Insights

What we're seeing across reimbursement and commercialization.

Short, practical perspectives from the work — written for operators, founders, and reimbursement leaders.

In progress

Perspectives currently in preparation.

Reimbursement

A code is not coverage. Coverage is not payment.

Why coding strategy, coverage strategy, and collections must be planned as three separate problems for novel assays.

Coming soon
Regulation

Operating through evolving federal diagnostic regulation

How laboratories and assay developers can build durable CLIA, quality, and documentation practices while federal oversight of laboratory-developed tests continues to evolve.

Coming soon
Commercialization

Launch readiness before the first claim

The validation, documentation, coding, and billing alignment that determines whether a launch produces revenue or rework.

Coming soon

Regulatory and coverage policy for diagnostics continues to change. Nothing here should be read as legal, regulatory, or reimbursement advice for a specific program — that work happens inside an engagement.

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