For
about
half
a
decade
now,
Americans
have
had
the
ability
to
receive
controlled
substances
via
telehealth
because
requirements
were
relaxed
during
the
Covid-19
pandemic.
This
has
greatly
expanded
access
particularly
for
those
in
remote
areas.
These
flexibilities
are
currently
set
to
expire
at
the
end
of
2025.
In
the
final
days
of
the
Biden
administration,
the
Drug
Enforcement
Administration
released
three
new
rules
relating
to
telemedicine
that
aim
to
keep
some
of
these
flexibilities
permanent
while
also
implementing
new
safeguards
to
promote
patient
safety.
“DEA’s
goal
is
to
provide
telehealth
access
for
needed
medications
while
ensuring
patient
safety
and
preventing
the
diversion
of
medications
into
the
illicit
drug
market,”
said
former
DEA
Administrator
Anne
Milgram
in
a
statement.
“We
understand
the
difficulties
some
patients
have
accessing
medical
providers
in-person,
and
we
want
to
ease
this
burden
while
also
providing
safeguards
to
keep
patients
safe.”
This
effort,
however,
has
telehealth
advocates
up
in
arms,
particularly
in
regards
to
two
of
the
three
proposals,
which
they
argue
include
arbitrary
guidelines
that
interfere
with
the
clinician’s
job
and
create
barriers
for
patients.
Now,
via
statements,
they
are
calling
upon
the
Trump
administration
to
make
things
right.
One
is
a
proposed
rule
that
would
create
a
special
registration
process
that
would
allow
a
clinician
to
prescribe
medications
through
telemedicine
visits
without
an
in-person
evaluation.
While
that
sounds
reasonable,
there
are
significant
restrictions,
including
requiring
physicians
to
be
physically
located
in
the
same
state
as
the
patient
when
being
prescribed
Schedule
II
medications.
Schedule
II
medications
are
drugs
that
have
a
high
potential
for
abuse,
including
Adderall
and
Ritalin.
The
second
rule
permits
patients
to
receive
a
six-month
supply
of
buprenorphine
(used
to
treat
opioid
use
disorder)
via
telehealth,
but
would
require
an
in-person
visit
after.
The
third
rule,
however,
actually
seems
to
expand
access
to
telehealth
by
exempting
Veterans
Affairs
practitioners
from
special
registration
requirements.
After
a
patient
has
had
an
in-person
medical
examination
from
a
VA
medical
practitioner,
“the
provider-patient
relationship
is
extended
to
all
VA
practitioners
engaging
in
telemedicine
with
the
patient,”
according
to
the
DEA.
The
new
rules
are
less
restrictive
than
a
previous
proposed
rule
released
in
2023.
Still,
many
advocates
argue
that
these
rules
were
rushed
by
the
previous
administration
and
will
only
create
barriers
to
access.
“One
of
the
challenges
that
so
many
in
the
community
have
with
the
first
proposal
the
DEA
made,
and
even
the
second
one
is
that
it
continues
to
really
bleed
into
medical
judgment
and
the
relationship
between
a
practitioner
and
a
patient,”
said
Christopher
Adamec,
executive
director
of
the
Alliance
for
Connected
Care.
“It
limits
the
care
that
can
be
provided.
It
puts
practitioners
in
really
unfortunate
situations
of
being
able
to
provide
some
care,
but
maybe
not
the
care
that
they
think
is
clinically
appropriate
for
their
patient.
That
is
not
the
right
way
for
these
rules
to
move
forward.”
Special
registration
rule
Under
the
special
registration
rule,
special
registration
would
be
available
to
medical
providers
treating
patients
who
require
Schedule
III-V
controlled
substances,
such
as
ketamine,
Xanax
and
Lomotil.
Special
registration
would
also
be
available
for
Schedule
II
medications
if
the
medical
practitioner
is
board
certified
in
one
of
these
specialities:
“psychiatrists;
hospice
care
physicians;
physicians
rendering
treatment
at
long
term
care
facilities,
and
pediatricians
for
the
prescribing
of
medications
identified
as
the
most
addictive
and
prone
to
diversion
to
the
illegal
drug
market,”
according
to
the
DEA.
