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CurrentIndependent HealthPolicy M20211221065

Skin Substitutes

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Medical necessity criteria and coverage policy for use of skin substitutes for wound care across Independent Health lines of business (Commercial, Medicare Advantage, MediSource, Essential Plan, Child Health Plus, and others). Affects providers requesting coverage for bioengineered tissue products.

Policy Summary

PayerIndependent Health

PolicySkin Substitutes

Policy CodePolicy M20211221065

Change TypeNo material changes

Effective DateMar 1, 2022

Last ReviewMar 1, 2022

Next Review Date

Key ActionObtain prior authorization using the listed product codes before rendering skin substitute services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>10applications limit

>=0.65ABI threshold

1–25 cm2eligible ulcer size

<=12%HbA1c max

Requiredphotographic documentation

~150+listed products

Coverage Criteria

All bioengineered tissue products not specifically listed as covered in this policy are considered investigational/unproven and are NOT COVERED for any indication due to insufficient evidence of efficacy. Examples of products treated as investigational are included in the policy code lists (see policy coding tables for specific HCPCS/CPT codes and descriptions).

When submitting requests, providers should confirm the requested product appears in the policy's list of covered skin substitutes for the intended indication; if a product is not listed, coverage will be denied as investigational unless an Independent Health Medical Director determines otherwise.

Coverage and payment for skin substitute services are subject to the member's eligibility, applicable contract exclusions, and any limitations in the member's contract at the time services are rendered. Providers must verify member benefits and eligibility prior to delivering services.

This policy sets medical necessity criteria that must be met for coverage; meeting clinical criteria does not override contractual exclusions or eligibility limitations documented in the member's plan.

Independent Health considers more than 10 applications of a skin substitute to a single wound within a 12‑week period to be Not Reasonable and Necessary and subject to review. Exceptions and product-specific weekly limits are noted in the policy (for example, EpiFix and Grafix are each limited to one application per week for up to 12 weeks).

Requests exceeding the application limit should include clinical justification and will be reviewed; prior authorization and documentation requirements still apply.

Policy Summary

PayerIndependent Health

PolicySkin Substitutes

Policy CodePolicy M20211221065

Change TypeNo material changes

Effective DateMar 1, 2022

Last ReviewMar 1, 2022

Next Review Date

Key ActionObtain prior authorization using the listed product codes before rendering skin substitute services.

SourceLink

On This Page

Coding and Product Lists

Covered products for diabetic foot ulcer indicationmixedCovered

Q4128	Allopatch HD
15271-15278	Apligraf CPT range
Q4151	Amnioband Membrance
15275	Dermagraft
Q4187	Epicord
Q4186	Epifix
Q4132	Grafix CORE / Grafix PL Core
Q4133	Grafix PRIME / Grafix PL Prime
28899	Integra
Q4105	Integra Dermal Regeneration Matrix (Omnigraft)

1–10 of 12

1/2

Covered products for burnsHCPCSCovered

Q4105	Integra Dermal Regeneration Matrix (Omnigraft) - burn indication
Q4100	Biobrane

Covered products for breast reconstructionmixedCovered

19357-19369	Alloderm (breast reconstruction)
Q4122	DermACELL AWM
Q4107	GraftJacket
C9358	Surgimend

Not covered / investigational products (partial list)HCPCSNot Covered

Q4356	Abiomed membrane and abioment hydromembrane per sq cm
Q4355	Abiomed XPlus membrane and Abiomed XPlus hydromembrane per sq cm
Q4325	ACApatch, per sq cm
C9354	Acellular pericardial tissue matrix of non-human origin (Veritas)
A2043	BIOBRANE, per sq cm
Q4145	EpiFix, injectable, 1 mg
Q4104	Integra bilayer matrix wound dressing (BMWD), per sq cm

Clinical indications (group 1)HCPCS

A2028	MicroMatrix Flex, per mg
Q4175	Miroderm, per sq cm
A2029	MiroTract Wound Matrix sheet, per CC
A2002	Mirragen advanced wound matrix, per sq cm
Q4256	MLG-Complete, per sq cm
Q4328	MOST, per sq cm
Q4226	MyOwn Skin, includes harvesting and preparation procedures, per sq cm
Q4396	Natalin, per sq cm
A2021	NeoMatrix, per sq cm
Q4176	Neopatch or therion, per square centimeter

