Centene skin and soft tissue substitutes Coverage Update

Coverage and Medical Necessity Criteria

inv-01: Initial therapy coverage criteria

Covered when ALL of the following are met for diabetic foot ulcer (DFU) or venous leg ulcer (VLU):

Root

Wound type: Wound is diabetic foot ulcer (DFU) OR venous leg ulcer (VLU)
Non-infected wound and indication: Presence of a non-infected wound and requested use complies with policy-specified indications (DFU or VLU)
Standard of Care (SOC) implemented: Documented implementation of standard of care for a minimum of 4 weeks with weekly measurements, including appropriate debridement, offloading for DFU or sustained compression for VLU, infection control, exudate management, and addressing modifiable risk factors
Failure of SOC: Failure to achieve at least 50% reduction in ulcer area despite compliance with SOC for a minimum of 4 weeks<50% reduction in 4 weeks
Documentation: Pre- and post-SOC ulcer measurements (including weekly SOC measurements), photographic documentation, and operative/clinician notes documenting product used (including package label or NDC), amount applied, and any wastage
Preferred product: Request is for one of the listed preferred HCPCS products or justification provided if requesting a non-preferred product
Application limits: Only one skin substitute simultaneously in place per wound episode; product change within an episode is allowed but total number of applications per wound per 12-16 week episode must not exceed the policy limit
Maximum applications per wound per 12-16 week episode (policy upper limit) not to exceed policy-specified application limit

DFU-specific documentation: For DFU include assessment of diabetes type and management history and review of current blood glucose/HbA1c; documentation that modifiable risk factors (eg, neuropathy, vascular disease, osteomyelitis) are being addressed

VLU-specific documentation: For VLU include clinical history (prior ulcers, BMI, pregnancies, activity), physical exam for edema and venous competence, and documentation supporting use of firm-strength compression (>20 mmHg) or multi-layer compression

inv-02: Extended therapy documentation

Extended or additional applications:

Extended use rationale: If more than four applications are applied in a 12-16 week period, documentation must include why the current plan has resulted in healing and the expectation it will continue to heal with this plan

Risk factor management: Documentation that modifiable risk factors (for example, diabetes optimization) are being addressed to improve likelihood of healing

Treatment plan: Estimated time for extended treatment, anticipated number of additional applications, and contingency plan if healing is not achieved as planned

VLU additional requirement: For venous ulcers, include appropriate consultation and management for diagnosis and stabilization of venous-related disease

inv-03: General medical necessity criteria (partial)

Covered when clinical criteria and coding align with policy tables and the patient meets clinical eligibility:

Indication match: Product is intended for a chronic wound or full-thickness skin-loss ulcer and the request is for an indication noted in the policy; request must comply with FDA‑approved indications and application limits where applicable

Policy applies to non‑Medicare plans

Diabetic control: HbA1c <8% OR documented improvement of blood glucose in the last 4 weeksHbA1c <8%

HbA1c >8% or no documented improvement in the last 4 weeks is a contraindication

Nicotine use: Documentation of effort to cease nicotine use OR no nicotine use for at least 4 weeks4 weeks

Nicotine replacement therapy does not count as cessation

inv-04: Covered indications with criteria

Covered when ALL of the following are met (policy updated):

General coverage: Indication matches policy-specified chronic wounds (including DFU, VLU, and full-thickness skin-loss ulcers), request complies with FDA-approved indications and application limits, and measurable wound response meets policy thresholdsWound area reduction <50% in 4 weeks used to define inadequate response

Policy text updated to include soft tissue substitutes and to clarify application limits and preferred product list

inv-05: HCPCS codes not supporting medical necessity

Not covered / Do not support medical necessity:

HCPCS codes that do not support medical necessity: Use of HCPCS codes listed in HCPCS Table 2 (codes enumerated in the policy coding tables) does not support medical necessity under this policy

Multiple Q- and A-codes have been moved to or added to Table 2 as not supporting medical necessity

Placement of skin or soft tissue substitutes on wounds with active infection, progressive necrosis, ischemia, or an otherwise nonviable wound bed is contraindicated and may result in claim denial. The policy explicitly states that products should not be placed on an infected, ischemic, or necrotic wound bed and lists active infection, progressive necrosis, active Charcot arthropathy, active vasculitis, and ischemia as conditions that may lead to denial.

