Skin and Soft Tissue Substitutes for Chronic Wounds
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Medical necessity criteria, coding, and documentation requirements for use of skin and soft tissue substitute grafts (CTPs) for diabetic foot ulcers and venous leg ulcers for Arizona Complete Health non‑Medicare plans.
Changed diabetic foot ulcer HbA1c requirement from ≤7% to ≤8%, or documented improvement of blood glucose in last 4 weeks; HbA1c >8% or no documented improvement is now a contraindication.
Changed nicotine requirement from no nicotine use for at least 4 weeks to documentation of effort to cease nicotine use, or no nicotine use for at least 4 weeks; nicotine replacement therapy is excluded from that requirement.
Updated HCPCS and CPT coding lists: added multiple HCPCS codes (A2001-A2010, many Q-codes) and CPT codes 15271-15278; created HCPCS Table 1 (supporting medical necessity) and Table 2 (not supporting medical necessity).
Policy scope clarified to apply to non‑Medicare plans and removed Medicare-specific HCPCS from the list; note added to refer Medicare plans to MC.CP.MP.185.
Multiple HCPCS codes were added to the table of codes that do not support medical necessity criteria (including A2026-A2029, C8002, a large series of Q4xxx codes).
Criteria sections I.A. through G. replaced previous criteria I.A. through I.; previous II.A.-C. were replaced with new criteria I.A. through G.
Coverage and Medical Necessity Criteria
Medical necessity criteria
Covered when ALL of the following are met for diabetic foot ulcer (DFU) or venous leg ulcer (VLU):
Overall
Wound-specific
- DFU: Failure to achieve ≥50% ulcer area reduction after a minimum of 4 weeks of documented SOC; assessment and management history of diabetes (type 1 or 2) with attention to comorbidities; review of current blood glucose/HbA1c; diet/nutrition/activity; updated medication history; physical exam including skin, ulcer, vascular perfusion and documentation of off‑loading or appropriate footwear.
- VLU: Failure to respond despite compliance with SOC for a minimum of 4 weeks; assessment of clinical history (prior ulcers, BMI, thrombotic history, number of pregnancies, activity level); updated medication history; physical exam assessing edema, skin changes and vascular competence (including venous reflux/perforator incompetence) and venous thrombosis; documentation supporting use of a firm compression garment (>20 mmHg) or multilayer compression dressing.
- Risk factor optimization: Documentation that modifiable risk factors (e.g., diabetes, venous insufficiency, neuropathy) are being addressed to improve likelihood of healing.
- Standard of Care treatments implemented: Debridement as appropriate to a clean granular base; evidence of off‑loading for DFU or sustained compression for VLU; infection control (removal of foreign body/nidus); management of exudate maintaining a moist environment; documentation of smoking history and counseling for cessation.
- Healing documentation: Measurements documenting initial, pre‑SOC, weekly SOC, and post‑completion SOC ulcer size following at least 4 weeks of SOC; other interventions documented as applicable.
- Product and application limits: Request is for a listed preferred product (HCPCS Q‑codes in policy); requested use complies with FDA‑approved indications; only one skin substitute simultaneously in place per wound episode; maximum of 8 applications per wound per 12–16 week episode, with the first application starting the episode.
- Application technique and documentation: Graft applied appropriately (single layer as indicated); operative note must document each application (reason, full procedure description including product and package label or NDC, findings); baseline and follow‑up photos and measurements required; if >4 applications in 12–16 weeks, additional justification and plan including expected healing trajectory and risk‑factor management required.
Covered when ALL of the following are met (summary)
Coverage and medical necessity are determined by meeting all specified indication-specific criteria and by using HCPCS/CPT codes listed in the policy tables:
Policy criteria (structure change)
Criteria sections have been reorganized and replaced in the latest revision:
See policy for full text of new I.A.–G. criteria and updated coding tables.
Requests that exceed the policy's application limits are considered not supported. Specifically, placement of a skin substitute graft/CTP beyond the allowed frequency is excluded: more than 8 applications per wound within a single episode of care (up to 12–16 weeks) is not medically necessary. Repeat applications after an unsuccessful prior application (defined as increase in size or depth, no measurable change, or no sign that improvement is likely) are also not supported. Providers should ensure each requested application is within the episode limit and that prior applications demonstrated progress toward healing before requesting additional applications.
