CurrentCareSourcePolicy PASSE-MM-1417

Skin Substitutes

Customize your policy alerts

Sign up for CareSource Policy PASSE-MM-1417 alerts

Get alerted when Policy PASSE-MM-1417 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs when CareSource considers skin substitutes medically necessary for chronic diabetic foot ulcers, venous insufficiency ulcers, burns, scar contractures, and pressure ulcers, as well as required clinical documentation and non-covered uses. It applies to providers treating Arkansas PASSE members.

Policy Summary

PayerCareSource

PolicySkin Substitutes

Policy CodePolicy PASSE-MM-1417

Change TypeMaterial update

Effective DateSep 1, 2026

Next Review DateN/A

Key ActionDocument that the patient meets the medical-necessity criteria and provide all applicable wound, perfusion, disease-control, and treatment documentation before requesting skin substitute treatment.

SourceLink

POLICY UPDATE CHANGES

The policy added clinical coverage requirements for diabetic foot ulcers, venous insufficiency ulcers, burns, scar contractures, and pressure-ulcer support surfaces.

The policy added documentation requirements for standard-of-care treatment and treatment plans.

The policy expanded non-covered uses for skin substitutes and cellular and tissue-based products.

The policy was updated with additional skin substitute examples and references.

5Clinical treatment circumstances addressed

4 weeksDFU standard-of-care period

Policy Summary

PayerCareSource

PolicySkin Substitutes

Policy CodePolicy PASSE-MM-1417

Change TypeMaterial update

Effective DateSep 1, 2026

Next Review DateN/A

SourceLink

On This Page

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentCareSourcePolicy PASSE-MM-1417

Skin Substitutes

Customize your policy alerts

Sign up for CareSource Policy PASSE-MM-1417 alerts

Get alerted when Policy PASSE-MM-1417 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerCareSource

PolicySkin Substitutes

Policy CodePolicy PASSE-MM-1417

Change TypeMaterial update

Effective DateSep 1, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

The policy added clinical coverage requirements for diabetic foot ulcers, venous insufficiency ulcers, burns, scar contractures, and pressure-ulcer support surfaces.

The policy added documentation requirements for standard-of-care treatment and treatment plans.

The policy expanded non-covered uses for skin substitutes and cellular and tissue-based products.

The policy was updated with additional skin substitute examples and references.

5Clinical treatment circumstances addressed

4 weeksDFU standard-of-care period

Policy Summary

PayerCareSource

PolicySkin Substitutes

Policy CodePolicy PASSE-MM-1417

Change TypeMaterial update

Effective DateSep 1, 2026

Next Review DateN/A

SourceLink

On This Page

Venous ulcer duration criterion

>3 / 12 weeksApplication threshold linked to non-coverage

50%DFU ulcer-area reduction benchmark

0.7-1.2Acceptable DFU ABI range

Medical Necessity and Coverage Criteria

Diabetic Foot Ulcers

Covered when ALL of the following requirements are met:

Diabetic foot ulcer coverage

ONE accepted circulation measure
- A palpable pedal pulse is present
- Ankle-brachial index (ABI) is between 0.7 and 1.2ABI 0.7–1.2
- Dorsum transcutaneous oxygen (TcPO2) is at least 30 mm Hg within the last 60 daysTcPO2 ≥30 mm Hg within 60 days
- Triphasic or biphasic Doppler arterial waveforms are present at the ankle of the affected leg
Additional clinical requirements: Appropriate glycemic control is present and there is no wound infection
Failure of conventional therapy: The ulcer has not responded to conventional therapy, including offloading or pressure relief, appropriate dressings to facilitate healing, and debridement as neededMinimum 4 weeks with documented compliance

Venous Insufficiency Ulcers

Covered when ALL of the following requirements are met:

Venous insufficiency ulcer coverage

Diagnostic, perfusion, and concurrent-care requirements: Noninvasive duplex ultrasound documents chronic venous disease; the involved limb has adequate perfusion; appropriate surgical venous interventions have been performed; concurrent conventional wound care is provided; and concurrent glycemic management is provided if the patient is diabetic
Ulcer and safety requirements: The ulcer is partial-thickness or full-thickness and due to venous insufficiency; the patient has no allergy to bovine products; and there is no wound infection
Failure of conventional therapy: The ulcer has not responded to compression therapy, surgical intervention for UVD when applicable, dressings that maintain a moist wound environment, and sharp debridement
Moist-environment dressings may include saline-moistened dressings or negative pressure wound therapy

