CurrentCommunity Health Plan WashingtonPolicy MC.CP.MP.185

Skin and Soft Tissue Substitutes for Diabetic Foot Ulcers and Venous Leg Ulcers (PDF)

Defines medical necessity criteria, documentation, product lists, limitations, and coding/billing implications for use of cellular and/or tissue-based skin substitutes (CTPs) in Medicare-affiliated plans for diabetic foot ulcers (DFU) and venous leg ulcers (VLU). Applies to initial and continued applications, exclusions, documentation and coding guidance.

Policy Summary

PayerCommunity Health Plan Washington

PolicySkin and Soft Tissue Substitutes for Diabetic Foot Ulcers and Venous Leg Ulcers (PDF)

Policy CodePolicy MC.CP.MP.185

Change TypeTable updates; application limits; documentation additions

Effective Date

Next Review Date

Key ActionProviders must document criteria and request authorization for up to four initial applications and provide justification and documentation for continued treatment beyond four applications (up to total eight) including explanation why extended therapy is necessary and expected healing trajectory.

SourceLink

POLICY UPDATE CHANGES

Replaced original Table 2 with new Table 2 for DFU and added Table 3 for VLU; updated Table 4 (codes that do not support medical necessity) with many added HCPCS codes.

This establishes explicit numeric limits on approved applications.

Defines product types that meet medical necessity for each indication.

Operational documentation requirements referenced in policy; intended to support medical necessity review.

Several prior criteria were removed or renumbered; many wording updates stated to have no clinical significance.

Policy contextual note clarifying intended operational use.

Up to 4Initial applications authorized

Up to 8Max total applications per episode

>=4 weeksRequired prior conservative care duration

<50% in 4wFailure threshold for wound improvement

ABI >=0.6Minimum circulation criteria (ABI/toe)

120+HCPCS codes listed as not supporting medical necessity

Coverage Summary

This policy (Reference Number: MC.CP.MP.185) is issued for Medicare-affiliated health plans and addresses the use of cellular and/or tissue-based products (CTPs) commonly described as skin substitutes for treatment of chronic diabetic foot ulcers (DFU) and venous leg ulcers (VLU).

Coverage stance: these products are covered with criteria when the policy's medical necessity requirements are met, including required prior conservative care and documentation (see policy criteria).

High-level limits: the policy authorizes up to four initial applications of specified skin substitute products and permits up to a total of eight applications per wound during a single 12–16 week episode when continuation criteria are satisfied.

Required conservative care: the wound must be chronic and have failed to respond to at least four weeks of organized, comprehensive conservative wound treatment prior to CTP use.

Operational context: the criteria are intended to align with applicable Medicare LCDs and Coverage Articles and were derived from those LCDs and peer-reviewed literature; providers should review LCDs/LCA when applying this policy.

See the policy's stats_bar for the numeric badges summarizing the policy limits and thresholds rather than repeating metric cards here.

Key thresholds and operational limits

Duration of prior conservative wound care>= 4 weeks

Wound area reduction threshold< 50% reduction in 4 weeks

Ankle-Brachial Index (ABI) requirement>= 0.6

Toe pressure requirement> 30 mmHg

Maximum initial applications authorizedUp to 4 initial applications

Maximum total applications per episodeUp to 8 applications per wound per 12-16 week episode

Retreatment restriction timeframeNo retreatment within 1 year of a prior course

I. Initial therapy (up to four initial applications)

Covered when ALL of the following are met:

ALL of the following

Wound is chronic, defined as a wound that does not respond to at least four weeks of standard wound treatment as a component of organized, comprehensive, conservative therapy.
Wound characteristics and treatment plan are documented.
Standard wound care has failed
- The ulcer or skin deficit has been treated with appropriate wound-care measures, including debridement, standard dressings, compression, off-loading.
- Wound area has reduced by <50% in four weeks

II. Continued therapy (beyond initial four up to total eight applications)

Covered when ALL of the following are met:

