ModifiedSecurity Health Plan of Wisconsin, Inc.Policy N/A

Skin and Tissue Substitutes

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This policy governs coverage, medical necessity, limitations, exclusions, and prior authorization requirements for bioengineered skin and soft-tissue substitutes and skin substitute grafts. Requirements vary by product, indication, and line of business, including Commercial, Medicaid, Family Health Center, Medicare Advantage, and third-party administration arrangements.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicySkin and Tissue Substitutes

Policy CodePolicy N/A

Change TypeModified

Effective DateJuly 1, 2026

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Commercial and Medicare Advantage members beginning April 1, 2026.

SourceLink

POLICY UPDATE CHANGES

Prior authorization is required for Commercial and Medicare Advantage members beginning April 1, 2026.

CMS LCD information was removed after CMS withdrew the LCDs scheduled to become effective January 1, 2026.

The June 2026 annual review documented no changes to the policy.

10Maximum applications per wound in 12 weeks

4 weeksMinimum conservative-care period

8Covered skin substitutes under Commercial criteria

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ModifiedSecurity Health Plan of Wisconsin, Inc.Policy N/A

Skin and Tissue Substitutes

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Sign up for all security_health_plan_of_wisconsin_inc policy alerts

Know when security_health_plan_of_wisconsin_inc releases new policies or updates existing guidance.

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Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicySkin and Tissue Substitutes

Policy CodePolicy N/A

Change TypeModified

Effective DateJuly 1, 2026

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Commercial and Medicare Advantage members beginning April 1, 2026.

SourceLink

POLICY UPDATE CHANGES

Prior authorization is required for Commercial and Medicare Advantage members beginning April 1, 2026.

CMS LCD information was removed after CMS withdrew the LCDs scheduled to become effective January 1, 2026.

The June 2026 annual review documented no changes to the policy.

10Maximum applications per wound in 12 weeks

4 weeksMinimum conservative-care period

8Covered skin substitutes under Commercial criteria

4/1/2026Commercial and Medicare Advantage authorization start

0.60 ABIMinimum adequate perfusion threshold

2Product-specific reference criteria

Medical Necessity and Coverage Criteria

General covered skin substitute criteria

Covered when all general requirements and the applicable product-specific criteria are met.

General requirements

The product is provided in accordance with its FDA-approved package label and indications for use.
For a chronic wound, the wound has failed or had an insufficient response to no fewer than four weeks of conservative wound-care measures.>= 4 weeks
The wound is of reasonable size given the clinical circumstances. Routine use in a small wound measuring 1.0 cm in the smallest diameter requires documentation that the wound is refractory to conservative treatment but otherwise healable.
The wound has adequate circulation and oxygenation to support tissue growth and healing, evidenced by acceptable peripheral pulses and/or Doppler toe signals, an ABI of no less than 0.60, or toe pressure greater than 30 mm Hg.ABI >= 0.60 or toe pressure > 30 mm Hg

Covered product-specific indications

The applicable product must meet at least one of the following indication pathways.

Product-specific pathways

Alloderm is used for breast reconstructive surgery; surgical repair of complex abdominal wall wounds; or eardrum augmentation, skull base defect repair, or temporal bone lining.
Apligraf is used for a qualifying full-thickness neuropathic diabetic foot ulcer or a chronic, noninfected partial- or full-thickness venous stasis ulcer after failed conservative treatment.
Dermagraft is used for a qualifying full-thickness diabetic foot ulcer or a wound related to dystrophic epidermolysis bullosa.
Epicord is used for a qualifying partial- or full-thickness neuropathic diabetic foot ulcer.
EpiFix is used for a qualifying neuropathic diabetic foot ulcer or a difficult-to-heal chronic venous or diabetic lower-extremity ulcer.

Integra Flowable indications

Integra Flowable is medically necessary for the following wound-care indications, subject to the general coverage requirements and applicable product requirements.

Management of osteoradionecrosis of the jaw.
Partial- or full-thickness wounds.
Pressure ulcers.
Venous ulcers.
Diabetic ulcers.
Chronic vascular ulcers.

Commercial limitations and exclusions

Coverage is subject to all of the following limitations and exclusions.

Utilization and clinical limitations

Application timing, frequency, and reapplication are appropriate for the product and the clinical condition.
Total applications or treatments do not exceed 10 per wound during a 12-week period of care, including when more than one product is used.<= 10 applications per wound per 12 weeks
Simultaneous use of more than one skin substitute product during the wound episode is not used. A product change during the episode must remain within the 10-application limit.
Treatment of a chronic skin wound typically lasts no more than 12 weeks.

