Fidelis Care Skin Substitutes Coverage Update

Medical Necessity Coverage Criteria

Initial Therapy

Covered when ALL of the following are met specific to the wound

ALL of the following

General request and wound status: Request indicates the specific wound to which the skin substitute/CTP will be applied; wound is not infected; requested use complies with the product's labeled indications; only one skin and soft tissue substitute/CTP will be simultaneously in place per wound episode
Wound-specific preconditions: For DFU: failure to achieve at least 50% ulcer area reduction despite compliance with standard of care (SOC) wound treatment for a minimum of four weeks, AND assessment and management of diabetes (including review of blood glucose/HbA1c), nutrition, medications, and physical exam including off‑loading; For VLU: failure to respond despite compliance with SOC wound treatment for a minimum of four weeks, AND assessment of venous history and examination (including venous reflux/perforator competence) and documentation supporting use of firm strength compression (>20 mmHg)
Risk factor and SOC management: Documentation that modifiable risk factors (e.g., diabetes control, venous insufficiency, neuropathy, smoking) are being addressed and that SOC has been implemented including appropriate debridement to a clean granular base; infection control; exudate management; and off‑loading or compression as applicable
Documentation of SOC failure/stalled healing: Measurements of the initial ulcer, pre‑SOC measurements, weekly SOC measurements, and post‑SOC measurements after at least four weeks of SOC demonstrating failure to achieve expected healing
Preferred product selection: Request is for a preferred product listed in the policy (examples include Kerecis A2019/A4158; Apligraf Q4101; Oasis Q4102; Integra Q4104/Q4105; Dermagraft Q4431; Graftjacket Q4107; Theraskin Q4121; Grafix Q4132/Q4133; Epifix Q4186)
Application technique and documentation: Graft will be applied in a single layer without overlay and in compliance with label application techniques; for each application provide graphic/photo evidence of wound size, depth and characteristics, complete procedure description including product/package label or NDC and size used, rationale for size selection to minimize wastage, and documentation of amount administered and wasted with date/time/reason

ALL of the following

Smoking status: Member is a non‑smoker OR has been counseled and is enrolled in or has completed smoking cessation therapy

ALL of the following

Single product episode: Only one skin and soft tissue substitute/CTP will be simultaneously in place per wound episode; product change within episode allowed but initial authorization limited to up to four applications

ALL of the following

Glycemic and comorbidity review: Assessment of diabetes type and management history, review of current blood glucose/HbA1c, diet/nutrition/activity, updated medication history and pertinent medical problems

ALL of the following

Eligibility summary: All of the above criteria must be met for the specific wound to support up to four initial applications of a skin and soft tissue substitute/CTP

Continuation Therapy

Covered when ALL of the following are met specific to the wound

ALL of the following

General: Request indicates the specific wound; requested product is one of the preferred products listed in the policy; requested use complies with the product's labeled indications; only one skin and soft tissue substitute/CTP will be simultaneously in place per wound episode
Documentation for extension: Provide explanation why additional applications beyond the initial four are medically necessary for this specific wound; evidence that the initial four applications resulted in wound improvement and expectation that continued applications will continue healing; estimated time and number of additional applications anticipated and plan if healing not achieved
Risk factor management for extension: Modifiable risk factors (e.g., diabetes, venous insufficiency, neuropathy, smoking) continue to be addressed; for VLU include documentation of appropriate venous consultation/management

Burn Therapy

Covered when ALL of the following are met specific to the wound

ALL of the following

Indication and wound status: Request indicates the specific burn wound to which the skin substitute/CTP will be applied; burn is deep partial‑thickness or full‑thickness; no evidence of burn wound infection; sufficient autograft is not available or is not feasible
Risk factors & assessment: Modifiable risk factors for impaired wound healing are being addressed; review of blood glucose/HbA1c if history of prediabetes/diabetes; diet, nutritional status and activity level reviewed; updated medication history; member is a non‑smoker or has completed/is enrolled in smoking cessation therapy
Allowed products for burns: Treatment with allograft (human cadaver), xenograft (porcine), or listed tissue‑engineered products such as Biobrane (A2043/A2044), Transcyte (Q4182), Integra variants (Q4108/C9363/Q4104/Q4105), Suprathel (A2012), or Epicel (C9399) per HDE

Breast Reconstruction

Covered when ALL of the following are met specific to the wound

ALL of the following

Indication: Request indicates the specific wound; for post‑mastectomy breast reconstruction; no evidence of wound infection
Risk factors & assessment: Modifiable risk factors are being addressed; review of current blood glucose/HbA1c if history of prediabetes/diabetes; diet, nutritional status and activity level reviewed; updated medication history; member is a non‑smoker or has completed/is enrolled in smoking cessation therapy
Allowed products for breast reconstruction: Treatment with listed products for breast reconstruction such as AlloDerm (Q4116), Cortiva (Q4433), DermaCell (Q4122), FlexHD/AllopatchHD (Q4128) are acceptable
Application technique and documentation:

