Concerns with the New Liver Distribution Policy


Concerns with the New Liver Distribution Policy

In December of 2018, the Organ Procurement and Transplantation Network (OPTN) and the United Network for Organ Sharing (UNOS) voted unanimously to approve a new liver distribution policy. Among the policy’s provisions, it moved to a national rather than regional sharing system, and to a more standardized review of exception to the patient’s MELD scores (basically a numerical representation of severity of illness).

Eight people die everyday waiting for a liver transplant. While I certainly appreciate the hard work that has gone into the development of these policies by UNOS expert volunteers and staff, as a liver transplant recipient, and former UNOS staff/member of the Membership and Professional Standards committee, I have concerns with these new policies. They will undermine the community benefit of community organ donation, reward underperforming organ procurement organizations, and ignore the science of negative impact of longer ischemic time on organ viability and patient outcomes.

Apparently, 20 Senators share my concerns. On January 24th 2019, U.S. Senator Chuck Grassley of Iowa, and U.S. Senator Roy Blunt of Missouri, led their Senate colleagues in sending a bipartisan letter to Secretary Alex Azar of the U.S. Department of Health and Human Services (HHS) demanding answers from OPTN.

The Senators asked several key questions such as:

  • To what extent did the OPTN Board consider the 2018 recommendation of the Liver and Intestine Transplantation Committee in making this policy change?

  • Did the department question why the Liver and Intestine Transplantation Committee’s recommendation was overruled?

  • To what extent did the OPTN board account for regional variations in liver donation rates, and regional disparities in OPO’s performance in considering this change?

  • What modeling was conducted on the effect of this change on individual’s willingness to donate?

  • What data did the OPTN Board use to support this decision, and to what extent did the Board consider the potential adverse effects of its policy change on low-income populations and residents of rural communities?

  • To what extent will this change increase transportation costs and impose logistical barriers for hospitals in different regions of the country?

GLI, and I will continue to keep our fingers on the pulse of this important issue. We expect answers from HHS, and will have an update for our readers in future issues of the Liver Health Policy Update.


Donna R. Cryer, JD
President & CEO
Global Liver Institute


OPTN (see “Perspective” above) invites public comments on policy and bylaws proposals. Comments on their policy proposal on “expedited placement of livers” are being accepted until March 22, 2019. Check out the OPTN site to review the proposed policy and to record comments.

Rare Disease Day will be celebrated on February 28, 2019. If you or someone you know has been affected by a rare liver disease, GLI encourages you to participate by advocating for rare diseases. National Organization for Rare Disorders (NORD) offers a variety of example advocacy opportunities for you to advocate on behalf of those with rare disorders. To learn more about Rare Disease Day and how you can celebrate, visit NORD’s website.



Applications for GLI’s Advanced Advocacy Academy (A3) Class of 2019 are now open! A3 2019 will offer liver patients, caregivers, and professionals the opportunity to learn from experts in the fields of drug development, state and federal legislation, media and communications, and liver health and disease. If you or someone you know is interested in attending, visit the A3 website to learn more and to apply.



World Health Organization (WHO)

WHO published a report detailing ten threats to health in 2019. Noncommunicable diseases, such as liver cancer, NALFD, and NASH, are all examples of threats to the health of people across the globe. Noncommunicable liver disease can be attributed to physical inactivity, genetic abnormalities, tobacco and alcohol use, and unhealthy diet. To combat noncommunicable disease, WHO is attempting to reduce physical inactivity by 15% by 2030. To learn more about noncommunicable disease and how WHO is trying to combat noncommunicable disease, read their report here.

British Liver Trust

The NHS Organ Donor Register has released new donor cards that contain information about a donor’s faith and/or beliefs. This update comes after a study done in England that revealed that some people felt as though faith and beliefs were under-recognized in organ donation. NHS hopes that this development will encourage more people and families to consent to organ donation, increasing the number of livers available for transplant. Read British Liver Trust’s press release to learn more about the role of faith and beliefs in organ donation and how you can register to be an organ donor.