This policy does not support use of liquid or gel formulations of skin substitute products for ulcer care; those product types are listed as not medically necessary. Additionally, routine simple or repeat skin replacement surgery and use of surgical preparation services alone (for example debridement) with application of a skin substitute are identified as excluded scenarios.

Application technique and documentation requirements: products must be applied in a single layer without overlay and in accordance with the product label. An operative note must document the product used (including package label or NDC), the amount administered, photo documentation of ulcer baseline and follow-up with measurements (size and depth), and any wastage (date, time, amount, and reason). Where multiple sizes exist, the size that best fits the wound with the least wastage must be used.

Requests for skin and soft tissue substitutes for indications that are not specifically listed in this policy are outside the scope of coverage. The policy adds an explicit note that uses other than the indications noted here are not covered and may be denied.

Providers should verify that the requested indication (for example diabetic foot ulcer, venous leg ulcer, or full‑thickness skin‑loss ulcer) is included in the policy before submitting an authorization request; requests for indications not described by the policy should not be submitted under this coverage document.

Substitutes requested for conditions or purposes other than those enumerated in the policy (chronic wounds and full‑thickness skin‑loss ulcers as specified) are outside the policy scope. The policy reiterates that only the indications noted in the document fall under this coverage guideline.

If providers seek authorization for a product as a substitute for an unlisted indication, that request is considered out of scope and may be administratively denied or redirected to the appropriate policy covering that indication.

Repeat applications are considered not medically necessary when a prior application was unsuccessful. The policy defines an unsuccessful prior application as one where the ulcer has increased in size or depth, shows no measurable change from baseline, and demonstrates no sign of improvement or indication that improvement is likely (for example absence of granulation or epithelialization).

The policy also limits the number of applications per episode of care: more than 8 applications within an episode of care (up to 16 weeks) is not medically necessary. For extended or additional applications beyond routine limits, the documentation must include clinical rationale, evidence that the current plan has resulted in healing and is expected to continue, management of modifiable risk factors, estimated number and timing of additional applications, and a contingency plan if healing is not achieved.

When HCPCS codes listed in the policy's "do not support medical necessity" table are used for chronic wound indications governed by this policy, those codes are governed by this document and considered not to support medical necessity. Use of these codes for covered indications may trigger denial under this policy.

Providers must select and submit the HCPCS codes that correspond to products listed in the policy's supporting table (Table 1). Codes moved to or listed in Table 2 (the not‑supporting list) should not be submitted for indications covered under this policy.

Products or services billed with HCPCS codes that appear in the policy's "do not support medical necessity" table are considered to not support medical necessity for chronic wound indications under this policy. The policy documents that multiple Q‑ and A‑codes have been moved into the not‑supporting list and that items billed under those codes are not supported.

Operationally, submission or billing using a not‑supporting HCPCS code for an indication governed by this policy may result in claim denial; providers should confirm the correct HCPCS code from the policy's Table 1 (supporting codes) before submitting authorization requests or claims.

Coding, HCPCS and CPT Tables

Covered CPT CodesCPT

15271	Application of skin substitute to trunk; arms; total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area
15272	Application of skin substitute to trunk; arms; total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area
15273	Application of skin substitute to trunk; arms; total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area
15274	Application of skin substitute to trunk; arms; total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area
15275	Application of skin substitute 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
15276	Application of skin substitute to face... each additional 25 sq cm
15277	Application of skin substitute to face... total wound surface area greater than or equal to 100 sq cm; first 100 sq cm
15278	Application of skin substitute to face... each additional 100 sq cm

HCPCS product codes referencedHCPCS

A2008	TheraGenesis (per sq cm)
A2019	Kerecis Omega3 Margen Shield (per sq cm)
Q4101	Apligraf (per sq cm)
Q4102	Oasis Wound Matrix (per sq cm)
Q4104	Integra Bilayer Matrix Wound Dressing (per sq cm)
Q4105	Integra dermal regeneration template/Omnigraft (per sq cm)
Q4106	Dermagraft (per sq cm)
Q4107	Graftjacket (per sq cm)
Q4110	PriMatrix (per sq cm)
Q4111	Gammagraft (per sq cm)

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HCPCS codes that support medical necessity (partial list)HCPCSCovered

A2008	.
A2019	Kerecis Omega3 MariGen Shield_per sq cm
Q4101	Apligraf,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
Q4106	Dermagraft_per sq cm
Q4107	Graftjacket_per sq_cm_
Q4110	PriMatrix,_per sq cm
Q4111	Gammagraft_per sq cm
Q4115	Alloskin,_per sq cm

