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.

[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]