ModifiedArizona Complete HealthPolicy N/A

Skin and Soft Tissue Substitutes for Chronic Wounds (coverage criteria)

Medical policy for non‑Medicare Arizona Complete Health plans defining coverage and coding for skin and soft tissue substitute products for chronic wounds; identifies codes that support or do not support medical necessity and documents updated criteria (I.A.–I.G.).

Policy Summary

PayerArizona Complete Health

PolicySkin and Soft Tissue Substitutes for Chronic Wounds (coverage criteria)

Policy CodePolicy N/A

Change TypeMaterial revisions to clinical criteria and coding tables (HbA1c, nicotine, coding lists, preferred product list)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization per policy and document HbA1c ≤8% or documented glucose improvement and nicotine‑cessation efforts; follow preferred product sequencing where required.

SourceLink

POLICY UPDATE CHANGES

Changed HbA1c requirement from ≤7% to ≤8%, or allowed if documented improvement in blood glucose in last 4 weeks; changed HbA1c contraindication to >8% or with no documented improvement in last 4 weeks.

Replaced requirement of no nicotine use for at least 4 weeks with documentation of effort to cease nicotine use, or no nicotine use for at least 4 weeks (excluding nicotine replacement therapy).

Removed requirement that neuropathy be present for diabetic foot ulcer criteria.

Updated HCPCS/CPT coding tables: added many new HCPCS codes to the supported and not‑supported lists and added CPT codes 15271-15278 and A2001-A2010 in various updates.

Multiple HCPCS codes were added to the 'HCPCS codes that do not support medical necessity criteria' table, including A2026-A2029, C8002, and numerous Q4xxx codes.

Criteria sections were replaced and renumbered (previous criteria I.A.-I. and II.A.-C. replaced with new I.A.-G.).

100+

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HCPCS/Q codes listed

50+Codes added to 'do not support' list

15271-15278CPT codes added

Coverage and Medical Necessity Criteria

Covered when policy criteria I.A–I.G are met

Covered when ALL of the following policy criteria I.A through I.G are met:

Policy requirement: All of criteria I.A through I.G must be satisfied for coverage of skin and soft tissue substitutes for chronic wounds.

See detailed criteria I.A–G (next block) for specific clinical and documentation requirements.

Scope: Request is for an indication within the policy scope (e.g., chronic wounds including diabetic foot ulcers and full‑thickness skin‑loss ulcers) and not for out‑of‑scope indications.

Requests for substitutes other than the indications noted in the policy are outside the scope and will not support medical necessity.

Coding and prior authorization: The HCPCS/CPT code submitted must be listed in the policy tables and prior authorization requirements followed; codes listed in the 'do not support medical necessity' table do not meet medical necessity under this policy.

Policy tables were updated and many HCPCS codes were reclassified; verify code status before submission.

Updated medical necessity criteria (I.A.-G.)

Updated medical necessity criteria I.A through I.G — itemized requirements and exclusions:

I.A. Patient and wound selection: Patient is an adult and wound type is eligible under the policy (chronic wound such as diabetic foot ulcer or full‑thickness skin‑loss ulcer).

Policy was updated to include full‑thickness skin‑loss ulcers and removed age/diabetes gating language from earlier versions.

I.B. Standard wound care optimization: Conservative and standard wound care measures have been applied and documented prior to use of a skin or soft tissue substitute.

Standard optimization requirements remain part of the medical necessity assessment per policy context.

I.C. Wound progression criteria: Wound area has reduced <50% in four weeks (or other policy‑specified lack of improvement) despite appropriate care.<50% area reduction in 4 weeks

Policy language revised to specify wound area reduction threshold as evidence of failure of conservative care.

This policy governs coverage for the use of skin and soft tissue substitutes for chronic wounds (for example, diabetic foot ulcers and full‑thickness skin‑loss ulcers) for Arizona Complete Health non‑Medicare plans. Coverage is limited to the clinical indications explicitly described in the policy and is conditional on meeting the policy’s medical necessity criteria (see criteria I.A.–I.G.). HCPCS/CPT product codes are used to identify billed products; only codes associated with indications and clinical criteria described in this policy are considered within scope. Requests for products or indications not described in the policy are outside the scope of this coverage policy.

HCPCS codes listed in the policy’s separate table titled HCPCS codes that do not support medical necessity criteria are excluded from medical necessity support under this policy. If a requested product is billed with a HCPCS code appearing in that table, the code will not, by itself, meet the policy’s medical necessity requirements.

The policy has placed multiple HCPCS codes into the table of codes that do not support medical necessity and this list has been revised across updates. Codes have been moved between the supporting and not‑supporting tables and new HCPCS codes have been added over time; consult the current HCPCS tables in the coding section for the latest classification of any specific code.

