Aetna skin and soft tissue substitutes Coverage

Coverage and Medical Necessity Criteria

Initial medical necessity — general

Covered when ALL of the following are met:

Initial general criteria: 1) Product is being used for a medically necessary indication for that specific product listed in the product-specific section; AND 2) Member is 18 years of age or older; AND 3) Attestation that the member is a non-smoker, has completed, or is currently enrolled in smoking cessation therapy; AND 4) Submission of wound characteristics and treatment plan including a photo with a ruler; AND 5) Wound is a partial- or full-thickness skin defect, at least 1 cm2, clean and free of necrotic debris; AND 6) Wound has increased in size or depth or has not changed after at least 4 weeks of standard wound care (including debridement, standard dressings, and elimination of contributing factors); AND 7) No involvement of tendon, muscle, joint capsule, or exposed bone or sinus tracts; AND 8) No wound infection, underlying cellulitis, osteomyelitis, foreign body, or malignant process; AND 9) Elimination/adequate management of underlying conditions and/or factors that prevent wound healing (e.g., arterial insufficiency, nutritional deficiencies).

Derived from Aetna policy general medical necessity criteria.

Condition-specific medical necessity

Additionally, one of the following condition-specific sets must be met:

Diabetic foot ulcer (DFU): DFU at least 1 cm2 in size AND Hgb A1c ≤ 8 or documentation of improving glycemic control AND wound has increased or not changed after ≥4 weeks of standard wound care (debridement, moist dressings, off‑loading) AND no evidence of osteomyelitis or nidus of infection AND adequate circulation to the affected extremity (e.g., palpable dorsalis pedis or posterior tibial pulse or ABI > 0.7 - 1.2 without evidence of severe vessel calcification) AND application in conjunction with conservative therapy (for DFU this includes off‑loading).Hgb A1c ≤ 8; ABI >0.7 - 1.2

See product-specific sections for any additional device indications and billing guidance.

Venous leg ulcer (VLU): VLU at least 1 cm2 in size AND wound has increased or not changed after ≥4 weeks of standard wound care including compression AND adequate circulation (e.g., palpable dorsalis pedis or posterior tibial pulse or ABI ≥ 0.7) AND application in conjunction with conservative therapy such as compression wraps.ABI ≥ 0.7

Compression therapy must be part of standard care prior to or concurrent with application.

Partial- or full-thickness burn wounds when sufficient full-thickness autograft is not available or is not feasible due to the member's physiological condition AND no evidence of burn wound infection AND excision of non‑viable tissue is complete and hemostasis achieved; AND product-specific indications are met.

Applies when autograft is not available/feasible; follow product-specific instructions.

Continuation therapy

Covered continuation when ALL of the following are met:

Continuation of therapy: 1) Total continued treatment for a chronic wound does not exceed 12 weeks per treatment course; AND 2) Applications comply with FDA guidelines for the specific product and do not exceed 10 applications per 12‑week period of care (product-specific exceptions noted, e.g., EpiFix limited to one application per week up to 12 weeks); AND 3) Only one skin or soft tissue substitute product is in place simultaneously per wound episode; AND 4) Product changes within an episode are allowed but must be documented and not exceed application limits; AND 5) Progressive wound healing is demonstrated with measurable changes and wound measurements taken no more than 14 days apart; AND 6) Photographic documentation with a ruler and evidence in the medical record that the wound is improving in response to care.≤ 12 weeks; ≤ 10 applications per 12-week period

Documentation of serial measurements and photos required for continuation approvals.

Not medically necessary

Not medically necessary when ANY of the following apply:

Not medically necessary: 1) Indications not listed in the clinical criteria/product-specific sections; OR 2) Pressure ulcer treatment (explicitly listed as not medically necessary for skin substitutes in this policy); OR 3) Continued treatment when the ulcer fails to heal by ≥50% within the first 6 weeks of treatment; OR 4) Treatment beyond 12 weeks; OR 5) Continued use after treatment failure defined as repeat or alternative application within 1 year for VLU or DFU; OR 6) Repair following Mohs surgery (listed as not medically necessary for skin substitute use); OR 7) Retreatment of healed ulcers (defined as >75% size reduction and residual <1 cm2).

These items are specified as not medically necessary and may be grounds for denial.

