policy and procedure 1 26 12/9/15 340b compliance.pdf · utmb cmc pharmacy departmental policy and...
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UTMB CMC
PHARMACY DEPARTMENTAL
POLICY AND PROCEDURE
Effective Date: 11/6/13
NUMBER: 30.55
Page 1 of 26
Reviewed:
Revised: 12/9/15
340B PROGRAM COMPLIANCE
SUBJECT: 340B Program Compliance
PURPOSE: To ensure that the UTMB CMC Department of Pharmacy is in compliance with 340B program
standards on an ongoing basis.
POLICY: The UTMB CMC Department of Pharmacy complies with all requirements and restrictions of
Section 340B of the Public Health Service Act and any accompanying regulations or guidelines
including, but not limited to, the prohibition against duplicate discounts/rebates under Medicaid,
and the prohibition against transferring drugs purchased under 340B to anyone other than a
patient of UTMB. Policies, procedures, systems, and internal controls are in place to reasonably
ensure ongoing compliance with all 340B requirements.
DEFINITIONS:
340B Eligible Entity - 340B covered entities are facilities/programs listed in the 340B Statute as eligible to
purchase drugs through the 340B Program and appear on the Office of Pharmacy Affairs 340B Database.
340B Eligible Patient - In summary, an individual is a “patient” of a covered entity (with the exception of
State-operated or funded AIDS drug purchasing assistance programs) only if:
1. the covered entity has established a relationship with the individual, such that the covered entity
maintains records of the individual’s health care; and
2. the individual receives health care services from a health care professional who is either employed by
the covered entity or provides health care under contractual or other arrangements (e.g. referral for
consultation) such that responsibility for the care provided remains with the covered entity; and
3. the individual receives a health care service or range of services from the covered entity which is
consistent with the service or range of services for which grant funding or Federally-qualified health
center look-alike status has been provided to the entity. Disproportionate share hospitals are exempt
from this requirement.
An individual will not be considered a “patient” of the entity for purposes of 340B if the only health care
service received by the individual from the covered entity is the dispensing of a drug or drugs for subsequent
self- administration or administration in the home setting.
340B Program - Section 340B of the Public Health Service Act (1992) requires drug manufacturers
participating in the Medicaid Drug Rebate Program to sign an agreement with the Secretary of Health and
Human Services. This agreement limits the price manufacturers may charge certain covered entities for covered
outpatient drugs. The resulting program is called the 340B Program.
Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) – The
government agency that administers the 340B program.
UTMB CMC
PHARMACY DEPARTMENTAL
POLICY AND PROCEDURE
Effective Date: 11/6/13
NUMBER: 30.55
Page 2 of 26
Reviewed:
Revised: 12/9/15
340B PROGRAM COMPLIANCE
Group Purchasing Organization (GPO) - A Group Purchasing Organization (GPO) is an organization created
to leverage the purchasing power of entities to obtain discounts from vendors based on the collective buying
power of the GPO members. The Prime Vendor Apexus Portfolio is not considered a GPO.
GPO exclusion - Disproportionate share hospitals participating in the 340B Program under 42 U.S.C.
256b(a)(4)(L) and (M) are subject to 42 U.S.C. 256b(a)(4)(L)(iii), which states that in order to participate in the
340B Program, these entities may not “obtain covered outpatient drugs through a group purchasing organization
or other group purchasing arrangement.” The GPO exclusion applies to hospitals and their off-site outpatient
clinic sites that are registered on the OPA 340B database as participating in the 340B Program and they cannot
purchase any covered outpatient drugs through a GPO or other group purchasing arrangement. A hospital
subject to the GPO prohibition may not purchase covered outpatient drugs through a GPO for any of its
clinics/departments within the four walls of the hospital (same physical address) under any circumstance.
However, certain off-site outpatient facilities of the hospital may use a GPO for covered outpatient drugs if
those off-site outpatient facilities meet all of the following criteria:
Are located at a different physical address than the parent;
Are not registered on the OPA 340B database as participating in the 340B Program;
Purchase drugs through a separate pharmacy wholesaler account than the 340B participating parent; and
The hospital maintains records demonstrating that any covered outpatient drugs purchased through the
GPO at these sites are not utilized or otherwise transferred to the parent hospital or any outpatient
facilities registered on the OPA 340B database.
Outpatient Status – All patients housed at correctional facilities served by UTMB CMC Department of
Pharmacy have an outpatient status and are served by the onsite clinics.
In-house Pharmacy - A pharmacy that is owned by, and a legal part of, the 340B entity. Typically in-house
pharmacies are listed as shipping addresses of the entity.
PROCEDURE:
I. UTMB CMC uses an in-house pharmacy and pharmacy services are performed in accordance with OPA
requirements and guidelines.
A. 340B drugs are only used for patients at UTMB CMC outpatient clinics that appear in the 340B
database. All patients at the clinics are 340B eligible.
B. UTMB maintains the records of the patients’ health care.
C. UTMB directly employees the prescribers or the prescribers are under contractual agreement.
D. Patients receive their health care from UTMB providers and the providers are responsible for
their care.
