Dynamic List Information
Dynamic List Data
Title
EXPIRED: Solid Transplant Programs - Outcome Thresholds - Revised Guidelines
Memo #
16-24-Hospitals (EXPIRED)
Posting Date
2024-11-18
Fiscal Year
2024
Title
EXPIRED AS OF 11/18/2024. FOR CURRENT GUIDANCE, REFER TO QSO-25-03-Transplant: Revisions to the State
Operations Manual (SOM), Chapter 2- The Certification Process; SOM Appendix X,
Guidance to Surveyors: Organ Transplant Programs; and SOM Chapter 9- Exhibits –
Advance Copy for current guidance.
• Background on Organ Transplant Outcomes Standards: Medicare Conditions of Participation (CoPs) require that each solid organ transplant program maintain patient and graft survival rates that are within certain Centers for Medicare & Medicaid Services (CMS) tolerance limits. Specifically, when the total number of patient deaths or graft failures that occur within one year of transplant exceeds 150% of the risk-adjusted expected number (i.e., 1.5 times the expected number) for a 2.5-year period, and the result is both statistically significant (p<.05) and numerically meaningful (O – E >3), then the program is not in compliance with CMS requirements.
• Revisions to Interpretive Guidelines: We are revising the CMS Survey & Certification interpretive guidelines to provide that such outcomes between 150% and 185% of the risk-adjusted expected number will generally constitute a “standard level” deficiency. A standard level deficiency requires improvement efforts but does not by itself put a program’s Medicare participation at risk. One-year post-transplant patient deaths or graft failures that exceed 185% of the expected number will generally be classified at the more serious “condition-level” if such a finding occurs in more than one (SRTR) report.
• Reasoning: Since mid-2007 (the effective date of the CMS transplant regulations), national patient and graft survival rates have improved. Because individual programs are compared against the national risk-adjusted average, the national improvement has made the CMS outcomes standard increasingly stringent. We are concerned that transplant programs may avoid using certain available organs that they believe might adversely affect the program’s outcome statistics. We expect that this revised policy, by lessening such concerns and augmenting the policy with other efforts, will promote more effective use of available organs and help more waitlisted individuals to benefit from a transplant, while continuing to promote high rates of patient and graft survival.
Operations Manual (SOM), Chapter 2- The Certification Process; SOM Appendix X,
Guidance to Surveyors: Organ Transplant Programs; and SOM Chapter 9- Exhibits –
Advance Copy for current guidance.
• Background on Organ Transplant Outcomes Standards: Medicare Conditions of Participation (CoPs) require that each solid organ transplant program maintain patient and graft survival rates that are within certain Centers for Medicare & Medicaid Services (CMS) tolerance limits. Specifically, when the total number of patient deaths or graft failures that occur within one year of transplant exceeds 150% of the risk-adjusted expected number (i.e., 1.5 times the expected number) for a 2.5-year period, and the result is both statistically significant (p<.05) and numerically meaningful (O – E >3), then the program is not in compliance with CMS requirements.
• Revisions to Interpretive Guidelines: We are revising the CMS Survey & Certification interpretive guidelines to provide that such outcomes between 150% and 185% of the risk-adjusted expected number will generally constitute a “standard level” deficiency. A standard level deficiency requires improvement efforts but does not by itself put a program’s Medicare participation at risk. One-year post-transplant patient deaths or graft failures that exceed 185% of the expected number will generally be classified at the more serious “condition-level” if such a finding occurs in more than one (SRTR) report.
• Reasoning: Since mid-2007 (the effective date of the CMS transplant regulations), national patient and graft survival rates have improved. Because individual programs are compared against the national risk-adjusted average, the national improvement has made the CMS outcomes standard increasingly stringent. We are concerned that transplant programs may avoid using certain available organs that they believe might adversely affect the program’s outcome statistics. We expect that this revised policy, by lessening such concerns and augmenting the policy with other efforts, will promote more effective use of available organs and help more waitlisted individuals to benefit from a transplant, while continuing to promote high rates of patient and graft survival.