Medicare spending on skin substitutes grew from $250 million to over $10 billion between 2019 and 2024. The DOJ's 2025 National Health Care Fraud Takedown charged 324 defendants across 50 federal districts.
The Gehrke/King scheme produced a $1.2 billion fraud conviction and 15-year prison sentences — driven by a distributor paying $279 million in illegal kickbacks.
Dermalynx was built in that environment. With the compliance infrastructure to prove we operate differently.
Fixed-fee, non-volume-contingent sales representative compensation. No per-unit bonuses. No volume thresholds.
OIG/SAM exclusion screening before account activation. Quarterly re-screening of all active accounts.
Every account signs a Compliance Certification before first order. No exceptions.
No Dermalynx representative ever directs a clinical decision. Product selection is the provider's domain.
Immediate order suspension for any customer under federal investigation or with exclusion status changes.
Monthly compliance dashboard review. Annual training for all personnel. Continuous OIG list monitoring.
| Credential | Status |
|---|---|
| FDA HCT/P Establishment Registration (21 CFR § 1271.21) | Active |
| SAM.gov Registration | Active |
| OIG Exclusion List Screening | Monthly (all personnel + customers) |
| cGTP Compliance Program | Implemented |
| Anti-Kickback Statute Training | Annual (all personnel) |
| Customer Due Diligence Program | Pre-onboarding + quarterly |
Ready to work with a distributor built for the compliance era?
Request Account