OrCel for mitten hand deformities

Covered when ALL of the following are met specific to the wound

ALL of the following

Indication: Request indicates the specific wound; OrCel is used according to the FDA Humanitarian Device Exemption (HDE); no evidence of wound infection
Risk factors & documentation: Modifiable risk factors for impaired wound healing are being addressed; review of current blood glucose/HbA1c if history of prediabetes/diabetes; diet, nutrition, activity and updated medication history reviewed; member is a non‑smoker or has completed/is enrolled in smoking cessation therapy; required documentation per application (graphic/photo measurements and full procedure description including product/package label or NDC and size) is provided

Post-Reconstruction Abdominal Wall Wounds (Medical Necessity)

Covered when ALL of the following are met for post-reconstruction abdominal wall wounds:

Post-reconstruction abdominal wall wound criteria: A. Request indicates the specific wound to which the skin substitute/CTP will be applied; B. Indication is repair of hernias or surgical repair of complex abdominal wall wounds; C. No evidence of wound infection; D. Documentation that: 1) modifiable risk factors for impaired wound healing are being addressed; 2) review of current blood glucose/HbA1c if history of prediabetes/diabetes; 3) diet, nutritional status and activity level reviewed; 4) updated medication history and pertinent medical problems reviewed; 5) smoking status addressed (non‑smoker or enrolled/completed smoking cessation); E. Treatment uses one of the listed products (examples include AlloDerm Q4116, Phasix ST C1781, Strattice Q4130); F. Only one skin substitute will be simultaneously in place per wound episode; G. Graft applied in single layer without overlay of product or adjacent skin in compliance with label application techniques; H. Documentation per application includes graphic/photo measurements, complete procedure description with product/NDC and size, selection of size to minimize wastage, and documentation of administered and wasted amounts with date/time/reason

From sections VII and documentation requirements.

Initial Therapy

Covered when ALL of the following are met for the specific wound to which product will be applied (initial applications):

Initial Application Requirements: Request indicates the specific wound to which the skin substitute/CTP will be applied; medical necessity criteria are specific to that wound

See I. in policy

Application limit: Applicable to up to four initial applications per wound<=4 applications

See policy statement I.

Smoking/nicotine: Documentation of effort to cease nicotine use or no nicotine use for at least 4 weeks; participation in smoking cessation therapy required for smokersno nicotine for 4 weeks or participation in cessation

I.D.5 and related text

Continuation Therapy

Covered when ALL of the following are met for additional applications beyond initial four (up to total of eight):

Beyond-initial application: Requests for applications beyond the initial four and up to a total of eight require the policy‑specified extension criteria: explanation of medical necessity for additional applications; evidence of response to initial four applications and expectation of continued healing; estimated time and number of additional applications and plan if not healing; modifiable risk factors addressed; for VLU, appropriate venous consultation/management; full procedure records for prior and proposed applications<=8 applications total

See policy statement II.

Liquid or gel formulations of skin and soft tissue substitutes/CTPs are not appropriate as sole ulcer care and are listed among uses the policy excludes; requests must instead document the specific wound and that the chosen product's labeled indications support the intended use. Products must be applied to a clean, non‑infected wound bed and in compliance with label instructions, including single‑layer application without overlay. Only one skin and soft tissue substitute/CTP may be simultaneously in place per wound episode, and product selection should prioritize preferred products listed in the coding tables. For each application, maintain complete procedure documentation and photographic or graphic measurement evidence of wound size and depth, with package/NDC identification and wastage details as specified in the policy.

Uses considered not medically necessary include any indication not specifically listed as medically necessary in sections IV–VII (for example, pressure ulcers when not listed), and any product not listed as medically necessary for the requested indication. The policy also specifies that therapies exceeding defined application limits or outside the wound‑specific criteria are non‑covered, and providers should consult HCPCS Code Table 3 for examples of products that do not support medical necessity.

HCPCS codes enumerated in Code Table 3 are designated by the policy as not supporting medical necessity for any indication. Uses billed with these codes (examples include codes beginning A2001, A2002, A2004, A2005 and many Q4xxx entries) may be denied because the policy explicitly lists them as non‑supportive of medical necessity.

The policy states that any use not listed in section II. (the policy's specified indications and related application criteria) is considered not medically necessary. Requests for indications or application patterns outside those sections risk denial under the policy.

