CurrentCountyCarePolicy 2742.CC

Skin Substitutes for Wound Management

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This policy governs medical-necessity review and prior authorization for skin substitutes used as adjunctive treatment for chronic, hard-to-heal wounds and other specified skin-loss conditions. It applies to CountyCare providers and members receiving covered medical services.

Policy Summary

PayerCountyCare

PolicySkin Substitutes for Wound Management

Policy CodePolicy 2742.CC

Change TypeNo material change

Effective DateJune 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for all skin substitute services and any newly added applicable procedure codes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 weeksStandard-care period before considering a skin substitute

40-50%

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CurrentCountyCarePolicy 2742.CC

Skin Substitutes for Wound Management

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Policy Summary

PayerCountyCare

PolicySkin Substitutes for Wound Management

Policy CodePolicy 2742.CC

Change TypeNo material change

Effective DateJune 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for all skin substitute services and any newly added applicable procedure codes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 weeksStandard-care period before considering a skin substitute

40-50%

Expected wound-size reduction with standard care

Up to 8Maximum applications in a 12-16-week episode

>4Applications requiring additional documentation

31Listed skin substitute HCPCS codes

RequiredAuthorization requirement

Medical Necessity and Coverage Criteria

Initial Medical-Necessity Criteria

Skin substitutes may be considered when ALL of the following requirements are met:

ALL of the following

The wound is chronic, hard to heal, and appropriate for adjunctive treatment with a skin substitute after failure or inadequate response to standard of care (SOC).
ONE applicable clinical condition
- Diabetic foot ulcer (DFU): a full-thickness neuropathic ulcer measuring at least 1.0 cm² that has not healed after at least 4 weeks of SOC, including offloading, infection control, debridement, limb elevation, and appropriate dressings.
- Venous, pressure, or vascular leg ulcer (VPU/VLU): a chronic, nonhealing wound that has failed standard therapy.
- Second- or third-degree burn where an autograft is insufficient or unavailable.
- Post-surgical reconstruction or other surgical wound where skin coverage is inadequate, particularly when healing is compromised.
- Primary dermatologic condition with a large area of skin breakdown, such as a bullous disease, when standard care is insufficient.
At least 4 weeks of documented SOC has been provided, including wound assessment; infection control; debridement of necrotic tissue; a moist wound environment with appropriate dressings; vascular and metabolic optimization; mechanical offloading when indicated; compression therapy for venous ulcers; tobacco cessation; and management of relevant comorbidities.
The wound has not reduced by approximately 40% in size or depth with conventional treatment and shows no meaningful signs of healing, such as granulation or epithelialization.
The request is supported by appropriate clinical documentation and, for new skin substitutes or procedure codes added to the fee schedule, prior authorization is obtained.

Contraindications and Suitability

The member and wound must be suitable for treatment; coverage is not appropriate when any applicable contraindication or treatment barrier is present.

ALL of the following

The wound bed has no active infection; any infection has been treated before graft consideration.
The member has no known allergy to the proposed graft materials, including collagen or bovine or porcine derivatives.
The wound has adequate vascularization to support graft integration and survival.
Systemic conditions that impair healing, including uncontrolled diabetes or severe malnutrition, are controlled or adequately addressed.
The member can comply with the required wound-care plan and follow-up; concerns include dementia, involuntary motor disease, or other barriers to adherence.

Continuation and Application Limits

Concurrent approval requires ALL of the following continuation and application-limit requirements:

ALL of the following

Treatment goals are reviewed and progress is assessed as treatment continues.
Ongoing documentation demonstrates progress toward a successful outcome, including one or more applicable milestones: no clinical signs of acute infection, formation of granulation tissue, re-epithelialization, reduction in wound size, or successful removal of staples, sutures, or wound-closure strips.
Applications do not exceed eight during a 12- to 16-week episode of care.
More than four applications require strict documentation justifying the additional applications.
A repeat application is not requested after an unsuccessful prior application, defined as increased ulcer size or depth, no measurable change from baseline with no sign of improvement, or no indication that improvement is likely, such as granulation, epithelialization, or progress toward closure.

Any skin substitute not outlined in this policy is considered unproven or experimental and investigational, but may be subject to clinical review.

Coverage requires resolution or adequate management of active infection, allergy to graft materials, inadequate vascular supply, uncontrolled diabetes, severe malnutrition, other systemic healing barriers, and adherence or compliance concerns before treatment. Known or suspected ulcer malignancy and active or major deformity that compromises healing or increases complications are also contraindications.

Repeat applications are not reasonable and necessary when a previous application was unsuccessful, including when the ulcer has increased in size or depth, has shown no measurable change from baseline and no sign of improvement, or lacks an indication that improvement is likely, such as granulation, epithelialization, or progress toward closure.

Application is not reasonable and necessary when underlying conditions or exacerbating factors are inadequately controlled, including active infection, progressive necrosis, active Charcot arthropathy of the ulcer extremity, active vasculitis, or ischemia.

Ulcers that are too superficial—those that do not extend to tendon, muscle, capsule, or bone—are not appropriate for effective skin-substitute coverage and/or healing.

