CMS SOM App. X, Tag X-081

Transplant programs must have written patient management policies for the transplant

and discharge phases of transplantation. If a transplant program performs living donor

transplants, the program also must have written donor management policies for the donor

evaluation, donation, and discharge phases of living organ donation.

Guideline §482.94

Transplant patient management policies for the transplant and discharge phases of

transplantation are critical to protect the rights of any potential transplant recipient.

Policies for transplantation must incorporate, at a minimum, all patients who have chosen to

undergo all or any portion of the evaluation process. The Medicare standards for transplant

programs require programs to manage any patient that has received an evaluation, has been

placed on the program’s waiting list, and/or received a transplant (e.g., Patient Selection

requirements for Transplantation at 482.90, Waiting List Management requirements at 482.94(b),

and Informed Consent requirements for Transplant Patients at 482.102(a)). As such, transplant

programs should define the structure of their evaluation and transplant processes and ensure that

it maintains documentation of any patient who receives services from the transplant program.

Patient management policies for the discharge phase of transplant should have mechanisms in

place to identify, assess, and meet the medical and psychosocial needs of the patient to ensure

they have the resources necessary to care for their transplant. Organ transplant recipients have

complex medical needs, including existing chronic disease(s), multiple comorbidities, complex

medication regimen post-transplant, and lifestyle changes following surgery necessary to

maintain the health and life of the organ. These patients will require discharge planning at an

early stage of their hospitalization to ensure their discharge needs are identified and addressed

prior to actual discharge. Transplant programs should ensure its discharge policies are based on

the hospital policies for discharge planning. See §482.43 (Tags A-0799 to A-0843) for more

information on CMS’ requirements for hospital discharge planning.

Transplant programs that provide living donor transplant services must develop and implement

living donor policies that direct the care and management of donors through their evaluation,

donation, and discharge after donation. The transplant program must determine the structure of

its evaluation and donation processes and ensure that it maintains documentation of any potential

transplant donor that receives services from the transplant program. The evaluation policies

must ensure it incorporates at a minimum, all potential donors that have chosen to undergo all or

any portion of the transplant program’s evaluation process. Transplant programs should ensure

its discharge policies for living donors are based on the hospital policies for discharge planning.

See § 482.43 (Tags A-0799 to A-0843) for more information on CMS’ requirements for hospital

discharge planning.

Some transplant programs perform living donor services under arrangement with other hospitals.

See below for additional information. In these cases, the transplant program retains all

responsibility for compliance with management of the living donor. The transplant program

must communicate the donor management activities that are required as a part of the living donor

organ recovery to the hospital under the arrangement and ensure that the activities are completed

appropriately.

Living Donor Services under Contract or Arrangement

There are requirements for transplant recipient programs providing living donor services under

contract/arrangement. There are several types of arrangements in which a transplant program

provides living donor services under contract or arrangement with another transplant program.

This enables a transplant program to offer living donor services and receive donor organs from a

separate hospital that does not provide services to the organ recipient. There may be an ongoing

arrangement between two transplant programs, such as children and adult programs. There are

also episodic arrangements as part of a single donation or multi-organ exchange where more than

two transplant programs are “swapping” organs.

The CoPs for organ transplant programs include several provisions that apply to any program

that is performing transplants with an organ from a living donor. If the services for a living donor

for the recipient transplant program are provided by a transplant program located at another

hospital, these services are considered to be provided by the recipient transplant program under

contract or arrangement. The transplant program providing services to the transplant recipient is

responsible for certain activities to ensure that the program is Medicare-approved and that certain

basic services are provided to those living donors.

A recipient’s transplant program that has its living donor services provided by one or more

programs under contract or arrangement on either an ongoing or episodic basis must:

1) Have written evidence of a contract or agreement with the living donor transplant

program(s). This may be a specific contract or agreement between two hospitals or programs,

or it may include participation in a transplant registry for paired donation of living donors

and recipients.

2) Have a copy of the Medicare-approval letter for the living donor transplant program with

which it has a contract or agreement, or have documented evidence that the CMS website

listed below was reviewed prior to accepting the living donor organ to ensure that the

program was a Medicare-approved program.

CMS Approved Transplant Program List Link:

https://qcor.cms.gov/default.jsp?referer=https://qcor.cms.gov/main.jsp

3) Retain copies of the medical records up to the point of admission to the hospital for the

donation of any living donors whose organs were transplanted by the recipient transplant

program. These records must be kept separate from the recipient’s medical record. It is not

expected that the medical record would include those records that occur on the day of

donation such as labs and the anesthesia report. The recipient transplant program must review

the records in advance of the donation to ensure the following minimum requirements are

met:

a) There is a complete medical and psychosocial evaluation in the medical record completed

by the relevant professionals of a multidisciplinary team which has determined that the

individual is a suitable living donor. (42 CFR §482.90)

b) An Independent Living Donor Advocate (ILDA) has met and worked with the potential

living donor and has been included in the discussions of the potential donor’s suitability.

(42 CFR §482.98)

c) There is a fully documented informed consent process in the living donor’s medical

record that meets the minimum Medicare requirements. (42 CFR §482.102)

Note: This is not an exhaustive list of the requirements that apply to living donor services.

The identification of this subset does not mean that the other CoPs for living donors are

waived. This subset of CoPs is outlined because the recipient’s transplant program must

verify that these requirements have been met for any given living donor prior to the donation

occurring.

4) As part of the Quality Assessment and Performance Improvement (QAPI) requirement,

ensure that there is a feedback system between the recipient and donor hospital to address

any adverse events that occur in the donor or the recipient for a specific donation or

transplant.

If the recipient’s program does not perform any living donor services directly (i.e., all living

donor services are contracted), the program is still expected to track objective indicators to

review the quality of the contracted service.

Additional Clarification

CMS requires the receiving transplant programs ensure that the requirements described above are

met prior to accepting a living donor organ. It is not CMS’ intention to establish a single standard

of practice in how living donors are evaluated, provided with informed consent, or the specific

activities of the independent living donor advocate. It is permissible for a transplant recipient’s

program to use another hospital’s policies and procedures for any given living donor as long as

the minimum standards described above are met. For example, if a transplant recipient program

usually requires a nutritional evaluation by a dietitian for any living donor candidate with a BMI

over 30, but a living donor organ is available through a “swap” where the individual has a BMI

over 30, the transplant recipient hospital does not have to require a full nutritional evaluation

before accepting that individual as a suitable living donor.