DEA
Administrator Anne Milgram's agency and HHS are at odds
over the proposal, according to a former DEA official. |
Damian Dovarganes/AP
The
DEA intends to propose substantial limits on providers’
ability to prescribe controlled substances via
telemedicine, according to a former DEA official familiar
with the proposal.
The
draft proposal is awaiting White House review and could
still change. But if finalized, it would be a significant
blow to the telemedicine industry that took off during the
pandemic and the hundreds of thousands of patients who
have come to rely on virtual prescribing. HHS and DEA are
at odds over the rule, and HHS did not concur with the
proposal, said the former official granted anonymity to
discuss an unreleased draft.
Under
pandemic-era rules that DEA extended through the end of
the year, providers have been able to prescribe most
controlled substances seen to pose a risk of misuse —
Schedule II-V drugs — without an in-person visit.
The
draft proposal, which is not yet public, would allow no
more than half of a provider’s prescriptions to be given
virtually, according to the former official.
Many
telemedicine companies have little to no in-person
presence, though some have traditional brick and mortar
clinics. Many traditional health care providers and health
systems use telemedicine.
The
proposal would also require providers prescribing any
controlled substances to check prescription drug
monitoring programs intended to prevent diversion in all
50 states. However, a system linking the programs doesn’t
connect to every state, a situation which the former
official said would make telemedicine prescribing
essentially impossible.
“If
the final rule publishes as is, nobody would be able to do
telemedicine,” the former DEA official said.
A
DEA spokesperson declined to comment, citing the ongoing
rulemaking process. The DEA has said it is committed to
allowing all Americans to access necessary treatments, and
wants to balance access with preventing overprescribing.
A
spokesperson for HHS didn’t immediately respond to a
request for comment.
The
draft proposal would also prohibit virtual prescribing of
Schedule II drugs — including Adderall for ADHD and
methadone for opioid use disorder — without an in-person
visit first, unless the prescriber is a specialist.
It
would allow patients to get Schedule III, IV and V drugs —
including buprenorphine for opioid use disorder, ketamine
for depression and testosterone for gender-affirming care
— without an in-person visit.
The
backdrop: The
draft comes as time winds down for the DEA to release its
proposal, take public comments and then finalize the rules
before the end of the year.
It
also comes after the Justice Department this summer
indicted top executives at digital health firm Done on
charges related to overprescribing stimulants for ADHD.
Prosecutors allege the two executives conspired to
structure the platform to offer “easy access” to
stimulants, including by mandating initial visits be less
than 30 minutes and prescribing Adderall even if the
member didn’t qualify.
The
company has said it "strongly disagrees" with
the charges in the alleged $100 million scheme and said
providers have “full autonomy” to decide whether to
prescribe stimulants after prosecutors alleged it told
providers to prescribe them regardless of necessity.
Top
telemedicine groups have said Done's alleged behavior
doesn't reflect the vast majority of telehealth providers
and that the case shows the system of accountability is
working.
The
backlash: The
telemedicine industry and treatment advocates are critical
of the news.
Krista
Drobac, founder of the Alliance for Connected Care, which
has members including mental health advocates, health
systems and firms including Walmart, said the group is
calling on the Biden administration for a two-year
extension of current rules to allow time to write policy
that balances access with the need to prevent misuse.
"We're
extremely concerned and disappointed," Drobac said.
"It's time to have health care agencies writing the
[rules] because it's clear that a law enforcement agency
can't ensure access to care."
Kyle
Zebley, executive director of the American Telemedicine
Association’s lobbying arm, ATA Action, said he's
hopeful the DEA will change course, "if this is
true." He also called for an extension of current
rules, given time is running short.
"The
folks at DEA are really trying to do their best,"
Zebley said. "If these rumors are true, they've all
but discounted the supermajority of the 38,000 comments
they've taken."
Eric
Triana, chief compliance officer and counsel for online
psychiatry firm Talkiatry and a former DEA diversion
control official, said the rules would essentially
eliminate virtual-only telemedicine practices.
“This
has no bearing on the diversion of controlled substances,
is not a safeguard and is outside the scope of DEA’s
mission to regulate controlled substances for the purpose
of preventing diversion,” Triana said.
The
regulatory history: The
DEA has moved slowly in writing rules for telemedicine.
Congress
tasked the agency with setting up a special registration
process to expand access to controlled substances via
telemedicine in a 2008 law. But the agency missed a 2019
deadline Congress set.
During
the Covid-19 public health emergency, the Trump and Biden
administrations eased rules to allow controlled substances
to be prescribed without an in-person visit, which had
been used as a way to prevent drug misuse.
In
February 2023, the DEA proposed significantly cutting back
on those rules after the public health emergency ended
that May.
Under
that proposal, Adderall for
attention-deficit/hyperactivity disorder and Oxycontin for
pain relief could not have been prescribed without an
initial in-person visit. Patients seeking buprenorphine
for opioid use disorder, testosterone for gender-affirming
care or ketamine for depression would have been able to
get an initial 30-day supply via telemedicine but would
then be required to visit a provider’s office for
subsequent prescriptions.
That
proposal came under bipartisan firein
Congress
and treatment advocates, particularly in mental health
care and substance use disorder, who argued it
unnecessarily restricted access to care.
The
DEA walked back that proposal after receiving a record
number of public comments, many negative. It held a
listening session on the regulations in September 2023 and
has extended
pandemic rules
through the end of 2024 while it crafts new regulations.
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