42 C.F.R. §§ 482.80–482.104

§482.80. Condition of participation: Data submission, clinical experience, and outcome requirements for initial approval of transplant programs.

42 C.F.R. § 482.80

Except as specified in paragraph (d) of this section, and § 488.61 of this chapter, transplant programs must meet all data submission, clinical experience, and outcome requirements to be granted initial approval by CMS.

(a)

Standard: Data submission. No later than 90 days after the due date established by the OPTN, a transplant program must submit to the OPTN at least 95 percent of required data on all transplants (deceased and living donor) it has performed. Required data submissions include, but are not limited to, submission of the appropriate OPTN forms for transplant candidate registration, transplant recipient registration and follow-up, and living donor registration and follow-up.

(b)

Standard: Clinical experience. To be considered for initial approval, an organ-specific transplant program must generally perform 10 transplants over a 12-month period.

(c)

Standard: Outcome requirements. CMS will review outcomes for all transplants performed at a program, including outcomes for living donor transplants, if applicable. CMS will review adult and pediatric outcomes separately when a program requests Medicare approval to perform both adult and pediatric transplants.

(1)

CMS will compare each transplant program's observed number of patient deaths and graft failures 1-year post-transplant to the center's expected number of patient deaths and graft failures 1-year post-transplant using the data contained in the most recent Scientific Registry of Transplant Recipients (SRTR) program-specific report.

(2)

CMS will not consider a program's patient and graft survival rates to be acceptable if:

(i)

A program's observed patient survival rate or observed graft survival rate is lower than its expected patient survival rate or expected graft survival rate; and

(ii)

All three of the following thresholds are crossed over—

(A)

The one-sided p-value is less than 0.05,

(B)

The number of observed events (patient deaths or graft failures) minus the number of expected events is greater than 3, and

(C)

The number of observed events divided by the number of expected events is greater than 1.85.

(d)

Exceptions.

(1)

A heart-lung transplant program is not required to comply with the clinical experience requirements in paragraph (b) of this section or the outcome requirements in paragraph (c) of this section for heart-lung transplants performed at the program.

(2)

An intestine transplant program is not required to comply with the outcome performance requirements in paragraph (c) of this section for intestine, combined liver-intestine or multivisceral transplants performed at the program.

(3)

A pancreas transplant program is not required to comply with the clinical experience requirements in paragraph (b) of this section or the outcome requirements in paragraph (c) of this section for pancreas transplants performed at the program.

(4)

A program that is requesting initial Medicare approval to perform pediatric transplants is not required to comply with the clinical experience requirements in paragraph (b) of this section prior to its request for approval as a pediatric transplant program.

(5)

A kidney transplant program that is not Medicare-approved on the effective date of this rule is required to perform at least 3 transplants over a 12-month period prior to its request for initial approval.

Notes, amendments, and revision history

Amendments

[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014; 81 FR 79880, Nov. 14, 2016; 84 FR 51822, Sept. 30, 2019]

Source

Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014; 81 FR 79880, Nov. 14, 2016; 84 FR 51822, Sept. 30, 2019]

§482.90. Condition of participation: Patient and living donor selection.

42 C.F.R. § 482.90

The transplant program must use written patient selection criteria in determining a patient's suitability for placement on the waiting list or a patient's suitability for transplantation. If a program performs living donor transplants, the program also must use written donor selection criteria in determining the suitability of candidates for donation.

(a)

Standard: Patient selection. Patient selection criteria must ensure fair and non-discriminatory distribution of organs.

(1)

Prior to placement on the program's waiting list, a prospective transplant candidate must receive a psychosocial evaluation, if possible.

(2)

Before a transplant program places a transplant candidate on its waiting list, the candidate's medical record must contain documentation that the candidate's blood type has been determined.

(3)

When a patient is placed on a program's waiting list or is selected to receive a transplant, the center must document in the patient's medical record the patient selection criteria used.

(4)

A transplant program must provide a copy of its patient selection criteria to a transplant patient, or a dialysis facility, as requested by a patient or a dialysis facility.