E. Medicaid claims and reimbursement are not used for UTMB CMC outpatient clinics.
II. UTMB policies, procedures, systems, and internal controls are in place to reasonably ensure ongoing
compliance with all 340B requirements.
UTMB CMC
PHARMACY DEPARTMENTAL
POLICY AND PROCEDURE
Effective Date: 11/6/13
NUMBER: 30.55
Page 3 of 26
Reviewed:
Revised: 12/9/15
340B PROGRAM COMPLIANCE
III. Staff Competency
A. Training is conducted on the 340B inventory management program initially upon hire and
competency is also verified by the Pharmacy Supervisor or designee through verbal assessment as
needed.
B. Pharmacy purchasing and accounting staff engaged in monitoring and using the 340B Program and
program compliance complete training upon hire via webinar on the 340B and Prime Vendor
Programs (https://www.340bpvp.com) and attend the 340B University offered by Apexus.
C. Information about the 340B program is received from the OPA, 340B Prime Vendor Program, and/or
any OPA contractor.
IV. Staff Engaged in 340B Program Compliance
A. Director of Pharmacy
1. Accountable agent for 340B compliance
2. Ensure current policy statements and procedures are in place to maintain program
compliance
3. Must maintain knowledge of the policy changes that impact the 340B program which
includes, but not limited to, HRSA/OPA rules
4. Must communicate any change in clinic eligibility or information to the UTMB Office of
Cost Reimbursements and pharmacy staff
B. Assistant Director of Pharmacy, Regulatory Compliance & Systems
1. Assure appropriate safeguards and system integrity
2. Assist with annual 340B integrity audit
3. Responsible for documentation of policy and procedures
C. Finance Manager
1. Performs the annual 340B integrity audit
2. Responsible for semi-annual physical inventory of pharmacy items
3. Responsible for establishment of pricing methodology and procedures
4. Define process and access to data for compliant identification of utilization for eligible
patients
5. Archive the data so as to be available to auditors when audited
6. Responsible for monitoring the ordering processes, receiving process, and data and
pricing of PIPS (pharmacy inventory pricing system)
7. Responsible for establishment and maintenance of wholesaler and reverse distributor
accounts (340B versus non-340B)
8. Responsible for establishment and maintenance of pharmacy system accounts (340B
versus non-340B) such as IMS, HCC, and Datalogic
9. Review 340B reports detailing purchases and dispensing patterns
D. Senior Pharmacist of Purchasing
1. Responsible for overseeing the ordering of all drugs from the specific accounts as
specified by the process employed
UTMB CMC
PHARMACY DEPARTMENTAL
POLICY AND PROCEDURE
Effective Date: 11/6/13
NUMBER: 30.55
Page 4 of 26
Reviewed:
Revised: 12/9/15
340B PROGRAM COMPLIANCE
2. Oversees the purchasing control processes
3. Monitors product minimum and maximum levels to effectively balance product
availability and cost efficient inventory control
4. Knowledgeable of products covered by 340B and Prime Vendor Program pricing
E. Stores Clerk II in Charge of PIPS Management
1. Responsible for monitoring the receiving process, and data and pricing of PIPS
(pharmacy inventory pricing system)
2. Responsible for making corrections in PIPS if needed
F. Senior Technologists Rotation 1, 2 and 3
1. Responsible for daily maintenance of dual inventories in their respective areas
2. Responsible for training staff on use and controls of dual inventories
V. 340B Enrollment
A. Initial Enrollment - The UTMB Office of Cost Reimbursements is responsible for evaluating a
new facility to determine if the location is eligible for participation in the 340B Program. The criteria
used include: service area must be fully integrated into the hospital, appear as allowable on the most
recently filed cost report, have outpatient drug use, and have patients that meet the 340B patient
definition. If the facility meets criteria, the UTMB Office of Cost Reimbursements completes the
OPA online registration process. B. Enrollment Recertification - The UTMB Office of Cost Reimbursements is responsible for the
recertification of information listed in the OPA 340B database annually to ensure the covered
entity listing is complete, accurate, and correct.
C. Changes to Enrollment - A quarterly review of information listed in the OPA 340B database is
conducted by the UTMB Office of Cost Reimbursements. Changes to information (e.g., changes
to entity contact information or shipping address) are reported to the OPA through an online
change request.
VI. 340B Inventory Management
A. 340B inventory is shipped to the UTMB CMC Department of Pharmacy and distributed to the
UTMB CMC outpatient clinics.
B. The UTMB CMC Department of Pharmacy maintains physically separate inventories for 340B
and non-340B inventory items. It does not use a replenishment model (accumulator or split-bill
software) to manage its inventory.
C. Pharmacists and technicians only distribute or dispense 340B drugs to 340B facilities where
eligible patients are housed. 340B eligible UTMB CMC outpatient clinics include:
1. UTMB CMC outpatient clinics located on Texas Department of Criminal Justice
facilities (i.e., UTMB Sector)
2. UTMB CMC outpatient clinics located on Texas Juvenile Justice Department facilities
D. Pharmacists and technicians only distribute or dispense non-340B, non-GPO (e.g., WAC) drugs
to non-340B eligible facilities.
