NCD Comments to CMS RFI about organ procurement
Chiquita Brooks-LaSure, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS–3409–NC, P.O. Box 8010
[Submitted via U.S. mail and electronically to www.regulations.gov
Subject: NCD Advisory Letter on CMS-3409-NC: Request for Information; Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities, of December 3, 2021
Dear Administrator Brooks-LaSure:
The National Council on Disability (“NCD”) is an independent federal agency charged with advising the President, Congress, and fellow federal agencies on matters of disability law and policy. I am writing to you in my capacity as the Chairman of NCD to thank you for your effort to increase equity in organ transplantation and procurement processes and to respond to several questions in the Request for Information (RFI).
As you highlight in the RFI, NCD’s 2019 report, Organ Transplant Discrimination Against People with Disabilities,1 found that people with disabilities, especially intellectual disabilities, have been denied access to organs because of subjective judgements about the value of a life with a disability, assumptions about their quality of life, and misconceptions about their ability to comply with post-operative care. NCD found that organ transplant programs have policies which exclude people with disabilities as candidates for a transplant - some with categorical exclusions based on disability, refusing to even evaluate a person’s medical suitability for an organ transplant because of their disability. Policies that foreclose the opportunity for an individualized assessment deem the lives of individuals with disabilities unworthy of an organ and life itself. As such, they are a deadly form of discrimination.
NCD also found that disability discrimination occurs in the organ procurement process, where policies have not adequately protected individuals and families from being contacted and even pressured by organ procurement organizations (OPOs) prior to a decision that life support will be withdrawn. The newly injured population is particularly vulnerable to abusive organ procurement policies because their recent trauma and uncertain future makes them susceptible to the message that their death would mean more to the people around them than their life. Individuals with disabilities in intensive care units whose prognoses are uncertain are likewise vulnerable to abuse in organ procurement practices.
We commend CMS for making clear in this RFI that individuals with disabilities “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.”2 NCD also commends CMS for explaining the obligation of OPOs to comply with section 504 of the Rehabilitation Act of 1973 (Section 504),3 and section 1557 of the Patient Protection and Affordable Care Act (Section 1557),4 in your 2020 Final Rule.5 It provides:
[S]ection 504 and section 1557 protect qualified individuals with a disability, including prospective organ recipients with a disability and prospective organ donors with a disability, from discrimination in the administration of organ transplant programs. Under these laws, OPOs must ensure that qualified individuals with a disability are afforded opportunities to participate in or benefit from the organ transplant programs that are equal to opportunities afforded others. Decisions to approve or deny organ transplants must be made based on objective facts related to the individual in question. Individuals with disabilities are also entitled to reasonable accommodations needed to participate in and benefit from a program, and auxiliary aids and services needed for effective communication. These rights extend in some circumstances to family members of a prospective organ donor or recipient. For example, health care providers and organ donation programs are required to provide auxiliary aids and services (including sign language interpreters) when necessary for effective communication between a relative involved in a prospective donor or recipient’s care and a health care provider or donation program. Additionally, if eligibility criteria for being a transplant recipient require an individual to be able to comply with post-transplant regimens, it would be a reasonable accommodation to allow an individual with a developmental or intellectual, or other disability to meet that requirement with the assistance of a relative, attendant, or other individual.
Responses to Questions on Equity In Organ Transplantation and Organ Donation
Are there revisions that can be made to the transplant program conditions of participation (“CoP”) or the organ procurement organization (“OPO”) conditions for coverage (“CfC”) to reduce disparities in organ transplantation?
To reduce disparities with regard to individuals with disabilities, NCD recommends that CMS revise CoPs and CfCs to:
- Include the requirement that transplant programs and OPOs must comply with the nondiscrimination requirements of Section 504, and Section 1557, and the Americans with Disabilities Act (ADA).
- Prohibit OPOs from approaching families about organ donation before the family has made a decision about the withdrawal of life-sustaining treatment and from approaching conscious potential donors until they have received psychological counseling and support to live.
