CurrentCentenePolicy CP.MP.185

Skin and Soft Tissue Substitutes for Chronic Wounds

Policy governs medical necessity criteria for use of skin and soft tissue substitutes/cellular and tissue-based products (CTPs) for diabetic foot ulcers (DFU) and venous leg ulcers (VLU) for non-Medicare health plans affiliated with Centene. It lists required clinical documentation, preferred HCPCS product codes that support medical necessity, HCPCS codes that do not support medical necessity, application limits per episode, contraindications and documentation/billing requirements.

Policy Summary

PayerCentene

PolicySkin and Soft Tissue Substitutes for Chronic Wounds

Policy CodePolicy CP.MP.185

Change TypeRevisions to criteria, coding tables, and documentation requirements

Effective Date

Next Review Date

Key ActionProviders must supply documentation of SOC and failure to achieve >=50% ulcer area reduction after at least 4 weeks of SOC, measurements (pre-, weekly, and post-SOC), operative note with product used and NDC/label, photos with measurements, and documentation of modifiable risk factor management.

POLICY UPDATE CHANGES

Multiple annual revisions updated HCPCS code lists, clarified indications and application limits, changed HbA1c threshold from <7% to <8% (with documented improvement option), and added age and type 1 diabetic criteria in prior revisions.

Removed requirement for MD review of all requests and removed several HCPCS codes no longer included.

Revised criteria and clarified applicability to non-Medicare plans; removed references to diabetes type and silver dressings.

Updated HCPCS coding tables: moved multiple codes between supporting and non-supporting medical necessity tables; added and removed numerous Q- and A- codes.

Updated description for HCPCS code A4225.

Removed note under description to refer to MC.CP.MP.185 for Medicare plans.

Added preferred product list to criteria I.E.

8Maximum applications per wound per episode

>=50% in 4 weeksSOC ulcer area reduction threshold

15271-15278CPT codes referenced

~200+HCPCS codes listed (supporting + not supporting)

annualReview frequency

Coverage Summary

This policy (CP.MP.185) governs medical necessity criteria for the use of skin and soft tissue substitutes/cellular and tissue‑based products (CTPs) to treat chronic wounds specifically diabetic foot ulcers (DFU) and venous leg ulcers (VLU) for non‑Medicare health plans affiliated with Centene. The policy requires documentation of standard of care (SOC) being performed (infection control, debridement, compression/off‑loading, management of systemic disease) and demonstration of failure to heal with SOC — defined as failure to achieve at least a 50% reduction in ulcer area after a minimum of 4 weeks of SOC — before CTPs are considered medically necessary. Preferred HCPCS product codes and a separate list of codes that do not support medical necessity are provided; applications are limited to a maximum of 8 applications per wound per 12–16 week episode, and only one skin substitute may be in place simultaneously per wound episode. The policy applies to FDA‑labeled indications and aligns with relevant CMS NCDs/LCDs and Medicare articles for coverage and coding guidance.

Quick thresholds and stats

Application limit per episodeMaximum 8 applications per wound per 12-16 week episode

SOC ulcer area reduction thresholdFailure defined as <50% reduction in ulcer area after at least 4 weeks of SOC (policy requires >=50% reduction to consider healed response)

Compression strength for VLUFirm strength compression garment or multi-layered compressive dressing >20 mmHg required/documented

HbA1c thresholdHbA1c <8% or documented improvement in blood glucose in last 4 weeks required; HbA1c >8% or no documented improvement is a contraindication

CPT codes referencedCPT codes 15271-15278 referenced for application procedures

Medical-Necessity Criteria

Application limits and episode rules

Application and episode of care limits and documentation

Application limits

Simultaneous use: Only one skin substitute applied simultaneously per wound episode
Max applications: Maximum of 8 applications per wound per 12-16 week episode of care8 applications per 12-16 weeks
First application begins episode of care
Product changes: Product change within the wound episode is allowed; total applications must not exceed the 8-application limit per wound per 12-16-week episode of care

Coding

Covered CPT (application procedure)CPTCovered

15271	Application of skin substitute graft to trunk, arms, legs; first 100 sq cm or less, or 1% of body surface area or less, full thickness wound
15272	each additional 100 sq cm, or each additional 1% of body surface area (list separately in addition to code for primary procedure)
15273	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears; first 100 sq cm or less, or 1% BSA or less
15274	each additional 100 sq cm, or each additional 1% of body surface area (list separately in addition to code for primary procedure)
15275	Application of skin substitute graft to hands, feet, digits; first 100 sq cm or less, or 1% BSA or less
15276	each additional 100 sq cm, or each additional 1% of body surface area (list separately in addition to code for primary procedure)
15277	Application of skin substitute graft to eyelid(s), nose, ears, lips, or mucous membrane; first 100 sq cm or less, or 1% BSA or less
15278	each additional 100 sq cm, or each additional 1% of body surface area (list separately in addition to code for primary procedure)

