340B Vendor Decision Checklist

Purpose: The purpose of this tool is to provide a decision checklist for entities to evaluate split-billing software.
The tool presents considerations for an entity when selecting, configuring, and maintaining split-billing software
to serve as a guide for supporting compliant operations.

Overview: 340B drugs may be used only for patients who meet certain eligibility requirements. Many 340B
entities serve both 340B and non-340B eligible patients; therefore, the entity needs a way to separate these
patients’ drug transactions. One option is for the entity to maintain two separately purchased physical
inventories. For some entities, however, that option is not acceptable because of space, operational, and/or
financial considerations.

Another option is for the entity to choose to operate a replenishment model to manage its drug inventory. A
replenishment model uses one physical drug inventory, but enables the entity to dispense from that inventory
both to patients who qualify for 340B and to those who do not qualify for 340B. This model works by
establishing a “neutral” physical inventory, collecting data about each drug dispensed and administered, and
then reordering that drug based on the appropriate accumulations from the utilization report. A replenishment
model is typically used in mixed-use areas where both 340B eligible and ineligible patients are served (e.g., a
hospital’s emergency department or cath lab, or an entity-owned or contract pharmacy). This tool focuses on
split-billing software in mixed-use areas of hospitals.

To manage a replenishment model, the entity tracks data feeds (such as inpatient or outpatient status, patient
and prescriber eligibility, clinic location, Medicaid status, drug identifier, and quantity dispensed) and sends
these data into split-billing software. This software uses logic based on configurations, chosen by the entity, to
virtually separate 340B from non-340B transactions after they occur. The software then determines from which
account each transaction should be reordered. The term “split billing” is used to describe this software, which
“splits” a purchase order into two or three different accounts. This software can help the entity place orders in
appropriate accounts, which should support 340B compliance while still having only one physical inventory.

The following are key points to remember about split-billing software:

1. There is no one perfect software, as the performance of the software depends on the
quality/accuracy of data imported to it, the options selected to configure the software, and the
ongoing maintenance of the software by the software provider and entity.

2. Entities have a choice about how to configure their software, but making certain configurations is
associated with a greater risk of noncompliance.

3. The entity is ultimately responsible for program compliance; this responsibility cannot be outsourced
to a split-billing software company. The entity itself is subject to HRSA and manufacturer audits, so
it is critical for the entity to take time to carefully select, configure, maintain, and check its split-billing
software.

The following checklist presents considerations for compliance, as well as approaches/options.

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340B Vendor Decision Checklist

Standard Met? Compliance Checklist Approaches/ Notes

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Initial Considerations for Startup

1. The entity is able to support initial The initial implementation of split-billing software requires resources
implementation cost and the from multiple departments within the entity.
maintenance cost of the software,
• There will be an implementation cost of the software, which is
which will include the following: variable based on the vendor selected. Ask about:
• Cost of implementation charged o Installation fees
by the vendor (request all
charges to be included) o Flat monthly or annual fees based on hospital size (i.e.
• Pharmacy staff resources number of beds)
required with the initial setup o Fee structure for retail/contract pharmacies (per-claim
and the ongoing maintenance of charge vs. a larger charge for claims that are 340B
the system eligible)
• Entity’s IT resources needed to o Exclusivity clauses that obligate the covered entity to use
implement the system the same software for hospital mixed-use 340B
qualification and contract pharmacies
• Pharmacy staff and pharmacy chargemaster staff will be needed
to provide support to create the drug OPAIS and provide
conversion tables between doses, HCPCS billing increments,
and package sizes. Vendors will have a process in place to help.
• The IT department will be required to ensure that locations are
correctly linked and interfaces of the entity software are correct to
provide information needed to implement.

2. Implementation of software should Implementation of the software generally takes 60 to 90 days from
be done in a timely manner. the signing of the contract. The time frame for implementation
depends on the vendor and the complexity of the entity’s program.
If possible, assign a dedicated and experienced project manager to
ensure adherence to the implementation timeline.
Ensure that test and production files are transmitted to the vendor
using a secure file transfer process.

