Does The End of the COVID-19 Public Health Emergency Bring An End To Telehealth?

   

‘This could actually be catastrophic’: What the end of the public health emergency means for telehealth

When the COVID-19 public health emergency ends in May, some patients will face new hurdles to the telemedicine services they’ve relied on for three years.

BY ISSIE LAPOWSKY, Fast Company, March 21, 2023 

Over the past few weeks, desperate messages have been pouring into the telehealth company Boulder Care from patients who say a new proposed rule by the federal government could put their health—and their lives—at risk.

The rule, proposed by the Drug Enforcement Agency (DEA), would require anyone being prescribed certain controlled substances via telemedicine to see a doctor in person in order to continue their care online. That includes drugs like buprenorphine, which Boulder Care’s providers use to treat people with opioid use disorder, but also testosterone therapy for transgender people, Adderall prescriptions for kids with ADHD, and any other controlled medications. When the pandemic began, the DEA had waived this in-person requirement as part of the public health emergency. Now that the public health emergency is set to end in May, the DEA wants to take away that waiver.

In the patient responses Boulder received, each message was more dire than the next. Some worried about being able to even travel to see a doctor. “There [aren’t] any clinics close to me, and I don’t have reliable transportation to get an hour to an hour and a half away, which is what I would have to do,” read one.

Others expressed fear at having to share their personal struggles with a local doctor in a small community. “Being able to protect my anonymity was the only way I was successfully able to get addiction treatment, and I’m sure most everyone using these telehealth services feels the same,” read another. 

According to Stephanie Strong, founder and CEO of Boulder Care, several hundred of the company’s patients live in a remote area, lack transportation, and don’t currently have a primary care provider. Now, she’s hoping that lifting up the voices of Boulder’s patients will help convince the DEA—or other parts of the federal government—that requiring in-person visits could have disastrous consequences. 

“The people who are struggling most in their addiction and in their lives are the very people who will struggle most with this rule,” Strong says. “We expect this could actually be catastrophic and put doctors in the really difficult position of denying care for someone’s life-threatening condition.”

Before President Biden’s State of the Union address this year, the White House laid out an agenda, which included a commitment to expand telehealth services for mental health and substance use disorder. The Department of Health and Human Services (HHS), meanwhile, said in February that while the public health emergency was ending, the DEA would soon propose a rule that would extend pandemic-era flexibilities for certain drug prescriptions. 

But while the DEA’s proposed rule is more flexible than the pre-pandemic law, the proposal would reinstate an in-person-visit requirement that didn’t exist during the pandemic. The rule wouldn’t apply to things like antibiotics or blood pressure medication, but it would impose new hurdles for patients being treated with certain controlled drugs. 

New patients would need to go see a doctor within 30 days of beginning telemedicine treatment for buprenorphine, while existing patients would have 180 days to do the same. For people seeking prescriptions for Adderall to treat ADHD, the rules will be even stricter once the public health emergency ends, requiring patients to have an in-person visit before receiving any further telehealth care. That could be a crisis for kids, in particular, given the monthslong wait times for child developmental specialists in the U.S.  

For Strong and others, these proposed hurdles suggest the administration isn’t keeping its promises. “It’s not what we expected,” says Zack Gray, cofounder and CEO of Ophelia, another telehealth company that treats people with opioid use disorder. “It is unfortunate; and if it holds, it’s going to have significant consequences for public health.” 

The DEA declined to comment, beyond its initial press release on the proposed rule. 

An HHS official tells Fast Company that the agency has been working in consultation with the DEA and considers the proposal a “middle ground” between the pre-pandemic law and the total flexibility of the COVID-19 era. According to the official, HHS’s main goal has been to ensure that there is a rule in place before the public health emergency ends, so that patients aren’t immediately required to see a provider in-person before continuing care. “If May 11 hits and we don’t have a final rule in place, it’s pre-pandemic law that we default back to,” the official says. “Pre-pandemic law is so much more restrictive than even the proposal that’s on the table right now.”

But the official says HHS is “very much aware” of the concerns Strong, Gray, and others are raising and that the agency has been discussing these issues with the DEA.

The Ryan Haight Act was signed into law in 2008 to regulate online prescriptions of controlled substances. That law directed the attorney general to promulgate rules that would allow for the special registration of telemedicine providers. But those rules never came. A decade later, former President Trump signed the Support Act into law, once again instructing the DEA to create rules regarding the special registration of telemedicine providers within a year. That deadline passed in October 2019. For people who have waited for years for the special registration process to materialize, it’s frustrating to see this proposed rule sidestep the question altogether. 

