CurrentUnitedHealthcarePolicy CS153NJ.U

Skin and Soft Tissue Substitutes (for New Jersey Only)

UnitedHealthcare Community Plan medical policy (New Jersey only) defining medical necessity criteria, product-specific coverage, application limits, a long list of products considered unproven/not medically necessary, applicable HCPCS/A-codes/Q-codes, and clinical evidence background for skin and soft tissue substitutes.

Policy Summary

PayerUnitedHealthcare

PolicySkin and Soft Tissue Substitutes (for New Jersey Only)

Policy CodePolicy CS153NJ.U

Change TypeRevised unproven product list; Added and removed HCPCS codes; Clinical evidence updates

Effective DateOct 1, 2025

Next Review Date

Key ActionDocument vascular status, prior 4 weeks of standard wound care failure, and recent HbA1c when requesting coverage for EpiFix/Grafix and obtain prior authorization as required.

POLICY UPDATE CHANGES

Revised list of skin and soft tissue substitutes that are unproven and not medically necessary for any indication; added multiple product names including XWRAP Dual and XWRAP Plus.

Added HCPCS codes A2030, A2031, A2032, A2033, A2034, A2035, Q4354, Q4355, Q4356 to Applicable Codes.

Removed HCPCS code Q4231 from Applicable Codes.

Updated Clinical Evidence and References sections to reflect most current information.

1Products with explicit proven indication in this part

2Products with stated application limits (EpiFix, Grafix)

100+

Products listed as unproven / not medically necessary (enumerated)

manyHCPCS/Q-codes referenced

severalProducts with RCT evidence (examples)

Coverage Summary & Scope

This New Jersey–specific UnitedHealthcare Community Plan policy (Policy CS153NJ.U, effective 10/01/2025) covers skin and soft tissue substitutes (biologic, synthetic, biosynthetic) used for wounds, burns, and other soft-tissue indications and summarizes product-specific coverage rationales, application limits, and evidence considerations. The policy takes a mixed coverage stance: a small number of products (notably certain placental/amnion-derived grafts such as selected dHACM/dHACA and specific cryopreserved placental matrices) are described as proven/medically necessary for defined indications under trial-like criteria, while a very large, enumerated list of products is designated as unproven and not medically necessary for any indication due to insufficient evidence. The document also defines trial-aligned thresholds (e.g., ABI 0.7–1.2, HgA1c ≤ 12%, and a minimum 4-week standard wound care trial) that guide coverage of proven uses.

Medical-Necessity Criteria (by product / indication)

EpiFix or Grafix (Non-Injectable) - Diabetic Foot Ulcer Coverage

EpiFix or Grafix (Non-Injectable) is proven and medically necessary for treatment of diabetic foot ulcers when ALL of the following criteria are met:

ALL of the following

- ONE OF
  - Pedal pulses palpable or pulses confirmed with doppler examination
  - Ankle-brachial index (ABI) between 0.7 and 1.2
Glycated hemoglobin test (HgA1c)<= 12%
HgA1c must be documented within the last 90 days
- ALL of the following
  - Debridement of necrotic tissue, if present
  - Application of dressings to maintain a moist wound environment
  - Offloading
No active Charcot deformity or major structural abnormalities of the affected foot
Active Charcot deformity is an exclusion
- ANY of the following
  - Chronic infection at the ulcer site
  - Ulcer that extends to tendon, muscle, capsule, or bone
  - Known or suspected malignancy of the current ulcer being treated

EpiFix and Grafix Application Limitations

Application frequency and duration limits for EpiFix and Grafix when used for covered indications:

ALL of the following

Grafix: limited to one application per week<= 1/week
EpiFix: limited to one application per week<= 1/week
Maximum duration of therapy: up to 12 weeks for either product<= 12 weeks

EpiFix and Grafix - Not Medically Necessary Indications

Not medically necessary / Unproven uses for EpiFix and Grafix due to insufficient evidence:

ANY of the following

Grafix application more frequently than once per week
Grafix application beyond 12 weeks
EpiFix application more frequently than once per week
EpiFix application beyond 12 weeks
Any other indication for EpiFix or Grafix not listed as proven/covered above

TransCyte

TransCyte is proven and medically necessary for the following specific indication:

ALL of the following

Surgically excised full-thickness thermal burn wounds prior to autograft placement
Deep partial-thickness thermal burn wounds prior to autograft placement

ANY of the following

TransCyte for any other indication is unproven and not medically necessary due to insufficient evidence of efficacy

Evidence Summary & Product-Level Assessments

Systematic reviews and meta-analyses generally report that adding dermal/placental matrix products to standard of care improves diabetic foot ulcer (DFU) healing at 6 and 12 weeks and shortens time to closure, though pooled estimates show heterogeneity across trials and products. Key limitations across the evidence base include small sample sizes, short follow-up, variable products and application regimens, lack of blinding, and selective/manufacturer funding. Technology assessments (AHRQ, Hayes, ECRI) likewise describe an overall mixed quality of evidence, with meaningful signals of benefit for some dHACM/dHACA and select other products but important evidence gaps for long-term outcomes and head-to-head comparative effectiveness.

Evidence-based coverage conclusions for listed products

Coverage conclusions summarized per product based on available studies:

ALL of the following

When randomized controlled trials (RCTs) or systematic reviews/meta-analyses show benefit in selected populations under trial inclusion criteria, evidence supports improved healing rates and faster time to closure versus standard of care (examples include certain dHACA/dHACM products)
Trials required adequate tissue perfusion, absence of infection, and other inclusion criteria described in individual studies.

Not Medically Necessary / Unproven Products

The policy enumerates an extensive list of named skin and soft tissue substitute products that are considered unproven and not medically necessary for any indication under the revised coverage rationale effective 10/01/2025. The list is intended to identify products lacking adequate evidence to support clinical benefit across indications and to guide coverage and medical-review decisions.

Coverage Rationale (summary of changes)

Revised list of skin and soft tissue substitutes that are unproven and not medically necessary for any indication (effective 10/01/2025):

The following listed products are considered unproven and not medically necessary for any indication: Abiomend Hydromembrane; Abiomend Membrane; Abiomend Xplus Hydromembrane; Abiomend Xplus Membrane; AmchoPlast FD; Amnio Burgeon Dual-Layer Membrane; Amnio Burgeon Membrane and Hydromembrane; Amnio Burgeon Xplus Membrane and Xplus Hydromembrane; AmnioCore SL; ChoriPly; CYGNUS Disk Dual Layer; Amnio Burgeon X-Membrane; EPIXPRESS Foundation Dermal Regeneration Scaffold (DRS) Solo; Miro3D fibers; MiroDry Wound Matrix; Myriad Matrix; Myriad Morcells; PalinGen Dual-Layer Membrane; Theracor P or Allacor P; XWRAP Dual; XWRAP Plus.

Effective date and policy revision listed in Policy History

An exhaustive, itemized product list and mapping to HCPCS/A/Q codes is provided elsewhere in the policy (Applicable Codes / code_groups). Refer to the coding section for the full enumerated list and the newly added/removed HCPCS codes rather than duplicating the long product enumeration here.

Coding HCPCS / Q-codes / A-codes

HCPCS A-codes referenced productsHCPCS

A2001	InnovaMatrix AC, per sq cm
A2009	Symphony, per sq cm
A2030	Miro3D fibers, per mg
A2031	MiroDry Wound Matrix, per sq cm
A2032	Myriad Matrix, per sq cm
A2033	Myriad Morcells, 4 mg
A2034	Foundation DRS Solo, per sq cm
A2035	Corplex P or Theracor P or Allacor P, per mg

HCPCS Q-codes referenced productsHCPCS

Q4138	BioDFence DryFlex, per sq cm
Q4140	BioDFence, per sq cm
Q4145	(Referenced product)
Q4146	(Referenced product)
Q4147	(Referenced product)
Q4148	(Referenced product)
Q4149	(Referenced product)
Q4150	(Referenced product)
Q4151	(Referenced product)
Q4152	(Referenced product)

1–10 of 25

1/3

Added HCPCS codes (Applicable Codes Added 10/01/2025)HCPCS

A2030	Miro3D fibers, per mg
A2031	MiroDry Wound Matrix, per sq cm
A2032	Myriad Matrix, per sq cm
A2033	Myriad Morcells, 4 mg
A2034	Foundation DRS Solo, per sq cm
A2035	Corplex P or Theracor P or Allacor P, per mg
Q4354	(New Q-code)
Q4355	(New Q-code)
Q4356	(New Q-code)

Removed HCPCS codes (Removed 10/01/2025)HCPCS

Q4231

(Removed Q-code)

Provider Actions — Authorization, Documentation & Billing

Documentation Required

Document vascular status and HbA1c

Document adequate circulation and glycemic control when treating DFU with EpiFix/Grafix: record pedal pulses or Doppler confirmation; report ABI between 0.7 and 1.2; and document a recent glycated hemoglobin (HgA1c) within 90 days ≤ 12%.

Pedal pulses palpable or pulses confirmed with Doppler examination
Ankle-brachial index (ABI) between 0.7 and 1.2
Glycated hemoglobin (HgA1c) ≤ 12% within the last 90 days

Documentation Required

Document prior standard wound care failure

Document failure of an adequate trial of standard wound care prior to advanced allograft use: include evidence of debridement (if necrotic tissue present), application of dressings to maintain a moist wound environment, use of offloading, and at least 4 weeks of SOC with monitoring of wound response (e.g., percent area reduction).

Definitions & Terms

Term	Definition
dHACM	Dehydrated human amnion/chorion membrane (dehydrated human amnion/chorion membrane allograft) — e.g., EpiFix; used as an acellular placental membrane product for wound adjunctive therapy
dHACA	Dehydrated human amnion and chorion allograft (alternate wording for dHACM) — placental membrane allograft used for wound coverage and to promote healing
DFU	Diabetic foot ulcer — chronic wound of the lower extremity related to diabetes; trial inclusion commonly ≥4 weeks duration with specified size limits
SOC	Standard of care — wound cleaning, debridement, appropriate dressings, offloading/compression as applicable; typically a ≥4-week trial before adjunctive therapy
BLCC	Bioengineered living cellular construct — example Apligraf, a bilayer cellular skin substitute
VCPM	Viable cryopreserved placental membrane — Grafix (human viable wound matrix) used as a cryopreserved placental allograft
HCT/P	Human Cells, Tissues, and Cellular and Tissue-Based Products — FDA regulatory category (21 CFR 1270 & 1271) for minimally manipulated human-derived tissues
Full-Thickness Burn	Full-thickness thermal burn (third-degree): destruction of all layers of the skin including epidermis and dermis, with varying subcutaneous involvement
Partial-Thickness Burn	Partial-thickness thermal burn (second-degree): involves epidermis and part or most of the dermis; deep partial-thickness leaves few intact appendages and nerve endings
dACM	Dehydrated amnion–chorion membrane allograft (alternate abbreviation used in document) — placental-derived product evaluated in DFU trials

Key Evidence & Technology Assessments

Citation	Key finding / metric
Gordon et al. systematic review/meta-analysis	Pooled RR of healing with biologic dressings vs SOC at 12 weeks = 1.67; at 6 weeks = 2.81 (reported pooled analyses) — biologic dressings favored over SOC
Sui et al. (2024) systematic review	15 RCTs (n=1,524): dermal matrix + SOC improved time to healing (MD = 2.84 days shorter?) and higher complete healing rate vs SOC; limitations: heterogeneity, small samples
Alomairi et al. (2024) meta-analysis	10 RCTs (n=633): human amniotic membrane accelerated ulcer closure vs SOC; follow-up limited to 12-16 weeks
Hayes HTA (2020, updated 2023)	Concludes low-quality evidence that acellular/cellular skin substitutes may improve healing in DFUs/VLUs when adjunctive to SOC; limited comparative data
DiDomenico et al. (2016/2018) dHACA RCTs	DiDomenico 2016: 6‑week healing 70% vs 15%; 12‑week healing 85% vs 25% (dHACA vs SOC); mean time to heal 36 vs 70 days
Zelen et al. (2013/2014/2016) EpiFix trials	Small RCTs: EpiFix vs SOC or Apligraf — e.g., 12‑week healing up to 97% in some EpiFix arms; faster median time to heal (e.g., 13 days vs 49 days) in small trials; weekly application improved outcomes
Tettelbach et al. (2019) EpiCord RCT	Moderate-quality multicenter RCT: higher 12‑week healing in per‑protocol analyses for EpiCord vs alginate dressings (PP: 81% vs 54%); ITT results less robust
Mohammed / other pooled DFU meta-analyses	Meta-analyses (e.g., Mohammed 2022) report DHACA superiority: pooled RR at 6 and 12 weeks (examples reported RR ≈ 2.0–3.8 depending on analysis); shorter mean time to heal
Haugh et al. (2017) meta-analysis	Pooled RR for amniotic products vs control ≈ 2.74 in selected trials — indicates improved healing but limited by trial heterogeneity and small numbers
Lavery et al. (2014) Grafix RCT	Grafix: 62% healed vs 21% SOC at 12 weeks; median time to heal 42 vs 69.5 days; fewer adverse events with Grafix
Mirragen / Armstrong (2022) RCT	Bioactive glass microfiber matrix (Mirragen): 70% healed vs 25% SOC at 12 weeks in small RCT; improved PAR and no treatment-related AEs reported; further studies needed
Cazzell et al. (2018) AmnioFix injectable RCT	n=73 vs 72 placebo for plantar fasciitis: 3‑month VAS pain reduction 76% vs 45%; FFI‑R improvement 60% vs 40%; safety acceptable — placebo comparator only

Medicare Determinations & Coding Guidance

Informational note: CMS has published HCPCS application summaries and coding recommendations (HCPCS cycle documentation) with coding guidance effective 2024-04-25. Consult CMS HCPCS resources when determining the applicability of HCPCS/Q/A codes and claims coding for skin and soft tissue substitute products.

Revision History

2025-10-01material_revisionLatest

Revised list of skin and soft tissue substitutes designated as unproven and not medically necessary (coverage rationale updated); multiple product names added including XWRAP Dual and XWRAP Plus.

2025-10-01material_code_additionsLatest

Added HCPCS codes A2030, A2031, A2032, A2033, A2034, A2035, Q4354, Q4355, Q4356 to Applicable Codes.

2025-10-01material_code_removal

Policy Summary

PayerUnitedHealthcare

PolicySkin and Soft Tissue Substitutes (for New Jersey Only)

Policy CodePolicy CS153NJ.U

Change TypeRevised unproven product list; Added and removed HCPCS codes; Clinical evidence updates

Effective DateOct 1, 2025

Next Review Date

Key ActionDocument vascular status, prior 4 weeks of standard wound care failure, and recent HbA1c when requesting coverage for EpiFix/Grafix and obtain prior authorization as required.

On This Page

For many named products, studies are lacking or insufficient to conclude benefit (policy lists individual product summaries)

Conclusion language: 'Studies are lacking' or 'insufficient evidence' or 'few published studies' repeated per product

When RCT evidence exists (examples: AmnioBand/dHACA trials), reported endpoints included proportion healed at 6 and 12 weeks, mean time to heal, number of grafts per healed wound, and adverse events; results favored some dHACA products over SOC or other comparators in several trials

Systematic reviews/meta-analyses generally found pooled benefit of amniotic membrane products plus SOC for DFUs at 6 and 12 weeks but noted heterogeneity, small study sizes, and bias risks; further larger RCTs needed

Evidence-based coverage determinations / assessments (product-level)

Coverage assessment statements summarized by product when evidence is inadequate or inconclusive:

AmnioFix (MiMedx) — Evidence described as insufficient for many wound indications; some RCTs for injectable micronized product in tendinopathies/plantar fasciitis show short-term benefit but surgical wound evidence is inconclusive; larger RCTs needed.

ECRI and Hayes assessments cited

AmnioFix Injectable — RCT (Cazzell et al. 2018) showed statistically significant pain and function improvement at 3 months vs saline placebo for plantar fasciitis; limited by short follow-up and placebo comparator.

Products with limited/insufficient evidence (policy lists numerous products including AMNIOMATRIX/BioDMatrix, Amnio-Maxx, AmnioPlast, AmnioCore variants, Apis, Architect, ArthroFLEX, Biovance, CorMatrix, many others) — studies lacking or low quality so benefit on health outcomes cannot be concluded.

Evidence-based coverage inference for individual products (narrative)

No explicit coverage decision language in this excerpt; document provides evidence summaries and notes where evidence is insufficient or favorable.

ALL of the following

Products with few published studies: Cymetra; Cytal; DermaBind variants; DermaPure; Dermacyte; Dermavest/Plurivest; Derm-Maxx; Dual Layer Amnio Burgeon X-Membrane; DuoAmnion; EPIEFFECT; EpiFix Injectable; Emerge Matrix; Enclose TL Matrix; Enverse; E-Graft; Derma-Gide; Dermacyte products
Few published studies; evidence insufficient to conclude benefit
Products with limited/moderate evidence: DermACELL; EpiFix (dHACM); EpiCord; TheraSkin; Kerecis Omega3; Mirragen etc.
Limited/moderate RCTs or meta-analyses suggest benefit but heterogeneity and small trials limit confidence
Common limitations: Most positive studies are small, sometimes industry-sponsored, heterogeneous in methods, lack blinding, have short follow-up, and limited head-to-head comparisons

Clinical guidelines (SVS/APMA/SVM, Wound Healing Society, NICE, and IWGDF) position adjunctive biologic/skin-substitute therapies as options only after optimization of standard wound care and reassessment of vascular status and infection control. Recommendations consistently emphasize trialing and optimizing standard of care first (debridement, moisture balance, offloading/compression) and consider biologic or placental-derived products as adjuncts for wounds that fail to improve (for example, >50% area reduction not achieved after a minimum 4 weeks), with most guideline recommendations graded as conditional/low or acknowledging limited evidence.

