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ModifiedAmbetter NevadaPolicy CP.MP.185

Skin and Soft Tissue Substitutes for Diabetic Foot Ulcers and Venous Leg Ulcers

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Medical necessity criteria, documentation, coding, and coverage limits for use of skin and soft tissue substitutes (cellular and tissue-based products) to treat diabetic foot ulcers (DFU) and venous leg ulcers (VLU) for non-Medicare Ambetter Nevada plans.

Policy Summary

PayerAmbetter Nevada

PolicySkin and Soft Tissue Substitutes for Diabetic Foot Ulcers and Venous Leg Ulcers

Policy CodePolicy CP.MP.185

Change TypeMaterial revisions to criteria and code lists

Effective Date

Last ReviewJan 22, 2024

Next Review Date

Key ActionObtain prior authorization and document standard-of-care failure (≥4 weeks), product ID, photos/measurements, and HbA1c ≤8% or documented improvement for each application.

SourceLink

POLICY UPDATE CHANGES

Criteria limited to up to four initial applications and added a separate policy statement for beyond the initial four applications up to a total of eight.

Replaced 'FDA-approved' wording with 'labeled' in criterion I.F.

Added many HCPCS codes to the list of codes that do not support medical necessity and updated the HCPCS tables (Table 1 and Table 2).

Changed HbA1c requirement from ≤7% to ≤8% or documented improvement in the last 4 weeks; HbA1c contraindication changed to >8% or no documented improvement.

Nicotine policy updated to require documentation of effort to cease nicotine use or no nicotine use for at least 4 weeks; nicotine replacement therapy does not count as cessation.

up to 4initial applications authorized per wound

up to 8maximum applications per wound per episode

≥4 weeksminimum SOC before consideration

HbA1c ≤8%glycemic threshold

manyHCPCS codes not supporting medical necessity

Coverage Criteria for Skin and Soft Tissue Substitutes

inv-04: Initial Therapy (up to 4 applications)

Covered when ALL of the following are met for initial therapy (applicable to up to four initial applications):

InitialApplicationLimit: Request is for skin or soft tissue substitute for DFU or VLU as defined in policy and for a non‑Medicare planup to 4 initial applications

Policy I applies to up to 4 initial applications

GlycemicControl: For diabetic foot ulcer, HbA1c is ≤8% or there is documented improvement of blood glucose in the last 4 weeksHbA1c ≤8% or documented improvement

HbA1c >8% or no documented improvement is a contraindication

NicotineUse: Documentation of effort to cease nicotine use, or no nicotine use for at least 4 weeks (nicotine replacement therapy does not count as cessation)4 weeks or documented effort

LabeledUse: Requested use complies with product labeling and application limits ('labeled')per product labeling

Replaced 'FDA-approved' wording with 'labeled' in criterion I.F.

inv-05: Continuation Therapy (beyond initial 4 up to total of 8)

Covered beyond initial therapy when ALL of the following are met (policy statement II for additional applications up to total of 8):

ContinuationLimit: Request is for additional applications beyond the initial four and up to a total of eight and meets the specified continuation criteria in the policy (including demonstration of healing response, justification for additional applications, plan and documentation from prior applications)total up to 8 applications

Separate criteria in policy statement II govern these requests

This policy identifies scenarios that are considered not medically necessary for skin and soft tissue substitutes. Examples include any use not listed in sections I or II, placement on infected, ischemic, or necrotic wound beds, use of liquid or gel skin substitute products, and greater than eight applications of a skin substitute graft/CTP within an episode of care (up to 16 weeks). Repeat applications after an unsuccessful prior application (defined as increase in size or depth, no measurable change, or no sign of improvement) are also considered not medically necessary. All documentation supporting these determinations must be maintained in the member's medical record and made available upon request.

The policy includes an extensive list of HCPCS/C codes that do not support medical necessity criteria (Table 2). Representative codes in this list include, but are not limited to, A2001, A2002, A2005, A2006, A2007, A2009, A2010, A2011, A2012, A2013 and many additional A- and Q- series HCPCS codes and several C- codes. Requests billed using these codes will not support a determination of medical necessity under this policy.

Requests for skin and soft tissue substitutes that are outside the indications specified in this policy are outside the policy scope. The policy explicitly notes that certain HCPCS codes are assigned to a Table 2 of codes that do not support medical necessity; use of codes or products outside the listed indications or outside the labeled application limits should be considered out of scope for coverage under this clinical policy.

