CurrentUniversity Health Alliance (HSA)Policy MPP-0090-120918

Bio-Engineered Skin and Soft Tissue Substitutes Reimbursement

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This UHA payment policy governs reimbursement coverage and medical necessity criteria for bio-engineered skin and soft tissue substitutes (including acellular dermal matrices, allografts, and specific commercial products) for procedures such as breast reconstruction, tendon repair, diabetic and venous lower-extremity ulcers, dystrophic epidermolysis bullosa, and certain burns. It affects UHA providers and members subject to benefit terms and administrative guidelines.

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CurrentUniversity Health Alliance (HSA)Policy MPP-0090-120918

Bio-Engineered Skin and Soft Tissue Substitutes Reimbursement

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Policy Summary

PayerUniversity Health Alliance (HSA)

PolicyBio-Engineered Skin and Soft Tissue Substitutes Reimbursement

Policy CodePolicy MPP-0090-120918

Change TypeNo material changes

Effective DateAug 1, 2022

Last ReviewAug 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and submit required documentation (diabetic management compliance, ulcer location/size, prior treatments tried and failed, relevant diagnosis documentation, and imaging/photos when applicable).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 weeksmin standard therapy duration

>=30% TBSAEpicel TBSA threshold

multiplenamed products listed

I–IVpolicy sections

1prior auth required (some products)

Coverage Criteria and Limitations

Coverage Criteria

Covered when ALL of the following criteria for the indicated clinical scenario are met (subject to Limitations/Exclusions and Administrative Guidelines):

ALL of the following

ONE of
- There is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required.
- There are viable but compromised or thin post-mastectomy skin flaps that are at risk of dehiscence or necrosis.
- The infra-mammary fold and lateral mammary folds have been undermined during mastectomy and re-establishment of these landmarks is needed.

Allograft products are covered for shoulder tendon repair (subject to Limitations/Exclusions and Administrative Guidelines).

ALL of the following

The ulcer has not adequately responded after six weeks of standard wound therapy.
The patient is on a comprehensive diabetic management program.
Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities.
No bone or tendon is exposed.
There is no active or latent infection.

For chronic, non-infected lower-extremity ulcers due to venous insufficiency, Apligraf or Oasis Wound Matrix is covered when the ulcer has not adequately responded after six weeks of standard wound therapy.

OrCel is covered for the treatment of dystrophic epidermolysis bullosa (subject to Limitations/Exclusions and Administrative Guidelines).

Treatment of second- and third-degree (deep dermal or full-thickness) burns with specified tissue-engineered skin substitutes is covered when FDA/HDE or product-specific criteria are met; Epicel is covered for deep dermal or full-thickness burns comprising total body surface area greater than or equal to 30% when provided in accordance with the FDA HDE specifications; Integra Dermal Regeneration Template is included.

Not covered: Bio-engineered skin and soft tissue substitutes have not been shown to improve health outcomes for conditions not listed under Criteria/Guidelines; all other substitutes not listed under Criteria/Guidelines are not covered.

Administrative provisions: Coverage is subject to Limitations/Exclusions and Administrative Guidelines; provider contract terms and member benefit plans may affect payment; UHA may apply this policy and require prior authorization per Administrative Guidelines.

Products Listed Under Limitations/Exclusions

The policy's Limitations/Exclusions section enumerates numerous branded products that are subject to limitations or exclusion; the listing below reproduces product names as shown in the Limitations/Exclusions fragments of the policy.

Permacol

PriMatrix / PriMatr ix Dermal Repair Scaffold

CellerateRX Clarix Flo Collagen Sponge (Innocoll)

Collagen Wound Dressing (Oasis Research)

CollaGUARD

Microderm Neox Flo

Limitations/Exclusions — Product Listing

The Limitations/Exclusions section contains an extended enumerated list of wound care products (grouped and repeated with numeric markers in the source). The following reproduces representative product names and groupings as listed in the policy excerpts.

Durepair Regeneration Matrix

Matrix Stim

Conexa

Coreleader Cola-Pad

Puros Dermis

Repliform

Repriza

Limitations/Exclusions — Fragment

Additional product names appear in fragmented portions of the Limitations/Exclusions listing; these are reproduced here as shown in the source fragment.

