Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Wound Care: Skin Substitutes for the Treatment of Burns and Chronic, Non-Healing Wounds

Policy #:11.08.20s

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

CHRONIC NON-HEALING WOUNDS

Skin substitute products with FDA clearance/approval or regulated as human cells, tissue, and cellular and tissue-based products (HCT/Ps), when used in the treatment of chronic, non-healing wounds, are considered medically necessary and, therefore, covered, when provided in accordance with that product's FDA-labeled or cleared indication, and in accordance with that product's individualized application guidelines when the following criteria are met:
  • The wound has a skin deficit at least 1.0 cm2 in size
  • The wound is clean and free of necrotic debris or exudate
  • The wound has adequate circulation/oxygenation to support tissue growth/wound healing as evidenced by physical examination (e.g., Ankle-Brachial Index (ABI) of no less than 0.60, toe pressure > 30 mm Hg)

In addition to the above criteria, for the following types of wounds, the associated criteria must be met:
  • Partial-thickness ulcers do not involve tendon, muscle, joint capsule or exhibit exposed bone or sinus tracts, and have a clean granular base.
  • Full-thickness ulcers do not involve tendon, muscle, joint capsule or exhibit exposed bone or sinus tracts, and have a clean granular base. The full-thickness ulcer is the result of abscess, injury, or trauma that has failed to respond to appropriate control of infection, foreign body, tumor resection, or other disease process for a period of four weeks or longer.
  • Diabetic foot ulcer has failed to respond to documented standard wound therapy of greater than four weeks, during which the individual is compliant with recommendations, and without evidence of underlying osteomyelitis or nidus of infection. The individual's medical record reflects a diagnosis of Type 1 or Type 2 diabetes.
  • Venous stasis ulcer has been present for at least three months but unresponsive to standard wound therapy for at least 30 days with documented compliance.

The use of a skin substitute for indications not approved by the FDA or in accordance with the manufacturer's package insert instructions/guidelines are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this product cannot be established by review of the available published peer-reviewed literature.

Refer to Attachment A for a list of skin substitutes, which are represented by a specific HCPCS code, and their approved indications. This list does not include all FDA-approved/regulated skin substitutes.

When the associated medical necessity criteria above are not met, skin substitutes are considered not medically necessary.

DEEP SECOND-DEGREE (PARTIAL-THICKNESS) BURNS AND THIRD-DEGREE (FULL-THICKNESS) BURNS

For superficial, second-degree burns, refer to the medical necessity criteria listed in the chronic, non-healing wound section of the policy, above.

BIOBRANE
Biobrane is considered medically necessary and, therefore, covered for the treatment of deep second-degree (partial-thickness) burn wounds when all of the following medical necessity criteria are met:
  • The treatment is specific to noninfected partial-thickness burn wounds and donor site wounds.
  • Initial excision of the burn wound is complete (i.e., eschar and nonviable tissue are removed).
  • Hemostasis is achieved.
  • Sufficient autograft tissue is not available at the time of excision (e.g., inadequate amounts of donor autograft tissue available).
  • Autograft is not desirable due to the individual's physiologic condition (e.g., individual has multisystem injuries such that creating new wounds may cause undue stress).

All other uses of Biobrane are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this product cannot be established by review of the available published peer-reviewed literature.

EPICEL
Epicel is considered medically necessary and, therefore, covered for the treatment of deep dermal or full-thickness burns when all of the following medical necessity criteria are met:
  • For the treatment of deep dermal or full-thickness burns when both of the following criteria are met:
    • The burns comprise 30 percent or greater of total body surface area
    • When used in conjunction with split-thickness autografts or alone in individuals for whom split-thickness autografts may not be an option due to the severity and extent of their burns

Approval has been obtained for the use of Epicel in accordance with the above FDA-labeled indications under the Humanitarian Device Exemption (HDE).

An HDE may only be used in facilities that have an institutional review board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-approved indications. In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the HDE indications.

