DEPARTMENT OF HEALTH HUMAN SERVICES Centers for Medicare Medicaid Services 7500 Security Boulevard, Mail Stop C2-21-16 Baltimore, Maryland 21244?1850 CENTERS FOR MEDICARE MEDICAID SERVICES Center for Clinical Standards and Quality/Quality Safetv 8: Oversight Group JUN 2 2 2318 Macon S. Woodward, MHSM, BSN, RN Baylor St. Luke?s Medical Center 6720 Bertner Ave., MC 2-11A Houston, TX 77030 Dear Mr. Woodward: On January 19, 2018, the Centers for Medicare Medicaid Services (CMS) noti?ed you that the Medicare approval for the CHI St. Luke?s Baylor College of Medicine Adult Heart Only (AHO) transplant program would be terminated on August 17, 2018 due to the program?s non- compliance with 42 CFR 482.82 Data submission, clinical experience, and outcome requirements for re-approval of transplant centers. However, CMS is authorized, pursuant to Special procedures for approval and re?approval of organ transplant centers, to consider evidence of mitigating factors that may have prevented a transplant program from demonstrating full compliance with ?482.82 if the program requests the consideration and submits evidence of the mitigating factors. CHI St. Luke?s Baylor requested this consideration and submitted documents to CMS for review on May 18, 2018. CMS has concluded its review of the documents and ?nds that the evidence submitted does not support an approval of mitigating factors. Described below are the elements considered in the CMS review of the documents submitted and the CMS ?ndings for each element. 1) The extent to which outcome measures are not met or exceeded: The documents submitted included a projection of anticipated compliance with ?482.82 at the time of the upcoming January 2019 Scienti?c Registry of Transplant Recipients (SRTR) report based upon program improvements since 2016. According to the most recent SRTR data report (January, 2014 ?June 2016), which included all deaths and graft failures within one (1) year of transplantation, CHI St. Luke?s Baylor AHO had a standardized mortality ratio of 2.06, indicating twice as many deaths as expected. This ratio is statistically greater than the expected. 2) ?488.61 Availability of Medicare-approved transplant centers in the area: The documents submitted by CHI St. Luke?s Baylor did not make any assertion that a lack of available Medicare?approved AHO transplant centers in the Houston, Texas area would negatively impact access for heart transplant recipients if the program approval was removed. Page 2- Macon S. Woodward CMS con?rmed that there are two (2) other Medicare approved heart transplant programs within the immediate area which are in compliance with the Medicare outcome requirements at 482.82 3) ?488.6l Extenuating circumstances (for example, natural disasters, that have a temporary effect on meeting the conditions of participation: The documents submitted by CHI St Luke?s did not assert extenuating circumstances for its non?compliance with 4) ?488.6l Program improvements that substantially address root causes of graft failures or patient deaths, that have been implemented and institutionalized on a sustainable basis that are supported by the outcomes more recent than the latest available SRTR report, for which there is suf?cient post-transplant patient and graft survival period and a suf?cient number of transplants such that CMS finds that the program demonstrates present day compliance with the requirements at Root Cause Analysis/Documentation of Improvement Implementation: The program did submit evidence of analysis of all deaths which occurred during the data non-compliance period. The analysis identi?ed the causes of the lower than expected outcomes as: l) intraoperative surgical processes, 2) right heart failure, and 3) vaso- dilatory shock. As a result of the analysis, the program identi?ed three improvements to be needed: 1) improve or streamline intraoperative surgical procedures; 2) procedures to minimize cardiopulmonary bypass and 3) reduce risk factors for right heart failure. However, it could not be con?rmed, from the documentation submitted, that the program implemented improvements to surgical processes or implemented procedures to minimize CPB time and reduce right heart failure. There was no documentation of program oversight to ensure that any improvements were implemented and sustained. Although the needed improvements were identi?ed by the program in 2016, as recent as the 2018 death analyses submitted, the program continued to identify the need to improve intraoperative surgical methods to reduce risk for right heart failure, safe stemal re-entry, and minimizing CPB time. The program also indicated in its application for consideration of mitigating factors that improvements were made to reduce issues with donor and recipient matching and recipient and donor selection. However, the documentation did not include information as to how issues with these factors were identi?ed (not included in submitted root cause analysis reports). The documentation also did not explain how the program implemented improvements in this area and how these improvements led to improved outcomes. 5) ?488.61 Whether the program has made extensive use of innovative transplantation practice relative to other transplant CMS ?nds that the innovative practices are supported by evidence-based published research literature Page 3? Macon S. Woodward 6) or nationally recognized standards or Institutional Review Boards (IRB) approval and the SRTR risk adjustment methodology does not take the relevant key factors into consideration: CHI St. Luke?s Baylor did not attribute innovation, which was not accounted for in the SRTR risk adjustment, as a mitigating factor for non-compliance with ?488.6l Whether the program?s performance, based on the OPTN method of calculating patient and graft survival, is within the thresholds for acceptable performance and does not flag OPTN performance review under the applicable OPTN policy: CHI St. Luke?s Baylor did not assert a discrepancy between CMS methodology and OPTN methodology for calculating patient and graft survival. CMS con?rmed that the program was not within the thresholds for acceptable performance July 2104 through December, 31 2016. Based upon the ?ndings noted above at and CMS will not approve mitigating factors for CH1 St. Luke?s Baylor AHO for its non-compliance with outcome measures at ?482.82. The Dallas Regional Of?ce of CMS has been copied on this letter and accordingly will CC: proceed with the termination of the approval of the adult heart program at CHI St. Luke?s Baylor. If you have any questions please submit them to us via SC Transplantteamavcms.hhsgov. Sincerely, tat Davi . rig CMS Dallas Regional Of?ce Ms. Gay Lord, CEO St Luke?s Baylor