Skin and Soft Tissue Substitutes
(TX.CP.MP.585)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| New Policy:
- Description:
- Patients receiving treatment with a skin substitute graft should be under the care of a wound care physician or surgeon and systemic disease should be monitored/treated to ensure adequate healing of the wound site. This policy addresses the medical necessity criteria for skin substitutes in an outpatient setting.
- Skin substitutes range widely in terms of origin, additives, and processing. Processing variations lead to broad differences between products within the same class, with a need for more comparative product studies. The result is that products within the same class vary significantly and the impact on the product’s function is indeterminant in many cases.32 A 2024 systematic review/meta-analysis concluded that “enough evidence is still lacking to determine a statistical difference between broad categories of CAMPs [cellular, acellular and matrix-like products]; hence decision-makers should consider published head-head comparative studies, real-world evidence, and cost-effectiveness evidence between individual CAMPs to decide on which to use in practice.”33
- Medical necessity determinations regarding preferred products when deemed medically necessary are applicable to FDA-labeled indications. Preferred products are subject to change based on new product launches, product approvals, product withdrawals and other market changes.
- This policy provides the medical necessity criteria for the following products: STAR, STAR+PLUS, STAR Health, STAR Kids, and CHIP.
- Note: For criteria applicable to:
- Burn treatment (other than skin substitutes), please see CP.MP.186 Burn Surgery.
- Policy/Criteria:
- It is the policy of Superior Healthplan that up to four initial applications of skin and soft tissue substitutes/cellular and tissue-based products (CTPs) are medically necessary for diabetic foot ulcers (DFU) or venous leg ulcers (VLU) when all the following criteria are met, specific to the wound for which the skin substitute/CTP is being requested:
- Request indicates the specific wound to which the skin and soft tissue substitute/CTP will be applied;
- The wound is > 1 square centimeter;
- The wound is not infected and one of the following:
- For patients with a DFU, documentation of all the following:
- Failure to achieve at least 50% ulcer area reduction, despite compliance with standard of care (SOC) wound treatment for a minimum of four weeks, as noted in I.D.;
- Assessment of type 1 or type 2 diabetes and management history with attention to certain comorbidities (e.g., vascular disease, neuropathy, osteomyelitis);
- Review of current blood glucose levels/hemoglobin A1c (HbA1c);
- Diet, nutritional status, and activity level;
- Updated medication history, including review of pertinent medical problems diagnosed since the previous ulcer evaluation;
- Physical exam assessing skin, ulcer, and vascular perfusion, as well as off-loading devices or use of appropriate footwear;
- For patients with a VLU, documentation of all the following:
- Failure to respond, despite compliance with SOC wound treatment for a minimum of four weeks, as noted in I.D;
- Assessment of clinical history (prior ulcers, body mass index, history of pulmonary embolism or superficial/deep venous thrombosis, number of pregnancies, and physical inactivity);
- Updated medication history, including review of pertinent medical problems diagnosed since the previous ulcer evaluation;
- Physical exam assessing for edema, skin changes and evaluation of vascular competence (including venous reflux and perforator incompetence) and venous thrombosis;
- Documentation supporting the use of a firm strength compression garment (>20 mmHg) or multi-layered compressive dressing;
- Documentation that modifiable risk factors, such as diabetes, venous insufficiency, and neuropathy are being addressed adequately to improve likelihood of healing;
- Documentation of implemented SOC treatment plan demonstrating all the following:
- Debridement as appropriate to a clean, granular base;
- Documented evidence of one of the following:
- Offloading for DFUs;
- Sustained compression dressings for VLUs;
- Infection control, with removal of foreign body or nidus of infection, as applicable;
- Management of exudate with maintenance of a moist environment;
- One of the following:
- The member/enrollee is a non-smoker;
- The member/enrollee has been counseled on the effect of smoking on wound healing and has completed, or is currently enrolled in, smoking cessation therapy;
- Documentation to support failure to heal or stalled healing with SOC, as applicable, including all the following:
- Measurements of the initial ulcer;
- Pre-SOC ulcer measurements;
- Weekly SOC ulcer measurements;
- Post-completion SOC ulcer measurements following at least four weeks of SOC treatment;
- Other interventions, as applicable;
- Request is for one of the following preferred products:
- Apligraf (Q4101);
- Oasis Wound Matrix (Q4102);
- Integra Bilayer Matrix Wound Dressing (Q4104);
- Integra dermal regeneration template or Integra Omnigraft dermal regeneration matrix (Q4105);
- Theraskin (Q4121);
- Grafix Core and Grafix PL Core (Q4132);
- Grafix PRIME, GrafixPL; PRIME, Stravix and Stravix PL (Q4133);
- Kerecis Omega3 (Q4158);
- Epifix (Q4186)
- Requested use complies with the requested product’s labeled indications;
- Only one skin and soft tissue substitute/CTP will be simultaneously in place per wound episode with the first skin and soft tissue substitute/CTP application beginning the episode of care.