The
American
Telemedicine
Association
(ATA)
has
concerns
—
three
that
are
tied
to
the
special
registration
proposed
rule,
according
to
Kyle
Zebley,
senior
vice
president
of
public
policy
at
the
association.
One
is
that
practitioners
can
only
prescribe
less
than
50%
of
Schedule
II
controlled
substances
via
telemedicine,
and
the
rest
would
have
to
be
in
person.
Zebley
argues
that
this
threshold
is
“arbitrary
and
clinically
inappropriate,”
and
that
there
is
no
medical
reason
that
this
is
needed.
The
rule
would
also
require
the
provider
to
be
in
the
same
state
as
the
patient
when
prescribing
Schedule
II
controlled
substances.
“That
doesn’t
allow
for
the
full
potential
of
telehealth.
That
would
be
a
massive
backwards
step
in
terms
of
the
level
of
access
that’s
been
achieved
now
for
half
a
decade,”
Zebley
said.
Adamec
of
the
Alliance
for
Connected
Care
echoed
this,
stressing
that
the
“promise
of
telehealth”
is
creating
access
for
people
who
don’t
have
in-person
access
to
care,
such
as
if
they’re
in
a
mental
health
shortage
area
or
in
a
rural
community.
In
addition,
the
special
registration
rule
would
require
practitioners
to
conduct
a
Prescription
Drug
Monitoring
Program
(PDMP)
check
of
all
50
states.
A
PDMP
is
an
electronic
database
that
tracks
controlled
substance
prescriptions
and
allows
practitioners
to
see
patients’
prescribed
medication
history.
Currently,
providers
can
check
PDMP
records
on
a
state-by-state
basis.
However,
in
three
years,
the
DEA
envisions
a
provider
checking
all
50
states’
PDMP
records
for
all
controlled
substances,
and
this
is
currently
challenging,
according
to
Zebley.
“That
is
not
something
the
federal
government
can
mandate,”
he
said.
“It
requires
state
governments
to
comply,
and
some
states
are
obviously
very
protective
of
this.
There’s
no
single,
unified
database
to
do
this,
it’s
very
time
intensive.
So
you
can’t
do
it,
and
if
you
could,
there’s
no
easy
way
to
do
so.”
One
digital
health
executive
noted
that
it
would
be
great
if
there
was
a
way
to
do
a
national
check
of
PDMP
records,
but
agreed
that
there
is
no
feasible
way
to
do
it
today.
“I
don’t
even
know
who
would
undertake
[a
national
PDMP
database],”
said
Robert
Krayn,
CEO
and
co-founder
of
Talkiatry,
a
virtual
psychiatry
company.
“There’s
no
pathway.
It
just
says,
‘Oh,
you’ve
got
to
check
it
nationally.’
But
there
is
no
one
even
working
on
this,
to
my
knowledge.
Where’s
the
money
coming
from,
who’s
working
with
all
the
states?
What
is
the
technology?
This
is
like
starting
at
zero.
This
rule
doesn’t
require
anybody
to
actually
create
the
database.”
The
buprenorphine
rule
Telehealth
advocates
also
have
concerns
with
the
buprenorphine
final
telemedicine
rule,
which
would
allow
a
patient
to
receive
a
six-month
supply
of
buprenorphine
through
telephone
consultation.
Additional
prescriptions
of
buprenorphine
would
require
an
in-person
visit.
“Stopping
something
at
an
arbitrary
period
after
six
months
is
concerning,”
Krayn
said.
“Patients
become
opioid
naive
at
that
point
in
time.
And
so
if
you
cut
off
their
access
and
they
go
back
to
using
substances,
it
could
have
a
material
effect
on
an
increase
in
overdoses.”
This
rule
could
greatly
disrupt
care
for
someone
who
is
struggling
with
a
substance
use
disorder,
noted
T.J.
