CurrentUnitedHealthcarePolicy MMP105.18

Skin Substitutes Grafts/Cellular and Tissue-Based Products (Injections and/or Applications)

Defines UnitedHealthcare’s references, coding list, and Medicare LCD/LCA alignment for coverage and billing of skin substitutes and other cellular and tissue‑based products (including amniotic/placental products) used for wound and non‑wound indications; affects providers submitting claims to UnitedHealthcare and Medicare Advantage plans.

Policy Summary

PayerUnitedHealthcare

PolicySkin Substitutes Grafts/Cellular and Tissue-Based Products (Injections and/or Applications)

Policy CodePolicy MMP105.18

Change TypeArchived supporting codes

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionWhere Medicare LCDs/LCAs exist for amniotic/placental or skin substitute CTPs, providers must comply with those contractor policies and retain documentation to support coverage decisions.

SourceLink

POLICY UPDATE CHANGES

Archived supporting information for Q4378, Q4379, Q4380, Q4382.

No additional material clinical or coverage changes in this revision.

11 pagesdocument length

400+codes enumerated

MultipleMedicare LCD/LCA refs

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Coverage Alignment and Governance

Coverage alignment and cross‑references

Coverage aligns with applicable Medicare Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs). Where Medicare contractor policies exist for amniotic/placental or skin substitute CTPs, compliance with those LCDs/LCAs is required; for jurisdictions or indications without an applicable LCD/LCA, UnitedHealthcare guidance applies as noted.

ALL of the following

Medicare contractor policies: When an applicable LCD/LCA exists for the product or indication, compliance with that LCD/LCA is required
No applicable LCD/LCA: For states/territories or indications without an LCD/LCA, refer to the UnitedHealthcare Commercial Medical Policy: 'Skin and Soft Tissue Substitutes' or, for breast reconstructive procedures, the UnitedHealthcare Medicare Advantage Medical Policy 'Cosmetic and Reconstructive Procedures'
Reference table: Refer to the LCD/LCA tables in this policy for specific jurisdictional requirements and contractor names (CMS-related documents list relevant LCDs/LCAs)

Coverage governance and precedence

Medicare Advantage policy documents support UnitedHealthcare coverage decisions but are subordinate to member-specific benefit plan documents and to Medicare source materials where conflicts exist.

ALL of the following

Member-specific benefit plan document determines final coverage and supersedes this policy in the event of a conflict
Where there is a conflict between this policy and Medicare source materials (statutes, regulations, NCDs, LCDs, manuals), the Medicare source materials apply
ALL of the following
- Providers are expected to retain or have access to appropriate documentation to support coverage decisions and to submit accurate claims
- Providers must follow delegate utilization management/authorization requirements where applicable

Applicable Codes and Coding Notes

Representative HCPCS/HCPCS Q-code listHCPCS

A2001	InnovaMatrix AC, per sq cm
Q4112	Cymetra, injectable; 1 CC
Q4145	EpiFix; injectable, 1 mg

Applicable/archived HCPCS Q-codesHCPCS

Q4378	Referenced in policy summary as archived supporting information
Q4379	Referenced in policy summary as archived supporting information
Q4380	Referenced in policy summary as archived supporting information
Q4382	Referenced in policy summary as archived supporting information

Code list completeness note

Scope of code listThe procedure and/or diagnosis code lists are provided for reference only and may not be all‑inclusive.

No coverage implicationListing of a code in this policy does not imply that the service described by the code is a covered or non‑covered health service.

Benefit and payment determined by planBenefit coverage and reimbursement are determined by the member‑specific benefit plan document and applicable law; inclusion does not guarantee payment.

Other policies may applyOther UnitedHealthcare policies and guidelines may affect coverage or billing for services described by listed codes.

Reference onlyInclusion of a code does not imply any right to reimbursement or guarantee claim payment; lists are for provider reference.

Provider Responsibilities and Compliance

Documentation Required

LCD/LCA Compliance Requirement

Medicare does not have a National Coverage Determination (NCD) for these products. Where Local Coverage Determinations (LCDs) or Local Coverage Articles (LCAs) exist for amniotic/placental derived products or skin substitutes/CTPs, compliance with those Medicare contractor policies is required. Refer to the applicable LCD/LCA table(s) for state-specific guidance.

Applicable LCDs/LCAs must be followed where they exist.
Refer to UnitedHealthcare Commercial or Medicare Advantage policies for guidance where no LCD/LCA applies (e.g., Skin and Soft Tissue Substitutes; Cosmetic and Reconstructive Procedures for breast reconstruction).

Documentation Required

Documentation Responsibility

Providers must retain or have access to appropriate documentation to support coverage and claims when requested. This includes documentation supporting medical necessity, coding, and any authorization determinations. UnitedHealthcare uses Medicare Advantage policy documents to support coverage decisions; these documents and the member-specific benefit plan determine coverage applicability. In the event of a conflict, the member-specific benefit plan supersedes this policy.

Key Terms

CTP — Cellular and/or Tissue‑Based Products definition

Term definedCellular and/or Tissue‑Based Products (CTPs): terminology inclusive of current and future technologies used to describe skin substitute grafts and related products.

Includes synthetic productsASTM updated its standard to include synthetic products within the definition of CTPs.

Adopted terminologyCTP terminology has been adopted by the wound care community, Medicare contractors, and other government agencies.

Intended useUsed to describe products for wound care and related clinical applications, including grafts and biologic matrices.

LCD/LCA references relevant to skin substitutes and amniotic/placental‑derived products

Relevant LCDs/LCAs — skin substitutesIncludes CMS LCDs/LCAs such as L36377, L35041 and corresponding LCAs (e.g., A57680, A54117) addressing skin substitute grafts/CTPs for DFU and VLU and lower‑extremity wounds.