Congress begins Fiscal Year 2025 appropriations process and the Administration approves new treatments improving the lives of liver disease patients.

In the post-election work period, “must-do” program reauthorizations are expected to be considered. Lawmakers will be eyeing action on these health care policies and more during the “lame duck” session after the November elections and before the 118th Congress gavels out.

Advanced Advocacy Academy Success Building Support for Policy Priorities

GLI is proud to share that the Advanced Advocacy Academy’s meetings on Capitol Hill on October 2, 2023 – and all of your continued advocacy efforts – have reaped positive results!

GLI is grateful for Congressional leadership to advance fatty liver disease research, a positive response to A3 and GLI’s requests for appropriations. The final appropriations bill for Fiscal Year 2024 was accompanied by report language encouraging AHRQ & others to evaluate the prevalence, diagnoses, treatments, and complications associated with NAFLD (now known as MASLD, which leads to NASH (now known as MASH). The final report also directed NCI’s Clinical Trials and Translational Research Advisory Committee (CTAC) to issue a report listing research focus areas for liver cancers, as well as directing hepatitis B vaccination efforts.

We are proud to also share that since A3 advocates met with Congress last October, the Medicare Multi-Cancer Early Detection Screening Coverage Act has added 14 House cosponsors and 70 more Senate cosponsors; the Living Donor Protection Act has added 9 Senate cosponsors and 42 House cosponsors; and the Treat and Reduce Obesity Act has added 54 House cosponsors and 7 Senate cosponsors!

GLI Thanks Senator Bill Cassidy for His Leadership in Fatty Liver Disease Research – AHRQ to Lead Prevalence Study

GLI applauds the announcement of a federally-funded study by the Agency for Healthcare Research and Quality (AHRQ) to assess the prevalence of fatty liver disease (known as metabolic-associated fatty liver disease or nonalcoholic fatty liver disease) as well as its associated costs and barriers in the US. GLI expresses gratitude to Senator Bill Cassidy (R-LA) for working alongside GLI’s community of advocates and holding the torch for liver health. Read more.

GLI Celebrates Hepatitis Awareness Month!

The month of May is designated as Hepatitis Awareness Month in the United States, and May 19th is Hepatitis Testing Day. GLI encourages all of our partners to work with us to shed light on the impact of hepatitis by raising awareness while encouraging testing and vaccination. A recent New York Times article titled “U.S. Lags Behind Other Countries in Hepatitis-C Treatment” notes that, of those diagnosed in the United States since 2013, just 34 percent have been cured. It has also been reported that the Congressional Budget Office is actively grappling with how to estimate the cost of potential legislation to advance the White House plan to eliminate hepatitis C, potentially looking at the cost over a 10-year window instead of a 5-year window to better capture its benefits. GLI looks forward to legislation advancing the White House Hepatitis C Elimination Plan. In the meantime, to raise awareness and encourage testing, reference the GLI Toolkit on Liver Health is Public Health here. Learn more how to get involved with the CDC’s efforts this month here.

Medicare Covers Obesity Medications Indicated for Cardiovascular Disease

The Centers for Medicare & Medicaid Services (CMS) recently decided to cover semaglutide, an anti-obesity medication (AOM) that is now indicated for cardiovascular risk reduction in people with existing cardiovascular disease. GLI strongly supports the expansion of coverage to allow AOM treatment for all people with obesity and urges Congress to pass the Treat and Reduce Obesity Act (TROA), which would allow obesity medications to have Medicare coverage consistent with other medications to treat chronic disease. The next step for the legislation is to be voted out of the committees with jurisdiction over Medicare – the House Ways and Means Committee, House Energy and Commerce Committee, and the Senate Finance Committee. GLI strongly supports committee action on the bill and its final passage by Congress. Reach out to your Member of Congress here. 

GLI Supports Obesity Care for the Armed Forces

GLI is proud to support decisive action by the U.S. Department of Defense to rectify systemic issues preventing individuals with obesity from accessing evidence-based treatments including behavioral therapy, AOMs, and bariatric surgery. View the letter from advocacy organizations here. 

