340B covered entities with contract pharmacies

Your contract-pharmacy 340B claims, independently audited — and signed.

Connect your TPA accumulator and EHR encounter feed. We test every contract-pharmacy Audited Claim for diversion, duplicate discounts, and pricing exceptions, and return a Signed Independent Opinion — reviewed by an Apexus-certified 340B expert and a pharmacist reviewer. You stay the party of record to HRSA; your program stays defensible.

An independent 340B audit vendor — not a law firm, not your Contract Administrator. You remain the covered entity of record. Risk Scan is free on a sample of your claims.

$81.4B340B drug purchases in 2024 — up 23% in one yearDrug Channels / HRSA
200,000+contract-pharmacy arrangements across ~2,800 hospitalsHRSA / AHA
10×HRSA scrutinizes hospitals versus manufacturersGAO-26-108784
Annualindependent audit HRSA requires for contract-pharmacy entitiesHRSA FAQ / Apexus

What an unverified claim actually costs you

The covered entity — not the pharmacy, not the TPA, not the software vendor — is strictly accountable for every contract-pharmacy 340B claim. When a claim is wrong, four things can happen, and multi-TPA networks make each more likely.

The failures HRSA finds

Diversion. A 340B-priced drug reaches a patient who is not eligible under the entity's encounter relationship. Duplicate discounts. A 340B-priced claim also collects a Medicaid rebate because carve-in/carve-out status was never reconciled against the Medicaid Exclusion File.

Fatal exception — blocked from the opinion Diversion finding Duplicate-discount exception open Repayment demand or program removal

Now layer the current environment on top: the post-Genesis patient-definition ruling is contested, the rebate-model pilot was vacated in February 2026, and 13 states passed new contract-pharmacy access laws in 2025 alone. Health systems running multiple TPAs across sites routinely apply inconsistent eligibility logic — putting millions of dollars in compliance-critical savings at risk, while HRSA audits hospitals at 10× the rate of manufacturers.

What you get: the Audit Package

One outcome, priced per audit or per audited claim — never hourly. Every term below is the same word we use in the package, the FAQ, and the operating dossier.

Eligibility Match

Every Audited Claim matched to an eligible encounter and priced against NDC/WAC, with a rule citation on every determination — testing 100% of contract-pharmacy volume, not a sample.

Compliance Lint

Deterministic Medicaid Exclusion File, GPO-prohibition, carve-in/carve-out, and pricing checks run as code, so a fixable exception never becomes an HRSA finding.

Duplicate-Discount Reconciliation

Every discrepancy against the Medicaid Exclusion File identified and resolved the compliant way, with a documented resolution note before delivery.

Certified Review

An Apexus-certified 340B expert and a pharmacist reviewer clear every contested-eligibility and low-confidence claim before it enters the opinion.

Exception Register

Every flagged claim, the specific rule it failed, and the remediation — the record an HRSA examiner asks for first.

Recapture File

Legitimately eligible claims your TPA logic missed, ready to submit for savings — never a claim we invented to inflate the number.

How it works

Intake → Normalize → Match & Test → Compliance Lint → Certified Review & Sign → QA Reconcile → Deliver. Humans hold the one commitment a model must never fake: the certified sign-off.

1

Connect your feeds

Read-only TPA accumulator export, EHR encounter data, dispensing and purchasing records, and Medicaid carve-in status — into a secure, least-privilege intake under a signed data agreement.

2

We match & test

Every claim is matched to an encounter, priced against NDC/WAC, and tested against the Medicaid Exclusion File, GPO-prohibition, and sampling-integrity rules — no claim skipped, no volume sampled unless you choose it.

3

Compliance Lint runs

Deterministic rules run as code; every duplicate-discount discrepancy is drafted for resolution before it becomes a finding.

4

Certified Review clears the queue

An Apexus-certified expert and a pharmacist reviewer judge contested-eligibility and low-confidence claims — nothing auto-clears into the opinion.

5

We sign; you stay of record

The certified reviewer signs the Signed Independent Opinion within scope. You remain the covered entity of record to HRSA — we never certify on your behalf.

6

Deliver & defend

The Audit Package — opinion, Exception Register, Recapture File, audit trail — ships to your authorizing official, ready if an examiner asks for it.

Pricing

Priced per audit or per audited claim — anchored to the program-continuation risk you remove, never to labor hours. Never hourly; recapture-share only after legal review, never the sole model.

$0
Diversion & Duplicate-Discount Risk Scan
  • Sample of your contract-pharmacy claims reviewed
  • Your likely exception cohorts & recapture range, named
  • One sample Exception Register page
Start free
$12k–$35k
Contract-Pharmacy Eligibility Integrity Audit · per audit
  • Signed Independent Opinion on contract-pharmacy eligibility
  • Exception Register + Recapture File
  • 100%-of-volume testing, not sampled
  • Delivered in three weeks
Run a capped audit
$3k–$9k
Continuous-Integrity Subscription · per month, per entity
  • Ongoing eligibility & duplicate-discount monitoring
  • Always-audit-ready Exception Register
  • Reduces your next full-audit rate
Get a quote

Also: Full Annual Independent Audit at $25,000–$60,000 per entity/year (eligibility + diversion + duplicate-discount + GPO-prohibition + pricing scopes) · per-audited-claim add-on at $0.03–$0.12/claim for full-population testing · rush under two weeks, +$3,000–$8,000 per audit. Never hourly.