Applicable Codes and Clinical Thresholds

Applicable skin substitute codesHCPCSCovered

Q4101	Apligraf, per sq cm (add-on, list separately in addition to primary procedure)
Q4102	Oasis wound matrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4103	Oasis burn matrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4104	Integra bilayer matrix wound dressing (BMWD), per sq cm (add-on, list separately in addition to primary procedure)
Q4105	Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4107	GRAFTJACKET, per sq cm (add-on, list separately in addition to primary procedure)
Q4108	Integra matrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4110	PriMatrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4111	GammaGraft, per sq cm (add-on, list separately in addition to primary procedure)
Q4112	Cymetra, injectable, 1 cc

1–10 of 19

1/2

CodesHCPCS

Q4101	Apligraf, per sq cm (add-on, list separately in addition to primary procedure)
Q4102	Oasis wound matrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4103	Oasis burn matrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4104	Integra bilayer matrix wound dressing (BMWD), per sq cm (add-on, list separately in addition to primary procedure)
Q4105	Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4107	GRAFTJACKET, per sq cm (add-on, list separately in addition to primary procedure)
Q4108	Integra matrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4110	PriMatrix, per sq cm (add-on, list separately in addition to primary procedure)
Q4111	GammaGraft, per sq cm (add-on, list separately in addition to primary procedure)
Q4112	Cymetra, injectable, 1 cc

1–10 of 31

1/4

Diabetic Foot Ulcer Size

Minimum wound area≥1.0 cm²

Wound typeFull-thickness diabetic foot ulcer

Required statusHas not healed after at least 4 weeks of standard care

Standard-Care Duration

Required treatment periodAt least 4 weeks of standard wound care

Standard-care componentsIncludes offloading, infection control, debridement, limb elevation, proper dressings, and management of relevant comorbidities

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for skin substitute services and applicable procedure codes. The listed codes are not inclusive of all codes that may require prior authorization.

Q4101 — Apligraf, per sq cm; add-on, list separately in addition to primary procedure
Q4102 — Oasis wound matrix, per sq cm; add-on, list separately in addition to primary procedure
Q4103 — Oasis burn matrix, per sq cm; add-on, list separately in addition to primary procedure
Q4104 — Integra bilayer matrix wound dressing (BMWD), per sq cm; add-on, list separately in addition to primary procedure

Prior Authorization

New Skin Substitute Codes Require Authorization

Any new skin substitute procedure code added through Illinois Healthcare and Family Services (HFS) or the Enhanced Ambulatory Patient Grouping (EAPG) system will require prior authorization and must meet this policy’s requirements.

Applies to new skin substitute products and procedure codes added to current fee schedules

Policy Background

Skin substitutes are bioengineered, biological, or synthetic materials used to replace or repair damaged skin. They may provide temporary or permanent coverage, support tissue regeneration, and protect against mechanical trauma, infection, and fluid loss. In wound management, they are generally used as an adjunct to conventional treatment for chronic, nonhealing wounds that fail to close or substantially reduce after standard care.

Skin Substitute Definitions

Skin Substitutes

Material typesBioengineered, biological, or synthetic materials

Primary purposeDesigned to replace or repair damaged skin and provide temporary or permanent coverage

Additional functionsPromote tissue regeneration and protect against mechanical trauma, infection, and fluid loss

Epidermal Substitutes

Substitute categoryEpidermal substitute

Layer replacedThe outermost skin layer

Skin structureThe epidermal layer

Policy Summary

PayerCountyCare

PolicySkin Substitutes for Wound Management

Policy CodePolicy 2742.CC

Change TypeNo material change

Effective DateJune 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for all skin substitute services and any newly added applicable procedure codes.

SourceLink

On This Page

The ulcer is not associated with known or suspected malignancy.

There is no active deformity or major structural deformity that could compromise healing or increase complications.

The ulcer extends to an appropriate depth for effective coverage and healing and is not limited to a superficial ulcer that does not extend to tendon, muscle, capsule, or bone.

Timing of consideration

A skin substitute may be considered after the wound fails to improve during the required standard-care period

Wound Response to Standard Care

Closure expectationThe wound has not closed

Size-reduction expectationThe wound has not reduced by approximately 40–50% with standard care

Policy measurement criterionFailure to reduce by 40% in size or depth

Healing signsNo signs of healing, such as granulation or epithelialization

Venous-Ulcer Compression

Compression strengthFirm compression greater than 20 mmHg

Alternative treatmentA multilayered compressive dressing

Treatment roleAn essential component of standard care for venous stasis ulcers

Maximum Applications

Maximum applicationsUp to 8 applications

Episode of careWithin a 12–16-week episode of care

Additional documentationStrict documentation is required to justify more than 4 applications

Coverage remains subject to medical-necessity review under this policy

Documentation Required

Complete Standard Wound Care First

Before requesting a skin substitute, document completion of an appropriate standard-of-care (SOC) wound-management plan. Skin substitutes are adjunctive therapies for chronic, hard-to-heal wounds that fail to improve with SOC.

