Sickest of Liver Transplant Patients Increasingly Excluded from Waiting Lists

An increasing number of the sickest liver transplant candidates are being removed from waiting lists. Despite an initiative put in place by the Center for Medicare and Medicaid Services (CMS), these numbers have only grown.

Authors of a recent study published in the Journal of the American College of Surgeons reported that more than 4300 Americans with life threatening liver diseases were removed from the transplant waiting list (delisted) between mid-2007 and 2012.

This number was nearly double that of delisted candidates in April 2002 to June 2007.

“The central tenet of liver transplant allocation is to prioritize the sickest patients first,” said senior investigator Adel Bozorgzadeh, MD, FACS. “Yet, more and more patients who could potentially benefit from a liver transplant are being denied this lifesaving procedure.”

In 2007, CMS started a new regulatory policy titled Conditions of Participation (CoP) that looked to establish expectations for safe and high quality transplant services in Medicare-participating facilities.

Under the new policy, the outcome reports were used to label transplant centers as either “good” or “bad.” Facilities that performed below the benchmark for the number of transplant procedures and the 1-year survival rates for the patient and the transplanted organ could potentially be faced with consequences.

The unmet conditions could result in the loss of Medicare funding and coverage by private insurers, or even face closure.

For the study, researchers gathered data from the Scientific Registry of Transplant Recipients to examine trends in delisting rates, 1-year post-transplant morality, and death rates for 90,795 adults on the transplant waiting list from April 2002 through December 2012 at 102 liver transplant centers.

Trends were compared during the 5 years before the implementation of CoP versus after implementation. The results of the study revealed that the CoP policy was not associated with a significant improvement in 1-year post-transplant mortality rates.

The 1-year survival rate increased slightly from 86.6% before CoP to 88.5% after CoP implementation.

“Although the CoP policy was a quality improvement initiative designed to improve transplant patient outcomes, in reality, it failed to show beneficial effects in the liver transplant population,” said lead study author Natasha Dolgin, PhD.

Immediately after CoP was implemented, researchers saw a 16% spike in liver transplant candidates who were delisted because they had become “too sick for transplant” or were “medically unsuitable.”

The likelihood of delisting continued to rise by 3% per quarter through the end of the study. Before CoP, on average, there was 1 delisting for every 9 transplants. However, this ratio increased to 1:5 after implementation.

Researchers believe that the changes in waiting list management may be due to the CoP inadvertently influencing transplant centers to become more adverse to risk, especially the centers flagged for underperformance.

According to the study authors, the transplant teams responsible for patients who are removed from the waiting list should weigh the risk of death after the transplant against the patient’s risk of death without a transplant.

However, CMS only considers death rates in transplant recipients and do not include patients who did not receive a transplant. Researchers believe that future transplant research and policy decisions should balance improving survival rates post-transplant with the survival rates of transplant candidates.