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.”