End oform Dermal Template

E- Z Derm / E- Z Derm SS Matrix

TruSkin

GammaGraft

SS Matrix

Z Derm

Prior Authorization and HCPCS-based Coverage Stance

Coverage for specified products is conditional on prior authorization and submission of required documentation; the policy also lists HCPCS codes that are applicable and codes that do not meet payment determination criteria.

Prior authorization is required for the application of the following products: Apligraf, Dermagraft, Epicel, OrCel, Integra Dermal Regeneration Template, amniotic membrane grafts (e.g., Biovance, Epifix, Grafix), TransCyte, and Oasis Wound Matrix.

ALL of the following

Clinical notes documenting the patient’s compliance with a diabetic management program.
Exact location of the ulcer and the initial ulcer size.
Duration and description of the standard treatments that were tried and failed.
Documentation of the presence of dystrophic epidermolysis bullosa when that is the indication.

Coding and HCPCS/CPT Guidance

No billing codes listedmixed

No specific CPT/HCPCS/ICD-10 codes are provided in these chunks.

Codes not specified in this sectionmixed

No CPT/HCPCS/ICD-10 or modifier codes are provided in this extract.

Named products (no codes in fragment)mixed

Multiple named biologic and dermal matrix products (e.g., DermaPure, Excellagen, StrataGraft, SurgiMend, TheraSkin, GraftJacket Xpress, Veritas Collagen Matrix) are listed in the limitations/exclusions section; no CPT/HCPCS codes provided in this fragment.

Applicable HCPCS CodesHCPCS

Q4100	Skin substitute, not otherwise specified
Q4101	Apligraf, per square centimeter
Q4102	Oasis wound matrix, per square centimeter
Q4105	Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per square centimeter
Q4106	Dermagraft, per square centimeter
Q4107	GRAFTJACKET, per square centimeter
Q4116	AlloDerm, per square centimeter
Q4122	DermACELL, per square centimeter
Q4124	OASIS ultra tri-layer wound matrix, per square centimeter
Q4128	FlexHD, AllopatchHD, or Matrix HD, per square centimeter

1–10 of 17

1/2

HCPCS codes that do not meet payment determination criteria (examples)HCPCSNot Covered

C9349	PuraPly and PuraPly Antimicrobial, any type, per square centimeter (does not meet payment determination criteria)
C9354	Acellular pericardial tissue matrix of nonhuman origin (Veritas), per square centimeter (does not meet payment determination criteria)
C9356	Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (TenoGlide), per square centimeter (does not meet payment determination criteria)
Q4103	Oasis Burn Matrix, per square centimeter (does not meet payment determination criteria)
Q4104	Integra Bilayer Matrix Wound Dressing (BMWD), per square centimeter (does not meet payment determination criteria)
Q4108	Integra Matrix, per square centimeter (does not meet payment determination criteria)
Q4110	PriMatrix, per square centimeter (does not meet payment determination criteria)
Q4112	GammaGraft/Cymetra, per square centimeter or injectable, 1 cc (does not meet payment determination criteria)
Q4113	GRAFTJACKET XPRESS, injectable, 1 cc (does not meet payment determination criteria)
Q4114	Integra Flowable Wound Matrix, injectable, 1 cc (does not meet payment determination criteria)

1–10 of 14

1/2

Epicel coverage threshold

Epicel TBSA thresholdEpicel is covered for deep dermal or full‑thickness burns when total body surface area (TBSA) is greater than or equal to 30% and provided in accordance with the FDA HDE specifications

Associated productEpicel® (tissue‑engineered skin substitute) — coverage tied to TBSA >=30% for indicated burns

ConditionTreatment limited to deep dermal or full‑thickness burns as specified in policy

Numbered item qualifiers (placeholders)

ObservationMultiple entries in the Limitations/Exclusions lists are formatted with numeric placeholders such as '1 =', '2 =', '3 =' without accompanying numeric thresholds or quantities

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Request UHA reconsideration with supporting documentation

A provider may request that UHA reconsider the application of the medical necessity criteria by submitting supporting documentation; prior authorization requirements are referenced in the administrative guidelines.

Billing Rule

Products listed under Limitations/Exclusions (examples)

The policy lists numerous branded biologic and collagen wound dressings under Limitations/Exclusions (examples shown in the policy include Permacol, PriMatrix, CellerateRX Clarix Flo Collagen Sponge, CollaGUARD, Neox Flo, NuShield, Oasis Burn Matrix, Oasis Ultra Tri-Layer Matrix).

