Request for Information; Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities

CourtCenters For Medicare & Medicaid Services
Citation86 FR 68594
Record Number2021-26146
SectionProposed rules
Published date03 December 2021
Federal Register, Volume 86 Issue 230 (Friday, December 3, 2021)
[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
                [Proposed Rules]
                [Pages 68594-68608]
                From the Federal Register Online via the Government Publishing Office []
                [FR Doc No: 2021-26146]
                Centers for Medicare & Medicaid Services
                42 CFR Chapter IV
                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.
                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
                 1. Electronically. You may submit electronic comments on this
                regulation to 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.
                 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: Follow the search instructions on that website to
                view public comments. CMS will not post on 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.
                 \1\ U.S. Health Resources and Services Administration. Organ
                Procurement and Transplantation Network--DATA. Accessed January 13, 2021. Accessed January 13, 2021.
                 \2\ U.S. Health Resources and Services Administration. Annual
                record trend continues for deceased organ donation, deceased donor
                transplants. Published January 11, 2021. Accessed January 13, 2021.
                January 11, 2021. Accessed January 13, 2021.
                 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\
                 \3\ Chronic Kidney Disease Initiative.
                atment%20for%20kidney%20failure. Accessed November 4, 2021.
                 \4\ Kidney Disease: The Basics. National Kidney Foundation.
                 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
                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.
                 \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.
                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
                 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?
                 \8\ Organ Procurement and Transplantation Network website.
                 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.
                 \9\ Mohan S, ``Kidney Transplantation: Good intentions and
                missed opportunities leave patients behind.'' Centers for Medicare &
                Medicaid Grand Rounds. June 13, 2019.
                 Specifically, we are seeking public comments on the following
                 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
                 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
                 Specifically, we are seeking public comments on the following
                 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
                 \10\ Executive Order on Advancing Racial Equity and Support for
                Underserved Communities Through the Federal Government, January 20,
                 \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.
                 \12\, Race,
                Ethnicity, & Kidney Disease.
                 \13\ Race,
                Ethnicity, & Kidney Disease.
                 \14\ Social Determinants of Health: Going Beyond the Basics to
                Explore Racial Disparities in Kidney Transplantation. Access.
                 \15\ Organ Donation and African Americans--The Office of
                Minority Health ( Accessed June 10, 2021.
                 U.S. Transplant Waiting List--Candidates by Race/Ethnicity
                 Number of Black percent Number of White percent
                 Organ All candidates Black of all White of all
                 candidates candidates candidates candidates
                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
                 Transplants Performed in the U.S. by Recipient Ethnicity, 2020
                 Percentage of
                 Number total 2020
                Black................................... 8,414 21.6
                White................................... 20,997 53.8
                Total Transplants....................... 39,036 100
                Source: HRSA. U.S. Organ Procurement and Transplantation Network (OPTN).
                 Based on OPTN data as of August 23, 2021. Tables
                 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\
                 \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.
                 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.
                 \19\ Organ Transplant Discrimination Against People with
                Disabilities: Part of the Bioethics and Disability Series, National
                Council on Disability, September 25, 2019.
                 \20\ Organ Transplant Discrimination Against People with
                Disabilities: Part of the Bioethics and Disability Series, National
                Council on Disability, September 25, 2019.
                 \21\ Organ Transplant Discrimination Against People with
                Disabilities: Part of the Bioethics and Disability Series, National
                Council on Disability, September 25, 2019.
                 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
                 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
                 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.
                 \23\ Goldberg, David, et al. Rejecting Bias: The case against
                race adjustment for OPO performance in communities of Color. March 17, 2020.
                 \24\ Siminoff, Laura, et al. Racial Disparities in Preferences
                and Perceptions Regarding Organ Donation. September 21,
                 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
                 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
                 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
                 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. 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 (
                 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
                 \27\ UNOS.
                 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
                 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 44, pp. 591-600).
                \31\ Marslais, P., et al. The First 2 Years of Activity of a
                Specialized Organ Procurement Center: Report of an Innovative
                Approach to Improve Organ Donation. American Journal of
                Transplantation 2017; 17: 1613-1619.
                 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
                 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?
                 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\
                 \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.
                 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
                 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:
                 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
                 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\
                 \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:
                 \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
                 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
                 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\
                 \40\ March 2021 Report to the Congress: Medicare Payment Policy
       (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.
                 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
                 \42\ Medicare Fee-For-Service Public Provider Enrollment.
                 \43\ Public Provider and Supplier Enrollment Files.
                 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.
                 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
                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

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT