Centene Skin Substitutes Coverage Update

Medical Necessity and Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Overall prerequisites: Wound is chronic (no response to ≥4 weeks of organized, comprehensive, conservative therapy); wound characteristics and treatment plan documented; standard wound care has failed; nicotine cessation effort documented (or no nicotine use); wound meets specified characteristics; circulation adequate; product use complies with FDA indications and application limits; only one skin substitute in place per wound episode; treatment duration typically ≤12 weeks; no contraindications.

See detailed child nodes.

Standard wound care failed: The ulcer or skin deficit has been treated with appropriate wound-care measures including debridement, standard dressings, compression, off-loading, and wound area has reduced <50% in four weeks.<50% reduction in 4 weeks indicates failure

From Policy/Criteria C.1-2

Nicotine: Documentation of effort to cease nicotine use (excluding nicotine replacement therapy) for at least four weeks during conservative wound care and prior to planned bioengineered skin replacement therapy, or documentation of no nicotine use.4 weeks

Policy/Criteria D

Wound characteristics: Partial- or full-thickness ulcer with a clean, granular base; no involvement of tendon, muscle, joint capsule, exposed bone or sinus tracts unless Integra is used per FDA guidelines; no wound infection; wound must be clean and free of necrotic debris or exudate; member has adequate circulation/oxygenation to support healing (e.g., ABI ≥ 0.6 or toe pressure > 30 mmHg).ABI ≥ 0.6 or toe pressure > 30 mmHg

Policy/Criteria E

Indication-specific: One of: (1) Diabetic foot ulcer in a patient with Type 1 or 2 diabetes under medical management with ≥4 weeks documented conservative care and no osteomyelitis; (2) Venous leg ulcer: chronic, non-infected VLU failed ≥4 weeks documented conservative care with documented compliance and completed assessment including history, physical exam, ABI and duplex/venous duplex; (3) Full-thickness skin-loss (e.g., from abscess, injury, trauma) that has failed appropriate control of infection/foreign body/tumor resection or other disease process for ≥4 weeks.4 weeks for conservative care

Policy/Criteria F.1-3

Product limits & FDA compliance: Requested use must comply with FDA-approved indications for the specific product; requested applications must not exceed 10 applications per wound per 12-week episode; only one skin substitute may be simultaneously in place per wound episode (product change within episode allowed but total applications still must not exceed 10).<= 10 applications per wound per 12-week episode

Policy/Criteria G-H

Contraindications: None of the following present: inadequate control of underlying conditions or exacerbating factors (e.g., uncontrolled diabetes, active infection, active Charcot arthropathy, vasculitis, continued tobacco smoking without physician attempt at cessation); known hypersensitivity to product components (e.g., avian, bovine, porcine, equine); partial-thickness loss with retention of epithelial appendages.

Policy/Criteria I

Not Medically Necessary / Exclusions

Not reasonable and necessary scenarios: Partial-thickness loss with retention of epithelial appendages (epithelium will repopulate the deficit); simultaneous use of more than one product for the episode of wound care is not covered (product change within episode allowed but total applications must not exceed 10); repeat or alternative applications when a previous full course was unsuccessful (defined as increase in size/depth or no change and no sign of improvement for 4 weeks past start of therapy); retreatment of healed ulcers (>75% size reduction and <0.5 sq cm) is not covered; retreatment within one year for venous leg ulcers or diabetic foot ulcers is considered treatment failure and not reasonable and necessary; skin substitute grafts are contraindicated with inadequate control of underlying conditions or continued tobacco smoking without cessation attempt.

Policy/Criteria II.A-II.G

Simultaneous application of more than one skin substitute product during a single episode of wound care is not covered. The policy permits a product change within the episode only if the total number of applications does not exceed 10 applications per wound per 12-week episode, and the clinical record documents the rationale for changing products. Partial-thickness wounds that retain epithelial appendages are excluded from grafting or replacement because the residual appendages are expected to re-epithelialize the deficit. Additionally, retreatment within one year for venous leg ulcers or diabetic foot ulcers following a previous full course that was unsuccessful is considered treatment failure and is not medically necessary. These exclusions align with the policy limits that typical treatment duration is ≤ 12 weeks and that repeat or alternative applications after an unsuccessful full course are not reasonable and necessary.

The HCPCS and Q-codes listed in this policy segment are specifically designated as codes that do not support the policy’s medical necessity criteria. Inclusion on these lists indicates that billing or use of those codes/products is not supported by the medical necessity requirements described in this document and may subject the claim to denial or require additional review.

Examples of HCPCS/Q-codes identified as not supporting the medical necessity criteria include (non‑exhaustive): A2005–A2018, C9358, C9360, C9363 and multiple Q‑codes such as Q4112, Q4113, Q4114, Q4130, Q4145, Q4189–Q4200, Q4210–Q4235, Q4244–Q4252, Q4263–Q4279, Q4287–Q4304. These specific product codes and their descriptions are listed in the coding section of the policy; presence on these lists means the code is not supported by the medical necessity criteria in this segment.

Use or billing of the HCPCS/Q-codes identified as not supporting medical necessity within this policy segment may be considered not medically necessary under the referenced criteria and could trigger claim denial. Providers should verify coverage and, when appropriate, select products and codes that meet the policy’s documented clinical prerequisites (for example, prior organized conservative care for ≥ 4 weeks, evidence of failed response defined as <50% wound area reduction in 4 weeks, and documented adequate perfusion).

Billing and Coding

Covered CPT CodesCPTCovered

15271	Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area.
15272	Application of skin substitute graft to trunk, arms, legs, total 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).
15273	Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children.
15274	Application of skin substitute graft to trunk, arms, legs, total wound surface area 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).
15275	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area.
15276	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total 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).
15277	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children.
15278	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area 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).

HCPCS/Covered product codesHCPCSCovered

A2001	InnovaMatrix AC, per sq cm.
A2002	Mirragen Advanced Wound Matrix, per sq cm.
A2004	XCelliStem, per sq cm.
A2008	TheraGenesis, per sq cm.
Q4100	Skin substitute, not otherwise specified.
Q4101	Apligraf, per sq cm.
Q4102	Oasis wound matrix, per sq cm.
Q4103	Oasis burn matrix, per sq cm.
Q4104	Integra bilayer matrix wound dressing (BMWD), per sq cm.
Q4105	Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per sq cm.

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HCPCS codes that do not support medical necessity criteriaHCPCSNot Covered

A2005	Microlyte Matrix, per sq cm.
A2006	NovoSorb SynPath dermal matrix, per sq cm.
A2007	Restrata, per sq cm.
A2009	Symphony, per sq cm.
A2010	Apis, per sq cm.
A2011	Supra SDRM, per sq cm.
A2012	Suprathel, per sq cm.
A2013	Innovamatrix FS, per sq cm.
A2014	Omeza Collagen Matrix, per 100 mg.
A2015	Phoenix Wound Matrix, per sq cm.

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HCPCS codes that do not support medical necessity criteria (part 1)HCPCSNot Covered

A2005	Microlyte Matrix, per sq cm
A2006	NovoSorb SynPath dermal matrix, per sq cm
A2007	Restrata, per sq cm
A2009	Symphony, per sq cm
A2010	Apis, per sq cm
A2011	Supra SDRM, per sq cm
A2012	Suprathel, per sq cm
A2013	Innovamatrix FS, per sq cm
A2014	Omeza Collagen Matrix, per 100 mg
A2015	Phoenix Wound Matrix, per sq cm

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HCPCS codes that do not support medical necessity criteria (part 2)HCPCSNot Covered

Q4189	Artacent AC, 1 mg
Q4190	Artacent AC, per sq cm
Q4191	Restorigin, per sq cm
Q4192	Restorigin, 1 cc
Q4193	Coll-e-Derm, per sq cm
Q4194	Novachor, per sq cm
Q4198	Genesis Amniotic Membrane, per sq cm
Q4199	Cygnus matrix, per sq cm
Q4200	SkinTE, per sq cm
Q4202	Keroxx (2.5 g/cc), 1 cc

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Ankle-Brachial Index (ABI) threshold

Ankle-Brachial Index (ABI) thresholdABI ≥ 0.6

Measurement purposeEvidence of adequate circulation/oxygenation to support tissue growth and wound healing

Documentation requirementRecord ABI value in medical record prior to CTP application

Toe pressure

Toe pressure thresholdToe pressure > 30 mmHg

Measurement purposeSupports adequate peripheral perfusion for wound healing

Provider Responsibilities, Authorization, and Documentation

Prior Authorization

Prior Authorization and Coverage Verification

Prior authorization is required. Providers must verify member coverage and obtain prior authorization per the Health Plan’s policies and any applicable Medicare NCDs/LCDs before scheduling or performing skin substitute applications.

Prior authorization required for listed CPT and HCPCS codes (see coding section).
Verify member benefits, eligibility, and prior authorization requirements with the Health Plan before treatment.

Documentation Required

Conservative Therapy Prerequisite

Conservative, organized wound care must be completed and documented prior to consideration of skin substitute therapy. Conservative therapy includes infection and edema control, debridement, appropriate dressings, mechanical off‑loading (for DFU), compression or limb elevation (for VLU), and management of comorbid conditions (e.g., glycemic control, nicotine cessation).

Wound must have failed at least four weeks of documented organized conservative therapy.

Clinical Background

Chronic lower‑extremity wounds such as diabetic foot ulcers (DFU), venous leg ulcers (VLU), and full‑thickness skin loss commonly result from diabetic neuropathy, venous stasis disease, pressure, or trauma and often require comprehensive measures including infection and edema control, mechanical off‑loading or compression, debridement, and management of systemic disease. When a wound fails to respond to organized conservative therapy for at least 4 weeks—for example, showing <50% area reduction in 4 weeks—the wound may be considered for application of a cellular and/or tissue‑based product (CTP) provided other criteria are met (clean granular base, no tendon/muscle/joint capsule/exposed bone unless allowed by FDA labeling, absence of infection, and adequate circulation such as ABI ≥ 0.6 or toe pressure > 30 mmHg). CTPs are biologic products intended to stimulate healing of refractory full‑thickness wounds but are not substitutes for addressing underlying systemic or local factors that impede healing.

Definitions and Key Terms

Failed response — definition

DefinitionAn ulcer or skin deficit that has failed to respond to documented appropriate wound-care measures, has increased in size or depth, or has not changed from baseline and shows no indication that improvement is likely (e.g., no granulation or epithelialization)

Clinical implicationFailure determination supports escalation to CTPs when other criteria are met

Typical evidenceDocumented organized conservative therapy including debridement, dressings, compression/off-loading for ≥4 weeks with <50% area reduction

Cellular and/or Tissue-Based Products (CTPs)

DefinitionBiologic products composed of matrices, proteins, growth factors or cells intended to stimulate healing of refractory full‑thickness wounds

Scope

OpenPayer

Skin Substitutes for Chronic Wounds of the Lower Extremities

Medical Necessity and Coverage Criteria

Billing and Coding

Provider Responsibilities, Authorization, and Documentation

Clinical Background

Definitions and Key Terms