340B Universe Mapping Template

Purpose: The purpose of this tool is to identify the locations in which 340B drugs are provided within a 340B covered entityand where and how 340B drugs are purchased. This is the covered entity’s 340B Drug Operations Environment. Mapping of the 340B Drug Operations Environment ensures that the entity includes all areas in its340B Program integrity initiatives.

The maintenance of auditable records, including documented 340B Program compliant policies and procedures, is a 340B Program requirement. All 340B Drug Operations Environments should be reflected in policies and procedures and self-audit systems, and a covered entity’s practice must align with its policies and procedures. Systems or mechanisms must be in place to ensure ongoing compliance with all 340B Program requirements, including accuracy of 340B OPAISrecords and prevention of diversion and duplicate discounts (both at the covered entity and a contract pharmacy).

This tool was created in collaboration with the HRSA Peer-to-Peer Program.

Tool Definitions:

340B drug:

  • Describes a drug that is purchased using a 340B purchasing account.

Non-340B drug:

  • Describes a drug purchased using a non-340B purchasing account such as a wholesaler acquisition cost (WAC) account or a group purchasing organization (GPO) account.

Providedrug:

  • Describes when a drug purchased by the covered entity is dispensed for take-home use or administered/dispensed as part of a medical encounter.

Use this mapping tool to:

  • Document all locations that provide 340B drugs.
  • Document the inventory type, method, and system(s) used to track the purchase, dispensation, and administration of drugs at each location, including outpatient location, mixed-use pharmacy, entity-owned outpatient pharmacy, and contract pharmacy.
  • Document Medicaid billing and NPI numbers used to bill 340Bdrugs and non-340Bdrugs that must align with the location’s listing in the Medicaid Exclusion File.

This tool includes opportunitiesto document any non-340B drug operations environment(s) connected to or interfacing with a 340B Drug Operations Environment, as these drug operations environments can affect 340B drug systems and program integrity initiatives.

Instructions: Complete tables in the sequence listed below:

Step 1: Complete Table 1 Overall Drug Operations Environment

Step 2: Complete Table 2340B ID Site-Specific Drug Operations Environment

A unique entry should be completed for each

340B ID site listed in Table 1.

Step 3:Complete Table 3Entity-Owned Pharmacy Drug Operations Environment

A unique entry should be completed for each entity-owned pharmacy listed in Table 1.

Step 4:Complete Table 4Contract Pharmacy Drug Operations Environment

A unique entry should be completed for eachcontract pharmacy service location.

Table 1
Overall Drug Operations Environment
  1. Document the Parent 340B ID.

  1. Document the 340B ID of each outpatient facility (child site) registered on the 340B OPAIS.

  1. Document the 340B ID(s) of each associated site providing 340B drugs (if applicable).
Note: An associated site has a different 340B ID type, but is associated by management control. For example, a hospital organization may have a DSH 340B ID at one location and a CAH 340B ID at a different location. A grantee organization may have both a CHC 340B ID and an HV 340B ID at the same location.
  1. Document the name and address of any location that provides 340B drugs and is not registered in the 340B OPAIS. (Do not include any pharmacies or locations that are not part of the entity.)
Note: Every eligible location must first be registered in the 340B OPAIS before providing 340B drugs. Ineligible sites may not provide 340B drugs.
  1. Document the name of each ENTITY-OWNED pharmacy.
Note: Pharmacies are not covered entities and are not eligible to be registered on the 340B OPAIS separately.
  1. Document the name of each CONTRACT pharmacy organization (not locations) that provides drugs to patients of the parent, outpatient facility(s) (child site(s)), and associated site(s). A contract pharmacy organization may be a chain or independent pharmacy and have multiple service site addresses.

