Part B billing, payment methodology and documentation requirements for non-sheet skin substitute products
Purpose
This article provides billing, payment methodology and documentation requirements for non-sheet skin substitute products, including applicable Healthcare Common Procedure Coding System (HCPCS) A-codes and Q-codes, and clarifies claim submission requirements for associated application services. Adherence to these requirements is necessary to ensure proper claim processing and to avoid claim rejection.
Background
The Centers for Medicare and Medicaid Services (CMS) distinguishes between sheet and non-sheet skin substitutes products and maintains a published product classification list identifying each product type.
Methodology for pricing non-sheet skin substitutes
First Coast Service Options (FCSO) classifies non-sheet skin substitute products as supplies for pricing and reimbursement purposes. FCSO established payment allowances using a standardized per square-centimeter methodology to ensure consistency and transparency.
FCSO assigned a Relative Value Unit (RVU) of 3.81 and applied it on a per square centimeter basis to determine the base allowance. This RVU reflects the standardized valuation assigned to the product for pricing purposes.
FCSO will apply the Geographic Practice Cost Indices (GPCIs) to the assigned RVU to calculate locality-specific payment amounts. (FCSO, Novitas) then converts the adjusted RVU to the dollar amount using the applicable conversion factor to establish the final allowance.
This methodology ensures that payment reflects the product’s assigned relative value and accounts for geographic cost variation, while maintaining a consistent, reproductive pricing framework across jurisdictions.
Applicable non-sheet skin substitute product codes
HCPCS A-codes
- A2004 – Xcellistem, 1 mg
- A2014 – Omeza collagen matrix, per 100 mg
- A2017 – Permeaderm glove, each
- A2020 – AC5 advanced wound system (AC5)
- A2023 – Innovamatrix PD, 1 mg
- A2025 – Miro3D, per cubic centimeter
- A2026 – Restrata minimatrix, 5 mg
- A2028 – Micromatrix flex, per mg
- A2029 – Mirotract wound matrix sheet, per cubic centimeter
- A2030 – Miro3D fibers, per milligram
- A2033 – Myriad morcells, 4 milligrams
- A2035 – Corplex P or Theracor P or Allacor P, per milligram
- A2037 – G4derm plus, per milliliter
- A4100 - non-sheet form skin substitute,
HCPCS Q-codes
- Q4112 – Cymetra, injectable, 1 cc
- Q4113 – GraftJacket Xpress, injectable, 1 cc
- Q4114 – Integra flowable wound matrix, injectable, 1 cc
- Q4118 – MatriStem MicroMatrix, 1 mg
- Q4139 – AmnioMatrix or BioDMatrix, injectable, 1 cc
- Q4145 – EpiFix, injectable, 1 mg
- Q4149 – Excellagen, 0.1 cc
- Q4155 – NeoxFlo or ClarixFlo, 1 mg
- Q4162 – WoundEx Flow, BioSkin Flow, 0.5 cc
- Q4168 – AmnioBand, 1 mg
- Q4171 – Interfyl, 1 mg
- Q4174 – Palingen or ProMatrx, 0.36 mg per 0.25 cc
- Q4177 – FlowerAmnioFlo, 0.1 cc
- Q4185 – Cellesta flowable amnion (25 mg per cc); per 0.5 cc
- Q4189 – Artacent AC, 1 mg
- Q4192 – Restorigin, 1 cc
- Q4202 – Keroxx (2.5 g/cc), 1 cc
- Q4206 – Fluid Flow or Fluid GF, 1 cc
- Q4212 – Allogen, per cc
- Q4213 – Ascent, 0.5 mg
- Q4215 – Axolotl Ambient or Axolotl Cryo, 0.1 mg
- Q4230 – Cogenex flowable amnion, per 0.5 cc
- Q4233 – Surfactor or NuDyn, per 0.5 cc
- Q4240 – Corecyte, for topical use only, per 0.5 cc
- Q4241 – Polycyte, for topical use only, per 0.5 cc
- Q4242 – Amniocyte Plus, per 0.5 cc
- Q4245 – Amniotext, per cc
- Q4246 – Coretext or Protext, per cc
- Q4310 – Procenta, per 100 mg
Non-sheet application codes
- G0681 – Application of a premarket approval (pma), 510(k), 361 human cells, tissues, or cellular and tissue-based products (hct/p) non-sheet form skin substitute for a wound surface area up to 100 sq cm; first 25 sq cm or less of wound surface area
- G0682 – Application of a premarket approval (pma), 510(k), 361 human cells, tissues, or cellular and tissue-based products (hct/p) non-sheet form skin substitute for a wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (list separately in addition to code for primary procedure)
- G0683 – Application of a premarket approval (pma), 510(k), 361 human cells, tissues, or cellular and tissue-based products (hct/p) non-sheet form skin substitute graft for a wound surface greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children
- G0684 – Application of a premarket approval (pma), 510(k), 361 human cells, tissues or cellular and tissue-based products (hct/p) non-sheet form skin substitute graft for a wound surface greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area or part thereof, or each additional 1% of body area of infants and children, or part thereof (list separately in addition to code for primary procedure)
Billing and documentation requirements
Documentation requirements
Claims for non-sheet skin substitute products must include supporting documentation at the time of claim submission to allow:
- Identification of the furnished product
- Verification of the quantity used
- Determination of the appropriate payment amount
At a minimum, documentation must include:
- Product name and/or manufacturer
- Total wound size in square centimeters
- Medical documentation supporting medical necessity for the service performed
Under Section 1833(e) of the Social Security Act (SSA), Medicare payment cannot be made when the claim lacks the information necessary to determine payment. Accordingly, claims submitted without sufficient documentation will be denied.
Claims submission and payment requirements
Effective for all claims submitted on or after July 6, 2026, for dates of service on or after January 1, 2026, providers must submit all required supporting documentation with the initial claim. They must report the appropriate non-sheet application code (G0681-G0684) on the same claim as a non-sheet skin substitute product (A-codes and Q-codes).
FCSO requires submission of the appropriate application codes(s) with each claim. FCSO will reject claims that do not include the required application code(s), that report Not Otherwise Classified (NOC) codes in place of application code(s), or that use injection codes in lieu of the appropriate application code(s)
The JW and JZ modifiers are not appropriate for billing incident-to supplies, even if such incident-to supplies are payable separately. In addition, discarded amounts of incident-to supplies are not payable by Medicare. Therefore, claims submitted with the JW or JZ modifier will be rejected for claims submitted with dates of service on or after January 1, 2026.
Provider action
Providers should review their billing and documentation practices to ensure compliance with the requirements before submitting claims.