Coverage determinations using this clinical policy are subject to the terms, conditions, exclusions and limitations of the member's coverage documents and to applicable state and federal requirements. The policy is a guide to medical necessity and does not constitute a contract or guarantee of payment; when conflicts exist, legal and regulatory requirements and the member's plan documents govern.

Uses not listed in sections I or II of the policy are considered not medically necessary. The policy also limits applications per episode: more than eight applications within an episode (up to 16 weeks) is not covered. Additionally, repeat applications after an unsuccessful treatment (increase in wound size or depth, no measurable change, or no sign of improvement) are not covered under the policy.

Multiple HCPCS/C codes and numerous specific product codes are designated in the policy as not supporting medical necessity. Table 2 enumerates many A-, Q-, and C-series codes (for example, A2001, A2002, A2005–A2009, A2010–A2013, C8002 and a long list of Q-codes) that will not support a medical necessity determination for DFU or VLU under this policy.

HCPCS codes listed in the policy's 'do not support medical necessity' table (Table 2) — including codes moved into Table 2 and newly added codes — will not support coverage. Any use of a skin or soft tissue substitute that is not listed as an approved indication in sections I or II of the policy should be treated as not supported by this clinical policy.

For diabetic foot ulcer criteria, adequate glycemic control is required: HbA1c ≤8% or documented improvement in blood glucose in the last 4 weeks is a condition for approval. Conversely, an HbA1c of greater than 8% or no documented improvement in the last 4 weeks is a contraindication to use under this policy.

Coding — CPT, HCPCS and Related Codes

Referenced CPT codes for application of skin substitute graftsCPT

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.
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.
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.
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.

Preferred product HCPCS/Q-codes listed in policyHCPCS

A2008	TheraGenesis
A2019	Kerecis Omega3 Margen Shield
Q4101	Apligraf
Q4102	Oasis Wound Matrix
Q4104	Integra Bilayer Matrix Wound Dressing
Q4105	Integra dermal regeneration template/Omnigraft
Q4106	Dermagraft
Q4107	Graftjacket
Q4110	Primatrix
Q4111	Gammagraft

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Referenced CPT codes for application of skin substitute graftsCPT

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.
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.
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.
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.

HCPCS codes that support medical necessity criteriaHCPCSCovered

A2008	TheraGenesis, per sq cm.
A2019	Kerecis Omega3 MariGen Shield, per sq cm.
Q4101	Apligraf, per sq cm.
Q4102	Oasis wound matrix, per sq cm.
Q4104	Integra bilayer matrix wound dressing (BMWD), per sq cm.
Q4105	Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per sq cm.
Q4106	Dermagraft, per sq cm.
Q4107	Graftjacket, per sq cm.
Q4110	PriMatrix, per sq cm.
Q4111	Gammagraft, per sq cm.

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1/5

HCPCS/C codes that do not support medical necessity criteriamixedNot Covered

A2001	InnovaMatrix AC, per sq cm.
A2002	Mirragen Advanced Wound Matrix, per sq cm.
A2005	Microlyte Matrix, per sq cm.
A2006	NovoSorb SynPath dermal matrix, per sq cm.
A2007	Restrata, per sq cm.
A2009	Symphony, per sq cm.
A2010	Apis, per sq cm.
A2011	Supra SDRM, per sq cm.
A2012	Suprathel, per sq cm.
A2013	Innovamatrix FS, per sq cm.

1–10 of 277

1/28

HCPCS codes listed in policy text (examples)HCPCS

Q4361	AmchoPlast FD, per sq cm.
Q4362	EPIXPRESS, per sq cm.
Q4363	CYGNUS Disk, per sq cm.
Q4364	Amnio Burgeon Membrane and Hydromembrane, per sq cm.
Q4365	Amnio Burgeon Xplus Membrane and Xplus Hydromembrane, per sq cm.
Q4366	Amnio Burgeon Dual-Layer Membrane, per sq cm.
Q4367	Dual Layer Amnio Burgeon X-Membrane, per sq cm.
Q4368	AmnioCore SL, per sq cm.
Q4369	AmchoThick, per sq cm.
Q4370	AmnioPlast 3, per sq cm.