“We needed a solution to this years ago,” says Libby Baney, a partner at the law firm Faegre Drinker Biddle & Reath and an advisor to the Alliance for Safe Online Pharmacies, an industry group focused on addressing the illegal online drug trade.

The public has until the end of March to comment on the proposal before the DEA finalizes its rule or pulls it altogether. Already, thousands of responses have flooded in. “We thought that they were going to make an announcement about a special registration that said, ‘Here’s how legitimate telehealth prescribers can get around the in-person visit requirement,’” Gray of Ophelia says. “That’s not what happened.”

“We’re kind of begging to be regulated, as a sector,” Strong of Boulder Care says. “We want telemedicine rules that are common sense and protect patient safety and all the things that we know are important. And this rule is not that.”

And yet, the HHS official warns that there is no guarantee that this long-awaited special registration for telemedicine providers wouldn’t come with the same in-person requirements as the DEA’s proposed rule. “I don’t think you can just assume that the statute says create a list, the list is created, and no other guard rails will be there,” the official says, adding that the absence of the special registration may actually end up saving providers from having to jump through additional hoops.

Since the start of the pandemic, telehealth use has grown 38 times pre-pandemic levels. But the end of the public health emergency is bringing uncertainty even to telemedicine providers who don’t deal with controlled substances. TimeDoc Health offers chronic-care management services for providers whose patients need long-term monitoring in between appointments with their doctor. The reimbursement policy that allows for those services predated the pandemic, but according to Will Boeglin, cofounder and CEO of TimeDoc, it’s still unclear whether the Centers for Medicare & Medicaid Services will reinstate the in-person requirement for enrollment in those services when the public health emergency ends. Reverting to the pre-pandemic rules, Boeglin says, would likely lead to a drop off in adoption of these services, which help providers with staffing shortages and also reduce costs for Medicare. 

“I think everyone’s kind of hoping and expecting that they’re not going to revert some of these changes, because it feels like a step backwards,” Boeglin says. CMS did not respond to Fast Company’s request for comment.

While the DEA’s proposed rule wasn’t what most of the telemedicine sector was hoping for, it also wasn’t a complete surprise. Last year, the Department of Justice launched an investigation into Cerebral, a telemedicine company focused on mental health, for possible over-prescribing of controlled substances, including Adderall. Cerebral’s CEO has said he’s “confident” the company’s prescribing practices have been above board. 

At a time when the government is concerned about reckless prescribing of drugs like Adderall, Baney says, it stands to reason that they’d want to implement a rule that slows down the process. “You can think of it as a stop sign, which to some patients means they just won’t get access to care anymore,” Baney says. “But a stop sign could be a very good thing if you’re the DEA, and you’re trying to limit overprescribing of controlled substances. A stop sign is exactly the intent.” But Baney warns that this stop sign might actually be an offramp, leading patients to less safe online marketplaces for prescription drugs.

When it comes to opioid use disorder treatment at least, telehealth executives, including Strong, point to mounting evidence that during the three years that the in-person waiver was in place, access to telehealth services increased people’s chances of sticking with treatment and reduced their risk of an overdose. “They’re ostensibly trying to regulate it to prevent an overdose crisis,” Strong says. “We are trying to stop an overdose crisis that already exists.”

Gray, meanwhile, argues that no one in the government has made much of a case for why in-person visits are medically necessary to treat people with substance use or mental health issues. “If you’ve ever been to a psychiatrist for anxiety, depression, they don’t take your shirt off and take your blood pressure. They talk,” he says. “Nobody has come out and explained what the physical exam is supposed to accomplish.”

If the DEA moves forward with the rule, there are other levers the government could pull to address at least some of the concerns telehealth companies have. Legislators, for one, could pass a law waiving the in-person-visit requirement, which Baney says Congress specifically opted not to do last year, as it was drafting its omnibus bill, offloading the responsibility instead to the DEA. 

Another option would be for HHS and the Attorney General to agree to extend the in-person waivers for buprenorphine prescriptions specifically under the opioid public health emergency, once the COVID-19 public health emergency ends. The HHS official says that the agency is “still evaluating” that option, but acknowledged that that would only address concerns for a subset of patients whose medication is impacted by the rule.

For now, Strong and her team at Boulder Care are trying to prepare patients as best they can, using their network of patient navigators to help direct people to in-person providers. But she has little doubt that there will be people for whom this requirement will mean stopping treatment or turning to illicit markets for the drugs they need, with potentially tragic results.

“If you’re choosing between going to a doctor, which is really hard, and getting Suboxone or Xanax or something on the street, which is really easy, as the DEA [itself] says, it only takes one pill to kill,” Strong says, “and that’s how people overdose.”