Request for Information; Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities, 68594-68608 [2021-26146]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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 https://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: https://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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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:
---------------------------------------------------------------------------

    \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 (<1 
percent) appear to receive dialysis treatment in a nursing home setting 
annually. There are no limitations to the number of agreements a 
dialysis facility may have with nursing homes to provide home dialysis 
services. We have received reports where some nursing homes are over 
100 miles away or across the state from the dialysis facility where the 
agreement to provide care exists. We are concerned that this poses 
concerns for oversight of the dialysis care and services in providing 
timely support services and patient assessments as well as necessary 
equipment & supplies. We must ensure that these patients are receiving 
safe and appropriate dialysis care. We seek answers to the following 
questions:

    1. Should dialysis facilities have geographical limitations for 
distance between the certified dialysis facility and nursing homes 
where they provide home dialysis services? Would health and safety 
issues be mitigated if there were some type of geographical 
limitation? Are there areas where placing a geographical limitation 
could create access issues where there are no dialysis facilities 
near the nursing home? If so, why, and how could these issues be 
mitigated?
    2. Should there be a limit to the number of agreements that a 
given dialysis facility can have to provide home dialysis services 
in nursing homes? Why or why not?
    3. Should CMS enhance protections for dialysis in institutional 
settings in the CfCs, such as including a written agreement to 
outline the roles and responsibilities of the dialysis facility and 
nursing home when home dialysis services are provided to residents, 
have protections for residents incapable of self-care, including 
clarifying staff roles, responsibilities, safety, and supervision 
when the home dialysis services are not administered by the dialysis 
facility staff?
b. Alternative Types of Dialysis Treatment Facilities Including Mobile 
Dialysis
    We are also seeking information on the potential certification and 
safe use of alternate types of facilities that can provide dialysis 
treatments outside of an individual's home or resident care facility, 
such as mobile units. Mobile dialysis units are not currently defined 
or certified by CMS.

    1. Should the use of mobile dialysis be limited to emergency 
circumstances and enrollment as a Special Purpose Renal Dialysis 
Facility?
    2. How can mobile dialysis be used? Should these units be 
independently certified or used as an extension to an existing 
facility if approved outside of emergency circumstances?
    3. What are the oversight considerations of these mobile 
dialysis units if units do not have a brick and mortar location and 
are moving among various locations? If used outside of an emergency 
circumstance, should there be geographical limitations?
    4. Should mobile units have separate/different physical 
environment requirements compared to a brick and mortar building?
    5. What health and safety standards are necessary to ensure a 
safe physical environment in mobile units?
    6. What are the concerns related to equipment handling and 
maintenance related to mobile units that are different from brick 
and mortar facilities?
    7. How can CMS ensure appropriate staffing roles, 
responsibilities and oversight of patient's dialysis care and needs 
by interdisciplinary team members for mobile units? Would these 
units require different staffing mix or requirements than a 
stationary dialysis unit?
    8. What other alternative types of dialysis treatment facilities 
should we consider?
    9. What should be the appropriate use of alternative types of 
facilities, such as only for emergency situations?
    10. How should CMS certify these alternative types of 
facilities?
    11. Are these facilities able to meet current patient safety and 
equipment standards?
    12. Given the importance of water quality for dialysis, how do 
we ensure safe water standards with facilities that do not have 
water treatment centers?
    13. Do patients in Medicare Advantage plans have a choice 
whether or not to dialyze at one of these alternative facilities?
    14. What kind of emergency plans would be appropriate for mobile 
units or other alternative settings?
c. Alternate Models of Care
    We have received significant public interest and questions related 
to staff-assisted home dialysis, which is not a separately paid 
service, but is covered as part of the ESRD Prospective Payment System 
(PPS) bundled

[[Page 68601]]

payment. A dialysis facility may provide qualified staff members in the 
patient's home to assist them in performing their home dialysis 
treatments as long as the facility provides Home Training and Support 
services specified at (42 CFR 494.100(a)). The dialysis staff member 
functions in the role of the patient's caregiver and monitors the 
patient throughout the dialysis treatment. The dialysis facility 
maintains overall responsibility and oversight to ensure appropriate, 
qualified staff are assigned and trained and provides supervision of 
staff members as indicated. Employees performing staff assisted 
dialysis must meet the personnel qualification requirements at Sec.  
494.140. In addition, staff who provide staff-assisted home dialysis 
must meet any state scope of practice requirements and any other 
applicable state laws.

    1. Should there be two sets of guidelines for staff-assisted 
home dialysis in residential homes and staff-assisted home dialysis 
in alternative settings; and if so, how should they differ?
    2. What factors should be taken into consideration for 
establishing different guidelines?