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340B Vendor Decision Checklist

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3. Entity employees receive The software vendor provides the following:

comprehensive training on
• Ability for the project team to view data and accumulations prior to
software. going live
• Initial education for pharmacy directors, pharmacy buyers, and
program coordinators, at a minimum
• Follow-up training sessions to answer more in-depth questions
once users become comfortable with the basics of the
software
Assess adequate training and training time requirements specific to
user roles and access.
Identify access to online and/or hard-copy user manual for assistance.

4. Vendor provides ongoing customer The amount and type of support will vary among vendors. Some will
support at no additional cost. be available onsite in the event of an audit to ensure that all questions
concerning software use are accurately addressed; for others, this is a
paid service they provide. Some vendors will provide extensive help
with reporting and troubleshooting, whereas others leave these tasks
up to the entity. The contract should address these arrangements and
services.
• Ask about turnaround time for support requests and the best
mechanism to submit requests for faster resolution (phone call vs.
online
submission)
• The vendor may offer a strategic account manager.
• If possible, continue regular project management calls with the
vendor for 1 to 2 months after going live so new problems can
be resolved quickly.

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5. Software will interface with the The entity’s electronic medical record (EMR), perpetual inventory
covered entity’s current software management system, billing or financial software, and admission,
and entity’s wholesaler. discharge, and transfer (ADT) software must interface with the split-
billing software. Otherwise, additional costs may be incurred to
provide interfaces.
Determine the level of interface and report details needed, such as
required data elements, frequency of uploading data, and the vendor’s
software interface experience with your EMR and with the wholesaler
selected.
Determine whether the vendor accepts “flat files” or wants an
interface, and whether the covered entity IT department will allow an
interface.

6. Covered entity resources required The entity must have internal IT support, as well as pharmacy
to implement and maintain split- support, to provide ongoing management of the program
billing software are known, requirements during the implementation phase and maintenance
present, and achievable. phase. The amount of support will vary depending on the software
and entity size/complexity. A disproportionate share hospital (DSH)
with more than 100 beds, for example, could anticipate 0.5 to 1 full-
time equivalent (FTE) of a dedicated resource with most split-billing
systems. Identify and establish dedicated FTEs for ongoing
maintenance of the program.
If a report writer is not within the pharmacy department, a resource
person must be readily accessible for questions and corrections to
data files.
Dispensing files, ADT files, encounter files, and prescriber lists may
come from different departments or different subdepartments within
IT. Ensure that the IT project manager is aware of the need for an
expert from each source software package.
Frequent file uploads into vendor software facilitate more rapid
attainment of a full package size dispensed and minimize
purchasing on the WAC account (especially at first). Daily file
uploads are ideal.

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340B Vendor Decision Checklist

Standard Met? Compliance Checklist Approaches/ Notes

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Diversion Prevention

7. Data feed and logic are in place Entities most often use a data feed from the ADT system, which
to determine patient status and includes the patient identifier, a time stamp (which shows that at the
location that are consistent with specific time the drug was ordered, dispensed, or administered, the
the 340B patient definition and patient was in an inpatient or outpatient status [including observation
are trackable. patients]), and a location code (which shows that at the time
captured, the particular patient was receiving services in a specific
clinic or location within the hospital). Even if the hospital has bar-
code scanning that captures the NDC on administration, most EMRs
are set for NDCs to have a one-to-many relationship, with one NDC
being the primary. Some systems have data come from their billing
system, which converts the charge code to a BV code for CMS J-
code drugs. This results in the accumulation being tied to one NDC.
The NDCs purchased must be correctly linked to the CDM and the
CDM constantly updated to assure correct accumulation of products
in the split-billing software.
The entity needs to fully understand the feeds that generate
accumulations in regard to:
• When the accumulation is generated at discharge or time of
medication dispensation
• Quantity field in relationship to billing unit
• All the different patient types to group into either inpatient or
outpatient status
For hospital outpatient areas that have recently become provider
based but are not yet 340B eligible, or for areas that use the hospital’s
billing system but are not 340B eligible, opt to suppress those areas’
dispenses prior to sending the data files to the vendor rather than
relying on the vendor to suppress.
Determine how the vendor deals with duplicate data (e.g., data
supplied during testing and again during production).

