Client Results
Real engagements, anonymized. What the client faced, what the analysis found, and what happened next.
When a Competitor Says You Can't Use the Code
The situation. A device company had developed a new technology in an established procedure space — one dominated by a single market leader. Their device performed the same procedure through a different mechanism. As they prepared for their pivotal clinical trial, a problem surfaced: the market leader's sales reps were telling customers that the existing procedure codes couldn't be used with the new device.
What was at stake. If the incumbent was right, the company faced building a coding strategy from scratch — a process that can take years — before their trial could proceed cleanly. Trial sites would need billing guidance. Timelines, and everything downstream of them, were suddenly at risk. The company didn't need a full reimbursement assessment at that stage; they needed one question answered with confidence: can we use these codes?
The work. Ascalon Market Access analyzed the question the way a payer auditor would — word by word. First, the code descriptions themselves: what does the language actually require? Then the clinical vignettes behind the codes: what procedure do they describe in practice? Finally, the coding-change articles published when the codes were created: what was the intent at the code's origin?
The finding. Nothing in the code language, the vignettes, or the origin documentation supported the competitor's claim. The codes describe a procedure, not a brand — consistent with how the AMA constructs codes across device categories.
The outcome. The company proceeded with its pivotal trial, which fully enrolled with no reimbursement-related delays. When the company was later acquired by a major strategic buyer, Ascalon's coding analysis was presented as part of due diligence — and Ascalon helped draft the reimbursement statements the acquirer reviewed. The conclusion held.
The takeaway. Coding questions are language questions. A confident answer requires scrutinizing every word of a code's description, history, and intent — because that's exactly what an auditor will do. When the analysis is done at that standard, it holds up under the most demanding review there is: an acquisition.
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CODING ANALYSIS
Pricing a First-of-Its-Kind Device Before the Market Exists
The situation. A medical device startup had developed the first treatment of its kind for an acute condition that currently has no treatment at all — today, patients are simply admitted, supported with fluids, and monitored for days or weeks until the episode resolves. With no existing treatment, there was no existing reimbursement playbook: no established codes, no coverage precedent, no payment benchmark.
What was at stake. The founder — a seasoned operator who understood reimbursement — faced a strategic fork that would shape the entire commercial model: price the device low and live within existing hospital payment, or price high and pursue a pathway to increased payment. Investors would ask which. He needed to know what each path actually looked like before he could raise the next round.
The work. Ascalon Market Access delivered a full reimbursement assessment mapping the potential payment pathways for the technology — what payment looks like if nothing changes, and what mechanisms exist to pursue higher payment. The engagement went a step further: a working pro-forma model showing the hospital economics if the device reduces length of stay and complication costs. Not a sales tool — the device wasn't yet cleared for that — but a structured way to have credible conversations with investors and the key opinion leaders the company needed to recruit as study sites and investigators.
The outcome. The founder took the assessment on the road. He's now pitching internationally, building KOL relationships, and raising the round that funds the pivotal trial — with a reimbursement story built in from the start, not bolted on after FDA approval.
The takeaway. For first-of-a-kind technology, reimbursement strategy isn't a post-approval task — it's an input to pricing, fundraising, and trial design. The companies that treat it that way walk into investor conversations with answers instead of assumptions.
Wondering where your technology stands?