GLI: Liver Community Policy Priorities�March 2, 2025�

Overview

• Engage patients and communities.
• Work with administration on efforts to prevent chronic liver disease and prevent more advanced disease for those with disease.
• Improve access to care.
• Promote early diagnosis and screening.
• Promote research and innovation.

Liver Action Network

• Launched in 2021 to unite liver health advocates, capitalize on the eagerness of patients and physicians to be active, and address community needs.
• Meets monthly.
• GLI also engages specific communities through its Fatty Liver Alliance, Pediatrics and Rare Liver Diseases Council and Liver Cancer Council.
• Join us!

Coordination with HHS

• President Trump signed an Executive Order establishing the Make America Healthy Again Commission.
• It stated, “18% of teens suffer from fatty liver disease, nearly 30% are prediabetic, and more than 40% are overweight or obese – these conditions were virtually unheard of in prior generations.”
• Goal to reverse chronic disease.
• Address what makes people sick, work toward healthy food, expand treatment options and coverage for “beneficial lifestyle changes and disease prevention.”
• Receive “expert input from leaders in public health”.
• Excellent opportunity for digestive diseases community.
• Promote recommendations to BOTH prevent disease (nutrition, etc) AND prevent advanced disease through early diagnosis and treatment.

Access to Care

Obesity treatment and coverage

• Medicare is barred from covering medications for weight loss.
• CMS proposed in late 2024 to cover medications for the disease of obesity.
• Legislation: Treat and Reduce Obesity Act
• As passed House Ways and Means, provides limited Medicare Part D coverage of FDA-approved obesity medications.
• Review and update of NCD for intensive behavioral therapy for obesity
• Regulation: CMS reinterpreted the law to provide for coverage of all anti-obesity medications (AOMs) by recognizing obesity as a disease.
• The Trump administration has not indicated whether will finalize proposed rule.
• Why important to liver patients:
• Research has closely linked the presence of NASH/MASH to metabolic comorbidities such as obesity and diabetes.
• Without treatment, by 2035, 1 in 4 individuals will be obese.

Medical Nutrition Equity Act

• No committee action yet, needs to be reintroduced.
• Ensures both public and private insurance cover medically necessary foods as a treatment option, which are required to support proper growth and development and to prevent medical complications, severe disabilities and death.
• Why important to liver patients:
• Medically Necessary Foods are costly and needed for people with rare liver diseases to address malnutrition, including special formulas, prescription food, and medically necessary supplements.

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Telehealth

• The 2024 end-of-year package included an extension of telehealth flexibilities until March 15.
• GLI supports long-term extension of telehealth flexibilities.
• In creating the MAHA commission, President Trump pointed to his expansion of telehealth in first administration.
• Why important to liver patients:
• Studies show access to telehealth can improve outcomes for patients with chronic liver disease and increase their quality of life.
• Access to care is essential for rural patients.
• Allows for more frequent communication and patient and family engagement.

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PBM Reforms

• PBM reforms had included the “Safe Step Act”, a bill advancing patient access to care by requiring ERISA (employer-based) health care plans to establish clear exceptions to step-therapy such as when another therapy was ineffective or expected to be ineffective or disabling. 
• Certain helpful PBM reforms were included in the original end-of-year package, although omitted in final package. They included major reforms to PBM practices intended to lower patient out-of-pocket costs and improve transparency.
• Efforts will continue to advance the Safe Step Act, whether as part of PBM reforms or otherwise.
• Why important to liver patients:
• When prescribed medication treating liver disease, gives patients a clear process to request exceptions to step therapy protocols if coverage denied.

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Living Donor Protection Act

• No committee action yet, not yet reintroduced.
• Prohibits insurance companies from denying or limiting coverage and from charging higher premiums for living organ donors.
• Amends the Family and Medical Leave Act of 1993 to specifically include living organ donation as a serious health condition.
• Why important for liver patients:
• Livers are the second-most awaited transplant, with nearly 10,500 people on the waiting list in 2023. 17 people die each day waiting.

Early Diagnosis and Screening

Medicare Multi-Cancer Early Detection Screening Coverage Act�

• 2024: Unanimously marked up by House Ways and Means Cmte and was included in one version of an end-of-year package – but did not pass.
• Creates a benefit category for MCED tests, which allows CMS to initiate an evidenced-based NCD process for multi-cancer tests upon FDA approval.
• Reintroduced as H.R. 842 and S. 339.
• Why important for liver patients:
• Each year in the U.S., 25,000 women and 11,000 men are diagnosed with liver cancer and 19,000 men and 9,000 women will die from it. Rates of liver have tripled since 1980.
• When caught early, survival rates increase. Localized liver cancer presents a 5-year survival rate of 37.3%, dropping to 3.5% for when cancer has had time to metastasize, yet, over half of liver cancer incidences are detected after it has spread.
• When caught early enough to receive a liver transplant — a wait period that can last more than 5 years — survival rates jump to more than 70%.

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Non-invasive screening and diagnosis: Beyond the Biopsy

• Clinical guidelines support use of non-invasive diagnostics such as imaging to diagnose fatty liver disease.
• Some payers, including the Veterans Administration, recommend a risky biopsy to diagnose MASH/NASH in order to access medication treatment.
• The liver patient community is working with AASLD in efforts to reverse the VA’s policy so that it is aligned with Tricare and clinical guidelines.

Hepatitis C Elimination Program

• No bill introduced yet.
• President’s budget sought to advance a federal mandatory program, including:
• Accelerating the availability of point-of-care (POC) diagnostic tests. 
• Provide broad access to curative hepatitis C medications through a subscription model.
• Advance comprehensive public health effort to engage, inform, identify, and treat people with hepatitis C. 
• Reduce liver cancer.
• Senators Cassidy (R-LA) and Van Hollen (D-MD) are working on legislation that may produce cost savings.
• Why important to liver patients:
• Left untreated, infection with hepatitis C leads to liver damage, brain fog, abdominal pain, and internal bleeding.

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Research and Innovation

Liver Illness, Visibility, Education and Research Act (LIVER Act) �

• No committee action yet, not yet reintroduced.
• First introduced in 2018, developed in collaboration with GLI.
• Promotes research on primary liver cancer, allows funding for experimental treatment and prevention programs and creates grant programs at the CDC for liver cancer prevention and awareness activities.

Appropriations

• GLI supports efforts by appropriators to recognize and address:
• Need for obesity coverage under Medicare.
• Deadliest cancers such as liver cancer.
• Rare diseases – protect FDA accelerated approval process.
• Primary pancreatic and liver cancers.
• Use of imaging technology where suitable instead of risky biopsy.
• Biliary tract cancers and liver cancers.
• Chronic hepatitis C as leading cause of liver cancer and liver transplantation.
• Liver disease as the ninth leading cause of death in the U.S. and NAFLD/MASLD as the most common cause of liver-related morbidity and mortality.
• Hepatitis B.
• Chronic liver disease.
• Nutrition.

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Thank you.