Advocacy for Equity in Transplantation Access for Alcohol-Associated Liver Disease: How Research Changed Medi-Cal Policy

Alcohol is the third most common preventable cause of death, and alcohol-associated liver disease (ALD) accounts for 50% of global liver-related deaths.¹ Liver transplantation (LT) is the only definitive therapy for end-stage liver disease, but patients with ALD have long been under-represented in access to transplantation.¹ A main barrier to transplantation access has been differing requirements of pre-transplantation alcohol abstinence for transplantation eligibility.² Whereas private insurers typically defer to multi-disciplinary transplant teams for eligibility and alcohol use risk assessment, the majority of Medicaid programs, which cumulatively provide health insurance for 75 million Americans, have additional state-specific requirements for financial reimbursement of transplantation based on longstanding abstinence policies.² For example, the California Medicaid program (Medi-Cal)—which provides health coverage for 13 million people—followed a policy for transplantation in ALD that was not amended since 1988.² This changed in February 2022: Medi-Cal revised their policy to allow expanded access to transplantation in selected patients with ALD without a mandated 6-month period of abstinence. This major policy revision is anticipated to reduce inequities to transplantation access in California and was the combined result of multidisciplinary research, societal trends, and efforts by patients, their families, advocates, and policy-makers—a winding and collaborative path taken by different stakeholders that serves as a roadmap for effective policy changes to promote equitable advances in public health Table 1.

Table 1.

Timeline and Key Stakeholder Actions Leading to Medi-Cal Policy Change for Early Liver Transplantation (LT) for Alcohol-Associated Liver Disease (ALD)

Year	Research	Clinical practice	Advocacy	Policy makers
1980s		• 1983: National Institutes of Health Consensus Development Conference on Liver Transplantation informally recommends 6 months of abstinence from alcohol for LT listing • “6-month rule” widely adopted throughout US		• 1988: Medi-Cal adopts policy that LT candidates should “not have […] active abuse of alcohol or other hepatotoxic drugs,” in practice, requiring documentation of 6 months of abstinence
1990–2000s	• Prognostic models9,10 developed to predict short-term mortality in AH • Studies11 suggest 6 months of abstinence is unreliable predictor of post-LT relapse	• “6-month rule” continues to be widely applied throughout US
2011	• New England Journal of Medicine publication5 of Franco-Belgian pilot study showing feasibility of early LT in 26 carefully selected patients with severe AH	• Cautious adoption of early (ie, without 6 months of abstinence) LT for AH in select US centers
2012–2019	• 2016–2017: Single-center studies12,13 validate feasibility of early LT for AH • 2018: ACCELERATE-AH Gastroenterology publication4 in large multi-center US cohort showing good outcomes in early LT for AH • 2019: Development of models to predict survival benefit14 and risk of alcohol relapse15 after early LT, refining selection processes	• Steady increase16 in early LT for ALD across US • 2018–2019: Early LT for AH endorsed by AASLD7 and ACG1 guidelines	• 2019: Initial discussions and drafting of petition by California LT providers recommending a revision to Medi-Cal requirement for 6 months of pre-LT abstinence, in favor of a more comprehensive psychosocial evaluation
2020	• Hepatology publication2 using UNOS database identifies and quantifies inequities associated with Medicaid abstinence policies: decreased LT for ALD paid by Medicaid in states with Medicaid abstinence policies vs states without restrictive Medicaid policies	• Early LT for AH endorsed by AST8 • AH becomes fastest rising indication for LT in US	• Petition signed by all LT directors in California and sent to leadership of the DHCS • Discussions with HCV patient advocates lead to recommendation to reach out directly to Medical Director of DHCS • Video meeting with key members of DHCS leadership: presentation reviewing history/context, studies/data (epidemiology and outcomes), proposed selection criteria, real patient/family stories	• Petition denied by California DHCS, proposing that patients with AH can be considered on “case-by-case basis” • After video meeting, California DHCS administers survey to each California LT center regarding their attitudes to the 6-month abstinence requirement for LT for AH and the broader ALD population, including anticipated effects to non-ALD waitlist candidates
2021
2022			• Continual post-meeting e-mail follow-up with DHCS leadership, including updated real patient/family stories	• February: Medi-Cal revises LT policy to allow early LT for ALD with specific inclusion/exclusion criteria

