Survey and Approval Procedures for Organ

2062 - Survey and Approval Procedures for Organ Transplant Programs (Rev. 227; Issued: 12-13-24; Effective: 12-13-24; Implementation: 12-13-24) 2062A – Survey Composition and Scope Survey Team Composition SAs should schedule a minimum of two (2) surveyors for review of abdominal transplant programs (kidney, liver, intestine and pancreas) and a minimum of two (2) surveyors for thoracic transplant programs (heart and lung). These are separate survey teams and should not be combined, even if the programs are all surveyed simultaneously. Refer to the transplant program survey protocol in Appendix X for additional discussion on team composition. When more than one transplant program is surveyed at a hospital, all deficiency citations from all the programs may be entered onto one Form CMS-2567. However, the deficiencies cited for each program must be separate and clearly identifiable for the applicable program. The CMS survey database allows for the selection of distinct programs. Scope A transplant program must be located within a Medicare-certified hospital. In addition to meeting the transplant Conditions of Participation at §§482.72 through 482.104, the transplant program must also be in compliance with hospital CoPs at §§482.1 through 482.57. Most hospitals seek Medicare certification through private, CMS-approved accrediting organizations. Unlike hospitals, there are currently no CMS-approved accrediting organizations that are authorized to deem transplant programs and therefore, transplant programs remain under the oversight of the State Survey Agency. If a State Survey Agency conducts a hospital survey in conjunction with a transplant program survey, the transplant program and hospital survey findings are documented on separate CMS-2567 forms even though the surveys may be conducted together. During a stand-alone transplant program survey, a surveyor may also identify possible noncompliance with the hospital regulations. When hospital requirements are thought to be out of compliance and in need of investigation, the transplant program survey team must contact their supervisor to consult with the CMS Location. Non-deemed Hospital: If the hospital in which the transplant program is located is not a deemed hospital, these concerns may be investigated by the State Survey Agency as a hospital complaint investigation. Findings of non-compliance should be cited on a separate Form CMS-2567 under the name and CCN of the hospital in which the transplant program is located. Deemed Hospital: If the hospital in which the transplant program is located is a deemed facility, the surveyor must contact his/her office and receive authorization from CMS to conduct a hospital complaint investigation. Any deficiencies cited under the hospital requirements must be entered onto a separate CMS-2567. Chapter 5, Section 5100 of the SOM provides additional information for handling complaints of deemed facilities. 2062B Types of Surveys and Related Guidance 2062B.1 Initial Survey for Medicare Approval See Section 2061 above for instructions on requesting initial approval. Once the MAC notifies the SA of its approval of the updated CMS-855A, a survey may be scheduled. Initial surveys are unannounced. If the applicant transplant program is found to be in compliance with the CoPs, it is assigned a CCN. The program will not be issued a separate provider agreement. Once transplant program approval is completed, the CMS Location will forward a form CMS-2007 (Provider Tie-In Notice) to the MAC. The ESRD Networks must also be notified for the initial approval of a kidney transplant program. Approved transplant programs operating within a single hospital are issued a CCN in the 9800 series. All approved programs that operate within a hospital fall under this transplant CCN. No separate or additional transplant CCN is issued for approved transplant programs under a single transplant center. Data Submission, Clinical Experience, and Outcome Requirements for Initial Approval Transplant programs must meet requirements for data submission, clinical experience, and outcomes at §482.80 to receive their initial Medicare approval or may seek mitigating factors review for noncompliance associated with this requirement in accordance with §488.61. Surveyors will need to request and obtain CMS’ Initial Transplant Report (ITR) to determine whether the applicant program meets the criteria determined by §482.80. Upon receipt of a transplant program’s request for initial approval, CMS Baltimore will provide the CMS Location and SA with the ITR. This report contains data that measures the program’s data submission rate, volume (clinical experience), patient/graft survival rates (outcomes), and whether the transplant program under review has met these requirements. Provisions under §488.61 authorize CMS to consider mitigating factors when determining approval for a transplant program that has not met the data submission, clinical experience, or outcome requirements if the program submits a formal, written request for such a review. If the applicant does not wish to apply for mitigating factors consideration for non- compliance at §482.80, the initial application will be denied, and the provider will be notified of the denial in writing. If the applicant is determined to be out of compliance with any Condition of Participation other than §482.80, the initial application should be denied and all usual certification processes for denials should be followed. Determining the Level of the Deficiency for Non-Compliance Clinical Experience Requirements at 42 CFR §482.80(b): Compliance with the clinical experience (volume) standards at 42 CFR §§482.80(b) is determined by reviewing the program’s performance compared to the objective standards outlined in the regulation. The goal of this section is to achieve consistency in determining the level of a deficiency citation, (i.e., condition level, or standard level) under these CoPs. To be considered for initial approval, a transplant program must “generally perform 10 transplants over a 12-month period” (§482.80(b)). If the program performs at least eight transplants over a 12-month period, it may be approved with an acceptable plan of correction. If a transplant program other than a kidney transplant program has not performed at least eight transplants in the most recent 12 months at the time of the program’s request for initial approval, an initial approval survey cannot be conducted. Kidney programs that have not performed at least three transplants over a 12-month period may not be surveyed for initial approval. The program should be instructed to notify the SA when it has met the minimum requirement to initiate an onsite survey. If the program has performed at least eight but less than 10 transplants in that 12-month time period, non-compliance at X-033 will be cited as a standard-level deficiency. The program may still be approved with a standard-level citation for