- Note: Product change within the wound episode is allowed, with a total of up to four initially authorized and total applications not to exceed the ten-application limit per wound per 12-week episode of care;
- The graft will be applied in a single layer without overlay of product or adjacent skin and in compliance with the correct label application techniques for the skin and soft tissue substitute/CTP;
- The following documentation requirements will be met for each application:
- Documentation of the ulcer at baseline and follow-up, with measurements of wound including size and depth (may include detailed photograph documentation);
- A complete description of the procedure including product used (with identifying package label or National Drug Code [NDC] in the chart) and size of product used;
- If multiple sizes of a specific product are available, the size that best fits the wound is utilized, with the least amount of wastage;
- If a portion of a product is discarded, documentation includes all the following:
- The amount administered and wasted;
- The date, time, and amount of product wasted and the reason for the wastage. Note:
- When a portion of a single use package must be discarded, payment will be made for the portion discarded along with the amount applied up to the amount of the product on the package label.
- All documentation must be maintained in the member/enrollee’s medical record and made available upon request.
- It is the policy of Superior Healthplan that continued treatment beyond the initial four applications and up to a total of ten applications with skin and soft tissue substitutes/cellular and tissue-based products (CTPs) is medically necessary for diabetic foot ulcers (DFU) or venous leg ulcers (VLU) when all of the following criteria are met, specific to the wound for which the skin substitute/CTP is being requested:
- Request indicates the specific wound to which the skin and soft tissue substitute/CTP will be applied;
- The wound is > 1 square centimeter;
- Request is for one of the following preferred products:
- Apligraf (Q4101);
- Oasis Wound Matrix (Q4102);
- Integra Bilayer Matrix Wound Dressing (Q4104);
- Integra dermal regeneration template or Integra Omnigraft dermal regeneration matrix (Q4105);
- Theraskin (Q4121);
- Grafix Core and Grafix PL Core (Q4132);
- Grafix PRIME, GrafixPL; PRIME, Stravix and Stravix PL (Q4133);
- Kerecis Omega3 (Q4158);
- Epifix (Q4186)
- Requested use complies with the requested product’s labeled indications;
- Documentation includes all the following:
- Explanation of why extended time or additional applications (beyond the initial four) are medically necessary for the specific member/enrollee’s wound;
- That the treatment plan regarding the initial four applications has resulted in wound healing and expectation that the wound will continue to heal with this plan;
- Estimated time for extended treatment, number of additional applications anticipated, and plan of care if healing is not achieved as planned;
- Modifiable risk factors, such as diabetes, venous insufficiency, and neuropathy, are being addressed adequately to improve likelihood of healing;
- For venous leg ulcers, appropriate consultation and management for the diagnosis and stabilization of any venous-related disease;
- Additional documentation from each of the initial four applications, and for all subsequent applications, includes all the following:
- A complete description of the procedure including product used (with identifying package label or NDC in the chart) and size of product used;
- Documentation of the ulcer at baseline and follow-up, with measurements of wound including size and depth (may include detailed photograph documentation);
- The skin and soft tissue substitute/CTP is applied in a single layer without overlay of product or adjacent skin and in compliance with the correct label application techniques for the skin and soft tissue substitute/CTP;
- When multiple sizes of a specific product are available, the size that best fits the wound with the least amount of wastage is utilized;
- Only one skin and soft tissue substitute/CTP will be simultaneously in place per wound episode with the first skin and soft tissue substitute/CTP application beginning the episode of care;
- Note: Product change within the wound episode is allowed; total applications not to exceed the ten-application limit per wound per 12-week episode of care;
- When a portion of a product was discarded, the medical record clearly demonstrates the amount administered and wasted, in addition to the date, time, amount of product wasted and the reason for the wastage.
- Note:
- When a portion of a single-use package must be discarded, payment will be made for the portion discarded along with the amount applied up to the amount of the product on the package label.
- All documentation must be maintained in the member/enrollee’s medical record and made available upon request.
- It is the policy of Superior Healthplan that skin and soft tissue substitutes/CTPs for diabetic foot ulcers (DFU) and venous leg ulcers (VLU) are not medically necessary for the following indications or scenarios:
- Any usage not listed in section I. or II. of the policy;
- Greater than ten applications of a skin and soft tissue substitute/CTP within an episode of care (up to twelve weeks);
- Repeat applications of skin and soft tissue substitute/CTP when a previous application was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer, no measurable change from baseline, and no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closure);
- Inadequate control of underlying conditions or exacerbating factors, or other contraindications
- Skin substitute grafts are contraindicated for the following:
- Clients with known hypersensitivity to any component of the specific skin substitute graft (e.g., allergy to avian, bovine, porcine, or equine products).