(b)

Standard: Living donor selection. The living donor selection criteria must be consistent with the general principles of medical ethics. Transplant programs must:

(1)

Ensure that a prospective living donor receives a medical and psychosocial evaluation prior to donation,

(2)

Document in the living donor's medical records the living donor's suitability for donation, and

(3)

Document that the living donor has given informed consent, as required under § 482.102.

Notes, amendments, and revision history

Amendments

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

Source

Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

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

§482.92. Condition of participation: Organ recovery and receipt.

42 C.F.R. § 482.92

Transplant programs 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 program is responsible for ensuring the medical suitability of donor organs for transplantation into the intended recipient.

(a)

Standard: Organ receipt. After an organ arrives at a transplant program, prior to transplantation, the transplanting surgeon and another licensed health care professional must verify that the donor's blood type and other vital data are compatible with transplantation of the intended recipient.

(b)

Standard: Living donor transplantation. If a program performs living donor transplants, the transplanting surgeon and another licensed health care professional at the program must verify that the living donor's blood type and other vital data are 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).

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 77 FR 29076, May 16, 2012; 84 FR 51822, Sept. 30, 2019]

Source

Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 77 FR 29076, May 16, 2012; 84 FR 51822, Sept. 30, 2019]

§482.94. Condition of participation: Patient and living donor management.

42 C.F.R. § 482.94

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.

(a)

Standard: Patient and living donor care. The transplant program'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 program 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.

(b)

Standard: Waiting list management. Transplant programs must keep their waiting lists up to date on an ongoing basis, including:

(1)

Updating of waiting list patients' clinical information;

(2)

Removing patients from the program's waiting list if a patient receives a transplant or dies, or if there is any other reason the patient should no longer be on a program's waiting list; and

(3)

Notifying the OPTN no later than 24 hours after a patient's removal from the program's waiting list.

(c)

Standard: Patient records. Transplant programs must maintain up-to-date and accurate patient management records for each patient who receives an evaluation for placement on a program's waiting list and who is admitted for organ transplantation.

(1)

For each patient who receives an evaluation for placement on a program's waiting list, the program must document in the patient's record that the patient (and in the case of a kidney patient, the patient's usual dialysis facility) has been informed of his or her transplant status, including notification of:

(i)

The patient's placement on the program's waiting list;

(ii)

The program's decision not to place the patient on its waiting list; or

(iii)

The program's inability to make a determination regarding the patient's placement on its waiting list because further clinical testing or documentation is needed.

(2)

If a patient on the waiting list is removed from the waiting list for any reason other than death or transplantation, the transplant program must document in the patient's record that the patient (and in the case of a kidney patient, the patient's usual dialysis facility) was notified no later than 10 days after the date the patient was removed from the waiting list.

(3)

In the case of patients admitted for organ transplants, transplant programs must maintain written records of:

(i)

Multidisciplinary patient care planning during the transplant period; and

(ii)

Multidisciplinary discharge planning for post-transplant care.

(d)

Standard: Social services. The transplant program 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 program 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.

(e)

Standard: Nutritional services. Transplant programs 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.

Notes, amendments, and revision history

Amendments

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

Source

Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

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

§482.96. Condition of participation: Quality assessment and performance improvement (QAPI).

42 C.F.R. § 482.96

Transplant programs must develop, implement, and maintain a written, comprehensive, data-driven QAPI program designed to monitor and evaluate performance of all transplantation services, including services provided under contract or arrangement.

(a)

Standard: Components of a QAPI program. The transplant program's QAPI program must use objective measures to evaluate the center's performance with regard to transplantation activities and outcomes. Outcome measures may include, but are not limited to, patient and donor selection criteria, accuracy of the waiting list in accordance with the OPTN waiting list requirements, accuracy of donor and recipient matching, patient and donor management, techniques for organ recovery, consent practices, patient education, patient satisfaction, and patient rights. The transplant program must take actions that result in performance improvements and track performance to ensure that improvements are sustained.

(b)

Standard: Adverse events. A transplant program must establish and implement written policies to address and document adverse events that occur during any phase of an organ transplantation case.

