Expert advisory and technology for pharmaceutical manufacturers navigating 340B, chargebacks, and GPO compliance. We validate every claim in real time before payment, detect duplicate discounts, and settle to your ERP — deployed inside your infrastructure, not ours.
| Customer / Entity | Program | Status |
|---|---|---|
| St. Marian Health System HRSA ID 270089400 |
340B | ● Live |
| Cardinal · DEA 7841 Wholesaler |
Wholesaler | ● Live |
| Premier Inc. — Class A GPO |
GPO | ● Live |
| Vizient — Acute Network GPO |
GPO | ◐ Renewal review |
| McKesson Specialty Ship-and-Debit |
Ship-and-Debit | ● Live |
| AmerisourceBergen · DEA 7912 Wholesaler |
Wholesaler | ● Live |
The 340B regulatory landscape moved substantially since mid-2024. Here's the current state, accurate as of Q2 2026 — and what it means for your compliance posture.
"Manufacturers tried the rebate model. Court vacated it. The path forward is chargebacks — with even more uncertainty about whether and when the rebate model returns. Nobody can plan their compliance architecture around the assumption that rebates are coming soon. They have to invest in chargeback validation now."
Three buyers inside the manufacturer. Three problems that have to work as one system. Each discipline stands alone — together they cover the full pharma revenue cycle from allocation to settlement.
Channel demand forecasting per distributor. 340B-eligible allocation modeling. Distributor scorecards — which channels handle 340B cleanly, which don't. Tracking deviation between allocated and actual sales.
Active 340B, GPO, wholesaler, and ship-and-debit contracts as structured data — queryable by every downstream system. Negotiated terms authored once, propagated automatically to quoting, fulfillment, claims, and ERP. Contract is the source of truth.
EDI 844/867/849 ingestion. 11-rule validation engine — chargeback validated against live contract eligibility, HRSA OPAIS, and Medicaid SDUD before payment. Auto-settle or route for review. SAP posting with audit trail on every line.
Wholesaler chargebacks arrive via EDI 844. Each line is matched against active contracts, validated for duplicate-discount risk, and auto-settled or routed for review — with the contract trace on every decision.
A deterministic rule engine that runs in fixed order on every chargeback line. Decisions are persisted with full rule trace, OPAIS sync timestamp, ruleset version, and policy document URI. Replayable 12 months later.
Claimed quantity must be ≥ 0 units. Structural validation — catches malformed EDI 844 lines before they touch business logic.
Hard failNDC11 must exist in product master and cross-reference to at least one active contract. Catches unsupported products and NDC substitutions.
Hard failThe referenced contract must be in force on the date of the underlying resale transaction. Catches claims against expired or not-yet-effective agreements.
Hard failFor 340B claims: covered entity must be active in HRSA OPAIS on the transaction date — daily auto-poll. For GPO: customer must be on the current roster with valid effective date. Catches terminated CEs and lapsed memberships.
Hard failFor 340B claims: dispensing pharmacy NPI must appear on the covered entity's authorized contract pharmacy roster. Catches unauthorized dispensing locations — a leading HRSA audit finding.
Hard failDispense must comply with manufacturer's published 340B policy (quantity limits, eligible product list, covered-entity type restrictions). Policy document URI stamped on every decision.
Hard failClaim must not appear on State Medicaid SDUD file for the same dispense event. Uses state-level data (90–135 day rolling window) with annual federal SDUD backstop. Catches the duplicate-discount prohibition violation.
Soft — flagFor the first 10 IRA-negotiated drugs: claim must not also appear as a Medicare MFP-eligible transaction. CMS will not deduplicate through the Medicare Transaction Facilitator — this is now the manufacturer's obligation.
Soft — flagClaimed quantity must be supported by confirmed resale (EDI 867 indirect sales report) within ±30 days, oldest resale first (FIFO depletion). Partial approval when resale supports only a portion.
Soft — partialClaimed unit price must be within configurable tolerance (basis points) of the active contract price rule for the NDC on the transaction date. Catches pricing drift between wholesaler's price master and your contract.
Soft — partialTerminal rule: calculates approved amount, generates APPROVE / PARTIAL / REJECT / PEND decision, produces EDI 849 response, and creates a FinancialEvent (credit memo) for approved amounts ready for ERP posting.
TerminalMost pharma manufacturers run chargeback reconciliation with a team of 3–5 analysts, a shared drive of contracts, and a quarterly reconciliation sprint. Here's what Phase 1 go-live actually changes.
