CurrentUnitedHealthcarePolicy CS153NJ.W

Skin and Soft Tissue Substitutes (for New Jersey Only)

This Medical Policy governs coverage and medical necessity criteria for skin and soft tissue substitute products used in wound care for members in New Jersey; it specifies which products are covered, which are considered unproven, and lists applicable billing codes.

Policy Summary

PayerUnitedHealthcare

PolicySkin and Soft Tissue Substitutes (for New Jersey Only)

Policy CodePolicy CS153NJ.W

Change TypeNo material changes

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain and document prior standard wound care (e.g., at least 4 weeks with debridement, moist dressings and offloading or compression) and objective perfusion measures before requesting authorization for adjunctive skin substitute use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

NJState-specific

2Named covered products

manyUnproven / not medically necessary

4w/50%SOC trial before change

1.67xPooled DFU benefit

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multipleHCPCS Q/A codes listed

Coverage and Medical Necessity Criteria

EPIFIX / GRAFIX — diabetic foot ulcer

Covered when ALL of the following are met:

EPIFIX/GRAFIX diabetic foot ulcer criteria: Adequate circulation to the affected extremity as indicated by one or more of: palpable pedal pulses OR pulses confirmed with Doppler OR Ankle-Brachial Index between 0.7 and 1.2; Glycated hemoglobin (HbA1c) < 12% within the last 90 days; Ulcer has failed to demonstrate adequate healing after at least 4 weeks of standard wound care (including dressings to maintain a moist wound environment, debridement if present, and offloading); No known contraindications such as active Charcot deformity or major structural foot abnormalities, chronic infection at the ulcer site, known or suspected malignancy of the ulcer, or ulcer that extends to tendon, muscle, capsule, or bone.ABI 0.7-1.2; HbA1c <12%; >=4 weeks SOC

EPIFIX or GRAFIX are considered unproven for other indications.

TransCyte — thermal burns prior to autograft

Covered when ALL of the following are met:

TransCyte burn indication: Surgically excised full-thickness thermal burn wounds OR deep partial-thickness thermal burn wounds for which TransCyte is applied prior to autograft placement.N/A

TransCyte is unproven for other indications.

Unproven / not medically necessary products

The following products are considered unproven and not medically necessary for any indication due to insufficient evidence of efficacy:

Unproven products list: Extensive list of named skin and soft tissue substitutes (see policy product lists) including but not limited to Abiomend variants; ACApatch; Acelagraft; Acesso family; Activate Matrix; AdvoGraft; Affinity; AlloGen; alloPLY; AlloSkin; AlloWrap; AmchoPlast variants; AmchoThick; American Amnion variants; AmniCore products; AmnioBurgeo n variants; AmnioBand; AmnioBind/DermaBind; AMNIOFIX; AMNIOMATRIX/BioDMatrix; Amnio-Maxx; Artacent family; ArthroFLEX; BIOVANCE variants; many additional named products (full policy product list).N/A

Use of these products is considered not medically necessary for any indication in the absence of sufficient published evidence.

Adjunctive therapy criteria

Use of skin substitutes is considered as adjunctive therapy to standard wound care when specific clinical criteria are met and after an appropriate trial of standard treatments.

Adjunctive use for chronic wounds: Skin substitutes are adjunctive to standard of care (debridement, moisture balance, infection control, ischemia correction, compression for VLU, offloading for DFU); an appropriate trial of standard treatments (commonly at least 4 weeks with <50% wound-size reduction) must have failed before adjunctive biologic therapy is used.standard care trial: 4 weeks with <50% size reduction

Supported by systematic reviews and HTAs indicating improved healing when used with SOC.

Evidence summaries and product-level stance

High-level evidence summaries and product-specific stances informing coverage:

General evidence: Systematic reviews and meta-analyses indicate biological skin substitutes plus SOC improve DFU/VLU healing rates and time to healing versus SOC alone, but evidence is heterogeneous and product-level data are limited.

See pooled analyses and HTA conclusions.

Cellular vs acellular: Cellular skin substitutes may benefit DFU healing, and many acellular dermal substitutes report favorable outcomes, but comparative superiority among individual products is not established due to low-quality evidence for many products.

Hayes and AHRQ reviews cited.

Product-specific limitations: Numerous named products have few or no adequate published studies; benefit on health outcomes cannot be determined without higher-quality evidence.

Refer to product sections for details.

Products with insufficient evidence

Products for which published evidence is insufficient to determine a health benefit (examples listed in policy):

Insufficient evidence products: Specific amniotic/placental products (e.g., AmchoPlast variants; AmnioCore series; Amnio Burgeon variants; AmnioWrap2; AmnioArmor; AMNIOFIX; AMNIOMATRIX/BioDMatrix; AlloWrap; BIOVANCE variants; and many others listed in the policy) have too few or low-quality studies to establish clinical benefit; treatment requests should be supported by robust evidence to be considered.N/A

Registry or case-series data exist for some products but are insufficient for routine coverage.

AmnioBand — trial-based criteria and outcomes

AmnioBand (dHACA) — trial-based eligibility and outcomes informing coverage:

RCT eligibility-based coverage logic: In RCTs dHACA (AmnioBand) was studied in patients meeting trial criteria: objective adequate perfusion (ABI >0.75 OR skin perfusion pressure >30 mm Hg OR TcPO2 >30 mm Hg), wound area typically ≥2 and <20 cm^2, duration >1 month, full-thickness through dermis but not to muscle/tendon/bone, clean granulating base, and prior compression/offloading as appropriate for ≥14 days; infected ulcers, non-venous etiologies, wounds probing to deep structures, recent tobacco use, very uncontrolled diabetes (HbA1c >12%), or significant renal dysfunction were excluded.

Documentation should mirror these parameters when asserting medical necessity.

RCT outcomes: In multicenter RCTs, dHACA-treated groups had substantially higher healed-ulcer proportions at 12 weeks (e.g., 75% vs 30% in one trial) though trials had limitations (lack of blinding, short follow-up, manufacturer involvement); adverse events reported but not graft-related in the cited trial.

Trial results support coverage in matched populations.

dHACA (AmnioBand) — trial-aligned coverage criteria

dHACA (AmnioBand) — covered as adjunct when ALL trial-aligned criteria are met:

Eligibility criteria: Patient has a chronic diabetic foot ulcer or venous leg ulcer meeting study-like inclusion: objective adequate perfusion and no infection; wound size within studied ranges (commonly ≥1–2 cm^2 and <20–25 cm^2); duration >1 month despite SOC; completion of a screening/SOC period (commonly 2 weeks) with appropriate measures (offloading for DFU or compression for VLU) without adequate healing; and product applied per trial protocol (weekly or biweekly) with follow-up to 12 weeks.ABI >0.7–0.75 or TcPO2/Skin perfusion pressure >30 mm Hg; wound area >=1–2 and <20–25 cm^2; prior SOC run-in

Exclusions include infection, non-venous etiology (for VLU trials), ulcers probing to deep structures, very uncontrolled diabetes (HbA1c >12%), and other comorbid conditions listed in trials.

Other amniotic/placental products — limited evidence stance

Other amniotic/placental products — limited evidence stance:

Limited evidence products: Products such as AmnioExcel/BioDExcel, AMNIOFIX, AmnioBind, AmnioCore, AmnioDefend and similar have limited or inconclusive RCT evidence; consideration for use may be limited to clinical trials or when supported by documentation that mirrors trial-like eligibility (adequate perfusion, no infection, prior SOC failure).N/A

Larger RCTs or comparative studies are typically required to support routine coverage.

Coverage-evidence groupings

Coverage‑relevant evidence statements and implications:

AMNIOFIX / micronized dHACM: Micronized dHACM injections (AMNIOFIX Injectable) have RCT evidence for short-term benefit in plantar fasciitis (pain/function up to 3 months) but lack long-term and head-to-head comparative data; for wound indications evidence is insufficient.

Short-term RCTs exist but generalizability and comparative effectiveness remain uncertain.

General amniotic product grouping: For many listed amniotic/placental products, few RCTs or only small observational studies exist; therefore their effect on health outcomes cannot be reliably determined and routine coverage is not supported absent stronger evidence.

See product-specific entries.

Products with insufficient or low-quality evidence

Products with insufficient or low‑quality evidence — summary stance:

Insufficient evidence classification: Numerous listed products (for example Artacent variants; ArthroFLEX; Ascendion; Ascent; Axolotl products; BIOVANCE variants; Artacent family; many additional brands) have few, small, or low-quality studies so it is not possible to determine a beneficial effect on health outcomes; routine coverage is not supported without higher-quality evidence or RCT data.

Requests for these products should include clinical justification and robust supporting literature.

Limited observational/registry evidence

Limited observational/registry evidence — examples and limitations:

Artacent observational DFU study: An observational analysis of Artacent (n=26) reported 65% complete closure at 12 weeks in a per-protocol analysis among DFUs that failed to heal ≥50% after 2–4 weeks SOC; authors note need for larger trials.

Small observational study; not definitive evidence.

BIOVANCE registry: A heterogeneous multicenter registry of DDHAM (BIOVANCE) reported nearly 50% of chronic wounds achieved complete closure (median 6.3 weeks) in usual-care settings, but heterogeneity and lack of controls limit generalizability and require RCT validation.

Registry data are hypothesis-generating only.

Products with insufficient evidence / indeterminate benefit

Products with insufficient evidence / indeterminate benefit — policy stance:

Insufficient evidence for listed products: For each product listed in this segment (examples include BioWound family; CaregraFT; Celera products; CLARIX products; Cocoon; CorMatrix; Corplex; Cryo-Cord; CYGNUS products; Cytal; DermaBind variants; Dermacyte; DermACELL; and many others), available studies are few or lacking such that benefit on health outcomes cannot be determined; coverage requires higher-quality comparative evidence.

Apply this finding when evaluating medical necessity requests.

CorMatrix — insufficient/heterogeneous clinical evidence

CorMatrix — evidence summary and implications for coverage:

CorMatrix evidence: Preclinical data are largely positive, but clinical cohort studies show mixed results with variable inflammation, minimal evidence of regeneration/remodeling, and wide-ranging reintervention rates (4.5%–87.5%), indicating insufficient and inconsistent clinical evidence to establish effectiveness for cardiovascular applications.

Further high-quality, standardized clinical trials are needed; coverage should consider uncertainty.

HAM injections for plantar fasciitis — limited evidence

HAM injections for plantar fasciitis — evidence context:

HAM injections for plantar fasciitis: Randomized trials of micronized dHACM injections report short-term pain reduction and functional improvement versus placebo up to ~3 months; evidence is low quality and lacks long-term follow-up and active comparators, so routine coverage for plantar fasciitis injections should require stronger comparative RCT evidence.

Hayes review identifies substantial uncertainty about long-term and comparative effectiveness.

Product-specific coverage evidence summaries

Product‑specific coverage evidence summaries — selected examples:

CorMatrix summary: Clinical evidence for CorMatrix is inconsistent with heterogeneous outcomes and variable reintervention rates; insufficient to support routine coverage for cardiovascular indications without further trials.

See systematic review findings.

DermACELL summary: DermACELL has RCT and prospective study evidence in DFUs showing higher healed-ulcer rates versus conventional care (e.g., 16-week RCT with 67.9% vs 47.8% healed), supporting coverage when clinical criteria align with trial populations and documentation is provided.

Trial limitations include sponsor involvement and heterogeneity.

Other products summary: Many other listed products have few or no adequate studies; they should be considered investigational or not medically necessary pending higher-quality evidence.

Refer to product listings for specifics.

Evidence-based grouping

Evidence-based grouping — RCT-supported products vs insufficient-evidence products:

Products with supportive RCT data: DermACELL (multicenter RCT showing improved healing at 16 weeks) and EPICORD (RCT showing higher 12-week healing vs alginate) are examples of products with randomized trial evidence supporting adjunctive use in selected chronic wounds.

These products may be covered when trial-like clinical criteria are met and documentation provided.

Products with insufficient evidence: Multiple products (Dermacyte, Derma-Gide, DermaPure, DermaSpan, Dermavest/Plurivest, Derm-Maxx, many Amnio family products, EPIEFFECT/EPIFIX Injectable, etc.) lack adequate published trials; routine coverage is not supported without further evidence.

Policy treats these as investigational or not medically necessary absent stronger evidence.

Trial-derived coverage criteria for EPIFIX

Trial‑derived coverage criteria for EPIFIX — covered when ALL criteria met:

Wound characteristics: Ulcer size within studied range (commonly ≥1 cm^2 and <25 cm^2).>=1 cm^2 and <25 cm^2

Derived from multiple RCT inclusion criteria.

Duration and prior care: Chronic ulcer duration ≥4 weeks and failure to respond to a standardized run-in of SOC (e.g., ≤25% closure during run-in).>=4 weeks; <=25% closure in run-in

Run-in requirement used in randomized trials.

Infection and wound depth: No clinical signs of infection and no probing to tendon/muscle/capsule/bone.no infection; not probing to deep structures

Adjunctive use after standard care

Adjunctive use after standard care — covered when ALL criteria met:

Adjunctive use criteria: 1) Chronic VLU or DFU not involving muscle/tendon/bone (per trial inclusion); 2) Ulcer present ≥1 month; 3) Prior appropriate SOC (e.g., multilayer compression for VLU or offloading for DFU) for a minimum duration (trials used ≥14 days to several weeks/run-in) with inadequate healing; 4) Documentation of failed or insufficient progress with SOC; 5) Product application consistent with studied regimen (e.g., weekly or biweekly applications) and follow-up monitoring of healing up to trial endpoints (commonly 12–16 weeks).as stated

Derived from multiple RCT inclusion and treatment schedules.

Products lacking sufficient evidence

Products lacking sufficient evidence — policy stance:

Insufficient evidence products (examples): EPIXPRESS; Esano variants; Excellagen; E-Z Derm; FlowerAmnioFlo/Patch; Fluid Flow/GF; G4Derm Plus; GammaGraft; Genesis Amniotic Membrane; and numerous others listed in the policy have few or limited published studies and therefore their benefit on health outcomes cannot be determined from available evidence; routine coverage is not supported outside clinical trials or without robust justification.

Refer to product list for full details.

Coverage-relevant evidence summaries

Coverage‑relevant evidence summaries (selected findings):

GRAFIX DFU evidence: RCT data (Lavery et al.) showed higher 12-week closure (62% vs 21%) and faster median healing with cryopreserved placental membrane (GRAFIX) versus SOC; observational and real‑world analyses report closure rates in similar ranges but have design limitations.

Hayes HTA summarizes low-quality but consistent evidence.

Limited evidence products: GRAFIX Duo, GRAFIX CORE, GRAFIX Plus, hMatrix, HHF10P, Helicoll, Hyalomatrix and similar variants currently have limited or noncomparative evidence and are considered investigational/insufficient evidence for routine coverage.

Policy lists these as not medically necessary absent stronger evidence.

LPM (lyopreserved amniotic membrane) for VLU: A multicenter RCT reported improved healing and quality-of-life with LPM plus SOC vs SOC alone for venous leg ulcers (greater probability of closure for wounds 3–25 cm^2), but the study was open-label and lacked long-term follow-up.wound size 3-25 cm^2

Product-level coverage conclusions

Product-level coverage conclusions — selected products and evidence limits:

Hyalomatrix: Evidence is inconclusive (noncomparative small studies); clinical benefit is not established for routine coverage.

ECRI assessments cited.

InnovaMatrix / Integra / InteguPly / Integra Flowable: Available studies are limited or have methodological issues; evidence insufficient to determine benefit for chronic wounds.

Some RCTs excluded from HTA due to inadequate SOC comparators.

Fish skin grafts (Kerecis): RCTs in DFUs show improved healing rates versus SOC (examples: 12-week closure 67% vs 32%; 16-week closure 44% vs 26%); evidence is evolving and promising but studies have limitations (open-label design, manufacturer involvement, heterogeneous sites) and require confirmatory blinded trials.

Consider prior SOC failure and trial-like documentation when evaluating requests.

Fish skin graft evidence and limits

Fish skin graft evidence and limits — RCT-derived considerations:

Fish skin grafts for DFUs (trial context): Use of fish skin grafts (e.g., Kerecis Omega3, MariGen Pacto) was evaluated in DFUs nonresponsive to SOC after a screening/run-in; RCTs demonstrated higher closure rates and faster time to heal versus SOC, but limitations include open-label design, manufacturer involvement, site heterogeneity, and limited long-term follow-up.DFU nonresponsive to SOC after run-in period

Coverage may be supported when documentation shows prior SOC failure and wound characteristics match trial populations.

Insufficient-evidence group

Products lacking sufficient evidence — policy summary and examples:

Insufficient-evidence group: Multiple products listed (e.g., Keroxx, Lamellas, Mantle DL Matrix, MariGen Pacto, MatriDerm, Matrion, MatriStem MicroMatrix, Matrix HD, Mediskin, Membrane Wrap variants, MemoDerm, Miro3D family, Microlyte Matrix, MicroMatrix Flex, MIRODERM, MiroTract) have few or limited published studies; routine coverage is not supported without further high-quality evidence.insufficient published evidence

Requests for these products should include strong clinical justification and peer-reviewed evidence.

Refer to the Medical Policy titled Breast Reconstruction (for New Jersey Only) for information about coverage for skin and soft tissue substitutes when used during postmastectomy breast reconstruction procedures.

The policy notes that the overall evidence base for many skin and soft tissue substitute products is low to very low quality. Systematic reviews and HTAs report small trials, heterogeneous products and populations, and limited head-to-head comparisons, restricting conclusions about comparative effectiveness for most named products.

Important evidence gaps include a lack of data on long-term outcomes (wound recurrence, amputations, hospitalizations), incomplete safety reporting (adverse events, potential toxic or carcinogenic effects), and limited follow-up in trials, which prevents assessment of durability and late harms.

Clinical trial enrollment frequently excluded patients with infected ulcers and wounds requiring advanced modalities (for example, negative-pressure wound therapy or hyperbaric oxygen). Such exclusions mean trial results do not support use in these populations.

Several trials exclude ulcers of non-venous or non-diabetic etiologies and wounds that probe to or extend into tendon, muscle, capsule, or bone. These exclusion criteria limit applicability of positive trial findings to patients with deep tissue involvement or alternative wound causes.

Many products are described as having few published studies; the policy states such products have insufficient evidence to determine benefit and therefore are excluded from routine coverage until higher‑quality evidence is available.

Registry and observational data are reported for some products but are limited by heterogeneity of wound etiologies, variable prior treatments, and lack of concurrent controls; these factors restrict the ability to infer causal benefit from registry findings.

The document does not list broad categorical exclusions, but repeatedly characterizes many listed products as having insufficient evidence; in effect, this results in practical exclusion from coverage unless stronger evidence is provided.

Products with only a small number of published studies are effectively excluded from being considered established therapies until additional rigorous trials or comparative data are available.

Examples of products explicitly noted as having few published studies include Dermacyte, Derma-Gide, DermaPure, Dermavest/Plurivest, Derm-Maxx, and a long list of amniotic/placental and other substitutes identified throughout the policy; these are listed in the "Other Skin and Soft Tissue Substitutes" sections.

Trials commonly excluded wounds that probe to tendon, muscle, capsule, or bone and wounds with active infection. These trial-level exclusions are repeatedly cited as limits on generalizability to deeper or infected wounds.

The policy explicitly states there are insufficient published studies to determine healing benefit for several listed products (for example, EPIXPRESS and multiple Esano variants), and therefore their use is described as unsupported by current evidence.

Randomized trials that support some products generally enrolled patients with adequate tissue perfusion and without clinical infection (e.g., ABI or tcPO2 thresholds). The policy emphasizes limited applicability of trial results to patients with poor perfusion or infection.

Several products (Hyalomatrix, InnovaMatrix variants, InteguPly) are supported only by small, noncomparative, or single‑center studies; the policy rates this evidence as inadequate to establish benefit beyond investigational use.

Because many studies are small, heterogeneous, or noncomparative, the policy concludes that study limitations imply restricted applicability of results to routine clinical practice and that comparative superiority among products cannot be established.

The policy states that all products listed under the 'Other Skin and Soft Tissue Substitutes' heading are considered unproven and not medically necessary for any indication due to insufficient evidence of efficacy.

For multiple named amniotic/placental products the policy states that the lack of adequate published studies prevents determination of a beneficial effect on health outcomes; therefore routine coverage is not supported without further evidence.

The document concludes that for numerous listed products there are too few or too-low-quality studies to determine clinical benefit; explicit statements across product entries support classification as insufficient evidence.

Named products identified in the policy as having few or low‑quality studies include (but are not limited to) AmnioBind, AmnioCore, AmnioExcel/BioDExcel, BIOVANCE variants, CorMatrix, Corplex, DermACELL/Dermacyte entries, and multiple other amniotic/placental or ADM products; for these, the policy reports limited evidence and uncertainty about benefit.

Use of products for indications where evidence is insufficient — or when requests lack documentation of prior standard‑of‑care failure and trial‑like eligibility — is described as not medically necessary or investigational in the absence of supporting data.

The policy indicates that when product use is submitted without documentation establishing prior standard‑of‑care failure (for example, documented run‑in SOC and inadequate healing), the request may be considered not medically necessary because available studies are insufficient to show benefit.

Billing Codes and Code Lists

Applicable A codes (partial list)HCPCS

A2001	InnovaMatrix AC, per sq cm
A2002	Mirragen Advanced Wound Matrix, per sq cm
A2004	XCelliStem, 1mg
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 14

1/2

Applicable Q codes (partial list)HCPCS

Q4100	Skin substitute, not otherwise specified
Q4110	PriMatrix, per sq cm
Q4111	GammaGraft, per sq cm
Q4112	Cymetra, injectable, 1 cc
Q4114	Integra flowable wound matrix, injectable, 1 cc
Q4132	Grafix Core and GrafixPL Core, per sq cm
Q4133	Grafix PRIME, GrafixPL PRIME, Stravix and StravixPL, per sq cm
Q4182	Transcyte, per sq cm
Q4186	Epifix, per sq cm
Q4200	SkinTE, per sq cm

1–10 of 12

1/2

Applicable HCPCS Q-codes (enumerated)HCPCS

Q4219	SurgiGRAFT-DUAL, per sq cm
Q4220	BellaCell HD or Surederm, per sq cm
Q4221	Amnio Wrap2, per sq cm
Q4222	ProgenaMatrix, per sq cm
Q4224	Human Health Factor 10 Amniotic Patch (HHF10-P), per sq cm
Q4225	AmnioBind per sq cm or DermBind TL per sq cm
Q4226	MyOwn Skin, includes harvesting and preparation procedures, per sq cm
Q4227	AmnioCore, per sq cm
Q4229	Cogenex Amniotic Membrane, per sq cm
Q4230	Cogenex flowable amnion, per 0.5 cc

1–10 of 166

1/17

Products listed (no codes provided in this segment)mixed

No codes listed

Codes referenced in product summaries (no specific codes in excerpt)mixed

No codes listed

Products discussed without billing codes in excerptmixed

No codes listed

inv-60: Glycated hemoglobin — HbA1c < 12% (within last 90 days) (trial/documentation metric)

HbA1c requirementGlycated hemoglobin (HbA1c) < 12% within the last 90 days

PurposeDemonstrates acceptable glycemic control used in trial eligibility and coverage determinations

Documentation timeframeMost trials and policy require the HbA1c to be measured within the prior 90 days

inv-61: Ankle-Brachial Index — ABI between 0.7 and 1.2 (per trial/documentation expectations)

ABI range for eligibilityAnkle-Brachial Index (ABI) between 0.7 and 1.2

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior authorization expectations

Prior authorization is generally expected for advanced skin substitutes and biologic grafts. Requests should include clinical rationale for adjunctive use, comparative alternatives tried, and specific product justification when multiple options exist. PA may also be required for HCPCS/A and Q‑codes listed in the Applicable Codes section.

Prior authorization likely for many listed products (see Applicable Codes).
Include explanation of why product is needed vs standard alternatives.

Prior Authorization

Prior authorization likely required for products with limited evidence

For products with limited, low-quality, or heterogeneous evidence (including many amniotic/placental-derived products and multiple named brand products), prior authorization is likely required. Coverage requests should include supporting clinical data, peer-reviewed studies, and an evidence summary addressing benefit versus SOC.

List product-specific citations and summaries when evidence is limited.
Manufacturersponsored studies should be supplemented with independent data when available.

Clinical Background and Definitions

Background: Full‑thickness and deep partial‑thickness thermal burns destroy varying depths of skin layers and may require skin substitutes prior to autograft placement; similarly, chronic diabetic foot ulcers require adequate perfusion and metabolic control and are commonly evaluated after a trial of standard wound care before considering advanced biologic products.

inv-133: Full-Thickness Thermal Burn definition

DefinitionFull-Thickness Thermal Burn: destruction of all layers of the skin (epidermis and dermis), may involve subcutaneous tissue

SynonymAlso referred to as third-degree burn in clinical descriptions (Gomez and Cancio, 2007)

Clinical relevanceMay require skin substitutes or grafting as part of surgical management prior to autograft placement

inv-134: Partial-Thickness Thermal Burn definition

Definition

Policy Summary

PayerUnitedHealthcare

PolicySkin and Soft Tissue Substitutes (for New Jersey Only)

Policy CodePolicy CS153NJ.W

Change TypeNo material changes

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

On This Page

Exclusion criteria in trials.

Systemic and perfusion parameters: Acceptable renal function and glycemic control as in trials (serum creatinine <3.0 mg/dL; HbA1c <12% where reported) and adequate limb perfusion (tcPO2 ≥30 mm Hg, ABI 0.7–1.2, or triphasic/biphasic Doppler at the ankle).creatinine <3.0 mg/dL; HbA1c <12%; tcPO2 >=30 mm Hg or ABI 0.7-1.2

Trial enrollment criteria.

Further blinded, long-term studies needed.

Acceptable circulation indicatorsABI may be used alongside palpable pedal pulses or Doppler-confirmed pulses to document adequate perfusion

Use in documentationABI documented per trial-like criteria to establish adequate limb perfusion prior to adjunctive product use

inv-62: Duration of standard wound care trial — at least 4 weeks

Minimum SOC durationAt least 4 weeks of standard wound care prior to considering adjunctive skin substitute therapy

Components of SOCIncludes moist dressings, debridement if present, offloading (DFU) or compression (VLU), infection control and ischemia correction

Purpose of trial4-week SOC run-in identifies wounds that have failed to respond and may qualify for advanced therapies evaluated in trials

inv-63: Standard treatment trial — 4 weeks with <50% wound-size reduction as run-in/failure marker

Run-in failure markerStandard treatment trial of 4 weeks with <50% wound-size reduction indicates need to change or add therapies

SOC actions during run-inDebridement, moisture balance, infection control, offloading or compression as appropriate

Clinical implicationFailure to achieve ≥50% area reduction after 4 weeks is used in studies to define nonresponse to SOC

inv-64: Perfusion thresholds — ABI >0.75 (or >0.7), SPP >30 mm Hg or TcPO2 >30 mm Hg

Primary perfusion thresholdsABI > 0.75 (some DFU trials used >0.7) or other objective measures

Alternate perfusion measuresSkin perfusion pressure (SPP) > 30 mm Hg or transcutaneous oxygen (TcPO2) > 30 mm Hg

Trial contextTrials commonly enrolled patients with these perfusion thresholds and without clinical infection

inv-65: Wound area — typical trial inclusion wound area ≥1–2 cm² and <20–25 cm²

Typical minimum wound areaStudy inclusion typically required wound area ≥1–2 cm²

Typical maximum wound areaUpper limits commonly specified as <20–25 cm² in DFU/VLU trials

Duration and depth constraintsTrials required wounds present >1 month and full-thickness through dermis but not to muscle/tendon/bone

inv-66: HbA1c trial thresholds — HbA1c < 12% in several trials

HbA1c eligibility used in trialsHbA1c < 12% was used as an eligibility or documentation threshold in several trials

Time windowHbA1c measurement within the prior 90 days in trial documentation and policy examples

Clinical rationaleEnsures excessively uncontrolled diabetes (HbA1c >12%) is identified as an exclusion in some studies

Prior Authorization

Prior authorization: require SOC failure and perfusion metrics

Demonstrate prior standard-of-care (SOC) trial and provide objective perfusion metrics when applicable. PA reviewers expect documentation that mirrors RCT eligibility (run-in SOC, perfusion testing, infection status) and justification for adjunctive product use.

Document SOC trial duration (e.g., 2–4 weeks run-in, 4 weeks SOC for DFU before EPIFIX/GRAFIX).
Provide perfusion measures (ABI, TcPO2, SPP) and absence of clinical infection.
If applicable, show weekly debridement and offloading/compression during run-in.

Documentation Required

Evidence submission for DermACELL

When requesting coverage for DermACELL (DermACELL AWM/porous), supply RCTs or prospective study details, including study design, follow-up duration, wound severity (Wagner grade), number of applications, and outcomes (healed proportion, time to granulation/healing).

Include Cazzell et al. and Walters et al. trial citations and outcome summaries.
Document wound sizes, exposure of vital structures, and number of graft applications used.

Documentation Required

Prior authorization: require prior standard wound care documentation

Prior authorization requests must include prior standard wound care documentation: duration and content of SOC (dressings, debridement, offloading or multilayer compression), response to SOC (percent area reduction during run-in), and photographic measurement records.

State dates and modalities of SOC (e.g., 4 weeks SOC for DFU, 14 days compression for VLU run-in).
Provide sequential wound measurements and photos, plus documentation of weekly debridement when performed.

Prior Authorization

Prior authorization: clinical preconditions

PA requests should document clinical preconditions required by trials: wound duration and size thresholds, adequate circulation (ABI, TcPO2, SPP), HbA1c limits, and absence of infection or malignancy at the ulcer site. If device-specific contraindications exist, report them.

List measured values (ABI, TcPO2/SPP) and recent HbA1c.
State whether ulcer probes to tendon/muscle/bone or other exclusion criteria are present.

Prior Authorization

Prior authorization recommended for fish-skin grafts

For fish-skin grafts (FSGs) such as Kerecis products, prior authorization is recommended even though RCT evidence exists. Provide SOC run-in documentation, wound characteristics, and trial data supporting use for deep or treatment‑resistant DFUs.

Include RCT outcomes (12–24 week closure rates) and any site‑specific limitations.
Document prior SOC and run-in screening before FSG initiation.

Documentation Required

Prior authorization: document SOC failure and wound details

PA submissions must document SOC failure and wound details: duration, baseline and serial wound size, percent area reduction during run-in, number and timing of prior biologic applications, and evidence of failed conventional measures.

Provide explicit run-in results (e.g., ≤25% improvement threshold used in trials).
Include prior biologic/allograft exposure and outcomes if applicable.

Denial Risk

Non-indicated use denial risk

Use outside the studied or indicated indications may be denied. EPIFIX/GRAFIX and TransCyte have specific studied indications — requests for other uses face noncoverage risk.

Non‑indicated use denial risk is higher when trial eligibility and product-specific indications are not met.
Confirm product-indication alignment before submitting PA.

Billing Rule

State fee schedule exclusion notice

Codes marked with an asterisk in the Applicable Codes lists are not on the New Jersey Medicaid Fee Schedule and therefore may not be covered by the State of New Jersey Medicaid Program. Verify state fee-schedule status prior to billing.

Check asterisked A‑ and Q‑codes against NJ Medicaid Fee Schedule.
Anticipate additional payer-specific coverage or reimbursement restrictions.

Denial Risk

Evidence limitations may trigger denial

Evidence limitations (heterogeneity of studies, short follow-up, small sample sizes, manufacturer funding, and lack of long-term outcomes) can lead to PA denial. For many products, the available literature is insufficient to support routine coverage.

Highlight independent, peer-reviewed RCTs and long-term outcome data when possible.
If evidence is limited, include rationale for medical necessity tailored to the patient.

Denial Risk

Insufficient evidence may trigger denial

Insufficient or low-quality evidence for many listed products increases the likelihood of denial unless robust medical necessity and patient‑specific justification are provided. This applies to numerous amniotic/placental and other newer products.

Provide product-specific published studies or registries supporting use.
If evidence is lacking, document failure of SOC and why alternative established therapies are unsuitable.

Documentation Required

Perfusion and infection requirements reflected in clinical trials

Clinical trials commonly required perfusion and infection criteria (e.g., ABI 0.7–1.2, TcPO2 or SPP ≥30 mm Hg, no clinical infection). PA submissions should reflect these thresholds when applicable to the ulcer type.

Report numeric perfusion test results and recent infection assessments.
If perfusion metrics are borderline, include vascular consults or revascularization plans.

Denial Risk

Insufficient evidence may lead to denial

Many products lack high-quality comparative evidence; absence of strong data may result in denial. When requesting PA, provide the strongest available evidence and explain clinical rationale for use in the individual patient.

Consolidate relevant RCTs, registry data, and observational studies supporting benefit.
Address limitations (size, follow-up, sponsor bias) in the submission.

Denial Risk

CorMatrix: mixed/limited evidence risk

CorMatrix has mixed and limited clinical evidence; reviewers may deny coverage without robust supporting data. Provide study citations, reintervention rates, and discussion of heterogeneity and long-term outcomes when requesting coverage.

Supply systematic review findings and range of reported reintervention rates.
Explain indication-specific rationale and anticipated benefits vs risks.

Documentation Required

CorMatrix evidence limitations

CorMatrix evidence limitations include heterogeneous clinical cohorts, variable reporting, and inconsistent long-term outcomes. PA requests should address these gaps with explicit real-world data or trial evidence when possible.

Provide histologic, clinical, and reintervention outcome data if available.
Acknowledge heterogeneity and supply site-specific experience or registry data.

Denial Risk

Insufficient evidence for many products

Numerous listed products have limited published studies. Prior authorization submissions for these products must include product-specific evidence or be prepared for potential denial due to insufficient evidence.

Compile literature for the named product before submission.
If evidence is minimal, document exhaustive SOC attempts and rationale for experimental use.

Denial Risk

Potential denial trigger: inadequate prior wound care

Inadequate prior wound care (insufficient debridement, poor documentation of offloading/compression, or short/absent SOC trial) is a common denial trigger. Ensure SOC milestones are met and documented before requesting advanced therapies.

Document dates and types of debridement and frequency.
For DFUs, document offloading; for VLUs, document multilayer compression therapy.

Documentation Required

Eligibility and documentation expectations

PA submissions should meet trial-based eligibility and documentation expectations: wound size and duration thresholds, run-in response criteria, weekly debridement records, perfusion testing, HbA1c, creatinine where applicable, and photographic measurements.

Mirror RCT eligibility where possible (e.g., DFU ≥4 weeks, wound size ranges used in trials).
Provide serial wound measurements, photos, and documentation of adjunctive measures.

Documentation Required

Documentation of perfusion and infection status

Document perfusion testing and infection status clearly: include ABI, TcPO2/SPP values, Doppler waveforms, and recent clinical infection assessments or cultures. These elements are frequently required to demonstrate appropriateness for adjunctive biologics.

Attach perfusion study reports and dates.
State whether there are active signs of infection and how infection was managed.

Denial Risk

Limited evidence may trigger coverage denial

Limited evidence across many products increases coverage denial risk. When limited data exist, document medical necessity, failed SOC, and why established alternatives are not suitable for this patient.

Provide alternative therapy trials and outcomes.
Attach clinician rationale and, if available, multidisciplinary consult notes.

Denial Risk

Insufficient evidence triggers potential denial

Insufficient evidence across the long product list may trigger potential denials; include trial evidence, wound-specific data, and patient-level justification for each requested product.

For products with minimal data, provide real-world registry reports or institutional outcomes where possible.
Address gaps in the literature within the submission narrative.

Documentation Required

EPIFIX/GRAFIX required documentation

EPIFIX/GRAFIX (and GRAFIX family names) require documentation of circulation (ABI/TcPO2/Doppler), HbA1c within acceptable limits, and a documented SOC trial (e.g., 4-week run-in with offloading or compression and debridement) consistent with trial protocols.