Contraindications / Not eligible

Members are not eligible when ANY of the following contraindications are present:

Contraindications: 1) Active Charcot arthropathy of the ulcer surface; OR 2) Continued tobacco smoking without documentation of completion or current enrollment in smoking cessation therapy; OR 3) Evidence of active infection or vasculitis in the target ulcer(s); OR 4) Heavy bacterial contamination/exudate, eschar, or necrotic tissue that would interfere with graft take; OR 5) Hypersensitivity or allergy to any component of the skin substitute (for example avian, bovine, porcine, equine components); OR 6) Inadequate control of underlying conditions or exacerbating factors (e.g., uncontrolled diabetes with Hgb A1c > 8% or no documented improvement in the last 4 weeks); OR 7) Skin grafting/replacement for partial‑thickness loss when epithelial appendages are retained (epithelium expected to repopulate).Hgb A1c > 8%

Any single contraindication excludes eligibility; documentation must address modifiable factors prior to application.

Product-specific Medical Necessity

Medical Necessity sections are present for individual products:

Product-specific medical necessity: Individual named products (examples include DermACELL; Dermagraft; Epicel; Epicord; EpiFix; Grafix Core and Prime; Graftjacket; Integra DRT and BMWD; Oasis Wound Matrix; Orcel; Strattice; TheraSkin; TransCyte; Cryolife BioGlue) have dedicated medical necessity subsections that describe product-specific indications, required documentation, and applicable ICD‑10 diagnosis codes.

Refer to each product subsection for detailed selection criteria, HCPCS/Q-codes, and covered diagnoses.

Product-specific coverage

Covered when the product-specific selection criteria are met and an indicated ICD-10 diagnosis is provided:

Product and diagnosis match: 1) The HCPCS/Q-code corresponding to the specific product is billed AND 2) The submitted ICD‑10 diagnosis code is among those listed under that product (examples: diabetic foot ulcer codes, specified burn codes, chronic venous ulcer codes) AND 3) The product-specific clinical selection criteria and any prior conservative therapy/run‑in requirements are met (e.g., evidence of ≥4 weeks of standard care or product‑specified screening period).

Product sections list the HCPCS/Q-codes and the ICD-10 codes accepted for each product; match billing and diagnosis exactly.

Evidence limitations and need for clinically relevant outcomes

Evidence summary from systematic reviews:

Evidence limitations: Systematic reviews and technology assessments have identified many commercially available skin substitutes but concluded that most studies do not report clinically meaningful outcomes (amputation, wound recurrence, pain, return to function) and that higher‑quality, better‑reported trials with clinically relevant endpoints are needed to inform use across products and indications.

This supports cautious, indication‑ and evidence‑based application of skin substitutes.

Contexts where HSAM has clinical evidence

Clinical contexts in which HSAM has clinical evidence:

DFU randomized trial context: HSAM (hypothermically stored amniotic membrane) was evaluated as an adjunct to standard of care (debridement, infection management, moisture‑retentive dressings, aggressive off‑loading) in a randomized trial of DFUs that had failed standard care; HSAM was applied weekly and demonstrated higher closure rates and faster time to closure versus standard of care in the Serena trial (76 patients).failed SOC

Serena et al. RCT: improved closure at 12 and 16 weeks with HSAM.

VLU randomized trial context: HSAM plus standard of care was evaluated versus standard care alone in chronic, difficult‑to‑heal venous leg ulcers after a run‑in period; benefits were particularly seen in ulcers of prolonged duration (>6 months and >24 months) in the Vayser trial (206 patients).failed ≥4 weeks conventional therapy

Vayser et al. RCT: subgroup benefits in long-standing ulcers.

Real-world/retrospective context:

Coverage considerations for AlloDerm in abdominal wall reconstruction

Consider AlloDerm (or biologic mesh) coverage in abdominal wall and complex hernia repair when specific surgical goals and patient factors are met:

Primary fascial coaptation preferred: When feasible, primary fascial coaptation with mesh reinforcement should be attempted because mesh‑reinforced repairs with primary closure have substantially lower recurrence and complication rates than bridged repairs; if AlloDerm is proposed, justification should document why primary closure is not achievable.

Booth et al. and others report much higher recurrence and complications with bridged repairs (e.g., 56% vs 8%).