Debridement of necrotic tissue, if present
Application of dressings to maintain a moist wound environment
Offloading
At least 4 weeks of standard wound care with tracking of wound reduction

Billing Rule

EpiFix/Grafix application limits

Billing for EpiFix (Q4186) and Grafix (Q4132, Q4133) must reflect published application frequency limits: one application per week, with billing not to exceed weekly applications for up to 12 weeks per product.

HCPCS Q4186 (EpiFix)
HCPCS Q4132 (Grafix Core and GrafixPL Core)
HCPCS Q4133 (Grafix PRIME, GrafixPL PRIME)
One application per week, up to 12 weeks

Prior Authorization

Prior authorization may be required

Prior authorization considerations — operational items providers should prepare when plans may require PA for advanced biologics: verify whether the payer requires PA for advanced biologic allografts; supply documentation paralleling trial inclusion (run-in results, wound measurements, vascular adequacy, infection status); provide product-specific clinical evidence or RCT data when available; and confirm plan-specific PA rules before scheduling.

Likely PA for advanced biologic/allograft products per plan policy
Provide trial-like inclusion data (run-in, wound size/duration, percent area reduction)
Supply product-specific clinical evidence (RCTs, systematic reviews) to support request
Verify plan-specific prior authorization rules and required documentation

Denial Risk

Contraindications increase denial risk

Contraindications and excluded wound characteristics raise the risk of claim denial: ulcers that extend to tendon, muscle, capsule, or bone; presence of chronic infection at the ulcer site; known or suspected malignancy of the ulcer; and products/indications lacking sufficient evidence are at higher denial risk.

Ulcer extends to tendon, muscle, capsule, or bone
Chronic infection at the ulcer site
Known or suspected malignancy of the current ulcer
Claims for products or indications with insufficient evidence may be denied

Billing Rule

HCPCS code changes effective 10/01/2025

HCPCS coding updates effective 10/01/2025: report newly added A- and Q-codes and stop using removed codes per the policy update.

Newly added HCPCS A-codes: A2030, A2031, A2032, A2033, A2034, A2035
Newly added HCPCS Q-codes: Q4354, Q4355, Q4356
Removed HCPCS code: Q4231 (discontinued)

Documentation Required

Run-in and eligibility documentation for DFU trials (operational implication)

When seeking approval for advanced amniotic/placental products, document trial-like run-in and eligibility details used in DFU RCTs: include run-in duration and response, serial wound measurements, 4‑week percent area reduction, perfusion thresholds (ABI 0.7–1.2, TcPO2/SPP ≥ ~30 mmHg), and other common trial criteria (ulcer size/duration, HbA1c, serum creatinine) to align with evidence populations and payer expectations.

Run-in requirements (e.g., 2‑week run-in showing ≤25% reduction to qualify in many trials)
Wound measurements and serial percent area reduction tracking (assess 4‑week surrogate reduction like ≥40% predictor)
Perfusion thresholds: ABI between 0.7 and 1.2; TcPO2 or transcutaneous oximetry (TcPO2) ≥ 30 mmHg; SPP ≥ 30 mmHg
Other trial-like thresholds: ulcer duration ≥4 weeks, ulcer size inclusion (e.g., ≥1 cm2 and <25 cm2), HbA1c <12%, serum creatinine <3.0 mg/dL

Removed HCPCS code Q4231 from Applicable Codes.

2025-10-01non-material_updateLatest

Clarification/expanded evidence: Clinical Evidence and References sections updated to reflect most current information (literature and evidence summaries expanded/updated).

Skin and Soft Tissue Substitutes (for New Jersey Only)

Coverage Summary & Scope

Medical-Necessity Criteria (by product / indication)

Evidence Summary & Product-Level Assessments

Not Medically Necessary / Unproven Products

Coding  HCPCS / Q-codes / A-codes

Provider Actions — Authorization, Documentation & Billing

Definitions & Terms

Key Evidence & Technology Assessments

Medicare Determinations & Coding Guidance

Revision History

Coding HCPCS / Q-codes / A-codes