Ferrante,
partner
and
a
board-certified
healthcare
lawyer
with
Foley
&
Lardner
LLP.
“This
is
a
vulnerable
population,”
he
told
MedCity
News.
“Buprenorphine
is
for
substance
use
or
opioid
use
disorders,
and
especially
with
the
timeline
of
six
months,
they’re
still
in
the
early
stages
of
that
medication,
treatment,
management
and
care.
…
To
all
of
a
sudden
require
these
individuals
to
have
to
go
somewhere
could
be
very
disruptive.”
What’s
next
The
ATA
has
put
out
a
call
that
the
Trump
administration
withdraw
the
proposed
special
registration
rule
and
make
the
remote
prescribing
of
controlled
substances
permanent.
Specifically,
Zebley
of
the
ATA
wants
the
50%
threshold
for
Schedule
II
drugs
removed,
as
well
as
the
geographic
barriers
requiring
clinicians
to
be
in
the
same
state
as
the
patient.
He
also
wants
the
requirement
of
checking
national
PDMP
records
to
be
made
more
“manageable.”
Ferrante
called
for
similar
changes
and
noted
that
he’s
optimistic
the
rule
will
be
withdrawn
or
modified.
When
it
comes
to
the
buprenorphine
rule,
the
Alliance
for
Connected
Care
wants
it
to
be
reworked
or
pulled
back.
That
said,
getting
a
six-month
supply
of
buprenorphine
via
telemedicine
is
better
than
nothing,
according
to
Adamec.
Ultimately,
he
hopes
to
see
the
DEA
not
interfere
with
clinical
care.
“I
would
like
to
see
either
Congress
or
the
administration
move
forward
with
a
law
enforcement-focused
approach
that
creates
a
capability
for
the
DEA
to
monitor
the
sector,
understand
exactly
what’s
happening
and
take
the
action
that
it
needs
to
take
against
bad
actors
if
they
are
detected,”
he
said.
“But
we
don’t
necessarily
need
a
bunch
of
micromanagement
of
how
clinicians
and
patients
should
be
able
to
interact
when
providing
care.”
While
many
telehealth
advocates
are
against
the
new
rules,
at
least
one
digital
health
executive
considers
them
to
be
a
good
thing.
“Maybe
it’s
a
little
bit
more
red
tape,
but
honestly,
in
the
last
few
years,
I
think
VC-fueled
digital
health
has
been
a
little
bit
too
fast
and
loose
in
prescribing,
given
the
high
growth
profit
incentives
as
VC-backed
companies,”
said
Sean
Mehra,
founder
and
CEO
of
HealthTap.
“So
I
don’t
mind
a
little
bit
of
tension
on
the
other
side,
because
while
these
VC-backed
companies
may
complain
of
slightly
constrained
profits
in
the
short
term,
for
sure
the
thing
that
will
kill
them
in
the
long
term
is
compromising
patient
safety.”
While
Mehra
declined
to
give
specific
examples,
one
company
that
made
headlines
was
Cerebral,
a
mental
health
company
that
came
under
federal
investigation
for
its
prescribing
practices
of
controlled
substances,
including
Adderall.
Ultimately,
Cerebral
providers
stopped
prescribing
them.
HealthTap
is
a
virtual
primary
care
company.
It’s
worth
noting
that
the
company
has
a
clinical
policy
to
not
prescribe
controlled
substances.
Krayn
of
Talkiatry,
the
digital
psychiatry
company,
likely
disagrees.
He
believes
the
rules
as
written
will
only
jeopardize
patient
care.
“I
don’t
think
they
actually
add
any
guardrails,
and
the
guardrails
that
[the
DEA]
did
put
in
are
just
barriers
to
access
above
anything,”
he
argued.
“There’s
a
lot
that’s
wrong
with
it.
And
ultimately,
if
it
goes
through,
it
will
just
harm
patients.”
Photo:
Stas_V,
Getty
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