1. Non-340B eligible clinics include Texas Tech University Health Sciences Center clinics
located on Texas Department of Criminal Justice facilities (i.e., Texas Tech Sector).
UTMB CMC
PHARMACY DEPARTMENTAL
POLICY AND PROCEDURE
Effective Date: 11/6/13
NUMBER: 30.55
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Reviewed:
Revised: 12/9/15
340B PROGRAM COMPLIANCE
E. Staff places 340B orders from the primary wholesaler, Morris & Dickson, through daily
inventory reviews and shelf inspections by using the Morris & Dickson Web Portal. The 340B
orders are placed on a separate wholesaler account. The same process is used for the secondary
wholesaler, AmerisourceBergen, in the event of product shortages. F. Staff checks in 340B inventory by examining the wholesaler invoice against the order, and
reports inaccuracies to the wholesaler. Invoice information is downloaded or input into PIPS.
G. 340B inventory is stored in the pharmacy with a security system. Only pharmacy employees
have access through a badge-ID limited entry system (P&P 01-25 Pharmacy Security).
H. 340B inventory segregation (P&P 30-30 Inventory Management and Controls)
1. Physically separate 340B and non-340B inventories are established by purchase orders
through the use of separate accounts, which segregate inventories at the time of purchase.
2. Upon receipt, 340B inventory is placed into its physically separate inventory. 340B
blister pack cards are marked with a P in the man-readable portion of the barcode and
barcode.
3. Upon receipt, all non-340B inventory is designated (i.e., clearly marked) as non-340B
and placed into its physically separate inventory.
a. Case goods are marked with a non-340B master pack label.
b. Blister pack cards are marked with a W in the man-readable portion of the
barcode and barcode.
c. Unit of use items (e.g., ointments and inhalers) are marked with an X using a UV
marker.
4. All products returned to the wholesaler, other vendors or reverse distributor are returned
on the appropriate 340B or non-340B account to reflect the initial designation of that
item.
5. Non-340B medication drug orders (i.e., prescriptions) are processed at different times of
the day (i.e., wave 10) and on separate distribution sorters (i.e., 40-lane sorter) to
maintain segregation.
6. 340B medication drug orders (i.e., prescriptions) are processed at different times of the
day (i.e., waves 8, 12 and 14) to maintain segregation.
7. Distribution sorters perform a correct inventory check of blister pack cards at the time a
medication drug order is scanned to ensure that 340B inventory was used to fill an order
for 340B eligible patient and vice versa.
8. 340B medication drug orders or inventory returned from UTMB CMC Clinics are
credited to the correct clinic account and returned to the correct 340B inventory if they
can be reused. 340B inventory is identified by the unit designator in the patient label
barcode and/or P in the barcode (P&P 25-20 Returned Medications and Reclamation
Processing).
I. Inventory Transfers
1. Transfers between non-340B and 340B inventory are prohibited except in the case of an
emergency medical situation.
2. Only in the case of an emergency medical situation and with Director of Pharmacy approval
will drugs be transferred from a 340B inventory to a non-340B inventory (P&P 30-25
UTMB CMC
PHARMACY DEPARTMENTAL
POLICY AND PROCEDURE
Effective Date: 11/6/13
NUMBER: 30.55
Page 6 of 26
Reviewed:
Revised: 12/9/15
340B PROGRAM COMPLIANCE
Pharmacy Procurement of Drug and Non-Drug Products). In the case of an emergency,
the following procedures will be used:
a. From non-340B to 340B
i. Staff records the transaction on the Medication Borrow/Loan Log
ii. Staff reconciles the process by transfer back to the separated non-340B
inventory area through a purchase on the borrowing area’s 340B account
(340B account) of the same NDC and quantity that was borrowed.
b. From 340B to non-340B
i. Staff records the transaction on the Medication Borrow/Loan Log
ii. Staff reconciles the process by transfer back to the separated 340B
inventory area through a purchase on the borrowing area’s non-340B
account (WAC account) of the same NDC and quantity that was
borrowed.
J. Records will be maintained for a period of time that complies with the university’s official
record retention schedule and all applicable federal, state and local requirements.
VII. Monitoring
A. Auditable records will be maintained to demonstrate compliance with the 340B program.
B. Pharmacy staff will complete random weekly audits (P&P 55-25 Automation Sortation Device)
of shipments to ensure accuracy and to monitor 340B inventory compliance.
C. Pharmacy staff will complete monthly audits of the maintenance and segregation of pharmacy
inventory (340B versus non-340B drugs) to ensure inventory controls are being followed.
Monthly audits will include physical observation of the areas where inventory is stored to verify
340B and non-340B inventory is kept separate and marked appropriately (Attachment A).
D. The Pharmacy will conduct semi-annual 340B integrity audits to ensure that the agency’s
internal controls are in compliance with 340B program standards.
1. An audit report with findings will be written and maintained for a period of time that
complies with all applicable federal, state and local requirements. A copy will be sent to
the UTMB Office of Institutional Compliance.
2. If any internal compliance audit indicates that there has been a violation of 340B program
requirements, it will be reported to the UTMB Office of Institutional Compliance.