HCPCS codes that SUPPORT medical necessity (preferred/product list)HCPCSCovered

A2008	TheraGenesis
A2019	Kerecis Omega3 Margin Shield
Q4101	Apligraf
Q4102	Oasis Wound Matrix
Q4104	Integra Bilayer Matrix Wound Dressing
Q4105	Integra dermal regeneration template or Omnigraft dermal regeneration matrix
Q4106	Dermagraft
Q4107	Graftjacket
Q4110	Primatrix
Q4111	Gammagraft

1–10 of 45

1/5

HCPCS codes that DO NOT support medical necessityHCPCSNot Covered

No codes listed

HCPCS codes that support medical necessity (Table 1) - codes added/moved in revisionsHCPCSCovered

Q4185

(added in revisions)

HCPCS codes that do not support medical necessity (Table 2) - codes added/moved in revisionsHCPCSNot Covered

No codes listed

Provider Actions & Requirements

Prior Authorization

Medical necessity documentation required for CTP requests

Prior authorization and medical necessity documentation are required for requests for CTPs. Provide a concise packet showing the SOC and evidence of failure to heal to support the request.

Documentation of compliance with standard of care (SOC) and evidence of failure to achieve ≥50% ulcer area reduction after ≥4 weeks of SOC
Pre-, weekly, and post-SOC ulcer measurements (including baseline wound measurements and follow-up measurements)
Operative note for each application including product name and NDC when available
Baseline and follow-up wound photos showing size, depth, and characteristics
Documentation that modifiable risk factors (e.g., glycemic control, venous insufficiency, smoking cessation, offloading) are being identified and managed

Background, Evidence & Definitions

Skin substitutes and soft tissue substitutes vary widely by origin, composition, additives, and processing; evidence is heterogeneous and comparative effectiveness between products is limited, with systematic reviews and technology assessments calling for more head‑to‑head trials and better real‑world evidence. The policy applies to chronic wounds (defined consistent with CMS as wounds impaired for 4 weeks or longer) and addresses DFU and VLU specifically. Standard wound care (infection control, debridement, offloading for DFU, sustained compression for VLU, management of exudate and systemic disease, smoking cessation counseling) must be attempted and documented prior to CTP use. The policy also notes alignment with FDA‑labeled indications and references multiple CMS local coverage determinations and related billing/coding articles for Medicare guidance while specifying that this document governs non‑Medicare Centene plans.

Key Evidence

Definitions

Medicare Determinations

Type	Number	Name	Effective Date
NCD	A56696	CMS A56696
LCD	L39865	Skin substitute grafts/cellular and tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers	2025-04-13
Article	A59628	Billing and coding: Skin substitutes grafts/cellular and tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers	2025-04-13

Revision History

04/20material_revision

Revision (04/20): Multiple changes including removal of MD review requirement; changed HbA1c threshold from <7% to <8% (with documented improvement option); added age ≥18 or type 1 diabetic criterion; added CPT codes 15271-15278 and updated HCPCS lists. (detail: Revision history documents numerous code additions/removals and criteria wording changes; text: Multiple annual revisions updated HCPCS code lists, clarified indications and application limits, changed HbA1c threshold from <7% to <8% (with documented improvement option), and added age and type 1 diabetic criteria in prior revisions.)

05/20-06/20coding_update

Code updates (05/20–06/20): Added CPT codes 15271–15278; updated HCPCS lists and removed several HCPCS codes not included in Medicare article A56696. (detail: Revision history documents numerous code additions/removals and criteria wording changes; text: Examples: Added CPT codes: 15271-15278; updated list of HCPCS codes; HCPCS codes removed as not included in Medicare Article A56696.)

Policy Summary

PayerCentene

PolicySkin and Soft Tissue Substitutes for Chronic Wounds

Policy CodePolicy CP.MP.185

Change TypeRevisions to criteria, coding tables, and documentation requirements

Effective Date

Next Review Date

On This Page

>4 applications documentation

Explanation for extension: Explanation why extended time or additional applications is medically necessary for the specific member's wound
Healing expectation: That the current treatment plan has resulted in wound healing and expectation that the wound will continue to heal with this plan
Modifiable risk factors: Which modifiable risk factors (e.g., diabetes optimization) are being addressed to improve likelihood of healing
Estimated time and plan: Estimated time for extended treatment; number of additional applications anticipated, and plan of care if healing is not achieved as planned
VLU consultation: For venous ulcers, appropriate consultation and management for diagnosis and stabilization of venous-related disease

Documentation Required

Operative note content

An operative note must accompany each application and provide a clear clinical record of the procedure and product used. The note supports medical necessity and accurate billing.