Use in contaminated fields: Biologic meshes including AlloDerm are sometimes used in contaminated or potentially contaminated fields to permit single‑stage repair, but clinicians should document contamination status and justify biologic mesh use given substantial wound morbidity and variable recurrence rates reported.

Romain et al. report high overall morbidity in contaminated single‑stage reconstructions.

Avoid bridging when possible: Bridging repairs with AlloDerm are associated with higher recurrence, laxity, and need for reoperation; bridging should be justified in the record only for specific clinical circumstances when reinforcement with primary fascial closure is not possible.

Other indications and evidence strength

Other clinical indications with summarized evidence:

Frey syndrome prevention: Acellular dermal matrices (including AlloDerm) have randomized and controlled trial evidence and meta‑analyses showing substantial reductions in the incidence of Frey syndrome after parotidectomy compared with no grafting.

Meta-analyses report large relative risk reductions (e.g., ~82–85%).

Breast reconstruction: AlloDerm is indicated for use in breast reconstruction per product labeling; evidence for routine wound‑healing benefits outside labeled homologous uses is limited to small series and cohort studies.

Apligraf/AlloDerm labeling and evidence limited for non‑labeled wound uses.

Burn and soft-tissue grafting: Small case series report favorable graft take and functional/cosmetic outcomes when AlloDerm is used as dermal scaffold with ultra‑thin autografts in full‑thickness burns, but evidence is limited and mostly nonrandomized.

Tsai et al. reported high composite graft take rates in small series.

Supported clinical uses

Coverage considerations and clinical findings summarized from cited studies:

Indications supported by evidence: Selected indications (complex abdominal wall reconstruction with documented rationale; contaminated ventral hernia repair when biologic mesh is justified; closure of chronic DFUs and VLUs after failed standard care) have supporting evidence from observational studies and some randomized trials (e.g., HR‑ADM and other products in DFU/VLU RCTs), but evidence quality and applicability vary by product and indication.

Outcomes and durability are influenced by technique, patient factors and product type; evaluate per‑product evidence when authorizing coverage.

Higher-risk situations

Instances associated with worse outcomes:

High-risk scenarios: Bridged repairs, contaminated/dirty surgical fields, use of human cadaveric ADM in certain contexts, smoking, high BMI, and larger defect size are associated with higher hernia recurrence, wound morbidity, and surgical site occurrences; these factors should be considered when assessing medical necessity and surgical planning.

Studies report substantially higher recurrence and complication rates in bridged repairs and contaminated fields.

Clinical evidence and typical trial-based application parameters

Evidence and indications summarized in this section (no explicit policy criteria in these chunks):

Trial-based application parameters: Randomized controlled trials of amniotic/placental allografts and other substitutes commonly used a screening/run‑in period with standard of care (e.g., 2–4 weeks), then applied products weekly (or per product protocol) for up to 12 weeks; endpoints evaluated included proportion healed at 6–12 weeks, time to closure, and percent area reduction. Trial protocols and dosing/scheduling vary by product.weekly application up to 12 weeks commonly used in trials

Clinical trial parameters inform expected application frequency and documentation for authorization.

Product-specific evidence variability: Some products (e.g., dHACA/AmnioBand, AmnioGuard, HSAM, Apligraf) have randomized controlled trial evidence of benefit vs standard of care; many other amniotic/placental products lack peer‑reviewed evidence demonstrating effectiveness.

Products lacking peer‑reviewed evidence may be treated as investigational or unsupported unless additional data are provided.

Background evidence and regulatory statements

Product-specific effectiveness and regulatory statements in background section:

Products with insufficient evidence: Several amniotic/placental products (examples include AmnioBind, AmnioShield, AmnioStrip, Amniotext, Amniorepair, AltiPly, Amnio Wound) are described in the background as having a lack of peer‑reviewed evidence regarding clinical effectiveness; absence of evidence may inform an investigational or non‑coverage stance without supporting data.

Policy lists many products and notes evidence insufficiency for several.

Regulatory-cleared or approved products: Some products have explicit regulatory status described (e.g., Apligraf has FDA PMA approvals for venous leg ulcers and diabetic foot ulcers; Apis has FDA 510(k) clearance). Regulatory status and labeled indications should be documented when requesting coverage.

