42 CFR §447.505 Every formula, on every pack — verified, not assumed

The most rigorous government-price submission pack a manufacturer can file.

The Pharma Government Pricing Engine assembles a documentation-complete submission pack — every statutory price type, every required reconciliation, the certified file, and the submission calendar — checked against the letter of 42 CFR §447.505 and CMS guidance before a specialist releases it.

Every formula under 42 CFR §447.505Five price types, gate-checkedAMP · Best Price · URA · 340B · ASPSpecialist release on every pack5-business-day SLA
Why submissions fail

A single miscalculation can trigger False Claims Act exposure.

A pharmaceutical manufacturer's government-price submission is only as strong as the calculation behind it. Misclassify a class of trade, miss a Best Price exclusion, or miscalculate the Unit Rebate Amount — and the submission can be challenged, restated, or expose the manufacturer to FCA liability with historic settlements exceeding $784 million.

Most manufacturers run this by hand, in spreadsheets, or on legacy platforms that require scarce GP analysts to configure and operate. The statute has not been read end-to-end since the last restatement. That is exactly where completeness gaps hide.

The Pharma Government Pricing Engine exists to close that gap with a single, exhaustive standard applied identically to every file.

$784.6M
largest AMP/Best-Price FCA settlement (Wyeth/Pfizer)
The benchmark

Measured against the letter of the regulation — subsection by subsection.

We do not summarize the law and hope. Every pack is scored against a versioned rule pack tied to the exact text of 42 CFR §447.505 and related CMS guidance. These are the provisions each pack is held to.

42 CFR §447.505(b)

AMP calculation

Average Manufacturer Price computed from gross sales net of customary prompt-pay discounts, chargebacks, and rebates — all reconciled to the penny.

42 CFR §447.505(c)

Best Price determination

The lowest price available to any wholesaler, retailer, or provider, excluding statutory exceptions — classified deterministically, not by guess.

42 CFR §447.505(d)

Unit Rebate Amount

URA derived from AMP and Best Price, with the inflation-adjusted component — verified against CMS's own formula.

42 CFR §447.505(e)

340B ceiling price

Ceiling price computed as AMP minus URA, with quarterly updates — cross-referenced to the published 340B ceiling price list.

42 CFR §447.505(f)

ASP for Part B

Average Sales Price for Medicare Part B products, including volume-weighted calculation and reconciliation to manufacturer-reported data.

42 CFR §447.505(g)

Reconciliation & restatement

Cross-price reconciliation across AMP, BP, URA, 340B, and ASP — any discrepancy blocks release until resolved.

How a pack is built

Intake to specialist release, with deterministic gates the AI cannot overrule.

AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A human specialist signs every release. That order is never reversed.

01

Gap Scan

Upload transactional sales, chargeback, rebate, and admin-fee data. We return a free completeness read: which price types and reconciliations you already have, and which are missing.

02

Data ingestion & normalization

As your authorized clerical agent, we ingest and normalize data from your ERP, revenue management, and contract systems — building a single source of truth.

03

Grounded calculation

The five price types are calculated from your validated data and the 42 CFR §447.505 rule pack into field-locked templates — no legal opinions, no invented facts.

04

Deterministic completeness gates

Amounts reconcile to the penny; class-of-trade and Best-Price eligibility are verified; cross-price reconciliation is resolved; any failure blocks release.

05

Specialist release

A licensed government-pricing expert reviews the exception queue and signs the release. High-value or novel products route to attorney review first.

06

Delivery

You receive the pack: certified price file, reconciliation log, methodology memo, submission calendar, and CMS-ready submission — ready for your authorized official to certify.

The bar we hold

Rigor you can measure.

100%
Specialist-released
No pack ships without a human signature.
5 days
Standard SLA
From complete intake to released pack.
<1%
Critical-defect target
Tracked against a gold-standard pack library.
5
Price types reconciled
AMP · Best Price · URA · 340B · ASP, every applicable file.
Why the Pharma Government Pricing Engine

Built to be the most thorough option a manufacturer has.

Documentation-complete, by design

The deliverable is completeness itself — every statutory price type and reconciliation accounted for or explicitly exception-coded. Nothing is left implicit.

Deterministic, not vibes

The gates that decide completeness are code, not a model's opinion. A calculation error cannot slip past a statutory requirement.

In its lane, on purpose

We prepare documentation and run calculations as your clerical agent. We never give legal advice, certify prices, or submit on your behalf.

Engagement

Flat fee, per released pack. No contingency, ever.

Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.

  • A free Gap Scan before you commit — see exactly what is missing.
  • One flat fee per released Government Price Submission Pack; disclosed pass-through data costs.
  • Optional fixed-fee attorney review for novel or high-value products.
  • Optional Submission Continuity Add-on for the advertisement and submission-day exhibits, pre-dated to your reporting calendar.
FAQ

Questions, answered precisely.

Is the Pharma Government Pricing Engine a law firm?
No. The Pharma Government Pricing Engine, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Attorney review is available and recommended for novel or high-value products.
Do you certify or submit prices on our behalf?
Never. The Pharma Government Pricing Engine is not a certified public accountant or authorized official. The manufacturer's authorized official remains the party responsible for certifying and submitting all government prices.
What makes a pack 'complete'?
Completeness is defined by the regulation: the five price types (AMP, Best Price, URA, 340B, ASP) calculated, cross-reconciled, and gap-checked against CMS submission specs. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days from complete intake to a specialist-released pack. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released pack, plus disclosed pass-through data costs. No contingency and no percentage of any recovered amount or sale proceeds.

See what's missing before it costs you a restatement.

Start with a free Gap Scan. Send your transactional data and we'll return a completeness read against every formula under 42 CFR §447.505.

Documentation-completeness service · not legal advice · the manufacturer certifies every submission.