- Skin substitute grafts will not be considered reasonable and necessary for clients with inadequate control of underlying conditions or exacerbating factors, such as the following:
- Clients with uncontrolled diabetes
- Clients with active infection
- Clients with active Charcot arthropathy of the ulcer extremity
- Clients with vasculitis
- Clients who continue smoking tobacco and have not received smoking cessation guidance from their physician
- Use of surgical preparation services (e.g., debridement), with routine, simple, or repeat skin replacement surgery with a skin and soft tissue substitute/CTP;
- Use of liquid or gel skin and soft tissue substitute/CTP for ulcer care;
- Placement of skin and soft tissue substitute/CTP on an infected, ischemic, or necrotic wound bed
- It is the policy of Superior Healthplan that burn treatment with skin and soft tissue substitutes/CTPs (including the procedure, product, service) is considered medically necessary when meeting all the following, specific to the wound for which the skin substitute/CTP is being requested:
- Request indicates the specific wound to which the skin and soft tissue substitute/CTP will be applied;
- Request is for four weeks of treatment at a time;
- The wound is > 1 square centimeter;
- Sufficient autograft is not available at the time of excision or is not feasible due to the physiological condition of the member/enrollee;
- No evidence of burn wound infection;
- Burn is either deep partial-thickness or full-thickness;
- Documentation of all the following:
- Modifiable risk factors for impaired wound healing are being addressed adequately to improve likelihood of healing;
- Review of current blood glucose levels/hemoglobin A1c (HbA1c), if member/enrollee has history of prediabetes or diabetes;
- Diet, nutritional status, and activity level;
- Updated medication history and review of pertinent medical problems diagnosed;
- One of the following:
- The member/enrollee is a non-smoker;
- The member/enrollee has been counseled on the effect of smoking on wound healing and has completed, or is currently enrolled in, smoking cessation therapy;
- Treatment with any of the following skin replacement/substitutes:
- Allograft (human cadaver);
- Xenograft (porcine);
- Tissue-engineered skin and soft tissue substitute/CTP:
- Integra® Wound Matrix (Q4108);
- Integra® bilayer matrix wound dressing (Q4104);
- Integra® Dermal Regeneration Template (Q4105)
- Only one skin and soft tissue substitute/CTP will be simultaneously in place per wound episode with the first skin and soft tissue substitute/CTP application beginning the episode of care;
- The graft will be applied in a single layer without overlay of product or adjacent skin and in compliance with the correct label application techniques for the skin and soft tissue substitute/CTP;
- The following documentation requirements will be met for each application:
- Documentation of the ulcer at baseline and follow-up, with measurements of wound including size and depth (can include detailed photograph documentation);
- A complete description of the procedure including product used (with identifying package label or National Drug Code [NDC] in the chart) and size of product used;
- If multiple sizes of a specific product are available, the size that best fits the wound is utilized, with the least amount of wastage;
- If a portion of a product is discarded, documentation includes all the following:
- The amount administered and wasted;
- The date, time, and amount of product wasted, and the reason for the wastage.
- Note:
- When a portion of a single use package must be discarded, payment will be made for the portion discarded along with the amount applied up to the amount of the product on the package label.
- All documentation must be maintained in the member/enrollee’s medical record and made available upon request.
- It is the policy of Superior Healthplan that Texas Medicaid preferred product skin and soft tissue substitutes/CTPs for:
- breast reconstruction; or
- dystrophic epidermolysis bullosa; or
- post-reconstruction surgery of abdominal wall wounds
- are considered medically necessary when reviewed using relevant nationally recognized decision support tool criteria
- It is the policy of Superior Healthplan that skin and soft tissue substitutes/CTPs for any indication listed in sections IV to VII above are considered not medically necessary for any of the following:
- Treatment longer than twelve weeks
- Repeat applications when initial treatment was unsuccessful for a period of four weeks past the start of therapy (unsuccessful treatment is defined as increase in size or depth of an ulcer or no change in baseline size or depth and no sign of improvement or indication that improvement is likely such as granulation, epithelialization or progress towards closing)
- Retreatment of healed wounds (those showing greater than 75% size reduction and smaller than 0.5 square cm)
- Re-treatment within one year of any given course of skin substitute treatment for the same wound
- Note: All skin substitute products used in wound care services that are provided in a facility setting are considered part of the application services (procedure codes listed in the table above) and are not separately reimbursed.
- It is the policy of Superior Healthplan that current evidence does not support the use of skin and soft tissue substitutes/cellular and tissue-based products (CTPs) in the outpatient setting for either of the following:
- Indications other than those listed as medically necessary above, including but not limited to, pressure ulcers
- Any skin and soft tissue substitute/CTP product not listed as medically necessary for the respective indications in sections I to VII above.
- Note: Please see HCPCS Code Table 3 for a list of products not considered medically necessary for any indication (not all-inclusive).