Show run-in results and that ulcer failed to respond to SOC prior to adjunctive EPIFIX/GRAFIX.
Include perfusion and metabolic lab results (HbA1c, creatinine if required).

Documentation Required

TransCyte required documentation

TransCyte requests should include burn‑specific documentation: burn depth, details of surgical excision, and indication aligning with the studied use (full-thickness and deep partial‑thickness burns prior to autograft). Use outside of these studied indications may be denied.

Document operative reports describing excision depth and timing.
Attach wound assessments consistent with trial indications.

Documentation Required

Product and indication documentation

PA submissions must clearly identify the exact product and indication, and provide supporting clinical documentation and literature specific to that product. Generic descriptions are insufficient for products with mixed evidence profiles.

Specify product name, formulation, and intended use.
Attach product-specific peer-reviewed citations and manufacturer instructions for use when relevant.

Documentation Required

Required clinical documentation elements (implied from RCT eligibility)

Required clinical documentation elements (derived from RCT eligibility) include: wound type and depth, precise baseline area, duration, serial percent area reductions during run-in, perfusion metrics (ABI, SPP, TcPO2), HbA1c, creatinine when applicable, debridement record, and photographic evidence.

Provide a timeline of care with dates and measurements.
Include third-party adjudication or Silhouette camera measurements when available.

Documentation Required

Suggested clinical documentation to mirror trial eligibility

To mirror clinical trial eligibility, submit suggested documentation: run‑in SOC details (length and interventions), weekly debridement notes, offloading or multilayer compression confirmation, objective perfusion testing results, and serial wound measurements and photos.

Include percent area reduction at 2 and 4 weeks during run-in where trials used these thresholds.
Attach consults for vascular surgery or infectious disease if relevant.

Documentation Required

Clinical evidence to support requests

Support PA requests with the best available clinical evidence: RCTs, prospective studies, registries, and adverse event data. Cite randomized trials when available and summarize outcomes relevant to the patient (healed proportion, time to heal, adverse events).

Attach PDFs or citations for key RCTs and prospective cohorts.
Summarize safety signals and device-related adverse events.

Documentation Required

Documentation supporting medical necessity

Documentation supporting medical necessity should include wound characteristics, prior SOC details, photographic evidence, trial-like follow-up data, and clinician rationale linking patient-specific factors to the chosen product.

Provide clear chronology showing SOC failure and rationale for escalation.
Include expected benefit and monitoring plan.

Documentation Required

Provide supporting clinical evidence for CorMatrix

Provide supporting clinical evidence for CorMatrix requests: include systematic review findings, reported reintervention rates, heterogeneity discussion, and any available longer-term outcome or registry data to support expected benefit for the indicated use.

Attach Bruun et al. systematic review summary and reported reintervention ranges.
Discuss how local practice and patient selection mitigate reported concerns.

Documentation Required

Provide evidence for listed amniotic/placental products

For listed amniotic/placental products and other named biologics with limited evidence, supply peer-reviewed studies and RCTs where available; otherwise, expect PA denial or requests for additional justification.

Compile RCTs, prospective cohorts, and systematic reviews relevant to the specific product.
When only small or noncomparative studies exist, explain why the therapy is needed for this patient.

Documentation Required

Provide RCT evidence for DermACELL

Provide RCT evidence when available for DermACELL and note study sponsorship and limitations; include study design, endpoints (12–24 week healed rates), number of applications, and follow-up outcomes to substantiate the request.

Cite Walters et al. and Cazzell et al. RCT/prospective studies with outcomes.
Disclose funding sources and blinding limitations in the submission.

Documentation Required

Clinical documentation expectations

Clinical documentation expectations include weekly debridement notes, wound measurements and photographs, perfusion studies, lab values (HbA1c, creatinine), and follow-up visit records consistent with trial protocols to allow outcome adjudication.

Maintain a clear, dated measurement log and photographic library.
Document any secondary therapies and their timing relative to the graft application.

Documentation Required

Clinical documentation to match study criteria

Required clinical documentation should match study criteria where possible (e.g., full‑thickness VLU or DFU characteristics, size and duration thresholds, run‑in response criteria). Mismatches with trial eligibility should be justified in the clinical narrative.

If patient falls outside RCT criteria, provide rationale and alternative evidence supporting use.
Attach wound classification and measurement methodology used.

Documentation Required

Document wound characteristics and prior SOC

Document wound characteristics (size, depth, exposed structures) and prior SOC measures (offloading, multilayer compression, dressing types, debridement dates). Matching these to trial enrollment criteria strengthens PA approvals.

Include baseline wound area, percent area reduction during SOC, and whether wound probed to tendon/muscle/bone.
List prior adjunctive treatments and their outcomes.

Documentation Required

Provide trial evidence and wound specifics

Provide trial evidence and wound-specific endpoints (e.g., percent closed at 12 or 16 weeks, time to granulation, number of grafts used, wastage) to support requests for product coverage.

Attach RCT endpoint tables or registry outcome summaries.
Detail number of applications and product wastage if relevant to medical necessity.

Step Therapy

Required trial of standard wound care

A trial of standard wound care is required prior to many advanced grafts (for example, EPIFIX/GRAFIX and multiple RCTs used 2‑ to 4‑week screening/run-in SOC). Ensure run-in SOC documentation is included in PA submissions.

Report screening/run-in dates and specific SOC interventions used.
State run-in response (percent reduction) and threshold for randomization in trials.

Step Therapy

Standard care milestone before adjunctive therapy

Before initiating adjunctive biologic therapy, standard care milestones should be met and documented: adequate debridement, moisture balance via proper dressings, infection control, offloading for DFU, and compression for VLUs.

Document dates and types of debridement and dressing changes.
Show evidence that offloading/compression protocols were implemented.

Step Therapy

Step therapy implication

Step therapy is implied by trial designs: exhaustion of SOC is expected before biologic use. PA reviewers will look for documented trials of conservative measures prior to approving advanced skin substitutes.

List conservative modalities attempted and their duration.
If step therapy is bypassed, provide strong clinical justification.

Step Therapy

Step therapy: trial of SOC before biologic

Trials commonly required a documented trial of SOC before randomization to biologic intervention. PA requests should reflect similar ordering of care: conservative measures first, then adjunctive biologic if SOC fails.

Specify the SOC trial length used locally and how it matches trial run-ins.
Attach measurement of SOC response (e.g., ≤25% improvement thresholds).

Step Therapy

Mandatory SOC screening prior to product use

Many trials mandated mandatory SOC screening (e.g., 2‑week or 14‑day run-in) to identify nonresponders prior to enrollment. PA submissions should include the screening period results when available.

Provide documentation of the exact screening protocol and response criteria used.
If screening was not performed, explain why and provide supporting clinical rationale.

Prior Authorization

Use after failure of standard of care

Several products (e.g., Artacent) were studied after failure of standard of care. Requests to use such products should present run-in failure documentation and alignment with the study population.

Attach trial references that used SOC nonresponders for inclusion.
Describe how the patient mirrors the study population.

Documentation Required

Compare to standard care

PA reviewers will compare the requested product to standard care and expect documentation showing why SOC alone is inadequate and why the requested product is likely to benefit this patient.

Provide comparative discussion versus SOC and any prior advanced therapies tried.
If relevant, include cost-benefit or expected resource utilization rationale.

