340B Drug
Pricing Program Flexibilities During Disasters
During disasters, HRSA can help by making
it easier for entities
already covered by the 340B Drug Pricing
Program to dispense pharmaceuticals
to displaced patients and by making it
easier for eligible
new entities (including DHHS grantees,
DSH hospitals, and FQHC look-alikes)
to register for the 340B Program in counties
with federal major disaster declarations,
federal emergency declarations, and federal
public health emergency declarations.
340B Dispensing
Q: Can drugs purchased under
the 340B Program be dispensed by an FQHC
or other 340B Covered Entity within a
county covered by a Federal Declaration
during the declaration period to an individual
from another State under a prescription
written in another state?
A: Yes, provided that
the individual is a patient (as defined
by the 340B Program) of the covered entity.
First, in order to be considered a patient
under the 340b Program the services provided
to the individual must be within the scope
of eligibility of the covered entity.
Second, the covered entity must maintain
health records of care provided to the
individual. Finally, the individual must
receive services from a health care professional
who is employed by the covered entity,
under contract with the covered entity,
or has another arrangement with the covered
entity such that responsibility for the
care remains with the covered entity.
Health Record:
In a declared emergency, an abbreviated
health record is adequate for purposes
of the 340B program. However, the record
must identify the patient, record the
medical evaluation (including any testing,
diagnosis or clinical impressions) and
the treatment provided or prescribed.
Where staff and supplies are an issue:
For purposes of 340B Program eligibility,
the record may be a single form or note
page with no folder. It's the recorded
information that creates a record. You
may not have the resources to meet standard
health record practice standards. For
example, under these circumstances the
patient may be without insurance cards
or identity papers and you will probably
have no access to documented medical histories.
Self reporting of identity, condition
and history are adequate for purposes
of 340B record keeping requirements.
340B Refills:
Q: Are entities within a county
covered by a Federal Declaration able
to refill prescriptions for disaster victims
unknown to them with 340B drugs during
the declaration period without medical
staff intervention?
A: No. Prescriptions
cannot be refilled using 340B drugs without
the personal involvement of medical or
health professionals with prescribing
authority who are employed by, are under
contract with, or maintain another arrangement
with the covered entity. In the event
of a declared emergency, where volunteer
health professionals may be used, emergency
paperwork should be generated to make
the relationship between the provider
and the covered entity clear and to make
clear the covered entity’s responsibility
for providing care. This document should
recognize the emergency nature of the
situation, the relationship of the volunteer(s)
to the clinic, and should be kept on file
by the covered entity.
Expediting New 340B Registrations
Q: Normally, HRSA issues new
340B registrations on a quarterly basis.
Can HRSA do anything to expedite these
registrations during a federal declaration?
A: Yes. Upon request,
within a county covered by a Federal Declaration
during the declaration period, HRSA can
initiate ‘rolling registrations’
to get temporary (or permanent) address
changes on the database as soon as we
get the information rather than on the
normal quarterly basis.
Contacting the 340B/Office of Pharmacy
Affairs
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