Congress debates appropriations and other end-of-year legislation. Biden administration issues more rulemakings. Agencies prepare for new leadership.

Members of Congress have returned to Washington, DC. It is unclear if many healthcare priorities will make it to final passage this year. The incoming administration has submitted names for its new Cabinet and to lead key agencies.

CMS Proposes to Cover Obesity Medications Under Medicare

On On November 26, CMS proposed to reinterpret an existing statute and permit coverage of anti-obesity medications (AOMs) for weight loss when treating obesity, and CMS would apply this reinterpretation across all Part D plans and Medicaid programs. Comments in response to the proposed rule are due no later than January 27, 2025. Notably, the rule will be finalized after the comment period concludes under the upcoming Trump administration. It is typical practice for incoming administrations, regardless of political affiliation, to “freeze” pending regulations to allow newly appointed officials to review and align rulemaking with the policy goals of the new administration. It is possible that his administration may amend the final version of the rule. Therefore, it is unclear whether and how the rule will impact efforts to pass legislation that allows for more restrictive coverage of obesity medications. GLI has shared its strong support for the rule covering obesity medications and intends to provide favorable comments as part of the rulemaking process.

CMS Finalizes Kidney Transplant Model

On November 26, CMS finalized its Increasing Organ Transplant Access (IOTA) Model, a six-year mandatory model designed to increase access to kidney transplants. The launch date has been delayed to July 1, 2025, in response to stakeholder concerns that a more ambitious timeline would potentially disrupt the transplant ecosystem. The model includes 103 kidney transplant hospitals, covering half of all donation service areas and all transplant hospitals nationwide. Under the finalized model, participating hospitals will receive performance-based payments for increasing transplant volumes and face penalties for underperformance, though these penalties will not take effect until the program’s second year. In response to comments from GLI and the National Alliance for Caregiving, CMS discussed that the final rule is intended to address caregiver readiness and discussed the newly created Organ Transplantation Affinity Group (OTAG) as part of improving the transplant system for caregivers. While the model is considered progress, kidney disease advocates were disappointed that some provisions about patient communication and transparency were not included in the new model. However, the rule’s timing places it within the Congressional Review Act lookback period, allowing the Trump administration to review and potentially rescind or modify the policy.

Congress Must Take Action to Keep Government Funded

Congress passed H.R.9747, a Continuing Resolution (CR) that funds the government through December 20th. That means Congress must act before the new year to hash out appropriations and funding levels for the government, including health care programs. Congress will debate topics such as whether to increase funding for the CDC’s Division of Viral Hepatitis or reduce funding for the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as proposed by the House. GLI supports the higher Senate funding levels for most HHS programs while supporting the increased funding level proposed by the House for the CDC’s work on viral hepatitis. While Congressional appropriators generally support a traditional year-long bill that provides certainty for government program spending, other Congressional leaders have pushed for a short-term CR that would force Congress to continue debating appropriations into March 2025.

Tracking Trump 2.0 Administration Appointees

President-elect Donald Trump has selected Cabinet-level officials for his next administration. Here are his picks in the healthcare arena:

• HHS: Robert F. Kennedy Jr.
• CMS: Dr. Mehmet Oz
• CDC: Dr. Dave Weldon
• FDA: Dr. Martin Mackary
• NIH: Dr. Jay Bhattacharya
• Surgeon General: Dr. Janette Nesheiwat
• VA: Former Rep. Doug Collins (R-GA)
• Attorney General: Pam Bondi (former Florida attorney general)

Cassidy To Lead Senate HELP Committee In 119th Congress

Sen. Bill Cassidy (R-LA), the current Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP), announced that he will be chair of the HELP Committee during the 119th Congress.

CMS Finalizes CY 2025 Payment Updates

The Centers for Medicare & Medicaid Services (CMS) has finalized a series of payment updates for calendar year (CY) 2025. Summaries for these final rules from our policy counsel at Thorn Run Partners are linked below:

• Physician Fee Schedule
• End-Stage Renal Disease
• Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC)
• Home Health Services

Join GLI in Pushing for Patient Access to Care for NASH/MASH
Veterans continue to be denied coverage for NASH/MASH treatment without a biopsy or experience delayed care due to requirements to receive “comprehensive lifestyle intervention” for 6 months before being eligible for treatment. The VA’s decision is contrary to the label from the Food and Drug Administration and clinical guidelines. As part of GLI’s Beyond the Biopsy initiative, GLI and its partners sent a letter to the VA Clinical Care Guidelines & Guidances in NAFLD/NASH. We continue to encourage signatures here on a petition to all payers calling for coverage without biopsy!