AASLD, American Association for the Study of Liver Diseases; ACCELERATE-AH, American Consortium of Early Liver Transplantation for Alcohol-Associated Hepatitis; ACG, American College of Gastroenterologists; AH, alcohol-associated hepatitis; ALD, alcohol-associated liver disease; AST, American Society of Transplantation; DHCS, California Department of Health Care Services; HCV, hepatitis C virus; LT, liver transplantation; UNOS, United Network for Organ Sharing.

In 1983, the National Institute of Health convened a Consensus Development Conference on Liver Transplantation, in which a group of transplant physicians informally recommended 6 months of abstinence from alcohol before a patient could be listed for transplantation.³ Although the recommendation was arbitrary, informal, and not evidence based, it was widely adopted by transplantation centers around the world. Over the years, research on alcohol use disorder, particularly in the setting of acutely decompensated liver disease from alcohol (eg, alcohol-associated hepatitis) revealed flaws in the requirement of a fixed period of pre-transplantation abstinence. More specifically, the duration of pre-transplantation abstinence was found to be an unreliable predictor of post-transplantation alcohol use, which called into question the veto prioritization of fixed periods of abstinence above other risk factors and mitigating factors for post-transplantation alcohol relapse.⁴ In addition, the majority of deaths from severe alcohol-associated hepatitis occurred within 2 months of hospitalization, leaving many patients in need of transplantation ineligible regardless of their commitment and ability to abstain from alcohol.⁵ This research laid the foundation for a pilot European study published in the New England Journal of Medicine in 2011,⁵ showing, among 26 carefully selected patients with life-threatening alcohol-associated hepatitis, an “early” (ie, without mandated 6-month period of abstinence) transplantation provided a life-saving therapy with low rates of post-transplantation alcohol use.

The European findings were subsequently confirmed in larger U.S. experiences,⁴ both in alcohol-associated hepatitis and the broader ALD population. These data have changed the national landscape of transplantation and ushered in a new era of greater acceptance for ALD as an indication for transplantation, prompting transplant center-level changes in policies to eschew the “6-month rule,” allowing early transplantation for carefully selected patients with life-threatening ALD and a commitment to lifelong post-transplantation abstinence. These center-level policy changes, coinciding with a significant rise in alcohol-associated cirrhosis and alcohol-associated hepatitis in the U.S., have led to ALD becoming the leading indication for transplantation, increasing 4.9-fold in volume from 2000 to 2020.⁶

Some patients, however, have been excluded and left behind from this expanded access to transplantation owing to static Medicaid policies that have not evolved with clinical practice. National registry data from 2002 to 2017 showed that state Medicaid programs with requirements for mandated periods of pre-transplantation alcohol abstinence were associated with a 5% lower proportion of transplantations for ALD paid by Medicaid and a reciprocal increase in transplantations for ALD paid by private insurers, suggesting inequities in transplantation access based on geography and insurance type.² Differing Medicaid policies likely affected thousands of patients needing transplantation.

