Source: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&n=42y5.0.1.1.1.5&r=SUBPART&ty=HTML%23se42.5.482_168
Timestamp: 2019-10-18 17:40:01
Document Index: 217942637

Matched Legal Cases: ['§482', '§482', '§482', '§482', '§482', '§482', '§482', '§121', '§482', '§482', '§488', '§488', '§482', '§482']

§482.68 Special requirement for transplant centers.
§482.78 Condition of participation: Emergency preparedness for transplant centers.
Link to an amendment published at 84 FR 51821, Sept. 30, 2019.
(d) Standard: Recording progress. Progress notes must be recorded by the doctor of medicine or osteopathy responsible for the care of the patient as specified in §482.12(c), nurse, social worker and, when appropriate, others significantly involved in active treatment modalities. The frequency of progress notes is determined by the condition of the patient but must be recorded at least weekly for the first 2 months and at least once a month thereafter and must contain recommendations for revisions in the treatment plan as indicated as well as precise assessment of the patient's progress in accordance with the original or revised treatment plan.
A transplant center located within a hospital that has a Medicare provider agreement must meet the conditions of participation specified in §§482.72 through 482.104 in order to be granted approval from CMS to provide transplant services.
(b) In addition to meeting the conditions of participation specified in §§482.72 through 482.104, a transplant center must also meet the conditions of participation in §§482.1 through 482.57, except for §482.15.
[81 FR 64030, Sept. 16, 2016]
Adverse event means an untoward, undesirable, and usually unanticipated event that causes death or serious injury, or the risk thereof. As applied to transplant centers, examples of adverse events include (but are not limited to) serious medical complications or death caused by living donation; unintentional transplantation of organs of mismatched blood types; transplantation of organs to unintended beneficiaries; and unintended transmission of infectious disease to a beneficiary.
Heart-Lung transplant center means a transplant center that is located in a hospital with an existing Medicare-approved heart transplant center and an existing Medicare-approved lung center that performs combined heart-lung transplants.
Intestine transplant center means a Medicare-approved liver transplant center that performs intestine transplants, combined liver-intestine transplants, or multivisceral transplants.
Pancreas transplant center means a Medicare-approved kidney transplant center that performs pancreas transplants alone or subsequent to a kidney transplant as well as kidney-pancreas transplants.
Transplant center means an organ-specific transplant program (as defined in this rule) within a transplant hospital (for example, a hospital's lung transplant program may also be referred to as the hospital's lung transplant center).
Transplant program means a component within a transplant hospital (as defined in this rule) that provides transplantation of a particular type of organ.
Link to an amendment published at 84 FR 51822, Sept. 30, 2019.
A transplant center must be located in a transplant hospital that is a member of and abides by the rules and requirements of the Organ Procurement and Transplantation Network (OPTN) established and operated in accordance with section 372 of the Public Health Service (PHS) Act (42 U.S.C. 274). The term “rules and requirements of the OPTN” means those rules and requirements approved by the Secretary pursuant to §121.4 of this title. No hospital that provides transplantation services shall be deemed to be out of compliance with section 1138(a)(1)(B) of the Act or this section unless the Secretary has given the OPTN formal notice that he or she approves the decision to exclude the transplant hospital from the OPTN and also has notified the transplant hospital in writing.
(a) A transplant center must notify CMS immediately of any significant changes related to the center's transplant program or changes that could affect its compliance with the conditions of participation. Instances in which CMS should receive information for follow up, as appropriate, include, but are not limited to:
(1) Change in key staff members of the transplant team, such as a change in the individual the transplant center designated to the OPTN as the center's “primary transplant surgeon” or “primary transplant physician;'
(2) Termination of an agreement between the hospital in which the transplant center is located and an OPO for the recovery and receipt of organs as required by section 482.100; and
(3) Inactivation of the transplant center.
(b) Upon receiving notification of significant changes, CMS will follow up with the transplant center as appropriate, including (but not limited to):
A transplant center must be included in the emergency preparedness planning and the emergency preparedness program as set forth in §482.15 for the hospital in which it is located. However, a transplant center is not individually responsible for the emergency preparedness requirements set forth in §482.15.
Except as specified in paragraph (d) of this section, and §488.61 of this chapter, transplant centers 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 center 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 beneficiary 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 center must generally perform 10 transplants over a 12-month period.
(c) Standard: Outcome requirements. CMS will review outcomes for all transplants performed at a center, including outcomes for living donor transplants, if applicable. CMS will review adult and pediatric outcomes separately when a center requests Medicare approval to perform both adult and pediatric transplants.
(1) CMS will compare each transplant center'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 Beneficiaries (SRTR) center-specific report.
(2) CMS will not consider a center's patient and graft survival rates to be acceptable if:
(i) A center's observed patient survival rate or observed graft survival rate is lower than its expected patient survival rate or expected graft survival rate; and
(d) Exceptions. (1) A heart-lung transplant center 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 center.