Providers should consult applicable Medicare local coverage determinations (LCDs), national coverage determinations (NCDs), and state Medicaid rules for consistency with this policy when treating Medicare or Medicaid members. The policy's references include multiple LCDs for cosmetic and reconstructive surgery and the NCD for breast reconstruction; when state Medicaid provisions conflict with this clinical policy, state rules take precedence.

Repeat applications beyond the initial authorized series require documentation that the initial course produced healing and that continued applications are expected to further healing. Extension requests must explain why additional applications are medically necessary, provide an estimated number and timeframe for further applications, and include complete procedure records and photographic measurements from prior applications. For venous leg ulcers, documentation should also show appropriate venous evaluation and management.

The policy lists specific not medically necessary scenarios: treatment extending beyond 12 weeks; repeat applications when initial treatment was unsuccessful after 4 weeks (defined as increase in size/depth or no change and no sign of improvement); retreatment of healed wounds (those with > 75% size reduction and <0.5 sq cm); and re‑treatment within one year of a prior course for the same wound.

The policy identifies a set of HCPCS and A‑series product codes that do not support medical necessity and are therefore considered not medically necessary for any indication. Examples and representative codes are listed in HCPCS Code Table 3 (e.g., A2001, A2002, A2004, A2005, and a broad range of Q4xxx codes added in subsequent revisions).

The policy explicitly states that indications not listed in section II. and uses outside the wound‑specific criteria and application limits are non‑medical necessity reasons. Any request for an indication not enumerated in the policy (sections IV–VII/II depending on version) should be considered non‑covered per the policy language and may be denied.

The policy includes a neutral listing of skin and soft tissue substitute codes used in the criteria and coding tables. These include commonly used products such as Q4101 (Apligraf), Q4102 (Oasis), Q4104 (Integra BMWD), Q4107 (Graftjacket), Q4116 (AlloDerm), and others used for specified indications; see the coding tables for the full neutral list used to identify preferred or supporting products.

Billing and Coding

Covered CPT CodesCPTCovered

15271	Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area.
15272	Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure).
15273	Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children.
15274	Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure).
15275	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area.
15276	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure).
15277	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children.
15278	Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof (continued).

Covered HCPCS G-codesHCPCSCovered

G0681	Application of a premarket approval (PMA), 510(k), 361 human cells, tissues or cellular and tissue-based products (HCT/P) nonsheet form skin substitute for a wound surface area up to 100 sq cm; first 25 sq cm or less of wound surface area.
G0682	Application of a premarket approval (PMA), 510(k), 361 human cells, tissues or cellular and tissue-based products (HCT/P) nonsheet form skin substitute for a wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof.
G0683	Application of a premarket approval (PMA), 510(k), 361 human cells, tissues or cellular and tissue-based products (HCT/P) nonsheet form skin substitute graft for a wound surface greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children.
G0684	Application of a premarket approval (PMA), 510(k), 361 human cells, tissues or cellular and tissue-based products (HCT/P) nonsheet form skin substitute graft for a wound surface greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area or part thereof, or each additional 1% of body area of infants and children, or part thereof.

Covered HCPCS/Product CodesHCPCSCovered

A2012	SUPRATHEL, per sq cm.
A2019	Kerecis Omega3 MariGen Shield, per sq cm.
A2043	BIOBRANE, per sq cm.
A2044	BIOBRANE Glove, each.
A4100	Nonsheet form skin substitute, FDA-cleared as a device, not otherwise specified [OrCel].
C1781	Mesh (implantable) [Phasix ST or Alloderm].
C9363	Skin substitute (Integra Meshed Bilayer Wound Matrix), per sq cm.
C9399	Unclassified drugs or biologicals [Epicel].
Q4101	Apligraf, per sq cm.
Q4102	Oasis wound matrix, per sq cm.

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Supporting procedure/G-codeHCPCSCovered

G0684

Application of a premarket approval (PMA), 510(k), 361 human cells, tissues or cellular and tissue-based products (HCT/P) nonsheet form skin substitute graft for a wound surface greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area or part thereof, or each additional 1% of body area of infants and children, or part thereof.