Product name and identifying package label or National Drug Code (NDC)
Complete description of the procedure and relevant intraoperative findings
Amount of product administered (by weight, volume, or units)
Documentation of any product wastage and disposition

Billing Rule

Wastage documentation and payment

When a portion of a single-use package is discarded, document the wasted portion thoroughly to support payment. Payment may be made for the discarded portion up to the labeled package amount when properly documented.

Document the amount wasted, date and time of wastage, and reason for wastage
Use the size of the product that best fits the wound to minimize wastage; when discarded, payment may be made for the discarded portion along with the amount applied up to the package amount

Billing Rule

HCPCS coding must reflect current table assignment

HCPCS coding on claims must reflect the current table assignment for the product at the time of service to ensure proper adjudication. Codes may be reassigned between HCPCS tables across revisions; verify current code-to-product mapping before billing.

Confirm HCPCS code assignment as of the service date; codes have moved between tables in prior revisions and may do so again
Bill using the HCPCS code that corresponds to the specific product and size applied

Documentation Required

Product selection / preferred product list

When applicable, use the policy's preferred product list to guide product selection for medically necessary CTPs. Preferred products are maintained for FDA-labeled indications and may change with market or regulatory updates.

Refer to the policy's preferred product list when the requested use is within FDA-approved indications
Preferred products are subject to change based on new product launches, approvals, or withdrawals

Denial Risk

Claims may be denied if contraindications present or criteria unmet

Claims may be denied if contraindications are present or required criteria are not met. Review diagnostic and treatment documentation carefully before submission to reduce denial risk.

Requests outside the indications listed in the policy or without required SOC documentation
Placement on infected, ischemic, or necrotic wound beds or active conditions listed as contraindications (e.g., active Charcot arthropathy, progressive necrosis, active vasculitis)
Exceeding allowed application limits (e.g., greater than policy-specified maximum applications per episode)
Insufficient documentation of failure to respond to SOC (missing pre/weekly/post measurements or photos)

Documentation Required

Apply non-Medicare policy scope

This policy applies to non-Medicare Centene-affiliated plans. Medicare members are governed by CMS NCDs/LCDs; consult the Medicare-specific policy for Medicare-covered determinations.

Apply non-Medicare policy scope for Centene-affiliated commercial and Medicaid lines of business
For Medicare members, refer to Medicare-specific policy MC.CP.MP.185 and applicable NCDs/LCDs

04/21-04/22coding_update

Annual/code revisions (04/21–04/22): Added new HCPCS codes (A2001–A2010, Q4199, Q4201, Q4232, Q4254) and removed others; referenced CMS A56696. (detail: Revision history documents numerous code additions/removals and criteria wording changes; text: Added the following HCPCS codes: A2001-A2010, Q4199, Q4201, Q4232 and Q4254; removed specific codes.)

04/23material_revision

Revision (04/23): Policy title/statement updates to include soft tissue substitutes, HCPCS table reorganization into supporting (Table 1) and non-supporting (Table 2) lists; moved multiple codes between tables and added Q4253, Q4262–Q4264 to supporting table. (detail: Updated HCPCS coding tables: moved multiple codes between supporting and non-supporting medical necessity tables; added and removed numerous Q- and A- codes; text: Moved codes between tables and added new codes to Table 1 including Q4253, Q4262-4264.)

03/24material_revision

Revision (03/24): Specified policy applies to non‑Medicare plans; replaced wound response criterion with wound area reduction threshold (<50% in four weeks); moved codes (e.g., A2002, Q4236, Q4262) from not-supporting to supporting lists and added Q4278. (detail: Policy statements I and II updated to specify non-Medicare plans; C2 criterion replaced with wound area reduction threshold (<50% in four weeks); text: Removed language related to Type 1/2, replaced C2 with 'Wound area has reduced <50% in four weeks'; coding moves noted.)

03/25material_revision

Revision (03/25): Added preferred product list to criteria I.E and updated criteria sets (I.A–G); coding updated to reflect addition of preferred product list; description/background reviewed. (detail: Coding updated to reflect addition of a preferred product list in criteria I.E.; text: Added preferred product list to criteria I.E.)

06/25coding_updateLatest

Revision (06/25): Large coding cleanup — numerous Q-codes (Q4336–Q4382 and many others) and C8002 added to HCPCS codes that do not support medical necessity; date of last revision updated to 06/25. (detail: Revision history documents numerous code additions/removals and criteria wording changes; text: Added many Q43xx–Q43xx codes to non-supporting table in later revisions; Date of Last Revision: 06/25.)

ongoingadministrativeLatest

Administrative/coding cleanup: Removed requirement for MD review of all requests and removed/deleted specific HCPCS codes (e.g., deleted A2003) as part of iterative administrative maintenance. (detail: Administrative and coding cleanup across revisions; text: Removed requirement for MD review of all requests and removed several HCPCS codes no longer included.)