- Background
- Standard care for lower extremity wounds and ulcers includes infection control, management of edema, mechanical offloading of the affected limb, mechanical compression, limb elevation, debridement of necrotic tissue, management of systemic disease and counseling on the risk of continued tobacco use. Additionally, maintenance of a therapeutic wound environment with appropriate dressings can facilitate development of healthy granulation tissue and re-epithelialization. Dressings are essential to wound management because the appropriate dressing not only maintains the moisture balance within the wound, but the dressing also controls exudate, which protects the wound from additional trauma.2-9
- The Centers for Medicare & Medicaid Services (CMS), define a chronic wound as a wound A wound that is physiologically impaired due to a disruption of the wound healing cycle because of impaired angiogenesis, innervation, or cellular migration, or other deficits for 4 weeks or longer. Even with advancements in standard wound care and synthetic occlusive dressings, some ulcers fail to heal and may benefit from a skin substitute.2-9 The United Kingdom’s National Institute for Health and Care Excellence (NICE) recommends consideration of dermal or skin substitutes as an adjunct to standard care when treating diabetic wounds that are not healing.30 Skin substitutes promote wound healing by replacing extracellular matrix.21 Skin substitutes are categorized based on the composition of epidermal, dermal, and composite skin present.20 They are heterogeneous and can be largely separated into two primary categories: cellular (comprised of living cells); or acellular (composed of synthetic materials or tissue from which living cells have been removed).22,23 The categories are further split based on composition and source of material, including xenograft, acellular allograft, cellular allograft, autograft and synthetic skin substitute choices.21 Allografts, which use skin from another human (e.g., cadaver), and xenografts, which use skin from another species (e.g., porcine or bovine), may also be employed as temporary skin replacements. However, they are contraindicated in patients with known hypersensitivity to any component of the specific skin substitute graft (e.g., allergy to avian, bovine, porcine, equine products) and must later be replaced by an autograft or the ingrowth of the patient’s own skin.2-4
- Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs)
- For a VLU, an evaluation for the presence of saphenous vein reflux is essential prior to consideration of skin substitutes. If there is significant saphenous vein incompetency and reflux (valve closure time defined as > 500 milliseconds), or if ulcer bed veins are identified as contributory on ultrasound, a referral to a vascular surgeon or interventional radiologist is required. Endovascular laser or radiofrequency ablation can enhance rates of healing compared to other treatments for significant saphenous vein reflux. Without significant reflux, sclerotherapy may also be more beneficial.18
- According to a 2016 Cochrane review, the overall therapeutic outcome of skin grafts and tissue replacements used with standard wound care demonstrated an increase in the healing rate of foot ulcers and slightly fewer amputations in patients with diabetes compared with standard wound care alone.24 The Wound Healing Society updated their guidelines in 2016, indicating that cellular and acellular skin equivalents positively affect healing in diabetic ulcers by “releasing therapeutic amounts of growth factors, cytokines, and other proteins that stimulate the wound bed.”25 A health technology assessment of skin substitutes conducted for adults with neuropathic diabetic foot ulcers and venous leg ulcers found that adults with difficult to heal neuropathic diabetic ulcers and difficult to heal venous leg ulcers who used skin substitutes were more likely to experience complete wound healing than those who used standard care alone.28 A systematic review of 17 trials using several skin substitutes to treat diabetic foot ulcers noted that completed closure of diabetic ulcers was significantly improved when compared to standard care alone.27
- Outlined in a 2020 technical brief prepared for the Agency for Healthcare Research and Quality (AHRQ) are the various products commercially available in the United States that may be considered skin substitutes and identifies and assesses the clinical literature evaluating skin substitutes and their efficacy. Synder et al. (2020) conducted a systematic review of the published literature, grey literature and scientific packets received from manufacturers. The authors searched for systematic reviews/meta-analyses, randomized controlled trials (RCTs), and prospective nonrandomized comparative studies examining commercially available skin substitutes. The authors identified 76 commercially available skin substitutes and categorized them based on the Davison-Kotler classification system. Sixty-eight (68%) were categorized as acellular dermal substitutes, mostly replacements from human placental membranes and animal tissue sources. Three systematic reviews and 22 RCTs examined use of 16 distinct skin substitutes, including acellular dermal substitutes, cellular dermal substitutes, and cellular epidermal and dermal substitutes in diabetic foot ulcers, pressure ulcers, and venous leg ulcers. Of the 22 included RCTs, 16 studies compared a skin substitute with standard of care (e.g., debridement, glucose control, compression bandages for venous leg ulcers, daily dressing changes with moisture-retentive dressing, such as an alginate or hydrocolloid). Twenty-one ongoing clinical trials (all RCTs) examined an additional nine skin substitutes with similar classifications. The authors found that the studies rarely reported clinical outcomes, such as amputation, wound recurrence at least two weeks after treatment ended, or patient-related outcomes, such as return to function, pain, exudate, and odor. The authors concluded that there is a lack of studies examining the efficacy of most skin substitute products and the need for better-designed and -reported studies providing more clinically relevant data. Before findings can be relied upon, more data are needed on hospitalization, pain reduction, need for amputation, exudate and odor control, and return to baseline activities of daily living and function.20
- Burns21,23
- A burn is defined as a traumatic injury to the skin or other organic tissue primarily caused by heat or exposure to electrical discharge, friction, chemicals, and radiation. Burns are classified in terms or degrees. First-degree burns, also called superficial partial thickness, only involve the outer layer of skin, the epidermis. These burns are red and painful but remain dry and without blisters. First-degree burns typically heal within about one week. Second degree, or partial thickness burns, extend deeper into the dermis, include blisters, and have a wet appearance. Second-degree burns are extremely painful and can take two to three weeks to heal. Third-degree, or full thickness, burns have a white or leathery appearance and are dry to the touch. These burns are often without sensation due to nerve damage. They extend the full depth of the skin. Skin grafts are typically required for healing third-degree burns. The most severe burns are called fourth-degree or are classified as with extension to deep tissues. These burns will extend to the muscles, tendons, and/or bone. Skin grafting and even more intensive surgeries or amputations may be required for healing.
