Covered Entity 340B Contract Pharmacy Audit Protocol

Transcription

1 2018 Contract Diversion Duplicate Name and Title Signature Pharmacy Audit Discount Eligibility Audit Audit January February March April May June July August September October November December *insert date, name and title, and sign each time an audit is conducted 1

2 Covered Entity 340B Contract Pharmacy Audit Protocol Eligibility Self-Audit Tool 1. Entity s name 2. Entity s 340B ID Covered Entity & Contract Pharmacy Information 3. Name of the contract pharmacy organization(s) (not locations) being audited. 4. Date of the LAST self-audit. 5. Date of THIS self-audit. 6. Name and title of individual completing THIS self-audit. 7. Summary of results: Note areas for improvement identified 2

3 Covered Entity 340B Contract Pharmacy Audit Protocol Instructions: Covered entities are encouraged to complete this tool quarterly for each contract pharmacy service organization. Proceed through the steps as follows: 1. Identify the staff member to complete this self-audit tool. 2. Identity and collect relevant data. a. Contract pharmacy utilization report (from contract pharmacy or vendor) to identify which contract pharmacy locations are providing 340B drugs to the covered entity s patients b. Covered entity s HRSA 340B Database record from c. Contract pharmacy service agreement(s) 3. Complete Table 1 and answer assessment questions. 4. Complete the Summary of Results. a. This section is a brief summarizing statement of the self-audit results for senior leadership and other key 340B stakeholders. 5. Review the results with the 340B Steering Committee (or other compliance oversight committee) 3

4 CONTRACT PHARMACY LOCATION VERIFICATION Table 1 List the name and store number of each contract pharmacy location used by the covered entity in column 1. List the address of each contract pharmacy location used by the covered entity in column 2. List the covered entity 340B IDs served by the contract pharmacy location in column 3. Compare the information in columns 1 3 with the executed contract pharmacy service agreements and the covered entity s HRSA 340B Database records to complete columns 4 6. Name, Store # of each Address of each location 340B IDs served at Are all contract Is the pharmacy Does the address on contract pharmacy Pharmacy pharmacy locations registered on the the database match location listed in the HRSA 340B the agreement? agreement? database? 4

5 Covered Entity 340B Contract Pharmacy Audit Protocol Diversion Self-Audit Tool 1. Entity s name 3. Entity s 340B ID Covered Entity & Contract Pharmacy Information 4. Name of the contract pharmacy organization(s) (not locations) being audited. 5. Date of the LAST self-audit. 6. Date of THIS self-audit. 7. Name and title of individual completing THIS self-audit. 8. Summary of results: Note areas for improvement identified 5

6 Covered Entity 340B Contract Pharmacy Audit Protocol Instructions: Covered entities are encouraged to complete this tool monthly for each contract pharmacy service organization. Proceed through the steps as follows: 1. Identify the staff member to complete this self-audit tool. 2. Identify and collect relevant data for the most recent 3-month period, as follows: a. List of eligible covered entity locations (clinics/departments/service units) b. List of eligible providers c. Proof of provider eligibility (contract/employment records, referral for consultation) d. Patients health care records e. Contract pharmacy 340B purchasing invoice f. 340B dispensing records (including signature capture records) g. NDC crosswalk (for virtual inventory) h. Pharmacy accumulation report (for virtual inventory) i. Pharmacy inventory report (for physical inventory) j. For grantee: grant that qualifies the grantee to participate in the 340B Program 3. Select audit samples a. Select 20 contract pharmacy invoices, as follows: 10 invoices with the highest volume (number of lines) and 10 invoices with the highest total cost. b. Randomly select 20 different drugs from the 340B purchasing invoices identified in step 3a (recommend one per invoice). c. Randomly select 1 dispensation for each of the 20 different drugs identified in step 3b. d. Randomly select 5 prescriptions returned to stock (not picked up) from contract pharmacy dispensing records. 4. Complete Tables 1 through 4 and answer the corresponding assessment questions. 5. Complete the Summary of Results. a. This section is a brief summarizing statement of the self-audit results for senior leadership and other key 340B stakeholders. 6. Review the results with the 340B Steering Committee (or other compliance oversight committee) 6

7 PATIENT ELIGIBILITY VERIFICATION Table 1 For each of the 20 prescriptions selected in step 3c of instructions and for the date range selected in step 2 of instructions, verify patient eligibility by validating the contract pharmacy dispensing record against the entity s health care record. Validate that the prescription is the result of a health care service provided to a covered entity patient at an eligible site by an eligible provider such that the covered entity documents its responsibility for care in its health care record. Contract Rx# Date Is the location Is the provider If otherwise Is there a Does it match the Is the Rx from a Pharmacy filled where the employed, related, is there a prescription in the information service within the Location prescription was contracted or documented patient records? provided by the scope of the written registered otherwise related referral in the contract grant? with OPA? to the Covered patient record? pharmacy? Entity? 7

8 Contract Rx# Date Is the location Is the provider If otherwise Is there a Does it match the Is the Rx from a Pharmacy filled where the employed, related, is there a prescription in the information service within the Location prescription was contracted or documented patient records? provided by the scope of the written registered otherwise related referral and contract grant? with OPA? to the Covered referral visit pharmacy? Entity? summary in the patient record? 8

