340B HRSA Self-Audit Checklist Using eAuditor

340B HRSA Self-Audit Checklist – Maintain Compliance. Build Confidence. Protect Your 340B Program.

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🔍 Introduction

Running a 340B Drug Pricing Program isn’t easy. Between patient eligibility rules, contract pharmacy oversight, and HRSA compliance expectations, you’ve got a lot on your plate. That’s where self-audits come in.

Think of a self-audit as a dress rehearsal before the real show. It helps you catch mistakes, fix issues, and prove that your program is in control. And when you use a digital platform like eAuditor, you not only stay organized—you build a compliance culture that stands up to HRSA scrutiny.

This guide walks you through a detailed 340B HRSA Self-Audit Checklist using eAuditor. We’ll explain each section, share real-life examples, and include tips from the field to help you humanize compliance.

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🛠️ Why Use eAuditor for 340B Self-Audits?

Let’s start with the “why.” Most covered entities juggle spreadsheets, folders, emails, and PDFs when auditing. Things slip through. eAuditor solves this by:

• Centralizing documents and evidence

• Creating customizable templates for repeat audits

• Assigning action items to staff

• Tracking corrective actions automatically

• Generating clean, exportable reports for HRSA

In short, it keeps your team aligned, accountable, and audit-ready.

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✅ 340B HRSA Self-Audit Checklist with eAuditor

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1. Program Eligibility Verification

Checklist:

• Confirm OPAIS registration is current.

• Ensure all child sites and contract pharmacies are listed.

• Review Medicare cost report to validate eligibility.

• Document most recent HRSA recertification.

eAuditor Tip: Upload screenshots of your OPAIS listing. Link it to a task that repeats annually with a deadline reminder.

Anecdote: At a rural health center in Georgia, the compliance officer realized during a self-audit that a satellite clinic wasn’t listed on OPAIS. They corrected it in time before a real HRSA audit flagged it.

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2. Patient Eligibility Review

Checklist:

• Confirm that prescriptions originate from a valid patient encounter.

• Validate that the patient received services from a qualified provider.

• Check that the patient had an established relationship with the covered entity.

Use Case: Select 20 claims each quarter. Upload EMR notes and tie each to a patient eligibility 340B HRSA Self-Audit checklist in eAuditor.

Real Example: A CHC in Michigan discovered that a locum tenens physician wrote scripts outside the clinic’s system. Those claims were disqualified. Self-audits helped them revise their onboarding process.

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3. Prescriber Eligibility Audit

Checklist:

• Ensure prescribers are employed or contracted by the entity.

• Confirm that prescriptions are written within the scope of service.

• Maintain a current provider roster.

eAuditor Workflow: Create a provider roster checklist. Link contract PDFs, credentialing documents, and a timeline for quarterly updates.

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4. Duplicate Discount Prevention

Checklist:

• Confirm Medicaid carve-in/carve-out status.

• Review Medicaid claims for 340B flagging accuracy.

• Ensure coordination with state Medicaid billing rules.

Quick Tip: Add a section in eAuditor titled “Medicaid Billing Risk” with yes/no validations and flag anything questionable.

Human Moment: A compliance tech once shared that their audit uncovered 340B-tagged prescriptions being billed to Medicaid because of a TPA flagging error. Fixing it avoided thousands in potential rebate clawbacks.

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5. Diversion Controls

Checklist:

• Make sure only eligible patients receive 340B drugs.

• Review dispensing logs against patient encounter records.

• Confirm prescribing location matches covered site.

Case Example: One hospital’s outpatient cancer clinic mistakenly dispensed a 340B drug to an inpatient due to a charting error. Their self-audit policy caught it, preventing a pattern from developing.

Pro Tip: Link 5-10 prescription claims in eAuditor and tag the corresponding patient encounters. If they don’t match, mark it for corrective action.

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6. Inventory Reconciliation

Checklist:

• Confirm purchase records align with dispense records.

• Review replenishment logic used by TPA or inventory system.

• Ensure separation of 340B, GPO, and WAC accounts.

Use eAuditor To: Create a monthly inventory spot-check task. Assign pharmacy techs to upload wholesaler invoices and dispensing logs.

In Practice: A pharmacist in Oregon shared how their manual records often missed WAC purchases labeled as 340B. With eAuditor, they now flag any mismatch in real time.

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7. Contract Pharmacy Oversight

Checklist:

• Verify contract pharmacy registration in OPAIS.

• Review one claim per week per pharmacy for eligibility.

• Check for diversion or duplicate discounts.

• Ensure audit rights are enforced.

eAuditor Use: Schedule recurring pharmacy audits. Upload audit reports. Assign follow-ups if issues appear.

Lesson Learned: A nonprofit health center discovered that one of their three contract pharmacies had no way of flagging Medicaid MCO claims. They paused dispensing, rewrote the contract, and resumed operations after full review.

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8. TPA & System Configuration Audit

Checklist:

• Confirm logic for 340B claim qualification.

• Review system settings for each payer type.

• Check how TPA manages real-time claim evaluation.

Example in Action: Use eAuditor to review and log settings quarterly. If logic changes, document who approved it and why.

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9. Policy & Training Validation

Checklist:

• Review 340B policies for accuracy and alignment with practice.

• Confirm policy review date is within the past year.

• Validate staff completion of 340B training.

eAuditor Advantage: Track staff acknowledgment of policies. Upload training materials and collect digital sign-offs.

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10. Corrective Actions & Documentation

Checklist:

• Log all findings from the audit.

• Assign corrective actions with due dates.

• Monitor completion and retest where needed.

Pro Tip: Use eAuditor’s “Action Items” tab to assign tasks. Mark items resolved and store evidence. Run a summary report for HRSA prep.

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🧾 Final Thoughts

Self-audits aren’t just checkboxes—they’re your shield against program risk. When you use eAuditor, you don’t just document. You build a compliance rhythm that’s repeatable, reliable, and ready for review.

Remember: Mistakes aren’t failures. Failing to catch them is.

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💬 Bonus Tip from the Field

“We used to dread audits. Now, we look forward to them. eAuditor helped us turn compliance into confidence.”
— Compliance Coordinator, Federally Qualified Health Center, Texas

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