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 |
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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 | ||
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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 | ||
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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 |
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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 | |
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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 | ||||
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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.