U.S POLICY

Beyond the Biopsy
Guidelines indicate that MASLD and MASH can typically be diagnosed and treated without a costly and invasive biopsy. This is consistent with clinical practice. However, the Veterans Health Administration and some payers still require a biopsy procedure prior to treatment. GLI has spearheaded the effort to move beyond the biopsy, consistently advocating against this barrier to patient access.

Viral Hepatitis Control & Elimination
With effective vaccination and direct-acting antiviral drugs available, society has the tools to dramatically reduce transmission of viral hepatitis B and C and cure over 95% of hepatitis C cases. With science in hand, progress now relies on shared, determined commitment to developing, implementing, and expanding effective public health programs to identify, treat, and prevent infection.
- Broad Coalition Voices Support for AAP Vaccine Recommendations (2026)
- ACIP review of the hepatitis B birth dose vaccination remains a grave concern
- Statement from Leading Medical, Health and Patient Advocacy Groups on CDC Vaccine Meeting (2025)
- Hepatitis Letter to Appropriators – Senate FY 26
- 23 patient groups letter to Senate Appropriations in support of additional FY26 hepatitis programs funding | HIV+Hepatitis Policy Institute
- 23 patient groups letter to House Appropriations in support of additional FY26 hepatitis programs funding | HIV+Hepatitis Policy Institute
- Letter to DOL on Essential Health Benefits (EHB) Loophole
- Cure Hepatitis C Act Fact Sheet
- Immunization Alliance for Equity and Access letter on KP hepatitis B vaccination practices

Innovative Care for Pediatric and Rare Disease
Because of small patient populations, investment in rare and pediatric diseases can be economically prohibitive, leaving many patients with rare diseases without options for treatment on the horizon. Creative policy incentives allow these investments to move forward and create hope and solutions. At the same time, the specific needs of many diseases also require unique coverage to ensure patients receive the specialized care and treatment they need.
- EOY Letter to Congressional Leaders on Give Kids a Chance Act and Accelerating Kids’ Access to Care Act (2025)
- 101 patient advocacy organizations request the establishment of a complementary town hall-style meeting series to strengthen engagement between the FDA and patient advocacy groups (2025)
- HHS Letter on Elimination of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) and newborn screening (2025)
- Letter of support for ORPHAN Cures Act Sponsors (2025)
- Little Hercules Foundation Letter on IBX policy discriminating against rare disease coverage of treatments approved through the accelerated approval pathway (2025)

Prevention & Treatment of Metabolic Disease
As rates of obesity and diabetes have increased, metabolic dysfunction-associated steatotic liver disease (MASLD) and its more advanced form, metabolic dysfunction-associated steatotic liver disease, have become We advocated on behalf of AOMs for the Treat and Reduce Obesity Act (TROA) with several coalitions to promote access and coverage for these necessary drugs. This includes letters to legislators, CMS, and relevant committees.
- OCAN Open Letter to Secretary Hegseth on obesity prevention and treatment (2026)
- TROA Fact Sheet
- OCAN Letter to House HHS Appropriations Regarding the Proposed Elimination of DNPAO (2025)
- OCAN Letter to Senate HHS Appropriations Regarding the Proposed Elimination of DNPAO (2025)
- Open Letter on Medi-Cal Obesity Medicine Coverage (2025)
- Letter to CMS on AOM coverage (2025)
- More than 65 Organizations Advocate for Coverage of Obesity Care in Open Letter to Leading Employers
- Obesity Action Coalition & The Obesity Society Send Letter to FDA on Behalf of More Than 20 Leading Organizations & Providers Urging Enforcement of Compounding Regulations

Increased Five-Year Survival Rate of Liver Cancers
Though it is the sixth most common cancer type, liver cancer leads to the third most deaths. It is one of the few cancers that remains steady in a time when death from cancer overall is declining. Nearly every liver disease increases the risk of liver cancer developing. From coverage of diagnostics to investment in innovative research, many policies can push the needle towards survival for liver cancer patients.

Access & Coverage
Breakthrough technologies cannot transform health if they never reach the patients who stand to benefit the most. From utilization management and changing formularies to AI-assisted coverage decisions, the policies of entities like payers (health insurance providers) and pharmacy benefit managers (PBMs) can be the difference between disease progression or effective treatment. GLI is part of consistent and coordinated efforts to promote PBM reform in legislative and regulatory methods to lower the costs of and promote patient access to drugs by eliminating harmful policies such as step therapy requirements.
- PIPC GLOBE Model Comment (2026)
- PIPC GUARD Model Comment (2026)
- Living Donor Protection Act of 2025 Passes out of Senate HELP Committee (2026)
- PBM Explainer
- PBM Transparency and Accountability Employer/Patient Letter (2025)
- The Ad Hoc Group for Medical Research NIH Appropriations Conference Recommendation
- CDC Coalition Letter Opposing FY 2026 Cuts to HHS Appropriations
- The Ad Hoc Group for Medical Research FY 2026 Appropriations Request
- Reject Health Policies that Devalue and Ration Care for Any American
- Letter to Appropriators to Reject HHS FY 26 Discretionary Budget “Passback”
- Research!America FY 2026 NIH Funding Letter
- Research!America FY25 Community Sign On for NIH Appropriations
- Letter of Support to Ensure Community Access to Pharmacist Services (ECAPS)
- FY26 Defense Health Research Letter (House)
- FY26 Defense Health Research Letter (Senate)
- Letter from Chronic Disease Partners Opposing Elimination of CDC National Center for Chronic Disease Prevention and Health Promotion
- CDC Coalition FY 2026 letter to Congress
- CDC Coalition FY 2026 House and Senate conference letter
- FOVA Recommendations for FY 2026 Medical Research Program
- Modern Medicaid Alliance Congressional Letter on Cuts FY 25