Experimental and investigational products or indications

The following products or uses are not covered as medically necessary because they are considered experimental and investigational unless a specific covered indication is stated.

Experimental or investigational products and uses

Alloderm or Alloderm-RTU is used for an indication other than the listed covered uses, such as hernia repair, reduction of Frey's syndrome after parotidectomy, or upper-extremity reconstruction.
Apligraf is used for an indication other than the listed covered uses, such as traumatic wounds.
Dermagraft is used for an indication other than the listed covered uses, including infected ulcers or ulcers with sinus tracts.
Epicord is used for an indication other than the listed covered use.
EpiFix is used for an indication other than the listed covered uses, or injectable EpiFix is used.

Family Health Center coverage

For Family Health Center members, coverage requires Medicaid-aligned criteria plus all of the following restrictions.

Family Health Center requirements

The substitute is not Amnioexcel, Apligraf, or Primatrix.
The service is performed in an office setting.Office setting only
The applicable coverage criteria are met.
The service is not skin grafting for breast reconstruction following a mastectomy.

BadgerCare Plus and Medicaid SSI coverage

Coverage follows ForwardHealth guidelines and requires all of the following.

Medicaid requirements

The member meets the applicable clinical criteria.
The service is payable under ForwardHealth requirements for the procedure, application code, diagnosis, provider type, specialty, and place of service.

Medicare Advantage coverage

Medicare Advantage coverage varies by plan.

Plan-specific Medicare Advantage pathways

For Security Medicare Advantage plans, Medicare guidelines apply and the Commercial clinical policy criteria are followed, including the 10-application limit per wound per 12-week treatment period.<= 10 applications per wound per 12 weeks
For Align, Align DSNP, and Great Plains Medicare Advantage plans, medical necessity is determined using InterQual criteria and the applicable plan requires prior authorization through the Health Plan beginning January 1, 2026.

Apligraf qualifying indications

Apligraf is supported for the following qualifying wound types when used with standard therapy and when no specific contraindication is present.

Qualifying Apligraf indication

Venous leg ulcer pathway: The patient has a noninfected venous leg ulcer of more than one month’s duration that has not responded to standard compression therapy and is treated with standard therapy.> 1 month
Diabetic foot ulcer pathway: The patient has type 1 or type 2 diabetes mellitus and a full-thickness, neuropathic diabetic foot ulcer present for more than three weeks that has not adequately responded to standard therapy, with no tendon, muscle, capsule, or bone exposure.> 3 weeks

Dermagraft qualifying indication

Dermagraft is supported for the following qualifying diabetic foot ulcer population when used with standard therapy.

Dermagraft criteria

The patient has type 1 or type 2 diabetes mellitus.
The patient has a full-thickness, neuropathic ulcer of the plantar foot present for more than three weeks.> 3 weeks
The ulcer has not adequately responded to standard therapy.
There is no tendon, muscle, capsule, or bone exposure.
There is no infection, nonvascularity at the wound site, or sensitivity to any component of the product or storage medium.

Routine application of graft material to a wound measuring 1.0 cm in the smallest diameter is not covered unless the medical record demonstrates that the wound is refractory to conservative treatment but otherwise healable. Grafting is also not covered when the wound is adequately healing with conservative care.

Simultaneous use of more than one skin substitute product during the wound episode is not covered. A product change during the episode may be allowed, but the total number of applications must remain within the 10-application limit per wound per 12-week period.

A partial-thickness wound with retained epithelial appendages is not a candidate for grafting or replacement because the epithelium is expected to repopulate the deficit from those appendages, reducing the benefit of overgrafting.

Repeat surgical preparation services performed with skin substitute application codes are not considered reasonable and necessary beyond the expected initial wound preparation. Each wound is expected to receive an appropriate wound preparation service at least once at the initiation of care before placement of the graft.

For Family Health Center members, skin grafting for breast reconstruction following mastectomy is not covered. Covered skin substitute services are also excluded when performed in an inpatient, outpatient, observation, or ambulatory surgical setting; qualifying services must be performed in an office setting. If the substitute itself is not covered, the related application services are not covered.

Apligraf and Dermagraft are contraindicated when the wound has infection or nonvascularity at the wound site, or when the patient has sensitivity to any component of the product or its storage medium.

