The U.S. COVID-19 Public Health Emergency Ends in May, but FDA’s EUA Authority Remains
On January 30, the Biden Administration announced its plans to extend the COVID-19 national emergency and public health emergency (PHE) until May 11, and then end both emergencies on the same day.
The emergency declarations are currently set to expire on March 1 and April 11, respectively, but the administration said allowing more time would honor its previous commitment to provide at least 60 days’ notice.
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Emergencies that Gave Flexibility to Government and Healthcare Providers
With COVID-19 declared a PHE in January 2020, the federal government gained access to funds and resources to pay for personal protective equipment, tests, and vaccines, and other pandemic response measures. Under the PHE, the government could also modify Medicare and Medicaid reimbursement policies to increase access to treatments and other resources critical to controlling the spread of COVID-19. Two months later, President Trump declared a state of national emergency regarding COVID-19, which allowed for additional funding, including continued coverage for Medicaid recipients and expanded funds for hospitals to treat the disease.
The Biden Administration Opposes Immediate Termination
As the majority party holding the House of Representatives, the Republicans introduced a bill (H.R. 382, titled the Pandemic is Over Act) and a joint resolution (H.J. Res.7) to the House in January, demanding immediate termination of both national emergency and PHE. According to a statement issued by the White House Office of Management and Budget, the administration is against legislation to immediately end the public health emergencies because it “would create wide-ranging chaos and uncertainty throughout the health care system.”
The White House pointed out that tens of millions of Americans could be at risk of abruptly losing their health insurance if the PHE was immediately terminated. Besides, states could be at risk of losing billions of dollars in funding. Additionally, hospitals and nursing homes that have relied on flexibilities enabled by the emergency declarations will be plunged into chaos without sufficient time to retrain staff and establish new billing processes, likely leading to disruptions in care and payment delays.
The statement also indicated that the administration supports an orderly, predictable wind-down of Title 42, which was used by the Trump administration to block land entry for many migrants since the early days of the pandemic, and has been continued by the Biden administration with expansion. Enactment of H.R. 382 would lift Title 42 immediately, and result in a substantial additional inflow of migrants at the Southwest border without the necessary alternative policies in place.
FDA’s EUA Authority Continues
The eventual lifting of the emergencies will not stop the U.S. Food and Drug Administration (FDA) from issuing new emergency use authorizations (EUAs) or allowing drugs, tests and treatments under EUAs to continue to be offered. The U.S. Department of Health and Human Services may decide when EUAs should cease to be issued.
According to a FDA spokesperson, the existing EUAs for products will remain in effect and the agency may continue to issue new EUAs going forward when the criteria for issuance are met. Besides, access to free vaccines and boosters will not end, at least until federal supplies run out.
In addition, although the Pandemic is Over Act was passed in the House in a 220-210 party-line vote a day after the release of the White House’s statement, the bill is unlikely to move in the Democratic-controlled Senate. Democratic Congressman Frank Pallone described ending the COVID-19 PHE immediately as “deeply irresponsible and dangerous ” since it would disrupt insurance coverage for millions of Americans who are in need of healthcare by allowing states to begin kicking people out immediately without protections.©www.geneonline.com All rights reserved. Collaborate with us: email@example.com