NCD 310.1 Every determination, on every analysis — verified, not assumed

The most rigorous Medicare Coverage Analysis a clinical trial site can get.

The Coverage Analysis Engine assembles a defensible, audit-ready Medicare Coverage Analysis and billing grid for each protocol — every procedure classified, every payer identified, every determination cited — checked against NCD 310.1, applicable NCDs/LCDs, and the False Claims Act before a specialist releases it.

Every procedure classified under NCD 310.1Five statutory notice elements, gate-checkedDHSMV · USCG · UCC · judgment lien searchesSpecialist release on every pack5-business-day SLA
Why analyses fail

A single misclassified procedure can trigger a False Claims Act liability.

Before a clinical trial site can enroll a single patient, someone has to decide — line by line — which of the protocol's procedures Medicare and other payers may be billed for as 'routine costs,' and which must be charged to the study sponsor. Get it wrong and the site isn't just out a few dollars: it has filed false claims with the government. The penalty regime is brutal — treble damages plus a per-claim civil penalty (roughly $14k–$28k per claim in 2024 dollars) — and real sites have paid for it, including a $3.39M University of Alabama at Birmingham settlement and a $1.5M Emory settlement, both for clinical-trial billing the sponsor was supposed to cover.

Most sites run this by hand, from memory, once or twice a year. The regulations have not been read end-to-end since the last time it mattered. That is exactly where completeness gaps hide.

The Coverage Analysis Engine exists to close that gap with a single, exhaustive standard applied identically to every file.

1 of 5
missing notice elements is enough to jeopardize a sale
The benchmark

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

We do not summarize the law and hope. Every analysis is scored against a versioned rule pack tied to the exact text of NCD 310.1 and applicable NCDs/LCDs. These are the provisions each analysis is held to.

NCD 310.1

Qualifying clinical trial framework

Every procedure classified as routine cost, investigational, or sponsor-covered under the QCT criteria — all present, or the analysis does not release.

42 CFR §411.35

Medicare coverage of routine costs

The routine-cost determination is verified against the regulatory definition, computed deterministically — never estimated.

NCD 310.1 §B

Every required payer identification

Medicare, sponsor, or other payer assigned to each item based on the protocol and consent — established by search, not assumption.

NCD 310.1 §C

Out-of-network search duty

For items not covered by Medicare, a reasonable search for alternative coverage is ordered and evidenced.

NCD 310.1 §D

Conspicuous documentation

A documentation checklist for both the site and the sponsor, with the exact regulatory placement requirements.

42 CFR §411.35(c)

Advertisement, surplus, title

The 2-week publication rule, surplus-proceeds handling, and the bill-of-sale title path — sequenced on the calendar so nothing is missed.

How an analysis 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

Delinquency Gap Scan

Upload the protocol, consent, and budget. We return a free completeness read: which statutory elements and searches you already have, and which are missing.

02

Evidence & lien searches

As your authorized clerical agent, we order the DHSMV, USCG/NVDC, UCC, and judgment-lien searches and build the lienholder matrix, corroborated across sources.

03

Grounded drafting

The five notice elements are drafted from your validated data and the §328.17 rule pack into field-locked templates — no legal opinions, no invented facts.

04

Deterministic completeness gates

Amounts reconcile to the ledger to the penny; the 60-day window is verified; the search checklist is resolved; SCRA is screened. Any failure blocks release.

05

Specialist release

A notice specialist reviews the exception queue and signs the release. High-value or federally documented vessels route to attorney review first.

06

Delivery

You receive the pack: notices, matrix, evidence log, posting checklist, certified-mail packet with labels, and the 60-day ICS calendar — ready for the marina to send under its own name.

The bar we hold

Rigor you can measure.

100%
Specialist-released
No analysis ships without a human signature.
5 days
Standard SLA
From complete intake to released analysis.
<1%
Critical-defect target
Tracked against a gold-standard analysis library.
4
Lien-search sources
DHSMV · USCG · UCC · judgment, every applicable file.
Why Coverage Analysis Engine

Built to be the most thorough option a site has.

Documentation-complete, by design

The deliverable is completeness itself — every statutory element and search 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 statutory requirement.

In its lane, on purpose

We prepare documentation and run searches as your clerical agent. We never contact the vessel owner, give legal advice, or conduct the sale.

Engagement

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

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

  • A free Delinquency Gap Scan before you commit — see exactly what is missing.
  • One flat fee per released Notice Completeness Pack; disclosed pass-through search fees.
  • Optional fixed-fee attorney review for high-value or federally documented vessels.
  • Optional Sale Continuity Add-on for the advertisement and sale-day exhibits, pre-dated to your 60-day window.
FAQ

Questions, answered precisely.

Is Coverage Analysis Engine a law firm?
No. Coverage Analysis 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 high-value or federally documented vessels.
Do you contact the boat owner or collect the debt?
Never. Coverage Analysis Engine is not a debt collector and does not contact vessel owners or debtors. The marina remains the lien claimant and the party responsible for sending all notices and conducting any sale.
What makes an analysis 'complete'?
Completeness is defined by the statute: the five §328.17(5)(b) notice elements present, the 60-day window verified, the a–e lien searches resolved or exception-coded, identity corroborated, and SCRA screened. 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 analysis. 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 analysis, 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 sale.

Start with a free Delinquency Gap Scan. Send your ledger and vessel details and we'll return a completeness read against every subsection of §328.17.

Documentation-completeness service · not legal advice · the marina sends every notice.