340B Compliance and Optimization

340B consulting for covered entities, grantees, and contract pharmacy programs

Program reviews, HRSA audit readiness, and contract pharmacy oversight, led by an Apexus Advanced 340B Certified pharmacist who has run one of the larger 340B programs in the region and sat on the entity side of the table during audit.

Financial opportunity

The margin between the 340B price and what the payer actually reimburses.

Protected by compliance

Rewards the community

Reinvested in charity care, clinical staff, and the patients the program was built for.

What this covers

Engagements are scoped to entity type, size, and the specific exposure you are carrying. Covered entity or grantee, in-house or contract pharmacy.

Program review and self-assessment

A structured look at whether the program you are running is the program you are registered to run.

  • Eligibility, registration, and OPAIS record accuracy
  • Patient definition, provider scoping, and child site review
  • Policy, procedure, and oversight documentation
  • Grant alignment for grantee entities

HRSA audit readiness

A mock audit against the current protocol, run the way an auditor would run it, before anyone else does.

  • Mock audit and sampling against the current HRSA protocol
  • Documentation trail and evidence retrieval testing
  • Corrective action planning and self-disclosure posture
  • Board and executive briefing on residual exposure

Contract pharmacy and TPA oversight

Most leakage and most exposure live in the same place: the configuration nobody has reviewed since go-live.

  • TPA configuration and qualification logic review
  • Claim capture, true-up, and reconciliation testing
  • Vendor performance review and displacement analysis
  • Contract terms, fee structure, and audit rights

Mixed use, split billing, and duplicate discount

Get the accumulator wrong and you lose on compliance and margin at the same time, and usually nobody notices until an audit or a bad quarter forces the question.

  • Split-billing configuration and accumulator logic
  • GPO prohibition and carve-out design
  • Orphan drug exclusions where applicable
  • Medicaid exclusion file and duplicate discount prevention

Buy-and-bill and infusion capture

In most 340B programs, oncology and infusion carry the largest dollar volume, and that is also where capture most often breaks down.

  • NDC to HCPCS mapping and units reconciliation
  • Waste documentation and JW/JZ modifier capture
  • Replenishment triggers and inventory model review
  • Biosimilar and therapeutic conversion impact

Savings and margin analytics

What is leaking, what each gap costs on an annualized basis, and what it takes to close it.

  • Capture rate analysis by site, class, and payer
  • Program savings attribution and trend
  • Wholesaler and account structure review
  • Cost-of-inaction framing for executive and board audiences

What you get

Deliverables are short by design. The test is whether your team can run them after I leave.

Deliverables

  • Findings report with severity-ranked issues and the exposure attached to each
  • Prioritized 90-day fix list with a named owner per item
  • Policy and procedure redlines you can adopt directly
  • A self-audit cadence and checklist your team maintains after the engagement

When people call

  • A HRSA audit notice has landed, or a self-audit turned up something
  • A new contract pharmacy, TPA conversion, or wholesaler change is in flight
  • Finance is asking why program savings moved and pharmacy cannot fully answer
  • A child site, new clinic, or new service line needs to be registered correctly
  • Leadership changed and nobody currently owns the program end to end

Start with a 30-minute call

Bring the audit finding, the number that is not adding up, or the workflow that keeps stalling. If I can help I will tell you how. If I cannot, I will point you to someone who can.