340B PROGRAM COMPLIANCE. To ensure that the UTMB CMC Department of Pharmacy is in compliance with 340B program standards on an ongoing basis.

Transcription

1 UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective Date: 11/6/13 NUMBER: Page 1 of 26 Revised: 7/8/16 Reviewed: 6/1/16 340B PROGRAM COMPLIANCE SUBJECT: PURPOSE: POLICY: 340B Program Compliance To ensure that the UTMB CMC Department of Pharmacy is in compliance with 340B program standards on an ongoing basis. 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.

2 UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective Date: 11/6/13 NUMBER: Page 2 of 26 Revised: 7/8/16 Reviewed: 6/1/16 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 for the purposes of the GPO prohibition. GPO Prohibition - 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 eligible outpatient clinics. 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.

3 UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective Date: 11/6/13 NUMBER: Page 3 of 26 Revised: 7/8/16 Reviewed: 6/1/16 340B PROGRAM COMPLIANCE III. IV. 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 and periodically 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. 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 Government Reimbursement 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 semi-annual 340B integrity audits 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, PRS, 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 2. Oversees the purchasing control processes

4 UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective Date: 11/6/13 NUMBER: Page 4 of 26 Revised: 7/8/16 Reviewed: 6/1/16 340B PROGRAM COMPLIANCE 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 Government Reimbursement is responsible for evaluating a new facility to determine if the location is eligible for participation in the 340B Program. If the facility meets criteria, the UTMB Office of Government Reimbursement completes the OPA online registration process. B. Enrollment Recertification - The UTMB Office of Government Reimbursement 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 Government Reimbursement. 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 eligible 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). 2. County Jails 3. MTC units 4. Galveston Teen Center 5. Bonita House

5 UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective Date: 11/6/13 NUMBER: Page 5 of 26 Revised: 7/8/16 Reviewed: 6/1/16 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 Pharmacy Security). H. 340B inventory segregation (P&P 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 B 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 B 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 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

6 UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective Date: 11/6/13 NUMBER: Page 6 of 26 Revised: 7/8/16 Reviewed: 6/1/16 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 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:

7 UTMB CMC PHARMACY DEPARTMENTAL POLICY AND PROCEDURE Effective Date: 11/6/13 NUMBER: Page 7 of 26 Revised: 7/8/16 Reviewed: 6/1/16 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 February 7, Sample 340B Policy & Procedure Manual. A Guide for Disproprionate Share Hosptial (DSH) Leaders. Apexus. Version B Compliance Self-Assessment: Policy. A Quick Self-Assessment for DSH Leaders. Apexus. Version df 340B Compliance Self-Assessment: Self-Audit Process. A Sample Self-Audit Process for DSHs. Apexus. Version nsactions.pdf

8 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 Noncompliant (explain below) 2. Physical observation of inventory 3. Review of completed Medication Borrow/Loan Log Describe any areas of noncompliance observed: 340B and non-340b inventories are kept in physically separate locations Transfers between 340B and non-340b inventories are documented with the required approvals per policy Noncompliant (explain below) Noncompliant (explain below) List opportunities for improvements or suggested changes: CC: Finance Manager Assistant Director Pharmacy Services, Regulatory Compliance & Systems Director, Pharmacy Services

9 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 1. Policies and procedures related to 340B are current 2. Clinics receiving 340B medications are registered on the OPA database Policies contain relevant criteria from sample DSH 340B Comprehensive Policy and Procedure Manual Policies reviewed annually Date: OPA database 340B ID: Last Quarterly Review Sent to UTMB: Recertification Date: B Transaction samples 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 4. Non-340B Transaction Samples Sample Size n=25 Patient received services from non-eligible sites confirmed by review of healthcare records B Inventory - Starting inventory balance at beginning of sample timeframe and end of sample timeframe 6. Non-340B Inventory - Starting inventory balance at beginning of sample timeframe and end of sample timeframe Non-eligible provider wrote prescriptions 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). 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). 7. Interviews with Key Staff Key staff interviewed Staff able to answer interview questions correctly and familiar with 340B internal controls 8. Price Plan Verification Customers accounts setup with correct price pay plan Noncompliant (explain) Noncompliant (explain) Noncompliant (explain) Noncompliant (explain) Noncompliant (explain) Noncompliant (explain) Noncompliant (explain)