1–10 of 15

1/2

Clinical indications (group 2)HCPCS

Q4389	NeoThelium 4L Plus, per sq cm
Q4148	Neox Cord 1K, Neox Cord RT, or Clarix Cord 1K, per sq cm
Q4156	Neox 100 or Clarix 100, per sq cm
Q4155	Neox Flo or Clarix Flo, 1 mg
Q4194	Novachor, per sq cm
Q4254	Novafix DL, per sq cm
Q4208	Novafix, per sq cm
A2045	NovaShield or NovoGen Wound Matrix, per sq cm
A2006	Novosorb Synpath Dermal Matrix, per sq cm
Q4285	NuDYN DL or NuDYN DL MESH, per sq cm

1–10 of 16

1/2

Clinical indications (group 3)HCPCS

Q4196	PuraPly AM, per sq cm
Q4197	PuraPly XT, per sq cm
Q4296	Rebound Matrix, per sq cm
Q4314	Reeva FT, per sq cm
Q4315	RegeneLink Amniotic Membrane Allograft, per sq cm
Q4255	REGUaRD, for topical use only, per sq cm
Q4257	Relese, per sq cm
Q4321	RenoGraft, per sq cm
Q4435	Renati Membrane, per sq cm
Q4436	Renati AC Membrane, per sq cm

1–10 of 15

1/2

Clinical indications (group 4)mixed

Q4180	Revita, per sq cm
Q4157	Revitalon, per sq cm
Q4437	Revival AC, per sq cm
Q4424	Revive FT, per sq cm
Q4425	Revive TL, per sq cm
Q4289	RevoShield+ Amniotic Barrier, per sq cm
Q4319	SanoGraft, per sq cm
Q4308	Sanopellis, per sq cm
Q4260	Signature APatch, per sq cm
Q4340	SmipliGraft, per sq cm

1–10 of 16

1/2

Clinical indications (group 5)HCPCS|CPT|HCPCS

A2011	Supra SDRM, per sq cm
A2012	SUPRATHEL, per sq cm
Q4233	SurFactor or NuDyn, per 0.5 cc
Q4218	SurgiCORD, per sq cm
Q4183	Surgigraft, per sq cm
Q4219	SurgiGRAFT-DUAL, per sq cm
Q4393	SurGraft AC, per sq cm
Q4394	SurGraft ACA, per sq cm
Q4268	SurGraft FT, per sq cm
Q4263	SurGraft TL, per sq cm

1–10 of 17

1/2

Clinical indications (group 6)HCPCS

A2008	TheraGenesis, per sq cm
Q4342	TheraMend, per sq cm
Q4121	TheraSkin, per sq cm
Q4330	TOTAL, per sq cm
Q4182	Transcyte, per sq cm
Q4344	Tri-Membrane Wrap, per sq cm
Q4167	Truskin, per sq cm
Q5135	Tyenne, 1mg
Q4279	Vendaje AC, per sq cm
Q4252	Vendaje, per sq cm

1–10 of 26

1/3

Select CPT/HCPCS / C-codes present in listsHCPCS|CPT

C9364	Porcine implant, Permacol, per sq cm
C9363	Integra Meshed Bilayer Wound Matrix, per sq cm
C9356	TenoGlide Tendon Protector Sheet, per sq cm

inv-19: Ankle-Brachial Index (ABI) threshold

ABI thresholdAnkle‑brachial index (ABI) >= 0.65 in the limb being treated

PurposeDemonstrates adequate arterial blood supply prior to skin substitute application

Applies toDiabetic foot ulcers and venous ulcers as part of initial coverage criteria

inv-20: Ulcer size eligibility

Eligible ulcer size>1 cm and <25 cm²

Measurement guidanceSize requirement applies to diabetic foot ulcers and venous ulcers in initial coverage criteria

Exclusion by sizeUlcers ≤1 cm or ≥25 cm² do not meet the size criterion for coverage

inv-21: HbA1c threshold for diabetic foot ulcer eligibility

HbA1c thresholdPatient's current HbA1c does not exceed 12% within the last 60 days

ApplicabilityRequired for diabetic foot ulcer coverage as part of initial criteria

Documentation periodLaboratory result must be within 60 days of request

inv-22: Unit/measure thresholds per product (per sq cm, per mg, per 0.5 cc, etc.)

