CurrentCentenePolicy CP.PHAR.562

Allogeneic Cultured Keratinocytes and Dermal Fibroblasts in Murine Collagen-dsat (StrataGraft)

Policy governing medical necessity and coverage criteria for StrataGraft for treatment of adults with deep partial-thickness thermal burns; applies to Centene-affiliated health plans and providers submitting requests for coverage.

Policy Summary

PayerCentene

PolicyAllogeneic Cultured Keratinocytes and Dermal Fibroblasts in Murine Collagen-dsat (StrataGraft)

Policy CodePolicy CP.PHAR.562

Change TypeNo material change

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit prior authorization with clinical documentation demonstrating all approval criteria are met, including specialist consultation and prescriber attestation that surgical intervention is indicated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum age for coverage

One-timeapplication allowed

3 moinitial approval duration

Q4100referenced code

Coverage Criteria for StrataGraft

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Initial Approval — Thermal Burns

Covered when ALL of the following are met:

Thermal Burns initial criteria: Member meets all of the following: diagnosis of deep partial-thickness thermal burns containing intact dermal elements; prescribed by or in consultation with a burn specialist; age >= 18 years; prescriber attestation that surgical intervention is clinically indicated; member is not allergic to products of bovine or porcine origin; requested number of StrataGraft constructs does not exceed wound bed size (number of constructs may be rounded up to the nearest whole number); request is for a one-time application only; approval duration: 3 months (one application only per thermal burn occurrence)

Re-authorization

Re-authorization policy: Re-authorization is not permitted; members must meet the initial approval criteria for coverage. Approval duration: Not applicable.

Other diagnoses/indications

Coverage for uses not specified under the main indication follows formulary/non-formulary or off-label policies:

Alternate handling: If the product has undergone a recent label change (within the last 6 months) not yet reflected in this policy, follow the referenced formulary or non-formulary policies for the relevant line of business (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16). If the requested use is not listed under excluded diagnoses and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per the applicable off‑label use policies (see referenced policies).

Coverage determinations under this policy are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan administrative policies; compliance with those documents and policies is required for payment and may affect authorization decisions.

Requests for StrataGraft for non‑FDA approved indications without sufficient supporting documentation of efficacy and safety are not authorized. Providers should refer to the Health Plan's off‑label use policies (e.g., CP.CPA.09, CP.PMN.53) for requirements and acceptable evidence when seeking coverage for off‑label uses.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Submit clinical documentation (such as office chart notes, lab results, or other clinical information) supporting the diagnosis and that the member meets all approval criteria.

Affected indication: deep partial-thickness thermal burns
Documentation examples: office notes, lab results, other clinical information

Documentation Required

Documentation Required for Off‑Label Uses

Provider must submit documentation to support off-label use when applicable. Requests that do not meet approval criteria or that lack required documentation (including for non‑FDA indications) will be denied or handled per the plan's off‑label use policies.

See off‑label policies: CP.CPA.09 (commercial), HIM.PA.154 (Marketplace), CP.PMN.53 (Medicaid)

Note

Therapeutic Use Limited to Adults with Specified Burns

Therapeutic use is limited to adults (age ≥ 18 years) with deep partial‑thickness thermal burns containing intact dermal elements for which surgical intervention is clinically indicated. Prescriptions must be by or in consultation with a burn specialist.

Age requirement: ≥ 18 years
Diagnosis: deep partial‑thickness thermal burns with intact dermal elements
Prescriber: burn specialist or in consultation with one

Note

Follow Health Plan Administrative Policies and Member Coverage Documents

Follow Health Plan‑level administrative policies and the member's coverage documents when submitting prior authorization requests and claims. Coverage decisions are subject to the member's evidence of coverage, terms, conditions, exclusions, limitations, and applicable Health Plan policies and procedures.

Adhere to Health Plan administrative policies and procedures
Verify member coverage documents (EOC, certificate of coverage, policy) before submission

Documentation Required

Submission Requirements

Submission requirements: include office chart notes, prescriber attestation that surgical intervention is clinically indicated, documentation of wound size to justify number of constructs requested, allergy information (bovine/porcine), and any other clinical data supporting the request.

Prescriber attestation that surgical intervention is clinically indicated
Documentation of wound size (to support requested number of constructs)
Allergy status for bovine or porcine products

Denial Risk

Denial Risk for Incomplete or Non‑compliant Requests

Requests that do not meet the approval criteria (including exceeding one‑time application per thermal burn occurrence or lacking required documentation) or requests for non‑covered indications will be denied or processed per policy.

One‑time application only per thermal burn occurrence
Number of constructs must not exceed wound bed size (may round up)

Note

Coverage Subject to Health Plan Terms

Coverage decisions are subject to the Health Plan's terms, conditions, exclusions, and applicable administrative policies. This clinical policy is a guide to medical necessity and does not guarantee payment.

Coverage subject to member evidence of coverage and Health Plan policies
Policy does not constitute a payment guarantee

Definitions

StrataGraft construct

Product descriptionOff-white rectangular sheet (~100 cm²; ~8 cm x 12.5 cm)

Cellular compositionViable allogeneic keratinocytes grown on gelled collagen

Dermal componentCollagen contains dermal fibroblasts

Construct typeBioengineered allogeneic cellularized scaffold

Deep partial-thickness burn

DefinitionBurn injury in which damage extends through the entire epidermis and into the lower part of the dermis

Clinical complexityComplex skin injury often requiring surgical management

Relevant to policyIndication: deep partial-thickness thermal burns containing intact dermal elements

Health Plan

DefinitionA health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC or its affiliates, as applicable

RoleMakes no guarantee of payment; policy is a guide to medical necessity

ScopeCoverage decisions subject to terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan administrative policies

OpenPayer

Allogeneic Cultured Keratinocytes and Dermal Fibroblasts in Murine Collagen-dsat (StrataGraft)

Coverage Criteria for StrataGraft

Coding and Age Requirements

Provider Actions and Prior Authorization

Definitions

Background