Regulatory status may limit covered uses to labeled/homologous indications.

Product application details: Manufacturers specify product handling and application details (e.g., stromal side placed on wound bed, rehydration instructions, single‑use packaging, size options) which should be followed and documented in the medical record.

Document product identity, size applied, technique and packaging per manufacturer guidance.

Aetna’s clinical policy for skin and soft tissue substitutes explicitly lists a Not medically necessary category that includes use of these products for pressure ulcer treatment. This means applications intended primarily to treat pressure ulcers are excluded from coverage under the policy and claims for such indications are subject to denial. Providers should therefore not submit requests or billing for skin substitute products when the primary diagnosis is a pressure ulcer without prior discussion and authorization from the plan.

The policy identifies specific products that Aetna considers experimental, investigational, or unproven for diabetic foot ulcers; among these, MariGen (including Omega3 variants) is explicitly named as not supported for DFU treatment. Use of MariGen for diabetic foot ulcers is therefore treated as investigational and is not supported by this policy.

A Policy Limitations and Exclusions section is included and referenced throughout the document. In addition to the named not‑medically‑necessary uses (for example, pressure ulcer treatment), the policy contains broader limitations and exclusions that delineate indications, codes, and circumstances that are out of scope for coverage under this clinical bulletin. Where exclusions apply, related claims and prior authorization requests may be denied if submitted for those excluded indications.

The policy enumerates multiple CPT and HCPCS code ranges and vendor‑specific HCPCS codes that are designated as not covered for indications listed in the clinical policy bulletin. Examples include autologous heterogeneous skin‑construct CPT codes (e.g., 1044T–1049T) and multiple HCPCS A2000‑series identifiers (e.g., A2001–A2036 and related A‑series entries). The document notes that many vendor/product HCPCS codes and certain CPT/T codes are not covered when used for CPB‑listed indications.

Across the CPT, HCPCS and ICD‑10 code listings the policy explicitly identifies numerous codes that are not covered for the indications specified in the CPB. Examples span CPT injections and procedure ranges (e.g., 0232T, 0481T), HCPCS entries (e.g., S9055, Q4112, Q4108, Q4114, Q4103), and a variety of C‑codes and device codes (e.g., C9355, C9361, C9358, C9364). Submissions using these codes for CPB‑excluded indications may be denied or require prior authorization justification.

The clinical policy bulletin provides targeted examples of CPT/HCPCS and ICD‑10 codes that are not covered for specific indications in the CPB. Examples called out include injectable allograft and Integra-related HCPCS codes (e.g., Q4112, Q4108, Q4114), Oasis burn matrix code (Q4103), several implant and nerve‑wrap C‑codes (e.g., C9355, C9361, C9358, C9360, C9364), and numerous ICD‑10 diagnosis codes tied to excluded conditions. When these codes are billed for indications excluded by the CPB, coverage is not supported.

ActiGraft is described in the background section as an FDA‑cleared regenerative wound care solution that generates in‑vitro blood clots from a patient’s whole blood. However, the policy states there is a lack of evidence to support use of ActiGraft for the treatment of chronic diabetic foot ulcers or any other indications, and this evidence gap is cited as a basis for treating ActiGraft as unsupported for CPB‑listed indications.

AlloDerm is presented as an acellular dermal matrix processed from human cadaver skin and is indicated by labeling for use in association with breast reconstruction. The policy notes that evidence to support routine use of AlloDerm for general wound healing is limited, and long‑term results for some applications—particularly abdominal wall closure—have been disappointing in series reporting laxity, recurrence, and the need for secondary interventions. These limitations inform the policy’s cautious stance on routine coverage of AlloDerm outside its labeled homologous uses.

Several retrospective series and comparative reports cited in the policy document identify high recurrence and laxity rates after certain AlloDerm applications, especially when used to bridge fascial defects. Reported outcomes include substantially higher recurrence with bridged repairs compared with reinforced repairs, and cases of progressive laxity requiring secondary procedures. Given those findings, the policy advises that AlloDerm bridging repairs are not routinely supported and long‑term outcomes remain a concern.

