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.
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.”
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