9 INVENTORY PURCHASE AND DISPENSATION RECONCILIATION Table 2 For each of the 20 drug audit samples selected in step 3b of the instructions and for the date range selected in step 2 of the instructions, use purchasing, dispensing, and inventory records to reconcile inventory units. Note that inventory units refers to either the number of units in stock (actually on the shelves if using physical inventory) or number of units in the accumulator (if using virtual replenishment). Any identified variance will need to be resolved and documented to demonstrate that the 340B drug was not diverted. Drug name NDC Date Beginning (-) less (+) plus (=) equals Reconciled Variance For physical inventory: For physical inventory: and strength inventory dispensed purchased ending? resolved? does one of the are 340B drugs on the units units units inventory wholesaler packing slip shelves identifiable or units match the actual isolated from non-340b invoice? drugs? 9

10 VIRTUAL INVENTORY ACCUMULATION AND REPLENISHMENT RECONCILIATION Table 3 Randomly select one (1) day of accumulations for each of the 20 drugs selected in step 3b of the instructions. Use the NDC crosswalk and pharmacy accumulation report to ensure that the accumulation and replenishment process uses an exact 11- digit NDC match for each drug. Sample ID Accumulation Date of accumulation Drug NDC quantity NDC billed NDC and quantity NDC and quantity received match identifier as it matches quantity matches NDC ordered match drug NDC drug NDC and quantity ordered? related to accumulated? accumulated? and quantity from prescription accumulator? number or dispensation tracking number 10

11 RETURN TO STOCK VERIFICATION Table 4 For each of the 5 prescriptions selected in step 3d of the instructions, verify that the accumulator or physical on-hand amount was manually adjusted to reflect the return of inventory to stock. TABLE 4 Return to Stock Process Verification Table Time period tested: begin date to end date (attach data to substantiate inventory adjustment for each sample) Prescription # Date filled Date returned to stock Manual adjustment of accumulator or physical onhand amount? YES NO Date manual adjustment documented 11

12 Covered Entity 340B Contract Pharmacy Audit Protocol Duplicate Discount Self-Audit Tool 1. Entity s name 4. Entity s 340B ID Covered Entity & Contract Pharmacy Information 5. Name of the contract pharmacy organization(s) (not locations) being audited. 6. Date of the LAST self-audit. 7. Date of THIS self-audit. 8. Name and title of individual completing THIS self-audit. 9. Summary of results: Note areas for improvement identified 12

13 Covered Entity 340B Contract Pharmacy Audit Protocol Instructions: Covered entities are encouraged to complete this tool quarterly for each contract pharmacy organization. Proceed through the steps as follows: 1. Identify the staff member to complete this self-audit tool. 2. Identify and collect relevant data, as follows: a. Covered entity s 340B contract pharmacy Medicaid billing policies and procedures b. Contract pharmacy billing codes identifying Medicaid payers (e.g., BIN/PCN) c. Contract pharmacy accumulation report, if applicable d. Contract pharmacy dispensing records for the most recent 3-month period e. Communications with state Medicaid agency (if applicable) f. Any agreements/arrangements with state Medicaid programs for contract pharmacies billing with 340B drugs (if applicable) g. Contract pharmacy carve-in listing on HRSA 340B Database (if applicable) 3. Complete tables and answer corresponding assessment questions. 4. Complete the Summary of Results. a. This section is a brief summarizing statement of the self-audit results for senior leadership and other key 340B stakeholders. 5. Review the results with the 340B Steering Committee (or other compliance oversight committee). 13

14 CONTRACT PHARMACY CARVE-OUT MEDICAID BILLING ASSESSMENT Table 1 From the contract pharmacy dispensing records: Identify billing codes (e.g., BIN/PCN) used by the contract pharmacy to bill Medicaid claims. From the contract pharmacy dispensing records, select all prescriptions for the most recent 3-month period, including primary, secondary and tertiary billing codes. Sort report by billing codes. Verify that a Medicaid billing code is not a payer for any 340B drug. Contract Pharmacy Location Is a Medicaid billing code the payer for any 340B drug? 14

15 CONTRACT PHARMACY CARVE-IN VERIFICATION Table 2 List the name of each contract pharmacy location that carves in in column 1. Complete columns 2 and 3. Validate the contract pharmacy location s carve-in listing on the HRSA 340B Database to complete column 4. TABLE 1 Contract Pharmacy Carve-In Verification Table Date documented: (Attach data to substantiate each contract pharmacy location) Contract pharmacy name and store # State Medicaid billing policy available? Documented arrangement with all applicable state Medicaid agencies to prevent duplicate discounts? Listed with a Carve-In Effective Date in HRSA 340B Database? 15

16 CONTRACT PHARMACY CARVE-IN MEDICAID BILLING ASSESSMENT Table 2 Identify billing codes (e.g., BIN/PCN) used by the contract pharmacy to bill Medicaid claims. From the most recent 3-month contract pharmacy period of pharmacy dispensing records (including primary, secondary, and tertiary billing codes) randomly select 20 prescriptions for which Medicaid was the payer. Complete columns 1 through 5. Verify that the Medicaid carve-in practice matches the arrangement on file with HRSA and complete column 6. TABLE 2 Contract Pharmacy Carve-in Medicaid Billing Assessment Table Time period tested: begin date to end date (Attach actual data to substantiate Medicaid billing for each Rx#) Rx number or sample identifier Date filled 340B drug name NDC Insurance payer Covered entity/state Medicaid carve-in practice matches documented arrangement on file with HRSA? 16