42 CFR 403 Every subsection, on every pack — verified, not assumed

The most rigorous Open Payments report pack an emerging life-sciences company can file.

ClearField assembles a documentation-complete annual transparency report pack — every reportable transfer of value, every recipient resolution, every CMS validation rule, the dispute-clean submission, and the state filings — checked against the letter of 42 CFR 403 and non-preempted state statutes before a specialist releases it.

Every subsection of 42 CFR 403 Subpart IFive statutory submission elements, gate-checkedNPI · CMS · state · entity-resolution searchesSpecialist release on every pack5-business-day SLA
Why packs fail

A single missing transfer can trigger a $100K penalty.

Every applicable manufacturer and GPO must file an accurate, complete Open Payments report each year or face civil penalties of $10K–$100K per knowing unreported transfer (up to $1M/year), plus non-preempted state filings and reputational exposure from public data. Yet the data required to file correctly is scattered across expense, events/CRM, grants, sample-accountability, and contracts systems; recipients must be resolved to the right covered-recipient identity; and manual reconciliation leaves most spend unaudited.

Most emerging and mid-size companies run this by hand, from memory, once a year. The regulation has not been read end-to-end since the last time it mattered. That is exactly where completeness gaps hide.

ClearField exists to close that gap with a single, exhaustive standard applied identically to every file.

~80%
of expense spend typically goes unchecked under manual reconciliation
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 403 Subpart I and non-preempted state statutes. These are the provisions each pack is held to.

42 CFR 403.904

Five reportable categories

General payments, research payments, ownership/investment interests, physician ownership, and indirect payments — all captured, or the pack does not release.

42 CFR 403.908

Recipient identity resolution

Every covered recipient (physician, teaching hospital, NP/PA) resolved to NPI and CMS profile — established by search, not assumption.

42 CFR 403.912

Penalty-defensible validation

All CMS validation rules run; dispute-clean submission with documented audit trail that eliminates penalty exposure.

42 CFR 403.910

Physician review-and-dispute cycle

Managed 45-day review window, dispute resolution, and final attestation — sequenced on the calendar so nothing is missed.

State statutes (MN, MA, NV, WV, DC, CT)

Non-preempted state filings

State-specific aggregate-spend reports prepared and filed alongside the federal submission.

42 CFR 403.914

Publication and correction

Post-submission correction window managed; public data monitored for accuracy.

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

Reporting-Readiness Diagnostic

Upload your expense, CRM, grants, samples, and contracts data. We return a free completeness read: which reportable transfers and recipient resolutions you already have, and which are missing.

02

Evidence & recipient searches

As your authorized clerical agent, we order NPI, CMS, state-license, and entity-resolution searches and build the recipient matrix, corroborated across sources.

03

Grounded drafting

The five reportable categories are drafted from your validated data and the 42 CFR 403 rule pack into field-locked templates — no legal opinions, no invented facts.

04

Deterministic completeness gates

Amounts reconcile to source systems to the penny; recipient identities are verified; the validation rulebook is resolved; SCRA is screened. Any failure blocks release.

05

Specialist release

A transparency-compliance specialist reviews the exception queue and signs the release. High-value or complex matters route to attorney review first.

06

Delivery

You receive the pack: final CMS submission file, state filings, evidence log, recipient matrix, dispute-management timeline, and the annual calendar — ready for the compliance officer to attest and submit.

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.
4
Recipient-search sources
NPI · CMS · state license · entity resolution, every applicable file.
Why ClearField

Built to be the most thorough option a life-sciences company has.

Documentation-complete, by design

The deliverable is completeness itself — every reportable transfer and recipient resolution 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 drafting error cannot slip past a regulatory requirement.

In its lane, on purpose

We prepare documentation and run searches as your clerical agent. We never contact the covered recipient, give legal advice, or submit the report 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 Reporting-Readiness Diagnostic before you commit — see exactly what is missing.
  • One flat fee per released Annual Transparency Report Pack; disclosed pass-through search fees.
  • Optional fixed-fee attorney review for complex or high-value matters.
  • Optional State Filing Add-on for non-preempted state reports, pre-dated to your filing window.
FAQ

Questions, answered precisely.

Is ClearField a law firm?
No. ClearField, 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 complex or high-value matters.
Do you contact the covered recipient or submit the report?
Never. ClearField is not a debt collector and does not contact covered recipients or submit reports on your behalf. The client's compliance officer remains the party responsible for attestation and submission.
What makes a pack 'complete'?
Completeness is defined by the regulation: the five 42 CFR 403.904 categories present, recipient identities resolved to NPI/CMS, validation rules run, dispute cycle managed, and state filings prepared. 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 Diagnostic 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 search costs. No contingency and no percentage of any recovered amount or sale proceeds.

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

Start with a free Reporting-Readiness Diagnostic. Send your expense, CRM, grants, samples, and contracts data and we'll return a completeness read against every subsection of 42 CFR 403.

Documentation-completeness service · not legal advice · the client's compliance officer attests every submission.