REVISED: Outcome Requirements for Initial Transplant Program Approval

CMS issued QSO-25-04-Transplant REVISED on October 30, 2026, revising its October 10, 2024 guidance on outcome requirements for initial transplant program approval under 42 C.F.R. §§ 482.80 and 488.61. The CoPs at § 488.61 require that applicant transplant programs meet all data submission, clinical experience, and outcome requirements at § 482.80 before CMS grants initial Medicare certification. Because § 482.80(c) mandates one-year post-transplant survival data, CMS acknowledges that up to 18 months may elapse after a program performs its first transplant before the required data appear in the SRTR program-specific report. During that interval, neither CMS nor State Survey Agencies may initiate an onsite initial-approval survey. The revision introduces flexibility in the timing of compliance determinations and in the data CMS uses to assess a program's compliance. Under § 488.61(a)(2), CMS is authorized to review data "contained in" the most recent SRTR program-specific report. CMS states it will use raw 1-year patient and graft survival data available before SRTR completes its statistical methodology and comparative ranking to assess compliance and move forward with reviewing other CoPs while the final statistical comparison is pending. This conditional review is not a final certification determination and does not override the final outcome decision. CMS also clarifies that neither § 482.80 nor § 488.61 specifies when an onsite survey must occur relative to the final outcomes determination. CMS and the SA may conduct the onsite survey for all other Medicare CoPs and hold the outcome compliance determination open until the applicable SRTR program-specific report is published. Intestine and pancreas transplant programs remain exempt from the outcome requirements under § 482.80(d). Regarding effective dates under § 488.61(a)(5), where a program's other CoPs have already been surveyed and the program is awaiting only SRTR's final published statistical confirmation, CMS states it may set the certification effective date to the later of: the date the program achieved compliance with the data in the most recent SRTR report per § 482.80(c)(1), or the date other CoPs were shown to have been met based on the initial survey or an acceptable plan of correction. If the published SRTR report shows non-compliance with § 482.80, CMS denies initial approval. This flexibility applies case-by-case and does not alter the substantive requirement that all data submission, clinical experience, and outcome requirements must be met before certification is granted.