3. Audit procedures will include:
a. Semi-annual audits
i. Review of a sample of 50 prescriptions (twenty-five 340B and twenty-five
non-340B prescriptions) covering the preceding six-month period
(Attachments C-D).
ii. The review will include whether the relationship between UTMB and the
individual met HRSA’s patient definition standards (i.e., verification of
clinic and patient eligibility).
iii. The audits will be considered compliant if all 50 prescriptions are found to
be compliant.
b. Once a year the semi-annual audit will also include:
UTMB CMC
PHARMACY DEPARTMENTAL
POLICY AND PROCEDURE
Effective Date: 11/6/13
NUMBER: 30.55
Page 7 of 26
Reviewed:
Revised: 12/9/15
340B PROGRAM COMPLIANCE
i. Review of relevant policies and procedures and how they are
operationalized
ii. Review of the maintenance and segregation of pharmacy inventory (340B
versus non-340B drugs) and evidence of compliance with the required
GPO exclusion for covered entities by testing a random sample of 340B
inventory transaction records. The review will include 10 medications in
340B inventory and 10 medications in non-340B inventory (Attachments
E-F) to include beginning inventory balance, purchases, sales, and returns
iii. Interviewing key staff members to ensure understanding of program and
requirements (Attachment G).
References:
US Department of Health and Human Services. Health Resources and Services Administration. Office of
Pharmacy Affairs. Statutory Prohibition on Group Purchasing Organization Participation. 340B Drug Pricing
Program Notice. Release No. 2013-1. February 7, 2013.
Sample 340B Policy & Procedure Manual. A Guide for Disproprionate Share Hosptial (DSH) Leaders.
Apexus. Version 06302015.
https://docs.340bpvp.com/documents/public/resourcecenter/DSH_PolicyManual.docx
340B Compliance Self-Assessment: Policy. A Quick Self-Assessment for DSH Leaders. Apexus. Version
05062015.
https://docs.340bpvp.com/documents/public/resourcecenter/DSH_340B_Compliance_SelfAssessment_Policy.p
df
340B Compliance Self-Assessment: Self-Audit Process. A Sample Self-Audit Process for DSHs. Apexus.
Version 05062015.
https://docs.340bpvp.com/documents/public/resourcecenter/DSH_340B_Compliance_SelfAssessment_DataTra
nsactions.pdf
Attachment A
Monthly Inventory Audit
Select 2 areas where inventory is stored to verify 340B and non-340B inventory is kept separate and marked
appropriately.
Date: Auditor:
Inventory Location:
Data Assessment Criteria Findings 1. Physical observation of
inventory
The price plan (340B and non-340B) is clearly identified on
drug packages
Compliant
Noncompliant (explain
below)
2. Physical observation of
inventory
340B and non-340B inventories are kept in physically
separate locations Compliant
Noncompliant (explain
below)
3. Review of completed
Medication Borrow/Loan Log
Transfers between 340B and non-340B inventories are
documented with the required approvals per policy 30-25.
Compliant
Noncompliant (explain
below)
Describe any areas of noncompliance observed:
List opportunities for improvements or suggested changes:
CC: Finance Manager
Assistant Director Pharmacy Services, Regulatory Compliance & Systems
Director, Pharmacy Services
Attachment B
340B Self-Audit Report
Date: Auditor:
Department:
This audit was performed at the request of the UTMB Office of Institutional Compliance.
Data Assessment Criteria Findings 4. Policies and procedures related
to 340B are current Policies contain relevant criteria from sample DSH 340B
Comprehensive Policy and Procedure Manual
Policies reviewed annually
Date:________________
Compliant
Noncompliant (explain)
5. Clinics receiving 340B
medications are registered on
the OPA database
OPA database
340B ID:______________
Last Quarterly Review Sent to UTMB:_______
Recertification Date:__________
Compliant
Noncompliant (explain)
6. 340B Transaction samples
(attachment B)
Sample Size n=25
Patient received services from UTMB CMC and
healthcare records are maintained in the EMR
UTMB CMC employee or contract employee wrote
prescriptions
Compliant
Noncompliant (explain)
7. Non-340B Transaction Samples
(attachment C)
Sample Size n=25
Patient received services from non-eligible sites
confirmed by review of healthcare records
Non-eligible provider wrote prescriptions
Compliant
Noncompliant (explain)
8. 340B Inventory - Starting
inventory balance at beginning
of sample timeframe and end of
sample timeframe (attachment
D)
Sample Size n=10
Able to provide an accounting disposition for all
inventory supplied in the sample.
GPO was not used to purchase covered outpatient
medications for 340B patient/facility
Separate accounts are used and maintained for 340B and
non-340B purchases
Separate accounts for 340B and non-340B inventory are
used and maintained for returns
Expired, damaged or unused 340B medications are
returned to wholesaler, returned to reverse distributor, or
destroyed (i.e., not donated or diverted).
Compliant
Noncompliant (explain)
9. Non-340B Inventory - Starting
inventory balance at beginning
of sample timeframe and end of
sample timeframe (attachment
D)
Sample Size n=10
Able to provide an accounting disposition for all
inventory supplied in the sample.
