Innovations-Magazine-April-2023 - 4

POLICY PERSPECTIVES
Fifteen Years in the Making: New DEA Proposed Rules on
Remote Prescribing of Controlled Substances
to remotely prescribe CS to patients.
However, the agency did not propose
rules on telemedicine until recently.
With the imminent end of the PHE and
Nisha K. Quasba, MPH
Faegre Drinker Biddle
& Reath LLP
Elliot D. Vice
Faegre Drinker Biddle
& Realth LLP
It is 2023 - three years since the beginning
of the pandemic, yet the repercussions are
still being felt. Millions of Americans have
struggled with their mental and behavioral
health needs, but with the relaxation of
a number of telehealth policies during
the pandemic, patients have been able to
connect with services that they critically
need and will continue to need.
For example, Drug Enforcement
Administration (DEA) loosened restrictions
on remote prescribing of Schedule II-V
controlled substances (CS) for the duration
of the coronavirus disease 2019 public
health emergency (PHE). Providers benefit
from increased flexibility, allowing them to
prescribe patients clinically appropriate CS
medication without having to see them in
person, which was extremely crucial during
the PHE, when many felt that the world
had shut down. However, those flexibilities
will be removed next month, when the
PHE is set to end on May 11, 2023.
DEA's role as an enforcement agency
is to regulate CS and prevent diversion,
abuse, and sale on illegal domestic and
international markets. As a result, it has
oversight power over the prescribing,
dispensing, and distribution of CS, starting
with manufacturers and going all the way
down to pharmacies and prescribers. DEA
was mandated by Congress through the
Ryan Haight Act of 2008 to create a special
registration process for telemedicine, which
ideally would allow prescribers to be able
to register with the agency to streamline
a currently burdensome, state-by-state
process for practitioners to be allowed
2 | APRIL 2023
patients at risk of losing access to needed
medication, DEA has been under pressure
from Congress to act. The agency has
now released proposed rules that revise
regulations, in their view, to get to a middle
ground between the restrictive regulations
that existed prior to the pandemic and the
current waivers that are in place.
Though DEA explicitly wrote in its
press release that its intention was to
design a rule that ensures patients do
not experience a lapse in care, the larger
telemedicine and patient advocacy
community opposes the new regulations,
stressing that they are more restrictive than
necessary. Importantly, DEA noted in the
proposed rule that the special registration
process, which many stakeholders had
hoped to be the silver bullet in resolving
many of the administrative process
issues, will not be created. As the agency
noted, " it was deemed potentially
burdensome for both prospective
telemedicine providers and patients. "
What Does the Proposed Rule Say?
On February 24, 2023, DEA announced
its proposed rule; it was formally published
on March 1, kicking off a 30-day comment
period for stakeholder and public input
that ended on March 31. This leaves
the agency only 41 days to review and
respond to each of the comments (which
numbered in the thousands), modify the
rule, if desired, and publish it. Based on
the current timeline, that is a significant
logistical challenge, to say the least. The
final rule should be published prior to
the end of the PHE on May 11. The
proposed rule states the following:
* To prescribe Schedule II drugs via
telemedicine, a DEA-registered
prescriber must either first see the
patient in person or receive a patient
referral from another DEA-registered
provider who has seen that patient
in person. No additional in-person
visits are necessary to prescribe CS
(Schedule II-V) to this patient via
telemedicine once the provider-patient
relationship has been established.
Referral guidelines are explicitly
outlined in the proposed rule.
* To prescribe Schedule III-V drugs, a
DEA-registered provider can prescribe
an initial 30-day supply of medication
to a patient via telemedicine. After
30 days, or when that supply runs
out, a provider must either see that
patient in person or be referred to that
patient by a provider who has seen that
patient in person in order to continue
prescribing Schedule III-V CS.
DEA's role as an enforcement agency is to regulate CS and
prevent diversion, abuse, and sale on illegal domestic
and international markets. As a result, it has oversight
power over the prescribing, dispensing, and distribution
of CS, starting with manufacturers and going all the way
down to pharmacies and prescribers.
Innovations-Magazine-April-2023

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