340B compliance software that ties every eligible dispense back to the patient and the purchase behind it
340B compliance is the discipline a covered entity keeps so that discounted outpatient drugs go only to its own patients and are never billed twice. The statute is short and unforgiving: a covered entity must not resell or transfer a 340B drug to anyone who is not a patient of the entity, and must not seek Medicaid payment for a drug that already carries a state rebate. A manufacturer that knowingly overcharges faces a civil penalty of up to $5,000 for each instance. Neurobird holds the accumulation, the purchase and the evidence.
Neurobird 340B Compliance in short
- Hold the eligibility decision for each accumulation instead of assuming it at the end of the month
- Keep the Medicaid exclusion decision on the claim rather than in a policy document
- Reconcile contract pharmacy dispenses against replenishment purchases while the data is still fresh
- $5,000 Maximum civil monetary penalty for each instance of overcharging by a manufacturer that knowingly and intentionally exceeds the ceiling price, assessed per order of a national drug code and on top of the repayment owed. 42 CFR 10.11
- 11.75 percent Disproportionate share adjustment percentage a hospital must exceed to be a covered entity under that category, alongside a requirement that it not obtain covered outpatient drugs through a group purchasing arrangement. 42 U.S.C. 256b
- Pricing runs 269 to 1850 US dollars per month across 3 tiers. Early access is free.
What covered entities and contract pharmacies actually deal with
Why it stays broken
340B is a purchasing programme policed as a records programme. The savings are real and immediate, the eligibility test is a patient relationship that lives in a clinical system, and the proof is a purchase record that lives in materials management, so the two halves of every compliance question sit in different departments with different owners. The statute says what must not happen and leaves each covered entity to invent the evidence that it did not, which is why audits turn into months of reconstruction.
Under 42 CFR 10.11 a manufacturer that knowingly and intentionally charges a covered entity more than the ceiling price may face a civil monetary penalty of up to $5,000 for each order of a national drug code that was overcharged.
A manufacturer must estimate the 340B ceiling price for a new covered outpatient drug as of the date the drug is first available for sale.
Neurobird 340B Compliance Compliance Platform
One record per accumulation: the encounter that made the patient eligible, the prescriber's relationship to the entity, the dispense, the replenishment purchase it drove, the Medicaid exclusion decision, and the contract pharmacy it happened at if it was not your own counter.
- 1Hold the eligibility decision for each accumulation instead of assuming it at the end of the month
- 2Keep the Medicaid exclusion decision on the claim rather than in a policy document
- 3Reconcile contract pharmacy dispenses against replenishment purchases while the data is still fresh
- 4Build the audit sample yourself, from your own records, before someone else builds it for you
What changes with Neurobird 340B Compliance?
The same work, read left to right: how it runs today, and how it runs once the record is in one place.
| Today | With Neurobird 340B Compliance |
|---|---|
| An accumulation builds against a prescription nobody can later tie to an eligible encounter | Hold the eligibility decision for each accumulation instead of assuming it at the end of the month |
| A Medicaid claim goes out on a drug that already carried a rebate, and the exclusion file was last checked in March | Keep the Medicaid exclusion decision on the claim rather than in a policy document |
| Contract pharmacy data arrives as a monthly file and gets reconciled by whoever has time, which is nobody | Reconcile contract pharmacy dispenses against replenishment purchases while the data is still fresh |
Who is this for?
The same statute, three very different entities.
You qualify on the DSH percentage
Your eligibility rests on a disproportionate share adjustment percentage and a prohibition on group purchasing for covered outpatient drugs. You need site registration and eligibility evidence to line up with your accumulations.
You run several sites
Grant funded clinics with contract pharmacies attached. You need per site registration and per prescriber eligibility on every accumulation, not a blanket assumption.
You dispense for someone else's entity
You hold data the covered entity is accountable for. You need a reconciliation both sides can read, rather than a monthly file and a phone call.
The accumulation board, as your pharmacy would work it
Qualify a dispense and watch the accumulation, the replenishment and the exclusion move together.
| Requirement | Status | Next due | |
|---|---|---|---|
| ACC-88301, contract pharmacy, awaiting reconciliation | current | in 42d | |
| ACC-88214, oncology clinic, eligible encounter linked | due soon | in 9d | |
| ACC-88355, Medicaid exclusion applied, carve out | current | in 120d | |
| PO-4471, replenishment order, 340B account | overdue | 3d late | |
| ACC-88355, Medicaid exclusion applied, carve out | current | in 64d |
Tick a requirement to file evidence against it.
What the statute says about 340B
The two prohibitions every audit tests, the price a manufacturer has to calculate, and the penalty and dispute paths that sit behind both.
Maximum civil monetary penalty for each instance of overcharging by a manufacturer that knowingly and intentionally exceeds the ceiling price, assessed per order of a national drug code and on top of the repayment owed.