This market has software vendors, rebate processors, CE-side tools, and one advisory firm that deploys inside your infrastructure pre-payment. Understanding where each sits helps you make the right call — including when to use us alongside something you already have.
| Vendor | Buyer side | When it runs | What it produces | Status · Apr 2026 |
|---|---|---|---|---|
| Nteli | Manufacturer | Pre-payment — before chargeback settles | Approve / Partial / Reject + EDI 849 + GL posting. 11-rule trace. Replayable for HRSA audit. | Mid-market focus |
| Kalderos (Discount Hub) | Manufacturer + CE | Post-payment collaborative validation | "Good faith" suspected duplicate finding; manufacturer takes to CE for resolution | Active growth |
| Kalderos (340B Pay) | Manufacturer | Rebate model processing | Rebate-model platform — was their bet on the rebate pilot | Pilot vacated Feb 2026 |
| Beacon Channel Mgmt (BRG) | Manufacturer | Rebate processing (designated platform) | Rebate processing for the 8-manufacturer pilot — now in limbo | Pilot vacated Feb 2026 |
| Model N (340B Vigilance) | Manufacturer | Enterprise GTN platform module | Contract pricing + chargeback module in a broader platform | Large-cap only (Vista PE) |
| Vistex | Manufacturer | SAP-native GTN | Complete GTN + chargeback suite, SAP-dependent | SAP installed-base |
| Second Sight (340B ESP) | Both | Submission utility | Chargeback claims submission — not a decision engine | 8+ manufacturers |
| Craneware / Cervey | Covered entity | CE-side compliance & audit readiness | Hospital/health system 340B compliance — not manufacturer-side | CE side only |
The mid-market manufacturer-side advisory position — real-time pre-payment validation, audit-grade trace, deployed in your infrastructure — is not currently occupied by a focused firm. April 2026.
Large-cap manufacturers have Model N and Vistex. Mid-market and lower has no credible incumbent option — and the compliance burden is identical. If your revenue falls in the band below, we know your situation before the first call.
Lower mid-market ($200M–$1B) specialty manufacturers with active 340B exposure, small compliance teams, and no deployed incumbent platform. We've done the research — 10-K filings disclose channel structure and government pricing exposure clearly.
All public — 10-K filings disclose channel structure and government pricing exposure.
Every workflow is designed around the control requirements your auditors, HRSA, CMS, and OIG expect. SOX-grade audit trail generated as a byproduct of running — not bolted on after the fact.
| Requirement | Scope | Nteli handling | Status |
|---|---|---|---|
| 340B chargeback validation (EDI 844/849) | All wholesalers | 11-rule engine at line level; EDI 849 response generated per claim; per-rule trace replayable 12 months | Automated |
| 340B Covered Entity eligibility (HRSA OPAIS) | All 340B claims | Daily OPAIS poll; per-transaction eligibility check on date of dispense; terminated CEs flagged at gate | Automated |
| Contract pharmacy authorization | 340B contract pharmacy programs | Pharmacy NPI validated against CE-authorized roster; unauthorized dispensing locations blocked | Automated |
| Duplicate Medicaid discount (42 CFR) | All 340B claims | State SDUD match (90–135 day rolling window) + annual federal SDUD backstop reconciliation | Controlled |
| IRA × 340B nonduplication (CMS) | 10 IRA-negotiated drugs, Jan 2026+ | R-08 joins claim-level data against CMS MFP eligibility; same engine as duplicate-discount check | Controlled |
| GPO contract price waterfall | GPO membership contracts | Multi-tier price selection; roster effective date management; class-of-trade pricing per contract | Automated |
| ASC 606 / Revenue Recognition | Chargebacks, rebates, returns | 14 canonical GL journal entry templates; credit memos from approved decisions; ERP posting with contract reference | Automated |
| SOX IT General Controls | All financial transactions | SoD enforcement on approval workflows; period lockdown; SHA-256 audit trail per event | Included |
| SOC 2 Type II readiness | Platform-wide | Evidence package included; customers typically certify within 6 months of go-live | Included |
Each diagnostic is fixed-fee, scope-defined, and ends with a real deliverable. Start with the buyer who feels the pain first. Most manufacturers eventually engage all three — because the architecture works as a system, not as parts.
Distributor forecasting accuracy. 340B-eligible allocation efficiency map. Distributor scorecards across your channel (which channels handle 340B cleanly, which are creating risk). Identifies where channel restriction is leaking and where it's blocking unnecessary exposure.
Contract inventory across 340B, GPO, wholesaler, ship-and-debit. Pricing-drift analysis showing where margin leaks across channels or acquired entities. Settlement-lag report measuring the finance handoff debt between commercial and AP.
Bring us 90 days of historical EDI 844s. The validation engine replays them and shows you exactly what your current process missed — duplicate-discount exposure, terminated CE credits, contract pharmacy violations, price tolerance overruns. 8 weeks. Pilot fee credits to first-year contract.
You pay once to deploy. No per-user fees, no monthly SaaS charges, no vendor lock-in. Your infrastructure, your data, your control. Annual support included.
We're accepting 2–3 early design partners to co-build the pharma vertical. Early partners get a significantly discounted Phase 1, direct access to the founding team, and material input on the product roadmap. We learn your specific chargeback and compliance workflow in depth.
Book a 30-minute call. We'll map your chargeback workflow, identify your 340B exposure, and show you what the validation engine would have caught on your last 90 days of claims.