ALL of the following

Requested product must be one of
- DFU list
  - AmnioBand (Q4151)
  - Affinity (Q4159)
  - Apligraf (Q4101)
  - DermACELL (Q4122)

III. Not medically necessary (Exclusions)

The following indications or scenarios are NOT medically necessary:

Partial thickness loss with retention of epithelial appendages
Simultaneous use of more than one product for the episode of wound
Repeat or alternative applications when a previous full course of applications was unsuccessful
Unsuccessful defined as increase in size or depth or no change in baseline size/depth and no sign of improvement for 4 weeks past start of therapy
Retreatment of healed ulcers, those showing greater than 75% size reduction and smaller than 0.5 square cm>75% reduction and <0.5 sq cm

Documentation & Billing Expectations

All documentation requirements that must be met and maintained in the medical record:

Every page legible with patient identification and legible signature of responsible clinician
Medical record must support use of selected ICD-10-CM code(s) and submitted CPT/HCPCS must describe service performed
Documentation must support medical necessity, that service was performed, appropriate diagnosis and response to treatment
Baseline wound description (size, location, stage, duration, infection presence), type of treatment given and response

Coding

Covered CPT (supporting medical necessity criteria)CPTCovered

15271	Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area
15272	Application ... each additional 25 sq cm wound surface area
15273	Application ... total wound surface area greater than or equal to 100 sq cm; first 100 sq cm
15274	Application ... each additional 100 sq cm wound surface area
15275	Application ... to face, scalp, ... hands, feet, total wound surface area up to 100 sq cm; first 25 sq cm or less
15276	Application ... each additional 25 sq cm wound surface area for face/hand/etc.
15277	Application ... to face/scalp/etc total wound surface area greater than or equal to 100 sq cm; first 100 sq cm
15278	Application ... each additional 100 sq cm for face/scalp/etc.

Covered HCPCS / DFU productsHCPCSCovered

A2019	Kerecis Omega3 MariGen Shield, per sq cm
Q4101	Apligraf, per sq cm
Q4102	Oasis wound matrix, per sq cm
Q4105	Integra dermal regeneration template or Integra Omnigraft dermal regeneration matrix, per sq cm
Q4106	Dermagraft, per sq cm
Q4107	GRAFTJACKET, per sq cm
Q4110	PriMatrix, per sq cm
Q4121	TheraSkin, per sq cm
Q4122	DermACELL, DermACELL AWM or DermACELL AWM Porous, per sq cm
Q4128	FlexHD, or AllopatchHD, per sq cm

1–10 of 18

1/2

Covered HCPCS / VLU productsHCPCSCovered

Q4101	Apligraf, per sq cm
Q4102	Oasis wound matrix, per sq cm
Q4106	Dermagraft, per sq cm
Q4151	AmnioBand or Guardian, per sq cm
Q4186	Epifix, per sq cm

HCPCS codes that do not support medical necessity (Table 4)HCPCSNot Covered

A2001	InnovaMatrix AC, per sq cm
A2002	Mirragen Advanced Wound Matrix, per sq cm
A2004	XCelliStem, 1 mg
A2005	Microlyte Matrix, per sq cm
A2006	NovoSorb SynPath dermal matrix, per sq cm
A2007	Restrata, per sq cm
A2008	TheraGenesis, per sq cm
A2009	Symphony, per sq cm
A2010	Apis, per sq cm
A2011	Supra SDRM, per sq cm

1–10 of 207

1/21

Background & Evidence

Background: the document summarizes regulatory and evidence context for CTPs/skin substitutes. The U.S. Food and Drug Administration does not use the term 'skin substitutes' as a regulatory designation; products commonly called skin substitutes are regulated and classified by the FDA under differing categories based on origin and composition.

Prior care requirement: standard, evidence-based wound care (infection and edema control, mechanical offloading, compression or limb elevation, debridement, appropriate dressings, and management of comorbidities such as glycemic control and tobacco use) must be attempted and corrected before considering skin substitutes; a 'failed response' is defined in the policy and typically requires at least four weeks of documented conservative care.

