For over 20 years, Mediclever has guided global medtech leaders through the complexities of the US healthcare system—from FDA clearance to consistent revenue.
Navigating the US Reimbursement Landscape
Success in the US market requires a dual focus on public (Medicare/Medicaid) and private (Commercial) payers. Our landscape analysis identifies:
- Coding Identification: Precision mapping to existing CPT (Level I) and HCPCS (Level II) codes or ICD-10-PCS for inpatient settings.
- Payment Mechanisms: Analysis of MS-DRG (Inpatient), APC (Outpatient), and various Fee-for-Service schedules.
- Gap Analysis: Determining if your device requires a new code application or a modification to existing Medicare National (NCD) or Local (LCD) coverage determinations.
- Our US-based consultants identify the key decision-makers at CMS and major private payers (UnitedHealthcare, Anthem, Aetna) to lay out a realistic timeline for market access.
Payer-Centric Evidence Planning
Payers like the Blue Cross Blue Shield Association’s TEC require specific clinical endpoints. We help you generate the "Value Story" they demand:
- Clinical Data Optimization: Aligning clinical trials with US payer expectations to prevent "Experimental/Investigational" denials.
- Economic Modeling: Creating Budget Impact Models (BIM) and Cost-Effectiveness Analyses (CEA) tailored for US stakeholders.
- Stakeholder Advocacy: We facilitate direct interviews with US payer medical directors to validate your reimbursement strategy before heavy investment.
Market Access Implementation
Execution is where the "Valley of Death" is crossed. We handle:
- CPT/HCPCS Applications: Managing the rigorous application process with the AMA and CMS.
- Provider Billing Guides: Equipping your sales team with clear instructions for hospital coding and billing staff.
- Interim Funding: Securing New Technology Add-On Payments (NTAP) and Transitional Pass-Through (TPT) status.
USA Reimbursement FAQs
How do medical devices obtain Medicare coverage in the USA?
Medicare coverage is established through National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs). Success depends on proving clinical benefit category alignment and medical necessity.
Can reimbursement be pursued before FDA clearance?
Yes. In fact, waiting until after FDA clearance often results in a 2-year "revenue gap." Planning for coding and evidence should happen during the clinical trial phase.
Why Mediclever for US Market Access?
We are not just analysts; we are advocates. Our team understands the nuances between Medicare Advantage and traditional Medicare, and how to navigate the regional variances of Medicare Administrative Contractors (MACs).