Examiner-Attributable-Finding Guarantee & out-clause

If HRSA issues a finding attributable to our testing on a claim we certified as clean, we re-audit the affected scope at no charge and credit your next audit. The Continuous-Integrity Subscription is month-to-month with 30-day notice — cancel anytime and keep every Audit Package already delivered. We do not guarantee any HRSA determination or program-continuation outcome; those belong to HRSA and your counsel. We never sell managed-services/TPA operation and an independent audit to the same entity for the same period — that would void the independence the opinion depends on.

Proof

We launched this desk recently. Rather than invent testimonials or numbers, we show you exactly where real results will appear as the first audits ship.

Fills when the first audits ship

Founding-cohort audit results

Examiner-defensible clearance rate, certified-reviewer minutes per audit, and dollars recaptured, from our founding entities.

Fills after the founding cohort

Named entity stories

Covered entities who moved from sampled hourly consulting to 100%-of-volume, certified-signed audits — with their permission and real figures.

Fills on first HRSA cycle

Clean-audit record

HRSA outcomes on serviced files as audit cycles complete — our target is zero examiner-attributable findings on audits we sign.

Questions program managers and compliance officers ask

Isn't this just what our TPA or capture software already does?
Software hosts the accumulator and flags anomalies for you to resolve; it cannot be your independent auditor because you operate it. HRSA requires an outside auditor for the annual independent audit. We sit on top of your data as the neutral, signed check — the finished outcome, not another login.
Do you certify or report to HRSA on our behalf?
No. You remain the covered entity of record and the party accountable to HRSA. We test, draft, and sign the independent audit opinion within our scope; you decide how and when to use it, including in any HRSA correspondence.
Can you also run our TPA or capture software?
No, by design. HRSA's independence requirement means an auditor cannot also operate the program it audits. We keep the independent-audit lane strictly separate from managed-services work and decline conflicted engagements.
How do you handle claim and encounter data?
Under a signed BAA/data-processing agreement, read-only feed access, encryption in transit and at rest, least-privilege role-based access, and full audit logs. Claims and encounter data are PHI; we treat them that way end to end.
What changed after the Genesis ruling and the vacated rebate-model pilot?
The patient-definition question is genuinely contested, and the rebate-model pilot was vacated in February 2026 with a new RFI open. We document our methodology against HRSA's currently stated position, flag contested cohorts rather than silently resolving them, and run a versioned rule pack we update as guidance changes.
Do you test every claim or just a sample?
The Contract-Pharmacy Eligibility Integrity Audit tests 100% of contract-pharmacy volume in scope by default — not a sample. A scoped sample is available where you choose it, with sampling-integrity validated against published sampling rules.
How fast is an audit?
A Signed Independent Opinion within three weeks of complete intake at launch, trending faster as the engine hardens. Rush under two weeks is available for an added per-audit fee.

Request a free Diversion & Duplicate-Discount Risk Scan

Tell us a little about your program. With your consent, we review a de-identified sample of your contract-pharmacy claims and send back your likely exception cohorts and an estimated recapture range — named — plus one sample Exception Register page. Next step is a capped Contract-Pharmacy Eligibility Integrity Audit.

After you submit: we reply within two business days to open a secure folder under a signed data agreement. We ask only what the scan needs — everything else comes later in the workflow.

Who we'll send the scan to.

We reply here within two business days.

Helps us size the scan and the audit scope.

Not legal advice. Not your Contract Administrator. You remain the party of record to HRSA.

The licensing boundary, in plain language

We test contract-pharmacy 340B claims and draft a signed independent audit opinion from the facts you provide and current HRSA program-integrity guidance. We match claims to encounters, resolve pricing, run the Compliance Lint, and reconcile the Medicaid Exclusion File. An Apexus-certified expert and a pharmacist reviewer sign the opinion within our scope. We do not make your eligibility or carve-in policy decisions, opine on contested legal questions, act as your Contract Administrator, or guarantee any HRSA determination or program-continuation outcome.

Independent 340B audit and documentation-preparation vendor. Not a law firm. Not your Contract Administrator. The customer remains the covered entity of record and the party accountable to HRSA. This service tests contract-pharmacy claims and drafts a signed independent audit opinion from information you provide and current HRSA program-integrity guidance; it is not legal advice and is not a guarantee of any HRSA determination, repayment outcome, or program-continuation decision. Eligibility policy, carve-in/carve-out decisions, and legal interpretation remain yours and your counsel's. Governing references: Section 340B of the Public Health Service Act; HRSA program-integrity and independent-audit guidance; the Medicaid Exclusion File; OPAIS.

[PLACEHOLDER] First-cohort audit turnaround — our per-audit price is $12,000-35,000 with a three-week target cadence. The real measured turnaround appears here once the first founding entities complete a full audit cycle.

[PLACEHOLDER] First covered-entity reference — added only with a named entity's written permission. ClaimClear never invents a testimonial or an entity name.

[PLACEHOLDER] Total 340B claims independently tested to date — a live, auditable count once real audits have been delivered and signed, never estimated.