glickman, and
M.S. McCoy. 2018. Dialysis facility joint-venture ownership--Hidden
conflicts of interest. New England Journal of Medicine 379, no. 14
(October 4): 1295-1297.
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The health care industry is increasingly interested in identifying
Medicare-enrolled providers and suppliers and their associations with
other health care groups/organizations. CMS has been working on
improving provider and supplier enrollment transparency by making data
available for use by the healthcare community for research and to
increase awareness in the provider and supplier community about
enrollment information on file with CMS.42 43 Recently, CMS
has received requests from the research community for data to study the
business practices of dialysis facilities and the effect of joint
ventures between nephrologists and dialysis facilities. These
researchers have reported difficulty in performing the research due to
the lack of information on these financial arrangements collected by
CMS.
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\42\ Medicare Fee-For-Service Public Provider Enrollment.
https://data.cms.gov/provider-characteristics/medicare-provider-supplier-enrollment/medicare-fee-for-service-public-provider-enrollment.
\43\ Public Provider and Supplier Enrollment Files. https://www.cms.gov/newsroom/fact-sheets/public-provider-and-supplier-enrollment-files.
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When a provider enrolls in Medicare, CMS collects information that
is self-reported by the provider on individuals and organizations with
5 percent or greater direct or indirect ownership of, a partnership
interest in, and/or managing control of the provider.\44\ Institutional
providers, such as dialysis facilities, may self-report whether their
affiliation with a Chain Home Office is a joint-venture or partnership
on their enrollment application.
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\44\ Medicare Enrollment Application. Institutional Providers.
https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/cms855a.pdf.
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In addition to efforts to increase transparency of Medicare
enrollment information and in order to learn more about the impact of
nephrology joint ventures for the purpose of these efforts, CMS is
seeking information on the following questions:
1. Would it be helpful for CMS to collect information on joint
venture arrangements as part of Medicare enrollment in order to
support analysis of the impact of these arrangements on the quality
of care furnished to Medicare beneficiaries?
2. Should a dialysis facility or nephrologist be required to
disclose information on joint venture arrangements to patients for
improved transparency?
3. Do joint ventures between nephrologists and dialysis
facilities have an impact on resource use, patient care, and/or
choice of modality? If so, please describe how joint venture
arrangements affect resource use, patient care, or choice of
modality.
III. Collection of Information Requirements
This is a request for information (RFI) only. In accordance with
the implementing regulations of the Paperwork Reduction Act of 1995
(PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is
exempt from the PRA. Facts or opinions submitted in response to general
solicitations of comments from the public, published in the Federal
Register or other publications, regardless of the form or format
thereof, provided that no person is required to supply specific
information pertaining to the commenter, other than that necessary for
self-identification, as a condition of the agency's full consideration,
are not generally considered information collections and therefore not
subject to the PRA.
This RFI is issued solely for information and planning purposes; it
does not constitute a Request for Proposal (RFP), applications,
proposal abstracts, or quotations. This RFI does not commit the United
States Government to contract for any supplies or services or make a
grant award. Further, we are not seeking proposals through this RFI and
will not accept unsolicited proposals. Responders are advised that the
United States Government will not pay for any information or
administrative costs incurred in response to this RFI; all costs
associated with responding to this RFI will be solely at the interested
party's expense. We note that not responding to this RFI does not
preclude participation in any future procurement, if conducted. It is
the responsibility of the potential responders to monitor this RFI
announcement for additional information pertaining to this request. In
addition, we note that CMS will not respond to questions about the
policy issues raised in this RFI.
We will consider all input as we develop future regulatory
proposals or future subregulatory policy guidance.
[[Page 68608]]
We may or may not choose to contact individual responders. Such
communications would be for the sole purpose of clarifying statements
in the responders' written responses. Contractor support personnel may
be used to review responses to this RFI. Responses to this RFI are not
offers and cannot be accepted by the Government to form a binding
contract or issue a grant. Information obtained as a result of this RFI
may be used by the Government for program planning on a non-attribution
basis. Respondents should not include any information that might be
considered proprietary or confidential. This RFI should not be
construed as a commitment or authorization to incur costs for which
reimbursement would be required or sought. All submissions become
United States Government property and will not be returned. In
addition, we may publicly post the public comments received, or a
summary of those public comments.
I, Chiquita Brooks-LaSure, Administrator of the Centers for
Medicare & Medicaid Services, approved this document on August 4, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-26146 Filed 12-1-21; 4:15 pm]
BILLING CODE 4120-01-P