The policy’s background review notes that AlloDerm or acellular cadaveric dermis are not listed as operative options for certain conditions in external clinical references (for example, trans‑sphincteric rectal fistula management in UpToDate). This absence from specialty guidance further supports limited or non‑routine use of AlloDerm for some indications outside its labeled homologous applications.

Clinical trials and case series summarized in the policy are generally limited to ulcers without exposure of tendon, joint capsule, muscle, or bone; the document explicitly states that results from these studies do not apply to deeper or more complex ulcers with such exposure. This restriction is reflected in the coverage criteria that exclude wounds with tendon, muscle, joint capsule, or bone exposure from eligibility for skin and soft tissue substitute coverage.

The policy includes numerous product‑specific background entries noting a lack of peer‑reviewed published evidence for many amniotic and placental allografts. Products cited as lacking or having insufficient evidence include AmnioBind, AmnioCyte Plus, Amnio‑Maxx / Amnio‑Maxx Lite, AmnioExCel/DAMA, AmnioRepair, AltiPly, among others. The policy indicates these evidence gaps may be treated as investigational or unsupported for CPB‑listed indications in the absence of robust clinical data.

Multiple named products appear in the policy with explicit statements that published clinical evidence is insufficient to support their effectiveness. Examples include AmnioBind, AmnioCyte Plus, Amnio‑Maxx/Lite, AmnioRepair/AltiPly. The absence of peer‑reviewed outcomes for these products is highlighted repeatedly and is a basis for considering them experimental or not medically necessary for CPB indications unless further supporting data are provided.

The background section contains a broad set of product summaries that identify many amniotic/placental and other allograft products as having insufficient or lacking evidence regarding clinical effectiveness. The policy treats these statements collectively to indicate that, absent peer‑reviewed clinical data, such products are often considered investigational or unsupported for coverage under the CPB.

For Apligraf, the policy notes that available randomized trials support its FDA‑approved indications, but the document also states there is insufficient information to extend coverage for other uses such as pressure sores, dermatologic surgery wounds, and burns at this time. That limited extension underscores that Apligraf coverage is reserved for labeled indications and supported clinical contexts rather than broader wound types.

The policy identifies several products and procedures for which evidence is insufficient to support use in the listed indications. For example, Artelon lacks sufficient evidence for orthopedic uses (ACL reconstruction, rotator cuff repair, TMC osteoarthritis) and ActiGraft lacks evidence for chronic diabetic foot ulcers; multiple amniotic products (e.g., AmnioBind) are stated to have insufficient peer‑reviewed evidence. Where evidence is insufficient, the policy treats these products as experimental or not medically necessary for CPB‑listed indications.

The policy’s continuation rules limit treatment courses and retreatment. Specifically, ongoing treatment is limited to no more than 12 weeks per treatment episode, and retreatment of healed ulcers (defined as >75% reduction in size and <1 cm2) or continued use after treatment failure (for example, repeat or alternate application within one year for VLU or DFU) are listed as not medically necessary. These limits are identified as denial triggers for continuation therapy.

MariGen is singled out as an example of a product considered experimental/investigational for diabetic foot ulcers and therefore not supported for DFU indications. The policy also generally lists many products as experimental or not medically necessary where peer‑reviewed evidence is lacking; MariGen is specifically called out in the product list and exclusion statements.

A Not medically necessary section exists and enumerates several categories and examples where use of skin and soft tissue substitutes is unsupported. It includes the policy’s continuation limits, exclusion of pressure ulcer treatment, products and indications not included in the clinical criteria, and products listed as experimental/investigational. The policy further ties non‑coverage to specific CPT/HCPCS/ICD‑10 code listings for excluded uses.

The policy contains a list titled Experimental and investigational wound care treatments; products enumerated there are treated as not medically necessary for CPB‑listed indications. The document also maps the use of listed CPT/HCPCS codes for CPB‑excluded indications to a not‑medically‑necessary stance, indicating that billing such codes for excluded uses may result in denials.

The policy clarifies that billing certain CPT/HCPCS codes for indications excluded by the CPB—examples include prevention of adhesions after orthopedic surgery and a variety of musculoskeletal or ocular indications—are considered not medically necessary. Providers should be aware that use of these codes for CPB‑excluded indications is not supported and may be denied.