GPO was not used to purchase covered outpatient
medications for non-340B patient/facility
Separate accounts are used and maintained for 340B and
non-340B purchases
Separate accounts for 340B and non-340B inventory are
used and maintained for returns
Expired, damaged or unused 340B medications are
returned to wholesaler, returned to reverse distributor, or
destroyed (i.e., not donated or diverted).
Compliant
Noncompliant (explain)
10. Interview Questions 340B Self-Audit
Opportunities for improvements or suggested changes:
Cc: Finance Manager
Assistant Director Pharmacy Services, Regulatory Compliance & Systems
Director, Pharmacy Services
AVP, Office of Institutional Compliance
Attachment C
Transaction Samples of Individual Prescriptions
Select 25 transactions (prescriptions) for 340B eligible clinics and complete audit of the sample. Attach a
copy to the 340B Self-Audit Report.
Date: Auditor:
340B Eligible Unit
Unit: Sector:
RX ID Number:
RX Date Written: Date Dispensed:
Patient ID Number: Prescriber:
Drug Description:
SCC #:
NDC#:
Data Data Source Compliant
(Yes/No)
Notes
Clinic Eligibility
Confirmed
Unit of assignment on report
Patient Eligibility
Confirmed
Documentation medication was
ordered in the EMR
Prescriber Eligibility
Confirmed
Report provided by CMC HR
Attachment D
Transaction Samples of Individual Prescriptions
Select 25 transactions (prescriptions) for non-340B eligible clinics and complete audit of the sample. Attach
a copy to the 340B Self-Audit Report.
Non-340B Eligible Unit
Unit: Sector:
RX ID Number:
RX Date Written: Date Dispensed:
Patient ID Number: Prescriber:
Drug Description:
SCC #:
NDC#:
Data Data Source Compliant
(Yes/No)
Notes
Clinic Eligibility
Confirmed
Unit of assignment on report
Patient Eligibility
Confirmed
Documentation medication was
ordered in the EMR
Prescriber Eligibility
Confirmed
Report provided by Texas Tech
EMR Sr Director
Attachment E
Transaction Samples of Individual Medications
Select 10 medications from the 340B inventory and complete audit of the sample. Include at least 3 high-cost medications. Use a 6 month
continuous time frame within the prior year to complete the audit. Attach a copy to the 340B Self-Audit Report.
340B Inventory
Date: Audit Date Range: Auditor:
Drug Name: SCC#: NDC#:
Wholesaler(s):
Invoice(s) #:
Audit Findings: Data Source Compliant Notes
WAC account was not used to purchase covered
outpatient medications for 340B inventory.
Yes
No
Separate accounts are used and maintained for 340B
and non-340B purchases (e.g., WAC).
Wholesaler Account #: Yes
No
WAC account was not used to return outpatient
medications from 340B inventory.
Yes
No
Expired, damaged or unused 340B medications from
the pharmacy inventory are returned to wholesaler,
returned to reverse distributor, or destroyed (i.e., not
donated or diverted).
Reverse Distributor Account #:
Source Report Name: Genco
report Order Details Report
Yes
No
Separate accounts are used and maintained for returns
from units.
Source Report Name: Datalogic
report Unit Totals by Population
by Region
Yes
No
Separate usage records are used and maintained for
340B and non-340B sales
Source Report Name:
PHO438-AU
PHO438-U
Yes
No
340B Inventory Confirmed P designator on blister pack
cards
No UV mark on UOU items
Yes
No
Able to provide an accounting disposition for all Yes
inventory supplied in the sample (calculated quantity
for ending inventory = inventory on hand during
audit).
No
Medication Inventory: Data Source Quantity
Beginning inventory
Semi-Annual inventory
Total purchased Invoices or wholesaler system report +
Total dispensed as prescription System reports
PRS PHO438
HCC 3rd party journal
-
Total distributed as stock System reports
HCC
IMS
-
Returns made by pharmacy (e.g.,
manufacturer, Genco, wholesaler)
Genco report Order Details Report -
Items returned to the pharmacy for
reuse (i.e., reclamation)
Datalogic report Unit Totals by Population by Region +
Calculated quantity for ending
inventory = inventory on hand
during audit
=
Inventory on hand
Location:
Location:
Location:
Location:
Attachment F
Transaction Samples of Individual Medications
Select 10 medications from the non-340B inventory and complete audit of the sample. Include at least 3 high-cost medications. Use a 6 month
continuous time frame within the prior year to complete the audit. Attach a copy to the 340B Self-Audit Report.
Non-340B Inventory
Date: Audit Date Range: Auditor:
Drug Name: SCC#: NDC#:
Wholesaler(s):
Invoice(s) #:
Audit Findings: Data Source Compliant Notes
WAC account was not used to purchase covered
outpatient medications for 340B inventory.
Yes
No
Separate accounts are used and maintained for 340B
and non-340B purchases (e.g., WAC).
Wholesaler Account #: Yes
No
WAC account was not used to return outpatient
medications from 340B inventory.
Yes
No
Expired, damaged or unused 340B medications from
the pharmacy inventory are returned to wholesaler,
returned to reverse distributor, or destroyed (i.e., not
donated or diverted).