1–10 of 34

1/4

Additional CPT/HCPCS codes referencedmixed

15271-15278	CPT codes added to policy (skin substitute related CPT range)
A2001-A2010	HCPCS range added
Q4199	HCPCS code added
Q4201	HCPCS code added
Q4232	HCPCS code added
Q4254	HCPCS code added
Q4176	New code added from CMS Article
Q4237	New code added from CMS Article
Q4238	New code added from CMS Article
Q4239	New code added from CMS Article

HCPCS codes added to 'do not support medical necessity' table (partial list)HCPCSNot Covered

A2026	Added to 'does not support medical necessity' table
A2027	Added to 'does not support medical necessity' table
A2028	Added to 'does not support medical necessity' table
A2029	Added to 'does not support medical necessity' table
C8002	Added to 'does not support medical necessity' table
Q4280	Added to 'does not support medical necessity' table
Q4311	Added to 'does not support medical necessity' table
Q4312	Added to 'does not support medical necessity' table
Q4313	Added to 'does not support medical necessity' table
Q4314	Added to 'does not support medical necessity' table

inv-22: Saphenous valve closure time value reference

Saphenous valve closure time threshold> 500 milliseconds

Clinical implicationIf valve closure time > 500 ms, referral to vascular specialist for evaluation/possible ablation is required before skin substitute consideration

Assessment methodDetermined by duplex ultrasound demonstrating saphenous vein reflux with valve closure time > 500 ms

inv-23: Glycemic control threshold (HbA1c ≤8% for approval; >8% or no improvement contraindicates)

Glycemic control approval threshold

Provider Actions, Authorization, Documentation and Billing

Prior Authorization

Prior authorization required; document medical necessity and product selection

Prior authorization is required for skin and soft tissue substitute/CTP applications; requests must document that the member meets the medical necessity criteria and that the requested product is from the listed preferred product list when applicable. Requests for initial therapy are limited to up to four initial applications; requests for continued therapy beyond the initial four require separate justification per policy II and may allow additional applications up to a total of eight per wound per 12–16 week episode when continuation criteria are met.

Document failure to heal or stalled healing with SOC and serial measurements for each application.
Specify product selection; use preferred HCPCS/Q-codes when indicated by the policy.
Requests beyond four initial applications must meet the continuation documentation requirements in policy II.

Background and Rationale

Chronic diabetic foot ulcers (DFU) and venous leg ulcers (VLU) may fail to progress after a period of standard care (commonly at least 4 weeks). Skin and soft tissue substitutes are intended to replace or supplement extracellular matrix and may be considered when wounds are stalled despite appropriate standard of care. The policy acknowledges that skin substitutes are heterogeneous (cellular versus acellular; xenograft, allograft, autograft, synthetic) and that evidence shows some improved healing versus standard care, although comparative and long-term outcome data are limited.

Definitions

inv-43: Chronic wound — defined as not progressing in normal healing cycle for ≥4 weeks

DefinitionA chronic wound is a wound physiologically impaired and not progressing in the normal healing cycle for 4 weeks or longer due to impaired angiogenesis, innervation, cellular migration, or other deficits.

Clinical contextChronic wounds may fail to heal despite standard wound care and may benefit from skin substitutes replacing extracellular matrix.

Standard care prerequisitesStandard care includes infection control, edema management, offloading/compression, debridement, systemic disease management, and appropriate dressings prior to considering substitutes.

inv-44: Labeled — use consistent with the product labeling/application limits; 'FDA-approved' replaced with 'labeled' in criteria I.F.

Meaning of 'Labeled'Use consistent with the product labeling and application limits (policy language replaced 'FDA-approved' with 'labeled' in criteria I.F.).

Policy Revision History

10/25policy_revision

Policy statement I specified as applicable to up to four initial applications; 'FDA approved' replaced with 'labeled' in I.F; criteria I.G–I.I added; new policy statement II created for additional applications up to a total of eight; multiple HCPCS codes added to the 'do not support medical necessity' table and some codes removed from that table; Q4104 and Q4106 removed from 'not supported' as they are on the preferred product list.

06/25coding_update

HCPCS Table 1 labeled to note support of medical necessity and HCPCS Table 2 added for codes that do not support medical necessity; several codes moved to Table 2 and new codes (including Q4253, Q4262–Q4264) added to Table 1.

04/23

Policy Summary

PayerAmbetter Nevada

PolicySkin and Soft Tissue Substitutes for Diabetic Foot Ulcers and Venous Leg Ulcers

Policy CodePolicy CP.MP.185

Change TypeMaterial revisions to criteria and code lists

Effective Date

Last ReviewJan 22, 2024

Next Review Date

Key ActionObtain prior authorization and document standard-of-care failure (≥4 weeks), product ID, photos/measurements, and HbA1c ≤8% or documented improvement for each application.