- Require a disability rights representative on UNOS, OPTN, and Medicare and Medicaid boards and key committees to help ensure that waitlists are utilized in a non-discriminatory manner, and to reform any guidelines that could be interpreted by organ transplant programs as allowing people with disabilities to be kept off the waitlist for a transplant.
- Require that organ procurement data collection incorporate disability information pertaining to the organ donor, including primary diagnosis and type of disability.
What changes can be made to the current requirements to ensure that transplant programs ensure equal access to transplants for individuals with disabilities?
NCD recommends that CMS revise current requirements to:
- Clarify transplant programs’ obligations under Section 504, Section 1557, and the ADA, including the obligation for individualized assessments and reasonable modifications, including:
Considering not only the person’s ability to manage post-operative care independently, but the full range of supports and services available to help the individual manage post-operative care, such as family members, programs, and service providers; and
The provision of necessary auxiliary aids and effective communication needed for a successful organ transplant and postoperative regimen.
- Require referrals of qualified individuals with disabilities for an organ transplant; admission of a qualified individual with a disability to an organ transplant program; and placement of a qualified individual with a disability on a waiting list for an organ transplant.
- Prohibit transplant program policies or practices that treat intellectual and developmental disabilities as an absolute contraindication to a transplant.
- Require transplant centers to provide supported decision making when needed to assist people with disabilities undergoing the organ transplantation process.
CMS should also develop, in conjunction with the HHS Office for Civil Rights, technical assistance to organ transplant centers and physicians in complying with the foregoing obligations. Issuing guidance and providing technical assistance would increase understanding of federal nondiscrimination laws as applied to the organ transplant process and increase compliance.
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?
NCD’s recommended revisions to requirements for transplant center’s policies and practices set forth above will help resolve explicit and implicit discrimination in the organ transplantation system by requiring objective processes that comply with federal nondiscrimination requirements. Such revisions will go far in preventing policies and decisions to be influenced, or based on, subjective judgements about the quality or relative worth of a life with a disability; beliefs that a patient does or would impose a burden on caregivers or society based on disability, or on biases and stereotypes based on disability.
Implicit and explicit discrimination must also be addressed through education and training. It is inconceivable to NCD that physicians in all specialties can attain board certification without having seen a patient with a disability, and without having any disability clinical-care education and training as part of their undergraduate graduate and graduate medical education.6 Thus, in general, CMS’s support for the inclusion of comprehensive disability clinical-care education and training curricula in all medical and health professional schools will help address these biases. More specifically, CMS’s inclusion, as a CoP, the requirement for residency and fellowship programs supported by federal funds to adopt and implement disability clinical-care training would help address explicit and implicit disability-based discrimination.
NCD appreciates the opportunity to provide information to help address disability discrimination in the organ donation and organ transplantation processes and CMS’ efforts to ensure equitable healthcare for people with disabilities. The recommendations herein would improve access and quality of care for millions of patients by helping to ensure that the civil rights of people with disabilities are recognized and eliminating the discriminatory policies and practices that have long prevented qualified individuals with disabilities from receiving life-saving organs. We urge CMS to move forward with rulemaking to implement these recommendations.
Should your staff have questions or wish to discuss this letter, please do not hesitate to contact Ana Torres-Davis, Senior Attorney Advisor, at (202) 272-2004.
Respectfully,
Andrés Gallegos
Chairman
1 National Council on Disability, Organ Transplant Discrimination Against People with Disabilities. (2019). </assets/uploads/docs/ncd-organ-transplant-508.pdf>
2 Request for Information; Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Disease Facilities, 86 Fed. Reg. 68594, 68598 (December 3, 2021).
3 29 U.S.C. 794.
4 42 U.S.C. 18116.
5 Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations, 85 Fed. Reg. 77898, 77899 (February 1, 2021).
6 The components of disability clinical-care education and training are set forth in a soon to be released NCD Health Equity Framework.