Regulatory and evidence sources: the criteria are sourced from Medicare Local Coverage Determinations (e.g., L36690, L36377, L35041) and Coverage Articles and are supported by peer-reviewed clinical trials and other literature cited throughout the policy.

Coding/tables note: the policy includes coding tables that classify HCPCS/CPT codes as supporting or not supporting medical necessity for DFU and VLU, and these tables were revised (Table 2 replaced/added and Table 3 added; Table 4 lists codes that do not support medical necessity).

Study / Source	Key finding
Apligraf RCT (DFU)
Wound closure at 12 weeks 56% (Apligraf) vs 28% (standard of care)
Epifix RCT (DFU)
Wound closure at 6 weeks 95% (EpiFix) vs 35% (standard of care) in one trial; other trials report high closure rates at 12 weeks (e.g., 70–97% vs ~50% SOC)
DermACELL RCT (DFU)
Healing at 16 weeks 67.9% (DermACELL) vs 48.1% (standard of care)
CMS LCD references
Local Coverage Determinations cited include L36690, L35041, L36377 (revisions noted in 2024); policy criteria are sourced from these LCDs/LCD articles
Clinical trials/studies summary
Numerous randomized controlled trials and observational studies referenced (multiple RCTs and meta-analyses across products supporting DFU and VLU efficacy; references 1–78+ in the policy)

Definitions

Failed responseUlcer/skin deficit that has failed to respond to documented appropriate wound-care measures, increased in size/depth, or no change with no indication improvement likely

Medicare Determinations

Number	Name	Type	Effective / Revision date
L36690
Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities
LCD
Published October 10, 2016 (revised September 5, 2024)
L36377
Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities
LCD
Published October 1, 2015 (revised November 8, 2024)
L35041
Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds
LCD
Published October 1, 2015 (revised November 8, 2024)

Policy statement I & Documentation requirements (highlights)

Policy statement I (summary): Up to four initial applications of specified skin substitute products are considered medically necessary for DFU and VLU when all criteria are met; continuation beyond the initial four may be considered with documentation up to a total of eight applications per wound per 12–16 week episode.

Documentation and product request requirements (I.I and I.J): providers must supply detailed documentation for each application (baseline and follow-up wound photos/measurements, procedure description including product identifier or NDC, size used, and amount wasted with date/time/reason) and, for continued therapy, explain why extended treatment is medically necessary and provide anticipated additional applications and healing expectations.

Material changes (has_material_change = true): changes include numeric limits on approved applications (added language authorizing 'up to four initial applications' and 'up to a total of eight' applications), defined product-type lists for DFU and VLU (I.F.1.d and I.F.2.d), and added operational/documentation requirements under I.I and I.J; coding tables were reorganized (Table 2 replaced and Table 3 added) with HCPCS codes moved between supporting and non-supporting lists.

Policy statement I (summary of applications and limits)

Policy includes limits on initial and total number of applications and defines medically necessary product types for DFU and VLU

Up to four initial applications of (specified) skin substitute products are approved

Revision History

03/24revised

Moved HCPCS codes A2009 and Q4304 from not-supporting to supporting lists; replaced original Table 2 with separate Table 2 (DFU) and added Table 3 (VLU); updated Table 4 with many added HCPCS codes; updated wording in multiple criteria (administrative/coding updates).

04/25revised

Annual review with clarification edits; reiterated movement of A2009 and Q4304 between code tables and updates to wording in criteria for clarity.

10/25added

Added explicit policy limits: 'up to four initial applications' and noted total applications not to exceed eight; added medically necessary product lists for DFU (I.F.1.d) and VLU (I.F.2.d); added documentation requirements I.I and I.J; updated coding tables to reflect DFU/VLU product classifications and codes considered not medically necessary.

