In addition to meeting the condition of participation “Patients rights” requirements at § 482.13, the transplant program must protect and promote each transplant patient's and living donor's rights.

(a) Standard: Informed consent for transplant patients. Transplant programs must implement written transplant patient informed consent policies that inform each patient of:

(1) The evaluation process;

(2) The surgical procedure;

(3) Alternative treatments;

(4) Potential medical or psychosocial risks;

(5) National and transplant program-specific outcomes, from the most recent SRTR program-specific report, including (but not limited to) the transplant program's observed and expected 1-year patient and graft survival, and national 1-year patient and graft survival;

(6) Organ donor risk factors that could affect the success of the graft or the health of the patient, including, but not limited to, the donor's history, condition or age of the organs used, or the patient's potential risk of contracting the human immunodeficiency virus and other infectious diseases if the disease cannot be detected in an infected donor;

(7) His or her right to refuse transplantation; and

(8) The fact that if his or her transplant is not provided in a Medicare-approved transplant program it could affect the transplant recipient's ability to have his or her immunosuppressive drugs paid for under Medicare Part B.

(b) Standard: Informed consent for living donors. Transplant programs 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 programs must ensure that the prospective living donor is fully informed about the following:

(1) The fact that communication between the donor and the transplant program 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 program-specific outcomes for recipients, and the national and transplant-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 program it could affect the transplant recipient's ability to have his or her immunosuppressive drugs paid for under Medicare Part B.

(c) Standard: Notification to patients. Transplant programs must notify patients placed on the program's waiting list of information about the program that could impact the patient's ability to receive a transplant should an organ become available, and what procedures are in place to ensure the availability of a transplant team.

(1) A transplant program served by a single transplant surgeon or physician must inform patients placed on the program's waiting list of:

(i) The potential unavailability of the transplant surgeon or physician; and

(ii) Whether the center has a mechanism to provide an alternate transplant surgeon or transplant physician.

(2) At least 30 days before a program's Medicare approval is terminated, whether voluntarily or involuntarily, the center must:

(i) Inform patients on the program's waiting list and provide assistance to waiting list patients who choose to transfer to the waiting list of another Medicare-approved transplant program without loss of time accrued on the waiting list; and

(ii) Inform Medicare recipients on the program's waiting list that Medicare will no longer pay for transplants performed at the program after the effective date of the program's termination of approval.

(3) As soon as possible prior to a transplant program's voluntary inactivation, the program must inform patients on the program's waiting list and, as directed by the Secretary, provide assistance to waiting list patients who choose to transfer to the waiting list of another Medicare-approved transplant program without loss of time accrued on the waiting list.

[72 FR 15273, Mar. 30, 2007, as amended at 84 FR 51822, 51824, Sept. 30, 2019]