WASHINGTON, D.C. – AdvaMed today sent the following letter to Health and Human Services (HHS) Secretary Azar requesting that he extend the declared federal public health emergency (PHE) beyond its current expiration date, so that the medical technology industry can continue to efficiently deliver the tools hospitals need to treat people with COVID-19. In light of recent reports that the PHE would likely be extended, AdvaMed president and CEO Scott Whitaker requested that the medical technology industry be given the opportunity to weigh in on any future decision to terminate the PHE.
"Our health care system is relying on medtech to continue delivering enormous amounts of diagnostics supplies, PPE, and treatments for COVID-19 patients," said Scott Whitaker, president and CEO of AdvaMed. "In turn, we're relying on the federal government to continue supporting our efforts by maintaining the current public health emergency status, which removes major regulatory and access barriers and expedites the manufacture and distribution of our lifesaving products."
The letter notes that the emergency declaration has facilitated much-needed regulatory flexibility and availability of resources, allowing medtech manufacturers to meet the demands of a pandemic-era health care system. Without that flexibility and availability, the letter cautions, medtech manufacturers' efforts will be significantly impaired.
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Specifically, once the emergency declaration expires, FDA can no longer authorize emergency use of COVID-19 diagnostics and treatments via expedited premarket review. Additionally, all currently used COVID-19 diagnostics and treatments – including virtually every COVID-19 test and several ventilator varieties – that have entered the market through this system will no longer be authorized to remain in the market until they are reevaluated, which is a long, costly process.
Other key flexibilities that will expire if the emergency declaration expires include payment parity for telehealth services under Medicare and the freedom to add beds to hospitals without going through a lengthy permitting process.
The full text of the letter follows:
Dear Secretary Azar:
At the end of January, your office declared a public health emergency (PHE) to bolster our healthcare community's COVID-19 relief efforts. It worked: Since then, we've delivered 86 commercial in vitro diagnostic tests for COVID-19 and tested millions of Americans; we've increased personal protective equipment production capacity above 100 percent; and we're delivering 10,000 ventilators per week to the hospitals that need them most. This historic ramp-up would not have been possible without the regulatory flexibilities and availability of resources facilitated by the PHE.