Policy Summary

PayerCommunity Health Plan Washington

PolicySkin and Soft Tissue Substitutes for Diabetic Foot Ulcers and Venous Leg Ulcers (PDF)

Policy CodePolicy MC.CP.MP.185

Change TypeTable updates; application limits; documentation additions

Effective Date

Next Review Date

SourceLink

On This Page

<50% reduction in 4 weeks

Documentation of effort to cease nicotine use, including from sources other than cigarettes, but excluding nicotine replacement therapy, for at least four weeks during conservative wound care and prior to planned bioengineered skin replacement therapy, or no nicotine use.

Wound characteristics (ALL)

Partial- or full-thickness ulcer with a clean, granular base.
No involvement of tendon, muscle, joint capsule, or exposed bone or sinus tracts, unless Integra® is used per U.S. Food and Drug Administration (FDA) guidelines.
No wound infection; wound must be clean and free of necrotic debris or exudate.
Member/enrollee has adequate circulation/oxygenation to support tissue growth/wound healing, as evidenced by physical examination (e.g., Ankle-Brachial Index [ABI] of no less than 0.6 or toe pressure greater than 30 mmHg).

DFU pathway (ALL)

Diagnosis of Type 1 or Type 2 Diabetes and medical management for the condition.
Documented conservative wound care for ≥ four weeks.
Wound is without evidence of osteomyelitis or nidus of infection.
Requested product (ANY)
- AmnioBand, guardian (Q4151).
- Affinity (Q4159).
- Apligraf (Q4101).
- DermACELL, DermACELL AWM, or DermACELL AWM porous (Q4122).
- Derma-Gide (Q4203).
- Dermagraft (Q4106).
- Epicord (Q4187).
- Epifix (Q4186).
- FlexHD or AllopatchHD (Q4128).
- Grafix PRIME, GrafixPL PRIME, Stravix and StravixPL (Q4133).
- GraftJacket (Q4107).
- Integra dermal regeneration template or Integra Omniograft dermal regeneration matrix (Q4105).
- Kerecis Omega 3 (Q4158).
- Kerecis Omega3 MariGen shield (A2019).
- NuShield (Q4160).
- Oasis wound matrix (Q4102).
- PriMatrix (Q4110).
- Theraskin (Q4121).

VLU pathway (ALL)

A chronic, non-infected VLU has failed to respond to documented conservative wound-care measures for ≥ four weeks with documented compliance.
Completed assessment
- History (prior ulcers, thrombosis risks).
- Physical exam (edema, skin changes).
- ABI (Ankle-Brachial Index) and duplex scan to confirm Clinical-Etiology-Anatomy-Pathophysiology (CEAP).
A venous duplex ultrasound has been completed to assess saphenous vein incompetency/venous reflux and contributory superficial ulcer bed perforators.
Requested product (ANY)
- AmnioBand, guardian (Q4151).
- Apligraf (Q4101).
- Dermagraft (Q4106).
- Epifix (Q4186).
- Oasis wound matrix (Q4102).

Requested use complies with FDA-approved indications for the specific product.

Only one skin substitute will be simultaneously in place per wound episode; product change within the wound episode is allowed, with a total of up to four initially authorized and total applications not to exceed the eight-application limit per wound per 12–16-week episode of care.

The graft will be applied in a single layer without overlay of product or adjacent skin in compliance with the correct label application techniques for the skin substitute graft/CTP.

Documentation and product request requirements (per application)

Graphic evidence of ulcer size, depth, and characteristics of the ulcer or photo documentation of the ulcer at baseline and follow-up with measurements of wound including size and depth.
A complete description of the procedure including product used (with identifying package label or National Drug Code (NDC) in the chart) and size of product used.
If multiple sizes of a specific product are available, the size that best fits the wound is utilized, with the least amount of wastage.
If a portion of a product is discarded, documentation includes the amount administered and wasted, the date, time, and amount of product wasted and the reason for the wastage.
When a portion of a single use package must be discarded, payment will be made for the portion discarded along with the amount applied up to the amount of the product on the package label. All documentation must be maintained in the member/enrollee's medical record and made available upon request.