Reverse Distributor Account #:
Source Report Name: Genco
report Order Details Report
Yes
No
Separate accounts are used and maintained for returns
from units.
Source Report Name: Datalogic
report Unit Totals by Population
by Region
Yes
No
Separate usage records are used and maintained for
340B and non-340B sales
Source Report Name: PHO438-T
Yes
No
340B Inventory Confirmed N designator on blister pack
cards
UV mark on UOU items
Yes
No
Able to provide an accounting disposition for all
inventory supplied in the sample (calculated quantity
Yes
No
for ending inventory = inventory on hand during
audit).
Medication Inventory: Data Source Quantity
Beginning inventory
Semi-Annual inventory
Total purchased Invoices or wholesaler system report +
Total dispensed as prescription System reports
PRS PHO438
HCC 3rd party journal
-
Total distributed as stock System reports
HCC
IMS
-
Returns made by pharmacy (e.g.,
manufacturer, Genco, wholesaler)
Genco report Order Details Report -
Items returned to the pharmacy for
reuse (i.e., reclamation)
Datalogic report Unit Totals by Population by Region +
Calculated quantity for ending
inventory = inventory on hand
during audit
=
Inventory on hand
Location:
Location:
Location:
Location:
Attachment G
Interview Questions 340B Self-Audit
Date: Auditor:
Finance Manager
Question Response
1. How do you identify areas eligible for 340B
medications?
2. Describe 340B internal audit process
3. Describe dual inventory process and controls
4. Describe drug charge and billing process
5. What type of wholesaler accounts do you use
to purchase outpatient drugs? (Provide list of
accounts)
6. What level of confidence do you have in the
entity’s compliance with 340B program?
Director, Pharmacy Services
Question Response
1. How often are 340B policies and procedures
updated?
2. Describe 340B internal audit process
3. How do you define outpatient in your
institution for 340B purposes?
4. Describe dual inventory process and controls.
5. Who has access to update the entity’s health
care professional list for 340B?
6. Explain how you handle referral prescriptions.
7. How do you know independent agreements for
pharmaceuticals do not violate the GPO
prohibition?
8. What level of confidence do you have in the
entity’s compliance with 340B program?
Senior Pharmacist Purchasing
Question Response
1. How many wholesaler accounts do you
purchase from?
2. What is your role in maintaining 340B
compliance?
3. Describe process for transferring items
between 340B and non-340B inventories on an
emergency basis.
4. What is the process for disposition of expired
medications?
Question Response
5. Describe dual inventory process and controls
6. What records do you provide to the return
company to ensure 340B price is credited?
7. What is the internal policy that addresses 340B
program compliance and where can it be
located?
Senior Technician – Rotation 1, 2 and 3
Question Response
1. What is your role in maintaining 340B
compliance?
2. Describe dual inventory process and controls.
3. Describe process for transferring items
between 340B and non-340B inventories on an
emergency basis.
4. What is the process for disposition of expired
medications?
5. What is the internal policy that addresses 340B
program compliance and where can it be
located?
Attachment E
Price Plan Verification
Unit Unit
Code Customer University
Patient
Pricing
Eligibility
Health Care
Staff Pricing
Eligibility
Officer Pricing
Eligibility Compliant