HCPCS codes that support medical necessity (Table 2)HCPCSCovered

A2012	SUPRATHEL, per sq cm
A2019	Kerecis Omega3 MariGen Shield, per sq cm
A2043	BIOBRANE, per sq cm
A2044	BIOBRANE Glove, each
A4100*	Nonsheet form skin substitute, FDA-cleared as a device, not otherwise specified [OrCel]
C1781*	Mesh (implantable) [Phasix ST or Alloderm]
C9363	Skin substitute (Integra Meshed Bilayer Wound Matrix), per sq cm
C9399*	Unclassified drugs or biologicals [Epicel]
Q4101	Apligraf, per sq cm
Q4102	Oasis wound matrix, per sq cm

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HCPCS codes that do not support medical necessity for any indication (Table 3 / additional listings)HCPCSNot Covered

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

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HCPCS product codes listed in policy examplesHCPCS

Q4400	Polygon3 Membrane, per sq cm
Q4401	Absolv3 Membrane, per sq cm
Q4402	XWRAP 2.0, per sq cm
Q4403	XWRAP Dual Plus, per sq cm
Q4404	XWRAP Hydro Plus, per sq cm
Q4405	XWRAP Fenestra Plus, per sq cm
Q4406	XWRAP Fenestra, per sq cm
Q4407	XWRAP Tribus, per sq cm
Q4408	XWRAP Hydro, per sq cm
Q4409	AmniomatrixF3X, per sq cm

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Additional HCPCS and A-series codes referenced in coding table updatesHCPCS

G0681	HCPCS code added to Code Table 1
G0682	HCPCS code added to Code Table 1
G0683	HCPCS code added to Code Table 1
G0684	HCPCS code added to Code Table 1
A2001-A2010	Series of codes referenced across code tables
A2002	Moved between supporting and non-supporting tables in revisions

C-codes added/removed in revisionsHCPCS

C1781	Listed in HCPCS Code Table 2 additions
C9363	Listed in HCPCS Code Table 2 additions
C9250	Included in HCPCS Code Table 3 additions

Standard of care trial duration — minimum 4 weeks

Standard of care trial durationMinimum 4 weeks of documented standard of care wound treatment prior to considering skin substitute/CTP application.

ApplicabilityApplies to DFU and VLU initial therapy criteria where failure to respond to SOC is required.

Documentation requirementSOC period and interventions must be documented (debridement, off‑loading/compression, infection control, moist wound environment).

DFU healing response threshold

Provider Requirements and Operational Guidance

Prior Authorization

Procedure and HCPCS Codes Affecting Authorization

Prior authorization is required for initial applications of skin and soft tissue substitutes/CTPs for DFU or VLU (up to four initial applications per wound when criteria are met). Providers must submit requests that specify the targeted wound and include required documentation (see documentation callout). Certain procedure and HCPCS/G-codes affect authorization decisions and must be billed correctly.

Request must indicate the specific wound to which the skin substitute will be applied (targeted wound).
Prior authorization expected for skin and soft tissue substitute HCPCS codes listed in HCPCS Code Table 2 and HCPCS Code Table 1 (supporting codes) and for G‑codes (G0681–G0684) and CPT procedure codes in CPT Code Table 1.
When billing skin substitutes, use the HCPCS codes from HCPCS Code Table 2 (codes supporting medical necessity) and the applicable CPT procedure codes (CPT Code Table 1) to support medical necessity.
G0684 (and other G‑codes) describe application increments and require correct use for authorization and claims.
Do not use HCPCS codes listed in HCPCS Code Table 3 (codes that do not support medical necessity) — these are not covered for any indication.
Check Medicare NCDs/LCDs and state Medicaid rules: for Medicare members review applicable NCDs/LCDs and Medicare Coverage Articles prior to applying this policy; for Medicaid members state Medicaid provisions take precedence over this clinical policy.

Clinical and Evidence Background

Skin substitutes and CTPs are heterogeneous products that differ by origin (allograft, xenograft, cellular, acellular), processing, and additives, which produces substantial variability between products even within the same class. Comparative evidence across categories is limited, so product‑specific evidence and labeled indications should guide selection and application.

For context within the background, the policy's code listings reflect the product heterogeneity: examples of listed products include Integra variants, Biobrane, Apligraf, Dermagraft and others, underscoring that the policy treats specific products and codes individually when determining medical necessity.

Definitions and Key Terms

Skin substitutes / CTPs — definition summary

DefinitionSkin substitutes / cellular and tissue‑based products (CTPs) are products used to cover, replace, or promote healing of skin and soft tissue wounds and include cellular, acellular, matrix-like, allografts, xenografts, and tissue-engineered products.

Product heterogeneityProducts vary by origin, additives, and processing; categories include cellular and acellular types with substantial heterogeneity between products.

Clinical useUsed as adjuncts to standard care when chronic wounds fail to heal, guided by product-specific evidence and labeled indications.

Chronic wound — definition

DefinitionChronic wound: a wound physiologically impaired due to disruption of the wound healing cycle (impaired angiogenesis, innervation, or cellular migration) persisting for 4 weeks or longer.

OpenPayer

Skin and Soft Tissue Substitutes

Medical Necessity Coverage Criteria

Billing and Coding

Provider Requirements and Operational Guidance

Clinical and Evidence Background

Definitions and Key Terms