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Medicare Final Rule 2007, 42 CFR
"Currently, the OPTN Living Donor Committee workgroup has identified living organ donor safety promotion as a major focus of the OPTN. However, standardized OPTN informed consent language for living donors has yet to be developed. In light of the fact that living donation is becoming more common, there is an increasing need to protect the health and safety of living donors."
March 2007 - Medicare & Medicaid released a "Final Rule" on standards of care and requirements for transplant centers to receive Medicare & Medicaid patients and reimbursement.
Section 482.102 (b)
(b) Standard: Informed consent for living donors. Transplant centers must implement written living donor informed consent policies that inform the prospective living donor of all aspects of, and potential outcomes from, living donation. Transplant centers must ensure that the prospective living donor is fully informed about the following:
(1) The fact that communication between the donor and the transplant center will remain confidential, in accordance with the requirements at 45 CFR parts 160 and 164.
(2) The evaluation process;
(3) The surgical procedure, including post-operative treatment;
(4) The availability of alternative treatments for the transplant recipient;
(5) The potential medical or psychosocial risks to the donor;
(6) The national and transplant center-specific outcomes for recipients, and the national and center-specific outcomes for living donors, as data are available;
(7) The possibility that future health problems related to the donation may not be covered by the donor’s insurance and that the donor’s ability to obtain health, disability, or life insurance may be affected;
(8) The donor’s right to opt out of donation at any time during the donation process; and
(9) The fact that if a transplant is not provided in a Medicare-approved transplant center it could affect the transplant recipient’s ability to have his or her immunosuppressive drugs paid for under Medicare Part B.
From original CMS announcement: (CMS adopted many of the informed consent elements contained in the Secretary’s Advisory Committee on Transplantation (ACOT) Recommendations.):
We note that transplant patients and living donors are uniquely vulnerable patients. Prospective transplant recipients desperately need scarce, life-saving organs, and many of them will die waiting. Prospective living donors are healthy individuals who are contemplating undergoing surgery, at some risk to themselves, to provide a life-saving transplant to another individual. These patients and prospective living donors must absorb a great deal of information in order to provide a truly informed consent.
Section 482.90 (b)
b) Standard: Living donor selection.
The living donor selection criteria must be consistent with the general principles of medical ethics.
Transplant centers must:
• Ensure that a prospective living donor receives a medical & psychosocial evaluation prior to donation.
• Document in the living donor’s medical records the living donor’s suitability for donation.
• Document that the living donor has given informed consent, as required under 482.102.
We expect a transplant center to assess the prospective living donor carefully to ensure, insofar as possible, that donation will not cause long-term harm to the individual’s health. Furthermore, we expect transplant centers to apply the ethical principle of ‘‘equipoise’’* to assess whether the benefits to both the donor and the recipient outweigh the risks associated with the donation and the transplantation.
We expect transplant centers to conduct psychosocial evaluations of all prospective living donors. An evaluation can assist the prospective living donor in evaluating the pros and cons of donating and the potential psychological impact of donating and thus aid the individual in making an appropriate donation decision.
We expect that transplant centers will use different informed consent forms for living donors since the informed consent components are slightly different than for transplant recipients.
Transplant centers must have written protocols for validation of donor-recipient blood type and other vital data for the deceased organ recovery, organ receipt, and living donor organ transplantation processes. The transplanting surgeon at the transplant center is responsible for ensuring the medical suitability of donor organs for transplantation into the intended recipient.
(c) Standard: Living donor transplantation.
• If a center performs living donor transplants, the transplanting surgeon and at least one licensed health care professional at the transplant center must verify that the donor’s blood type and other vital information is compatible with transplantation of the intended recipient immediately before the removal of the donor organ(s) and, if applicable, prior to the removal of the recipient’s organ(s).
§ 482.94 Condition of participation:
Patient and living donor management.