Clinical Experience if an acceptable plan of correction is received and the program is in substantial compliance with all remaining CoPs. During an onsite survey, transplant programs may provide evidence of conducting additional transplants which are more recent than the information provided in the ITR. Surveyors should use this information when reviewing a program’s compliance with CMS’ clinical experience requirement. The determination of condition-level non-compliance is made based upon the extent of any non-compliance findings with the standards under a CoP. A finding of non-compliance with the Clinical Experience standard alone with no other non-compliance with standards under the Condition would generally not result in condition-level non-compliance determination at §482.80. Note: A program’s inactivity does not create an exception to the clinical experience requirement. See section 2062B.5 for more information on transplant program inactivity. Outcome Requirements at 42 CFR §482.80(c): Transplant programs must meet or exceed national thresholds for one-year post-transplant patient and graft survival to be in compliance with CMS’ outcome requirements for initial certification at 482.80(c). Determining compliance with this requirement is made using data from the Initial Transplant Report, which is provided to the CMS Location and SA by CMS Baltimore. If there is no outcome data available, this may mean that not enough time has passed to determine one-year patient and graft survival rates, or the program has not performed enough transplant surgeries to generate a report. Outcomes data must be available in order to determine compliance with the requirement at 482.80(c). If the data is not yet available, an onsite survey cannot be initiated and the SA should notify the provider that the initial survey will occur once the data becomes available. The following transplant program types are subject to the outcome requirements, i.e., one- year patient and graft survival: • Adult Kidney • Adult Heart • Adult Lung • Adult Liver • Pediatric Kidney (includes only 1-year graft survival) • Pediatric Heart • Pediatric Lung • Pediatric Liver The following transplant program types are not subject to the outcome requirements: • Adult Pancreas • Pediatric Pancreas • Adult Intestine/Multivisceral • Pediatric Intestine/Multivisceral Initial Surveys after Outcomes Data Becomes Available The SA will conduct a full onsite survey for initial approval once they verify that all required certification materials have been submitted, received, and determined complete, including data required to determine compliance with the data submission, clinical experience and outcome requirements at §482.80. Once this verification is completed, the state agency will proceed with scheduling an onsite survey to determine compliance with the CoPs at §§482.72 through 482.76 and §§482.90 through 482.104. Results of the initial onsite survey for transplant programs: • Initial approval: If the SA determines that the transplant hospital is in substantial compliance with all CoPs or has standard-level deficiencies with an accepted plan of correction, CMS will notify the transplant hospital in writing of its approval and the effective date of the approval. The effective date of Medicare approval is determined using existing procedures in the State Operations Manual, Ch. 2, Section 2008D. • Initial denial: If the SA determines that the transplant program has failed to meet CoPs other than §482.80, CMS will notify the transplant hospital in writing of the denial. Mitigating factors will not be considered for condition-level deficiencies. The transplant hospital may reapply for Medicare approval after correcting any deficiencies. If the transplant hospital reapplies for initial Medicare approval, it will undergo a new initial onsite survey. • Initial approval or denial based on mitigating factors: If CMS determines that the transplant hospital is in substantial compliance with all CoPs, i.e., no condition- level deficiencies, except for §482.80, or has standard-level deficiencies with an accepted plan of correction, CMS will consider mitigating factors using procedures specified in §488.61(e) in its consideration of initial approval. Upon review of the program’s request to consider mitigating factors for failure to meet the outcome requirements, CMS will make a determination of Medicare-approval or denial. For more information on the mitigating factors process, see Section 2066. 2062B.2 Re-approval Surveys Once a transplant program has been approved to participate, it will be periodically re- surveyed for compliance with the CoPs. Re-approval surveys are unannounced surveys and are performed at a frequency consistent with the CMS Mission and Priority Document (MPD). SAs may follow usual recertification procedures for non-deemed hospitals (SOM Chapter 2, Section 2021A) in cases where the survey results in a determination of substantial compliance with all Conditions of Participation. 2062B.3 - Complaint Surveys Transplant program complaints may involve hospital CoPs, in addition to any transplant program CoPs. Additionally, most hospitals with transplant programs are deemed to meet CMS requirements based upon accreditation through an Accrediting Organization (AO) with a CMS-approved hospital program. If a transplant program complaint survey results in possible deficiencies with the hospital requirements at §§482.1 through 482.57, the CMS Location must approve any investigation of the hospital CoPs. A transplant program is an integral part of the hospital and must meet all applicable hospital Conditions of Participation. Transplant programs and hospitals share most operations including nursing staff and nursing administration, rules for the operating room, credentialing, and quality of patient care. While the transplant program CoPs include specific requirements for evaluation for transplant, wait-listing, and allocation of organs, the requirements for many of the shared services, such as surgical services and nursing services, are specified in the hospital CoPs rather than the transplant program CoPs. All complaints against a Medicare-certified transplant program will be referred to the applicable SA for triage and investigation by the SA hospital survey staff or applicable AO, if the hospital is deemed. If the nature of the allegations suggests non-compliance with any hospital CoPs, a hospital complaint survey would be performed. See SOM, Chapter 5, for a description of the general complaint investigation process. For complaint investigations of a transplant program, the scope of survey activities is generally limited to the specific transplant CoPs associated with the allegation(s). If allegations are substantiated, the scope may be expanded to review any associated CoPs. Complaints related to disease transmission via an organ from a deceased donor should be communicated to the RO for their determination of the need for an OPO complaint investigation.