Transcription

What, When and Why:Designing a 340B Self-AuditProgramTony Zappa, Pharm.D., MBAVice President, Visante Inc. 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com1

Agenda 340B Compliance Requirements: What DoesHRSA Expect? Components and Best PracJces of Self-AuditPrograms Key Take-aways Q&A 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Disclosures and Caveats Opinions stated are from Visante and myselfand are not official I am not a lawyer and am not offering legaladvice or opinion Always check with your aWorneys, Apexus orHRSA before making any changes that couldimpact your programs’ eligibility, complianceor performance 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

340B Compliance Requirements:What Does HRSA Expect? 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

340B Compliance Requirements Every covered entity isresponsible for programcompliance– Cannot be outsourced to auditfirms or 340B administratorsProgram Compliance HRSA looks for 3 things– Eligibility RegistrationP&PsContractsEligibilityDiversion– Diversion Ineligible patients– Duplicate Discounts Medicaid exclusion 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.comDuplicateDiscounts

What Does HRSA Expect? Keep 340B database informaJon accurate and up to date– Register new outpaJent faciliJes and contract pharmacies asthey are addedRecerJfy eligibility every yearPrevent duplicate discounts (Medicaid Exclusion File)Prevent diversion to ineligible paJentsPrepare for program audits. Maintain auditable recordsdocumenJng compliance with 340B Program requirements Stop purchasing covered outpaJent drugs from GPOs (DSHs,CANs, and PEDs) NoJfy suppliers that outpaJent drug purchases will now bemade at 340B prices 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

What Does HRSA Expect? Independent audits are “expected,” not required– SenJnel effect of HRSA’s audits has moved mostenJJes to implement an audit program RouJne self-audits are also expected––––What should this include?When should tasks be done? By whom?Who should provide oversight?How are correcJve acJon plans created, implementedand managed? And communicated! 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

What’s Coming in the OmnibusGuidance? Contract pharmacy oversight– “The covered enJty is expected to conduct quarterlyreviews and annual independent audits of eachcontract pharmacy locaJon; the results of thesereviews are included in the records’ requirements ofsecJon 340B(a)(5)(C) of the PHSA. Any 340B ProgramviolaJon detected through quarterly reviews or annualaudits of a contract pharmacy should be disclosed toHHS. Covered enJJes are subject to the applicablepenalJes for instances of duplicate discounts anddiversion.” 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

What’s Coming in the OmnibusGuidance? Maintenance of Auditable Records– “A covered enJty must maintain auditable recordsdemonstraJng compliance with all 340B Programrequirements for itself, any child site, and any contractpharmacy for 5 years from the date the 340B drug wasordered or prescribed, regardless of whether theenJty conJnues to parJcipate in the 340B Program.Ifan enJty, any child site, or any contract pharmacyterminates its 340B Program parJcipaJon, an enJtymust maintain applicable auditable records for 5 yearsaeer the date of terminaJon.” 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

What’s Coming in the OmnibusGuidance? Annual RecerJficaJon– “In order to conJnue to be listed as an eligiblecovered enJty and purchase 340B drugs, acovered enJty annually recerJfies that thecovered enJty, its child sites, and its contractpharmacy arrangements meet all 340B Programeligibility and compliance requirements. ThisrecerJficaJon shall be carried out in a manner andJme frame specified by HHS.” 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

How is Compliance Enforced? Audits by HRSA/OPA– PermiWed in the original legislaJon, implemented in 2011 Audits by manufacturers– Must demonstrate reasonable cause and get HRSA’s prior approval– Manufacturers can only audit for compliance with paJent definiJon and theduplicate discount prohibiJon Annual recerJficaJon process– Authorizing officials must aWest to full compliance during recerJficaJon,including compliance at contract pharmacies PenalJes– Failure to comply with the program’s anJ-diversion and duplicate discountprovisions: forfeiture of discounts– If knowing and intenJonal: interest on the discounts that they refund– If systemaJc and egregious as well as knowing and intenJonal: disqualifica9onthe program “for a reasonable 9me,” to be determined by HRSA 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Components and Best PracJcesof Self-Audit Programs 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Components and Best Practices Create a 340B program governing council– Pharmacy operaJons (represenJng in-clinic andretail distribuJon)– Finance– IT/IS– Reimbursement– Legal– Compliance– Senior leadership 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Components and Best Practices Provide comprehensive training to all 340Bprogram staff, with at least annual refreshers(parJcularly on compliance topics)– Consider short tests to gauge comprehension– Consider sending all key staff to 340B Universityannually Updates and networking opportuniJes 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Components and Best Practices Develop and document wriWen policies and proceduresfor all 340B-related topicsProgram governancePaJent definiJonGPO prohibiJonDuplicate discount prevenJon (including Medicaid carvein/carve-out)– Inventory management– Systems maintenance– Compliance reviews and self-audit tasks–––– DefiniJon of a material breach– Use of 340B savings 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Components and Best Practices Ensure that ALL systems used for 340Bprogram management are conJnuouslymaintained– Splimng soeware, inventory management,contract pharmacy administraJon, billing systems,EMRs, dispensing systems Ensure that ALL records needed for audit arereadily available– Including from outside vendors 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