Where CPT and HCPCS codes are listed as not covered for the CPB indications, the policy treats use of those codes for excluded indications as not medically necessary. The document provides many examples (e.g., injectable allograft codes, Integra and Oasis product codes, nerve wrap and implant C‑codes, and related ICD‑10 diagnoses) to guide coding and coverage determinations.

The policy highlights that use of AlloDerm for wound healing beyond its labeled homologous uses has limited evidence and may be considered not medically necessary in those contexts. Additionally, use of AlloDerm as a bridging material has been associated with high recurrence rates and laxity in multiple series; such outcomes temper routine coverage of AlloDerm for non‑labeled wound‑healing applications.

The policy documents multiple series and comparative reports showing that use of AlloDerm as a bridging material for fascial defects is associated with substantially higher recurrence and secondary procedures. Given these outcome concerns and the increased cost of biologic materials, the policy does not support routine use of AlloDerm for bridged repairs unless specific clinical justification is provided.

The policy repeatedly points to evidence limitations—small sample sizes, open‑label designs, and potential bias in some trials—which raise questions about generalizability to broader or more complex wound populations. These evidence‑quality concerns inform the policy’s cautious coverage approach and the need for stronger, peer‑reviewed clinical outcomes before wider coverage is extended.

AmnioBind is specifically noted in the background as having a lack of evidence in the peer‑reviewed literature to support its clinical effectiveness. The policy treats such evidence gaps as a basis for noncoverage or investigational classification for CPB‑listed indications.

The document states that many listed allografts (examples include AmnioBind, AmnioCyte Plus, Amnio‑Maxx/Lite, AmnioRepair/AltiPly) lack peer‑reviewed evidence demonstrating clinical effectiveness. Where such evidence is absent, the policy indicates these products may be treated as investigational or not medically necessary for the CPB indications.

Finally, the policy contains multiple, explicit background statements that a number of amniotic/placental products have insufficient evidence regarding clinical effectiveness. These background summaries are used in the policy to support investigational/not‑medically‑necessary designations and to inform prior authorization and documentation expectations when providers request coverage for such products.

Billing Codes and Coding Guidance

CPT / HCPCS codes referencedmixed

15271-15278	Application of skin substitute grafts.
96574	Debridement of premalignant hyperkeratotic lesion(s) followed with photodynamic therapy.
G0681-G0684	Application of a premarket approval (PMA), 510(k), 361 HCT/P non-sheet form skin substitute.
C7500	Debridement, bone including epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed, first 20 sq cm or less with manual preparation and insertion of deep drug-delivery device(s).
11042-11047	Debridement codes: subcutaneous tissue, muscle and/or fascia, bone, etc.
15002-15005	Surgical preparation or creation of recipient site.
15011-15018	Skin cell suspension autograft preparation, harvesting, application.
15777	Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue reinforcement.
17311-17315	Mohs related codes.

Other CPT/HCPCS codes related to CPBmixed

15271-15278	Application of skin substitute grafts.
96574	Debridement of premalignant hyperkeratotic lesion(s) followed with photodynamic therapy.
G0681-G0684	Application of a premarket approval (PMA), 510(k), 361 HCT/P non-sheet form skin substitute.
C7500	Debridement, bone including epidermis, dermis, subcutaneous tissue, muscle and/or fascia...

HCPCS codes covered if selection criteria are metHCPCSCovered

Q4101	Apligraf, per sq cm.
Q4102	Oasis Wound Matrix, per sq cm.
Q4105	Integra Dermal Regeneration Template (DRT), per sq cm.
Q4104	Integra Bilayer Matrix Wound Dressing (BMWD), per sq cm.
Q4116	Alloderm, per sq cm.
Q4132	Grafix core, per sq cm.
Q4133	Grafix prime, per sq cm.
Q4186	Epifix, per sq cm.
Q4122	DermACELL, per sq cm.
Q4130	Strattice TM, per sq cm.

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CPT codes not covered for CPB indicationsCPTNot Covered

1044T-1049T

Autologous heterogeneous skin-construct harvest/application CPT codes (listed as not covered for CPB indications).

HCPCS codes not covered for CPB indicationsHCPCSNot Covered

A2001-A2036

HCPCS codes listed as not covered for CPB indications (list of specific vendor/product codes).