ALLRED JA TDCJ Texas Tech WAC WAC WAC Yes
No
B MOORE BM TDCJ UTMB 340B WAC WAC Yes
No
BARTLETT BL TDCJ UTMB 340B WAC WAC Yes
No
BATEN NJ TDCJ Texas Tech WAC WAC WAC Yes
No
BETO OB TDCJ UTMB 340B WAC WAC Yes
No
Bonita House TDCJ UTMB WAC Not applicable Not applicable Yes
No
BOYD BY TDCJ UTMB 340B WAC WAC Yes
No
BRADSHAW BH TDCJ UTMB 340B WAC WAC Yes
No
BRIDGEPORT BR TDCJ UTMB 340B WAC WAC Yes
No
BRISCOE DB TDCJ UTMB 340B WAC WAC Yes
No
BYRD DU TDCJ UTMB 340B WAC WAC Yes
No
C MOORE CM TDCJ UTMB 340B WAC WAC Yes
No
CLEMENS CN TDCJ UTMB 340B WAC WAC Yes
No
CLEMENTS BC TDCJ Texas Tech WAC WAC WAC Yes
No
CLEVELAND CV TDCJ UTMB 340B WAC WAC Yes
No
COFFIELD CO TDCJ UTMB 340B WAC WAC Yes
No
COLE CL TDCJ UTMB 340B WAC WAC Yes
Unit Unit
Code Customer University
Patient
Pricing
Eligibility
Health Care
Staff Pricing
Eligibility
Officer Pricing
Eligibility Compliant
No
CONNALLY CY TDCJ UTMB 340B WAC WAC Yes
No
COTULLA N4 TDCJ UTMB 340B WAC WAC Yes
No
CRAIN GV TDCJ UTMB 340B WAC WAC Yes
No
DALHART DH TDCJ Texas Tech WAC WAC WAC Yes
No
DANIEL DL TDCJ Texas Tech WAC WAC WAC Yes
No
DARRINGTON DA TDCJ UTMB 340B WAC WAC Yes
No
DIBOLL DO TDCJ UTMB 340B WAC WAC Yes
No
DOMINGUEZ BX TDCJ UTMB 340B WAC WAC Yes
No
DUNCAN N6 TDCJ UTMB 340B WAC WAC Yes
No
EASTHAM EA TDCJ UTMB 340B WAC WAC Yes
No
ELLIS OE TDCJ UTMB 340B WAC WAC Yes
No
ESTELLE E2 TDCJ UTMB 340B WAC WAC Yes
No
ESTES VS TDCJ UTMB 340B WAC WAC Yes
No
FERGUSON FE TDCJ UTMB 340B WAC WAC Yes
No
FORMBY FB TDCJ Texas Tech WAC WAC WAC Yes
No
FT STOCKTON N5 TDCJ Texas Tech WAC WAC WAC Yes
No
GARZA NH TDCJ UTMB 340B WAC WAC Yes
No
GIST BJ TDCJ UTMB 340B WAC WAC Yes
No
Unit Unit
Code Customer University
Patient
Pricing
Eligibility
Health Care
Staff Pricing
Eligibility
Officer Pricing
Eligibility Compliant
GLOSSBRENNER SO TDCJ UTMB 340B WAC WAC Yes
No
GOODMAN GG TDCJ UTMB 340B WAC WAC Yes
No
GOREE GR TDCJ UTMB 340B WAC WAC Yes
No
GURNEY ND TDCJ UTMB 340B WAC WAC Yes
No
HALBERT BB TDCJ UTMB 340B WAC WAC Yes
No
HAMILTON JH TDCJ UTMB 340B WAC WAC Yes
No
HAVINS TH TDCJ Texas Tech WAC WAC WAC Yes
No
HENLEY LT TDCJ UTMB 340B WAC WAC Yes
No
HIGHTOWER HI TDCJ UTMB 340B WAC WAC Yes
No
HILLTOP HT TDCJ UTMB 340B WAC WAC Yes
No
HOBBY HB TDCJ UTMB 340B WAC WAC Yes
No
HODGE HD TDCJ UTMB 340B WAC WAC Yes
No
HOLLIDAY NF TDCJ UTMB 340B WAC WAC Yes
No
HOSPITAL GALVESTON HG TDCJ UTMB 340B Not applicable Not applicable1 Yes
No
HUGHES AH TDCJ UTMB 340B WAC WAC Yes
No
HUNTSVILLE HV TDCJ UTMB 340B WAC WAC Yes
No
Huntsville Memorial Hospital HH TDCJ Not
applicable Not applicable WAC
Yes
No
HUTCHINS HJ TDCJ UTMB 340B WAC WAC Yes
No
JESTER I J1 TDCJ UTMB 340B WAC WAC Yes
Unit Unit
Code Customer University
Patient
Pricing
Eligibility
Health Care
Staff Pricing
Eligibility
Officer Pricing
Eligibility Compliant
No
JESTER III J3 TDCJ UTMB 340B WAC WAC Yes
No
JESTER IV J4 TDCJ UTMB 340B WAC WAC Yes
No
JOHNSTON JT TDCJ UTMB 340B WAC WAC Yes
No
JORDAN JN TDCJ Texas Tech WAC WAC WAC Yes
No
KEGAN HM TDCJ UTMB 340B WAC WAC Yes
No
KYLE KY TDCJ UTMB 340B WAC WAC Yes
No
LEBLANC BA TDCJ UTMB 340B WAC WAC Yes
No
LEWIS GL TDCJ UTMB 340B WAC WAC Yes
No
LINDSEY LN TDCJ UTMB 340B WAC WAC Yes
No
LOCKHART LC TDCJ UTMB 340B WAC WAC Yes
No
LOPEZ RL TDCJ UTMB 340B WAC WAC Yes
No
LUTHER P2 TDCJ UTMB 340B WAC WAC Yes
No
LYNAUGH LH TDCJ Texas Tech WAC WAC WAC Yes
No
LYNCHNER AJ TDCJ UTMB 340B WAC WAC Yes
No
MARLIN N1 TDCJ UTMB 340B WAC WAC Yes
No
MCCONNELL ML TDCJ UTMB 340B WAC WAC Yes
No
MICHAEL MI TDCJ UTMB 340B WAC WAC Yes
