Request for Medicare Approval of an Organ

2061 – Request for Medicare Approval of an Organ Transplant Program (Rev. 227; Issued: 12-13-24; Effective: 12-13-24; Implementation: 12-13-24) Hospitals seeking initial approval for a new organ transplant program must submit a revised CMS-855A to its Medicare Administrative Contractor (MAC) to indicate the addition of service. The applicant transplant program must also submit a request for Medicare approval to the applicable State Survey Agency (SA) and copy CMS Baltimore (QSOG_TransplantTeam@cms.hhs.gov). Upon receipt of the applicant transplant program’s written request seeking initial approval, the SA will provide a packet of information to the applicant including a list of documents that must be submitted to the SA. CMS Baltimore will provide the applicant transplant program’s report specific to clinical experience, data submission, and outcomes requirements to the appropriate State Survey Agency and CMS Location. This will be reviewed prior to the onsite survey to determine compliance with initial approval requirements under §482.80. See Section 2062B.1 for additional guidance for determining compliance with the clinical experience, data submission, and outcome requirements at §482.80. The SA should confirm receipt of all necessary documents with the applicant and inform the applicant that the initial survey will be scheduled upon notification from the MAC that the revised CMS-855A has been approved. Office of Civil Rights clearance is not required separately for the transplant program located within the Medicare-certified hospital. 2061A - Transplant Services Medicare-certified Transplant Programs A transplant program located within a Medicare-approved hospital must meet the Conditions of Participation for transplant programs to be granted CMS approval to provide transplant services. These requirements apply to the following programs: Heart transplant program Liver transplant program Lung transplant program Pancreas transplant program* Kidney transplant program Intestine transplant program** *In order to perform pancreas transplants, a hospital must have an approved kidney transplant program. **In order to perform intestinal transplants, a hospital must have an approved liver transplant program. Pediatric or adult pancreas and intestine transplant programs that apply for initial Medicare approval must operate as a component of an existing Medicare-approved kidney or liver transplant program, respectively, which is in compliance with the CoPs (§§482.72-482.104). An onsite survey for initial approval of an adult or pediatric pancreas or intestine transplant program is not required and compliance with applicable requirements listed at §482.80 must be verified prior to approval using procedures specified in Section 2062B.1 of this Chapter. Enforcement action taken by CMS against a kidney or liver transplant program may impact the Medicare approval of the hospital’s pancreas and intestine transplant program. Programs Serving both Adult and Pediatric Populations Transplant hospitals may perform both adult and pediatric transplants, either under separate program approval or under a single transplant program approval. If a transplant program is seeking separate approval of its adult and pediatric programs, the programs will be surveyed separately. If a program plans to perform both adult and pediatric transplants under a single transplant program, e.g. adult kidney transplant program, the program must seek approval for the primary age group, either adult or pediatric, that it serves and perform the majority of its transplants within that age group. That is, a program that provides more than 50 percent of its transplants in a 12-month period to pediatric patients must apply as a pediatric program. A program that provides more than 50 percent of its transplants in a 12-month period to adults must apply as an adult program. Transplant Programs Performing Living Donation CMS does not require separate approval for transplant programs that may also provide living donor services. If living donor services are provided by a hospital other than the transplanting hospital, these services are considered to be provided under arrangement. As such, there must be a formal arrangement between the hospital in which the transplant program is located and any other hospital which provides living donor services for the transplant program. It is the transplant program’s responsibility to ensure that the CoPs applicable to living donors are met by the associated hospital providing the living donor services. The medical record of the living donor must confirm that all the requirements of the CoPs were met. Combined or Simultaneous Transplants In order for combined transplants to be performed in a transplant hospital, the Medicare- certified hospital must have separate approvals of transplant programs for each organ type to provide transplant services and meet the conditions of participation specified in §§482.72 through 482.104. For example, to perform a combined heart-lung transplant, the hospital must have an approved heart transplant program and a separately approved lung transplant program. Note: §482.70 defines a heart-lung program as a transplant program that is located in a hospital with an existing Medicare-approved heart transplant program and an existing Medicare-approved lung program that performs combined heart-lung transplants. To perform combined (or simultaneous) heart-lung transplants, a transplant hospital must have a Medicare-approved lung and a Medicare-approved heart transplant program. Separate approval as a “heart-lung” transplant program is not required. Combined transplants will be reviewed during the onsite survey of a transplant program. The transplant program survey protocol includes a review of individuals who received combined or simultaneous transplants during the survey process. See State Operations Manual, Appendix X for more information on the transplant program survey protocols and procedures. 2061B Organ Procurement and Transplantation Network Membership Membership in the OPTN by the transplant hospital in which the transplant program is located is a requirement for Medicare approval. OPTN membership means that the transplant hospital meets OPTN requirements and that it plays an active role in forming the policies that govern the transplant community. If a transplant program is determined to be non-compliant by the OPTN Board, it may deem the program a “Member Not in Good Standing” and refer the case to the Secretary for review. The OPTN maintains a member directory of transplant programs on its website, which can be accessed here: OPTN Member Directory. Key personnel for transplant programs can be searched on the OPTN website through the following link, Transplant Program, Key Personnel Member Directory. Use the "Transplant Center by Organ," search option and choose the specific organ.