340B ID Specific Drug Operations Environment completed by:
(name) and (title)
(date)
Table 2
340B ID Site-Specific Drug Operations Environment
From Table 1, list the 340B ID of each location registered on the HRSA 340B OPAIS and document the following: / 340B ID# 1: / 340B ID # 2: / 340B ID # 3:
  1. Document the location name.
/ Name / Name / Name
  1. Document the physical address, including suite number.
/ Address / Address / Address
  1. Do providers generate prescriptions for patient take-home medication use that are subsequently filled with 340B drugs?
/ Yes or No / Yes or No / Yes or No
  1. Does this 340B ID site administer/dispense drugs as part of outpatient encounters?
/ Yes or No / Yes or No / Yes or No
4a. Document type(s) of drug inventory administered/dispensed.
Note: A covered entity subject to the GPO Prohibition is prohibited from providing GPO drugs to outpatients. / 340B
WAC
GPO / 340B
WAC
GPO / 340B
WAC
GPO
4b. Document wholesaler/ manufacturer name and account number used for each inventory type administered/dispensed. / 340B Account# with__
WAC Account# with__
GPO Account# with __ / 340B Account# with__
WAC Account# with__
GPO Account# with __ / 340B Account# with__
WAC Account# with__
GPO Account# with __
4c. Document inventory method used for administered/dispensed drugs. / Physical
Virtual
Both Physical & Virtual / Physical
Virtual
Both Physical & Virtual / Physical
Virtual
Both Physical & Virtual
4d. Document automated dispensing devices used. / Device Name / Device Name / Device Name
4e. Document the inventory tracking system used for administered/dispensed drugs. Specify software name, if applicable. / Vendor software
Paper tracking log
Electronic tracking log / Vendor software
Paper tracking log
Electronic tracking log / Vendor software
Paper tracking log
Electronic tracking log
  1. Does this 340B ID carve in Medicaid and bill 340B drugs to Medicaid?
/ Yes or No / Yes or No / Yes or No
5a. Document all Medicaid and/or NPI numbers used to bill 340B drugs to Medicaid.
Note: Billing numbers used to carve in Medicaid must be listed in the Medicaid Exclusion File. / Billing numbers used / Billing numbers used / Billing numbers used
  1. Document all Medicaid and/or NPI numbers used to bill non-340B drugs to Medicaid.
/ Billing numbers used / Billing numbers used / Billing numbers used
340B ID Specific Drug Operations Environment completed by:
(name) and (title)
(date)
Table 3
Entity-Owned Pharmacy Drug Operations Environment
From Table 1, list the name of each entity-owned pharmacy in the column heading and document the following: / Name #1 / Name #2
  1. Document the physical address, including suite number if applicable.
/ Address / Address
  1. Is a “closed door” pharmacy providing drugs only to patients of the covered entity?
/ Yes or No / Yes or No
  1. Is an “open door” pharmacy providing drugs to covered entity patients andthe general public?
/ Yes or No / Yes or No
  1. Under what 340B ID(s) is the pharmacy purchasing 340B drugs?
/ 340B ID / 340B ID
  1. In addition to dispensing prescriptions for take-home use, does the pharmacy provide drugs to departments for administration/dispensation as part of medical encounters?
/ Yes or No / Yes or No
5a. Document the type of department(s) for which drugs are provided. / Inpatient and/or
Outpatient / Inpatient and/or
Outpatient
  1. Provides 340B drugs to patients with an entity health record including a referral arrangement that demonstrates the entity’s responsibility for care?
/ Yes or No / Yes or No
  1. Document type(s) of drug inventory provided to patients.
Note: A covered entity subject to the GPO Prohibition is prohibited from providing GPO drugs to outpatients. / 340B
WAC
GPO / 340B
WAC
GPO
  1. Document the wholesaler/manufacturer name and account number used for each inventory type provided.
/ 340B Account# with___
WAC Account# with___
GPO Account# with ___ / 340B Account# with__
WAC Account# with__
GPO Account# with __
  1. Document the inventory method used by the pharmacy.
/ Physical
Virtual
Both Physical & Virtual / Physical
Virtual
Both Physical & Virtual
  1. Document the inventory tracking system used by the pharmacy. Specify software name, if applicable.
/ Vendor software
Paper tracking log
Electronic tracking log / Vendor software
Paper tracking log
Electronic tracking log
  1. Does the entity-owned pharmacy serve as a contract pharmacy to other covered entities?
/ Yes or No / Yes or No
  1. Does the entity-owned pharmacy carve in Medicaid and bill 340B drugs to Medicaid?
/ Yes or No / Yes or No
13. Document the pharmacy Medicaid and/or NPI numbers used to bill 340B drugs to Medicaid.
Note: Billing numbers used to carve in Medicaid at the pharmacy must be listed in the Medicaid Exclusion File. / Billing numbers used / Billing numbers used
  1. Document the pharmacy Medicaid and/or NPI numbers used to bill non-340B drugs to Medicaid.
/ Billing numbers used / Billing numbers used
340B ID Specific Drug Operations Environment completed by:
(name) and (title)
(date)
Table 4
Contract Pharmacy Drug Operations Environment
List the name of the contract pharmacy service location in the column headings and document the following: / Name #1 / Name #2
  1. Document the physical address.
/ Address / Address
  1. Do the name and address of the contract pharmacy location appear on an executed contract?
Note: Each contract pharmacy service location must be listed on an executed contract pharmacy agreement and be registered on the 340B OPAIS before providing 340B drugs. / Yes or No / Yes or No
  1. Is this location listed on the 340B OPAIS under the parent 340B ID, such that the patients of any site (parent or child site) receive 340B drugs?
/ Yes or No / Yes or No
  1. Provides 340B drugs to patients with an entity health record including a referral arrangement that demonstrates the entity’s responsibility for care?
/ Yes or No / Yes or No
  1. Document type(s) of drug inventory provided to patients.
Note: A covered entity subject to the GPO Prohibition is prohibited from providing GPO drugs at a contract pharmacy. / 340B
WAC
GPO / 340B
WAC
GPO
  1. Document covered entity’s wholesaler/manufacturer name and account number used for each inventory type provided.
/ 340B Account# with__
GPO Account# with __ / 340B Account# with__
GPO Account# with__
6a. Is each account number listed above set up as “ship to” the contract pharmacy and “bill to” the covered entity? / Yes or No / Yes or No
  1. Document the inventory method used at contract pharmacy for 340B drugs.
/ Physical
Virtual
Both Physical & Virtual / Physical
Virtual
Both Physical & Virtual
  1. Document the inventory tracking system used for providing 340B drugs at contract pharmacy. Specify software name, if applicable.
/ Vendor Software
Paper Tracking Log
Electronic Tracking Log / Vendor Software
Paper Tracking Log
Electronic Tracking Log
  1. Document any third-party administrator (TPA) used for 340B Program administration.
/ TPA Name / TPA Name
  1. Has HRSA posted the carve-in contract pharmacy arrangement on the 340B OPAIS if the location is billing 340B drugs to Medicaid?
Note: Contract pharmacies must carve out unless HRSA has approved the mechanism to prevent duplicate discounts. / Yes or No / Yes or No
340B ID Specific Drug Operations Environment completed by:
(name) and (title)
(date)

This tool is writtento 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 all stakeholders to include legal counsel as part of their 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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