Mitigating Factors

2066 - Mitigating Factors (Rev. 227; Issued: 12-13-24; Effective: 12-13-24; Implementation: 12-13-24) Background Under 42 CFR §488.61(e), a transplant program may request that the CMS consider mitigating factors for the initial approval of a transplant program that does not meet the CoP at §482.80 for data submission, clinical experience, or outcome requirements. Mitigating factors will not be considered in situations of immediate jeopardy or any other cited deficiency. The regulation describes general considerations that will be reviewed in determining whether a program can be approved based on mitigating factors at 42 CFR §488.61(e)(1). These areas include (but are not limited to): 1. The extent to which outcome measures are not met or exceeded; 2. Availability of Medicare-approved transplant programs in the area; 3. Extenuating circumstances (for example, natural disasters) that have a temporary effect on meeting the CoPs; 4. Program improvements that substantially address root causes of graft failures or patient deaths, that have been implemented and institutionalized on a sustainable basis, and that are supported by outcomes more recent than the latest available Scientific Registry of Transplant Recipients (SRTR) report, for which there is a sufficient post-transplant patient and graft survival period and a sufficient number of transplants such that CMS finds that the program demonstrates present-day compliance with the requirements at §482.80(c)(2)(ii); 5. Whether the program has made extensive use of innovative transplantation practices relative to other transplant programs, such as a high rate of transplantation of individuals who are highly sensitized or children who have undergone a Fontan procedure, where CMS finds that the innovative practices are supported by evidence-based published research literature or nationally recognized standards or Institution Review Board (IRB) approvals, and the SRTR risk- adjustment methodology does not take the relevant key factors into consideration; and 6. Whether the program's performance, based on the Organ Procurement and Transplantation Network (OPTN) method of calculating patient and graft survival, is within the OPTN's thresholds for acceptable performance and does not flag OPTN performance review under the applicable OPTN policy. Requesting Initial Approval Based on Mitigating Factors Once a survey has been performed and the applicant transplant program is determined to be out of compliance with §482.80, it may request consideration of mitigating factors to address this non-compliance. A transplant program requesting initial approval based on the presence of mitigating factors must complete the following steps: 1. Send Timely Letter of Intent to Apply for Mitigating Factors: if CMS determines a transplant program has not met the data submission, clinical experience, or outcome requirements for initial approval, CMS may deny the request for initial approval. The program will receive a letter notifying the program of its denial. The transplant program must respond to CMS’s letter with its intent to apply for mitigating factors review. Within 14 calendar days after CMS has issued to the program a formal written notice of a condition-level deficiency under §482.80, CMS must receive notification of the program's intent to seek mitigating factors review. All requests for consideration of mitigating factors should be sent electronically to the CMS Location where the hospital is certified and CMS Baltimore at QSOG_TransplantTeam@cms.hhs.gov. 2. Send Timely and Complete Mitigating Factors Application: all information necessary for consideration must be received within 120 calendar days of CMS’ written notification of noncompliance at §482.80. See the Mitigating Factors Web Instructions in the “Downloads” section of the CMS Transplant page for additional information on the required contents to deem an application complete. The complete mitigating factors application should be sent electronically to both the CMS Location where the hospital is certified and CMS Baltimore at QSOG_TransplantTeam@cms.hhs.gov. Failure to meet any of these timeframes may be the basis for denial of mitigating factors. Preparing the Mitigating Factors Application A request for consideration of mitigating factors must include sufficient information to permit an adequate review and understanding of the transplant program, the factors that have contributed to outcomes, program improvements or innovations that have been implemented or planned, and in the case of extenuating circumstances, such as a natural disaster, fire, or a pandemic, the recovery actions planned. In order to ensure a complete and thorough application, the following criteria should be followed: • The application must include all elements noted in the mitigating factors application checklist. See the Mitigating Factors Web Instructions in the “Downloads” section of the CMS Transplant page for additional information on the required contents to deem an application complete and ready for submission to CMS. The mitigating factors application checklist that was used must also be submitted as part of the application record. • The pages of application documents should be sequentially numbered and sent as a single Adobe Portable Document Format (.pdf) or Microsoft Word (.doc or .docx) file. CMS strongly suggests the mitigating factors application be sent electronically, without the use of encryption or password protection. This will ensure that CMS is aware of all supporting documentation provided and will help facilitate the review process. • Mitigating factors application materials must have all Personally Identifiable Information (PII) removed prior to submission to ensure a timely review. • The application narrative should be concise and the supporting documentation relevant to the rationale and mitigating factors requested. See the Mitigating Factors Web Instructions in the “Downloads” section of the CMS Transplant page for more information on Mitigating Factors: Areas for Consideration. • The program should limit the file size to a maximum of 200 pages. Outcomes of a Mitigating Factors Application Review All mitigating factors applications will be reviewed by CMS Baltimore. The CMS review will include analysis by CMS staff and technical experts with programmatic and clinical expertise for each transplant program on a case-by-case basis. Following the review, CMS Baltimore will provide a recommendation to the respective CMS Location for approval or denial of the mitigating factors application based on review criteria and elements for approval. Following the recommendation, the respective CMS Location may take the following actions: 1. Grant initial approval of a program's Medicare participation based upon mitigating factors. 2. Deny the program's request for Medicare approval based on mitigating factors. 3. Offer a time-limited Systems Improvement Agreement (SIA) in accordance with 42 CFR §488.61(g), when a transplant program has waived its appeal rights, has implemented substantial program improvements that address root causes and are institutionally supported by the hospital's governing body on a sustainable basis, and has requested more time to design or implement additional improvements or demonstrate compliance with CMS outcome requirements. Upon completion of the SIA or a CMS finding that the hospital has failed to meet the terms of the SIA, CMS makes a final determination of whether to approve or deny a program's request for Medicare approval based on mitigating factors.