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Why dealing with 340B
is important in a drug
supply chain?
One of the main concerns that arise out of the
implementation of the 340B drug program is
the need to maintain a separate inventory to
scrutinize the prescription drugs under 340B
from among other drugs. An apprehension for
supply chain stakeholders and healthcare entities
functioning under this program alike, this issue can
be eradicated with systematized management of
the supply chain on a daily basis; This may include
storage of GS1 data that can easily identify which
drugs are circulated under the 340B program with
a single scan.
The need for effective dealing with 340B drugs in
the supply chain is further reinstated by the billing
restrictions it has. The Federal Law prohibits using
340B for drugs that are dispensed to Medicaid
free-for-service (FFS) patient and are subject
to Medicaid rebates, unless the covered entity
complies with certain requirements. This law is
also known as the ‘duplicate discount prohibition’
because it intends to protect manufacturers from
giving duplicate concession in the form of 340B
discount and Medicaid FFS rebate.
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How to deal with drugs under 340B?
Effective dealing of the consignments can avoid misplaced or mismatched inventories, apart from saving
manufacturers hundreds of dollars that go in duplication of rebates.
AR-enabled multiscanning
solutions used for tracking and
tracing drugs using the RapidRX
technology can be a sure-shot
solution in inventory and data
management, while making fast
error-free sorting of data and
consignments possible.
Imagine a way to see through
the consignments without even
having to open them individually
and check with the help of a
mobile-edge scanner whether
or not it falls under the 340B
program; Thus, saving millions
that would have gone in manual
tallying of the consignments with
the EPCIS form.
The Traceability platform
is the next big thing that can
manage data about a 340B
drug effectively, enabling
manufacturers to keep a tab on
their billing cycle and also ensure
that the drugs that reach the end
users are safe. Enhanced drug
visibility also empowers contract
pharmacies distributing 340B
drugs to covered entities to
ensure that these drugs are not
mistakenly diverted to end users
who are not covered under the
program.
Cloud-base masterdatabase can
be used optimally to maintain
nancial statements and invoices
that contract pharmacies share
with the covered entities at the
end of the year. Some of the other
things that can be seamlessly
stored include a detailed status
report of collections, and a
summary of receiving and
dispensing records that must be
stored under applicable law. On
the ip side, covered entities are
also responsible for monitoring
and ensuring contract pharmacy
compliance with 340B programs
such as patient denition and the
duplicate discount prohibition.
This also enables both covered
entities and contract pharmacies
to be audit-ready at any stage
a compliance breach as per the
340B law is discovered.
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Who benets from the 340B
program?
The 340 B program has been designed to benet
the manufacturers, the healthcare provider
(hospitals and the healthcare providers for the
vulnerable and the uninsured) and covered entities
(the vulnerable and the needy).
Section 340B of the Public Health Service Act,
created under Section 602 of the Veterans
Healthcare Act of 1992 requires pharmaceutical
manufacturers to enter into an agreement called
the pharmaceutical pricing agreement (PPA), with
the Department of Health and Human Services
(HHS) secretary in exchange for having all their
FDA-approved drugs covered by Medicaid and
Medicare Part B.
Gauging the benets that manufacturers get from
participating in the 340B program is multi-layered
and indirect. Federal Law requires manufacturers
who want their drugs covered in the Medicaid
program to rebate a portion of drug payments
to the government (which is the 340B program).
Most of the manufacturers prefer to participate
in the Medicaid program because it helps them
in regulating the drug prices. How? Medicaid
essentially maintains an open formulary in which
states are required to provide nearly all prescribed
drugs made by manufacturers.
Interestingly, these drugs form the list of
outpatient prescription drugs that is being
encouraged by the state to the providers to
prescribe over other drugs. As per a study by
DRUG CHANNELS, purchases by Covered
Entities under the 340B program increased
from $13.5 billion in 2014 to $61.0 billion in
2019. A consideration of the above-mentioned
statistics will tell you the business benets that
manufacturers have inadvertently received from
the 340B program.
Eligibility for 340B program
To be eligible under the 340B program, a
manufacturer has to meet the following
requirements:
• Sign a Pharmaceutical Pricing
Agreement and Addendum. (340B
Ofce of Pharmacy Affairs (OPAIS)
Account Creation and Manufacturer
PPA/PPA Addendum registration
tutorial can be found on the 340B
OPAIS page.)
• Register with 340B OPAIS and
routinely verify that manufacturer
information is accurate and up-to-date.
• Submit quarterly pricing data through
the pricing component of the 340B
OPAIS.
• Comply with all 340B Program
requirements.
Some interesting facts:
of 340B volume goes through
80%
45%
64%
DSH hospitals, even though
they make up to 9% of 340B
entities.
of all medicare acute care
hospitals participate in 340 B
of hospitals have charity
care rates below 2.2% of the
national average of hospitals
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Contact us today!
1-(321) 418-7147
1601 Park Center Dr. Suite 10A
Orlando, FL 32835
© TrackTraceRx Inc. All rights reserved
(11) 98518-0481 / (11) 4118-4179
Alameda Terracota 185 Sala 726 - Torre Park
Cerâmica - São Caetano do Sul/SP
Cep. 09531-190
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