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340B Vendor Decision Checklist

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Understand how drug charges are set up in the billing system and
confirm that the billing units match the “build” units set up in the
accumulator.
Examples:
• Ensure that the CDM item is tied correctly to the actual
dispensed size (e.g., enoxaparin 30 mg charge is linked to
enoxaparin 30 mg NDC and 40 mg is linked to 40 mg NDC).
• Ensure that the data for a J-code item correctly interfaces to the
accumulator, accounting for the CMS billing unit, to build
accumulation for the product dispensed (e.g., all enoxaparin
charges are billed by multiples of a 10 mg charge code).

8. Providers of the entity will be The providers of the entity are employed, under contractual
identified accurately. agreement, or other arrangement. A feed is typically sent from the
credentialing office to the split-billing software to accomplish this.
The software will identify the providers and the location of patient
encounters to determine whether the patient definition is followed.
Some vendors accept only a list of providers who practice only in
340B- eligible areas (i.e., 100% provider list), which may limit 340B
qualification, especially if not used with an encounter file.
Some vendors accept a list of providers who are 100% 340B and
another list of providers who sometimes work in 340B-eligible areas
and sometimes do not.
The best practice is to combine a provider list with an encounter file.
Cross-referencing the provider list with the encounter file will screen
out “curbside” consults for family members and hospital employees
who did not attend a bona fide 340B-eligible clinic appointment.

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Options

For entities subject to the orphan drug provisions, a code match

is desirable to determine whether a drug is being used for the
reason the patient was seen by the eligible provider.

9. Location of the patient encounter Accurately identify eligible locations registered on the HRSA OPAIS or
will be accurately captured in the within the entity’s four walls of a parent site. Most systems accomplish
software. this by a feed from the EMR. Confirm accuracy of the electronic feed.
Do not simply rely on location as the qualifier, as non-eligible patients
may be seen in a location that should be used for all eligible patients.
Cross-reference revenue locations with HRSA-registered child sites.
Ensure that IT can identify areas with revenue redirection and write
queries to ensure that those areas appear in dispensing reports sent
to software vendor.

10. The system can support proper Keeping the statutory definition in mind, HRSA permits the entity to
accumulation, in alignment with further define the term “covered outpatient drug.” Hospitals subject to
the entity’s definitions of covered the GPO Prohibition are able to buy non-covered outpatient drugs
outpatient drugs. via a GPO, pursuant to the definition established by the hospital.
Confirm that the vendor software has functionality to not accumulate
non- covered outpatient drugs for 340B replenishment with
documented audit trail and rationale.

11. The system supports Some systems are unable to support an auditable mechanism that
accumulation based on actual can show the precise amounts given to individual patients receiving
usage of a product to the patient products such as anesthesia gases.
level.

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340B Vendor Decision Checklist

Standard Met? Compliance Checklist Approaches/ Notes

Options

Duplicate Discount Prevention

12. Payer source is identified to The software is configured to support the Medicaid Exclusion File
accurately reflect Medicaid (MEF)-reported decision of the entity.
patients and the intent of the
Some systems have the ability to identify Medicaid as the payer for
entity to bill for the patients.
any part of a claim (e.g., secondary or tertiary) and exclude from
accumulation when the entity has elected to carve out.
Some systems cannot account for carve-in and carve-out for different
sites at one 340B organization (although HRSA permits this).
As mandatory “carve in” exists for some states, the entity must refer
to its local state requirements.
Ensure that the software’s default for Medicaid for contract
pharmacies is always set to “carve-out.”

Other Operational Considerations

13. Accumulation and replenishment Some systems do not rely on an NDC match; rather, they make
should use an 11-digit NDC assumptions based on a crosswalk to the charge code and
match as the standard process. sometimes use recent purchasing history to improve on that guess;
and they may not be compliant.
Other systems allow the entity to routinely configure the system to a
9-digit or less NDC match, which does not meet HRSA’s compliance
expectations.

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340B Vendor Decision Checklist

14. The software handles shortages Some systems allow accumulations to be transferred to a new NDC
and product substitutions by (which is noncompliant), whereas other systems require new NDCs to
adding new NDCs and begin a new accumulation.
accumulating on the new product.
Some software will identify when a new NDC with the same
generic sequence number is purchased and prompt the software
user to make a decision about whether the new NDC is a
permanent change or just a temporary change due to a shortage
situation.
Some software will have a begin date and end date of usage of each
NDC number purchased for the same generic sequence number to
allow sequential qualification of different NDC numbers.