• Transplant center must have written patient management policies
and patient care planning for the pre-transplant, transplant, and
discharge phases of transplantation.
• Center must have written donor management policies for the living donor evaluation, donation, and discharge phases of living organ donation if it performs living donor transplants.
[As of April 2012: Transplant centers must have written patient management policies for the transplant and discharge phases of transplantation. If a transplant center performs living donor transplants, the center also must have written donor management policies for the donor evaluation, donation, and discharge phases of living organ donation.]
From 2007 CMS announcement: We believe that well-written patient and living donor selection criteria can reduce the legal risk for a transplant center, as long as the center adheres to its criteria or documents the reason why it has deviated from its criteria.
We expect transplant centers to coordinate follow-up care for living donors upon discharge as well. Although this final rule does not specifically delineate transplant centers’ responsibilities for living donors’ post-discharge care, we expect a transplant center to provide care, as needed, if a living donor experiences donation-related problems or complications post-discharge.
[LD101 note: According to a 2009 study (130), 78% of transplant centers prefer the follow-up be done by the living donor's primary care physician, so a transplant center could have no idea if or what complications, issues or problems their living donors experience post-discharge and therefore not report them. In fall 2010, OPTN has proposed a policy to make the transplant center that performs the donor's surgery to be fully responsible for follow-up.]
(a) Standard: Patient and living donor care.
(as of April 2012)
The transplant center's patient and donor management policies must ensure that:
(1) Each transplant patient is under the care of a multidisciplinary patient care team coordinated by a physician throughout the transplant and discharge phases of transplantation; and
(2) If a center performs living donor transplants, each living donor is under the care of a multidisciplinary patient care team coordinated by a physician throughout the donor evaluation, donation, and discharge phases of donation.]
(d) Standard: Social services. (updated April 2012)
The transplant center must make social services available, furnished by qualified social workers, to transplant patients, living donors, and their families. A qualified social worker is an individual who meets licensing requirements in the State in which he or she practices; and
(1) Completed a course of study with specialization in clinical practice and holds a master's degree from a graduate school of social work accredited by the Council on Social Work Education; or
(2) Is working as a social worker in a transplant center as of the effective date of this final rule and has served for at least 2 years as a social worker, 1 year of which was in a transplantation program, and has established a consultative relationship with a social worker who is qualified under (d)(1) of this paragraph.
[LD101 note: transplant centers differ on their definition of 'make available'. Is a business card stuck in a folder enough, or should transplant centers assign social workers to proactively follow-up with donors? Also, affiliation with or employment at a transplant program, which is by its nature recipient-centered, does not mean a social worker will be more knowledgeable about living donor issues. And for pity's sake, it's not as if social workers are the only game in town: what about state licensed counselors, and psychologists?]
(e) Standard: Nutritional services. (as of April 2012) Transplant centers must make nutritional assessments and diet counseling services, furnished by a qualified dietitian, available to all transplant patients and living donors. A qualified dietitian is an individual who meets practice requirements in the State in which he or she practices and is a registered dietitian with the Commission on Dietetic Registration.
Related: 42 CFR Part 121.9(a) Designated Transplant Program Requirements
OPTN Bylaw Appendix B, Attachment I,
III.C.15 Transplant Programs: Social Support—
Psychiatric and social support services must be available in
transplant programs approved under 121.9(a)(2).
The OPTN bylaw does not define qualification of a qualified social worker. Qualification is much broader. CMS requirement complements OPTN bylaw.
(e) Standard: Nutritional services. Nutritional assessments and diet counseling services furnished by a qualified dietitian must be available to all transplant patients and living donors. Definitions for a qualified dietitian included.
§ 482.98 Condition of participation: Human resources.
(c) Standard: Clinical transplant coordinator.