SourceLink

On This Page

Hemoglobin A1c (HbA1c) ≤ 8%

Contraindication thresholdHbA1c > 8% or no documented improvement in blood glucose in the last 4 weeks is a contraindication

Documentation requirementRecord of recent HbA1c and/or evidence of documented improvement in blood glucose over prior 4 weeks must be provided

Billing Rule

Code-based coverage distinction — support vs do-not-support lists

Use the policy's code tables to determine which HCPCS/Q codes support medical necessity and which do not; submission using codes listed in the 'do not support medical necessity' table will not support medical necessity determinations.

Refer to Table 1 (HCPCS codes that support medical necessity) for covered product codes (e.g., A2008, Q4101, Q4102, etc.).
Refer to Table 2 (HCPCS/C codes that do not support medical necessity) for codes that will not support approval (e.g., A2001, A2002, many A20xx/Q4xxx codes).

Prior Authorization

Prior authorization and application limits (up to 4 initial; up to 8 total with continuation criteria)

Prior authorization and the clinical criteria apply to requests for skin and soft tissue substitutes; initial therapy is limited to up to four applications and continuation beyond four is governed by separate criteria allowing up to a total of eight applications when continuation requirements are met.

Initial therapy: up to 4 initial applications per wound when policy I criteria are met.
Continuation: additional applications beyond four require documentation per policy II and may allow up to a total of 8 applications per wound per 12–16 week episode.

Prior Authorization

Prior authorization and medical necessity guidance — follow plan administrative policies

Medical necessity determinations are guided by this clinical policy but providers must follow Health Plan-level administrative policies for authorization and payment; the clinical policy is a guide to assist coverage decisions rather than a payment guarantee.

Follow the policy criteria when preparing prior authorization requests; administrative and payment rules are set at the Health Plan level.
This policy informs medical necessity determinations but does not guarantee payment.

Documentation Required

Document standard-of-care (debridement, offloading/compression, infection control, moisture management, systemic factors)

Ensure standard of care measures are performed and documented before applying a skin substitute: debridement, appropriate offloading/compression, infection control, moisture balance/dressing selection, and addressing systemic factors that impede healing.

Document at least four weeks of SOC with evidence of failure to achieve required healing thresholds (e.g., <50% area reduction for DFU).
For VLU, document firm compression (>20 mmHg) and appropriate venous management as indicated.

Note

Coding implication reminder — verify current coding guidance

Providers should note the coding implications statement: inclusion or exclusion of codes in the policy is informational only and does not guarantee coverage; reference current professional coding guidance before claim submission.

Check up‑to‑date CPT/HCPCS coding guidance prior to submitting claims.
Do not assume a code listed in the policy guarantees payment.

Prior Authorization

Use preferred product list for continuation requests

The policy includes a preferred product list; requests for continuation beyond four applications must be for one of the preferred products listed in policy II.A when continuation criteria apply.

Preferred product examples include TheraGenesis (A2008), Kerecis Omega3 Margen Shield (A2019), Apligraf (Q4101), Oasis (Q4102), Integra (Q4104/Q4105), Dermagraft (Q4106), Graftjacket (Q4107), Primatrix (Q4110).
Coding in the policy was updated to reflect the preferred product list.

Note

Additional provider guidance and policy reminders

If applicable, follow additional guidance in the policy for clinical and administrative questions (see policy reminders and purpose statements).

The policy is a guide to medical necessity and coverage decisions are subject to coverage documents and law.
Providers retain professional judgment in treatment decisions.

Documentation Required

Documentation per application — photos, measurements, and procedure note with product ID and wastage

For each skin substitute application, document baseline and follow-up photos with measurements of wound size and depth, and include a procedure note that identifies the product by package label or NDC, size used, amount applied, and amount wasted with date/time and reason when a portion is discarded.

Graphic evidence (photos) with measurements at baseline and follow-up for each application.
Procedure note must list product identification (package label or NDC), size used, and justification for any wastage; single‑layer application per label must be documented.

Billing Rule

Provider coding responsibility — verify up-to-date coding guidance

Providers are responsible for using current professional coding resources and guidance when selecting and submitting procedure and HCPCS/C codes for reimbursement; codes in the policy are informational only.

Verify CPT/HCPCS code applicability and billing rules prior to claim submission.
Inclusion in the policy does not replace professional coding resources.

Documentation Required

Nicotine cessation documentation — effort to quit or ≥4 weeks nicotine-free (NRT not counted)

Document nicotine status: either documentation of effort to cease nicotine use or documentation of no nicotine use for at least four weeks; nicotine replacement therapy does not count as cessation for this policy.