Use of any HCPCS code that appears in the policy’s ‘do not support medical necessity criteria’ table is considered by this policy to be not supported by medical necessity. Such codes are subject to prior authorization review and may be denied as not medically necessary when billed for skin and soft tissue substitute products outside the policy’s covered indications.

HCPCS / CPT / Coding Lists

HCPCS/Q and C codes listed in documentHCPCS

A2032	Myriad Matrix, per sq cm
A2033	Myriad Morcells, 4 mg
A2034	Foundation DRS Solo, per sq cm
A2035	Corplex P or Theracor P or Allacor P, per mg
C8002	Preparation Skin Cell Susp Autograft, automated, including all enzymatic processing and device components
C9358	Dermal substitute, native, nondenatured collagen, fetal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm
C9360	Dermal substitute, native, nondenatured collagen, neonatal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm
C9363	Skin substitute (Integra Meshed Bilayer Wound Matrix), per sq cm
C9364	Porcine implant, Permacol, per sq cm
Q4100	Skin substitute, not otherwise specified

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HCPCS codes that do not support medical necessity criteriaHCPCSNot Covered

A2026	listed in 'HCPCS codes that do not support medical necessity criteria'
A2027	listed in 'HCPCS codes that do not support medical necessity criteria'
A2028	listed in 'HCPCS codes that do not support medical necessity criteria'
A2029	listed in 'HCPCS codes that do not support medical necessity criteria'
C8002	listed in 'HCPCS codes that do not support medical necessity criteria'
Q4102	listed in 'HCPCS codes that do not support medical necessity criteria'
Q4104	listed in 'HCPCS codes that do not support medical necessity criteria'
Q4107	listed in 'HCPCS codes that do not support medical necessity criteria'
Q4111	listed in 'HCPCS codes that do not support medical necessity criteria'
Q4115	listed in 'HCPCS codes that do not support medical necessity criteria'

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inv-09: HbA1c

HbA1c thresholdHbA1c ≤ 8% required for coverage OR documented improvement in blood glucose in the last 4 weeks

ContraindicationHbA1c > 8% or no documented improvement in blood glucose in the last 4 weeks

Applicable contextRequirement applies to diabetic foot ulcer criteria per policy revisions

inv-10: Preferred product requirement

Preferred product referenceUse of products per the preferred product list added to criteria I.E.; coverage and sequencing follow criteria I.E.

Location in policyPreferred product list is referenced in criteria I.E. and coding was updated to reflect its addition

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for many of the HCPCS/CPT codes listed in the coding tables. Providers must obtain prior authorization before rendering services for skin and soft tissue substitutes when the code billed appears in the policy’s supported or not‑supported code lists.

Affected codes include HCPCS codes listed in the policy’s HCPCS Table 1 (codes that support medical necessity) and HCPCS Table 2 (codes that do not support medical necessity).
Follow the payer’s prior authorization process and submit all required clinical documentation with the request.

Denial Risk

Denial Risk When Billing ‘Do Not Support’ HCPCS Codes

Billing codes that are listed in the policy’s ‘do not support medical necessity’ table are at high risk for denial. Submissions that bill these HCPCS codes without meeting the policy criteria will likely be denied.

Background and Scope

This policy addresses the clinical use of biologic and synthetic dermal matrices, amniotic products, flowable/allograft products and other skin and soft tissue substitutes when used to treat chronic wounds. Clinical context and constraints include alignment with FDA‑approved indications and application limits, documentation of required optimization (for example, glycemic control and efforts to cease nicotine use), and specified contraindications (for example, active Charcot arthropathy of the ulcer surface). The Background and policy sections identify product classes and the clinical scenarios in which these substitutes may be considered when criteria I.A.–I.G. are met.

Key Definitions and Contraindications

inv-20: Active Charcot arthropathy of the ulcer surface

Definition/contraindicationContraindication clarified to 'active Charcot arthropathy of the ulcer surface' (replaced prior wording 'ulcer extremity')

ScopeApplies specifically to the ulcer surface rather than more general phrasing in prior policy language

Actionable notePresence of active Charcot arthropathy of the ulcer surface contraindicates use of skin and soft tissue substitutes per policy

inv-21: Nicotine cessation requirement

Documentation requirementDocumentation of effort to cease nicotine use, or no nicotine use for at least 4 weeks, is required

Nicotine replacement therapyNicotine replacement therapy (NRT) does not count as meeting the nicotine‑cessation requirement

Policy Summary

PayerArizona Complete Health

PolicySkin and Soft Tissue Substitutes for Chronic Wounds (coverage criteria)

Policy CodePolicy N/A

Change TypeMaterial revisions to clinical criteria and coding tables (HbA1c, nicotine, coding lists, preferred product list)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization per policy and document HbA1c ≤8% or documented glucose improvement and nicotine‑cessation efforts; follow preferred product sequencing where required.