Unit/measure examplesVarious unit measures specified per product: per sq cm, per mg, per 0.5 cc, per 100 mg, per CC, each

Billing codes tied to measuresMany HCPCS/CPT codes list the unit of measure (e.g., Q4175 per sq cm; A2028 per mg; Q4233 per 0.5 cc)

Provider actionUse the specified unit of measure on the product-specific code when requesting authorization and billing

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the skin substitute products listed in this policy. Lack of preauthorization may result in claim denial or payment delay. Prior authorization must be obtained before services are rendered except where retroauthorization is permitted by the payer.

Preauthorization required for listed skin substitutes (see policy product list)
Preauthorization may be required for MediSource/MediSource Connect/Child Health Plus/Essential Plan per payer rules

Documentation Required

Photographic Documentation Required

Photographic documentation of the wound(s) must be submitted prior to treatment and a photograph must be obtained and retained by the provider with each skin substitute application; these photos may be subject to retrospective review.

Photograph prior to first treatment
Photograph with each application and retain in medical record

Documentation Required

Proof of Prior Standard Wound Care Failure

Documentation must show failure of standard wound care prior to advanced skin substitute therapy. For diabetic foot ulcers this requires at least 4 weeks of standard wound care; for venous ulcers at least one month of standard wound care. Standard wound care must include dressings to maintain a moist wound environment, debridement when indicated, and offloading (for diabetic foot) or standard therapeutic compression (for venous ulcers).

Diabetic foot ulcer: documentation of >=4 weeks failed standard care
Venous ulcer: documentation of >=1 month failed standard care
Standard care components: moist dressings, debridement if present, offloading or compression

Documentation Required

Standard Wound Care and Clinical Preconditions Before Advanced Therapy

Standard wound care must be in place and documented before initiating a bioengineered tissue product. Providers must document adequate arterial blood supply (ABI ≥ 0.65 for limb treated), patient ability to participate in follow-up, appropriate ulcer size and depth criteria, control of underlying disease processes, absence of infection or conditions interfering with adherence, and HbA1C ≤ 12% within the last 60 days where applicable.

ABI ≥ 0.65 documented when applicable
Ulcer size >1 cm and <25 cm2
Full- or partial-thickness ulcer criteria and absence of interfering conditions
HbA1C ≤ 12% within 60 days (when applicable)

Denial Risk

Unlisted / Investigational Products Not Covered

Use of unlisted or investigational bioengineered tissue products that are not named in this policy is considered investigational and not covered. Providers requesting coverage for products not listed must expect denial unless an Independent Health Medical Director determines clinical utility for the requested indication.

All bioengineered tissue products not explicitly listed are investigational/not covered
Requests for unlisted products will be reviewed by an Independent Health Medical Director

Billing Rule

Excessive Application Volume

Greater than 10 applications for the treatment of a single wound within a 12-week period will be considered Not Reasonable and Necessary and subject to review. Exceptions: EpiFix and Grafix are limited to one application per week for up to 12 weeks.

>10 applications per single wound in 12 weeks = Not Reasonable and Necessary
EpiFix: limited to 1 application/week for up to 12 weeks
Grafix (all variants): limited to 1 application/week for up to 12 weeks

Documentation Required

Medical Necessity and Eligibility Documentation

Medical necessity determinations and payment are subject to member eligibility, contract exclusions, and limitations in the member's contract at the time services are rendered. Providers should submit full clinical documentation (including prior authorization, photographic documentation, wound care history, ABI, HbA1C, and other supporting records) to support medical necessity.

Payment subject to member eligibility and contract limitations
Submit documentation to support medical necessity: prior auth, photos, wound care history, ABI, HbA1C

Background

Chronic wounds — such as diabetic foot ulcers and venous leg ulcers — are wounds that have failed to progress through the normal, orderly healing process and often require adjunctive interventions to restart healing. Skin substitutes are bioengineered tissue products used as adjuncts to standard wound care for uninfected wounds and are classified broadly as cellular (living cells) or acellular (no living cells).