Contraindications (NONE of the following)

Inadequate control of underlying conditions or exacerbating factors (e.g., uncontrolled diabetes, active infection, active Charcot arthropathy of the ulcer extremity, vasculitis or continued tobacco smoking without physician attempt to effect smoking cessation).
Known hypersensitivity to any component of the specific skin substitute graft (e.g., allergy to avian, bovine, porcine, equine products).
Partial thickness loss with the retention of epithelial appendages (epithelium will repopulate the deficit).

HCPCS coding support for medical necessity

Q4101 — Apligraf.
Q4102 — Oasis wound matrix.
Q4105 — Integra dermal regeneration template / Omniograft dermal regeneration matrix.
Q4106 — Dermagraft.
Q4107 — GraftJacket.
Q4110 — PriMatrix.
Q4121 — Theraskin.
Q4122 — DermACELL (and variants).
Q4128 — FlexHD / AllopatchHD.
Q4133 — Grafix / Stravix family.
Q4151 — AmnioBand, guardian.
Q4158 — Kerecis Omega 3.
Q4159 — Affinity.
Q4160 — NuShield.
Q4186 — Epifix.
Q4187 — Epicord.
Q4203 — Derma-Gide.
Providers must document product NDC or package label in the record; billing should use the appropriate HCPCS code corresponding to the product supplied.

FlexHD/AllopatchHD (Q4128)

Grafix PRIME/Stravix (Q4133)

Integra DRT/Omniograft (Q4105)

Kerecis Omega3 (Q4158)

Kerecis Omega3 MariGen shield (A2019)

VLU list

AmnioBand (Q4151)
Apligraf (Q4101)
Dermagraft (Q4106)
Epifix (Q4186)
Oasis (Q4102)

Requested use complies with labeled indications

Documentation required for continued therapy (ALL)

Explanation of why extended time or additional applications are medically necessary for the specific member's wound
That the treatment plan regarding the initial four applications has resulted in wound healing and expectation that the wound will continue to heal with this plan
Estimated time for extended treatment, number of additional applications anticipated, and plan of care if healing is not achieved as planned
Modifiable risk factors (diabetes, venous insufficiency, neuropathy) are being addressed adequately
For VLU, appropriate consultation and management for diagnosis and stabilization of venous-related disease
Additional documentation from each initial four and subsequent applications (ALL)
- Complete description of procedure including product used (with identifying package label or NDC in the chart) and size of product used
- Graphic evidence of ulcer size, depth, and characteristics at baseline and follow-up with measurements
- Skin substitute is applied in a single layer without overlay of product or adjacent skin per label techniques
- When multiple sizes available, size that best fits wound with least wastage is utilized

Waste documentation

When a portion of a product was discarded, medical record clearly demonstrates amount administered and wasted, date, time, amount wasted and reason

Re-treatment within one (1) year of any given course of skin substitute treatment for a venous stasis ulcer or diabetic neuropathic foot ulcer1 year

Wound description updated throughout treatment and pre/post treatment with skin substitute graft used

If worsening or lack of response is noted, continuing treatment not reasonable without documentation of reasonable rationale

Documentation of smoking history, counseling and outcome of counseling (if applicable)

Amount of utilized and wasted skin substitute clearly documented in procedure note with date, time and location of ulcer treated; name of skin substitute and how product supplied; amount used; amount discarded; reason for wastage; manufacturer's serial/lot/batch or other unit identification

When portion of single use package discarded, payment made for portion discarded along with amount applied up to amount on package label

Repeat use of surgical preparation services in conjunction with skin substitute application considered not reasonable and necessary; appropriate wound preparation code expected at least once at initiation

Documentation Required

Detailed wound and product documentation

Procedure notes must include the product name, identifying package label or NDC, the size of product used, amount applied and amount wasted, date/time of application, and manufacturer's lot/serial/batch number when available. Maintain legible records with clinician identification and signature. Photographic and measurement documentation at baseline and follow-up are expected.