The transplant center must have a clinical transplant coordinator to
ensure the continuity of care of patients and
living donors during the pre-transplant, transplant, and discharge
phases of transplantation and the donor evaluation, donation, and
discharge phases of donation. The clinical transplant
coordinator must be a registered nurse or clinician licensed by the
State in which the clinical transplant coordinator practices,
who has experience and knowledge of
transplantation and living donation issues.
The clinical transplant coordinator's responsibilities must include,
but are not limited to, the following:
(1) Ensuring the coordination of the clinical aspects of transplant patient and living donor care;
(d) Standard: Independent Living Donor Advocate or Living Donor Advocate Team.
The transplant center that performs living donor transplants must identify either an independent living donor advocate or an independent living donor advocate team to ensure protection of the rights of living donors and prospective living donors.
[Original 2007 text] This final rule provides transplant centers with great flexibility in providing either a living donor advocate or donor advocate team. We do not specify requirements for a donor advocate’s background, education, or training or the donor advocate team’s composition. Instead, we specify their duties and the skills they must be able to demonstrate, specifically:
(1) Knowledge of living organ donation, transplantation, medical ethics, and informed consent; and
(2) understanding of the potential impact of family and other external pressures on the prospective living donor’s decision whether to donate and the ability to discuss these issues with the donor.
The independent living donor advocate or living donor advocate team is responsible for:
(1) Representing and advising the donor;
(2) protecting and promoting the interests of the donor; and
(3) respecting the donor’s decision and ensuring that the donor’s decision is informed and free from coercion.
A transplant center must identify either an independent living donor advocate or an independent living donor advocate team to ensure protection of the rights of living donors and prospective living donors. The living donor advocate or living donor advocate team must not be involved in transplantation activities on a routine basis.
As of April 2012:
(1) The living donor advocate or living donor advocate team
must not be involved in transplantation
activities on a routine basis.
(2) The independent living donor advocate or living donor advocate team must demonstrate:
(i) Knowledge of living organ donation, transplantation, medical ethics, and informed consent; and
(ii) Understanding of the potential impact of family and other external pressures on the prospective living donor's decision whether to donate and the ability to discuss these issues with the donor.
(3) The independent living donor advocate or living donor advocate team is responsible for:
(i) Representing and advising the donor;
(ii) Protecting and promoting the interests of the donor; and
(iii) Respecting the donor's decision and ensuring that the donor's decision is informed and free from coercion.
LD101 note: A Living Donor Coordinator is not the same as an Independent Living Donor Advocate. A 2010 discussion on a living-donor related email list revealed that some transplant centers consider them to be one and the same, or don't understand the exact role the IDA.
Consequently, some transplant centers and their Living Donor Advocates think they are only responsible for the living donor pre-surgically. Some Advocates are available to their donors long-term, but some consider their job 'done' once the living donor is discharged from the hospital. Also bear in mind that usually the Living Donor Advocate is employed by the same hospital responsible for the transplant surgery.
Commenters pointed out that the rule sets consistent and unified standards and provides an established infrastructure for performance monitoring and review of transplant centers.
Response: We are
responsible for establishing minimum standards to protect patient
health and safety, and for implementing oversight mechanisms to
ensure that transplant centers provide quality transplant and living
donor care to Medicare beneficiaries through the development of
health and safety requirements. In developing this rule, we worked
closely with HRSA, which oversees the OPTN and SRTR, to ensure
consistency and minimize the burden on transplant centers where
We have made a change to the definition of ‘‘adverse event’’ for clarification purposes. The proposed definition listed two examples of adverse events related to living donors: ‘‘living donor death due to mismanagement of the donor’’ and ‘‘avoidable loss of a healthy living donor.’’ We have replaced these two examples with ‘‘serious medical complications or death caused by living donation’’ to clarify that the death of any living donor or a living donor’s serious medical complications caused by living donation should be investigated as an adverse event.
*Equipose: A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient. An investigator who has a treatment preference or finds out that one arm of a comparative trial offers a clinically therapeutic advantage should disclose this information to subjects participating in the trial.