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.
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.
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.
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.
Every procedure classified as routine cost, investigational, or sponsor-covered under the QCT criteria — all present, or the analysis does not release.
The routine-cost determination is verified against the regulatory definition, computed deterministically — never estimated.
Medicare, sponsor, or other payer assigned to each item based on the protocol and consent — established by search, not assumption.
For items not covered by Medicare, a reasonable search for alternative coverage is ordered and evidenced.
A documentation checklist for both the site and the sponsor, with the exact regulatory placement requirements.
The 2-week publication rule, surplus-proceeds handling, and the bill-of-sale title path — sequenced on the calendar so nothing is missed.
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.
Upload the protocol, consent, and budget. We return a free completeness read: which statutory elements and searches you already have, and which are missing.
As your authorized clerical agent, we order the DHSMV, USCG/NVDC, UCC, and judgment-lien searches and build the lienholder matrix, corroborated across sources.
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.
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.
A notice specialist reviews the exception queue and signs the release. High-value or federally documented vessels route to attorney review first.
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 deliverable is completeness itself — every statutory element and search accounted for or explicitly exception-coded. Nothing is left implicit.
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a statutory requirement.
We prepare documentation and run searches as your clerical agent. We never contact the vessel owner, give legal advice, or conduct the sale.
Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.
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.