No
MIDDLETON NE TDCJ Texas Tech WAC WAC WAC Yes
No
Unit Unit
Code Customer University
Patient
Pricing
Eligibility
Health Care
Staff Pricing
Eligibility
Officer Pricing
Eligibility Compliant
MONTFORD JM TDCJ Texas Tech WAC WAC WAC Yes
No
MONTFORD RMF HP TDCJ Texas Tech WAC WAC WAC Yes
No
MT.VIEW MV TDCJ UTMB 340B WAC WAC Yes
No
MURRAY LM TDCJ UTMB 340B WAC WAC Yes
No
NEAL KN TDCJ Texas Tech WAC WAC WAC Yes
No
NEY HF TDCJ UTMB 340B WAC WAC Yes
No
PACK P1 TDCJ UTMB 340B WAC WAC Yes
No
PLANE LJ TDCJ UTMB 340B WAC WAC Yes
No
POLUNSKY TL TDCJ UTMB 340B WAC WAC Yes
No
POWLEDGE B2 TDCJ UTMB 340B WAC WAC Yes
No
RAMSEY R1 TDCJ UTMB 340B WAC WAC Yes
No
ROACH RH TDCJ Texas Tech WAC WAC WAC Yes
No
ROACH CAMPS C1 TDCJ Texas Tech WAC WAC WAC Yes
No
ROBERTSON RB TDCJ Texas Tech WAC WAC WAC Yes
No
RUDD RD TDCJ Texas Tech WAC WAC WAC Yes
No
SAN SABA N2 TDCJ UTMB 340B WAC WAC Yes
No
SANCHEZ RZ TDCJ Texas Tech WAC WAC WAC Yes
No
SAYLE SY TDCJ Texas Tech WAC WAC WAC Yes
No
Unit Unit
Code Customer University
Patient
Pricing
Eligibility
Health Care
Staff Pricing
Eligibility
Officer Pricing
Eligibility Compliant
SCOTT RV TDCJ UTMB 340B WAC WAC Yes
No
SEGOVIA EN TDCJ UTMB 340B WAC WAC Yes
No
SKYVIEW SV TDCJ UTMB 340B WAC WAC Yes
No
SMITH SM TDCJ Texas Tech WAC WAC WAC Yes
No
STEVENSON SB TDCJ UTMB 340B WAC WAC Yes
No
STILES ST TDCJ UTMB 340B WAC WAC Yes
No
STRINGFELLOW R2 TDCJ UTMB 340B WAC WAC Yes
No
TELFORD TO TDCJ UTMB 340B WAC WAC Yes
No
TERRELL R3 TDCJ UTMB 340B WAC WAC Yes
No
TORRES TE TDCJ UTMB 340B WAC WAC Yes
No
TRAVIS TI TDCJ UTMB 340B WAC WAC Yes
No
TULIA N3 TDCJ Texas Tech WAC WAC WAC Yes
No
VANCE J2 TDCJ UTMB 340B WAC WAC Yes
No
WALLACE WL TDCJ Texas Tech WAC WAC WAC Yes
No
WARE DW TDCJ Texas Tech WAC WAC WAC Yes
No
WHEELER WR TDCJ Texas Tech WAC WAC WAC Yes
No
WILDERNESS 3 W3 TDCJ Texas Tech WAC WAC WAC Yes
No
WILLACY WI TDCJ UTMB 340B WAC WAC Yes
No
WOODMAN WM TDCJ UTMB 340B WAC WAC Yes
Unit Unit
Code Customer University
Patient
Pricing
Eligibility
Health Care
Staff Pricing
Eligibility
Officer Pricing
Eligibility Compliant
No
WYNNE WY TDCJ UTMB 340B WAC WAC Yes
No
YOUNG GC TDCJ UTMB 340B WAC WAC Yes
No
Ayres AY TJJD UTMB 340B WAC WAC Yes
No
Beto BE TJJD UTMB 340B WAC WAC Yes
No
Brownwood Halfway House H2 TJJD UTMB WAC WAC WAC Yes
No
Corsicana CS TJJD UTMB 340B WAC WAC Yes
No
Cottrell CT TJJD UTMB 340B WAC WAC Yes
No
Evins EV TJJD UTMB 340B WAC WAC Yes
No
Gainsville GA TJJD UTMB 340B WAC WAC Yes
No
Giddings GI TJJD UTMB 340B WAC WAC Yes
No
McFadden Ranch MC TJJD UTMB 340B WAC WAC Yes
No
McLennan MN TJJD UTMB 340B WAC WAC Yes
No
Ron Jackson I BS TJJD UTMB 340B WAC WAC Yes
No
Schaeffer SC TJJD UTMB 340B WAC WAC Yes
No
Tamayo VA TJJD UTMB 340B WAC WAC Yes
No
Willoughby WH TJJD UTMB 340B WAC WAC Yes
No
York YO TJJD UTMB 340B WAC WAC Yes
No
Galveston Teen Center UTMB WAC Not applicable Not applicable Yes
No
Unit Unit
Code Customer University
Patient
Pricing
Eligibility
Health Care
Staff Pricing
Eligibility
Officer Pricing
Eligibility Compliant
Bridgeport PPT T1 MTC UTMB WAC WAC Not applicable Yes
No
East Texas Treatment XQ MTC UTMB WAC WAC Not applicable Yes
No
South Texas ISF XM MTC UTMB WAC WAC Not applicable Yes
No
West Texas ISF XN
MTC UTMB WAC WAC Not applicable Yes
No
El Paso Co. Jail Annex A1 Burnet
Co. Jail UTMB WAC WAC Not applicable Yes
No
El Paso Co. Detention Facility A2 El Paso
Co. Jail UTMB WAC WAC Not applicable Yes
No
1 HG officers go to Young for vaccines and Postexposure prophylaxis