COVID-19 pandemic changing regulatory picture around medical devices, technology in healthcare

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The COVID-19 pandemic has changed the regulatory picture around medical devices and technology in healthcare, and the way in which those technologies are reimbursed. Take telehealth, for example, which has seen greater reimbursement flexibility from the Centers for Medicare and Medicaid Services.

Some of these changes have presented opportunities for entrepreneurs and product developers. Policymakers have taken note and learned lessons that may help grease the wheels for future product development and the regulatory structure that surrounds them.

In broad strokes, that was the topic covered in the HIMSS21 Digital session, "Regulations and Reimbursement: How to Navigate Compliance in an Uncertain World," which premiered on August 10. Speaking at the session were Amy Abernethy, former principal deputy commissioner and acting chief information officer at the U.S. Food and Drug Administration; Devem McGraw, chief regulatory officer at Citizen; and Kim Brandt, partner at Tarplin, Downs and Young, and former principal deputy administrator for operations and policy for the Centers for Medicare and Medicaid Services.

According to Abernethy, emergency regulations allowed the FDA to enact regulatory flexibilities, which allowed the agency to approve products much more quickly, thereby providing some measure of guidance for the industry as a whole. It allowed the industry to pressure-test what it would look like when the FDA and the federal government are working in more nimble ways.

The FDA, she said, could be more flexible with respect to digital health solutions and how they're used in everyday life. Clinical trials have allowed companies to use real-world data to fill in data sets when, say, a patient was unable to travel to a clinic. That set up a space in which the agency could evaluate what real-world data sharing does in terms of creating clinical trials for the future.

Companies, for instance, could use remote monitoring that's similar to telehealth to track patients' health at home, a practice that could continue after the pandemic, said Abernethy.

"The regulatory agencies are essentially required to go back to where they were before (the pandemic), but we don't unlearn," she said. "What it allows us to do is continued evidence development while maintaining more clinician- and patient-centric care."

A similar transformation occurred at CMS, with that federal agency moving in ways it never had before, doing things like establishing practice locations in parking lots or unused office space. They also had to come up with a hospital-at-home model to have services performed inside the home.

"We needed to think very quickly about telehealth, and how CMS would extend our flexibilities," said McGraw. "CMS issued 150 waivers of our traditional requirements. Normally, in the past, we would have done a dozen or so, if there had been some other public health emergency. Telehealth is Pandora's box. It's not going back. It's going to be really hard for CMS to go back, because so many people have become so dependent. It would change the way we do business. It allows for innovative approaches for everyone."

According to Brandt, the Office of Civil Rights issued guidance on enforcement discretion to enable healthcare providers to take off-the-shelf telehealth solutions and deploy them quickly.

"If anything, hackers are hyper-aware of circumstances where people are taking their guard down, because that's opportunity," said Brandt. "But at the same time, off-the-shelf tools made a lot of sense in the short term. Ordinarily, the ability to report on public health is limited by partnership agreements, but they have a lot of data, so all of the guidance was very critical."

Recently, the FDA published a final rule on breakthrough medical devices which created an opportunity for manufacturers to automatically receive up to four years of Medicare coverage, along with market clearance. McGraw said this could have a big impact.

"Part of the challenge is regulatory hurdles that had to be worked through," said McGraw. "Part of what CMS realized was there were a lot more breakthrough devices than they anticipated, and it was going to be a much bigger workload and have a bigger impact on the Medicare program than people expected. It will be a delicate dance moving forward."

The alignment between CMS and the FDA could be helpful in evaluating products, said Abernethy, and there could well be a move from traditional registry approaches to newer, technology-based approaches, as well as analysis of real-world data in new ways, which may prove valuable in evaluating some of those products in the future.

"These data sets might serve dual purposes, evaluating for safety and effectiveness as well as outcomes from a CMS perspective," said Abernethy. "While it doesn't specifically say it, it sets us up for a life cycle of continuous life cycle product evaluation – essentially thinking about how we use data to continuously evaluate a device once it's cleared, and across the product life cycle."

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com