- Breast Reconstruction30-36
- Reconstructive surgery is performed to restore and improve function and correct any deformities or abnormal structures of the body that have been caused by congenital defects, developmental abnormalities, trauma, infection, tumors or disease. Reconstructive breast surgery is designed to restore the normal appearance of a breast after a medically necessary mastectomy for breast cancer or other medical condition, injury or congenital abnormality, or unilateral hypertrophy resulting in symptoms following contralateral mastectomy
- Dystrophic Epidermolysis Bullosa (DEB)42,43
- Inherited epidermolysis bullosa is a group of rare genetic disorders characterized by skin fragility and mechanically induced blistering. It comprises of four main types: epidermolysis bullosa simplex, junctional epidermolysis bullosa, dystrophic epidermolysis bullosa, and Kindler syndrome. Skin blistering on sites of mechanical trauma is the main clinical feature of epidermolysis bullosa. Blisters may be superficial, or they may be more profound and lead to ulcerations. Blisters may be generalized, disseminated to different body sites, or localized to the extremities
- In 2001, OrCel was approved under a Humanitarian Device Exception (HDE) by the U.S. Food and Drug Administration (FDA) for use in individuals with mitten hand deformities due to recessive DEB as an adjunct to standard autograft procedures for covering wounds and donor sites created after surgical release of hand contractures
- Post-Reconstruction Surgery of Abdominal Wall Wounds46,54-58
- A hernia occurs when internal organs or tissues bulge outwards through a weak spot in the abdominal wall muscles. Abdominal wall hernias are generally classified by location or etiology, such as ventral hernias, groin hernias, and incisional hernias. Hernia management and treatment is dependent on a multitude of factors, with specific hernia sites requiring distinctive management
- Coding Implications
- This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2025, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services
- CPT Code Table 1: Procedure codes that support medical necessity criteria
- CPT Codes Description
- 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, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)
- HCPCS Code Table 1: HCPCS codes that support medical necessity criteria
- HCPCS
- Codes Description
- 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
- HCPCS Code Table 2: HCPCS codes that support medical necessity criteria
- HCPCS Codes Description
- 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
- Q4108 Integra matrix, per sq cm
- Q4121 TheraSkin, per sq cm
- Q4128 FlexHD, or AllopatchHD, per sq cm
- Q4132 Grafix Core and GrafixPL Core, per sq cm
- Q4133 Grafix PRIME, GrafixPL PRIME, Stravix and StravixPL, per sq cm
- Q4158 Kerecis Omega3, per sq cm
- Q4186 Epifix, per sq cm
- *Note: The product must be specified as noted in the table
- HCPCS Code Table 3: HCPCS codes that do not support medical necessity criteria for any indication in the outpatient setting
- HCPCS Codes Description
- 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
- A2012 SUPRATHEL, per sq cm
- A2013 Innovamatrix FS, per sq cm
- A2014 Omeza Collagen Matrix, per 100 mg
- A2015 Phoenix Wound Matrix, per sq cm
- A2016 PermeaDerm B, per sq cm
- A2017 PermeaDerm Glove, each
- A2018 PermeaDerm C, per sq cm
- A2019 Kerecis Omega3 MariGen Shield, per sq cm
- A2020 AC5 Advanced Wound System (AC5)
- A2021 NeoMatriX, per sq cm
- A2022 InnovaBurn or InnovaMatrix XL, per sq cm
- A2023 InnovaMatrix PD, 1 mg
- A2024 Resolve Matrix or XenoPatch, per sq cm
- A2025 Miro3D, per cu cm
- A2026 Restrata MiniMatrix, 5 mg
- A2027 MatriDerm, per sq cm
- A2028 MicroMatrix Flex, per mg
- A2029 MiroTract Wound Matrix Sheet, per cc
- A2030 Miro3D fibers, per mg