All other uses of Epicel are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this product cannot be established by review of the available published peer-reviewed literature.

INTEGRA BILAYER MATRIX WOUND DRESSING (BMWD), INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX, AND INTEGRA MESHED BILAYER WOUND MATRIX

Integra Bilayer Matrix Wound Dressing, Integra Dermal Regeneration Template, Integra Omnigraft Dermal Regeneration Matrix, and Integra Meshed Bilayer Wound Matrix are considered medically necessary and, therefore, covered for the treatment of burn wounds when all of the following medical necessity criteria are met:
  • The treatment is specific to noninfected deep partial- and full-thickness burn wounds.
  • Initial excision of the burn wound is complete (i.e., eschar and nonviable tissue are removed).
  • Integra Dermal Regeneration Template must be applied on the same day as the initial excision of the recipient site.
  • Hemostasis is achieved.
  • Sufficient autograft tissue is not available at the time of excision (e.g., donor autograft tissue is thin and frail).
  • Autograft is not desirable due to the individual's physiologic condition (e.g., individual has multisystem injuries such that creating new wounds may cause undue stress).

ORCEL

OrCel (bilayered cellular matrix) is considered medically necessary and, therefore, covered for the treatment of fresh, clean split-thickness donor site wounds in individuals with burns.

All other uses of OrCel are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this product cannot be established by review of the available published peer-reviewed literature.

TRANSCYTE
TransCyte is considered medically necessary and, therefore, covered for the treatment of burn wounds when all of the following medical necessity criteria are met:
  • The treatment is specific to a temporary wound covering of one of the following:
    • Noninfected deep partial-thickness and full-thickness burn wounds prior to autograft placement
    • Noninfected mid-dermal to indeterminate depth burn wounds that may be expected to heal without autografting
  • Initial excision of the burn wound is complete (i.e., eschar and nonviable tissue is removed).
  • Hemostasis is achieved.

All others uses of TransCyte are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this product cannot be established by review of the available published peer-reviewed literature.

EPIDERMOLYSIS BULLOSA / RECESSIVE DYSTROPHIC EPIDERMOLYSIS BULLOSA

ORCEL
OrCel is considered medically necessary and, therefore, covered for the treatment of noninfected surgical wounds and donor sites associated with mitten hand deformities in individuals with recessive dystrophic epidermolysis bullosa.

Approval has been obtained for the use of OrCel in accordance with the above FDA-labeled indications under the HDE.

An HDE may only be used in facilities that have an institutional review board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-approved indication. In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the HDE indication.

All other uses of OrCel are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this product cannot be established by review of the available published peer-reviewed literature.

COVERAGE LIMITATIONS
  • FDA labeling for most skin substitutes include language suggesting multiple applications; however, it is not expected that every wound in every individual will require the maximum number of applications listed on the product label.
  • Repeat or alternative applications of skin substitutes are considered not medically necessary when a previous full course of applications was unsuccessful. Unsuccessful treatment is defined as an increase in size or depth of a wound 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) for a period of four weeks past start of therapy.
  • Retreatment of healed wounds, those showing greater than 75% size reduction and smaller than 0.5 sq. cm, is considered not medically necessary.
  • Skin substitutes are contraindicated and considered not medically necessary in individuals with inadequate control of underlying conditions or exacerbating factors (e.g., uncontrolled diabetes, active infection, and active Charcot arthropathy of the ulcer extremity, vasculitis, or continued tobacco smoking without professional provider attempt to effect smoking cessation).
  • Skin substitutes are contraindicated in individuals with known hypersensitivity to any component of the specific skin substitute (e.g., allergy to avian, bovine, porcine, equine products).

