title: Decade-Long Trends in Liver Transplant Waitlist Removal Due to Illness Severity: The Impact of Centers for Medicare and Medicaid Services Policy.
abstract: The central tenet of liver transplant organ allocation is to prioritize the sickest patients first. However, a 2007 Centers for Medicare and Medicaid Services regulatory policy, Conditions of Participation (COP), which mandates publically reported transplant center performance assessment and outcomes-based auditing, critically altered waitlist management and clinical decision making. We examine the extent to which COP implementation is associated with increased removal of the "sickest" patients from the liver transplant waitlist.
  
  
  
  This study included 90,765 adult (aged 18 years and older) deceased donor liver transplant candidates listed at 102 transplant centers from April 2002 through December 2012 (Scientific Registry of Transplant Recipients). We quantified the effect of COP implementation on trends in waitlist removal due to illness severity and 1-year post-transplant mortality using interrupted time series segmented Poisson regression analysis.
  
  
  
  We observed increasing trends in delisting due to illness severity in the setting of comparable demographic and clinical characteristics. Delisting abruptly increased by 16% at the time of COP implementation, and likelihood of being delisted continued to increase by 3% per quarter thereafter, without attenuation (p < 0.001). Results remained consistent after stratifying on key variables (ie, Model for End-Stage Liver Disease and age). The COP did not significantly impact 1-year post-transplant mortality (p = 0.38).
  
  
  
  Although the 2007 Centers for Medicare and Medicaid Services COP policy was a quality initiative designed to improve patient outcomes, in reality, it failed to show beneficial effects in the liver transplant population. Patients who could potentially benefit from transplantation are increasingly being denied this lifesaving procedure while transplant mortality rates remain unaffected. Policy makers and clinicians should strive to balance candidate and recipient needs from a population-benefit perspective when designing performance metrics and during clinical decision making for patients on the waitlist.
authors.affiliation: Department of Surgery, Division of Organ Transplantation, UMass Memorial Medical Center, University of Massachusetts, Worcester, MA; Department of Quantitative Health Sciences, Clinical and Population Health Research, University of Massachusetts Medical School, Worcester, MA; Department of Surgery, Center for Outcomes Research, University of Massachusetts Medical School, University of Massachusetts, Worcester, MA. Electronic address: natasha.dolgin@umassmemorial.org.
authors.forename: Natasha H
authors.initials: NH
authors.lastname: Dolgin
authors.affiliation: Department of Surgery, Division of Organ Transplantation, UMass Memorial Medical Center, University of Massachusetts, Worcester, MA.
authors.forename: Babak
authors.initials: B
authors.lastname: Movahedi
authors.affiliation: Department of Surgery, Division of Organ Transplantation, UMass Memorial Medical Center, University of Massachusetts, Worcester, MA.
authors.forename: Paulo N A
authors.initials: PN
authors.lastname: Martins
authors.affiliation: Department of Quantitative Health Sciences, Clinical and Population Health Research, University of Massachusetts Medical School, Worcester, MA.
authors.forename: Robert
authors.initials: R
authors.lastname: Goldberg
authors.affiliation: Department of Quantitative Health Sciences, Clinical and Population Health Research, University of Massachusetts Medical School, Worcester, MA.
authors.forename: Kate L
authors.initials: KL
authors.lastname: Lapane
authors.affiliation: Department of Surgery, Center for Outcomes Research, University of Massachusetts Medical School, University of Massachusetts, Worcester, MA.
authors.forename: Frederick A
authors.initials: FA
authors.lastname: Anderson
authors.affiliation: Department of Surgery, Division of Organ Transplantation, UMass Memorial Medical Center, University of Massachusetts, Worcester, MA.
authors.forename: Adel
authors.initials: A
authors.lastname: Bozorgzadeh
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014487:Centers for Medicare and Medicaid Services, U.S. / Q000592:standards*; D005260:Female; D015276:Health Care Rationing / Q000592:standards*; D006291:Health Policy; D006801:Humans; D016031:Liver Transplantation / Q000592:standards / Q000639:trends*; D008297:Male; D008875:Middle Aged; D016012:Poisson Distribution; D012189:Retrospective Studies; D012720:Severity of Illness Index; D014481:United States; D014850:Waiting Lists; D055815:Young Adult