C. Organ Procurement Organizations (OPOs)

1. OPO Assessment and Recertification and Competition
    CMS recently revised the OPO performance metrics that will be 
implemented in the 2022 through 2026 recertification cycle (85 FR 
77898). The changes were made to improve upon the current measures by 
using objective and reliable data that will incentivize OPOs to ensure 
all viable organs are transplanted, apply greater oversight to OPOs 
while driving higher performance, and as a result, save more lives. We 
implemented a tiered approach based on thresholds set prior to the 
performance period using a previous year's data, while also using a 
median rate for assessing OPOs. We will assign OPOs to tiers based on 
whether performance exceeded these thresholds. OPOs assigned to tier 1 
are those OPOs with performance rates for both measures (donation rate 
and transplantation rate) that are not statistically below the lowest 
rates among the highest 25 percent of all OPOs. These OPOs are 
automatically recertified after successfully complying with the 
remaining Conditions for Coverage and can compete for other open areas 
(provided they meet all other requirements). OPOs assigned to tier 2 
are those whose performance for both measures statistically meet or 
exceed the median rates for all OPOs but do not meet tier 1 
requirements for both measures. The designated service areas (DSAs) for 
these OPOs will be opened for competition and these OPOs must compete 
to retain their DSA. Additionally, these OPOs can compete for other 
open areas (provided they meet all other requirements). OPOs assigned 
to tier 3 are OPOs whose performance rate for either measure is 
statistically below the respective median rate for all OPOs. These OPOs 
will be decertified and their areas opened for competition. If no OPO 
applies to compete for the area, CMS may select a single OPO to take 
over the entire open area or may adjust the service area boundaries of 
two or more contiguous OPOs to incorporate the open area.
    Although we believe our new assessment approach will incentivize 
OPO performance, resulting in clustering of rates close to the highest 
performers, eventually the margin between the top 25 percent and the 
median will begin to narrow. Once OPO performance on the outcome 
measures reaches this level, CMS will need to consider other factors 
that differentiate highly functioning OPOs from those that are less 
highly functioning. We are interested in exploring what factors CMS may 
consider in this regard and ways to measure performance in these areas.

    1. Independent of CMS' specific outcome measures, what other 
metrics or attributes reflect a model or highest performing OPO?
    2. What are quantitative or qualitative indicators of excellent 
performance and how can CMS incorporate these with outcome measures 
when assessing OPOs for recertification purposes?
    3. Should CMS consider additional metrics, such as those that 
measure equity in organ donation or an OPO's success in reducing 
disparities in donation and transplantation, and how should this be 
measured?
    4. Are there ways to scale, or rate, performance of other (new) 
factors that CMS may consider in assessing OPO performance?

    We are interested in ensuring our processes for the assessment of 
OPO performance are continually evolving and reflective of current 
industry standards and technological capabilities while providing the 
necessary incentives and rewards based on the dynamics within the OPO 
community and organ donation-transplantation ecosystem. We seek public 
comment to facilitate fair and equitable oversight of OPOs while 
ensuring we continually drive performance to ensure more lifesaving 
organs are available to individuals on transplant waitlists.
    In addition, we are assessing ways that we can improve the current 
recertification and competition processes. We ask the public for 
specific information on how these CfCs can be modified to ensure that 
OPOs are recertified and competition occurs in such a manner that would 
allow for the seamless determination of recertification for an OPO at 
the end of the recertification cycle, or the assignment of a new OPO to 
an open DSA. Therefore, we are asking the following questions:

    1. Are there additional factors or criteria that CMS should 
consider when determining which OPO should be selected for an open 
service area?
    2. Should CMS consider other performance measures when selecting 
an OPO for an open DSA? Such measures could include performance on 
converting donor referrals to potential donors or the number of 
``zero organ donors'' or the number of organ discards (see section 
C.5. for additional information), reflected in the discard rate, or 
improvement, over time.
    3. Should CMS continue to consider the contiguity of an OPO to 
an open DSA?
    4. What are the challenges that an OPO would face if taking over 
an open DSA? Are there specific disincentives within the current 
regulatory requirements to taking over an open DSA?
    5. Are the current CMS requirements for a governing body and 
advisory board adequate for OPO governance? Have OPOs included 
additional board positions or structures beyond what is required by 
CMS to improve operations? What structure best serves 
accountability, and efficient and effective organ procurement?
    6. What would be the anticipated impact from consolidation or 
expansion of the OPO community? Would consolidation or expansion of 
OPOs facilitate increased competition and improved performance or 
have a negative impact?
    7. Any other helpful information that could inform potential 
changes to the current recertification and competition processes.
2. Organ Transport and Tracking
    While many organs are transported to recipients with organ recovery 
teams, some organs need to be transported independently via common or 
commercial carrier in order to reach the intended recipient at a 
transplant hospital. A recent media report of organs being lost or 
delayed in transport, mainly through commercial airlines, have raised 
concern regarding the risks associated with unaccompanied organ 
transport. The tracking of these organs during transport is often 
subpar, using outdated methods.\26\ Lost or delayed organs lead to the 
unnecessary discards and missed opportunities for those waiting for a 
lifesaving organ transplant. Ensuring

[[Page 68602]]

that organs arrive at the transplant hospital in a timely manner is of 
the utmost importance.
---------------------------------------------------------------------------

    \26\ Kaiser Health News. How Lifesaving Organs for Transplant Go 
Missing In Transit. https://khn.org/news/how-lifesaving-organs-for-transplant-go-missing-in-transit/.
---------------------------------------------------------------------------

    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:
---------------------------------------------------------------------------

    \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)).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \29\ https://unos.org/news/media-resources/5-ways/automate-real-time-donor-referral/.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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 4, 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------

    \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