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HCPCS/C codes that do not support medical necessity (partial list)mixedNot Covered

A2001	ACS_ Advanced Wound System (ACS)
A2002	Mirragen Advanced Wound Matrix, per sq cm
A2005	Microlyte Matrix,per sq cm
A2007	Restrata,per sq cm
A2009	Symphony_per sqcm_
Q4100	Skin substitute, not otherwise specified
Q4103	Qasis burn matrix_per sq cm
Q4104	Integra bilayer matrix wound dressing (BMWD)per sq cm
Q4106	Dermagraft,_per sq cm
Q4116	AlloDerm,per sq_cm

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HCPCS codes (various tables)HCPCS

A2002	HCPCS code referenced (moved between tables)
A4225	HCPCS code description updated
A2003	Deleted HCPCS code (removed from policy)
Q4236	HCPCS code referenced (moved between tables)
Q4239	HCPCS code referenced in not-support list
Q4253	HCPCS code added to Table 1
Q4262	HCPCS code moved/added
Q4263	HCPCS code moved/added
Q4264	HCPCS code moved/added
Q4278	HCPCS code added to supporting list

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Standard of care trial duration — Minimum 4 weeks of SOC with documentation requirement

Minimum SOC durationMinimum 4 weeks of documented standard of care (SOC) with weekly measurements prior to considering a skin or soft tissue substitute

SOC documentation requiredPre- and post-SOC ulcer measurements and weekly SOC measurements must be recorded (including debridement, offloading for DFU or sustained compression for VLU)

SOC componentsSOC includes infection control, edema management, debridement, offloading/compression, exudate management, and addressing modifiable risk factors

SOC failure thresholdFailure to achieve at least 50% ulcer area reduction despite compliance with SOC for the minimum 4-week trial

Episode of care duration — 12-16 week episode of care and application limits per episode

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for the skin and soft tissue substitute products listed in the policy. Requests must demonstrate that the indication matches the policy criteria (including full‑thickness skin‑loss ulcers where applicable) and that application limits and FDA‑labeled indications are respected.

Prior authorization must document compliance with all medical necessity criteria and with any product‑specific application limits.
HCPCS codes supporting medical necessity are listed in the policy; codes in the "do not support" table should not be requested for covered chronic wound indications.

Documentation Required

Standard of Care (SOC) and Failure Documentation

Document the standard of care (SOC) delivered and the wound's response. Requests must include evidence that SOC was implemented for a minimum of 4 weeks and that the wound has failed to heal or is stalled despite SOC.

Pre‑SOC ulcer measurements and weekly SOC measurements must be in the record.

Background and Scope

Chronic wounds are wounds that have failed to progress through normal healing and are physiologically impaired for four weeks or longer. Examples include diabetic foot ulcers and venous leg ulcers that do not respond to standard management.

Standard of care (SOC) for lower‑extremity chronic wounds includes infection control, edema management, mechanical offloading for diabetic foot ulcers or sustained compression for venous leg ulcers, appropriate wound debridement, management of exudate, and optimization of systemic conditions (for example glycemic control and smoking cessation efforts). Skin and soft tissue substitutes (cellular or acellular products) may be considered adjuncts when ulcers fail to respond to SOC.

The policy requires documentation of SOC implementation and failure (including pre‑ and post‑SOC measurements and photographs) and operative documentation for each application (product identity with package label or NDC, amount used, and waste documentation) to support medical necessity for use of these products.

Definitions

Chronic wound definition — Physiologic impairment and examples

DefinitionA chronic wound is a wound physiologically impaired due to disruption of the wound healing cycle (impaired angiogenesis, innervation, cellular migration, or other deficits) for 4 weeks or longer

Clinical contextChronic wounds may fail to progress through normal healing despite SOC and may benefit from adjunctive skin or soft tissue substitutes

Standard care componentsSOC for chronic wounds includes infection control, edema management, offloading or compression, debridement, systemic disease management, and appropriate dressings

Skin substitute definition — Cellular vs acellular products and categorization

DefinitionSkin substitutes are products that replace extracellular matrix and may be cellular (comprised of living cells) or acellular (synthetic or devitalized tissue)

Categorization

OpenPayer

Clinical Policy: Skin and Soft Tissue Substitutes for Chronic Wounds

Coverage and Medical Necessity Criteria

Coding, HCPCS and CPT Tables

Provider Requirements, Prior Authorization, and Documentation

Background and Scope

Definitions