AdvaMed has 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 healthcare system is relying on medtech to continue delivering enormous amounts of diagnostics supplies, PPE, and treatments for COVID-19 patients,” says 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 healthcare system. Without that flexibility and availability, the letter cautions, medtech manufacturers’ efforts will be significantly impaired.
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.
You’ve signaled recently that you plan to extend the PHE, and we applaud and encourage that initiative. By extending the PHE, you’re extending our ability to meet the demands of a pandemic-era healthcare system.
For example, if the PHE is extended, FDA can continue to authorize emergency use of COVID-19 diagnostics and treatments via expedited premarket review. Dozens, if not hundreds, of currently used COVID-19 diagnostics and treatments—including virtually every COVID-19 test and several ventilator varieties—have entered the market successfully through this system. Under the PHE, new innovation will continue to flourish—not to mention those existing diagnostics and treatments can remain on the market without long, costly regulatory reevaluations.
The PHE has also allowed more and more American patients to access telehealth services, keeping those patients and their doctors and nurses safe from potential virus exposure. Policy changes under the PHE have empowered doctors to deliver care to more patients—not just patients in rural areas—through more convenient means—like Zoom and Skype—and for a wider variety of ailments, like psychological distress, vision and speech problems, and obesity. These policy changes must stay in place while social distancing and safer at home orders remain status quo.
There are plenty of other supports the PHE establishes: hospitals are able to increase bed capacity seamlessly, status reporting requirements are eased so reporters can focus more intently on delivery of care, and doctors are able to practice across state lines without penalty.
We encourage you to retain some of these supports permanently, beyond the public health emergency. We’d also recommend that industry stakeholders be given reasonable advance notice prior to any termination of the declared public health emergency, and an opportunity to comment on the impact of any discontinuations of COVID-19-related agency policies that went into effect during the declared public health emergency, as well as the time necessary for industry stakeholders to transition their operations to a post-public-health-emergency regulatory environment.
We commend you and your staff at HHS for recognizing their importance in the fight against COVID-19. Your work and the work of the White House Coronavirus Task Force have demonstrated what a truly successful public-private partnership can do for the good of the country. We look forward to continuing our work with you.