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U.S. Coding and Reimbursement Strategy for a Novel ENT Imaging Device

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Client Profile

Global Medical Device

Key Stakeholders

Market Access Manager

Asset

Pre-Launch / Clinical Development

Disease Area

ENT

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Client Profile

Global Medical Device

Key Stakeholders

Market Access Manager

Asset

Pre-Launch / Clinical Development

Disease Area

ENT

Situation

A global medical device company was evaluating an early-stage ENT imaging innovation as it moved toward clinical development.

The team had limited familiarity with U.S. coding and reimbursement pathways, and product features and timelines were still evolving, creating uncertainty around viable CPT strategy.

The client engaged Alkemi to rapidly assess coding feasibility, identify evidence gaps, and inform early U.S. commercial decision-making.

Approach

1. Assessed the U.S. coding and reimbursement landscape for novel diagnostic imaging devices.

2. Mapped potential coding pathways and eligibility criteria against the device’s attributes and intended use.

3. Identified evidence requirements and gaps that would influence coding feasibility and reimbursement success.

4. Delivered clear recommendations to guide evidence generation and early commercialization planning.

The focus throughout:

Reduce uncertainty early so the team could make confident development decisions.

Deliverables

1
Coding and reimbursement assessment evaluating existing procedural codes and identifying gaps for a novel device.
2
Evidence and criteria mapping to assess product fit against regulatory and coding requirements.
3
Coding and evidence recommendations to support code submission planning and evidence generation strategy.
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Impact

“This project provided much-needed clarity on coding feasibility and reimbursement pathways and helped inform our early commercial planning.” - Market Access Manager

Early, Clearer Decision-Making:

Delivered an early-stage assessment ahead of schedule to support timely coding and evidence strategy decisions.

Reduced Reimbursement Risk:

Identified coding pathways, evidence gaps, and practical next steps to support future U.S. commercialization.

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