Innovations-Magazine-April-2023 - 5

POLICY PERSPECTIVES
Though these new requirements have been established as safeguards to reduce the
chance of drug diversion and abuse, there is no outline or mechanism for pharmacies to
evaluate if the prescriber has complied with these requirements.
* Patients who established relationships
with providers during the PHE have
180 days after the PHE ends to see
their prescribing provider in person or
receive a referral from another provider
who has seen that patient in person in
order to continue receiving CS from
their preferred prescriber. This means
prescribers and patients would have
until November 2023 to come into
compliance with the new rule.
* All prescribers must follow all
applicable state laws, including
licensing, practice, and CS acts, as
well as federal laws related to licensing
and DEA registration. This includes
being appropriately licensed and
registered with DEA in the state where
the patient is located at the time the
medication is prescribed.
* All prescriptions must be electronically
submitted, and prescriptions resulting
from a telemedicine visit will need to be
indicated as such on the prescription.
A Prescription for Telemedicine
The proposed rule creates two new
requirements relevant to the pharmacy
community: a " telemedicine prescription "
notation and a requirement that the
prescriber check the prescription drug
monitoring program (PDMP) system prior
to issuing a prescription for a CS.
The responsibility of both provisions in
the regulation, as currently written, falls
on the prescriber, not the pharmacist.
However, pharmacists are an integral piece
of the pharmaceutical supply chain. If
prescribers will be facing restrictions on
their prescribing channels, then pharmacists
should be equipped with adequate tools
to ensure that the prescriptions they fill
comply with these new regulations.
The proposed rule requires prescriptions
issued pursuant to a telemedicine visit
to be noted as such on the face of
the prescription. This will flag for the
pharmacy the type of encounter the
prescription resulted from. However, there
is no guidance on how or whether the
" telemedicine stamp " should be verified
by the dispensing pharmacist. Though
the rule does call for all prescriptions
to be electronically submitted in an
effort to reduce the risk of fraudulent
prescriptions, it is unclear how the
new data fields will be transferred to
pharmacies in compliance with patient
privacy laws if they are not transmitted
through e-prescribing platforms.
Secondly, the practitioner who issues
a " telemedicine prescription " must
access the PDMP system to evaluate
if the patient has recently obtained a
prescription from another provider. If the
PDMP is non-operational, the prescriber
will be unable to prescribe a 30-day
supply of the CS and will be limited to
prescribing a seven-day supply until they
are able to access the PDMP system.
The practitioner will have to document
the number of attempts made to access
the PDMP and is required to access the
PDMP system within seven days of the
telemedicine encounter to be able to
prescribe the remaining supply (but not
to exceed a 30-day supply).
These requirements wedge a distinction
between care delivered in person versus via
telehealth. Though these new requirements
have been established as safeguards to
reduce the chance of drug diversion and
abuse, there is no outline or mechanism
for pharmacies to evaluate if the prescriber
has complied with these requirements.
The conundrum that pharmacists now
face is neither new nor unique, as
prescriptions were issued prior to the
pandemic when remote prescribing was
vastly more restrictive. Unfortunately, these
regulations will burden the system and
ultimately reduce patient access to clinically
appropriate care, especially for the most
vulnerable patient populations that depend
on remote CS prescribing to treat their
chronic illnesses. Though many outstanding
questions remain on the regulations, the
open comment period allowed DEA to hear
active feedback from those most impacted
by the regulations, which will hopefully
lead to clearer guidance in the final rule the
agency plans to publish in May 2023.
This article was written by Nisha K.
Quasba, MPH, and Elliot D. Vice, both
with Faegre Drinker Biddle & Reath LLP.
Please note, the opinions and views expressed
by Faegre Drinker Biddle & Reath do not
necessarily reflect the official views, opinions,
or policies of NABP or any member board,
unless expressly stated.
APRIL 2023 | 3
Innovations-Magazine-April-2023

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