EXPERIMENTAL/INVESTIGATIONAL

Skin substitutes that are FDA approved to treat conditions other than burns and chronic, non-healing wounds are considered experimental/investigational for the treatment of burns and chronic, non-healing wounds and, therefore, are not covered because the safety and/or effectiveness of these products cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Documentation of response requires measurements of the initial wound, measurements at the completion of at least 4 weeks of appropriate wound care, and measurements immediately prior to placement and with each subsequent placement of the skin substitute.

Prior to the application of the skin substitute for diabetic or venous insufficiency ulcers, it is expected that the medical record documentation will contain evidence of the following:
  • Documentation that conservative measures have failed or the medical record supports that the wound is so clinically severe that it requires immediate, aggressive therapy.
  • Documentation that the ulcer has failed to decrease in size and depth, or that there has been no change in baseline size or depth with no sign of improvement, or no indication that improvement is likely.
  • Documentation of venous insufficiency either by history of deep venous thrombosis in the affected leg, or documentation of valvular reflux by duplex ultrasound, venography, or air/photo plethysmography.

For the skin substitute for diabetic or venous insufficiency ulcers, it is expected that the medical record documentation will contain evidence of the following:
  • The individual's medical record must reflect the frequency of skin substitute application, and this should be consistent with each individual's history and response to the skin substitute application and product safety criteria. Repeated application to the same wound within the same treatment period without signs of improvement may be denied.
  • Documentation that the skin substitute product was appropriately applied and immobilized in accordance with the manufacturer’s label instructions.

BILLING REQUIREMENTS

Application codes are not intended to be reported for application stabilized with dressing (e.g., by simple gauze wrap) without surgical fixation of the skin substitute. The skin substitute is anchored using the surgeon's choice of fixation or by another appropriate technique as per manufacturer’s label or packaging instruction, which can include tissue adhesives, fibrin glue, skin tape, sutures, buttons, staples, clips, and screws that conform to various tissue geometries.
Application codes are not to be reported for application of non-graft wound dressings (e.g., gel, ointment, foam, liquid, or injected substances) or for a biologic implant for soft tissue reinforcement, including, but not limited to: AmnioBand Particulate, Amniogen-A, Amniogen-C, AmnioMatrix, AmnioPro Flow, BioDMatrix, BioRenew Flow, BioSkin Flow, ClarixFlo, Epifix Injectable, Excellagen, Graftjacket Xpress, Integra Flowable Wound Matrix, Interfyl, MatriStem MicroMatrix, NeoxFlo, PalinGen Flow, PalinGen SportFlow, ProMatrX ACF, and WoundEx Flow.
Guidelines

Chronic wounds are defined as wounds that do not respond to standard wound therapy for at least a 30-day period during organized comprehensive conservative therapy.

A non-healing wound (i.e., "a failed response") is defined as an ulcer or skin deficit that has failed to respond to documented appropriate standard wound therapy, has increased in size or depth, or has not changed in baseline size or depth and has no indication that improvement is likely (such as granulation, epithelialization, or progress towards closing).

Standard wound therapy includes:
  • control of edema, venous hypertension or lymphedema;
  • control of any nidus of infection or colonization with bacterial or fungal elements;
  • elimination of underlying cellulitis, osteomyelitis, foreign body or malignant process;
  • appropriate debridement of necrotic tissue or foreign body (exposed bone or tendon);
  • maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings;
  • optimization of glucose control (when applicable);
  • for diabetic foot ulcers, appropriate non-weight bearing or off-loading pressure;
  • assessment of a patient’s vascular status and correction of any vascular problems in the affected limb if possible;
  • for venous stasis ulcers, compression therapy provided with documented diligent use of multilayer dressings, compression stockings of > 20mmHg pressure, or pneumatic compression;
  • provision of wound environment to promote healing (protection from trauma and contaminants, elimination of inciting or aggravating processes); and
  • optimization of nutritional status.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, skin substitutes with US Food and Drug Administration (FDA) clearance/approval for use in the treatment of burns and chronic, non-healing wounds, are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in the medical policy are met.