- A2031 MiroDry Wound Matrix, per sq cm
- A2032 Myriad Matrix, per sq cm
- A2033 Myriad Morcells, 4 mg
- A2034 Foundation DRS Solo, per sq cm
- A2035 Corplex P or Theracor P or Allacor P, per mg
- A2036 Cohealyx Collagen Dermal Matrix, per sq cm
- A2037 G4Derm Plus, per ml
- A2038 MariGen Pacto, per sq cm
- A2039 InnovaMatrix FD, per sq cm
- A2040 Microlyte PainGuard, per sq cm
- A2041 Foundation DRS+ Duo, per sq cm
- A2042 Foundation DRS+ Solo, per sq cm
- A2045 NovaShield or NovoGen Wound Matrix, 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]
- C8002 Preparation of skin cell suspension autograft, automated, including all enzymatic processing and device components
- C9250 Human plasma fibrin sealant, vapor-heated, solvent-detergent (Artiss), 2 ml
- C9358 Dermal substitute, native, nondenatured collagen, fetal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm
- C9360 Dermal substitute, native, nondenatured collagen, neonatal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm
- C9363 Skin substitute (Integra Meshed Bilayer Wound Matrix), per sq cm
- C9364 Porcine implant, Permacol, per sq cm
- C9399* Unclassified drugs or biologicals [Epicel]
- Q4103 Oasis burn matrix, per sq cm
- Q4107 Graftjacket, per sq cm
- Q4110 PriMatrix, per sq cm
- Q4111 GammaGraft, per sq cm
- Q4112 Cymetra, injectable, 1 cc
- Q4113 GRAFTJACKET XPRESS, injectable, 1 cc
- Q4114 Integra flowable wound matrix, injectable, 1 cc
- Q4115 AlloSkin, per square centimeter
- Q4116 AlloDerm, per sq cm
- Q4117 HYALOMATRIX, per sq cm
- Q4118 MatriStem micromatrix, 1 mg
- 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, per sq cm
- Q4134 Hmatrix, per sq cm
- Q4135 Mediskin, per sq cm
- Q4136 EZ Derm, per sq cm
- Q4137 AmnioExcel, AmnioExcel Plus or BioDExcel, per sq cm
- Q4138 BioDFence DryFlex, per sq cm
- Q4139 AmnioMatrix or BioDMatrix, injectable, 1 cc
- Q4140 BioDFence, per sq cm
- Q4141 AlloSkin AC, per square centimeter
- Q4142 XCM biologic tissue matrix, per sq cm
- Q4143 Repriza, per sq cm
- Q4145 EpiFix, injectable, 1 mg
- Q4146 Tensix, per sq cm
- Q4147 Architect, Architect PX, or Architect FX, extracellular matrix, per sq cm
- Q4148 Neox Cord 1K, Neox Cord RT, or Clarix Cord 1K, per sq cm
- Q4149 Excellagen, 0.1 cc
- Q4150 AlloWrap DS or dry, per sq cm
- Q4151 AmnioBand or Guardian, per sq cm
- Q4152 DermaPure, per sq cm
- Q4153 Dermavest and Plurivest, per sq cm
- Q4154 Biovance, per sq cm
- Q4155 Neox Flo or Clarix Flo 1 mg
- Q4156 Neox 100 or Clarix 100, per sq cm
- Q4157 Revitalon, per sq cm
- Q4159 Affinity, per sq cm
- Q4160 NuShield, per sq cm
- Q4161 Bio-connekt wound matrix, per sq cm
- Q4162 WoundEx Flow, BioSkin Flow, 0.5 cc
- Q4163 Woundex, bioskin, per sq cm
- Q4164 Helicoll, per sq cm
- Q4165 Keramatrix or Kerasorb, per sq cm
- Q4166 Cytal, per sq cm
- Q4167 Truskin, per sq cm
- Q4168 AmnioBand, 1 mg
- Q4169 Artacent wound, per sq cm
- Q4170 Cygnus, per square centimeter
- Q4171 Interfyl, 1 mg
- Q4173 PalinGen or PalinGen XPlus, per sq cm
- Q4174 PalinGen or ProMatrX, 0.36 mg per 0.25 cc
- Q4175 Miroderm, per square centimeter
- Q4176 Neopatch or therion, per sq cm
- Q4177 FlowerAmnioFlo, 0.1 cc
- Q4178 FlowerAmnioPatch, per sq cm
- Q4179 FlowerDerm, per sq cm
- Q4180 Revita, per sq cm
- Q4181 Amnio Wound, per sq cm
- Q4182 TransCyte, per sq cm
- Q4183 surgiGRAFT, per sq cm
- Q4184 Cellesta or Cellesta Duo, per sq cm
- Q4185 Cellesta Flowable Amnion (25 mg per cc); per 0.5 cc
- Q4187 Epicord, per sq cm
- Q4188 AmnioArmor, per sq cm
- Q4189 Artacent AC, 1 mg
- Q4190 Artacent AC, per sq cm
- Q4191 Restorigin, per sq cm
- Q4192 Restorigin, 1 cc
- Q4193 Coll-e-Derm, per sq cm
- Q4194 Novachor, per sq cm
- Q4195 PuraPly, per sq cm
- Q4196 PuraPly AM, per sq cm
- Q4197 PuraPly XT, per sq cm
- Q4198 Genesis Amniotic Membrane, per sq cm
- Q4199 Cygnus matrix, per sq cm
- Q4200 SkinTE, per sq cm
- Q4201 Matrion, per sq cm
