Clinical Evidence = Value Care Modeling

In today’s healthcare landscape, clinical performance alone is not enough. Payers, providers, and hospital administrators demand proof of value—measurable, real-world impact that justifies cost, adoption, and reimbursement.

At Lonsberry Consulting™, we believe that clinical evidence should be designed with reimbursement in mind. Our PRECODE™ System integrates clinical strategy with economic intent, ensuring your trials, endpoints, and real-world evidence align with coverage decisions, coding pathways, and payment models.

It’s not just about showing that your technology works—it’s about proving that it improves care, reduces cost, or fills an unmet need that payers recognize.

We help you:

• Define economic value propositions early in clinical planning
• Align study endpoints with payer-relevant outcomes (e.g., reduced readmissions, shortened LOS, fewer complications)
• Structure trials to support NTAP, TPT, DRG reassignment, or coverage with evidence development (CED)
• Build a roadmap for real-world evidence (RWE) and post-market data collection
• Anticipate and answer the question every payer asks:
  “What’s the value of this over the standard of care—and why should we pay for it?”

Our clinical strategy services include:

• Trial design consultation aligned with CMS and HTA expectations
• Endpoint selection based on coding/payment relevance (not just regulatory approval)
• Evidence mapping across FDA, CMS, and payer expectations
• RWE planning for post-market economic studies and outcomes reporting
• Clinical + economic storytelling for value dossiers, NTAP submissions, and coverage advocacy

Clinical trials are not just for FDA approval. In the PRECODE™ framework, they’re a foundation for coverage, coding, and commercial success. We help you plan studies that do more than pass regulatory review—they unlock economic access.

• Devices or diagnostics pursuing NTAP, TPT, or Breakthrough status
• Startups preparing for pivotal trials or IDE submissions
• Companies needing a clear link between clinical outcomes and economic benefit
• Teams designing RWE studies to support commercial uptake

The strongest technologies fail when they can’t show value.
We help you prove that your innovation not only works—but works better, faster, or cheaper than the alternative.

That’s what gets paid.