Subject to the terms and conditions of the applicable benefit contract, devices that are used for the FDA-approved humanitarian device exemption (HDE) indications listed in this policy are covered under the medical benefits of the Company's products.

Subject to the terms and conditions of the applicable benefit contract, skin substitutes that do not meet the medical necessity criteria listed in the medical policy are not eligible for payment under the medical benefits of the Company’s products because they are considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are benefit contract exclusions for all products of the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous skin substitute products approved by the FDA for wound care.

Description

SKIN LAYERS

Skin is composed of two layers, the epidermis and the dermis. The outermost layer is called the epidermis, and immediately beneath the epidermis is the dermis. These layers are separated by a basement membrane, which helps stabilize the epidermis to the dermis. Because the epidermis contains no blood vessels, the underlying dermis is the supplier of nutrients to the skin. The dermis consists of a superficial papillary layer of loose connective tissue that contains capillaries, elastic fibers, reticular fibers, and some collagen. A deeper reticular layer of the dermis consists of dense connective tissue that contains larger blood vessels, interlaced elastic fibers, coarse branching collagen fibers, fibroblasts, mast cells, nerve endings, lymphatics, hair follicles, and sebaceous and sweat glands.

SKIN GRAFTS

Historically, skin grafts have been employed to cover a skin deficit or replace lost tissue. Autologous skin grafts, also referred to as autografts, are permanent covers that use skin from different parts of the individual's body. These grafts consist of the epidermis and a dermal component of variable thickness. A split-thickness skin graft (STSG) includes the entire epidermis and a portion of the dermis. A full-thickness skin graft (FTSG) removes all the layers of the skin. Although autologous skin grafts are the optimum choice for wound coverage, areas of skin for harvesting may be limited, particularly in cases of large burns; in addition, the procedures are invasive and painful. Allografts (which use skin from another human [e.g., a cadaver]) and xenografts (which use skin from another species [e.g., porcine or bovine]) may also be employed as temporary skin replacements, but they must later be covered by an autograft.

SKIN SUBSTITUTES

Because of problems inherent with autografts, allografts, and xenografts, skin substitutes were developed. Skin substitutes (also referred to as tissue-engineered skin substitutes, human skin equivalents, or skin alternatives) are products that contain cells such as fibroblasts and keratinocytes in scaffolds of natural or synthetic matrices. The matrices provide a framework for mechanical stability and tissue infiltration. Cellular elements are predominantly derived from epidermal components, dermal components, or both in a composite graft. Skin substitutes are manufactured under a variety of trade names and marketed for various purposes.

Skin substitutes are classified into the following types:
  • Human skin allografts: derived from donated human skin (cadavers) that has been processed to remove the cellular components and retain the structural proteins of the dermis, and to avoid immunologic rejection. They are available in different forms to allow scaffolding, soft tissue filling, growth factors, and other bioavailable hormonal or enzymatic activity.\
  • Allogeneic matrices: derived from human neonatal fibroblasts of the foreskin that may contain metabolically active or regenerative components primarily used for soft tissue support, though some have been approved for the treatment of full-thickness skin and soft tissue loss. Most are biodegradable and disappear after 3-4 weeks of implantation.
  • Composite matrices: derived from human keratinocytes and fibroblasts supported by a scaffold of synthetic mesh or xenogeneic collagen. These are also referred to as human skin equivalent but are unable to be used as autografts due to immunologic rejection or degradation of the living components by the host. Active cellular components continue to generate bioactive compounds and protein that may accelerate wound healing and epithelial regrowth.
  • Acellular matrices: derived from sources other than human skin and include the majority of skin substitutes. All are composed of allogeneic (i.e., from another human) or xenogeneic (i.e., from nonhuman species, such as bovine and porcine) derived collagen, membrane, or cellular remnants proposed to simulate or exaggerate the characteristics of human skin. All are proposed to promote healing by the creation of localized intensification of an array of hormonal and enzymatic activity to accelerate closure by migration of native dermal and epithelial components, rather than function as distinctly incorporated tissue closing the skin defect.

