Every compliance detail, published. The move no bad actor in this industry would dare make.
HCT/P establishment registration requirements. Donor eligibility, cGTP, and establishment registration.
Prohibits offering, paying, soliciting, or receiving anything of value to induce referrals. Dermalynx uses fixed-fee, non-volume-contingent compensation.
Liability for knowingly submitting false claims to government programs. Our documentation practices ensure accuracy.
Physician self-referral prohibition. Dermalynx's commercial structure avoids prohibited financial relationships.
Designated officer with authority to implement and enforce compliance policies.
All personnel complete AKS and compliance training annually. Documented and tracked.
Monthly screening of all personnel and customers against the OIG List of Excluded Individuals and Entities.
Pre-onboarding compliance certification required. Quarterly due diligence thereafter.
Confidential reporting mechanism for compliance concerns.
Monthly compliance dashboard. Quarterly internal audits. Annual program review.
Effective January 1, 2026, CMS implemented a flat-rate payment of approximately $127.14 per square centimeter for skin substitute grafts and cellular/tissue-based products (CAMPs) in the physician office and non-excepted off-campus provider-based department settings. This replaces the prior ASP- or WAC-based reimbursement methodology.
Prior to 2026, Medicare reimbursed most skin substitutes at ASP + 6% or WAC + 6%. The resulting pricing dispersion — with some products billed at more than ten times the cost of clinically comparable alternatives — became a focal point of Medicare Part B fraud enforcement and was the direct driver of the 2025 DOJ takedowns. The CY 2026 HOPPS / ASC / MPFS final rule consolidates payment into a single rate applied per square centimeter of applied product, regardless of brand.
The reform collapses the margin case for high-price products and shifts the basis for product selection from reimbursement arbitrage to clinical fit, coverage determination, and documentation integrity. Facilities should expect: product acquisition cost as a more meaningful line item, tighter pre-authorization and medical-necessity review, continued LCD/NCD-driven coverage rules by wound etiology, and heightened audit scrutiny of application volume and wound documentation.
Our pricing is uniform and transparent. Our sales representatives are compensated on a fixed-fee, non-volume-contingent basis — no incentive exists to drive per-unit application volume. Our customer onboarding includes a compliance certification affirming the facility will bill consistent with LCDs and NCDs and maintain wound-care documentation sufficient to support medical necessity on audit. We do not offer clawback insurance and will not participate in schemes designed to preserve pre-reform margins.
Primary source: CMS Calendar Year 2026 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System Final Rule (CMS-1809-FC). Current as of 17 April 2026.
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Policies last reviewed: April 2026 · Next scheduled review: October 2026