In 2007, the Centers for Medicare and Medicaid implemented the Conditions of Participation policy to establish expectations for liver transplant facilities that treat Medicare-insured patients. However, a new study shows that since then, more liver transplant patients on the waitlist have been delisted at a faster rate and 1-year posttransplant survival rates have only risen slightly.
“We illustrate that the 2007 implementation of the U.S. Centers for Medicare and Medicaid Conditions of Participation (CoP) regulatory policy was associated with an immediate, sharp increase in the likelihood of liver transplant candidate waitlist removal. This trend did not attenuate during the 5-year period after CoP,” Natasha Dolgin, PhD, of the University of Massachusetts Medical School MD/PhD program, told Healio.com/Hepatology. “Patients who could potentially benefit from liver transplantation are increasingly denied this life-saving procedure, and posttransplantation survival did not significantly improve pre-post COP implementation, resulting in a net population-level loss.”
Under the CoP, CMS used Scientific Registry of Transplant Recipient-generated transplant program-specific performance reports to determine which centers performed the best and worst, according to the research. If a center underperformed according to the policy, the center could be put at risk to lose CMS funds and other consequences.
Dolgin and colleagues sought to evaluate whether effects of CoP “flagging” at the transplant center level impacted the liver transplant waitlist at the national level. They evaluated data from the Scientific Registry of Transplant Recipients and studied trends in delisting rates and 1-year posttransplant mortality rates of 90,765 adults from 102 LT centers waiting for a liver from a deceased donor. They quantified the effect of COP implementation on trends in waitlist removal due to “illness severity,” and 1-year posttransplant mortality using interrupted time series analysis, according to the research.
Results showed that immediately after implementation of the CoP policy — based on illness severity — incidence of delisting abruptly increased by 16%. The likelihood of being delisted continued to increase by 3% per quarter thereafter, without attenuation (P < .001). The researchers report that on average, one patient was delisted for every five transplants in the years following CoP policy implementation compared with one for every nine transplants pre-implementation.
Of the patients who were delisted for being “too sick to transplant,” 88% died within 1 year of removal and 52% died within 1 week. Approximately 1,423 additional candidates died within 1 year after being delisted after CoP was implemented compared with before. There was a slight increase in transplant survival rates from 86.6% to 88.5%, but CoP did not have an impact on transplant mortality rate or trends (P = .38).
“We conclude that although the 2007 CMS CoP policy was a quality initiative designed to improve patient outcomes, in reality, it failed to show beneficial effects for the liver transplantation population overall,” Dolgin said. “Future studies on understanding these trends and efforts to rebalance the waitlist and transplant outcomes scale are warranted, and this balance should be considered during development of future national policies and in clinical decision making to better serve this patient population.” – by Melinda Stevens
Disclosure: The researchers report no relevant financial disclosures.