SourceLink

On This Page

I.D. Nicotine and other modifiable factors: Documentation of effort to cease nicotine use, or no nicotine use for at least 4 weeks; nicotine replacement therapy does not count as cessation.no nicotine use for >=4 weeks or documented cessation effort

Requirement changed from absolute no nicotine use to documentation of effort; nicotine replacement therapy excluded from counting as cessation.

I.E. Product selection and sequencing: Selected product is supported by policy criteria and, where applicable, is on the preferred product list or follows preferred-product sequencing per criteria I.E.

Policy coding was updated to reflect addition of a preferred product list; documentation must support use according to preferred‑product requirements.

I.F. Compliance with FDA indications and application limits: Request and proposed application comply with the product's FDA‑approved indications and application limits (where applicable).

Policy clarifies that requests must comply with FDA indications and application limits (see I.H in prior revisions).

I.G. Clinical contraindications and glycemic control for DFU: No contraindications present (e.g., active Charcot arthropathy of the ulcer surface). For diabetic foot ulcers, HbA1c ≤8% OR documented improvement in blood glucose in the last 4 weeks; HbA1c >8% or no documented improvement is a contraindication.HbA1c ≤8% OR documented improvement in last 4 weeks; contraindication if >8% or no improvement

HbA1c threshold changed from ≤7% to ≤8% and contraindication language updated; neuropathy requirement was removed.

Exclusions / Not medically necessary: Items that do not meet the criteria below or that use HCPCS codes listed in the 'do not support medical necessity' table are excluded from coverage.

Multiple HCPCS codes were added to the not‑supported list during revisions; verify code coverage status.

Implication for providersProviders should document use of preferred products or justification for non‑preferred products according to criteria I.E.

HCPCS codes added to the ‘do not support medical necessity’ list (see revision history and coding tables) may result in claim denials if used.

If a code from the ‘do not support’ table is submitted, provide documentation demonstrating medical necessity and prior authorization if applicable; otherwise expect denial.

Documentation Required

Required Clinical Documentation Highlights

Documentation must include the clinical evidence elements specified in the policy and must clearly show that all applicable criteria are met for the requested product.

Nicotine use: document effort to cease nicotine use, or no nicotine use for at least 4 weeks (note: documentation of effort does not include nicotine replacement therapy).
Diabetic foot ulcer (DFU): include required DFU-specific documentation, including wound measurements and evidence of response to prior standard wound care; HbA1c must be ≤8% or show documented improvement in blood glucose over the last 4 weeks.
Include wound history, prior conservative treatments and durations, debridement records (if applicable), vascular assessment when indicated, and any applicable contraindications.
When requesting continuation/repeat applications, include prior application details and clinical response (wound area reduction, healing trajectory).

Documentation Required

Documentation Must Support Adherence to Updated Criteria

All documentation submitted with authorization requests or claims must support adherence to the policy’s updated criteria (I.A.–I.G.) and any referenced preferred product sequencing. Failure to document compliance with these criteria may result in denial of the request or claim.

Ensure records demonstrate that each applicable criterion in I.A.–I.G. is met.
If the policy requires sequencing defined by the Preferred Product List (I.E.), include documentation showing trials of required products or justification for bypassing the step requirement.

Note

Preferred Product List Referenced

The policy references a Preferred Product List in criteria I.E. Providers should consult and follow the Preferred Product List when selecting products for treatment.

The Preferred Product List identifies products preferred by the plan and may affect coverage or prior authorization decisions.
Always confirm the current Preferred Product List as part of the prior authorization and product selection process.

Step Therapy

Preferred Product List and Step Requirements

The Preferred Product List may impose a step or sequencing requirement before certain products will be approved. When the policy’s criteria reference step requirements, providers must document trials of preferred products or a clinical rationale for using a non‑preferred product.

If a step requirement exists in I.E., include documentation of prior use of preferred products and clinical response.
Requests that do not document required sequencing or that lack justification for bypassing preferred products are at increased risk for denial.

Where statedRequirement changed in I.D from 'no nicotine use for at least 4 weeks' to allow documentation of effort to cease; NRT exclusion added

inv-22: HCPCS codes for skin substitutes

Purpose of HCPCS codesHCPCS codes identify specific skin and soft tissue substitute products for billing and coverage determinations

Use in policyHCPCS/Q/C codes listed in the policy are used to determine which products support medical necessity and which do not

Provider implicationProviders must bill using the appropriate HCPCS code for the product applied; codes inform prior authorization and coverage decisions