Record efforts to stop nicotine use or a documented 4‑week period of no nicotine use.
Note that nicotine replacement therapy (NRT) is not considered evidence of cessation.

Documentation Required

Glycemic control documentation — HbA1c ≤8% or documented improvement in last 4 weeks

Document glycemic control for DFU patients: provide HbA1c ≤8% or documented improvement in blood glucose in the last four weeks; HbA1c >8% or no documented improvement is a contraindication to use.

Include recent HbA1c result showing ≤8% or evidence of improved glucose measurements in the prior 4 weeks.
If HbA1c >8% or no improvement is documented, the request is contraindicated per policy.

Documentation Required

Check member coverage documents and state/federal requirements before applying policy

Consult the member's coverage documents and applicable state Medicaid or federal guidance prior to applying this policy; coverage decisions are subject to terms, conditions, exclusions, limitations, and applicable law.

Review evidence of coverage, certificate of coverage, policy contract, and any applicable NCDs/LCDs or state Medicaid requirements.
Policy does not supersede legal/regulatory requirements; law governs in case of discrepancy.

Denial Risk

Denial risk — requests exceeding limits, unlisted uses, or repeat applications after unsuccessful treatment

Requests that exceed eight applications per wound episode, requests for uses not listed in sections I or II, and repeat applications after an unsuccessful prior application are considered not medically necessary and may be denied.

Do not submit requests for >8 applications within a single episode (up to 16 weeks).
Repeat applications when prior treatment was unsuccessful (increase in size/depth, no measurable change, or no sign of improvement) are not eligible.

Note

Coding implication note — policy code lists are informational only

Inclusion or exclusion of codes in this policy is informational and does not guarantee coverage; verify current coding guidance and payer billing rules before submission.

Use up-to-date coding manuals and payer-specific billing instructions.
Policy code lists do not replace professional coding resources.

Denial Risk

Application limits — requests beyond 4 initial (up to 8 total only if continuation criteria met)

Requests that exceed the initial four applications (or exceed the allowed total up to eight without meeting the continuation criteria in policy II) may be considered not medically necessary and denied.

Initial authorization covers up to four applications; continuation beyond four requires meeting II.A–E documentation requirements.
Total applications per wound per episode must not exceed eight when continuation criteria are satisfied.

Denial Risk

Unsupported HCPCS codes — Table 2 codes will not support medical necessity

Use of HCPCS/C codes listed in the 'do not support medical necessity' table (Table 2) will not support medical necessity and may result in denial of the request or claim.

Do not rely on Table 2 codes to justify medical necessity; select codes from Table 1 where appropriate.
Table 2 includes many A20xx and Q4xxx/C codes that are designated as not supporting medical necessity.

Note

Coverage decisions subject to coverage documents, exclusions, limitations, and law

Coverage decisions and benefit administration are subject to the member's coverage documents, plan terms, exclusions, limitations, and applicable state and federal requirements; this clinical policy is a guide and does not alter contract terms.

Verify plan-level coverage, exclusions, and legal requirements prior to treatment.
The Health Plan may change, amend, or withdraw this clinical policy.

Scope of labeled useRequests must comply with the product's labeled indications and application limits to meet criteria.

Policy change noteThe term 'FDA‑approved' was replaced with 'labeled' in the policy's criteria to reflect use per product labeling.

inv-45: Skin substitutes — definition and related term entry

Skin substitutes — general definitionProducts that promote wound healing by replacing extracellular matrix; categorized as cellular (living cells) or acellular (synthetic or devitalized tissue).

Composition typesMay be xenograft, acellular allograft, cellular allograft, autograft, or synthetic—classified by epidermal/dermal/composite components.

Clinical roleConsidered as an adjunct to standard care for chronic diabetic foot ulcers and venous leg ulcers that fail to heal after ≥4 weeks of standard treatment.

Policy title and statements in I and II changed to include soft tissue substitutes for chronic wounds; removed deleted HCPCS code A2003; HCPCS Table 2 introduced and multiple codes moved into it.

04/20clinical_criteria_change

Nicotine requirement modified to allow documentation of effort to cease nicotine use (or ≥4 weeks abstinence); HbA1c threshold changed from ≤7% to ≤8% (with contraindication >8% or no documented improvement); removed several prior documentation requirements and other non‑substantive wording edits.

11/25title_and_scope_updateLatest

Policy title clarified to 'Skin and Soft Tissue Substitutes for Diabetic Foot Ulcers and Venous Leg Ulcers' and policy scope statements clarified to apply to DFU and VLU; additional code list updates documented.