Photos of wound at baseline and follow-up with measurements (size and depth)
Baseline and serial wound measurements (area and depth)
Amount applied and amount wasted with date/time and reason for wastage
Package label or NDC and manufacturer's serial/lot/batch number (when available)

Prior Authorization

Authorization for initial and continued applications

Providers must request authorization for up to four initial applications. Requests must document that the wound meets initial therapy criteria and include supporting clinical information; continued therapy beyond the initial four requires additional justification and documentation.

Prior Authorization

Limit on number of applications (initial and total)

Operational limits are: up to four initial applications and up to eight total applications per wound per 12–16 week episode of care. Prior authorization/processes must reflect and enforce these limits.

Denial Risk

Denial risk for inadequate prior conservative care or infection

Claims may be denied if the medical record does not document required conservative care for at least four weeks, failure to meet the <50% wound area reduction threshold in four weeks, presence of wound infection, or insufficient evidence of adequate circulation (e.g., ABI <0.6 or toe pressure ≤30 mmHg). Ensure complete documentation per policy to reduce denial risk.

Billing Rule

Payment for wasted portion of single-use package

When a portion of a single-use package is discarded, payment may be made for the discarded portion in addition to the amount applied up to the package quantity if the waste is documented. Documentation must show the amount used, amount wasted, reason for wastage, date/time, and identifying package information.

Amount of product unit used
Amount of product unit discarded
Reason for wastage
Date and time of application and waste
Package label or NDC and manufacturer's serial/lot/batch number

Billing Rule

Single product per wound episode

Only one skin substitute may be simultaneously in place per wound episode. Simultaneous use of more than one skin substitute for the same episode is considered not medically necessary.

Billing Rule

Surgical preparation code usage

Repeat use of surgical preparation services in conjunction with skin substitute application is considered not reasonable and necessary. An appropriate wound preparation code is expected at least once at initiation of care prior to placement.

Documentation Required

Provide documentation per new I.I and I.J requirements

When requesting skin substitute products, providers must supply the additional documentation and product request details newly added under criteria I.I and I.J (see policy). Failure to provide the required I.I/I.J documentation may affect approval decisions.

Billing Rule

Adhere to HCPCS code tables for coverage determination

Use HCPCS codes per the policy tables when determining coverage: Table 2 (HCPCS codes that support DFU medical necessity), Table 3 (HCPCS codes that support VLU medical necessity), and Table 4 (HCPCS codes that do not support medical necessity). Note that some codes (e.g., A2009 and Q4304) were moved between lists—claims should reflect the current table assignments in this policy.

Table 2 — HCPCS codes supporting DFU (see policy Table 2)
Table 3 — HCPCS codes supporting VLU (see policy Table 3)
Table 4 — HCPCS codes that do not support medical necessity (see policy Table 4); A2009 and Q4304 moved between tables

Documentation Required

Review applicable Medicare and Medicaid determinations

Providers should review applicable state Medicaid manuals and Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Coverage Articles prior to applying these clinical policy criteria for Medicaid or Medicare members.

Documentation Required

Exercise clinical judgment and follow contract terms

Providers are expected to exercise professional medical judgment and remain responsible for medical advice and treatment decisions. Providers are bound by contractual terms and conditions when submitting claims and should follow those terms in addition to this policy.

Chronic woundA wound that does not respond to at least four weeks of standard wound treatment as part of organized, comprehensive, conservative therapy

Up to 4 initial applications

Up to a total of eight applications may be approvedUp to 8 total applications

Medically necessary product types for DFU added in I.F.1.d

Medically necessary product types for VLU added in I.F.2.d

11/25updated

Title and scope refinements; specified that policy statements I and III apply to DFU and VLU and removed full-thickness skin loss indication in I.F.3 (administrative/content update without clinical significance).

12/25addedLatest

Policy description clarified intended operational use by Medicare health plans affiliated with Centene in MAC jurisdictions lacking full CMS/MAC coverage criteria; documented ongoing coding/table updates and maintained the four-initial / eight-total application limits and added documentation/product request requirements (I.I and I.J).