(2) An intestine transplant center 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 center.
(3) A pancreas transplant center 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 center.
(4) A center 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 center.
(5) A kidney transplant center 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.
[72 FR 15273, Mar. 30, 2007, as amended at 79 FR 27155, May 12, 2014; 81 FR 79880, Nov. 14, 2016]
Except as specified in paragraph (d) of this section, and §488.61 of this chapter, transplant centers must meet all data submission, clinical experience, and outcome requirements in order to be re-approved.
(a) Standard: Data submission. No later than 90 days after the due date established by the OPTN, a transplant center must submit to the OPTN at least 95 percent of the required data submissions on all transplants (deceased and living donors) performed during the prior 3 years. 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 re-approval, an organ-specific transplant center must generally perform an average of 10 transplants per year during the prior 3 years.
(1) CMS will compare each transplant center'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 data contained in the most recent SRTR center-specific report.
(2) An intestine transplant center is not required to comply with the outcome requirements in paragraph (c) of this section for intestine, combined liver-intestine, and multivisceral transplants performed at the center.
(4) A center that is approved to perform pediatric transplants is not required to comply with the clinical experience requirements in paragraph (b) of this section to be re-approved.
The transplant center 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 center performs living donor transplants, the center also must use written donor selection criteria in determining the suitability of candidates for donation.
(1) Prior to placement on the center's waiting list, a prospective transplant candidate must receive a psychosocial evaluation, if possible.
(2) Before a transplant center 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 center'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 center 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 centers must:
Transplant centers must have written protocols for validation of donor-beneficiary 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 beneficiary.
(a) Standard: Organ receipt. After an organ arrives at a transplant center, 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 beneficiary.
(b) Standard: Living donor transplantation. If a center performs living donor transplants, the transplanting surgeon and another licensed health care professional at the center must verify that the living donor's blood type and other vital data are compatible with transplantation of the intended beneficiary immediately before the removal of the donor organ(s) and, if applicable, prior to the removal of the beneficiary 's organ(s).
[51 FR 22042, June 17, 1986, as amended at 77 FR 29076, May 16, 2012]
(a) Standard: Patient and living donor care. The transplant center's patient and donor management policies must ensure that:
(b) Standard: Waiting list management. Transplant centers must keep their waiting lists up to date on an ongoing basis, including:
(c) Standard: Patient records. Transplant centers must maintain up-to-date and accurate patient management records for each patient who receives an evaluation for placement on a center's waiting list and who is admitted for organ transplantation.
(d) Standard: Social services. 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
(e) Standard: Nutritional services. 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.
(a) Standard: Components of a QAPI program. The transplant center'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 beneficiary matching, patient and donor management, techniques for organ recovery, consent practices, patient education, patient satisfaction, and patient rights. The transplant center must take actions that result in performance improvements and track performance to ensure that improvements are sustained.
(b) Standard: Adverse events. A transplant center must establish and implement written policies to address and document adverse events that occur during any phase of an organ transplantation case.
(2) The transplant center must conduct a thorough analysis of and document any adverse event and must utilize the analysis to effect changes in the transplant center's policies and practices to prevent repeat incidents.
(a) Standard: Director of a transplant center. The transplant center must be under the general supervision of a qualified transplant surgeon or a qualified physician-director. The director of a transplant center need not serve full-time and may also serve as a center'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 center and must devote sufficient time to carry out these responsibilities, which include but are not limited to the following:
(b) Standard: Transplant surgeon and physician. The transplant center 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.
(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:
(d) Standard: Independent living donor advocate or living donor advocate team. The transplant center 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.
(e) Standard: Transplant team. The transplant center 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 center 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.
Link to an amendment published at 84 FR 51823, Sept. 30, 2019.
In addition to meeting the condition of participation “Patients rights” requirements at §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:
(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;
(8) The fact that if his or her transplant is not provided in a Medicare-approved transplant center it could affect the transplant beneficiary 's ability to have his or her immunosuppressive drugs paid for under Medicare Part B.
(4) The availability of alternative treatments for the transplant beneficiary;
(6) The national and transplant center-specific outcomes for beneficiaries, and the national and center-specific outcomes for living donors, as data are available;
(9) The fact that if a transplant is not provided in a Medicare-approved transplant center it could affect the transplant beneficiary'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:
(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.
Link to an amendment published at 84 FR 51824, Sept. 30, 2019.
(a) Standard: End stage renal disease (ESRD) services. Kidney transplant centers must directly furnish transplantation and other medical and surgical specialty services required for the care of ESRD patients. A kidney transplant center must have written policies and procedures for ongoing communications with dialysis patients' local dialysis facilities.
(b) Standard: Dialysis services. Kidney transplant centers must furnish inpatient dialysis services directly or under arrangement.
(c) Standard: Participation in network activities. Kidney transplant centers must cooperate with the ESRD Network designated for their geographic area, in fulfilling the terms of the Network's current statement of work.