# 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.

- URL: https://neurobird.com/340bcompliance/
- Product: Neurobird 340B Compliance Compliance Platform
- Niche: 340B compliance
- Buyer: covered entities and contract pharmacies
- Status: in development, open for early access
- Updated: 2026-08-22

## What Neurobird 340B Compliance does

- 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
- Build the audit sample yourself, from your own records, before someone else builds it for you

## How it works

1. **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.
2. **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.
3. **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.

## From the source material

> 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.

Source: law.cornell.edu, https://www.law.cornell.edu/cfr/text/42/10.10

## Industry context

- **$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. (source: 42 CFR 10.11, https://www.law.cornell.edu/cfr/text/42/10.11)
- **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. (source: 42 U.S.C. 256b, https://www.law.cornell.edu/uscode/text/42/256b)
- **8 percent** Disproportionate 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. (source: 42 U.S.C. 256b, https://www.law.cornell.edu/uscode/text/42/256b)
- **120 days** Time 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. (source: 42 CFR 10.10, https://www.law.cornell.edu/cfr/text/42/10.10)
- **3 years** Window 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. (source: 42 CFR 10.21, https://www.law.cornell.edu/cfr/text/42/10.21)
- **$0.01** Floor 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. (source: 42 CFR 10.10, https://www.law.cornell.edu/cfr/text/42/10.10)

## Pricing

- Single site: $269 per month
- Health system: $780 per month
- Network: $1,850 per month

## Questions

### 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.

## Sources

- [42 U.S. Code 256b, limitation on prices of drugs purchased by covered entities](https://www.law.cornell.edu/uscode/text/42/256b)
- [42 CFR 10.10, ceiling price for a covered outpatient drug](https://www.law.cornell.edu/cfr/text/42/10.10)
- [42 CFR 10.11, manufacturer civil monetary penalties](https://www.law.cornell.edu/cfr/text/42/10.11)
- [42 CFR 10.21, claims in the administrative dispute resolution process](https://www.law.cornell.edu/cfr/text/42/10.21)
- [42 CFR 10.3, definitions for the 340B program](https://www.law.cornell.edu/cfr/text/42/10.3)
- [HRSA Office of Pharmacy Affairs, 340B program](https://www.hrsa.gov/opa)

## Contact

- office@neurobird.com
- https://neurobird.com/