Congress is entering the August recess period. Nevertheless, patients are increasingly signaling to policymakers their frustration related to coverage challenges and over-zealous utilization management practices such as non-medical switching and other barriers to care. And appropriations bills are out for FY 2025!

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!

Several GLI Legislative Priorities Teed Up for Possible End-of-Year Action, Focus on Access to Care 

Treat and Reduce Obesity Act (H.R.4818/S.2407): On June 27, 2024, The U.S. House Ways and Means Committee marked up legislation to extend Medicare coverage to obesity care. GLI supported the amended bill passed out of committee and looks forward to continued efforts to advance a bill into law.

Medicare Multi-Cancer Early Detection Screening Coverage Act (H.R. 2407/S.2085): The bill was marked up by the House Ways and Means Committee on a unanimous vote to increase access to cancer screenings. View the press release from the lead sponsor, Rep. Sewell.

Telehealth: Congress must pass legislation now to extend COVID-Era Telehealth and Supervision Flexibilities. 

Saving Access to Laboratory Services Act (SALSA, H.R.2377/S.1000): Avoiding cuts of up to 15 percent to laboratory services will require Congressional action before year end.

Protecting Health Care for All Patients Act (H.R.485): The House of Representatives passed legislation earlier this year to extend protections against the use of discriminatory value assessments (QALYs and similar measures) in Mediare to other federal health programs. It remains a priority for the Chair of the Energy and Commerce Committee, Rep. Cathy McMorris Rodgers. 

Safe Step Act (H.R.2630/S.652): The legislation is being considered as part of reforms to PBMs (S.1339) and would protect patients from insurers preventing access to prescribed care.

Congressional Committees Begin to Advance FY 2025 Appropriations

The House of Representatives and the Senate have begun their work on appropriations bills. While overall funding levels for health programs were decreased, the committees highlighted significant needs for the liver disease community in the report accompanying the bills. Highlights from the reports are below: 

• Encouraged CMS to work to ensure beneficiary access to care for obesity if determined as clinically appropriate by the patient’s physician and consistent with statutory and regulatory authority. 
• Called on HHS to report on the risks and benefits of GLP-1 agonists, including clinical trials and basic research that enhances our understanding of the physiological processes and pathways affected by these drugs, with an appreciation of the potential for sex-specific effects. 
• Urged NIH to focus on deadliest cancers such as liver cancer.
• Directed funding to the Childhood Cancer Data Initiative (CCDI) for enhancement of the CCDI Molecular Characterization Initiative for continued expansion of ultra-rare tumor types with limited therapeutic options.
• Commended NCI for seeking feedback on primary liver cancer and urged the NCI to use that feedback to inform a national agenda for early detection, screening, and prevention of primary pancreatic and liver cancers.
• Recognized Functional Precision Medicine and its importance in identifying individualized treatment options more rapidly for hard-to-treat cancers and supports efforts to establish a national center for functional precision medicine and artificial intelligence analysis.
• Recognized Medical Imaging Technologies in Cancer Screening Trials and supported NCI clinical trials to assess the potential role of blood tests to detect cancer in the body but encourages use of imaging technologies in the trials.
• Encouraged NIH to continue to support research to develop novel treatment strategies in biliary tract cancers, and for basic and translational research as well as clinical trials in liver cancers, also supporting research on novel cancer vaccines and immunotherapies. 
• Recognized millions of Americans with chronic hepatitis C, which is the leading cause of liver cancer and liver transplantation; supported efforts to increase access to diagnostic testing, including rapid diagnostics, to expand the availability of treatment, and to bolster public health strategies to prevent hepatitis C.
• Recognized 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 and recommended that agencies implement recently updated nomenclature for MASLD throughout their programs to appropriately identify, diagnose and treat this deadly disease.

GLI Expresses Serious Concerns about Implementation of U.S. OPTN Reform and Modernization

The reform of the U.S. Organ Procurement and Transplantation Network (OPTN) has faced turmoil about accountability processes and oversight of the new system’s board, which is to be independent of any contractor or vendor’s board.

Given the serious mismanagement, inefficiency, and unethical practices that dishonored organ donors and cost patient lives, the new law was passed by Congress to ensure the people who perpetrated injustice can no longer influence the organ transplantation system in the future. Despite an effort to explain the process from the Health Resources and Services Administration (HRSA) and the OPTN on August 2, the White House, Members of Congress, and GLI still have serious concerns about the implementation of this legislation as intended in the law.

The proposed process from HRSA and the OPTN simply gives new labels to the same people involved in the past. This not only circumvents Congressional intent, it also puts the lives of some of our most vulnerable patients at risk. We have reached out to the office of Senator Wyden, Chairman of the Senate Finance Committee, to express this concern.