Skin substitutes and tissue-based products, explained clearly.
Nine Line Solutions, LLC, a veteran-owned healthcare solutions business based in Houston, Texas, helps physicians, wound care centers, and practice teams across Houston and Southeast Texas understand skin substitutes and cellular and tissue-based products (CTPs), from product characteristics to documentation and reimbursement.
Skin substitutes include many different materials, technologies, and regulatory pathways. Knowing those differences is an important part of choosing a product.
Common product categories
Placental and amniotic allografts
Dehydrated or hydrated amniotic, chorionic, and umbilical tissue membranes processed from donated birth tissue. These products provide an extracellular matrix scaffold containing collagen, growth factors, and cytokines.
Acellular dermal matrices
Human or animal dermis processed to remove cells while keeping the collagen framework, used as a scaffold for tissue ingrowth.
Xenografts
Tissue-based matrices sourced from animals, such as porcine, bovine, equine, or fish skin, processed for wound applications.
Synthetic and bioengineered products
Synthetic polymer matrices and bioengineered constructs, some containing living cells, designed to support wound closure.
Wharton’s Jelly and umbilical tissue products
Umbilical cord connective tissue rich in collagen, hyaluronic acid, and growth factors. For more on Wharton’s Jelly, exosomes, and stem cell products, see our Biologics & Regenerative Medicine page.
Regulatory pathways matter
Skin substitutes reach the market through different FDA pathways, and the pathway affects how a product may be used, marketed, and paid for:
- 361 HCT/Ps: human cells, tissues, and cellular and tissue-based products regulated solely under Section 361 of the Public Health Service Act, generally minimally manipulated and intended for homologous use
- 510(k) cleared devices: products cleared as substantially equivalent to an existing device
- PMA approved devices: products approved through premarket approval
- 351 BLA biologics: products licensed through a Biologics License Application
2026 Medicare payment changes
Starting January 1, 2026, Medicare pays for most skin substitute products as incident-to supplies when used with a covered application procedure in the physician office or hospital outpatient setting, instead of paying a product-specific Average Sales Price. Medicare set a single national rate of about $127 per square centimeter, which is geographically adjusted. Products licensed under a Section 351 BLA continue to be paid under the ASP methodology.
- Medicare does not pay separately for discarded or unused portions, so estimate the size you need before opening a product
- Document the exact amount applied, wound measurements, and product identification in the medical record
- The coverage policies (Local Coverage Determinations) proposed for diabetic foot ulcers and venous leg ulcers were withdrawn before they took effect, so existing contractor policies still apply
- CMS has indicated it plans separate payment rates for each FDA category in future years
Sources: CMS CY 2026 Physician Fee Schedule Final Rule fact sheet; CMS billing and coding article A56696.
Questions we help you work through
- Product composition, sourcing, processing, and available sizes
- FDA pathway and intended use
- Published evidence relevant to the wound type
- Manufacturer instructions, application resources, and staff education
- Ordering, inventory, storage, and product tracking
- Payer coverage, prior authorization, coding, and documentation requirements
These products should be used within a full wound care plan that addresses underlying conditions and appropriate standard care.
Request Skin Substitute Information
This information is educational and is not medical, legal, or billing advice. Coverage, coding, and payment rules vary by payer, product, indication, setting of care, and date of service, and they change frequently. Practices are responsible for verifying current requirements and submitting accurate claims. Product selection and patient care decisions belong to qualified healthcare professionals. No product availability, treatment outcome, insurance coverage, or reimbursement is guaranteed.
Please do not submit medical records, insurance information, or other sensitive health information through public forms. For medical emergencies, call 911.