The increasing evidence from research of the need to reconsider abstinence requirements, coupled with a concern regarding inequities in access among patients with Medicaid, prompted a petition in 2020 signed by all transplant directors in California. This petition was addressed to the leadership of the California Department of Health Care Services (DHCS), recommending a revision to their requirement for 6 months of pre-transplantation abstinence. This petition was denied and countered with the suggestion that patients with alcohol-associated hepatitis not responding to medical therapy could be reviewed and approved on a case-by-case basis. After this disappointing response, we developed a partnership with patient advocates experienced in petitioning changes in Medicaid policies for hepatitis C antiviral therapy coverage, based on existing connections developed through our clinical work. After a couple of brainstorming sessions, the patient advocates recommended that we appeal to the Medical Director of the California DHCS. Together, we drafted an e-mail respectfully requesting an appeal, citing additional evidence in support of early LT for ALD, the United Network for Organ Sharing study² suggesting inequities in transplantation access due to restrictive Medicaid abstinence policies, and an exemplary case of a patient with alcohol-associated hepatitis who was approved by our LT selection committee, but deferred by Medi-Cal and ultimately died. Throughout 2021, starting with e-mail correspondence, we were eventually able to arrange a video-conference meeting with key members of the California DHCS. During that meeting, the most recent evidence-based data were presented, encompassing the survival benefit of early transplantation for ALD, along with criteria for selection aimed at maximizing post-transplantation survival and minimizing post-transplantation alcohol relapse. We specifically cited updated practice guidelines from the American Association for the Study of Liver Diseases,⁷ American College of Gastroenterologists,¹ and American Society of Transplantation⁸ endorsing early LT for ALD. We also highlighted how the Medi-Cal policy of “case-by-case” approval had led to significant variations in approvals by transplant center within California depending on the case reviewer. For example, in early 2021 in one California transplant center, there was not a single patient with ALD financially approved by Medi-Cal for early (ie, without a mandated 6-month period of abstinence) transplantation listing despite dozens of candidates approved by the transplant selection committee after rigorous evaluations by a multidisciplinary team (including psychiatrists, addiction specialists, social workers, hepatologists, and surgeons), whereas another California transplant center had over a dozen such patients financially approved for listing by Medi-Cal. As part of our advocacy, we also presented patient cases and messages from patients’ families who had been approved by multidisciplinary transplant teams for early transplantation for ALD but subsequently declined for financial approval by Medi-Cal.

The DHCS leadership started to take action. First, they surveyed California transplant centers, seeking provider opinions on early transplantation for ALD and a hypothetical policy revision. Then in February 2022, they announced that Medi-Cal had officially revised their transplantation policy to include early transplantation for ALD, with specific and transparent inclusion and exclusion criteria. Specifically, the new Medi-Cal policy eliminated the mandated 6-month abstinence period for patients with catastrophic liver decompensation and expected survival less than 6 months, providing standardized evidence-based criteria for LT through a comprehensive clinical and psychosocial assessment. This Medi-Cal policy now provides a pathway of clinical care similar to that for patients with non-Medicaid insurance, thus aiming to reduce inequities in transplantation access that were previously identified by research.

Given the growing incidence of alcohol-associated cirrhosis and alcohol-associated hepatitis, which have been disproportionately increasing among vulnerable populations (eg, low income, young adults, women, and Hispanics), this revision in Medi-Cal policy is timely and is intended to improve access to lifesaving therapy for those who need and would benefit most. The policy change was fueled by multidisciplinary research from addiction specialists, transplant physicians, and ethicists, as well as advocacy from stakeholders including patients, patient families, patient advocates, and medical professionals, channeled to policymakers who were willing to listen and review scientific evidence. Yes—research can be supplemented by advocacy to maximize the impact of science on public health, and researchers can take on active roles to enact such change. Ultimately, our advocacy was always centered on data produced by research, which provided credibility and numbers that could no longer be ignored. While we are hopeful for the progress that this policy revision represents, the success of implementation and effects are yet to be seen and need to be studied closely. At the time of this writing, our institution has now listed and transplanted 3 patients under Medi-Cal insurance with ALD without a mandated 6-month period of abstinence: early examples of success that would not have been imaginable a year before. Yet, we know that transplantation does not cure alcohol use disorder, which is a chronic and relapsing disease, and this policy does not necessarily affect access to therapies to promote alcohol abstinence and rehabilitation. Finally, most state Medicaid programs still maintain policies that have not been revised to reflect or allow early transplantation practices; this current experience provides proof and a framework to show how that might change to address ongoing health inequities.