- Q4202 Keroxx (2.5 g/cc), 1 cc
- Q4203 Derma-Gide, per sq cm
- Q4204 XWRAP, per sq cm
- Q4205 Membrane Graft or Membrane Wrap, per sq cm
- Q4206 Fluid Flow or Fluid GF, 1 cc
- Q4208 Novafix, per sq cm
- Q4209 SurGraft, per sq cm
- Q4211 Amnion Bio or AxoBioMembrane, per sq cm
- Q4212 AlloGen, per cc
- Q4214 Cellesta Cord, per sq cm
- Q4215 Axolotl Ambient or Axolotl Cryo, 0.1 mg
- Q4216 Artacent Cord, per sq cm
- Q4217 WoundFix, BioWound, WoundFix Plus, BioWound Plus, WoundFix Xplus or BioWound Xplus, per sq cm
- Q4218 SurgiCORD, per sq cm
- Q4219 SurgiGRAFT-DUAL, per sq cm
- Q4220 BellaCell HD or Surederm, per sq cm
- Q4221 Amnio Wrap2, per sq cm
- Q4222 ProgenaMatrix, per sq cm
- Q4224 Human Health Factor 10 Amniotic Patch (HHF10-P), per sq cm
- Q4225 AmnioBind or DermaBind TL, per sq cm
- Q4226 MyOwn Skin, includes harvesting and preparation procedures, per sq cm
- Q4227 AmnioCore TM, per sq cm
- Q4229 Cogenex Amniotic Membrane, per sq cm
- Q4230 Cogenex Flowable Amnion, per 0.5 cc
- Q4232 Corplex, per sq cm
- Q4233 SurFactor or NuDyn, per 0.5 cc
- Q4234 Xcellerate, per sq cm
- Q4235 AMNIOREPAIR or AltiPly, per sq cm
- Q4236 carePATCH, per sq cm
- Q4237 Cryo-Cord, per sq cm
- Q4238 Derm-Maxx, per sq cm
- Q4239 Amnio-Maxx or Amnio-Maxx Lite, per sq cm
- Q4240 CoreCyte, for topical use only, per 0.5 cc
- Q4241 PolyCyte, for topical use only, per 0.5 cc
- Q4242 AmnioCyte Plus, per 0.5 cc
- Q4245 AmnioText, per cc
- Q4246 CoreText or ProText, per cc
- Q4247 Amniotext patch, per sq cm
- Q4248 Dermacyte Amniotic Membrane Allograft, per sq cm
- Q4249 AMNIPLY, for topical use only, per sq cm
- Q4250 AmnioAmp-MP, per sq cm
- Q4251 Vim, per sq cm
- Q4252 Vendaje, per sq cm
- Q4253 Zenith Amniotic Membrane, per sq cm
- Q4254 Novafix DL, per sq cm
- Q4255 REGUaRD, for topical use only, per sq cm
- Q4256 MLG-Complete, per sq cm
- Q4257 Relese, per sq cm
- Q4258 Enverse, per sq cm
- Q4259 Celera Dual Layer or Celera Dual Membrane, per sq cm
- Q4260 Signature Apatch, per sq cm
- Q4261 TAG, per sq cm
- Q4262 Dual Layer Impax Membrane, per sq cm
- Q4263 SurGraft TL, per sq cm
- Q4264 Cocoon Membrane, per sq cm
- Q4265 NeoStim TL, per sq cm
- Q4266 NeoStim Membrane, per sq cm
- Q4267 NeoStim DL, per sq cm
- Q4268 SurGraft FT, per sq cm
- Q4269 SurGraft XT, per sq cm
- Q4270 Complete SL, per sq cm
- Q4271 Complete FT, per sq cm
- Q4272 Esano A, per sq cm
- Q4273 Esano AAA, per sq cm
- Q4274 Esano AC, per sq cm
- Q4275 Esano ACA, per sq cm
- Q4276 ORION, per sq cm
- Q4278 EPIEFFECT, per sq cm
- Q4279 Vendaje AC, per sq cm
- Q4280 Xcell Amnio Matrix, per sq cm
- Q4281 Barrera SL or Barrera DL, 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
- Q4290 Membrane Wrap-Hydro, per sq cm
- Q4291 Lamellas XT, per sq cm
- Q4292 Lamellas, per sq cm
- Q4293 Acesso DL, per sq cm
- Q4294 Amnio Quad-Core, per sq cm
- Q4295 Amnio Tri-Core Amniotic, per sq cm
- Q4296 Rebound Matrix, per sq cm
- Q4297 Emerge Matrix, per sq cm
- Q4298 AmniCore Pro, per sq cm
- Q4299 AmniCore Pro+, per sq cm
- Q4300 Acesso TL, per sq cm
- Q4301 Activate Matrix, per sq cm
- Q4302 Complete ACA, per sq cm
- Q4303 Complete AA, per sq cm
- Q4304 GRAFIX PLUS, per sq cm
- Q4305 American Amnion AC Tri-Layer, per sq cm
- Q4306 American Amnion AC, per sq cm
- Q4307 American Amnion, per sq cm
- Q4308 Sanopellis, per sq cm
- Q4309 VIA Matrix, per sq cm
- Q4310 Procenta, per 100 mg
- Q4311 Acesso, per sq cm
- Q4312 Acesso AC, per sq cm
- Q4313 Dermabind Fm, per sq cm
- Q4314 Reeva Ft, per sq cm
- Q4315 Regenelink Amniotic Membrane Allograft, per sq cm
- Q4316 Amchoplast, per sq cm
- Q4317 Vitograft, per sq cm
- Q4318 E-Graft, per sq cm
- Q4319 Sanograft, per sq cm
- Q4320 Pellograft, per sq cm
- Q4321 Renograft, per sq cm
- Q4322 Caregraft, per sq cm
- Q4323 alloPLY, per sq cm
- Q4324 AmnioTX, per sq cm
- Q4325 ACApatch, per sq cm
- Q4326 WoundPlus, per sq cm
