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Some changes to federal healthcare rulemaking that occurred due to the COVID-19 pandemic aren't likely to go away after it ends, several speakers said Tuesday at an online session during the annual meeting of the Healthcare Information and Management Systems Society (HIMSS).

The pandemic has forced CMS "to go in ways that CMS, just frankly, has never gone before and they had to go very quickly," said Kim Brandt, a partner at consulting firm Tarplin, Downs & Young and former principal deputy administrator for operations and policy at CMS. "They had to give unprecedented flexibilities to allow for people to be able to set up practice locations in things like parking lots or ... unused office space; they had to come up with a 'hospital at home' model to allow for certain types of services to potentially be done in the home."

In addition, "CMS actually ended up issuing over 150 waivers of our traditional sort of requirements" to cover telehealth when it normally would have issued only about a dozen of those, usually for a hurricane or other type of national emergency, Brandt said. "The result, though, is that for telehealth in particular, it's opened a Pandora's box, which is not going back ... because so many people have become so dependent" on that technology, which is also lower-cost.

"It's something that I think has [potential] to transform how we do business as a healthcare payer at CMS, but also is really exciting for patients because it allows for a lot of new innovative approaches, which is going to be good for everyone," she added.

Changes at FDA

FDA also needed to adopt some regulatory flexibilities during the pandemic, according to Amy Abernethy, president of clinical research platforms at Verily and former principal deputy commissioner of food and drugs at the FDA. "This allowed FDA to approve products more quickly and put in place public health emergency guidance for industry," Abernethy said. "It allowed the entire industry to pressure test: what does it look like when the FDA and the rest of government is working in more nimble ways?"

The FDA took several steps "that allowed us to be more flexible with respect to digital health solutions and how we use them in our everyday life," she continued. "For example, in the context of clinical trials, the public health emergency-related guidances allow companies to utilize real-world data to fill in clinical trial datasets when a patient otherwise could not get to the clinic to have a clinical trial visit. So now, this sets up a space where in the future we can evaluate, what does the marrying of real-world data plus clinical trials data do with respect to creating new mechanisms for clinical trials for the future?"

In the near term, "the regulatory agencies are required to essentially go back to the way it was before, but we don't unlearn," she added. "And so the goal would be to stop and say, what has been learned, and what should proceed into the future?" Examples might include looking at "what allows for continued evidence development while maintaining patient safety and data integrity, and how can we make sure that we're moving towards more patient- and clinician-centric care that takes less burden on physicians in the system and allows patients to get what they need quicker and smarter."

Health Privacy Issues

Health privacy and security was another area in which flexibility was essential, said Deven McGraw, chief regulatory officer at Ciitizen, a company aimed at getting everyone in the world access to their health records. "The HHS Office for Civil Rights (OCR), which has jurisdiction over HIPAA, issued a number of guidances ... to enable healthcare providers, hospitals, and doctors to be able to take off-the-shelf telemedicine solutions and to deploy them really quickly," she said.

"Security and privacy don't necessarily take a break during a national emergency, and if anything, hackers are hyper aware of circumstances where people might be letting their guard down because that's an opportunity for them. But at the same time, there was a need for entities who were not using telemedicine to do so very quickly, and off-the-shelf tools that may or may not be HIPAA-compliant would have made a lot of sense in the short term," she added.

Public health reporting rules also have been more relaxed during the pandemic, said McGraw. "We have these health information exchange entities that are business associates that ordinarily, their ability to report directly to public health is limited by agreements that they've executed with their participants -- healthcare providers -- and yet they have a lot of data," so making it easier for them to report was critical, she said.

"I think it's a little uncertain whether you can continue to sort of, not waive security concerns, but to put them on the back burner absent a public health emergency," McGraw added. "But I will say, some of the reporting to public health is something that I think people learned could be done, and should be done ... and might be sort of a candidate for kind of lasting change to the rules, but we'll see how OCR handles that long term."

New Rule on "Breakthrough" Devices

Panelists also were asked about a on so-called "breakthrough" medical devices; the rule says that once such devices are approved under the FDA's premarket clearance process, they also will get a guaranteed 4 years of coverage from Medicare. The rule was originally supposed to take effect on March 15, but has been delayed until at least December 15 under the usual "regulatory freeze" that happens during a change in administrations.

If and when the rule does take effect, "I think it's going to have a really big impact because it's going to allow Medicare beneficiaries to be able to get access to products much quicker than they would have been able to before, and that's huge from a patient perspective in terms of being able to treat their conditions," said Brandt. "I think part of the challenge is that CMS and FDA still have some regulatory hurdles to work through on the CMS side."

"Part of what CMS realized fairly quickly was there were a lot more of those breakthrough devices and products than they anticipated, and it was going to be a much bigger workload, and have a much bigger impact on the Medicare program than I think anyone had originally anticipated," she added. "So it's something that has great potential, but I think there's still a very close dance to be worked out between FDA and CMS, about how this is all going to work and how it moves forward."

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