10 (WAC or 340B). 9. Sorter Inventory Audits Weekly sorter audits performed and records available for review No diversion identified 10. Monthly physical audit of segregated inventory for target areas Note: Items 5-10 are only completed once per year Monthly physical audits of segregated inventory for targeted areas performed and records available for review No problems of inventory segregation identified Noncompliant (explain) Noncompliant (explain) Noncompliant (explain) Opportunities for improvements or suggested changes: Cc: Finance Manager Assistant Director Pharmacy Services, Regulatory Compliance & Systems Director, Pharmacy Services AVP, Office of Institutional Compliance

11 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: Patient ID Number: Date Dispensed: Prescriber: Drug Description: SCC #: NDC#: Data Data Source (Yes/No) Notes Clinic Confirmed Patient Confirmed Prescriber Confirmed Unit of assignment on report Documentation medication was ordered in the EMR Report provided by CMC HR

12 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: Patient ID Number: Date Dispensed: Prescriber: Drug Description: SCC #: NDC#: Data Data Source (Yes/No) Notes Clinic Confirmed Patient Confirmed Prescriber Confirmed Unit of assignment on report Documentation medication was ordered in the EMR Report provided by HR

13 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 Notes WAC account was not used to purchase covered outpatient medications for 340B inventory. Separate accounts are used and maintained for 340B and non-340b purchases (e.g., WAC). WAC account was not used to return outpatient medications from 340B inventory. Wholesaler Account #: Expired, damaged or unused 340B medications from Reverse Distributor Account #: the pharmacy inventory are returned to wholesaler, returned to reverse distributor, or destroyed (i.e., not donated or diverted). Source Report Name: Genco report Order Details Report Separate accounts are used and maintained for returns Source Report Name: Datalogic from units. report Unit Totals by Population by Region Separate usage records are used and maintained for Source Report Name: 340B and non-340b sales PHO438-AU PHO438-U 340B Inventory Confirmed P designator on blister pack cards UV mark on UOU items Able to provide an accounting disposition for all

14 inventory supplied in the sample (calculated quantity 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 3 rd party journal Total distributed as stock System reports HCC IMS - Returns made by pharmacy (e.g., Genco report Order Details Report manufacturer, Genco, wholesaler) - Items returned to the pharmacy for Datalogic report Unit Totals by Population by Region reuse (i.e., reclamation) + Calculated quantity for ending inventory = inventory on hand = during audit Inventory on hand Location: Location: Location: Location:

15 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 Notes WAC account was not used to purchase covered outpatient medications for 340B inventory. Separate accounts are used and maintained for 340B and non-340b purchases (e.g., WAC). WAC account was not used to return outpatient medications from 340B inventory. 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). Separate accounts are used and maintained for returns from units. Separate usage records are used and maintained for 340B and non-340b sales 340B Inventory Confirmed Able to provide an accounting disposition for all inventory supplied in the sample (calculated quantity Wholesaler Account #: Reverse Distributor Account #: Source Report Name: Genco report Order Details Report Source Report Name: Datalogic report Unit Totals by Population by Region Source Report Name: PHO438-T N designator on blister pack cards UV mark on UOU items

16 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 3 rd party journal Total distributed as stock System reports HCC IMS - Returns made by pharmacy (e.g., Genco report Order Details Report manufacturer, Genco, wholesaler) - Items returned to the pharmacy for Datalogic report Unit Totals by Population by Region reuse (i.e., reclamation) + Calculated quantity for ending inventory = inventory on hand = during audit Inventory on hand Location: Location: Location: Location:

17 Attachment G Interview Questions 340B Self-Audit Date: Auditor: Finance Manager Question 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? Response Director, Pharmacy Services Question 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? Response Senior Pharmacist Purchasing Question 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? Response

18 Question 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? Response Senior Technician Rotation 1, 2 and 3 Question 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? Response

19 Attachment E Price Plan Verification Date: Audit Date Range: Auditor: Unit Unit Code Customer University Patient Pricing Health Care Staff Pricing Officer Pricing ALLRED JA TDCJ Texas Tech WAC WAC WAC B MOORE BM TDCJ UTMB 340B WAC WAC BARTLETT BL TDCJ UTMB 340B WAC WAC BATEN NJ TDCJ Texas Tech WAC WAC WAC BETO OB TDCJ UTMB 340B WAC WAC Bonita House TDCJ UTMB WAC Not applicable Not applicable BOYD BY TDCJ UTMB 340B WAC WAC BRADSHAW BH TDCJ UTMB 340B WAC WAC BRIDGEPORT BR TDCJ UTMB 340B WAC WAC BRISCOE DB TDCJ UTMB 340B WAC WAC BYRD DU TDCJ UTMB 340B WAC WAC C MOORE CM TDCJ UTMB 340B WAC WAC CLEMENS CN TDCJ UTMB 340B WAC WAC CLEMENTS BC TDCJ Texas Tech WAC WAC WAC