- Q4327 DuoAmnion, per sq cm
- Q4328 MOST, per sq cm
- Q4329 Singlay, per sq cm
- Q4330 TOTAL, per sq cm
- Q4331 Axolotl Graft, per sq cm
- Q4332 Axolotl Dualgraft, per sq cm
- Q4333 ArdeoGraft, per sq cm
- Q4334 AmnioPlast 1, per sq cm
- Q4335 AmnioPlast 2, per sq cm
- Q4336 Artacent C, per sq cm
- Q4337 Artacent Trident, per sq cm
- Q4338 Artacent Velos, per sq cm
- Q4339 Artacent Vericlen, per sq cm
- Q4340 SimpliGraft, per sq cm
- Q4341 SimpliMax, per sq cm
- Q4342 TheraMend, per sq cm
- Q4343 Dermacyte AC Matrix Amniotic Membrane Allograft, per sq cm
- Q4344 Tri-Membrane Wrap, per sq cm
- Q4345 Matrix HD Allograft Dermis, per sq cm
- Q4346 Shelter DM Matrix, per sq cm
- Q4347 Rampart DL Matrix, per sq cm
- Q4348 Sentry SL Matrix, per sq cm
- Q4349 Mantle DL Matrix, per sq cm
- Q4350 Palisade DM Matrix, per sq cm
- Q4351 Enclose TL Matrix, per sq cm
- Q4352 Overlay SL Matrix, per sq cm
- Q4353 Xceed TL Matrix, per sq cm
- Q4354 PalinGen Dual-Layer Membrane, per sq cm
- Q4355 Abiomend Xplus Membrane and Abiomend Xplus Hydromembrane, per sq cm
- Q4356 Abiomend Membrane and Abiomend Hydromembrane, per sq cm
- Q4357 XWRAP Plus, per sq cm
- Q4358 XWRAP Dual, per sq cm
- Q4359 ChoriPly, per sq cm
- Q4360 AmchoPlast FD, per sq cm
- Q4361 EPIXPRESS, per sq cm
- Q4362 CYGNUS Disk, per sq cm
- Q4363 Amnio Burgeon Membrane and Hydromembrane, per sq cm
- Q4364 Amnio Burgeon Xplus Membrane and Xplus Hydromembrane, per sq cm
- Q4365 Amnio Burgeon Dual-Layer Membrane, per sq cm
- Q4366 Dual Layer Amnio Burgeon X-Membrane, per sq cm
- Q4367 AmnioCore SL, per sq cm
- Q4368 AmchoThick, per sq cm
- Q4369 AmnioPlast 3, per sq cm
- Q4370 AeroGuard, per sq cm
- Q4371 NeoGuard, per sq cm
- Q4372 AmchoPlast EXCEL, per sq cm
- Q4373 Membrane Wrap-Lite, per sq cm
- Q4375 duoGRAFT AC, per sq cm
- Q4376 Duograft AA, per sq cm
- Q4377 triGRAFT FT, per sq cm
- Q4378 Renew FT Matrix, per sq cm
- Q4379 AmnioDefend FT Matrix, per sq cm
- Q4380 AdvoGraft One, per sq cm
- Q4382 Advograft Dual, per sq cm
- Q4383 Axolotl Graft Ultra, per sq cm
- Q4384 Axolotl DualGraft Ultra, per sq cm
- Q4385 Apollo FT, per sq cm
- Q4386 Acesso TrifACA, per sq cm
- Q4387 NeoThelium FT, per sq cm
- Q4388 NeoThelium 4L, per sq cm
- Q4389 NeoThelium 4L Plus, per sq cm
- Q4390 Ascendion, per sq cm
- Q4391 AmnioPlast Double, per sq cm
- Q4392 GRAFIX Duo, per sq cm
- Q4393 SurGraft AC, per sq cm
- Q4394 SurGraft ACA, per sq cm
- Q4395 Acelagraft, per sq cm
- Q4396 Natalin, per sq cm
- Q4397 Summit AAA, per sq cm
- Q4398 Summit AC, per sq cm
- Q4399 Summit FX, per sq cm
- 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
- Q4410 AmchoMatrixDL, per sq cm
- Q4411 AmniomatrixF4X, per sq cm
- Q4412 CHORIOFIX, per sq cm
- Q4413 Cygnus Solo, per sq cm
- Q4414 SimpliChor, per sq cm
- Q4415 AlexiGuard SL-T, per sq cm
- Q4416 AlexiGuard TL-T, per sq cm
- Q4417 AlexiGuard DL-T, per sq cm
- Q4418 BioLab Membrane Wrap Flow, per sq cm
- Q4419 BioLab Membrane Wrap Lite Flow, per sq cm
- Q4420 NuForm, per sq cm
- Q4421 BioLab Membrane Wrap Solo, per sq cm
- Q4422 A/C Wrap, per sq cm
- Q4423 BioLab Tri-Membrane Wrap Flow, per sq cm
- Q4424 Revive FT, per sq cm
- Q4425 Revive TL, per sq cm
- Q4426 DermaBind TL + or DermaBind TL X, per sq cm
- Q4427 DermaBind DL N, DermaBind DL +, or DermaBind DL X, per sq cm
- Q4428 DermaBind SL N, DermaBind SL +, or DermaBind SL X, per sq cm
- Q4429 DermaBind CH N or DermaBind CH X, per sq cm
- Q4431* PMA skin substitute product, not otherwise specified [Dermagraft]
- Q4432 510(k) skin substitute product, not otherwise specified (list in addition to primary procedure)
- Q4433* 361 HCT/P skin substitute product, not otherwise specified [Allomax/Cortiva]
- Q4435 Renati Membrane, per sq
- Q4436 Renati AC Membrane, per sq cm
- Q4437 Revival AC, per sq cm
- Q4438 Pretect, per sq cm
- Q4439 InstaGraft, per sq cm
- Q4440 CuraMatrix, per sq cm
|
