340B Audit OS

Q2How many separate 340B covered entity IDs (parent 340B IDs) are in scope for this engagement?

12–34–78 or more

Q4How many in-house outpatient pharmacies dispense 340B drugs for your program?

012–34 or more

Q6Does your program use both in-house and contract pharmacies to dispense 340B drugs?

Yes — both in-house and contractNo — in-house onlyNo — contract pharmacy onlyNot sure

Q7What is your Medicaid billing approach for 340B drugs?

Carve-out (Medicaid claims excluded from 340B)Carve-in (Medicaid claims included in 340B)Mixed — varies by site or payerNot sure / varies

Q8Does your Medicaid carve-in/carve-out approach vary across different sites or pharmacies?

Yes — different rules at different sitesNo — consistent across all sitesNot sure

Q9Have you experienced manufacturer restrictions or disputes related to contract pharmacy ESP (Enforcement Strategy Programs) in the last 24 months?

Yes — active restrictions from one or more manufacturersYes — resolved but had restrictionsNo manufacturer restrictionsNot sure

Q10Has your program received any adverse findings, corrective action plans (CAPs), or repayment demands from HRSA in the last 5 years?

Q11Has your program been subject to a whistleblower complaint, manufacturer audit, or OIG inquiry in the last 3 years?

Yes — currently activeYes — resolvedNoNot sure

Q12Which of the following major operational changes has your program experienced in the last 18 months? (Select all that apply)Select all that apply

New child sites addedNew contract pharmacies addedEHR or billing system migrationNew 340B coordinator or key staff changeSignificant growth in 340B-eligible patient volumeNone of the above

Q13When were your 340B policies and procedures last reviewed and updated?

Q14If HRSA sent you a Data Request List (DRL) today, how ready is your documentation?

Very ready — all documents organized and currentMostly ready — minor gapsSomewhat ready — significant gapsNot ready — would need weeks to compileNot sure

Q15What best describes what you're looking for?

One-time mock audit before an expected or received HRSA notificationAnnual mock audit as part of our ongoing compliance programMulti-year recurring readiness programJust a quick readiness assessment to identify our biggest gapsNot sure yet

Can we run your mock audit?

Six quick questions to confirm your organization can provide the core materials needed. These don't affect your complexity score.

Q16Can your team provide a transaction-level export for your 340B activity?

The list of 340B drug transactions your TPA or split-billing software produces.

Yes — we can export this from our TPA or split-billing softwareLikely — we would need to check with our TPA or IT teamNot sureNo — we don't have a TPA or can't export this

Q17Can your team provide a current provider list for your 340B program?

Prescribers authorized to write 340B prescriptions, with NPIs and employment dates.

Yes — we have a current rosterLikely — we would need to compile it from credentialing or HRNot sureNo — we don't maintain a formal provider roster

Q18Can your team provide OPAIS registration details and Medicaid carve-in/out information?

OPAIS is the HRSA 340B registration portal. Carve-in/out is whether you bill Medicaid for 340B drugs.

Yes — we have OPAIS access and know our carve statusLikely — our 340B coordinator handles thisNot sureNo — we don't have OPAIS access or aren't sure

Q19Do you have current 340B policies and procedures available for review?

Written 340B policies covering diversion prevention, duplicate discount prevention, and self-disclosure.

Yes — written P&Ps reviewed within the last 2 yearsPartially — some policies exist but may need updatingNot sureNo — we don't have formal written 340B policies

Q20If you use contract pharmacies, can you provide agreements and oversight records?

Signed contracts with each pharmacy plus independent audit reports.

Yes — we have agreements and recent audit reportsPartially — we have some but may be missing itemsWe don't use contract pharmaciesNot sure

Q21Is there at least one person who can help gather files from pharmacy, billing, compliance, or IT?

Having internal support significantly speeds document gathering.

Yes — we have people available across relevant departmentsLimited — small team but we can manageNo — I would be doing this alone

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