Assess wound etiology, size, depth, and infection status
Control infection, including cultures and antibiotics when indicated
Debride necrotic tissue
Maintain a moist wound environment with appropriate non-adherent, hydrocolloid, foam, alginate, hydrofiber, or hydrogel dressings
Optimize vascular and metabolic status, including blood-sugar control and vascular assessment
Use mechanical offloading for diabetic foot ulcers and compression therapy for venous ulcers
Address tobacco use and other comorbidities

Documentation Required

Submit Supporting Records

Submit all appropriate supporting documentation from a licensed clinician to support medical-necessity review, including recent pertinent office visit notes and available clinical testing.

Recent office or treatment notes
Laboratory data
Results of special testing
Prior relevant imaging results, when applicable
The reason alternative imaging cannot be performed, when applicable

Documentation Required

Document Patient and Provider Assessment

Provide the patient’s and treating provider’s initial documentation in advance of review. The record must establish overall health, management of underlying disease, examination findings, diagnostic workup, and the implemented treatment plan.

Overall health and relevant comorbidities, such as diabetes and vascular disease
Care by a qualified provider managing underlying systemic disease, including venous insufficiency, diabetes, or neuropathy
Comprehensive history, examination, vascular assessment, and diagnostic tests as indicated
Smoking status and cessation medication or counseling attempts, if the patient smokes
Confirmation that the SOC treatment plan was completed

Documentation Required

Record Wound Measurements After Standard Care

After completion of SOC wound management, document the wound type and status together with pretreatment measurements and measurements obtained after at least four weeks of SOC treatment.

Record wound dimensions and depth before SOC
Repeat and report measurements after at least four weeks of SOC
Document whether the wound reduced by at least 40% in size or depth and whether healing signs are present

Documentation Required

Document Diabetic Foot Ulcer Factors

For diabetic foot ulcers, document diabetes type and management history, comorbidities, current glucose and HbA1c, diet and nutritional status, activity level, and the physical and offloading assessment.

Assess skin, ulcer characteristics, and vascular perfusion
Document off-loading devices or appropriate footwear
Document management of diabetes and related comorbidities
Include current blood glucose and hemoglobin A1c (HbA1c)
Include diet, nutritional status, and activity level

Documentation Required

Document Venous Leg Ulcer Factors

For venous leg ulcers, document relevant clinical history, risk factors, edema, skin changes, vascular competence, and venous testing. Compression is an essential component of SOC for venous stasis ulcers.

Include prior ulcers, body mass index, pulmonary embolism or superficial/deep venous thrombosis history, number of pregnancies, and physical inactivity
Assess edema, skin changes, and vascular competence
Evaluate venous reflux, perforator incompetence, and venous thrombosis
Use a firm-strength compression garment greater than 20 mmHg or a multilayer compressive dressing

Documentation Required

Maintain Ongoing Progress Documentation

For concurrent approval, continue to document treatment goals and clinical progress. The record should show milestones indicating that the wound is improving toward a successful outcome.

Review treatment goals and assess progress as treatment continues
No clinical signs of acute infection
Formation of granulation tissue
Re-epithelialization
Reduction in wound size
Successful removal of staples, sutures, or wound-closure strips

Denial Risk

Unlisted Products Require Clinical Review

A skin substitute not addressed in this policy is considered unproven or experimental and investigational and may be referred for clinical review. Medical necessity for an indication not directly addressed by the guideline is determined using widely accepted standard-of-care criteria and evidence-based or peer-reviewed sources.

Submit clinical rationale and supporting evidence for products or indications not specifically addressed

Denial Risk

Resolve Contraindications Before Application

Do not request or apply a skin substitute when contraindications or uncontrolled risk factors prevent effective integration, healing, or safe treatment.

Treat active wound infection before considering a graft
Do not use products to which the patient has a known allergy, including relevant collagen, bovine, or porcine derivatives
Address poor vascularization, ischemia, progressive necrosis, uncontrolled diabetes, severe malnutrition, and other systemic conditions that impair healing
Consider compliance concerns, including dementia or involuntary motor disease
Do not use for a known or suspected ulcer malignancy
Do not use with active or major structural deformity that compromises healing, including active Charcot arthropathy
Do not use with active vasculitis or inadequate control of underlying or exacerbating conditions

Denial Risk

Do Not Repeat an Unsuccessful Application

Repeat applications are not reasonable and necessary when a previous application was unsuccessful. Close oversight and documentation are required before considering continued treatment.

Unsuccessful application includes an increase in ulcer size or depth
No measurable change from baseline
No sign of improvement or indication that improvement is likely, such as granulation, epithelialization, or progress toward closure

Denial Risk

Confirm Adequate Ulcer Depth

The ulcer must extend to tendon, muscle, capsule, or bone to support effective coverage and/or healing. An ulcer that is too superficial does not meet this requirement.

Document wound depth and the involved underlying structure

Dermal Substitutes

Substitute categoryDermal substitute

Layer replacedThe deeper dermal layer

Skin structureThe dermal layer beneath the outermost skin layer

Composite Substitutes

Substitute categoryComposite substitute

Layers includedBoth epidermal and dermal layers

Primary useProvides comprehensive coverage