ICD-10 codes covered if selection criteria are met (examples)ICD-10Covered

E08.621, E09.621, E10.621, E11.621, E13.621	Diabetes mellitus with foot ulcer (product-specific covered diagnosis across many products).
T20.011A-T25.799S	Burns (used for multiple products' covered indications).
I83.001-I83.229	Varicose veins of lower extremity with ulcer (covered for selected products).
I87.311-I87.339	Chronic venous hypertension with ulcer (covered for selected products).
L97.101-L97.929	Non-pressure chronic ulcer of lower limb (mentioned for Epifix).

Experimental/investigational product listmixedExperimental

numerous product names

Long list of products identified as experimental and investigational / not covered (no specific code).

HCPCS A2000 series and related CPT/T codesHCPCS

1046T	Autologous heterogeneous skin-construct graft application, trunk, arms, legs; first 50 sq cm or less
1047T	Autologous heterogeneous skin-construct graft application, trunk, arms, legs; each additional 50 sq cm
1048T	Autologous heterogeneous skin-construct graft application, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; first 50 sq cm or less
1049T	Autologous heterogeneous skin-construct graft application, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; each additional 50 sq cm
A2001	InnovaMatrix AC, per sq cm
A2002	Mirragen Advanced Wound Matrix, per sq cm
A2003	Bio-connekt wound matrix, per square centimeter
A2004	XCelliStem, per sq cm
A2005	Microlyte Matrix, per sq cm
A2006	NovoSorb SynPath dermal matrix, per sq cm

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Q-code HCPCS list (selected examples)HCPCS

Q4110	PriMatrix, per sq cm
Q4111	GammaGraft, per sq cm
Q4113	GRAFTJACKET XPRESS, injectable, 1cc
Q4117	HYALOMATRIX, per sq cm
Q4118	Matristem micromatrix, 1 mg
Q4123	AlloSkin RT, per square centimeter
Q4124	OASIS ultra tri-layer wound matrix, per sq cm
Q4125	Arthroflex, per sq cm
Q4126	MemoDerm, DermaSpan, TranZgraft or InteguPly, per square centimeter
Q4127	Talymed, per sq cm

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C-codes / other device codesHCPCS

C1781	Mesh (implantable)
C1832	Autograft suspension, including cell processing and application [RECELL]
C9796	Repair of enterocutaneous fistula with plug (e.g., porcine SIS)
A4100	Skin substitute, FDA cleared as a device, not otherwise specified

Not covered / related CPT/HCPCS referencesmixedNot Covered

L8658	Interphalangeal joint spacer, silicone or equal
20100-29999	CPT musculoskeletal system (not covered for prevention of adhesions after orthopedic surgery)
11950-11960	CPT codes related to subcutaneous injection/filling material and tissue expander (examples listed as not covered)
0232T	Injection(s), platelet rich plasma (listed as CPT not covered for CPB indications)
S9055	Procuren or other growth factor preparation to promote wound healing (HCPCS not covered for CPB indications)
C9355	Collagen nerve cuff (neuromatrix), per 0.5 cm length (HCPCS not covered for CPB indications)

ICD-10 examples noted as not covered for CPB indicationsICD-10Not Covered

L89.000-L89.95	Pressure ulcer (ICD-10 listed among codes not covered for CPB indications)
M18.0-M18.52	Osteoarthritis of first carpometacarpal — listed in ICD-10 not covered for CPB indications
H18.821-H18.829	Corneal disorder due to contact lens (listed as ICD-10 not covered for CPB indications)

CPT codes mentioned (not covered for listed indications)CPTNot Covered

0232T	Injection(s), platelet rich plasma, any tissue, including image guidance, harvesting and preparation when performed.
0481T	Injection(s), autologous white blood cell concentrate (autologous protein solution), any site, including image guidance, harvesting and preparation, when performed.
S9055	Procuren or other growth factor preparation to promote wound healing.
P9020	Platelet rich plasma, each unit.
P9022	Red blood cells, washed, each unit.
64912	Nerve repair; with nerve allograft, each nerve, first strand (cable).
64913	Nerve repair; with nerve allograft, each additional strand.
96372	Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular.

