Innovations-Magazine-May-2023 - 5

POLICY PERSPECTIVES
agreement - such as products entirely in the
commercial sector or solely for state or local
activity - are set to end upon the expiration
of the PHE, but HHS is considering
continuing this coverage.
CMS Guidance on COVID-19 Testing
During the PHE, Centers for Medicare
& Medicaid Services (CMS) waived
requirements for ordering of and coverage
requirements for COVID-19 laboratory and
serology tests. These waivers expanded the
availability of testing to Medicare-enrolled
pharmacies and the ability of pharmacists
to order tests under certain conditions.
CMS later released guidance that authorized
pharmacies to enroll temporarily as
independent clinical diagnostic laboratories
for the duration of the PHE. This status
enabled pharmacies to bill Medicare for
COVID-19 testing services. For pharmacies
to maintain billing privileges as independent
clinical diagnostic laboratories post-PHE,
they must apply within 30 days of the PHE's
expiration. The waivers themselves will expire
when the PHE sunsets.
FDA's Role During PHEs
FDA's emergency use authorization (EUA)
authority permits the agency to increase
the scope of medical countermeasures in
response to a declared PHE. The PHE's
termination will not impact FDA's ability
to grant EUAs, which means that the
agency can choose to issue COVID-19related
EUAs for future products. On
March 13, 2023, FDA released a notice
describing which guidance documents will
end when the PHE expires and which ones
will continue temporarily beyond May 11,
2023. FDA's guidances and EUAs addressed
emergent issues during the COVID-19
pandemic and charged the pharmacy
industry with combating these challenges,
such as through the following:
* Compounding Flexibility to Address
Drug Shortages: FDA relaxed
compounding requirements under 503A
to account for shortages in hospitals.
FDA also issued guidance applicable to
503B facilities to allow such facilities
to compound drugs experiencing
shortages for COVID-19-related care.
Some stakeholders have urged FDA to
safeguard these flexibilities through rampup
and down periods or to ease the impact
of shortages, as compounding during
shortages is a significant resource and time
investment. The policy is set to end upon
the PHE's expiration.
* Prescribing Paxlovid™: In a July 2022
EUA, FDA authorized state-licensed
pharmacists to prescribe Paxlovid to
eligible patients under certain conditions,
including that sufficient patient health
information is available, such as through
health records, to assess drug interactions
and renal and hepatic functions in
patients prior to prescribing. The
expiration of this EUA and the hundreds
of other EUAs that FDA issued during the
pandemic has not yet been determined.
A Path Toward Permanence?
Since the beginning of the pandemic, the
federal government and state governments
have proposed numerous legislative proposals
that seek to codify pharmacy professionals'
expanded scope of authority. Because the
PREP Act established the majority of
pharmacy professionals' increased authority,
industry stakeholders have urged the
federal government to make the PREP
Act Declaration flexibilities permanent.
However, since the PREP Act provides no
basis for making declarations permanent and
is instead limited to providing immunity
from liability for qualified persons under
certain emergent situations, Congress would
likely need to act to make these flexibilities
permanent. The sunset of the PREP Act in
October 2024 means half of states will lose
the key authorities granted to pharmacists
and other pharmacy professionals under
the Declaration.
These calls for permanence align with
how American consumers expect to receive
care in the future. A Wolters Kluwer survey
found that approximately 72% of Americans
supported having a specialty-trained
pharmacist prescribe their medication. Survey
participants also indicated cost savings as
a motivation for having pharmacists take a
larger role in their health care.
MAY 2023 | 3
Pharmacists and pharmacy
professionals have served
as pillars of communities,
providing patients with
important information and
administering medication
critical to their health care.
Pharmacists and pharmacy professionals
have served as pillars of communities,
providing patients with important
information and administering medication
critical to their health care. The importance
of pharmacists became increasingly more
apparent during COVID-19. The pandemic
revealed how the US can further leverage
pharmacists to promote health equity and
access to care - not only to address public
health crises such as COVID-19 and the
opioid crisis, but also to serve as consistent,
trusted providers for all patients in the US
health care system.
This article was written by Larissa Morgan,
JD, MBE, and Nisha K. Quasba, MPH,
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.
Innovations-Magazine-May-2023

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