What are “Auditable Records?” Any documentationrelated to eligibility,registration and drugpurchases of/by:– Covered entity– Child sites– Contract pharmaciesExamples Medicare Cost Report orNoJce of Grant Award Contract with government toprovide services Contract pharmacyagreements Purchasing records (340Band non-340B) P&Ps regardingprocurement, GPO exclusion,contract pharmacy,compliance, etc. 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Components and Best Practices Review and update HRSA database records––––EnJty informaJonChild sitesAuthorizing officials and primary contactsContract pharmacies LocaJons Start and terminaJon dates Confirm you have actual contracts! 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Components and Best Practices Develop and implement good methods for self-audit– Establish controls for all systems and operaJons, with allowedvariances– RouJne reviews of 340B transacJons and prescripJons usingreasonable samples– RouJne eligibility reviews of providers, sites, pharmacies Including pharmacy volumes/uJlizaJon– Periodically visit contract pharmacy locaJons to check signaturelogs, inventory and dispensing pracJces– Periodically check contracts and agreements for validity andcompleteness– Document, document, document Obtain an independent audit at least annually 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Components and Best Practices Establish procedures to design and implementcorrecJve acJon plans– When they’re needed– Who will manage them– Who oversees them ConJnuously monitor and review 340B programchanges– HRSA/OPA– Apexus– Peer-to-peer 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Suggested Schedule: HospitalsAt Least AnnuallyAt Least QuarterlyAt Least Monthlyprogram HRSA databaseProvider file review Governance entries Policies and Transaction reviewsproceduresMedicare cost reportMixed-use Contract pharmacychild site listingContract Pharmacy agreements Orphan drug usage (if - GPO exclusionLow income serviceapplicable)Employee Rxs provision-Split-billerset-up DisproportionateNDC changes sharepercentageCharge masterchanges Medicaid status andexclusion file 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Suggested Schedule: Non-HospitalsAt Least AnnuallyAt Least QuarterlyAt Least Monthlyprogram HRSA databaseProvider file review Governance entries Policies and Transaction reviewsproceduresInventoryClinic-administered Contract pharmacyreconciliation (if usingmedications agreementsphysical inventory- Contract Pharmacyof Grant Awardmodel)Employee Rxs Notice- Scope of grantMedicaid status and exclusionfile 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Self-Disclosure Process Establish and document criteria that signify when a material breach of compliance has occurredFor situaJons that are a material breach, inform HRSA while correcJng the issue. Include thefollowing informaJon:––340B IDthe violaJon that occurred and scope––a correcJve acJon plan (CAP) to fix the problem moving forwarda strategy to inform affected manufactures (if applicable)–a plan for financial remedy if repayment is owed Work out any necessary financial remedy with manufacturer(s) in good faith HRSA reviews self-disclosure, including: –violaJon informaJon––CAP, ensuring that it fully addresses issues causing the violaJonrepayment plan and/or compleJon of plan–compleJon of contact to all affected manufacturersHRSA closes self-disclosure–When all criteria are met, HRSA sends wriWen communicaJon that the maWer is closed 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Self-Disclosure Best Practices Use ReporJng Tool–The 340B Prime Vendor Program has worked with HRSA, covered enJJes, and manufacturersto develop a suggested tool for the self-disclosure process. a sample leWer to HRSA,a list of Jps when contacJng manufacturers, a format for summarizing non-compliance,a template for a CorrecJve AcJon Plan (CAP), and Jps directly from manufacturers on the best ways to resolve issues quickly and completely Provide Detailed InformaJon to all Stakeholders Covered enJJes should provide an immediate remedy to correct the materialbreach, propose a plan for periodic assessment and conJnuous monitoring, andoutline a clear method to determine when the CAP is completed. Successfulcovered enJJes have also rouJnely idenJfied an implementaJon date, enJtycontact person, and clarified an internal 340B communicaJon/educaJon strategy. 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Key Take-Aways 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Key Takeaways Be confident in your paJent definiJon, 340B usage, and ability toprevent diversion and duplicate discounts Be prepared with wriWen, comprehensive 340B program policiesand procedures, including 340B program compliance Ensure that all records necessary to audit compliance are readilyaccessible to program leaders across the organizaJon and outsideauditors Conduct regular self-audits to idenJfy areas of weakness andimplement correcJons to any errors or oversights– Consider the use of a mock-audit tool and centralized documentaJonsystem Obtain an annual independent audit, and consider quarterly auditassistance 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

QuesJons and Discussion 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

For More InformaJon:Tony [email protected] 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com

Be confident in your paent definiJon, 340B usage, and ability to prevent diversion and duplicate discounts Be prepared with wriWen, comprehensive 340B program policies and procedures, including 340B program compliance Ensure that all records n