Sign the GLI Petition for Insurers to Provide Access to NASH/MASH Treatment!
GLI urges organizations and individuals to sign its petition calling for payers to avoid advancing adverse approval criteria of a new medication to treat nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH). Evidence is mounting that some payers have chosen to require a biopsy to access treatment, contrary to the label from the Food and Drug Administration and clinical guidelines. This short-sighted policy is also being embraced by the U.S. Department of Veterans Affairs. GLI is also concerned that the VA’s recommendation on lifestyle interventions will further delay access to care. This reflects ongoing efforts as part of GLI’s Beyond the Biopsy initiative, which most recently released a letter to the VA with 24 signatures from individuals and organizations. Click here to sign the petition to payers!
GLI Supports the Old Drugs New Cures Act!
Congressmen Don Davis (D-NC) and August Pfluger (R-TX) have introduced the Old Drugs, New Cures Act (H.R.8267), bipartisan legislation to improve access to lifesaving medications that benefit low-income Americans who rely on Medicaid, the Children’s Health Insurance Program, or Medicare Part D low-income subsidies. As GLI CEO Donna R. Cryer, JD, points out, “Reformulating existing drugs is an opportunity for innovation to address unmet needs in an efficient and timely manner.” New uses for existing drugs have long been supported by the rare disease community, for whom treatment options are highly limited. The bill remedies an interpretation of federal law that stifles research and development on reformulations of existing drugs for new uses, called the Medicaid line extension. The bill carves out an exemption for priority research drugs from the Medicaid line extension, allowing for a smoother path from drug development to patient access.
Obesity Coverage Advances in the House
On June 27, 2024, The U.S. House Ways and Means Committee marked up legislation to extend Medicare coverage to obesity care. The bill is a slimmed down version of the original Treat and Reduce Obesity Act (H.R.4818) and was offered at the markup by committee leadership as a substitute for the original bill. While limited, the bill represents a definite step forward in progress. As members of the Obesity Care Action Network (OCAN), GLI has supported its efforts to work with Congress on legislation to extend coverage as broadly as possible. GLI supported the amended bill passed out of committee and looks forward to continued efforts to advance a bill into law, particularly as we look to the Senate to act. GLI recognizes the relationship between obesity and fatty liver disease (and its advanced form, NASH/MASH). Preventing liver disease is directly associated with treating and reducing obesity, making it crucial for policymakers to utilize unbiased and science-based approaches to both NASH/MASH and obesity care. We stand alongside the obesity advocacy community in recognizing obesity as a serious and complex condition that is a risk factor for developing NASH/MASH. View the OCAN statement here.
House Advances Bill Covering Cancer Early Detection
GLI is excited to share that the Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 2407/S.2085) was marked up by the House Ways and Means Committee on a unanimous vote to increase access to cancer screenings. Today, only a few of more than 200 cancers have recommended routine screenings, which leaves most cancers undetected until symptoms appear, often in later stages. Liver cancer is among cancers rising, with 25,000 men and 11,000 women diagnosed with liver cancer each year and 19,000 men and 9,000 women dying from it each year. Yet, an annual Early Detection Survey conducted by Prevent Cancer Foundation in 2023 found 65% of Americans 21 years of age and older said they are not up to date with one or more routine cancer screenings. When caught early, survival rates are considerably higher compared to cases where cancer has spread. Localized liver cancer presents a five-year survival rate of 37.3% but drops to a mere 3.5% for cases in which the cancer has metastasized. This bill will modernize the Medicare program and ensure Medicare can make a timely coverage decision for new, innovative tests that can detect multiple types of cancer before symptoms develop, a goal strongly supported by GLI and essential to achieve the Cancer Moonshot. View the press release from the lead sponsor, Rep. Sewell.
Join GLI in Supporting the LIVER Act!
GLI is thrilled to share that Representative Nydia Velázquez has reintroduced the Liver Illness, Visibility, Education and Research (LIVER) Act (H.R.8601). The bill was first introduced in 2018 and developed in collaboration with GLI. With rising rates of liver cancer and fatty liver disease and new opportunities to prevent and treat viral hepatitis, GLI believes the time is now for Congress to move the field forward and shift the conversation to shine a spotlight on liver cancer and liver health disparities. View GLI’s statement here. Join us by reaching out to your Member of the U.S. House of Representatives here!
Hepatitis C Gets FDA-Approved Point-of-Care Test as Evidence of Prevalence Mounts
A May 2024 report found that the National Health and Nutrition Examination Survey (NHANES) underestimates the true prevalence of hepatitis C virus (HCV) infection. By accounting for populations inadequately represented in NHANES, new models estimate the prevalence of hepatitis C is substantially higher than previously reported. With the apparent need for expanded testing, treatment, and surveillance, GLI is excited that the FDA has approved a point-of-care test for hepatitis C. According to the FDA, it has “granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first HCV test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C.” The ability to diagnose HCV with a blood sample from a fingertip is a tremendous step forward and, combined with the existence of curative treatments, underscores that eliminating hepatitis C is possible. GLI urges Congress and the administration to advance a hepatitis C elimination strategy. View the FDA press release here.
GLI Celebrates Biomarker Legislation Advancing in States
GLI is proud to help lead coalition efforts to advance legislation in the states that require coverage of comprehensive biomarker testing, thus enabling access to biomarker testing and making precision medicine possible for cancer patients. With the recent passage of legislation in Pennsylvania, 20 states have now passed biomarker testing coverage laws. Emerging research shows that biomarkers could be a promising target for screening, diagnosis, and monitoring of hepatocellular carcinoma (HCC) patients with a history of fatty liver disease. HCC is the most common form of primary liver cancer with low five-year survival rates relative to other primary cancers. Learn more about precision medicine from the Personalized Medicine Coalition, of which GLI is a member. Click here for updates on state legislative activities to advance biomarker testing and coverage.
