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APPENDIX SIX:SELF-AUDIT TOOLSThis appendix contains tools that may be used by a health center in testing itscompliance with the 340B Program guidelines. In addition to the checklists andaudit guidance included in this appendix, additional audit tools are availablethrough 340B University .340B University (APEXUS)Apexus serves as the exclusive contractor for the 340B Drug PricingProgram. It is a verified source of 340B information with educationalservices including 340B University, 340B Tools, and other information ondemand and webinar offerings.340B University /340b-u-ondemandThis is an online education program designed to support compliance andintegrity for all 340B Program stakeholders. Topics include eligibility,registration, recertification, pricing, contract pharmacy, implementation,and audit preparedness.340B University Tool Guide“A Summary of Tools and lic/resourcecenter/340B Tool Guide.pdfThis guide provides a link to the most recent version of 340B University tools, as well as a short description of each tool.Vendors“340B Compliance Self-Assessment: Vendors”
center/340B Compliance SelfAssessment Vendors.pdfThis tool provides a series of questions which the entity can use to assesscompliance by contract pharmacy vendors.Material Breach“Defining Material Breach Documentation esourcecenter/EstablishingMaterial Breach Threshold.pdfThis is a one page tool that can be used to formulate internal policiesdefining a material breach and the action to take when a material breachis identified.Self-Assessment Policy“340B Compliance Self-Assessment: Policy – A Quick Self-Assessmentfor Community Health Center c/resourcecenter/CHC 340BCompliance SelfAssessment Policy.pdfThis tool provides a series of questions which the entity can use to assesscompliance by Community Health Centers.Self-Audit Process“340b Compliance Self-Assessment: Self-Audit Process – A Sample SelfAudit Process for Community Health c/resourcecenter/CHC 340BCompliance SelfAssessment DataTransactions.pdfThis tool provides a sample internal audit process for community healthleaders to conduct self-audits of their 340B Program operations.
Use of 340B Savings“340B Benefits and the Use of 340B Savings Documentation esourcecenter/340B Benefitand Use of 340B Savings.pdfThis tool provides guidance in documenting the use of 340B savings.Self-Audit ToolsThe following pages contain tools that can be used in conducting selfaudits of the 340B Program. Checklist for Review of the 340B Program Checklist for Review of Contract Pharmacy Agreement Example of Individual Prescription Testing
Checklist for Review of 340B ProgramIn addition to this checklist, complete Policy and Procedures manual checklist and Contract Pharmacy checklist.QuestionWho are the key employees associated with the 340B Program? Authorizing Official Primary Contact 340B Coordinator 340B Drug Purchasing Agent Contract Pharmacy Contacts Internal AuditorDoes the OPA 340B database contain accurate information regarding the AuthorizingOfficial, Primary Contact, and Contract Pharmacy contacts?Have key employees received initial training on the 340B Program and its requirements? Who received the training? When was the training? What was the form of training? Do key employees receive on-going training on the 340B Program and its requirements? Who received the training? When was the training? What was the form of training?How often are self-audits of the 340B Program conducted? When was the last self-audit? Was there a written report of findings? Who received the report? What corrective action taken to correct any issues identified?Are in house physical inventories used? If drugs are used for non-340B eligible patients, are there two separate physicalinventories? What safeguards are in place to ensure that the 340B inventory is only used foreligible patients?What types of contract pharmacy oversight activities take place? What reports are received monthly? Are reconciliations performed of 340B drugs ordered to 340B drugs dispensed?Do self-audits test for the following: Accurate information in OPA databaseoParentoChild sitesoContract pharmaciesoMedicaid carve-in/carve-out electionoRegistration dates DiversionoPatient eligibilityoPrescriber eligibilityoLocation eligibility Duplicate DiscountsoMedicaid compliant billingoInformation in Medicaid Exclusion FileoBilling of Medicaid and Medicaid MCO patients In-house pharmacy inventoriesoReconciliation of beginning inventory to endingoSteps to prevent diversionoSupport for 340B replenishment Contract Pharmacy ArrangementsoCompliance with Medicaid billingoPatient eligibilityoPrescriber eligibilityoLocation eligibilityoSupport for 340B replenishmentAre auditable records maintained for a minimum of 5 years? Copies of self-audits Copies of external 340B audits Pharmacy Service Agreements Patient records Invoices for 340B drugs purchased Reports of 340B drugs dispensed Inventory reconciliations Policy and Procedures manualResponseReference
