Update (9/30/23): Congress passed a short-term Continuing Resolution (CR), which will keep the government operating at Fiscal Year 2023 funding levels until mid-November buying more time to come to an agreement on a full FY 2024 budget. While a CR is preferable to a shutdown, the brain tumor community needs increases to research funding as well as predictable budgets to move treatment development forward. We’re still urging Congress to come together to pass an FY 2024 budget that prioritizes increased and consistent research funding.
The potential for a government shutdown is currently leading national news. If Congress can’t agree on a new budget to fund all of the federal government’s departments, agencies, and programs for Fiscal Year 2024 by Friday, September 29 (or pass what’s known as a “Continuing Resolution” or “CR” to give themselves more time), many of these offices will not have the resources they need to operate at maximum capacity.
While it is inevitable that a protracted government shutdown will have several negative impacts on government-funded brain tumor research and drug development activities, all federal agencies have contingency plans to operate essential services to minimize any immediate risk to patients and families. We’ve analyzed these implications for the brain tumor community.
Here’s what patients with brain tumors and their care partners need to know:
Care & Clinical Trials
The National Institutes of Health (NIH) and National Cancer Institute (NCI) – including the National Institute of Neurological Disorders and Stroke and the Neuro-Oncology Branch – operate a clinical center where some patients go to receive second-opinions, participate in clinical trials, and receive related care. All current patients at the NIH/NCI Clinical Center or on other NCI-sponsored clinical trials will still be able to receive treatment and care.
Some of the ancillary services typically offered at the Clinical Center will close, unfortunately. This includes psycho-social services, child-life care, the cafeteria, voucher services, and possibly other amenities usually available to patients and families at the Clinical Center. Additionally, no new trials will be able to start at the NIH/NCI Clinical Center during a shutdown and no new patients will be able to enroll on a trial at the clinical center or travel there for a consultation or second-opinion.
Health Insurance & Government Benefits
Government-funded health insurance plans and services like Medicare, Medicaid, the VA, and Social Security (namely for patients with brain tumors, Social Security Disability Insurance or SSDI) will continue to provide normal benefits during any shutdown, as they are funded differently and separately from other government programs. Patients and care partners should see no change in their ability to access these benefits. Healthcare plans run through marketplaces created by the Affordable Care Act (Obamacare), will also remain open.
The biggest impact on the brain tumor community during a government shutdown would likely be lost time for research efforts. The NIH and NCI are the largest funders of brain tumor research in the world. “Extramural” grants that the NIH/NCI have already distributed to researchers at medical and academic laboratories across the country won’t be affected, but these agencies also house “intramural” or on-site research laboratories that will largely close during a shutdown. Furthermore, the process for reviewing and issuing new extramural grants will also be impacted. This is in addition to the pause on launching new clinical trials mentioned above.
Beyond the NIH and NCI, other agencies that play crucial roles in biomedical research like the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) will also be impacted in the case of a shutdown.
The FDA regulates safety for new drugs and devices by making decisions about greenlighting new clinical trials, okaying study protocols and changes, approving new treatments, inspecting drug manufacturing facilities, and providing guidance documents to the industry. According to agency contingency plans, activities related to “the review and approval of new medical products, the review of requests to conduct important clinical research, the issuance of guidance, and other necessary activities to help patients have access to new therapies” will continue through the use of money that comes from “User Fees” – fees the FDA collects from companies that produce medical products. However, there are questions about how far User Fees could stretch to cover these costs in the event of an extended shutdown. Further, the FDA will likely be unable to collect new user fees, which also means that any review applications for new treatments that would typically require a user fee upon submission would be placed on hold. Additionally, the ability for FDA to conduct safety inspections at a normal level may be impacted.
The CDC runs a number of cancer-related programs, including programs in cancer surveillance that help the brain tumor field track trends in incidence rates and survival. A government shutdown would potentially interrupt these efforts through the furloughing of staff and possibly delay reporting of future data.
All of this means that research and treatment development efforts with the potential to transform the brain tumor landscape will likely slow down and take longer to see-through in the event of a long-term shutdown.
If you (or your loved one) is currently undergoing treatment for a brain tumor, you are unlikely to experience any significant impacts to your core medical care – whether you’re receiving that care at the NIH/NCI Clinical Center or at any other hospital or cancer center across the country. This is true whether you’re participating in a clinical trial or not. However, you may be affected, as noted above, by the closure of some ancillary services and amenities at the NIH/NCI Clinical Center.
Patients will also still receive benefits from the VA, Medicare, Medicaid, SSDI, or a marketplace health plan.
Brain tumor research overall, however, will be slowed down in a number of ways. In addition, patients who might have otherwise chosen to move their care to the NIH/NCI Clinical Center or joined a trial there in the future would be unable to do so during a shutdown.
Agency contingency plans and other sources of funding will help mitigate the most extreme impacts on patients with brain tumors, but a shutdown is far from ideal. That’s why it’s important for the community to stand together and take action to ensure patients come first.