Step Therapy

Step therapy expectation

Run-in periods and stepwise expectations are common in trials; document weekly debridement, offloading/compression, and percent area reduction during run-in to mirror RCT procedures and strengthen PA requests.

Provide weekly measurement logs and debridement notes.
State how the patient met or failed the run-in thresholds used in applicable trials.

Step Therapy

Run-in with standard care before advanced product

Many advanced-product RCTs used a run-in with SOC (often 2 weeks to 4 weeks) prior to enrollment. PA requests for similar products should include run-in documentation and the measured response to SOC.

Attach run-in protocol, dates, and response metrics.
If run-in was abbreviated, include justification and clinical urgency explanation.

Step Therapy

Stepwise use after standard compression

Stepwise use after standard compression is expected for venous leg ulcers: document multilayer compression therapy administration and its duration prior to adjunctive graft application.

Provide compression therapy start/end dates and adherence notes.
Include percent area reduction during compression run-in.

Step Therapy

SOC trial before advanced product

Randomized trials and guidance commonly required a SOC trial before use of advanced grafts. Ensure SOC trial documentation (duration, interventions, and response) is included with any PA request for these therapies.

For DFUs, typically 2–4 week offloading/debridement run-in; for VLUs, at least 14 days of compression.
Explicitly show failure to improve per trial thresholds (e.g., ≤25% or ≤30% reduction).

Partial-Thickness Thermal Burn: involves epidermis and part of the dermis; deep partial-thickness involves most of the dermis

Clinical detailDeep partial-thickness burns leave few intact skin appendages and nerve endings

Relevance to policyDeep partial-thickness burns are indications cited for certain skin substitute use prior to autograft (e.g., TransCyte)

inv-135: Class 1 skin substitute definition

DefinitionClass 1 skin substitute: temporary impervious dressing materials (single-layer biological or synthetic or bilayer tissue-engineered), with or without negative pressure

ExamplesIncludes naturally occurring membranes (e.g., amniotic membrane) and synthetic polymer sheets used as biological dressings

UseIntended as temporary coverings to promote wound healing and protect the wound environment

inv-136: Class 2 skin substitute definition

DefinitionClass 2 skin substitute: single-layer durable substitutes including epidermal and dermal substitutes (e.g., bovine or porcine collagen sheets/matrices)

CompositionDesigned to replace epidermal or dermal layers and provide structural matrix for cell ingrowth

Clinical roleUsed for more durable coverage than Class 1 materials in wound management

inv-137: Class 3 skin substitute definition

DefinitionClass 3 skin substitute: composite skin substitutes such as skin grafts (allograft, xenograft) and bioengineered skin

ComplexityMay replace both epidermal and dermal layers and include multiple tissue components

Clinical implicationOften used when deeper tissue replacement or permanent coverage is required

inv-138: Acellular dermal substitutes — definition and prevalence

DefinitionAcellular dermal substitutes: dermal scaffolds derived from human or animal tissue with cellular elements removed

PrevalenceMajority of commercially available skin substitutes (~89% in a review) were categorized as acellular dermal substitutes

PurposeProvide extracellular matrix into which host cells migrate to promote tissue regeneration

inv-139: Cellular skin substitutes — definition and evidence note

DefinitionCellular skin substitutes: products that contain living cells (autologous or allogeneic) intended to promote wound healing

Evidence noteEvidence base for cellular substitutes is smaller and overall quality is low, limiting ability to compare individual products

Examples in evidenceCellular substitutes evaluated include GRAFIX and other cellular matrices referenced in systematic reviews

inv-140: HAM / dHACM / allograft descriptions — terminology used

TerminologyHAM: human amnion membrane; dHACM: dehydrated human amnion/chorion membrane; allograft: donor-derived tissue used as protective wound covering

FormsProducts are available as sheets, wraps, particulates, micronized/injectable forms, and layered allografts

Clinical roleUsed as protective coverings and adjuncts to standard wound care in trials and clinical practice

inv-141: dHACA / AmnioBand description

DescriptiondHACA (AmnioBand): dehydrated human amnion and chorion allograft applied weekly or biweekly as an adjunct to standard of care for chronic wounds

Trial-based usageApplied per randomized trial protocols (weekly or biweekly) with documented run-in SOC failure before randomization

Indications in trialsEvaluated in DFU and VLU trials with specific perfusion, size, and duration inclusion criteria

inv-142: AmnioExcel / BioDExcel description

Product familyAmnioExcel / BioDExcel: dehydrated human amnion-derived tissue allograft intended to advance soft tissue repair

Evidence stanceEvidence insufficient or inconclusive; RCTs limited and results require larger confirmatory trials

Forms and useApplied weekly or biweekly in some studies for DFUs; application frequency varied among trials

inv-143: AMNIOFIX description

AMNIOFIX descriptionComposite amniotic tissue membrane available as sheet/particulate/wrap and as an injectable micronized form

Evidence noteInsufficient evidence for many wound indications; small RCTs show short-term benefits for injections in tendinopathies but not established for wound healing

FormsIncludes AMNIOFIX Injectable (micronized) used in tendon and soft tissue injections

inv-144: dHACM / micronized dHACM description

Micronized dHACMdHACM processed into micronized or injectable forms (example: EPIFIX Injectable, AMNIOFIX Injectable) for injection-based therapies

Clinical applicationUsed in RCTs for conditions like plantar fasciitis and tendon injuries; wound evidence for injectables is limited

Regulatory/formulation noteMicronized forms allow injection where sheet application is not feasible

inv-145: AMNIOMATRIX / BioDMatrix description

AMNIOMATRIX descriptionAMNIOMATRIX / BioDMatrix: morselized human placental allograft (amnion plus amniotic fluid components) intended for application to surgical sites and wounds

Evidence stanceFew published studies; insufficient evidence to determine health outcome benefit

Use formMorselized product may be mixed with saline or blood for application to complex wounds

inv-146: Dehydrated human amniotic membrane / DDHAM definition

DDHAM definitionDehydrated human amniotic membrane (HAM) / decellularized dehydrated human amniotic membrane (DDHAM): placental-derived membranes processed (dehydrated/possibly decellularized) serving as protective wound coverings

Intended roleUsed as covers to support tissue repair in acute and chronic wounds

Evidence noteMany DDHAM products have few studies and thus insufficient evidence for broad coverage

inv-147: Acellular dermal matrix (ADM) definition

ADM definitionAcellular dermal matrix (ADM): bioscaffold derived from dermal tissue with cellular components removed, used to provide structural support in soft tissue repair

Clinical roleEvaluated in RCTs for DFUs and other chronic wounds (e.g., DermACELL trials)

Evidence noteADM products have varied evidence; some (e.g., DermACELL) have RCT data showing improved healing versus conventional care

inv-148: Amniotic membrane allograft (HAM) — definition

HAM allograftAmniotic membrane allograft (HAM): minimally manipulated human amniotic membrane intended as a wound cover or protective barrier to support healing

ProcessingMay be dehydrated, lyophilized, or decellularized depending on product

Clinical useApplied as protective covering in acute and chronic wounds and surgical sites

inv-149: Porcine small intestinal submucosa extracellular matrix — definition

Porcine SIS ECMPorcine small intestinal submucosa extracellular matrix: non–cross-linked ECM derived from porcine small intestinal submucosa used as a biologic scaffold to promote tissue ingrowth