Requests for skin and soft tissue substitutes that are for indications not enumerated in Section I of this policy are outside the scope of coverage and are considered not medically necessary. The policy explicitly notes that requests other than for the specified chronic wound indications (eg, the chronic full‑thickness ulcers described in Section I) will be denied. Providers must document that the treated wound meets one of the policy’s covered indications prior to authorization or billing.
HCPCS and other product codes listed in the policy’s Table 2 — the table of codes that do not support medical necessity criteria — are effectively excluded from coverage under the medical necessity criteria of this policy. The policy identifies numerous A‑, C‑, and Q‑series codes that are categorized as not supporting medical necessity; use of those codes for the covered indications may trigger denial unless otherwise addressed in the policy or during prior authorization review.
The policy identifies several specific situations and product types that do not meet medical necessity. Use of products and HCPCS codes listed in the not‑supportive table, liquid or gel skin substitute products, and any applications that exceed the policy limits (for example, >8 applications per episode or placement on infected/ischemic/necrotic wound beds) are designated not medically necessary. Providers should avoid billing with codes that are listed as not supporting medical necessity and should not apply excluded product formulations (eg, liquid/gel CTPs) for the covered indications.
The policy enumerates many specific HCPCS (A‑ and Q‑series), C‑codes, and other entries in the 'do not support medical necessity' table. Examples from the document include A2001–A2031 and A2032–A2035 series entries, C8002, C9358, C9360–C9364, and a large series of Q‑codes (for example, Q4100–Q4118, and numerous Q42xx–Q43xx codes). These listed codes are explicitly identified in the policy as not supporting medical necessity for the covered indications and therefore are subject to exclusion under the policy rules.
Use of any HCPCS codes that are enumerated in the policy’s 'do not support medical necessity' lists may lead to denials or require additional review. The policy documents that many Q‑codes and A/C codes added across revisions (including codes listed in recent updates) are categorized as not supportive of medical necessity. When seeking coverage, providers must submit requests using the HCPCS/CPT codes designated by the policy and should expect that claims using codes from the not‑supportive table will not meet medical necessity criteria.
Procedure and Product Codes
| 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 (List separately in addition to code for primary procedure). |
| Q4101 | Apligraf, per sq cm. |
| Q4105 | Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per sq cm. |
| Q4106 | Dermagraft, per sq cm. |
| Q4110 | PriMatrix, per sq cm. |
| Q4121 | TheraSkin, per sq cm. |
| Q4128 | FlexHD, or AllopatchHD, per sq cm. |
| Q4137 | Amnioexcel, amnioexcel plus or biodexcel, per sq cm. |
| Q4151 | AmnioBand or Guardian, per sq cm. |
| Q4158 | Kerecis Omega3, per sq cm. |
| Q4166 | Cytal, per square centimeter. |
| 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. |
| Q4122 | DermACELL, DermACELL AWM or DermACELL AWM Porous, per sq cm. |
| Q4123 | AlloSkin RT, per sq cm. |
| Q4124 | Oasis ultra tri layer wound matrix, per sq cm. |
| Q4125 | ArthroFlex, per sq cm. |
| Q4126 | MemoDerm, DermaSpan, TranZgraft or Integuply, per sq cm. |
| Q4127 | Talymed, per sq cm. |
| Q4130 | Strattice TM, per sq cm. |
| Q4132 | Grafix Core and GrafixPL Core, per sq cm. |
| Q4133 | Grafix PRIME, GrafixPL Prime, Stravix and StravixPL, per sq cm. |
| Q4134 | Hmatrix, per sq cm. |
| 15271-15278 | CPT codes 15271 through 15278 added to coding table for application of skin substitute grafts (see individual code descriptions). |
| Q4279 | Added to HCPCS not supporting medical necessity criteria. |
| Q4287 | Added to HCPCS not supporting medical necessity criteria. |
| Q4288 | Added to HCPCS not supporting medical necessity criteria. |
| Q4289 | Added to HCPCS not supporting medical necessity criteria. |
| Q4290 | Added to HCPCS not supporting medical necessity criteria. |
| Q4291 | Added to HCPCS not supporting medical necessity criteria. |
| Q4292 | Added to HCPCS not supporting medical necessity criteria. |
| Q4279 | Vendaje AC, per sq cm. |
| Q4280 | Xcell Amnio Matrix, per sq cm. |
| Q4282 | Cygnus Dual, per sq cm. |
| Q4283 | Biovance Tri-Layer or Biovance 3L, per sq cm. |
| Q4284 | DermaBind SL, per sq cm. |
| Q4285 | NuDYN DL or NuDYN DL MESH, per sq cm. |
| Q4286 | NuDYN SL or NuDYN SLW, per sq cm. |
| Q4287 | DermaBind DL, per sq cm. |
| Q4288 | DermaBind CH, per sq cm. |
| Q4289 | RevoShield+ Amniotic Barrier, per sq cm. |
Prior Authorization, Documentation, and Billing Guidance
Prior Authorization Required
Prior authorization is required. Requests must meet medical necessity and are limited to listed preferred HCPCS (Q-codes) and FDA‑approved products where applicable. Prior authorization requests must reference the policy criteria sections I.A–G.
