[Code of Federal Regulations]
[Title 42, Volume 4]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR482.102]

[Page 540-541]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents
 
             Subpart E_Requirements for Specialty Hospitals
 
Sec.  482.102  Condition of participation: Patient and living donor rights.

    In addition to meeting the condition of participation ``Patients 
rights'' requirements at Sec.  482.13, the transplant center must 
protect and promote each transplant patient's and living donor's rights.
    (a) Standard: Informed consent for transplant patients. Transplant 
centers 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 center-specific outcomes, from the most 
recent SRTR center-specific report, including (but not limited to) the 
transplant center's observed and expected 1-year patient and graft 
survival, national 1-year patient and graft survival, and notification 
about all Medicare outcome requirements not being met by the transplant 
center;
    (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 center 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 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.
    (c) Standard: Notification to patients. Transplant centers must 
notify patients placed on the center's waiting list of information about 
the center 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 center served by a single transplant surgeon or 
physician must inform patients placed on the center's waiting list of:
    (i) The potential unavailability of the transplant surgeon or 
physician; and

[[Page 541]]

    (ii) Whether the center has a mechanism to provide an alternate 
transplant surgeon or transplant physician.
    (2) At least 30 days before a center's Medicare approval is 
terminated, whether voluntarily or involuntarily, the center must:
    (i) Inform patients on the center's waiting list and provide 
assistance to waiting list patients who choose to transfer to the 
waiting list of another Medicare-approved transplant center without loss 
of time accrued on the waiting list; and
    (ii) Inform Medicare beneficiaries on the center's waiting list that 
Medicare will no longer pay for transplants performed at the center 
after the effective date of the center's termination of approval.
    (3) As soon as possible prior to a transplant center's voluntary 
inactivation, the center must inform patients on the center'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 center without loss of time accrued on the 
waiting list.