Federal Court Ruling Means Liver Transplant Patients Locally and Nationally May Spend More Time on Wait List

KANSAS CITY, Kansas, Feb. 25, 2020 /PRNewswire/ -- Effective this week, liver transplant patients in many areas will spend more time on a wait list and the overall cost of liver transplants will increase.

A new policy adopted by the United Network for Organ Sharing (UNOS) in its capacity as the Organ Procurement Transplantation Network (OPTN) took effect Tuesday, despite a request for an injunction by several organ transplant centers and patients to stop it.

The policy, known as the "Acuity Circles Policy" will result in a dramatic shift -- from sharing donor livers based on medical need while prioritizing local patients to flying organs and transplant teams up to 500 nautical miles away from each donor hospital. The new policy means more risk for patients, donor organs, and transplant teams, more time spent on certain wait lists, as well as significantly higher transplantation costs.

The University of Kansas Health System, along with 13 other organizations, including organ transplant centers and patients, have been working together to ensure patients in rural regions and in lower socioeconomic areas maintain fair access to liver transplants.

"The Plaintiff institutions, located in regions with significant rural swaths of poverty as well as higher under-insurance rates, are predicted by the statistical modeling generated in connection with the Acuity Circles policy to lose their relative position of access to transplant organs," wrote U.S. District Judge Amy Totenberg in the ruling.

Despite this acknowledgement, the court allowed the new policy to proceed.

"The Acuity Circles Policy will not save more lives, it will increase costs for transplants and it will lead to a higher percentage of wasted organs nationally," said Sean Kumer, MD, transplant surgeon and vice president of Perioperative Services. "This is terrible news for any patient on a liver transplant waitlist, especially patients in rural or socio-economically disadvantaged areas of the country."

The coalition working against the new policy argues that Acuity Circles are based on flawed modeling data and the OPTN significantly underestimates the number of increased deaths likely to occur.

In fact, publicly available data from the OPTN following a similar change in the lung transplant policy already shows a net 16 percent increase in wasted organs.

It is also universally agreed the policy will increase the cost of transplantation. These costs will be disproportionately borne by transplant centers in the South and Midwest. The financial viability of certain centers is potentially at risk, and with loss of a transplant center, liver disease deaths in these communities will increase in ways not predicted by the OPTN's data models.

There will be fewer transplants in low-socioeconomic communities and areas of the country that have diminished access to quality health care and liver specialists, according to critics of the policy. Candidates in these areas are more likely to die without a transplant than candidates in parts of the country that will receive more organs under the policy. These already at-risk candidates are the very people who will be harmed most by the policy.

Currently, the United States is divided into 11 regions and 58 smaller geographic areas called "donation service areas" or DSAs. Donated livers are offered first to the sickest patients in the donor's DSA and region and then shared nationally.  A transplant candidate's level of illness is judged using something known as the Model for End-Stage Liver Disease score, or MELD, which is a calculation that gives patients scores ranging from 6 (least ill) to 40 (gravely ill). MELD is based on lab values and "bonus" points, which are called exception points.

With the new policy, three circles are drawn around the local donor hospital: small (150 nautical miles), medium (250 nautical miles) and large (500 nautical miles). In the proposed new system, donor livers using MELD scores with a revised system of exception points would be shared first nationally and then regionally and/or locally. So local liver donors are less likely to see their donated organs helping people in their region – they are more likely to be flown across the country, which increases the risk those organs can be transplanted in time.

"The University of Kansas Health System and its co-plaintiffs are disappointed that the court concluded Plaintiffs did not meet the legal burden at this preliminary phase to warrant continued suspension of the ill-conceived new liver allocation policy," said Dr. Kumer.

The court did identify troubling aspects of transplant policymaking that the opposition will continue to challenge:

• The court recognized that there were "serious" defects in the policy development process undertaken by HHS and its contractor, the United Network for Organ Sharing (UNOS).  For example, the court noted that Plaintiffs raised "credible issues regarding the reliability" of the statistical modeling used by HHS and UNOS to defend their new policy.
• The court found that Plaintiffs presented "colorable evidence" of "animosity" and "regional bias" on the part of UNOS executives and major players within the transplant community, who acted with an "agenda" in favor of the new policy, which will likely benefit their geographic regions.
• The court was especially "concerned about the absence of a transition policy," which, if adopted, would ensure that citizens in Kansas who are on the liver transplant waitlist before the effective date of the new policy are not disadvantaged by the new policy's implementation.  The court concluded that implementation of such a transition policy "should be an essential priority" to mitigate disruption and patient harm. 

So far, UNOS has expressed no plans to develop or adopt such a patient transition policy. 

"The University of Kansas Health System strongly supports the development and implementation of a transition policy so that gravely ill patients currently on the liver transplant waitlist are not unfairly harmed by rash policy changes and continue to have the same opportunity to receive a life-saving transplant they expected when they joined the waitlist," said Dr. Kumer. "Our most important priority is our patients. While we are waiting on notification from UNOS about the details of implementing the new policy, we will begin counseling our patients on the impact of that policy and how it affects their waitlist status, with or without a transition policy. Patient care is, of course, our primary concern. As always, we will continue to offer the best possible care to our waitlisted patients and will do all that we can to maximize each patient's opportunity to receive a life-saving transplant."

The video includes interviews with Dr. Kumer, Dr. Ryan Taylor, a nephrologist at The University of Kansas Health System, a patient, Lou Rider, who is awaiting a liver transplant, and his wife Edna. Also interviewed is another patient, Tyler Reimer, also awaiting transplant. Reimer is a teacher and coach in the Gardner School District, and video shows him doing both. The video also shows Dr. Taylor in an office visit and Dr. Kumer performing a liver transplant in the operating room.

SOURCE The University of Kansas Health System