Checklist for Review of Contract Pharmacy AgreementAudit Step1.2.3.Obtain a copy of the 340B OPA databaseregistration page for the FQHCObtain copy of Pharmacy ServicesAgreement(s)(i.e. contract pharmacy agreement)Compare database information to contract asfollows:a. Is signed contract date on or before the date ofthe OPA database registration date?b. Do the pharmacy name, location address, andcontact information per the contract agree withthe OPA database?c. Does the contract list each specific pharmacylocation address that is included in the 340BProgram?4.Audit ResponseCommentsCommon IssuesCan be found at:There must be a writtencontract between the coveredentity and the contractedpharmacy. Cannot locate contractA pharmacy cannot beregistered until the contract isfully executed.Demographic information andcontact information on OPAwebsite must agree tocontract.Contract must list all CHClocations that will be issuingprescriptions for filling at thatpharmacy site. Missing signatures Missing dates Does not agree Out of date contract New pharmacy location notadded to contractd. Is each specific pharmacy location addressdispensing 340B drugs under the contractregistered separately in the OPA database as acontract pharmacy?e. Is each health center location (parent and childsites) whose patients can use the specificcontract pharmacy listed in the pharmacycontract?f. Is contract pharmacy listed under parent site onthe OPA database if all patients of the healthcenter sites may utilize the pharmacy?Each pharmacy location mustbe registered separately.The contract must containlisting of all health center siteswhose patients can use thecontract pharmacy.All contract pharmacy locationsmust be listed under the parententity in order for ALL child sitepatients to use the pharmacy.If the pharmacy is listed underthe child site only, only patientsof that child site may use thecontract pharmacy. Contract not updated for newhealth center siteg. Is the pharmacy location (ship-toaddress) accurately listed in the OPAdatabase?h. If contract pharmacy is no longer used, isit listed as terminated in the OPAdatabase?The “ship to” address must bethe physical location of thepharmacy.If a contract pharmacy isterminated, OPA must benotified and the terminationdate will be noted in the OPAdatabase. P.O. Box used rather than streetaddressAre the following essential elements addressed inthe contract?a. Covered entity (CE) owns drugs and isbilled directly for drugs. (Ship to, bill to)b. Contract outlines responsibilities ofparties to provide comprehensivepharmacy services.c. Patient will be informed of freedom tochoose pharmacy provider.d. Regardless of services provided, accessto 340B pricing is only to eligible patients.e. Both parties will adhere to Federal, State,and local laws.f. Pharmacy must provide reportsconsistent with customary businesspractices.g. Contract pharmacy will establish andmaintain tracking system.h. Both parties will develop system to verifypatient eligibility.i. 340B drugs will not be dispensed toMedicaid patients without agreement withState Medicaid agency.j. Documentation must be available forindependent audits.k. Both parties understand they are subjectto audits by outside parties.l. Contract pharmacy services agreementwill be provided to OPA if requested. Location may be listed onlyunder child site Pharmacy no longer used butnot terminated in database
Examples of Internal Audit Findings
APPENDIX SIX: SELF-AUDIT TOOLS This appendix contains tools that may be used by a health center in testing its compliance with the 340B Program guidelines. In addition to the checklists and audit guidance included in this appendix, additional audit tools are available through 340B University . 340B University (APEXUS) Apexus serves as the exclusive contractor for the 340B Drug Pricing .