(1)

The policies must address, at a minimum, the process for the identification, reporting, analysis, and prevention of adverse events.

(2)

The transplant program must conduct a thorough analysis of and document any adverse event and must utilize the analysis to effect changes in the transplant program's policies and practices to prevent repeat incidents.

Notes, amendments, and revision history

Amendments

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

Source

Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

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

§482.98. Condition of participation: Human resources.

42 C.F.R. § 482.98

The transplant program must ensure that all individuals who provide services and/or supervise services at the program, including individuals furnishing services under contract or arrangement, are qualified to provide or supervise such services.

(a)

Standard: Director of a transplant program. The transplant program must be under the general supervision of a qualified transplant surgeon or a qualified physician-director. The director of a transplant program need not serve full-time and may also serve as a program's primary transplant surgeon or transplant physician in accordance with § 482.98(b). The director is responsible for planning, organizing, conducting, and directing the transplant program and must devote sufficient time to carry out these responsibilities, which include but are not limited to the following:

(1)

Coordinating with the hospital in which the transplant program is located to ensure adequate training of nursing staff and clinical transplant coordinators in the care of transplant patients and living donors.

(2)

Ensuring that tissue typing and organ procurement services are available.

(3)

Ensuring that transplantation surgery is performed by, or under the direct supervision of, a qualified transplant surgeon in accordance with § 482.98(b).

(b)

Standard: Transplant surgeon and physician. The transplant program must identify to the OPTN a primary transplant surgeon and a transplant physician with the appropriate training and experience to provide transplantation services, who are immediately available to provide transplantation services when an organ is offered for transplantation.

(1)

The transplant surgeon is responsible for providing surgical services related to transplantation.

(2)

The transplant physician is responsible for providing and coordinating transplantation care.

(c)

Standard: Clinical transplant coordinator. The transplant program 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; and

(2)

Acting as a liaison between a kidney transplant program and dialysis facilities, as applicable.

(d)

Standard: Independent living donor advocate or independent living donor advocate team. The transplant program that performs living donor transplantation 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.

(1)

The independent living donor advocate or independent living donor advocate team must not be involved in transplantation activities on a routine basis.

(2)

The independent living donor advocate or independent 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 independent 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.

(e)

Standard: Transplant team. The transplant program must identify a multidisciplinary transplant team and describe the responsibilities of each member of the team. The team must be composed of individuals with the appropriate qualifications, training, and experience in the relevant areas of medicine, nursing, nutrition, social services, transplant coordination, and pharmacology.

(f)

Standard: Resource commitment. The transplant program must demonstrate availability of expertise in internal medicine, surgery, anesthesiology, immunology, infectious disease control, pathology, radiology, blood banking, and patient education as related to the provision of transplantation services.

Notes, amendments, and revision history

Amendments

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

Source

Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

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

§482.100. Condition of participation: Organ procurement.

42 C.F.R. § 482.100

The transplant program must ensure that the hospital in which it operates has a written agreement for the receipt of organs with an OPO designated by the Secretary that identifies specific responsibilities for the hospital and for the OPO with respect to organ recovery and organ allocation.

Notes, amendments, and revision history

Amendments

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

Source

Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

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

§482.102. Condition of participation: Patient and living donor rights.

42 C.F.R. § 482.102

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.

Notes, amendments, and revision history

Amendments

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

Source

Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

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

§482.104. Condition of participation: Additional requirements for kidney transplant programs.

42 C.F.R. § 482.104

(a)

Standard: End stage renal disease (ESRD) services. Kidney transplant programs must directly furnish transplantation and other medical and surgical specialty services required for the care of ESRD patients. A kidney transplant program must have written policies and procedures for ongoing communications with dialysis patients' local dialysis facilities.

(b)

Standard: Dialysis services. Kidney transplant programs must furnish inpatient dialysis services directly or under arrangement.

(c)

Standard: Participation in network activities. Kidney transplant programs must cooperate with the ESRD Network designated for their geographic area, in fulfilling the terms of the Network's current statement of work.

Notes, amendments, and revision history

Amendments

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

Source

Source: 72 FR 15273, Mar. 30, 2007, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

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