HHS Final Nondiscrimination Rule Addresses GLI Comments on Organ Transplantation

Section 504 of the Rehabilitation Act protects the rights of people with disabilities in programs and activities receiving federal financial assistance. The final rule governing Section 504 was just released. In response to GLI comments, the final rule stated that “organ transplant discrimination against people with disabilities remains an ongoing problem” and that the rule’s protections apply “throughout the organ transplantation process, including the provision of information, referrals, evaluation, eligibility, prioritization and other aspects of the transplantation process.” The rule further clarified that it may violate the rule to deny access to a transplant if the entity did not consider the patient’s ability to manage their post-operative care needs with support from family, service providers, or others in the patient’s circle of support. GLI looks forward to doing the much-needed work to advance caregiving needs for organ transplant patients in collaboration with the National Alliance for Caregiving!

Telehealth Considered by House Energy and Commerce Committee

GLI has consistently supported access to telehealth as a key strategy for improving relationships between doctors and patients that allows patients to actively show doctors their medicine bottles, the environment in which they live, and even the contents of their refrigerators. Doing so allows doctors to better understand how to tailor a treatment plan around a patient’s real-world circumstances and thus improve treatment adherence. Therefore, GLI applauded the House Energy and Commerce Subcommittee on Health for convening a hearing on April 10, 2024, to examine a suite of legislative proposals that would bolster access to telehealth services. Discussion during the panel was largely centered on extending certain COVID-19 public health emergency (PHE) telehealth flexibilities beyond the current December 2024 expiration date. Lawmakers questioned witnesses on how to best extend such flexibilities to ensure patient access to quality care without significantly impacting costs to Medicare or hindering in-person visits. Notably, lawmakers on both sides of the aisle emphasized the importance of extending PHE-era telehealth flexibilities beyond their current expiration, with several members of the Subcommittee calling for permanent extension of the flexibilities through passage of the Telehealth Modernization Act of 2024 (H.R. 7623). GLI is encouraged by recent reports that the House Ways and Means Committee is considering action to mark up a two-year extension of Medicare telehealth rules, a key step for Congress to protect telehealth access and potentially pass telehealth legislation as part of a potential end-of-year package of health-related bills.

Senate Eyes Bipartisan Introduction of the Medical Nutrition Equity Act (H.R. 6892)

GLI is actively engaged in efforts on Capitol Hill to support the Medical Nutrition Equity Act and to achieve bipartisan introduction of the legislation in the Senate. Thousands of children and adults live with digestive (i.e. gastrointestinal, liver or pancreatic disease) or inherited metabolic disorders (IMD) that inhibit their bodies from digesting or metabolizing typical foods. Left untreated, food can become toxic, or the body can fail to absorb necessary nutrients. These individuals must rely on medically necessary nutrition, such as highly specialized formulas, to treat for their condition and to maintain growth and health. The Medical Nutrition Equity Act would require insurers to cover these critical treatments for patients. Share your support here!

Medicare Multi-Cancer Early Detection Act Has Majority Support in House and Senate

Representatives Jodey Arrington (R-Texas) and Terri Sewell (D-Ala.) recently shared their appreciation to advocates for the tireless and incredible commitment to the promise of multi-cancer early detection. They reported that the bill has a filibuster-proof majority of support in the Senate, as well as 256 cosponsors in the House. They are committed to finding opportunities for final passage of the legislation. The next step is for the legislation to be heard and voted on in the committees of jurisdiction – the House Ways and Means Committee, House Energy and Commerce Committee, and the Senate Finance Committee. GLI strongly supports consideration of the Multi-Cancer Early Detection Act and final passage by Congress.

FDA Plans AdComm for Treatment of Primary Biliary Cholangitis (PBC)

GLI is pleased to learn that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for obetacholic acid (Ocaliva) for the treatment of individuals with primary biliary cholangitis (PBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024 and is planning to hold an Advisory Committee meeting to discuss the application. Ocaliva received accelerated approval in 2016. This process is intended to satisfy the post-marketing requirements for FDA to confirm a clinical benefit in patients with PBC. GLI strongly supports allowing for in-person testimony from patients as part of the advisory process to ensure that patient experiences are heard and considered.

