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Approval is Not Revenue. Reimbursement Is.

Don't let your cleared device sit on the shelf. We engineer a Market Access Strategy targeting Korea's HIRA and the US CMS/AMA, ensuring your product gets paid for.

Korea HIRA Method

We pre-determine if you fall under "Existing Tech" or the rigorous "nHTA" track, predicting your exact reimbursement price (Won).

US CPT Strategy

We navigate the CPT/HCPCS coding maze and build coverage manuals for US Private Payers.

Value Story

Regulators care about safety; Payers care about money. We translate your clinical data into an economic value proposition that justifies your price.

Why Choose Leanabl?

Data-Driven Logic

We don't guess. We analyze thousands of precedent cases from HIRA and CMS to find the coding path with the highest probability of success.

Clinical-Economic Bridge

Our team includes both PhD researchers and billing specialists, ensuring your clinical arguments translate into financial reality.

Full Lifecycle Support

From early feasibility analysis to fighting claim denials post-launch, we stick with you until the money hits your account.

Our Engagement Process

1
Phase 1 - Week 1-2

Feasibility Audit

We review your device's mechanism of action and intended use to identify potential CPT/EDI codes.

2
Phase 2 - Week 3-6

Strategy Development

We model 3 scenarios (Best, Base, Worst case) for pricing and build the dossier to support the Best case.

3
Phase 3 - Week 7+

Payer Submission

We submit the application to HIRA (Korea) or guide your Key Opinion Leaders (KOLs) for AMA CPT applications.

Key Deliverables

Comprehensive Market Access Roadmap
Reimbursement Price Simulation Report
Payer Value Dossier (PowerPoint/PDF)
HIRA/CMS Application Filling