CurrentCareSourcePolicy Skin Substitutes-AR PASSE-MM-1417

Skin Substitutes (Arkansas PASSE)

CareSource medical policy governing use and reimbursement of skin substitute products for treatment of diabetic foot ulcers, venous insufficiency ulcers, burn wounds, and scar contracture repair for Arkansas PASSE members.

Policy Summary

PayerCareSource

PolicySkin Substitutes (Arkansas PASSE)

Policy CodePolicy Skin Substitutes-AR PASSE-MM-1417

Change TypeNo material change

Effective Date05/01/2024-04/30/2025

Next Review Date

Key ActionProvide documentation showing applicable clinical criteria are met (eg, ABI, TcPO2, Doppler waveform results, wound characteristics, prior conventional therapy) when requesting skin substitute coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

05/01/2024-04/30/2025Policy effective period

02/14/2024Last revised

02/15/2023Original issue

ArkansasJurisdiction (PASSE)

Coverage Criteria for Skin Substitutes

Diabetic foot ulcer

Covered when ANY of the following are met:

Diabetic foot ulcer circulation criteria: Treatment of diabetic foot ulcer when adequate circulation to the affected extremity is present as indicated by at least ONE of the following: ankle-brachial index (ABI) between 0.7 and 1.2; palpable pedal pulse; TcPO2 >= 30 mm Hg within the last 60 days.ABI 0.7-1.2; TcPO2 >= 30 mm Hg

From policy section A

Venous insufficiency ulcer

Covered when ALL of the following are met:

Venous insufficiency ulcer criteria: Treatment of venous insufficiency ulcers when ALL of the following criteria are met: triphasic or biphasic Doppler arterial waveforms at the ankle of the affected leg; adequate perfusion of the involved limb; concurrent conventional wound care (eg, dressings to maintain a moist environment); concurrent glycemic management if the patient is diabetic; partial-thickness or full-thickness ulcer due to venous insufficiency; duration greater than 1 month; no allergy to bovine products; no response to conventional therapy (including dressings, compression therapy, sharp debridement); no wound infection; and compression therapy as indicated.

Policy Summary

PayerCareSource

PolicySkin Substitutes (Arkansas PASSE)

Policy CodePolicy Skin Substitutes-AR PASSE-MM-1417

Change TypeNo material change

Effective Date05/01/2024-04/30/2025

Next Review Date

SourceLink

On This Page

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Use of skin substitutes requires documentation that the specified clinical criteria for the wound type are met. For example, treatment of diabetic foot ulcers requires evidence of adequate circulation to the affected extremity demonstrated by at least one of: ABI between 0.7 and 1.2, a palpable pedal pulse, or TcPO2 >= 30 mm Hg within the last 60 days. For venous insufficiency ulcers, coverage requires all listed conditions, including demonstration of adequate perfusion, appropriate Doppler waveforms at the ankle, concurrent conventional wound care and compression as indicated, duration >1 month, and no response to conventional therapy (eg, dressings to maintain a moist wound environment, compression therapy, sharp debridement). Absence of infection and no allergy to bovine products are additional required criteria where specified.

Provider Actions and Documentation Requirements

Documentation Required

Supportive documentation

Supportive documentation must be submitted with the prior authorization or claim to demonstrate that coverage criteria are met. Documentation should include, as applicable: objective vascular assessments (ABI, TcPO2, or arterial Doppler/waveforms), wound characteristics (location, depth — partial vs full thickness, size, duration), evidence of prior conservative therapy and response, relevant comorbid management (eg, glycemic control for diabetic patients), and allergy history (eg, bovine product allergy).

ABI results (report or numeric value)
TcPO2 value and date (performed within 60 days)
Doppler arterial waveform report (triphasic or biphasic at ankle)
Wound description: depth (partial/full thickness), size, location, duration
Documentation of concurrent conventional wound care (eg, compression therapy for venous ulcers)
Record of prior conservative therapies and lack of response (dressings, debridement, infection control)
Evidence of adequate perfusion: palpable pedal pulses or ABI 0.7–1.2
Glycemic management documentation when patient is diabetic
Allergy history (eg, bovine product allergy)

Documentation Required

Medical necessity documentation required

Medical necessity documentation is required to support use of skin substitutes. Include clinical notes, wound measurements, and any diagnostic test results referenced in the supportive documentation list.

Prior Authorization

Conservative therapy required prior to skin substitute

For venous insufficiency ulcers, conservative therapy (including appropriate compression therapy and conventional wound care) must be tried and documented prior to skin substitute placement.

Compression therapy documented (type, duration)
Conventional wound care documented (eg, moist dressings, sharp debridement)

Denial Risk

Non‑listed products may be denied

Products not listed on the payer's approved skin substitute product list may be considered experimental/investigational and may be denied as not reimbursable. Verify product coverage prior to ordering and include product identifiers in documentation.

Include product name, manufacturer, and HCPCS/CPT code (if available) with requests
Confirm product is on CareSource approved list

Definitions

Ankle‑Brachial Index (ABI) — Definition

DefinitionA comparison of the blood pressure measured at the ankle with blood pressure measured at the arm; lower numbers indicate narrowing or blockage of the arteries in the legs.

PurposeAssesses arterial perfusion to the lower extremity

Clinical relevanceUsed as an objective circulation measure in coverage criteria (ABI thresholds specified elsewhere in policy)

Autologous — Definition

DefinitionDerived from the same individual, such as an individual serving as both donor and recipient.

UsageRefers to biologic materials obtained from the patient for use in treatment

ContrastDistinct from allogeneic or xenogeneic products sourced from other individuals or species

Chronic Wounds — Definition

DefinitionWounds that have not progressed along the normal healing process, generally after a 4-week duration.

ExamplesIncludes pressure ulcers, diabetic foot ulcers, and venous leg ulcers when healing is delayed

Clinical implicationChronicity (≥4 weeks) signals need for advanced therapies such as skin substitutes when criteria are met

Diabetic Foot Ulcer — Definition

DefinitionAn open sore or wound located on the foot occurring in approximately 15% of patients with diabetes.

Coverage considerationTreatment with skin substitutes covered when adequate circulation is present (eg, ABI 0.7–1.2, palpable pedal pulse, or TcPO2 ≥30 mm Hg)

Clinical populationOccurs in patients with diabetes and carries risk of morbidity if not effectively managed

Chronic Venous Ulcer — Definition

DefinitionA wound that takes longer than usual to heal and often occurs on the legs or ankles when oxygen-poor blood flow is impaired and pools, creating pressure in the veins.

Typical locationLegs or ankles

Coverage criteria notePolicy requires multiple additional criteria (eg, duration >1 month, conventional therapy attempted) for skin substitute coverage

Pressure Ulcer — Definition

DefinitionInjuries to skin and underlying tissue resulting from prolonged pressure on the skin, including bedsores that most often develop on areas such as heels, ankles, hips, and tailbone.

Common sitesHeels, ankles, hips, and tailbone

Clinical relevancePressure-related tissue damage that may become chronic and require advanced wound therapies

Tissue Engineering — Definition

DefinitionThe practice of combining scaffolds, cells, and biologically active molecules into functional tissues to assemble constructs that restore, maintain, or improve damaged tissues or whole organs.

ComponentsScaffolds, cells, and biologically active molecules

ApplicationUnderpins development of advanced skin substitutes and regenerative therapies

OpenPayer

Skin Substitutes (Arkansas PASSE)

Coverage Criteria for Skin Substitutes

Coding and Clinical Thresholds

Provider Actions and Documentation Requirements

Background

Definitions