Permacol™
PriMatrix™

Definitions and Standard Wound Therapy

Definition — bio‑engineered skin and soft tissue substitutes

Derivation sourcesMay be derived from human tissue (autologous or allogeneic), nonhuman tissue (xenographic), synthetic materials, or composite materials

Clinical applicationsEvaluated for breast reconstruction, lower‑extremity ulcer healing, severe burns, and soft tissue repair

Includes ADM productsAcellular dermal matrix (ADM) products are included in the scope of bio‑engineered substitutes evaluated by the policy

Definition — standard wound therapy

Measurement frequencyEvaluation of wound with documentation of measurements (length, width, and depth) at baseline and at least weekly by a licensed medical professional

Topical care and debridement

Policy Summary

PayerUniversity Health Alliance (HSA)

PolicyBio-Engineered Skin and Soft Tissue Substitutes Reimbursement

Policy CodePolicy MPP-0090-120918

Change TypeNo material changes

Effective DateAug 1, 2022

Last ReviewAug 1, 2022

Next Review DateN/A

SourceLink

On This Page

Oasis Burn Matrix / Oasis Ultra Tri-Layer Matrix

Revi talon / Revi Stim

SIS Wound Dressing I / II

CorMatrix / CorMatrix CRXa

Cystal Dermadapt Wound Dressing

Revi talon / Revi Stim

SIS Wound Dressing II

ulen Collagen / StrataGraft

TheraForm Standard/Sheet

Dermal Template / oform Dermal Template

Imaging studies and color photographs, if applicable.

Exception: Prior authorization is not required for acellular dermal matrix products or Strattice when used in breast reconstruction surgery.

Denial condition: Application of these products outside of the guidelines and standard appropriate use criteria for hospitalized patients' wounds will result in denial of claims.

Coding stance: The policy lists applicable HCPCS codes (e.g., Q4100, Q4101, Q4102, Q4105, Q4106, Q4107, Q4116, Q4122, Q4124, Q4128, Q4130, Q4131, Q4132, Q4133, Q4145, Q4151, Q4154) and also enumerates HCPCS/C codes that do not meet payment determination criteria (e.g., C9349, C9354, Q4103, Q4104, Q4108, Q4110). Inclusion of a code does not guarantee reimbursement.

Affected sectionsNumerous product lines in IV. Limitations/Exclusions (examples shown in chunks 19, 36, 54)

ImplicationNumeric markers appear to be list grouping markers rather than defined numeric coverage thresholds; policy text does not define their meaning in these fragments

Per‑product numeric entries

Pattern notedMany product names in the Limitations/Exclusions section are followed by numeric suffixes '1', '2', '3' (e.g., repeated product lines with trailing '1 =', '2 =', '3 =') with no explanatory legend in the visible text

ExamplesCoreleader Cola‑Pad, Puros® Dermis, Repliform®, Repriza™ and many others appear repeatedly with numeric suffixes across chunks

InterpretationThe numeric suffixes are presented inconsistently and their meaning is unclear from the provided fragments

Prior authorization — required documentation elements

Ulcer location and sizeSubmit the exact location of the ulcer and the initial ulcer size

Standard treatments triedProvide duration and description of the standard treatments that were tried and failed

Dystrophic epidermolysis bullosa documentationIf DEB is the indication, submit documentation of its presence

Imaging and photographsInclude imaging studies and color photographs if applicable

CellerateRX® Clarix® Flo Collagen Sponge (Innocoll)

Oasis® Ultra Tri-Layer Matrix

Billing Rule

Limitations/Exclusions — additional product list

Additional product names are included in the Limitations/Exclusions section; this extract shows many product entries without associated prior authorization or other administrative steps in the fragment.

Coreleader Cola-Pad
CorMatrix®
Cymetra®
DermaPure™
PuraPly
Puros® Dermis
Repliform®
Repriza™

Documentation Required

Limitations/Exclusions — product listing (fragment)

The Limitations/Exclusions section contains a fragmented, repetitive listing of numerous wound care product names (e.g., Excellagen, StrataGraft, Suprathel, SurgiMend, TenoGlide, TheraSkin) without explicit coverage determinations in this fragment.

