Start Your Own Post-PHE Regulatory Checklist

Greg Fulton, Senior Manager, Market Access and Reimbursement, Philips

Speculating, plotting and predicting the end of the Public Health Emergency (PHE) had become something of a parlor game. Should we beware the Ides of April while leaning on the promised 60-day notice? There was of course merit and skin in this game. But it’s better to game that the end is not near (May 11) but here, specific to the many waiver policies impacting patients along with delivery, devices and reimbursement, meaning it’s already time to begin your own checklist.

Look back, for example, at the 71-page CMS FAQ on Medicare fee-for-service billing issued May 27, 2020 to regain a sense of the mobilization and details, a mobilization that spanned the Office of Civil Rights, the Office of the Inspector General, the FCC, FDA, HRSA grants, the VA and of course CMS and other HHS agencies.

Amid similar speculation that the federal government is busy with post-PHE policies that will inform or regulate the future, and although federal agencies and Congress have pushed out timelines for or solidified many waiver provisions into permanence, there are gaps to start tracking. 

What will you lobby for or comment toward? What has been left out of permanence, due to end with the PHE in May?

As the American Telemedicine Association opens its annual conference in March, three years after the PHE was declared on March 1, 2020, here are just some aspects to consider.

RPM devices and the FDA

Don’t forget that in March of 2020, the FDA issued a guidance allowing a host of modifications for remote physiologic monitoring (RPM) devices that included hardware and software architecture, connectivity, applications and even claims or indications without premarket notification.

Titled “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” as of this writing, it’s due to end with the PHE. 

Should this merit a review of your or your industry partners’ devices and implementations and patient usage?

Also within RPM, where some COVID waivers have been made permanent by CMS, the waiver of a prior or established relationship has not, and is also due to expire.

I personally don’t think this is a killer, though, if you look at published context regarding telehealth. An October 2022 study by the Bipartisan Policy Center found that from 2020 to 2021, telehealth was used by established patients from 74 to 82 percent of the time, belying any notions of “telemarketing” or doctor shopping in my opinion. It’s likely RPM patients would align, so if the waiver is working without negative effects, permanence is warranted. It’s likely RPM patients would align, so if the waiver is working without negative effects, permanence is warranted.

Telehealth payments and platforms

Currently telehealth payments remain on par with an office visit. But although Congress affirmed the telehealth list through the end of 2024 toward originating site permanence, this payment structure is due to end with the PHE. I won’t claim to know how the reimbursement landscape may change, but it’s noteworthy that fears of fraud and abuse have been tempered. A September 2022 report by HHS and OIG found ~1700 cases of dubious billing among ~700,000 providers, for example.

Also within telehealth, the Office of Civil Rights waived penalties on HIPAA-covered providers using telehealth platforms that may not comply with HIPAA. How many slide decks then included the terms Apple FaceTime, Facebook messenger video chat, Google hangouts … and Skype? How or will this landscape change and what are the financial and regulatory implications?

Of course we’ve seen great advances in telehealth and other digital delivery modalities and approaches toward permanence, such as telehealth inclusion within FQHCs and RHCs (where RPM should follow) and policies pertaining to audio-only, virtual supervision and mental health telehealth for example. But what about the remote prescription of controlled substances or the in-person requirement of the Ryan Haight Act?

Patient copays or cost sharing

The Office of the Inspector General allowed providers to reduce or waive cost-sharing for telehealth visits and other technology-based communication services during the PHE that are paid by federal healthcare programs.

Is it time to start drafting or considering patient education and communication strategies?

The next pandemic

If the end of the PHE and its implications on healthcare delivery is a time of reflection, then I wasn’t surprised to come across former Senator Lamar Alexander’s June 9, 2020 white paper from his time as chair of the Senate HELP Committee.

It is titled “Preparing for the Next Pandemic.” Well, isn’t that what we’re doing now, taking a hard industry look at what an increasingly modern and prepared healthcare system should maintain and advance?

Greg Fulton is a senior manager of market access and reimbursement at Philips and a member of the ATA Policy Council.