42 CFR 10.11Disproportionate share adjustment percentage a hospital must exceed to be a covered entity under that category, alongside a requirement that it not obtain covered outpatient drugs through a group purchasing arrangement.
42 U.S.C. 256bDisproportionate share adjustment percentage a rural referral center or sole community hospital must reach instead, which is why eligibility evidence differs by entity type rather than being one test.
42 U.S.C. 256bTime a manufacturer has to refund or credit a covered entity the difference once it determines that an estimated ceiling price on a new drug resulted in an overcharge.
42 CFR 10.10Window in which a covered entity or a manufacturer must file an administrative dispute resolution claim in writing, counted from the date of the alleged violation, absent extenuating circumstances.
42 CFR 10.21Floor for a 340B ceiling price. The price is average manufacturer price minus the unit rebate amount, calculated to six decimal places and published rounded to two, and where the result falls below a cent it is set at a cent.
42 CFR 10.10How does Neurobird 340B Compliance work?
Define eligibility
The registered sites, the eligible prescribers and the encounter types that create a patient relationship are written down once, so every later decision points back to a stated rule.
Accumulate and replenish
Dispenses build accumulations, accumulations drive purchases, and the link between the two stays visible instead of being reconstructed from a wholesaler statement.
Stand up to the audit
Duplicate discount exclusions, contract pharmacy reconciliation and self audit samples come out of the same record, which is the record an auditor is going to ask for anyway.
340b compliance software questions, answered
Key terms
- What is 340B compliance?
- It is the evidence a covered entity keeps that discounted outpatient drugs went only to its own patients and were never billed in a way that produced a second discount. The two prohibitions in 42 U.S.C. 256b, against resale to a non-patient and against duplicate discounts, are what every audit is testing.
- What are the penalties in the programme?
- On the manufacturer side, 42 CFR 10.11 allows a civil monetary penalty of up to $5,000 for each instance of knowingly and intentionally charging above the ceiling price, on top of repayment. On the covered entity side, an entity found in violation after audit is liable to the manufacturer for the amount of the discount it took.
How is the 340B ceiling price calculated?
Average manufacturer price for the smallest unit of measure from the preceding quarter, minus the unit rebate amount, calculated to six decimal places and published rounded to two. Where that falls below a cent, the ceiling price is a cent.
Does this replace our split billing system?
No. Accumulation logic can stay where it is. This is the compliance record around it: the eligibility rules you wrote down, the exclusions you applied, the contract pharmacy reconciliation and the self audit samples you actually ran.
How long do we have to raise a dispute?
Three years from the date of the alleged violation, in writing to the Office of Pharmacy Affairs, and every file associated with the claim has to be preserved until the final agency decision.
Why we are building this
We went looking for programmes where the money is easy and the evidence is hard, and 340B kept coming up. The savings arrive automatically at the point of purchase. The proof that each of those purchases was allowed has to be assembled by hand from a clinical system, a dispensing system and a wholesaler statement that were never designed to meet. That is a record problem, and record problems are what we build. The statute and the regulations we read while scoping this are linked above. If we have your entity type wrong, tell us and we will fix it.
Where the requirement comes from
Primary sources, straight from the regulators.
- 42 U.S. Code 256b, limitation on prices of drugs purchased by covered entities Who is a covered entity, the duplicate discount and resale prohibitions, and the audit and sanction powers.
- 42 CFR 10.10, ceiling price for a covered outpatient drug How the price is built, the six decimal calculation, the penny floor and the refund window on new drugs.
- 42 CFR 10.11, manufacturer civil monetary penalties What counts as an instance of overcharging, and why it cannot be offset against another discount.
- 42 CFR 10.21, claims in the administrative dispute resolution process The 3 year filing window, what documentation a claim needs and the record you must preserve.
- 42 CFR 10.3, definitions for the 340B program Consolidated and joint claims, the ADR panel, and the terms an audit letter will use.
- HRSA Office of Pharmacy Affairs, 340B program The administering office: registration windows, recertification and published audit results.
How much does Neurobird 340B Compliance cost?
Priced per covered entity because registration, eligibility and audit exposure all attach to the entity rather than to a user. Sites, accumulations and samples are unlimited on the upper tiers.
- One covered entity
- Eligibility rules
- Accumulation record
- Self audit samples
- Multiple registered sites
- Contract pharmacy reconciliation
- Exclusion tracking
- Recertification pack
- Many entities and sites
- Wholesaler purchase matching
- Audit response export
- Priority support
Get free early access
Early access means we load your registered sites, your eligible prescriber list and your current exclusion rules before you type anything, and the account stays free while we do it.
Straight answer on where this is: The software is in development. Nothing is purchasable today. Early access means you shape it and pay nothing while we build.
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