HCPCS and G-codes mentioned (not covered for listed indications)HCPCS | CPTNot Covered

Q4112	Cymetra, injectable, 1 cc
Q4108	Integra Matrix, per sq cm
Q4114	Integra Flowable Wound Matrix, injectable, 1 cc
Q4103	Oasis Burn Matrix, per sq cm
C9355	Collagen nerve cuff (neuromatrix), per 0.5 centimeter length
C9361	Collagen matrix nerve wrap (neuromend collagen nerve wrap), per 0.5 centimeter length
C9358	Dermal substitute, native, non-denatured collagen (SurgiMend), per 0.5 sq cm
C9360	Dermal substitute, neonatal bovine origin (SurgiMend), per 0.5 sq cm
C9356	Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (Tenoglide), per sq cm
C9364	Porcine implant, Permacol, per square centimeter

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ICD-10 codes mentioned (examples of not-covered or contraindications)ICD-10

L90.5	Scar conditions and fibrosis of skin
G96.00 - G96.09	Cerebrospinal fluid leak
T20.011A – T25.799S	Burns
M27.2	Inflammatory conditions of jaws
N81.0 - N81.9	Female genital prolapse
K56.1	Intussusception [rectum]
K62.3	Rectal prolapse
N81.6	Rectocele
L03.011 - L03.91	Cellulitis and acute lymphangitis
L95.8	Other vasculitis limited to the skin

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neutral — productmixed

AlloDerm

Acellular human dermal matrix product (product name rather than billing code) described in document

Regulatory statuses noted (no billing codes listed in this segment)mixed

No codes listed

No explicit codes in excerptmixed

No codes listed

Ankle brachial index (ABI) — circulation thresholds used to assess eligibility

ABI adequacy rangeAnkle‑brachial index (ABI) > 0.7 to 1.2 (or ABI ≥ 0.7 for VLU) without arterial calcification or with triphasic/biphasic Doppler waveforms as evidence of adequate circulation

ABI method examplesAdequate circulation may be demonstrated by palpable dorsalis pedis or posterior tibial pulses or by ABI within the specified range

ABI caveat — calcified vesselsABI must be interpreted in the absence of vessel‑calcification that would invalidate the measurement (use Doppler waveform assessment if calcification suspected)

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior authorization and documentation requirement

Obtain prior authorization when requested and include wound photos, a treatment plan, and clinical documentation demonstrating failure of ≥4 weeks of standard wound care; Aetna may require additional documentation as part of its coverage determination.

Photo of wound with ruler
Treatment plan and wound characteristics
Evidence member failed ≥4 weeks of standard care (debridement, dressings, off‑loading/compression as applicable)

Prior Authorization

Prior authorization may be required

Expect that prior authorization may be required for skin and soft tissue substitute requests because coverage depends on meeting product‑specific medical necessity and selection criteria; confirm PA rules for the specific code/product billed.

Check payer PA policies for product-specific instructions
Submit clinical justification tied to the named product when requested

Background, Product Descriptions, and Evidence Summaries

Definitions and Product Glossary

Chronic wound / failed response — A chronic wound does not heal within a normal timeframe (typically within three months). A failed response is defined as a wound that fai...

Definition — chronic wound and failed responseA chronic wound does not heal within a normal timeframe (typically within three months). A failed response is a wound that failed appropriate wound‑care measures, has increased in size or depth, or has not changed after ≥4 weeks of standard care

Standard care prior to advanced therapyFailed response requires documentation of at least 4 weeks of standard wound care (debridement, dressings, off‑loading/compression as appropriate)

Documentation requiredSubmission must include wound characteristics, treatment plan, and a photo with a ruler demonstrating chronicity and failed response

MariGen — A product that Aetna considers experimental, investigational, or unproven for DFU wounds.

MariGen coverage stanceAetna considers MariGen (including Omega3 MariGen variants) experimental, investigational, or unproven for diabetic foot ulcer wounds

Experimental, Investigational, and Limitations

Experimental/investigational product list

Experimental/investigational products and codes are listed as not covered for CPB‑listed indications:

Experimental/investigational product list: Numerous named products and product families are identified in the policy as experimental, investigational, or unproven for CPB‑listed indications (see policy product lists). Uses of those products for CPB indications are considered unsupported and subject to denial.

See full experimental/investigational product list in the policy.

Skin and Soft Tissue Substitutes

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