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What is a clinical trial billing grid generator? Definition and an example row

Zach Sawaged3 min read

A clinical trial billing grid, also called a coverage analysis grid, lists every procedure the protocol requires at every visit and assigns each one a payer: routine care billable to the participant's insurance, or a research cost paid by the sponsor. Sites use it to build the study budget, to set up billing in the CTMS, and to make sure research-only procedures are never billed to Medicare or a commercial insurer. In the United States the grid is the output of the Medicare Coverage Analysis (MCA).

What a billing grid generator does

A billing grid generator produces the grid from the protocol instead of having a coverage analyst rebuild the schedule of events by hand in a spreadsheet. Each row is one procedure at one visit, carrying the visit, the procedure, the payer designation and the protocol reference it came from. When the protocol is amended, the grid regenerates with it, so the budget and the billing schedule never fall out of step with the visits the coordinators actually run.

Example rows

Visit: Week 4 (Visit 3). Procedure: Complete blood count with differential. Designation: Routine care, billable to insurance, because the same test is part of standard monitoring for the condition. Source: Schedule of Activities.

Visit: Week 4 (Visit 3). Procedure: Pharmacokinetic blood draw. Designation: Research cost, paid by the sponsor, because it is performed only for the study. Source: Schedule of Activities.

How Concordare generates the billing grid

Concordare's billing grid generator is Censa. Apta converts the protocol PDF into the Clinical Trial Protocol Model (CTPM), a structured model of every visit and procedure, which the study team reviews and approves. Censa reads the approved CTPM and produces the per-visit, per-procedure billing grid and the Medicare Coverage Analysis, then exports the billing schedule to the site's CTMS. Because Structura generates the source documents and Porta builds the eCRFs from the same model, the budget, the visit worksheets and the EDC cannot drift apart. AI is used only to convert the protocol; the grid is generated deterministically from the approved model. Censa is currently in pilot with research sites.

Definitions

Billing grid. A table of every protocol procedure at every visit with its payer designation, used for budgeting and billing compliance.

Medicare Coverage Analysis (MCA). The review that decides which study procedures qualify as routine care billable to Medicare and which are research costs. Its output is the coverage analysis grid.

Billing grid generator. Software that produces the billing grid from the protocol and regenerates it when the protocol is amended.

To see a billing grid generated from your own protocol, request a demo.