20 Unit Unit Code Customer University Patient Pricing Health Care Staff Pricing Officer Pricing CLEVELAND CV TDCJ UTMB 340B WAC WAC COFFIELD CO TDCJ UTMB 340B WAC WAC COLE CL TDCJ UTMB 340B WAC WAC CONNALLY CY TDCJ UTMB 340B WAC WAC COTULLA N4 TDCJ UTMB 340B WAC WAC CRAIN GV TDCJ UTMB 340B WAC WAC DALHART DH TDCJ Texas Tech WAC WAC WAC DANIEL DL TDCJ Texas Tech WAC WAC WAC DARRINGTON DA TDCJ UTMB 340B WAC WAC DIBOLL DO TDCJ UTMB 340B WAC WAC DOMINGUEZ BX TDCJ UTMB 340B WAC WAC DUNCAN N6 TDCJ UTMB 340B WAC WAC EASTHAM EA TDCJ UTMB 340B WAC WAC ELLIS OE TDCJ UTMB 340B WAC WAC ESTELLE E2 TDCJ UTMB 340B WAC WAC ESTES VS TDCJ UTMB 340B WAC WAC FERGUSON FE TDCJ UTMB 340B WAC WAC FORMBY FB TDCJ Texas Tech WAC WAC WAC FT STOCKTON N5 TDCJ Texas Tech WAC WAC WAC

21 Unit Unit Code Customer University Patient Pricing Health Care Staff Pricing Officer Pricing GARZA NH TDCJ UTMB 340B WAC WAC GIST BJ TDCJ UTMB 340B WAC WAC GLOSSBRENNER SO TDCJ UTMB 340B WAC WAC GOODMAN GG TDCJ UTMB 340B WAC WAC GOREE GR TDCJ UTMB 340B WAC WAC GURNEY ND TDCJ UTMB 340B WAC WAC HALBERT BB TDCJ UTMB 340B WAC WAC HAMILTON JH TDCJ UTMB 340B WAC WAC HAVINS TH TDCJ Texas Tech WAC WAC WAC HENLEY LT TDCJ UTMB 340B WAC WAC HIGHTOWER HI TDCJ UTMB 340B WAC WAC HILLTOP HT TDCJ UTMB 340B WAC WAC HOBBY HB TDCJ UTMB 340B WAC WAC HODGE HD TDCJ UTMB 340B WAC WAC HOLLIDAY NF TDCJ UTMB 340B WAC WAC HOSPITAL GALVESTON HG TDCJ UTMB 340B Not applicable Not applicable 1 HUGHES AH TDCJ UTMB 340B WAC WAC HUNTSVILLE HV TDCJ UTMB 340B WAC WAC

22 Unit Unit Code Customer University Patient Pricing Health Care Staff Pricing Officer Pricing Huntsville Memorial Hospital HH TDCJ Not applicable Not applicable HUTCHINS HJ TDCJ UTMB 340B WAC WAC JESTER I J1 TDCJ UTMB 340B WAC WAC JESTER III J3 TDCJ UTMB 340B WAC WAC JESTER IV J4 TDCJ UTMB 340B WAC WAC JOHNSTON JT TDCJ UTMB 340B WAC WAC JORDAN JN TDCJ Texas Tech WAC WAC WAC KEGAN HM TDCJ UTMB 340B WAC WAC KYLE KY TDCJ UTMB 340B WAC WAC LEBLANC BA TDCJ UTMB 340B WAC WAC LEWIS GL TDCJ UTMB 340B WAC WAC LINDSEY LN TDCJ UTMB 340B WAC WAC LOCKHART LC TDCJ UTMB 340B WAC WAC LOPEZ RL TDCJ UTMB 340B WAC WAC LUTHER P2 TDCJ UTMB 340B WAC WAC LYNAUGH LH TDCJ Texas Tech WAC WAC WAC LYNCHNER AJ TDCJ UTMB 340B WAC WAC MARLIN N1 TDCJ UTMB 340B WAC WAC MCCONNELL ML TDCJ UTMB 340B WAC WAC WAC

