Rethinking regulatory tiers: Medicare real-world evidence shows CAMP outcomes are independent of FDA regulatory classification

In Medicare beneficiaries with hard-to-heal wounds, the regulatory pathway or category does not meaningfully predict real-world clinical effectiveness. CAMP therapy plus SoC, regardless of regulatory classification, consistently improves outcomes compared with SoC alone, reducing complications and hospital utilisation across wound sizes and aetiologies. These findings indicate that tiered reimbursement frameworks based on FDA regulatory categories lack empirical justification. Payment policy should instead prioritise demonstrated improvements in patient-centred outcomes, including reductions in amputations, infections, hospitalisations, and total Medicare spending. The evidence supports outcome-based rather than regulatory category-based reimbursement for CAMPs and reinforces the importance of timely CAMP initiation (≈30 days) along with consistent application following parameters for use.