Use of Apligraf or Dermagraft for wound types outside the specified qualifying indications is not supported as medically necessary because of insufficient evidence and/or safety. This includes use in wounds with the identified contraindications or other nonqualifying wound types.

For the qualifying diabetic foot ulcer indications for Apligraf and Dermagraft, exposure of the tendon, muscle, capsule, or bone excludes the described use.

A course or repeat course is not medically reasonable and necessary when the ulcer increases in size or depth, or remains unchanged in baseline size or depth without signs of improvement or a likelihood of improvement—such as granulation, epithelialization, or progress toward closure—for 4 weeks after therapy begins.

Grafting is not medically reasonable and necessary when underlying conditions or exacerbating factors are inadequately controlled, including uncontrolled diabetes, active infection, active Charcot arthropathy, vasculitis, or continued tobacco smoking without physician-directed cessation efforts.

Grafting is not medically reasonable and necessary for a patient with known hypersensitivity to any component of the specific product, including potential sensitivity to avian, bovine, porcine, or equine materials.

A product or indication is not medically necessary when it is classified as experimental or investigational under the product-specific exclusions or the policy's experimental and investigational product list. If the skin substitute is not medically necessary or is experimental or investigational, the related application code or charge is also denied.

Applications or treatments beyond 10 per wound per 12-week period of care are not covered or medically necessary, including when more than one product is used. For Security Medicare Advantage, applications beyond this limit are not medically necessary even when billed with the KX modifier.

Coverage Thresholds and Utilization Limits

Maximum applications or treatments

Maximum allowedNo more than 10 applications or treatments per wound during a 12-week period of care.

Multiple productsThe 10-application limit still applies when more than one specific product is used.

Product changesA product change during the wound episode is allowed only within the 10-application limit for that wound and 12-week period.

Minimum chronic-wound conservative-care period

Minimum periodAt least 4 weeks of conservative wound-care measures are required for chronic wounds.

Required responseThe wound must have failed or shown an insufficient response to those conservative measures.

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Commercial Prior Authorization and Claim Criteria

For Commercial members, prior authorization is not required. The member must meet the applicable clinical criteria when the claim is submitted or payment may be impacted.

Prior Authorization

BadgerCare Plus and Medicaid SSI Requirements

Prior authorization is not required for BadgerCare Plus or Medicaid SSI. Claims must meet the applicable clinical criteria, and coverage follows ForwardHealth requirements.

Confirm payable services, provider types, specialties, places of service, procedure codes, application codes, and diagnosis codes through the ForwardHealth Online Handbook.
Review the Physician’s Handbook sections for Cellular/Tissue-Based Products and, when applicable, Breast Reconstruction following mastectomy.

Unsupported block type: prior_auth

Policy Background

Bioengineered skin and soft-tissue substitutes may be acellular matrices with no biological component or cellular products containing living cells. Acellular dermal or extracellular matrices have their cellular material removed during manufacturing and use a scaffold made from materials such as collagen, elastin, fibronectin, and hyaluronic acid. Products may also vary by source, additives, hydration, and preparation requirements.

Key Definitions

Bioengineered skin and soft-tissue substitutes

Product typeBioengineered skin and soft-tissue substitutes are acellular or cellular matrices used as skin or soft-tissue substitutes.

Acellular matricesAcellular dermal or extracellular matrices have all cellular material removed during manufacturing.

Matrix materialsThe scaffold may contain materials such as collagen, elastin, fibronectin, and hyaluronic acid.

Product characteristicsProducts may vary by source, additives, hydration, and required preparation.

Unsuccessful treatment

Ulcer worseningTreatment is unsuccessful when the ulcer increases in size or depth.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicySkin and Tissue Substitutes

Policy CodePolicy N/A

Change TypeModified

Effective DateJuly 1, 2026

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Commercial and Medicare Advantage members beginning April 1, 2026.

SourceLink

On This Page

Grafix is used for a qualifying partial- or full-thickness neuropathic diabetic foot ulcer.

Integra Dermal Regeneration Template or Integra Bilayer Wound Matrix is used for a severe burn with limited autograft skin or inability to create additional wound sites, or for a qualifying neuropathic diabetic foot ulcer.

Tunneled or undermined wounds.

The wound is not being retreated after an unsuccessful full course, after healing, after a reduction of more than 75% with a remaining size smaller than 0.5 square cm, or within one year of a prior course for a venous stasis or diabetic neuropathic foot ulcer.

