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Mid-size Diagnostics
Commercial, Market Access, Medical Affairs, Finance
FDA-cleared, early commercialization
Infectious Disease Diagnostics
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Mid-size Diagnostics
Commercial, Market Access, Medical Affairs, Finance
FDA-cleared, early commercialization
Infectious Disease Diagnostics
A mid-size diagnostics company was preparing to commercialize a newly FDA-cleared diagnostic intended for use in the emergency department.
Early adoption depended on more than clinical performance. The team needed clarity on reimbursement feasibility, coding options, pricing strategy, and how to communicate value to hospitals and payers.
The client engaged Alkemi to validate reimbursement pathways, define the value story, and guide early commercialization priorities.
1. Assessed emergency department reimbursement pathways and how similar diagnostics achieved payment.
2. Identified relevant analogues and evaluated coding strategies, including PLA options and crosswalk pathways.
3. Interviewed decision-makers to validate real-world billing practices, documentation requirements, and adoption drivers.
4. Built an early value story and ROI model tailored to both clinical and administrative stakeholders.
Reduce reimbursement uncertainty and enable early commercial traction.
"The work provided us with much-needed clarity on reimbursement risk and helped us articulate a compelling value story as we move toward early adoption." - Commercial Leader
Crosswalk and ROI outputs supported CMS discussions and helped defend pricing in CLFS discussions.
The ROI model supported pilot-site engagement and helped build early interest.
Pilot outcomes informed commercialization planning and were used to support additional investor discussions.