Food and Drug Administration (FDA)

FDA Commissioner Dr. Scott Gottlieb MD issued a statement on FDA’s commitment to advancing its biosimilars policy framework. 2018 brought increased marketplace competition, record-breaking generic drug approval, lowered drug costs, and increased drug accessibility for patients. In 2019, FDA hopes to see similar themes in the biologics market. The Biosimilars Action Plan, released in July 2018, detailed advances to FDA’s Biologics Price Competition and Innovation Act (BPCIA) including improvements to biosimilar and interchangeable product development and approval processes. As the biosimilars market improves and expands, FDA will be adapting its policies. To learn more about how FDA plans to advance biosimilar competition, development, and regulation, read Commissioner Gottlieb’s statement.       

FDA’s Scott Gottlieb, M.D., Jeff Shuren, M.D., J.D., and Michelle Tarver, M.D., Ph.D. published a blog post detailing the importance of collaboration in improving patient healthcare. Engaging patients, caregivers, healthcare professionals, and researchers around the common goal of improving the safety and effectiveness of medical products and devices has the ability to improve patient care. In January 2018, FDA announced the development of Collaborative Communities with the goal of establishing a place for stakeholders to discuss common obstacles, objectives, desired outcomes, and opportunities. Read FDA‘s blog post to learn more about how Collaborative Communities have the potential to improve patient care and outcomes, and how FDA values and takes a role in fostering collaboration.

National Cancer Institute (NCI)

NCI Director Dr. Ned Sharpless MD released a blog post detailing NCI’s FY2019 budget and goals. 2019 marked the fifth consecutive year of increases to annual base appropriations for NCI. FY2019 appropriations were $79 million higher than those of FY2018. NCI will use these increased FY2019 funds to follow principles including increasing support for cancer research with research project grants, maintaining and supporting the Cancer Moonshot, and prioritizing and supporting early-stage investigators to increase innovation and encourage new research. Read Director Sharpless' blog post to learn more about NCI and NCI’s funding and goals.

Centers for Medicare and Medicaid Services (CMS)

CMS released the final snapshot for the Federal Health Insurance Exchange 2019 Open Enrollment Period, which showed steady enrollment with 8.4 million Americans already insured. Enrollment at the same time in 2018 was 8.7 million. The difference in enrollment can be attributed to increased jobs and decreased unemployment, increased access to job-based health coverage, and the expansion of Virginia’s Medicaid population. Learn more about the Federal Health Insurance Exchange 2019 Open Enrollment Period on the CMS website.


Patient-Centered Outcomes Research Institute (PCORI)

PCORI released their 2018 Year in Review report detailing their accomplishments throughout 2018. PCORI examined the role telehealth could play in hepatitis B infection and the role of engagement in healthcare research. PCORI funded over $2.3 billion in comparative clinical effectiveness research in 2018, and hopes to increase funding for related projects in 2019. Visit PCORI’s website to learn more about patient-centered research and PCORI’s 2019 goals.  

National Organization for Rare Disorders (NORD)

NORD recently announced the expansion and enhancement of their Rare Disease Database, a primary resource for those affected by rare diseases. NORD’s Rare Disease Database now includes an additional 7,000 rare diseases including several liver diseases, updated search and results features, and new NORD Rare Disease Reports. To learn more about NORD’s Rare Disease Database and how it may help you or someone you know, visit NORD’s website.

Cancer Support Community (CSC)

CSC’s Cancer Experience Registry allows cancer patients, survivors, and caregivers to share their stories and experiences with others who have been affected by a range of cancer types, including liver cancer. To join the registry and learn more about how you can help others affected by cancer, visit the Cancer Experience Registry website.


Mechanisms of Disparities in Chronic Liver Diseases and Cancer (R21). Funding available from NIH. Application deadlines: April 4th, 2019.

Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility. Funding available from NIH Application Deadlines: May 7th, 2021.



Senator Roy Blunt (R-Mo.), Chairman of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies.


Syndemic: A set of linked health problems involving two or more afflictions, interacting synergistically, and contributing to excess burden of disease in a population.

Policy UpdatesDonna Cryer