The wound is not a partial-thickness loss with retained epithelial appendages.

Underlying conditions and exacerbating factors are adequately controlled, and the patient has no known hypersensitivity to a component of the specific product.

Repeat surgical preparation services are not billed with skin substitute application codes beyond the expected initial wound preparation.

Grafix is used for an indication other than the listed covered use.

Integra Dermal Regeneration Template or Integra Bilayer Wound Matrix is used for an indication other than the listed covered uses, such as after malignant melanoma excision.

A listed product is used without supported evidence of clinical effectiveness, including Allomax, AmnioExCel, Arthroflex, Axogen for non-digital nerves, Clarix products, CuffMend, Dermaspan, DuraGen, Evicel, Kerecis Omega3, MicroMatrix, Neuragen, NuShield, Phasix mesh, Platelet-Rich Plasma, Primatrix, Puraply, Sinu-foam, Stravix, Theraskin, Tisseel, or Vistaseal.

Duraseal is used for an indication other than its FDA-approved neurosurgical sealant use.

Clinical applicationThe product must be applied in accordance with the applicable product-specific criteria in addition to the chronic-wound conservative-care requirement.

Small wound size

Small-wound measurementA small wound is one measuring 1.0 cm in its smallest diameter.

Routine useRoutine grafting of small wounds is not expected and is not covered when the wound is adequately healing with conservative care.

ExceptionCoverage may be considered when the medical record clearly demonstrates that the wound is refractory to conservative treatment but otherwise healable.

Adequate perfusion

ABI criterionAn ankle-brachial index of no less than 0.60 supports adequate circulation and oxygenation.

Toe pressure criterionToe pressure greater than 30 mm Hg is an alternative indicator of adequate perfusion.

Clinical indicatorsAcceptable peripheral pulses and/or Doppler toe signals may also evidence adequate circulation and oxygenation.

Product-specific diabetic foot ulcer duration

Typical durationProduct-specific diabetic foot ulcer pathways generally require the ulcer to be greater than 6 weeks in duration.

Wound depthThe listed pathways generally address partial- or full-thickness neuropathic diabetic foot ulcers extending through the dermis without specified tendon, muscle, capsule, joint, or bone exposure.

Standard careApplicable diabetic foot ulcer products are used in conjunction with standard diabetic ulcer care or standard wound-care regimens.

Retreatment size threshold

Size reductionRetreatment is not medically reasonable and necessary when the ulcer has shown greater than 75% size reduction.

Remaining sizeThe ulcer must also be smaller than 0.5 square centimeters for this retreatment exclusion to apply.

Coverage impactRetreatment of an ulcer meeting both thresholds is not considered medically reasonable and necessary.

Chronic wound treatment duration

Typical durationTreatment of a chronic skin wound will typically last no more than 12 weeks.

Episode of careThe duration applies to the chronic wound treatment episode.

Utilization contextApplication timing, frequency, and reapplication must remain appropriate for the product and the patient’s clinical condition.

Retreatment interval

Retreatment intervalRetreatment within 1 year of a prior course is considered treatment failure.

Specified ulcersThe interval applies to venous stasis ulcers and diabetic neuropathic foot ulcers.

Coverage impactRetreatment within that interval does not meet reasonable-and-necessary criteria for another skin substitute procedure.

Prior Authorization

Security Medicare Advantage Requirements

Security Medicare Advantage does not require prior authorization and follows Medicare guidelines. Payment is based on Medicare-allowed reimbursement for payable CPT codes.

The Commercial criteria and 10-application limit apply to Security Medicare Advantage as described in the policy.
Applications beyond the limit are not medically necessary, even when billed with the KX modifier.

Prior Authorization

Align, Align DSNP, and Great Plains Prior Authorization

Prior authorization is required through the Health Plan for Align, Align DSNP, and Great Plains Medicare Advantage beginning January 1, 2026. Medical necessity is determined using InterQual criteria, and payment is based on Medicare-allowed reimbursement for payable CPT codes.

Review applicable Medicare resources, including NCDs 270.3, 270.4, and 270.5.

Unsupported block type: prior_auth

Note

Breast Cancer Grafts

Grafts used for a breast cancer diagnosis do not require prior authorization and are not subject to the listed graft application limits. Refer to the Breast Reconstruction Post-Mastectomy policy.