Patient Highlight

GLI Ambassador and passionate advocate Terri has shared her story that underscores why it is imperative to advance the use of noninvasive diagnostics for fatty liver disease. Terri’s condition deteriorated rapidly after her biopsy, from being asymptomatic to experiencing ascites, compensated cirrhosis, hepatic encephalopathy, and brain fog. This experience has fueled her passion, and she shared “I will use my voice to advocate giving doctors – and the patients and veterans that depend on them – an updated toolkit for a smoother journey to wellness.”

CBO has Reportedly Assessed the Budget Impact of Legislation Advancing the Hepatitis C Elimination Plan

GLI continues to strongly support efforts to advance the Hepatitis C Elimination Plan. Senators Cassidy (R-LA) and Van Hollen (D-MD) have been working on legislation that has reportedly been reviewed by the Congressional Budget Office and determined to provide cost savings to the government. A bill with savings would be very attractive for end-of-year efforts to advance a package of health-related bills as it would offset the cost of bills that expand coverage. The reported legislation and CBO score are not yet public.

National Alliance for Caregiving Report Published on Transplant Caregiving Gaps

The National Alliance for Caregiving (NAC) released new research revealing significant gaps in family caregiver support across U.S. transplant centers. The report, “Gaps and Opportunities: Family Caregiver Programs in U.S. Transplant Centers,” documents critical shortfalls in support services and programs for family caregivers – whose contributions are vital to successful transplant outcomes. Based on a survey of 114 transplant centers, the report demonstrates an urgent need for healthcare system reforms to strengthen caregiver support and ultimately improve patient health outcomes. Jason Resendez, NAC’s CEO, provided insights into NAC’s work during GLI’s Advanced Advocacy Academy in September. GLI is proud to be a partner in efforts to advance NAC’s recommendations to close the gaps in transplant caregivers’ health and well-being. Click here to learn more.

GLI Supports the KIDNEY Patient Act

The KIDNEY Patient Act focuses on protecting access to Phosphate Lowering Therapies (PLTs) for patients with end-stage renal disease (ESRD), a condition highly associated with liver disease. The legislation ensures that these life-saving therapies remain accessible and affordable by delaying their inclusion in the ESRD payment bundle. Without this intervention, many patients risk losing access to essential treatments. Click here to learn more about the bill.

GLI Comments to the FDA on Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices   

On September 25th, 2024, the US Food and Drug Administration published a Federal Register Notice (FRN) #Docket No. FDA-2024-N-3533 to collect public comments on their proposed reclassification of hepatitis B virus. Currently, there are no FDA-cleared point-of-care (POC) tests available in the U.S., which is a significant barrier to increasing screening rates. Only laboratory-based hepatitis B diagnostics are available, meaning blood must be drawn and analyzed in a laboratory.  Ultimately, this reclassification will encourage companies to bring rapid tests for hepatitis B to the U.S., moving the nation one step closer to achieving viral hepatitis elimination goals. GLI and other organizations submitted comments to the FDA urging reclassification.

GLI Continues to Advocate for End-of-Year Action on Key Bills

• The Treat and Reduce Obesity Act (TROA, 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 that passed out of committee. GLI and its Liver Action Network partners have sent letters supporting Congressional action to the House Energy and Commerce Committee and the Senate Finance Committee. On November 19, 2024, GLI joined OCAN members in sending another letter to Congress pushing for end-of-year action on TROA. 
• 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 soon to extend COVID-Era Telehealth and Supervision Flexibilities. The House Energy and Commerce Committee marked up the Telehealth Modernization Act.
• 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 Medicare 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.

GLI Works to Build Momentum to Move More Legislative Priorities for Patients

Congress returns in September for one last push to advance key legislative priorities out of the committees of jurisdiction and onto a floor vote. GLI is deeply engaged in efforts to advocate and build momentum for several pieces of legislation:

• Old Drugs, New Cures Act (H.R.8267): Incentivizes the development of new uses for existing drugs to improve access to lifesaving medications that benefits low-income Americans who rely on Medicaid, the Children’s Health Insurance Program, or Medicare Part D low-income subsidies.
• The Liver Illness, Visibility, Education and Research Act (LIVER Act, H.R.8601): Increases federal assistance to study, prevent, and treat liver cancer.
• Medical Nutrition Equity Act (H.R. 6892): Ensures both public and private insurance cover medically necessary foods as a treatment option, since they are required to support proper growth and development and to prevent medical complications, severe disabilities, and death.
• Living Donor Protection Act (H.R.2923/S.1384): Would protect living organ donors and remove barriers to greater donation.
• John Walsh Home Infusion Act (H.R.4438): Would change the Medicare law to improve access to augmentation therapy infusions at home for individuals with Alpha-1 antitrypsin deficiency (Alpha-1) under Medicare Part B.