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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 HCPCS A-codes and Q-codes. It also clarifies claim-submission requirements for the associated application services.

Providers must follow these requirements to support accurate payment and avoid claim rejection or denial.

Background

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

CMS classifies non-sheet skin and sheet substitute products as supplies for pricing and reimbursement purposes.

The 3.81 relative value units that were assigned to the applicable non-sheet skin substitute product codes are used to establish payment based on the documented square centimeter wound size. This is consistent with the methodology CMS used to establish allowances for sheet skin substitute products under the Medicare Physician Fee Schedule. We understand that non-sheet skin substitute products are not packaged, labeled, or distributed in square-centimeter units. However, per CPT the definition of a skin substitute graft: Include non-autologous human skin (e.g., dermal or epidermal, cellular and acellular) grafts (e.g., homograft, allograft), non-human skin substitute grafts (i.e., xenograft), and biological products that form a sheet scaffolding for skin growth. Therefore, for payment purposes, the allowance is based on the documented wound size in square centimeters. The use of square centimeters provides a consistent basis for determining payment based on the area treated. It does not imply that the product itself must be packaged or marketed by square centimeter. 

First Coast then applies the applicable geographic practice cost indices, or GPCIs, applied when establishing the locality-specific allowances. This is consistent with the methodology CMS used to establish allowances for sheet skin substitute products under the Medicare Physician Fee Schedule.

Accordingly, the payment calculation reflects the 3.81 RVUs assigned to the non-sheet skin substitute product, the documented wound size in square centimeters, the applicable GPCIs, and the Medicare Physician Fee Schedule conversion factor.

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
  • A2026 – Restrata MiniMatrix, 5 mg
  • A2028 – MicroMatrix Flex, per mg
  • 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
  • A2044 - Biobrane glove, each
  • 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 amniotic, 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 amniotic, 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 square centimeters; first 25 square centimeters 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 square centimeters; each additional 25 square centimeters of wound surface area, or part thereof (list separately in addition to the code for the 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 area greater than or equal to 100 square centimeters; first 100 square centimeters of wound surface area, or 1% of the 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 area greater than or equal to 100 square centimeters; each additional 100 square centimeters of wound surface area or part thereof, or each additional 1% of the body area of infants and children, or part thereof (list separately in addition to the code for the 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 First Coast to:

  • Identify the furnished product;
  • Verify the documented wound surface area treated in square centimeters; and
  • Determine the appropriate product payment amount. 

At a minimum, documentation must include:

  • Product name and/or manufacturer
  • The total wound size in square centimeters, and 
  • Medical documentation supports the medical necessity for the service performed.

Under Section 1833(e) of the Social Security Act, Medicare cannot make payment when a claim lacks the information necessary to determine the appropriate payment amount. Accordingly, First Coast will deny claims submitted without sufficient documentation.

Claims submission and payment requirements

Effective for all claims submitted on or after January 1, 2026, providers must report the appropriate non-sheet application code (G0681–G0684) on the same claim and same date of service as the applicable non-sheet skin substitute product A-code or Q-code.

First Coast will reject claims that:

  • Do not include the required application code;
  • Report a Not Otherwise Classified code in place of the appropriate application code; or
  • Report an injection code in place of the appropriate non-sheet application code.

Skin substitute classification and wastage

CMS classifies both sheet and non-sheet skin substitute products as supplies for Medicare payment purposes. Skin substitute products are not treated as drugs or biologicals under the discarded-amount policy.

The JW and JZ modifiers and Medicare’s discarded-amount policy apply to applicable separately payable drugs and biologicals. They do not apply to supplies. Therefore, the JW and JZ modifiers are not appropriate for either sheet or non-sheet skin substitute products.

For non-sheet skin substitute products, First Coast determines payment based on the documented wound surface area treated in square centimeters - not on the total volume, weight, number of units, or amount of product contained in the package.

When a package or container contains more product than necessary to treat the documented wound surface area, any remaining unused or discarded product does not increase the payable amount. Medicare does not provide separate payments for the unused or discarded portion of a skin substitute supply.

Providers should not report unused or discarded skin substitute products as wastage. Claims for skin substitute products submitted with the JW or JZ modifier will be rejected for dates of service on or after January 1, 2026.

Provider action

Providers should review their billing, documentation, and coding practices to ensure compliance with these requirements before submitting claims.