Although the precise mechanism by which these products enhance wound repair is not understood, it is thought that maintenance of a biochemically balanced moist wound environment, the structural support for tissue regeneration, and/or the application of cytokines and growth factors to the wound bed may contribute to the healing process. Skin substitutes were originally designed to cover acute extensive burns in individuals with insufficient autologous skin for grafting. However, the use of skin substitutes has since been expanded to include treatment of chronic non-healing wounds.

REGULATION OF SKIN SUBSTITUTES

Based on the skin substitute's composition and origin, the U.S. Food and Drug Administration (FDA) regulates skin substitutes under one of the following categories:
  • Human- and human/animal-derived products regulated through the premarket approval (PMA) process
  • Animal-derived products and synthetic products regulated through the 510(k) process
  • Human-derived products regulated as human cells, tissue, and cellular and tissue-based products (HCT/Ps)
  • Human- and human/animal-derived products regulated as a Humanitarian Use Device (HUD) obtained through a Humanitarian Device Exemption (HDE)

FDA PREMARKET APPROVAL (PMA)
Premarket approval is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, the FDA has determined that general and special controls alone are insufficient to ensure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval application in order to obtain marketing clearance.

PMA is the most stringent type of device marketing application required by the FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by the FDA that there is sufficient valid scientific evidence to ensure that the device is safe and effective for its intended use(s).

FDA PREMARKETING NOTIFICATION (510[K])
A Premarketing Notification (510[k]) is a process in which applicants must demonstrate that the device to be marketed (i.e., a Class II device) is "substantially equivalent" to a pre-existing legally marketed device (predicate) in terms of safety and effectiveness. The predicate must have been approved either via PMA or 510(k). This process is usually used when manufacturers make small changes to a previously approved device that are thought to improve effectiveness without compromising safety, thus allowing for expedited approval without costly and lengthy scientific studies confirming safety and effectiveness.

HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)
Cells and tissues taken from human donors and transplanted to a recipient are regulated under Public Health Services (PHS) 361 [21 CFR 1270 & 1271]. This regulation describes the rules concerning the use of HCT/Ps for human medical purposes. The final rule, 21 CFR Part 1271, became effective on April 4, 2001, for human tissues intended for transplantation that are regulated under section 361 of the PHS Act and 21 CFR Part 1270. HCT/Ps are regulated by the Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Establishments producing HCT/Ps must register with the FDA and list their HCT/Ps. HCT/Ps establishments are not required to demonstrate the safety or effectiveness of their products and the FDA does not evaluate the safety or effectiveness of these products.

HUMANITARIAN DEVICE EXEMPTION (HDE)
In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the FDA through the Humanitarian Device Exemption (HDE) process. A device approved in this manner is designated as a Humanitarian Use Device (HUD). A HUD designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4,000 individuals annually. Because clinical investigation demonstrating the device's efficacy is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption to the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s).

Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.

COMMON TYPES OF NON-HEALING WOUNDS

BURNS
Burns are major threats that can lead to extensive tissue and fluid loss; they also provide openings for systemic infection. Burn severity is rated based on damage to skin layers. Superficial or first-degree burns involve only the outer layer of skin, the epidermis, and typically heal in 3-5 days. Partial-thickness or second-degree burns can be classified as superficial or deep. Superficial second-degree burns involve the entire epidermis and upper layers of the dermis, and should heal in 5-21 days without grafting. Deep second-degree burns involve the destruction of the entire epidermis and most of the dermis, and can quickly evolve into a full-thickness (or third-degree) burn. Deep second-degree burns will most likely need excision and skin grafting to heal. Full-thickness or third-degree burns involve the destruction of all layers of the skin, and often injure underlying subcutaneous adipose tissue as well. Conventional treatment for major burns consists of early staged surgical wound excision where eschar is removed and a granulating wound is exposed to serve as a bed for subsequent grafting and wound closure. Early burn wound excision has been shown to improve survival, decrease infection rates, decrease the formation of hypertrophic scars, and decrease the length of hospital stay.