Burn Wounds

Covered when ONE of the following burn-wound circumstances applies:

ONE burn-wound circumstance

Temporary covering before autograft: The product is used as a temporary wound covering for an excised full-thickness or deep partial-thickness burn wound in an individual who requires such coverage before autograft placement
Potentially non-grafted burn healing: The product is used to treat a mid-dermal to indeterminate-depth burn wound that typically requires debridement and may be expected to heal without autografting
These wounds typically require debridement

Scar Contracture Repair

Covered when ALL of the following requirements are met:

Scar contracture repair: More conservative therapeutic options have failed, and the skin substitute is used in conjunction with a breast reconstruction procedure

Read with the related breast reconstruction policy

Pressure Ulcers

Covered when the service provides the following support:

Pressure-ulcer support: Pressure redistribution support surfaces are provided for pressure ulcers

New quarterly skin substitutes or Q-codes that have not been used outside clinical trials are not covered.

Coverage is not provided for more than 3 applications of a skin substitute graft or cellular and tissue-based product over 12 weeks when wound volume has not decreased by at least 50%.

Repeat application is not covered when a prior application was unsuccessful. Unsuccessful treatment includes an increase in ulcer size or depth, no measurable change from baseline, or no significant improvement or indication that significant improvement is likely, such as granulation, epithelialization, or progress toward closure.

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

Surgical preparation services, including debridement, are not covered when performed with routine, simple, or repeat skin replacement therapy using a skin substitute graft or cellular and tissue-based product.

Liquid or gel skin substitute products or cellular and tissue-based products are not covered for ulcer care.

Placement of a skin substitute graft or cellular and tissue-based product is not covered on an infected, ischemic, or necrotic wound bed.

Skin substitute products that are not listed on the applicable fee schedule may not be reimbursable and may be considered experimental and investigational.

Treatment is not medically necessary when the patient's life expectancy does not allow sufficient time for long-term healing or clinical benefit, or for a decrease in substantive morbidity.

Coding and Coverage Thresholds

Non-covered or medically necessary product code categoryHCPCSNot Covered

Q-codes

New quarterly skin substitutes or Q-codes that have not been used outside clinical trials are non-covered or not medically necessary.

Diabetic Foot Ulcer Standard of Care

Minimum treatment periodAt least 4 weeks of standard-of-care treatment

ComplianceCompliance with standard-of-care treatment must be documented

Standard-of-care componentsTreatment includes offloading, appropriate dressings, and debridement as needed

Diabetic Foot Ulcer Response

Required responseThe ulcer must fail to achieve at least 50% area reduction

Measurement contextArea reduction is assessed after standard-of-care treatment

Associated condition

Provider Documentation and Denial Risks

Documentation Required

Meet Medical-Necessity Criteria

Meet medical-necessity criteria before requesting or billing skin substitute treatment. Covered use requires an eligible indication and the applicable clinical criteria, including documented standard-of-care treatment and compliance; for chronic DFU or venous insufficiency ulcers, document inadequate healing despite at least 4 weeks of SOC treatment and the required wound, perfusion, and disease-specific findings.

Diabetic foot ulcer: chronic, non-infected ulcer with less than 50% area reduction after at least 4 weeks of documented SOC and compliance; adequate circulation shown by palpable pedal pulses, ABI 0.7–1.2, TcPO2 ≥30 mm Hg within 60 days, or triphasic/biphasic ankle Doppler waveforms; appropriate glycemic control; and failure of offloading, appropriate dressings, and debridement as needed.
Venous insufficiency ulcer: chronic, non-infected ulcer with failure of documented SOC for at least 4 weeks and compliance; noninvasive duplex evidence of chronic venous disease, adequate limb perfusion, appropriate surgical venous intervention, concurrent conventional wound care, glycemic management when diabetic, and duration greater than 6 weeks.
Other covered indications: qualifying temporary coverage or treatment of specified full-thickness, deep partial-thickness, mid-dermal, or indeterminate-depth burns; scar-contracture repair after conservative options fail when used with breast reconstruction; and pressure-redistribution support surfaces for pressure ulcers.
Document the comprehensive assessment, diagnostic testing as indicated, wound measurements and response to SOC, and all applicable eligibility criteria before treatment.