These products are intended to be applied to a prepared wound bed (for example after sharp debridement and cleansing) and used alongside appropriate standard care components (dressings to maintain a moist environment, offloading for diabetic foot ulcers, compression for venous ulcers). Independent Health bases coverage decisions for skin substitutes on published evidence and requires specific medical necessity criteria to be met before approving use.

Providers must document wound status (including photographic documentation), adequate perfusion (for example ABI >= 0.65 where specified), failure of prior standard wound care, absence of infection or necrotic material, and other criteria described in the policy to support medical necessity.

Definitions

inv-34: Skin substitutes (definition / description)

DefinitionBioengineered tissue products used as adjuncts to standard wound care for uninfected wounds; heterogeneous group including cellular (living cells) and acellular (synthetic or cell‑removed) products

Intended useProvide temporary or permanent coverage of open skin wounds, replicating properties of normal skin

Clinical requirementWound bed must be prepared (typically sharp debridement and cleansing) prior to application

inv-35: Chronic wound — definition

DefinitionA wound that has failed to pass through the normal healing process in an orderly and timely manner (examples include diabetic foot ulcers and venous leg ulcers)

Clinical featuresMay require interventions to restart healing; care involves debridement, moist dressings, infection control, and restoring blood flow

ExamplesIncludes diabetic foot ulcers and venous leg ulcers

inv-36: Diabetic foot ulcer — definition

DefinitionAn open break of the skin of the foot associated with neuropathy and/or peripheral arterial disease of the lower limb in a patient with diabetes

Coverage contextCovered when all diabetic foot ulcer criteria are met (including ABI, size, prior standard care failure, infection status, and HbA1c)

Location and depthUlcers are located on foot or toes and typically full‑thickness extending through dermis without exposure of tendon, muscle, capsule, or bone

inv-37: Full-Thickness Thermal Burn (Third Degree Burn) — definition

DefinitionFull‑Thickness Thermal Burn (Third Degree Burn): a burn with destruction of all layers of the skin, involving epidermal and dermal layers with varying subcutaneous involvement

Clinical noteMay require skin substitutes when insufficient autograft is available or patient is too ill for additional donor sites (product‑specific criteria)

Implication for coverageCovered for burn indications when product‑specific requirements are met (e.g., Integra/Omnigraft criteria)

inv-38: Partial-Thickness Thermal Burn (Second Degree Burn) — definition

DefinitionPartial‑Thickness Thermal Burn (Second Degree Burn): a burn that involves the epidermis and only part of the dermis; deep partial‑thickness burns involve most of the dermis

Clinical noteSuperficial partial‑thickness burns (≤25% TBSA) may meet product‑specific coverage for Biobrane when clean and non‑infected

DifferentiationDeep partial‑thickness burns leave few intact skin appendages and nerve endings compared with more superficial burns

inv-39: Measurable signs of healing — definition

DefinitionMeasurable signs of healing: a wound diminishing in size (surface or depth) with decreased exudate and necrotic tissue

Use in policyUsed to document failure of standard wound care (e.g., no measurable signs after ≥4 weeks for diabetic foot ulcers or ≥1 month for venous ulcers)

Components monitoredReduction in wound surface area/depth, decreased exudate, and decreased necrotic tissue

inv-40: Venous stasis ulcer — definition

DefinitionVenous stasis ulcer: an open break of the skin in an area with sluggish circulation and poor venous return, commonly around the ankle

Coverage criteriaCovered when all venous ulcer criteria are met, including ABI >=0.65, size >1 cm and <25 cm², failure of ≥1 month of standard care including compression

Typical locationCommonly occurs around the ankle

inv-41: Skin substitutes — alternate definition (biologic/synthetic/biosynthetic)

Alternate definitionSkin substitutes: biologic, synthetic, or biosynthetic materials that provide temporary or permanent coverage of open skin wounds, replicating properties of normal skin

ClassificationBroadly classified as cellular (living cells) or acellular (no living cells) depending on composition

IndicationsUsed for burns, wounds, or reconstructive procedures when wound bed is prepared and criteria are met