Excellagen
StrataGraft®
Suprathel®
SurgiMend®
Talymed®
TenoGlide™
TheraSkin®

Prior Authorization

Prior authorization required; submission instructions

Prior authorization is required before application of specific products including Apligraf, Dermagraft, Epicel, OrCel, Integra Dermal Regeneration Template, amniotic membrane grafts (e.g., Biovance, EpiFix, Grafix), TransCyte, and Oasis Wound Matrix; submit requests via UHA's online portal (contact 808-532-4000 to establish a login if needed).

Apligraf
Dermagraft
Epicel
OrCel
Integra Dermal Regeneration Template
Amniotic membrane grafts (Biovance, EpiFix, Grafix)
TransCyte
Oasis Wound Matrix
Submit via UHA online portal; call 808-532-4000 to establish login

Documentation Required

Documentation required for prior authorization

When requesting prior authorization for the listed products, include the required clinical documentation: evidence of diabetic management program compliance, exact ulcer location and initial ulcer size, duration and description of prior standard treatments tried and failed, documentation of dystrophic epidermolysis bullosa if applicable, and imaging/color photographs if applicable.

Clinical notes documenting patient's compliance with a diabetic management program
Exact ulcer location and initial ulcer size
Duration and description of standard treatments tried and failed
Documentation of dystrophic epidermolysis bullosa if that is the indication
Imaging studies and color photographs, if applicable

Billing Rule

Exceptions — no prior authorization for ADM or Strattice in breast reconstruction

Prior authorization is not required for acellular dermal matrix products or for Strattice when used in breast reconstruction surgery.

Denial Risk

Denial risk for uses outside guidelines

Applications of these products outside the policy guidelines and standard appropriate use criteria for hospitalized patients' wounds will result in denial of claims or nonpayment.

Application of moist topical dressings and debridement of necrotic tissue if present

Infection and nutritionTreatment of infection if present and evaluation/provision of adequate nutrition

Comorbidity managementManagement of diabetes mellitus and evaluation/management of peripheral artery disease when applicable

Limitations/Exclusions — product listing (selected)

Products listedNumerous branded wound care products are enumerated under IV. Limitations/Exclusions (examples across fragments include Permacol™, PriMatrix™, Oasis® Burn Matrix, Puros® Dermis, Repliform®, Repriza™, DermaPure™, StrataGraft®, SurgiMend®, TheraSkin®, TenoGlide™, Talymed™, Excellagen)

Listing characteristicThe sections present repetitive, fragmented product name lists without accompanying exclusion rationale in the visible text

Coverage implicationProducts appearing in the Limitations/Exclusions lists are identified in the policy fragment but the specific coverage determinations or rationales are not provided in these chunks

Unlabeled fragment — inventory note

Fragment noteA fragmented product list entry is present in the Limitations/Exclusions section with no label or explanatory text visible in the extract

Examples presentShort repeated fragments reference DermaPure™, DressSkin, Dermavest™, Durepair Regeneration Matrix®, End oform Dermal Template™, and others

ActionRefer to full policy text for complete, authoritative product‑level coverage decisions and rationale

Limitations/Exclusions — fragmented product list

Repeated product listLimitations/Exclusions section contains fragmented and repetitive lists of wound care products (e.g., Endoform Dermal Template™, ENDURAGen™, Excellagen, Dermadapt™, DermaPure™, Dermavest™, Durepair Regeneration Matrix®, StrataGraft®, Suprathel®, SurgiMend®)

Formatting issueLists include numeric suffixes and repeated groupings that make the fragmentary product listing appear disjointed

RecommendationConsult the complete IV. Limitations/Exclusions section in the source policy for finalized exclusion determinations and any product‑specific notes

Definition — prior authorization (administrative)

Prior authorization definitionPrior authorization is required before application of specified skin substitutes and graft products listed in the policy in order for reimbursement to be considered

Retrospective reviewUHA reserves the right to perform retrospective reviews using the listed criteria to validate whether services met payment determination criteria

Definition — HCPCS codes referenced

HCPCS codes referencedPolicy lists multiple HCPCS codes as applicable (e.g., Q4100–Q4154) and additional codes that do not meet payment determination criteria (e.g., C9349, C9354, Q4103–Q4110, etc.)

Coverage caveatInclusion of a code in the policy does not guarantee reimbursement — some listed codes explicitly do not meet payment determination criteria