DIABETIC FOOT ULCERATIONS
Diabetic foot ulcerations are common and occur in individuals who have Type I or Type II diabetes. The current standard of care for diabetic ulcers includes removal of mechanical stress (e.g., non-weight-bearing regimen), sharp debridement when necessary, and wound care (e.g., saline-moistened dressings); however, because only 24 percent of these ulcers heal after 12 weeks of treatment, these regimens are not considered particularly effective.

VENOUS ULCERATIONS
Venous ulcerations are a result of a pathophysiologic process in the maintenance of tissue integrity. The standard therapy for venous ulcers is compression. Healing after initiation of compression therapy is predictive of long-term results. Ulcers that are not reduced by greater than 40 percent within three weeks of treatment are unlikely to heal and may require complex care.

EPIDERMOLYSIS BULLOSA / RECESSIVE DYSTROPHIC EPIDERMOLYSIS BULLOSA
Epidermolysis bullosa (EB) is a family of genetic disorders that cause the skin to be very fragile and to blister easily after minor injury or friction, such as rubbing or scratching. The disease may occur in a relatively mild form, but it may also be disabling and sometimes fatal. Dystrophic epidermolysis bullosa (DEB) is one of the major forms of epidermolysis bullosa. DEB can be classified into three major types based on severity:
  • Autosomal recessive dystrophic epidermolysis bullosa, Hallopeau-Siemens type (RDEB-HS): the most severe form of the condition (blisters are present over the whole body and affect mucous membranes; leads to severe scarring)
  • Autosomal recessive dystrophic epidermolysis bullosa, non-Hallopeau-Siemens type (non-HS RDEB): less severe than RDEB-HS (blisters are limited to the hands, feet, knees, and elbows, but may be widespread in more severe cases; scarring is limited to areas where blisters have occurred and are not as severe as in RDEB-HS)
  • Autosomal dominant type (DDEB): milder than the autosomal recessive forms (blisters limited to the hands, feet, knees, and elbows; blisters heal with scarring, but it is less severe).

Recently, recessive dystrophic epidermolysis bullosa wounds have been treated with skin substitutes, one of which (OrCel) has been approved by the FDA under the Humanitarian Device Exemption (HDE).

OTHER TYPES OF NON-HEALING WOUNDS
Other wounds that may develop into non-healing wounds include, but are not limited to: partial- and full-thickness wounds, pressure ulcers, chronic vascular ulcers, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, skin tears), and draining wounds.
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Schachner L, Feiner A, Camisulli S. Epidermolysis bullosa: Management principles for the neonate, infant and young child. [Medscape Web site].03/24/05. Available at: http://www.medscape.com/viewarticle/499497 [via subscription only]. Accessed February 20, 2017.

Schaum KD, Farley KL. A clinical and coding overview of Oasis Wound Matrix and Oasis Burn Matrix. [Healthpoint Web site]. 2006. Available at: http://www.o-wm.com/files/docs/Healthpoint_September.pdf. Accessed February 20, 2017.

Sclafani AP, Romo T 3rd, Jacono AA. Rejuvenation of the aging lip with an injectable acellular dermal graft (Cymetra). Arch Facial Plast Surg. 2002;4(4):252-257.

Serena TE, Carter MJ, Le LT, et al; EpiFix VLU Study Group. A Multi-center Randomized Controlled Clinical Trial Evaluating the Use of Dehydrated Human Amnion/Chorion Membrane Allografts and Multi-layer Compression Therapy vs. Multi-layer Compression Therapy Alone in the Treatment of Venous Leg Ulcers. Wound Repair Regen. 2014;22(6):688-93.