Congress begins Fiscal Year 2025 appropriations process and the Administration approves new treatments improving the lives of liver disease patients.

Congress finalizes last remaining FY 2024 spending bills

After a brief weekend shutdown, Congress passed the FY 2024 appropriations bills and President Joe Biden signed the $1.2 trillion government funding package on March 23, 2024, closing the books on fiscal year (FY) 2024 appropriations. Highlights include:

• Most health programs were flat funded, with the National Institutes of Health sustaining a disappointing .8% cut to its funding. 
• On a more positive note, the bill increased funding for the Organ Procurement and Transplantation Network (OPTN) Modernization Initiative by $23 million to strengthen and reform the nation’s organ donation and transplant system, with Congress stating in its summary, “There are more than 100,000 individuals on the organ transplant waitlist, and this initiative will allow OPTN to better serve patients and families and strengthen accountability.”  
• To support telehealth, it also included $42 million for HHS’ Office for the Advancement of Telehealth, $1 million to connect rural veterans to health care facilities and $20.9 million for rural hospitals to adopt health information technology. 
• It included level funding at $43 million for the Division of Viral Hepatitis.
• The bill’s Explanatory Statement urged ARPA-H to consider funding research on rare cancers that have low survival rates and for which there has been little advancement in therapeutics, including the evaluation of immune-based therapies, targeted therapies, and combination treatments. It also encouraged coordination between NCI and NIDDK on cancer outcomes among Native Americans. 
• The Department of Defense section included $130,000,000 for the peer-reviewed cancer research program to research certain cancers, including liver cancer.

Healthcare payment plans to include patient representatives on Pharmacy and Therapeutic Committees

As part of the final 2025 Notice of Benefits and Payment Parameters rule issued last week, the U.S. federal government will require plans beginning in 2026 to include knowledgeable patient representatives on Pharmacy and Therapeutic Committees to help develop drug formularies. The experienced representative will represent the patient perspective and help the committee integrate data with practical patient considerations. Per the advice of GLI and the Partnership to Improve Patient Care (PIPC), of which GLI is a member, the final regulation uses the terminology “patient” instead of “consumer” for this role. While more advocacy is needed to help serve patient interests in their health plans, this will help keep health care coverage patient-centric.

Congress fails to address expiring programs and other key health priorities

Congressional health leaders had been pushing for the inclusion of several pending health care efforts in the next government funding package, but some of these priorities are slipping to the post-election work period. Key health care riders — including extra funding for community health centers (CHC), price transparency for hospitals and pharmacy benefit managers (PBM), and reauthorization of the Pandemic and All-Hazards Preparedness Reauthorization Act — fell by the wayside when Congress passed the fiscal year 2024 appropriations bills. That also includes policies pertaining to the Medicare Physician Fee Schedule, reauthorization of opioid support programs, telehealth reimbursement, and more. Lawmakers will be eyeing action on these policies during the “lame duck” session after the November elections and before the 118th Congress gavels out.

Biden Administration releases FY 2025 budget proposal, outlines health care priorities

The Biden administration released its proposed FY 2025 budget, detailing what it wants for fiscal year 2025 appropriations. Among its priorities, the budget requests $43 million for the Division of Viral Hepatitis, equal to the amounts passed by Congress in FY 2023 and FY 2024, but below what the President proposed in the last budget. The budget also requests $48.3 billion for NIH, a 2.5% increase over FY 2024. As proposed, the Cancer Moonshot would also receive $1.5 billion in mandatory funding and the Advanced Research Projects Agency for Health would receive the same $1.5 billion. The budget request also includes a proposal to expand Medicare Parts A and B coverage to any living individual who donates a non-renal organ, such as a liver or lung, to a Medicare beneficiary to fully cover the costs, including deductibles and coinsurance, of such donation, a strong response to GLI’s advocacy efforts to support living donors. The budget again proposes to establish the National Hepatitis C Elimination Program, which would eliminate cost-sharing for hepatitis C treatment for Medicare Part D beneficiaries. It also includes $4 million to expand Medicare coverage of nutrition and obesity counseling and meet the goals of the White House National Strategy of Hunger, Nutrition, and Health. 

