CurrentAspirus ArisePolicy CP-AMCR24-010A

Skin-Substitute Grafts

Defines Aspirus Arise coverage stance for biologic, synthetic, and biosynthetic skin-substitute graft products used to manage acute and chronic open skin wounds for members of listed Aspirus Medicare Advantage products.

Policy Summary

PayerAspirus Arise

PolicySkin-Substitute Grafts

Policy CodePolicy CP-AMCR24-010A

Change TypeNo material changes

Effective DateJun 24, 2024

Next Review DateJan 9, 2026

Key ActionPrior authorization is not required for skin-substitute grafts under this policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥9Covered examples

ExtensiveNon-covered list

Not RequiredAuthorization

Medicare AdvantageApplies to

Coverage Criteria for Skin-Substitute Grafts

inv-01: Covered Indications

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Covered Indications: Diabetic lower extremity ulcer; Venous lower extremity ulcer; Second or third-degree burns; Pressure (decubitus) ulcer (stage 3 and 4); Breast reconstruction post mastectomy; Adjunct reconstruction of soft tissue defect during primary surgery; Stevens-Johnson syndrome; Toxic epidermal necrolysis; Dystrophic epidermolysis bullosa.

Coverage applies to products listed as Covered Products and Brand Name Products within the policy.

inv-02: Covered Products

Covered Products (representative list):

Covered Products: AlloDerm; Allopatch HD; AmnioBand; Apligraf; DermACELL; DermACELL AWM; DermACell AWM Porous; Dermagraft; Epicord; Epifix; FlexHD; Grafix Core; Grafix PRIME; GRAFTJACKET; Grafix PL PRIME; Guardian; Integra Dermal Regeneration Template (DRT); Integra Omnigraft Dermal Regeneration Matrix; Oasis Wound Matrix; PriMatrix; Stravix; Stravix PL; TheraSkin; TransCyte.

List is illustrative from policy; coverage limited to products listed as covered.

The policy identifies an extensive list of specific skin‑substitute products and brand names that are not covered. This non‑covered list includes (but is not limited to) many named products such as Axolotl™ Graft Ultra; Biovance® (and Biovance® 3L); Cellesta® products; Clarix® products; Graftjacket® Xpress; InnovaMatrix® variants; Oasis® wound matrix; PuraPly® (and variants); SkinTE; Strattice™; Talymed®; Theracor P; Vendaje® and many others. The published list is long and may not be all‑inclusive, so other skin‑substitute brand names not explicitly listed may also be considered non‑covered under this policy.

Coverage of skin‑substitute grafts is limited to the products specifically listed as covered by the policy; products appearing on the non‑covered lists are excluded from coverage regardless of clinical indication.

Use of any product included in the policy’s "Services not covered" lists is considered not covered and may result in denial of the claim. Providers should not submit requests for coverage or authorization for brand‑name skin‑substitute products that appear on the non‑covered lists because those products are excluded from payment under this policy.

Claims submitted for products on the non‑covered lists may be denied and should be avoided; if there is uncertainty about whether a product is covered, providers should confirm against the policy's covered product list or contact the plan for guidance.

Provider Actions and Requirements

Prior Authorization

Prior authorization is not required for skin-substitute grafts under this policy. Providers do not need to obtain prior authorization before delivering covered skin-substitute products.

Note

Provider Action

Providers should confirm patient eligibility and benefit coverage using the member's plan documents and verify any product-specific restrictions prior to service delivery.

Reference the patient’s Evidence of Coverage / Member Handbook for benefit details
Verify eligibility and coverage prior to claim submission

Documentation Required

Claims and Documentation Responsibility

Providers are responsible for submission of accurate and compliant claims and must retain appropriate documentation to support medical necessity. If there is a conflict between this coverage policy and the member's plan documents, the plan documents prevail.

Submit accurate and compliant claims
Maintain clinical documentation to support medical necessity
Refer to Aspirus plan documents when coverage questions arise

Denial Risk

Non-Covered Products

Use of products listed as non-covered may result in non-coverage and claim denial. The list of non-covered skin substitutes is illustrative and may not be all-inclusive; providers should confirm coverage before using products not explicitly listed as covered.

Using non-covered skin substitutes can lead to claim denial
The non-covered list is not exhaustive — verify product coverage

Background on Skin Substitutes

Skin substitutes are materials used to provide temporary or permanent coverage of open skin wounds and to replicate properties of normal skin. They may be biologic, synthetic, or biosynthetic and are used in the management of acute and chronic wounds—including diabetic and venous lower extremity ulcers, second‑ or third‑degree burns, pressure (decubitus) ulcers (stage 3 and 4), certain reconstructive procedures (for example post‑mastectomy breast reconstruction or adjunct soft tissue reconstruction), and rare conditions such as Stevens‑Johnson syndrome, toxic epidermal necrolysis, or dystrophic epidermolysis bullosa.

These products serve to protect wound beds, support tissue regeneration, and facilitate healing either temporarily or permanently depending on the product type and clinical indication. Coverage under this policy is determined by the clinical indication and whether the product is listed among the policy’s covered products or is explicitly listed as not covered.

Definitions

Skin substitute — definition and key attributes

DefinitionMaterials that provide temporary or permanent coverage of open skin wounds and aim to replicate properties of normal skin.

Material typesBiologic, synthetic, or biosynthetic materials.

FunctionUsed to manage acute or chronic wounds by providing wound coverage and supporting tissue repair.

Duration of coverageCan offer either temporary or permanent coverage depending on product and clinical indication.

Clinical uses (examples)Includes treatment of ulcers, burns, and other open-skin wound indications addressed elsewhere in the policy.