Clinical Background

Chronic wounds are disruptions of skin integrity that fail to progress through normal healing. They may recur and can result in loss of function and other morbidity. Major chronic-wound categories include pressure ulcers, diabetic foot ulcers, and venous leg ulcers. Skin substitutes are biologic, synthetic, or biosynthetic materials used to cover open wounds and may support healing in chronic wounds, burns, or reconstructive procedures.

Key Terms

Ankle-Brachial Index

DefinitionA comparison of blood pressure measured at the ankle with blood pressure measured at the arm

InterpretationLower values may indicate narrowing or blockage of the arteries in the legs

Clinical relevanceABI is used as one measure of adequate circulation to an affected extremity

Autologous

MeaningDerived from the same individual

Donor and recipientThe same individual serves as both donor and recipient

Application

Duration and standard-of-care requirements: Documented standard-of-care treatment has been provided with documented compliance for at least 4 weeks, and the ulcer has been present for more than 6 weeks≥4 weeks of standard care; >6 weeks ulcer duration

The ulcer must be chronic and non-infected

Adequate DFU Circulation by ABI

Acceptable ABI rangeAnkle-Brachial Index between 0.7 and 1.2

Clinical useABI is used to indicate adequate circulation to the affected extremity

Circulation criterionThe ABI range is one accepted measure of adequate circulation; other accepted measures include a palpable pedal pulse, qualifying TcPO2, or triphasic or biphasic ankle Doppler waveforms

Adequate DFU Circulation by TcPO2

Minimum TcPO2At least 30 mm Hg

TimingThe test must have been performed within the last 60 days

Clinical useTcPO2 is one accepted measure of adequate circulation to the affected extremity

Venous Insufficiency Ulcer Duration

Ulcer durationThe venous insufficiency ulcer must have been present for more than 6 weeks

Standard-of-care periodDocumented standard-of-care treatment must have been provided for at least 4 weeks

ComplianceCompliance with standard-of-care treatment must be documented

Skin Substitute Application Limit

Application thresholdMore than 3 skin substitute graft or cellular and tissue-based product applications over 12 weeks

Required wound responseWound volume must decrease by at least 50% to avoid this non-coverage condition

Coverage implicationApplications exceeding the threshold without the required wound-volume reduction are non-covered

Documentation Required

Complete Patient and Disease Assessment

Complete and retain a comprehensive patient and disease assessment as part of the implemented treatment plan. The record must support the diagnosis, identify comorbidities and exacerbating factors, and include vascular findings and diagnostic testing when indicated.

Document a complete history and physical examination, wound assessment, vascular assessment, and indicated diagnostic tests.
For DFU patients, document Type 1 or Type 2 diabetes, management history, comorbidities such as vascular disease, neuropathy, or osteomyelitis, current blood glucose levels including A1c, and assessment of offloading devices and footwear.
Record findings that establish adequate perfusion and absence of infection before skin substitute placement.

Documentation Required

Document Venous Ulcer History and Evaluation

For venous insufficiency ulcers, document the clinical history and evaluation needed to establish venous disease, assess healing barriers, and support the treatment plan.

Record prior ulcers, body mass index, history of pulmonary embolism or superficial/deep venous thrombosis, number of pregnancies, and physical inactivity.
Document the physical examination, evaluation of venous reflux, perforator incompetence, and venous thrombosis, and use of compression garments.
Include noninvasive duplex ultrasound evidence of chronic venous disease and adequate perfusion of the involved limb when establishing medical necessity.

Documentation Required

Document and Continue Standard-of-Care Treatment

Implement and document a standard-of-care treatment plan before and during skin substitute therapy. The record should demonstrate wound-bed preparation, pressure or edema management, infection control, exudate control, and attention to modifiable healing factors.