Shah AP. Using amniotic membrane allografts in the treatment of neuropathic foot ulcers. J Am Podiatr Med Assoc. 2014;104(2):198-202.

Sheikh ES, Sheikh SS, Fetterolf DE. Use of dehydrated human amniotic membrane allografts to promote healing in patients with refractory non-healing wounds. Int Wound J. 2014;11(6):711-717.

Sheridan R, Choucair R, Donelan M, et al. Acellular allodermis in burns surgery: 1-year results of a pilot trial. J Burn Care Rehabil. 1998;19(6):528-530.

Sheridan RL, Morgan JR, Cusick JL, et al. Initial experience with a composite autologous skin substitute. Burns. 2001;27(5):421-424.

Shores JT, Gabriel A, Gupta S. Skin substitutes and alternatives: A review. Advances in Skin & Wound Care: The Journal.2007;20(9 Pt 1):493-508. Also available online at: http://www.nursingcenter.com/prodev/ce_article.asp?tid=742183. Accessed February 20, 2017.

Shores JT, Hiersche M, Gabriel A, et al. tendon coverage using an artificial skin substitute. J Plast Reconstr Aesthet Surg. 2012;65:1544-1550.

Sibbald RG, Zuker R, Coutts P, et al. Using a dermal skin substitute in the treatment of chronic wounds secondary to recessive dystrophic epidermolysis bullosa: a case series. Ostomy Wound Manage. 2005;51(11):22-46.

Singer AJ, Clark RAF. Cutaneous wound healing. N Engl J Med.1999;341(10):738-746. Also available on the New England Journal of Medicine Web site at: http://content.nejm.org/cgi/content/full/341/10/738 [via subscription only]. Accessed February 20, 2017.

Sinha UK, Shih C, Chang K, Rice DH. Use of AlloDerm for coverage of radial forearm free flap donor site. Laryngoscope. 2002;112(2):230-234.

Steinberg JS, Edmonds M, Hurley DP, Jr. et al. Confirmatory data from EU study supports Apligraf for the treatment of neuropathic diabetic foot ulcers. J Am Podiatr Med Assoc. 2010;100(1):73-77.

Still J, Glat P, Silverstein P, et al. The use of a collagen sponge/living cell composite material to treat donor sites in burn patients. Burns. 2003;29(8):837-841.

Stiefel D, Schiestl C, Meuli M. Integra Artificial Skin for burn scar revision in adolescents and children. Burns.2010;36(1):114-120.

Still JM Jr, Orlet HK, Law EJ. Use of cultured epidermal autografts in the treatment of large burns. Burns. 1994;20(6):539-541.

Sood R, Roggy D, Zieger M, et al. Cultured epithelial autografts for coverage of large burn wounds in eighty-eight patients: the Indiana University experience. J Burn Care Res. 2010;31(4):559-568.

Subach BR, Copay AG. The use of a dehydrated amnion/chorion membrane allograft in patients who subsequently undergo reexploration after posterior lumbar instrumentation. Adv Orthop. 2015. Epub 2015 Jan 13.

Tausche AK, Skaria M, Böhlen L, et al. An autologous epidermal equivalent tissue-engineered from follicular outer root sheath keratinocytes is as effective as split-thickness skin autograft in recalcitrant vascular leg ulcers. Wound Repair Regen. 2003;11(4):248-252.

Tenenhaus M, Greenberg M, Potenza B. Dehydrated human amnion/chorion membrane for the treatment of severe skin and tissue loss in a preterm infant: a case report. J Wound Care. 2014;23(10):490, 492-5.

Tissue Regenix Wound Care Incorporated. DermaPure. [Tissue Regenix Web site]. Available at: http://tissueregenixus.com/DermaPure.html. Accessed February 20, 2017.

