Health agencies’ efforts to combat the Covid-19 pandemic would likely continue in the event of a government shutdown, but other key work—including enrolling patients in clinical trials, drug and disease surveillance, and rulemaking—could come to a halt.
Thursday is the deadline to fund the federal government and avert a shutdown. Both the House and Senate will likely have to pass a short-term spending bill that would need to be signed into law by 11:59 p.m. ET.
The looming shutdown comes as more than 2,000 people die from Covid-19 daily and hospitals in pandemic hot spots consider rationing care. Agencies with public safety functions must assess each activity they conduct to determine if it has a source of funding or falls into an emergency exception that would allow it to continue.
But even when “critical activities” are allowed to continue during a shutdown, “it’s actually very hard to do” those activities because many workers are furloughed or out of action, Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, told reporters.
“There are a lot of things that maybe aren’t critical and immediate, but they’re preventing things from becoming critical and immediate,” said Sharfstein, a former second-in-command at the Food and Drug Administration. For example, the CDC was prepared to suspend influenza surveillance during a previous government shutdown, he said.
The Health and Human Service Department would be able to keep a higher percentage of staff compared with 2018, when the last shutdown happened. In 2018, the department furloughed about half its staff—40,845 employees. This year it would furlough about 43%, or about 36,536 people. The HHS has about 3,000 more employees than it did three years ago.
The HHS’ contingency plan is unclear on what types of workers will be furloughed, however, and instead focuses on what work will continue. Here’s a rundown:
- The Food and Drug Administration would continue to authorize vaccines, therapeutics, and diagnostics, including Covid-19 vaccines for school-age children. The agency also would be able to continue any work that is funded by user fees, including the regulation and review of drugs, biologics, and medical devices. However, if the shutdown is prolonged, the agency could run out of the user fees that fund that work.
- The Centers for Disease Control and Prevention would continue addressing immediate ongoing disease outbreaks, including the Ebola outbreak in the Democratic Republic of Congo. The agency would also collect and report out data used to track, prevent, and treat diseases. The CDC’s labs and 24/7 emergency operations center would stay open.
- The National Institutes of Health would sustain its support for priority Covid-19 research and development. Supplemental funding from Covid-19 bills previously passed by Congress can be used to fund some of this work. The NIH would keep lean operations—about 25% of its staff or 4,500 personnel—to care for patients in its clinical center and to take care of animals and cell lines.
- The Centers for Medicare & Medicaid Services operations related to the pandemic were funded by the Coronavirus Aid, Relief, and Economic Security Act and won’t be affected by a shutdown. The agency will continue supporting the Medicare program and has enough money to fund Medicaid through the first quarter of fiscal 2022. The agency would also continue efforts to prevent fraud and abuse and the activities of the Center for Medicare & Medicaid Innovation. Some work maintaining the federal insurance exchange, including verifying eligibility, would be funded by user fees.
Here’s what work would stop if there is a lapse in government funding:
- High stakes work from the FDA, including policy-making functions and most surveillance inspections around compliance and safety, would stop in the event of a shutdown.
- Any less immediate surveillance from the CDC could be suspended, potentially slowing responses to emerging diseases.
- The NIH would have to furlough roughly 75% of its staff, a blowback that would exacerbate existing setbacks. The NIH already has lost or delayed at least $16 billion worth of research due to the pandemic. Work to enroll new patients in clinical trials, laboratories, and plans to build President Joe Biden’s proposed $6.5 billion biomedical incubator, dubbed the Advanced Research Projects Agency for Health, would be put on hold.
- The shutdown could delay the CMS’s release of several important regulations, including the 2022 Medicare physician fee schedule final rule, which determines how much doctors, surgeons, and other specialists are paid.
Shutdown at HHS: What Work Would Continue at the Health Agencies
Bloomberg
September 29, 2021 4:04 pm
Health agencies’ efforts to combat the Covid-19 pandemic would likely continue in the event of a government shutdown, but other key work—including enrolling patients in clinical trials, drug and disease surveillance, and rulemaking—could come to a halt.
Thursday is the deadline to fund the federal government and avert a shutdown. Both the House and Senate will likely have to pass a short-term spending bill that would need to be signed into law by 11:59 p.m. ET.
The looming shutdown comes as more than 2,000 people die from Covid-19 daily and hospitals in pandemic hot spots consider rationing care. Agencies with public safety functions must assess each activity they conduct to determine if it has a source of funding or falls into an emergency exception that would allow it to continue.
But even when “critical activities” are allowed to continue during a shutdown, “it’s actually very hard to do” those activities because many workers are furloughed or out of action, Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, told reporters.
“There are a lot of things that maybe aren’t critical and immediate, but they’re preventing things from becoming critical and immediate,” said Sharfstein, a former second-in-command at the Food and Drug Administration. For example, the CDC was prepared to suspend influenza surveillance during a previous government shutdown, he said.
The Health and Human Service Department would be able to keep a higher percentage of staff compared with 2018, when the last shutdown happened. In 2018, the department furloughed about half its staff—40,845 employees. This year it would furlough about 43%, or about 36,536 people. The HHS has about 3,000 more employees than it did three years ago.
The HHS’ contingency plan is unclear on what types of workers will be furloughed, however, and instead focuses on what work will continue. Here’s a rundown:
- The Food and Drug Administration would continue to authorize vaccines, therapeutics, and diagnostics, including Covid-19 vaccines for school-age children. The agency also would be able to continue any work that is funded by user fees, including the regulation and review of drugs, biologics, and medical devices. However, if the shutdown is prolonged, the agency could run out of the user fees that fund that work.
- The Centers for Disease Control and Prevention would continue addressing immediate ongoing disease outbreaks, including the Ebola outbreak in the Democratic Republic of Congo. The agency would also collect and report out data used to track, prevent, and treat diseases. The CDC’s labs and 24/7 emergency operations center would stay open.
- The National Institutes of Health would sustain its support for priority Covid-19 research and development. Supplemental funding from Covid-19 bills previously passed by Congress can be used to fund some of this work. The NIH would keep lean operations—about 25% of its staff or 4,500 personnel—to care for patients in its clinical center and to take care of animals and cell lines.
- The Centers for Medicare & Medicaid Services operations related to the pandemic were funded by the Coronavirus Aid, Relief, and Economic Security Act and won’t be affected by a shutdown. The agency will continue supporting the Medicare program and has enough money to fund Medicaid through the first quarter of fiscal 2022. The agency would also continue efforts to prevent fraud and abuse and the activities of the Center for Medicare & Medicaid Innovation. Some work maintaining the federal insurance exchange, including verifying eligibility, would be funded by user fees.
Here’s what work would stop if there is a lapse in government funding:
- High stakes work from the FDA, including policy-making functions and most surveillance inspections around compliance and safety, would stop in the event of a shutdown.
- Any less immediate surveillance from the CDC could be suspended, potentially slowing responses to emerging diseases.
- The NIH would have to furlough roughly 75% of its staff, a blowback that would exacerbate existing setbacks. The NIH already has lost or delayed at least $16 billion worth of research due to the pandemic. Work to enroll new patients in clinical trials, laboratories, and plans to build President Joe Biden’s proposed $6.5 billion biomedical incubator, dubbed the Advanced Research Projects Agency for Health, would be put on hold.
- The shutdown could delay the CMS’s release of several important regulations, including the 2022 Medicare physician fee schedule final rule, which determines how much doctors, surgeons, and other specialists are paid.