Debride as appropriate to a clean, granular base and document evidence of offloading for DFUs.
Document sustained compression dressings for venous insufficiency ulcers and appropriate dressings that facilitate healing.
Control infection by removing foreign bodies or the focus of infection; manage exudate while maintaining a moist wound environment.
Document smoking history, counseling regarding smoking's effects on wound healing, smoking-cessation treatment, and current smoking status.
For venous ulcers, document appropriate surgical venous interventions, concurrent conventional wound care, and glycemic management when the patient is also diabetic.

Denial Risk

Avoid Unproven, Liquid, or Non-Fee-Schedule Products

Do not assume coverage for products that are unproven, liquid, gel-based, or outside the applicable fee schedule. These products or uses may be denied as non-covered or experimental and investigational.

New quarterly skin substitutes or Q-codes that have not been used outside clinical trials are not covered or medically necessary.
All liquid or gel skin substitute products or CTPs for ulcer care are not covered.
Products not listed on the applicable fee schedule may not be reimbursable and may be considered experimental and investigational.

Denial Risk

Avoid Excessive or Unsuccessful Applications

Limit applications and assess wound response before repeating treatment. More than 3 applications over 12 weeks is subject to denial when wound volume has not decreased by at least 50%, and repeat treatment is not supported after an unsuccessful prior application.

More than 3 skin substitute graft/CTP applications over 12 weeks is not covered when wound volume has not decreased by at least 50%.
Do not repeat an application that increased ulcer size or depth, produced no measurable change from baseline, or showed no significant improvement or indication that significant improvement is likely.
Document serial wound measurements and signs of progress such as granulation, epithelialization, or progress toward closure.

Denial Risk

Control Conditions and Contraindications

Do not apply a skin substitute when underlying conditions, exacerbating factors, or contraindications are uncontrolled. Address infection, ischemia, necrosis, smoking, and other barriers to healing before treatment and document their status.

Do not place a graft/CTP on an infected, ischemic, or necrotic wound bed.
Evaluate for active infection, progressive necrosis, active Charcot arthropathy of the ulcer extremity, active vasculitis, and ischemia.
Document control of underlying conditions and exacerbating factors, including glycemic management and smoking status or cessation treatment when applicable.

Denial Risk

Use an Appropriate Wound Bed and Confirm Expected Benefit

Prepare an appropriate wound bed and confirm that treatment is likely to provide meaningful benefit. Skin substitute placement is not supported when the wound bed is infected, ischemic, or necrotic, when routine surgical preparation is separately paired with simple or repeat replacement therapy, or when the patient is unlikely to heal or benefit.

Do not use surgical preparation services such as debridement in conjunction with routine, simple, or repeat skin replacement therapy with a graft/CTP.
Do not place a graft/CTP on an infected, ischemic, or necrotic wound bed; first address infection, perfusion, and necrotic tissue.
Do not treat when life expectancy would not allow long-term healing or clinical benefit or decrease of substantive morbidity.

The term describes material obtained from and used in the same person

Cellular and Tissue-Based Products (CTPs)

DefinitionWound dressings or coverings that contain or consist of cells and/or tissue

PurposeUsed to promote wound healing

Potential useMay be used as alternatives to skin grafts for chronic wounds, burns, and ulcers

Chronic Wounds

DefinitionWounds that have not progressed along the normal healing process

General durationGenerally present after a 4-week duration

Healing statusThe wound has failed to progress through normal healing

Chronic Venous Ulcers

DefinitionA wound that takes longer than usual to heal

Typical locationCommonly occurs on the legs or ankles

Underlying problemImpaired venous blood flow can cause oxygen-poor blood to pool and increase pressure in the veins

Diabetic Foot Ulcers

DefinitionAn open sore or wound located on the foot

Associated conditionOccurs in patients with diabetes

Clinical categoryA diabetic foot ulcer is a chronic-wound condition addressed by the skin substitute policy

Pressure Ulcers

DefinitionInjuries to the skin and underlying tissue resulting from prolonged pressure

Common nameIncludes bedsores

Typical locationsOften develops over bony areas such as the heels, ankles, hips, and tailbone