23 Unit Unit Code Customer University Patient Pricing Health Care Staff Pricing Officer Pricing MICHAEL MI TDCJ UTMB 340B WAC WAC MIDDLETON NE TDCJ Texas Tech WAC WAC WAC MONTFORD JM TDCJ Texas Tech WAC WAC WAC MONTFORD RMF HP TDCJ Texas Tech WAC WAC WAC MT.VIEW MV TDCJ UTMB 340B WAC WAC MURRAY LM TDCJ UTMB 340B WAC WAC NEAL KN TDCJ Texas Tech WAC WAC WAC NEY HF TDCJ UTMB 340B WAC WAC PACK P1 TDCJ UTMB 340B WAC WAC PLANE LJ TDCJ UTMB 340B WAC WAC POLUNSKY TL TDCJ UTMB 340B WAC WAC POWLEDGE B2 TDCJ UTMB 340B WAC WAC RAMSEY R1 TDCJ UTMB 340B WAC WAC ROACH RH TDCJ Texas Tech WAC WAC WAC ROACH CAMPS C1 TDCJ Texas Tech WAC WAC WAC ROBERTSON RB TDCJ Texas Tech WAC WAC WAC RUDD RD TDCJ Texas Tech WAC WAC WAC SAN SABA N2 TDCJ UTMB 340B WAC WAC

24 Unit Unit Code Customer University Patient Pricing Health Care Staff Pricing Officer Pricing SANCHEZ RZ TDCJ Texas Tech WAC WAC WAC SAYLE SY TDCJ Texas Tech WAC WAC WAC SCOTT RV TDCJ UTMB 340B WAC WAC SEGOVIA EN TDCJ UTMB 340B WAC WAC SKYVIEW SV TDCJ UTMB 340B WAC WAC SMITH SM TDCJ Texas Tech WAC WAC WAC STEVENSON SB TDCJ UTMB 340B WAC WAC STILES ST TDCJ UTMB 340B WAC WAC STRINGFELLOW R2 TDCJ UTMB 340B WAC WAC TELFORD TO TDCJ UTMB 340B WAC WAC TERRELL R3 TDCJ UTMB 340B WAC WAC TORRES TE TDCJ UTMB 340B WAC WAC TRAVIS TI TDCJ UTMB 340B WAC WAC TULIA N3 TDCJ Texas Tech WAC WAC WAC VANCE J2 TDCJ UTMB 340B WAC WAC WALLACE WL TDCJ Texas Tech WAC WAC WAC WARE DW TDCJ Texas Tech WAC WAC WAC WHEELER WR TDCJ Texas Tech WAC WAC WAC

25 Unit Unit Code Customer University Patient Pricing Health Care Staff Pricing Officer Pricing WILDERNESS 3 W3 TDCJ Texas Tech WAC WAC WAC WILLACY WI TDCJ UTMB 340B WAC WAC WOODMAN WM TDCJ UTMB 340B WAC WAC WYNNE WY TDCJ UTMB 340B WAC WAC YOUNG GC TDCJ UTMB 340B WAC WAC Ayres AY TJJD UTMB 340B WAC WAC Beto BE TJJD UTMB 340B WAC WAC Brownwood Halfway House H2 TJJD UTMB WAC WAC WAC Corsicana CS TJJD UTMB 340B WAC WAC Cottrell CT TJJD UTMB 340B WAC WAC Evins EV TJJD UTMB 340B WAC WAC Gainsville GA TJJD UTMB 340B WAC WAC Giddings GI TJJD UTMB 340B WAC WAC McFadden Ranch MC TJJD UTMB 340B WAC WAC McLennan MN TJJD UTMB 340B WAC WAC Ron Jackson I BS TJJD UTMB 340B WAC WAC Schaeffer SC TJJD UTMB 340B WAC WAC Tamayo VA TJJD UTMB 340B WAC WAC Willoughby WH TJJD UTMB 340B WAC WAC

26 Unit Unit Code Customer University Patient Pricing Health Care Staff Pricing Officer Pricing York YO TJJD UTMB 340B WAC WAC Galveston Teen Center UTMB WAC Not applicable Not applicable Bridgeport PPT T1 MTC UTMB WAC WAC Not applicable East Texas Treatment XQ MTC UTMB WAC WAC Not applicable South Texas ISF XM MTC UTMB WAC WAC Not applicable West Texas ISF Burnet Co. Jail El Paso Co. Jail Annex El Paso Co. Detention Facility Comal Co. Jail XN A1 A2 A3 A4 MTC UTMB WAC WAC Not applicable Burnet Co. Jail El Paso Co. Jail El Paso Co. Jail Comal Co. Jail UTMB WAC WAC Not applicable UTMB WAC WAC Not applicable UTMB WAC WAC Not applicable UTMB WAC WAC Not applicable 1 HG officers go to Young for vaccines and Postexposure prophylaxis