Product exampleCorMatrix is an example used in cardiovascular and other surgical applications

Clinical considerationsEvidence for efficacy varies by application and is limited for some cardiovascular uses

inv-150: CorMatrix definition

CorMatrix definitionCorMatrix: porcine small intestinal submucosa extracellular matrix used in various cardiovascular and surgical applications

Evidence noteClinical evidence is heterogeneous and limited; larger studies needed to establish safety and effectiveness

Clinical useUsed for pericardial reconstruction, valve reconstruction, and vascular repairs among other indications

inv-151: Corplex definition

Corplex descriptionCorplex: dehydrated human umbilical cord tissue used as a wound covering or barrier membrane

EvidenceFew published studies available; insufficient evidence to determine clinical benefit

Intended useApplied as protective membrane for acute and chronic wounds

inv-152: Cytal (Cytal Wound Matrix) definition

Cytal definitionCytal (Cytal Wound Matrix): porcine-derived urinary bladder matrix extracellular matrix intended for wound management

Evidence noteEvidence is mixed and limited regarding superiority versus other skin substitutes

IndicationsUsed for acute and chronic wounds and second-degree burns per product labeling

inv-153: DermACELL / DermACELL AWM definition

DermACELL definitionDermACELL / DermACELL AWM: decellularized human acellular dermal matrix used as an allograft for chronic nonhealing wounds and burns

Evidence summaryEvaluated in RCTs (e.g., 16-week DFU RCT) demonstrating higher healed-ulcer rates versus conventional care

ApplicationUsed as a single or repeat application in DFU trials with documented follow-up

inv-154: Dermacyte product descriptions

Dermacyte descriptionDermacyte AC Matrix / Dermacyte Amniotic Wound Care Matrix: sterile, lyophilized or cross-linked human amnion/chorion allograft intended as protective covering and support for cell growth

Evidence noteFew published studies available; insufficient evidence to determine benefit

Intended useApplied to DFUs, venous ulcers, pressure ulcers, and burns per product labeling

inv-155: DermACELL product reference

DermACELL product noteDermACELL evaluated in multicenter RCTs for DFUs with evidence of increased healing rates vs conventional care

Trial featuresRCTs included weekly follow-up, 16-week endpoints, and one or two applications per investigator discretion

Evidence limitationsStudies had sponsor involvement and potential lack of investigator blinding noted

inv-156: EPICORD description

EPICORD descriptionEPICORD: minimally manipulated, dehydrated, nonviable cellular umbilical cord allograft intended for chronic or acute wounds and burns

Trial evidenceEvaluated in an RCT vs alginate dressings with higher 12-week healing rates in adequately debrided subgroups

Application frequencyApplied weekly in trial protocols with standardized SOC run-in

inv-157: EPIFIX / dHACM definition

EPIFIX definitionEPIFIX / dHACM: dehydrated human amnion/chorion membrane extracellular collagen allograft composed of amnion and chorion layers used as an adjunctive biologic graft

FormulationsAvailable as noninjectable sheets and as micronized/injectable forms (EPIFIX Injectable)

Evidence summaryReviewed in multiple studies and cited in systematic reviews with RCTs suggesting benefit when added to SOC

inv-158: EPIEFFECT and EPIFIX Injectable descriptions

EPIEFFECT / EPIFIX InjectableEPIEFFECT: lyophilized human placental allograft including amnion/intermediate/chorion layers; EPIFIX Injectable: micronized powder form of EPIFIX for injection

Evidence noteFew published studies for injectables; clinical applicability beyond injections in tendinopathies is limited

Intended roleProvides injectable option where sheet application is not feasible

inv-159: EPIXPRESS description

EPIXPRESS descriptionEPIXPRESS: minimally manipulated, lyophilized, nonviable cellular allograft derived from human amnion/chorion preserving multiple placental layers

EvidenceStudies are lacking; insufficient evidence to determine a beneficial effect on health outcomes

Intended usePreserves extracellular matrix components for topical wound coverage

inv-160: GRAFIX definition

GRAFIX definitionGRAFIX: cryopreserved placental membrane (cellular repair matrix) containing extracellular matrix and native cells used as a human viable wound matrix

VariantsProduct family includes GRAFIX PRIME, GRAFIX PL PRIME, GRAFIX Duo (dehydrated dual-layer), GRAFIX CORE (cryopreserved chorion matrix), and GRAFIX Plus (lyophilized chorionic membrane)

Evidence noteSome RCT and observational data exist for GRAFIX in DFU/venous ulcers but many variants lack sufficient published studies

inv-161: GRAFIX variants description

GRAFIX variants noteGRAFIX Duo, GRAFIX CORE, and GRAFIX Plus are commercial variants with limited or few published studies for many wound indications

ImplicationEvidence for individual variants may be insufficient to determine benefit without additional trials

Coverage stanceSome GRAFIX variants are considered investigational/insufficient evidence in the policy text

inv-162: Hyalomatrix / Helicoll definitions

Hyalomatrix definitionHyalomatrix: a hyaluronic acid–derived fibrous wound contact layer with a semipermeable silicone outer membrane used as a wound dressing/matrix

HelicollHelicoll: type I collagen, semiocclusive, self-adhering sheet derived from animal tissue used for wound care and burns

Evidence noteAvailable studies are noncomparative or limited; evidence inconclusive for broader effectiveness

inv-163: Hyalomatrix description

Hyalomatrix summaryA nonwoven pad with hyaluronic acid–derived wound contact layer and semipermeable silicone outer membrane intended for wound management

Clinical evidenceStudies are noncomparative and limited; ECRI deemed evidence inconclusive

IndicationsUsed for burns and chronic wounds per product labeling; comparative benefit vs other dressings unproven

inv-164: Fish skin graft (Kerecis) definition

Fish skin graft (FSG) descriptionDecellularized xenogeneic skin graft derived from cold-water fish (Atlantic cod) preserving omega-3 fatty acids and structural proteins

Brand exampleKerecis Omega3 (MariGen Shield) is a commonly studied commercial FSG

Clinical evidenceRCTs show improved healing rates in DFUs versus SOC in several trials, though study designs and follow-up vary

inv-165: Integra Flowable Wound Matrix definition

Integra Flowable Wound Matrix definitionGranulated, cross-linked bovine tendon collagen and glycosaminoglycan matrix intended for deep and tunneling wounds

Evidence noteRCTs and studies exist but were excluded from some reviews for inadequate standard-of-care comparators; overall evidence limited

IndicationDesigned for irregular geometry wounds and deep/tunneling defects

inv-166: Fish skin xenograft (FSG) definition

Fish skin xenograft (FSG) definitionBiologic wound graft derived from cold-water fish (Atlantic cod) used as a xenograft option for wound healing distinct from human allografts or autografts

MechanismProvides structural proteins and preserved lipids (omega-3) thought to support healing

Clinical roleEvaluated as adjunct to SOC in DFUs and for some acute wound models in RCTs

inv-167: Acellular dermal matrix (ADM) definition (alternate)

ADM (alternate) definitionAcellular dermal matrix (ADM): scaffold derived from human or animal tissue processed to remove cells, used as a wound cover or scaffold to support healing

ExamplesProducts include MatriDerm, DermACELL, Matrix HD Allograft Dermis and others evaluated in trials with variable quality

Clinical useApplied for chronic wounds, burns, surgical wounds, and tissue reconstruction depending on product labeling