GLI Supports the Charlotte Woodward Organ Transplant Discrimination Prevention Act

The Charlotte Woodward Organ Transplant Discrimination Prevention Act would prohibit discrimination against people with disabilities in the organ transplant system. It prohibits covered entities from determining that an individual is ineligible to receive a transplant, denying an organ transplant or related service, refusing to refer the individual to an organ transplant center, or refusing to place an individual on a waiting list based solely on the fact that the individual has a disability. It also recognizes the importance of auxiliary aids and services, the ability of an individual’s support network to help with post-operative care, and the need for reasonable modifications to policies and procedures to make organ transplant systems and facilities more accessible to people with disabilities. The bill was unanimously reported favorably out of committee on March 20, 2024, and is awaiting passage by the full House of Representatives before being considered in the Senate. Learn more here.

Congress Passes CBO Reforms

GLI  has long advocated for the Congressional Budget Office (CBO) to take into consideration prevention benefits related to policies that would expand access to care for patients. Therefore, GLI was excited that the U.S. House of Representatives passed H.R. 766, the Preventive Health Savings Act, which would provide a framework for CBO to evaluate the long-term budget impacts of preventive health care legislation. For 10 years, this bill has been led by Rep. Diana DeGette (D-CO) and Rep. Michael Burgess, M.D. (R-TX). It is now headed to the Senate for its consideration.

FDA Approves a New Cardiovascular Indication for Obesity Medication

The U.S. Food and Drug Administration (FDA) approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. For the Congressional Budget Office (CBO), the addition of a cardiovascular indication to the label could lead Medicare to cover the drug for obese patients with cardiovascular disease, which in turn would lower the predicted costs to the government should Congress pass the Treat and Reduce Obesity Act and require Medicare to finally cover obesity medications. View the FDA’s announcement here.

FDA’s Approval of Breakthrough NASH Treatment Opens Door for a Long-Neglected Patient Population

GLI recognizes the importance of the first approval by the U.S. Food and Drug Administration (FDA) of a medication for nonalcoholic steatosis (NASH). Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise. This breakthrough follows years of NASH patient-led, multi-stakeholder advocacy and partnership with researchers in both drug and diagnostic development. The hope of the NASH and larger liver health community is that this successful approval and the robust and diverse pipeline of therapies to follow will open up a new era of care options for people living with fatty liver disease. When announced by the FDA, Donna R. Cryer, JD, founder and CEO of GLI, stated, “Today’s announcement represents the culmination of the work of the united NASH community. It is particularly satisfying that we can mark Women’s History Month with a breakthrough from a female-founded company. We feel validated in establishing the GLI NASH Council back in 2017 as a collaboration that included endocrine and cardiology groups, organizations that served minority communities, and others outside hepatology from the beginning, anticipating that tackling fatty liver disease would need a larger and more diverse cadre of supporters than any other liver condition had had before.”

GLI Commends Repurposed Livmarli’s FDA Approval for Patients over 5 with PFIC

GLI celebrated a win for rare disease patients with the breaking news of the U.S. FDA’s approval for Mirum Pharmaceuticals’ Livmarli to treat cholestasis pruritus in patients 5 and older that have been diagnosed with progressive familial intrahepatic cholestasis (PFIC), a rare, genetic disorder in which bile builds up in the liver. “This repurposing of an already-approved medication brings hope to a population of patients who have had limited options for treatment, like so many others with a rare disease,” shared Donna R. Cryer, JD, founder and CEO of GLI. “Instead of facing certain disease progression to end-stage liver disease and the necessity of transplant, a renewed quality of life and longevity is now available for patients with PFIC.”