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340B Vendor Decision Checklist

Standard Met? Compliance Checklist Approaches/ Notes

Options

15. Software should accommodate Entities subject to the GPO Prohibition (DSH, PED, CAN) need to
two or three accounts based on have three accounts: GPO (inpatient), 340B (eligible outpatients),
the entity type. and non-GPO/WAC (ineligible outpatients).
Entities subject to the Orphan Drug Exclusion (CAH, SCH, RRC, CAN)
need to have two accumulators: GPO and 340B.

16. The terminal account (default The terminal account of the software is a default account used to
account) should be set to a non- order drugs when the entity does not have enough accumulation in
GPO/WAC account for entities the GPO or 340B accounts to purchase a drug.
subject to the GPO Prohibition.
For hospitals subject to the GPO Prohibition, initial purchases of a
drug, increases in par levels, and Medicaid carve-out must be set
to WAC in a 340B registered, mixed-use area using a
replenishment model.

17. If an error/noncompliance is Some systems will allow entities to “go negative” to correct for 340B
detected that involves the split- purchases that should not have been made; this is not HRSA
billing software, a system is in compliant.
place to correct and keep record
Some systems allow the user to keep records of when
of the modifications.
adjustments are made and why. Some systems facilitate
reclassification without transparency to the manufacturer.
Some systems will not allow buyers in mixed-use areas to buy
greater quantities on the 340B or GPO accounts than are in their
accumulators.
Large negative accumulations may indicate purchases greater than
accumulated dispenses, or may indicate a discrepancy between the
billing unit and the package size.
The system must provide accessible audit trail to identify individual
actions, system actions, and rationale.

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Options

18. Required manual Manual manipulations of the accumulator are often required by the
manipulations of the entity staff when drugs are purchased directly, purchased through a
accumulator will be minimal. specialty distributor, not purchased by the pharmacy (e.g., drop-
shipped), or when handling certain controlled substances (CII).
Software may be able to accept electronic data interface (EDI)
invoices from alternate suppliers as well as primary wholesalers.
Software must have a mechanism to record purchases outside the EDI
mechanism (including alternate suppliers and borrow-lends).

19. The software will have the Reports typically enable the entity to audit the accumulator for
capability to provide adequate the following:
reports for auditing of
• Compare drug purchased with drugs dispensed to all inpatients
accumulations and and outpatients.
dispensations for compliance
with the 340B Program. • Patient eligibility should include provider and location of service.
• Audit for addition of new CDMs and new NDCs to ensure
correct mapping of the drugs to all for appropriate
accumulations.
• Review multipliers that will be used to purchase appropriate
package size versus charge codes used in billing (e.g., a
multiplier of 10 is needed for infliximab that is billed in units of 10
mg but purchased in units of 100 mg).
The software vendor may send out an annual audit review report. A
summary of all filters, data reports, payors, providers, special rules,
and other indicators is provided so that the entity can review data for
accuracy. The vendor essentially assists with identifying potential
areas of liability.

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340B Vendor Decision Checklist

20. The software clearly addresses The software will accumulate multi-dose products based on the entity’s
options for handling of multi- billing practices. The drugs sometimes are used for multiple patients
dose products for multiple and each will be charged a dispensed unit, or they can be dispensed to
patients (e.g., insulin vials) a single patient and the patient will be charged for the whole unit at one
versus multi- dose products that time.
are for one patient (e.g., cream,
lotion).

This tool is written to align with Health Resources and Services Administration (HRSA) policy, and is provided only as an example for the purpose of encouraging 340B Program integrity. This information has not been endorsed by HRSA and is not dispositive in determining
compliance with or participatory status in the 340B Drug Pricing Program. 340B stakeholders are ultimately responsible for 340B Program compliance and compliance with all other applicable laws and regulations. Apexus encourages each stakeholder to include legal counsel as
part of its program integrity efforts.

© 2018 Apexus. Permission is granted to use, copy, and distribute this work solely for 340B covered entities and Medicaid agencies.

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