Prior Authorization

Prior Authorization Effective April 1, 2026

For Commercial and Medicare Advantage members, prior authorization is required beginning April 1, 2026, according to the policy update. Confirm the member’s plan and the effective date before submitting or scheduling treatment.

Note

Breast Cancer Graft Exception

Breast cancer grafts are an exception to the standard authorization and application-limit rules. No prior authorization is required; refer to the Breast Reconstruction Post-Mastectomy policy for applicable coverage criteria.

Unsupported block type: step_therapy

Unsupported block type: documentation

Denial Risk

Failure to Meet Clinical Criteria

If the service does not meet the applicable clinical criteria, it will be denied as not medically necessary. Only the covered substitutes and indications identified in the policy are eligible, and a related application code or charge may also be denied.

Do not bill an application code when the underlying skin substitute is not medically necessary or is experimental and investigational.
Confirm the product, indication, wound characteristics, and plan-specific coverage before treatment.

Denial Risk

Do Not Exceed Application Limits

Do not exceed 10 skin-substitute applications or treatments per wound during a 12-week period of care. The limit applies even when more than one product is used and, for Security Medicare Advantage, applies even when codes are billed with the KX modifier.

Track applications across all products used for the same wound.
Applications beyond the limit are considered not medically necessary.

Denial Risk

Concurrent Product Use

Simultaneous use of more than one product during the wound episode is not covered. A product change may be allowed, but the total number of applications must remain within the 10-application limit per wound per 12-week period.

Denial Risk

Unsuccessful Prior Treatment

Repeat or alternative applications are not medically reasonable and necessary after an unsuccessful full course. Unsuccessful treatment includes increased size or depth, or no improvement in baseline size or depth and no indication of likely improvement for four weeks after therapy begins.

Denial Risk

Retreatment and Repeat Preparation

Do not retreat healed ulcers or ulcers with greater than 75% size reduction that are smaller than 0.5 square centimeters. Repeat surgical preparation services are also generally not reasonable and necessary; each wound is expected to receive appropriate preparation at least once at initiation of care.

Retreatment of a venous stasis or diabetic neuropathic foot ulcer within one year of a prior course is considered treatment failure.
Document wound status and preparation history before repeat treatment or preparation.

Denial Risk

Contraindications

Skin substitutes are contraindicated when underlying conditions or exacerbating factors are inadequately controlled. They are also contraindicated for known hypersensitivity to any component of the specific product.

Address uncontrolled diabetes, active infection, active Charcot arthropathy, vasculitis, and continued tobacco use without a physician-directed cessation attempt.
Check for allergies or hypersensitivity to avian, bovine, porcine, equine, or other product components.
Partial-thickness loss with retained epithelial appendages is not a grafting candidate.

Denial Risk

Experimental or Investigational Indications

Products or indications not listed as covered, or otherwise identified as experimental and investigational, are not covered. If the substitute is not medically necessary or is experimental and investigational, the associated application code or charge may also be denied.

Alloderm, Apligraf, Dermagraft, Epicord, EpiFix, Grafix, and Integra products are experimental and investigational for indications outside those specifically listed.
EpiFix injectable is investigational, and products such as Kerecis Omega3, MicroMatrix, NuShield, Puraply, Stravix, Theraskin, and other products listed in the policy lack sufficient supporting evidence for the noted indications.
Confirm that the product and indication are covered before application or billing.

Denial Risk

Family Health Center Site-of-Service Exclusion

Family Health Center does not cover surgical services performed in an inpatient, outpatient, observation, or ambulatory surgical setting. For otherwise qualifying skin substitutes, coverage is limited to services performed in an office setting.

If the substitute is not covered, the application services are also not covered; office evaluation and management services may remain covered.
Amnioexcel, Apligraf, and Primatrix are not covered as experimental and investigational.

Denial Risk

Experimental Substitute Application Denial

When a skin substitute is experimental and investigational, the related application code or charge will also be denied. Do not submit the application separately as a covered service.

Note

Plan Document Limitations

Review the member’s Summary Plan Description for limitations, exclusions, and governing coverage terms. If the SPD does not contain specific criteria, TPA groups using the Health Plan to process services follow the Commercial criteria.

No measurable changeTreatment is also unsuccessful when baseline size or depth remains unchanged for 4 weeks after therapy begins.

Absent improvementThere must be no sign of improvement or indication that improvement is likely, such as granulation, epithelialization, or progress toward closure.

Treatment consequenceRepeat or alternative applications are not considered medically reasonable and necessary after an unsuccessful full course.