- Submit prior authorization with applicable HCPCS (and CPT 15271-15278 where applicable).
- Requests outside the specific indications in criteria I.A–G are considered not medically necessary.
Standard of Care (SOC) First / Step Requirement
Prior to use of a cellular or tissue‑based product (CTP), documentation must show failure to achieve ≥50% ulcer area reduction after a minimum of 4 weeks of documented standard of care (SOC) treatment for the current wound episode.
- SOC must include appropriate debridement, infection control, exudate management, and off‑loading (DFU) or sustained compression (VLU) as detailed in policy I.C.
- First CTP application begins the episode of care; maximum of 8 applications per wound per 12–16 week episode.
Required Documentation (Operative Note and Wound Photographs)
Maintain complete documentation in the medical record and make available on request. An operative note must document each application, including reason for procedure, full procedure description, product used with package label or NDC, and relevant findings. Graphic or photographic evidence of ulcer size, depth, and characteristics at baseline and follow‑up with measurements must be included.
- Document amount administered and wasted when partial product is discarded, including date, time, amount, and reason for wastage.
- When multiple sizes exist, select size that best fits wound to minimize wastage.
Required Clinical Documentation
Required clinical documentation must be included with the request to support medical necessity.
- For all requests: detailed wound measurements (initial, pre‑SOC, weekly SOC, and post‑SOC after ≥4 weeks), description of SOC interventions, and documentation that modifiable risk factors are being addressed.
- For diabetic foot ulcers (DFU): document diabetes diagnosis, recent HbA1c ≤8% or documented improvement in blood glucose in the last 4 weeks.
- Document nicotine cessation effort or evidence of no nicotine use for ≥4 weeks (note: excludes nicotine replacement therapy).
Document Indication per Updated Criteria
Document the clinical indication consistent with the updated policy criteria I.A–G. Ensure the request clearly maps to the applicable covered indication and includes evidence that all required criteria are met.
- If requesting a preferred product, identify the HCPCS Q‑code for that product and confirm FDA‑approved indication when applicable.
- If the request involves greater than four applications within a 12–16 week episode, include an explanation of medical necessity for extended use and a plan of care with anticipated number of additional applications and timeframe.
Denial Triggers and Billing/Coding Risks
Be aware of triggers that may lead to denial. Placement of a skin substitute on infected, ischemic, or necrotic wound beds, exceeding the 8‑application limit per wound per episode, >4 applications without additional required documentation, or repeat applications after unsuccessful prior treatment may result in denial.
- Use of HCPCS codes listed in the 'do not support medical necessity' table may trigger denials — confirm the code is appropriate and supported by policy.
- Requests that do not reference policy criteria I.A–G or lack required documentation are subject to denial.
Administrative Provider Actions
Administrative provider actions: include required supporting documents with the prior authorization and billing submission and ensure codes used align with policy tables. Placeholders included for administrative workflow steps.
- Attach operative notes, wound measurement documentation, photos, product package label or NDC, and clinical rationale for number of applications.
- Confirm submitted HCPCS/CPT codes match the product used and are not listed in the 'do not support medical necessity' code table.
Clinical Background
Chronic lower extremity wounds such as diabetic foot ulcers (DFU) and venous leg ulcers (VLU) require a multifaceted approach: infection control, regular debridement to a clean granular base, mechanical off‑loading for DFU or sustained compression for VLU, edema management, and optimization of relevant comorbid conditions (for example diabetes control and vascular status). Skin and soft tissue substitutes are adjunctive therapies reserved for wounds that have failed appropriate standard of care rather than first‑line treatments; evidence comparing products is heterogeneous and they should be used within the policy’s documented clinical and procedural criteria.
Definitions and Scope
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