Uccioli L, Giurato L, Ruotolo V, et al. Two-step autologous grafting using HYAFF scaffolds in treating difficult diabetic foot ulcers: Results of a multicenter, randomized controlled clinical trial with long-term follow-up. Int J Low Extrem Wounds. 2011;10(2):80-85.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Apligraf (Graftskin). Premarket approval letter. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P950032S016a.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Architect PX Extracellular Collagen Matrix. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf14/K140367.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Biobrane. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K801635. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Dermagraft. Premarket approval letter. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000036A.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Epicel. HDE approval letter. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/H990002a.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Excellagen. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K110318.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. E-Z Derm. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K935189. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. FortaDerm. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K011026. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Guidance for Industry and FDA staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers. [FDA Web site]. Available at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071473.htm. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Hyalomatrix. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K073251.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Integra Bilayer Matrix Wound Dressing. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K021792.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Integra Dermal Regeneration Template. Premarket approval letter. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p900033s008a.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Integra Flowable Wound Matrix. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072113.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Integra Matrix Wound Dressing. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/K022127.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Integra Meshed Bilayer Wound Matrix. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081635.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. MariGen Wound Dressing. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/K132343.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. MatriStem MicroMatrix. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060888.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. MatriStem Wound Matrix. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K112409.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Mediskin. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K113866.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Oasis Wound Matrix. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061711.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. OrCel. Premarket approval letter. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010016a.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. PriMatrix. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/K131286.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Strattice. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070560.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Talymed. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/K102002.pdf. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. TransCyte. Premarket approval letter. [FDA Web site]. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=23866. Accessed February 20, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Unite Biomatrix. 510(k) summary. [FDA Web site]. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K112399.pdf. Accessed February 20, 2017.

U.S. National Institutes of Health. ClinicalTrials.gov. http://clinicaltrials.gov/. Accessed February 20, 2017.

Vanstraelen P. Comparison of calcium sodium alginate (KALOSTAT) and porcine xenograft (E-Z DERM) in the healing of split-thickness skin graft donor sites. Burns. 1992;18(2):145-148.

Veves A, Falanga V, Armstrong DG, et al. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001;24(2):290-295.

Wainwright D, Madden M, Luterman A, et al. Clinical evaluation of an acellular allograft dermal matrix in full-thickness burns. J Burn Care Rehabil. 1996;17(2):124-136.

Warriner RA, 3rd, Cardinal M, TIDE Investigators. Human fibroblast-derived dermal substitute: Results from a treatment investigational device exemption (TIDE) study in diabetic foot ulcers. Adv Skin Wound Care. 2011;24(7):306-311.

Wax MK, Winslow CP, Andersen PE. Use of allogenic dermis for radial forearm free flap donor site coverage. J Otolaryngol. 2002;31(6):341-345.

Weigert R, Choughri H, Casoli V. Management of severe hand wounds with Integra(R) dermal regeneration template. J Hand Surg Europ. 2011;36(3):185-193.

Whang KK, Kim MJ, Song WK, Cho S. Comparative treatment of giant congenital melanocytic nevi with curettage or Er:YAG laser ablation alone versus with cultured epithelial autografts. Dermatol Surg. 2005;31(12):1660-1667.

Williams N, Stiller K, Greenwood J, et al. Physical and quality of life outcomes of patients with isolated hand burns—a prospective audit. J Burn Care Res. 2012;33:188-198.

Williamson JS, Snelling CF, Clugston P, et al. Cultured epithelial autograft: five years of clinical experience with twenty-eight patients. J Trauma. 1995;39(2):309-319.

Winters CL, Brigido SA, Liden BA, et al. A multicenter study involving the use of a human acellular dermal regenerative tissue matrix for the treatment of diabetic lower extremity wounds. Adv Skin Wound Care.2008;21(8):375-381.

Wood BC, Kirman CN, Molnar JA. Skin Grafts and Biologic Skin Substitutes. [Medscape Web site]. 03/27/2015. Available at: http://emedicine.medscape.com/article/1295109-overview. Accessed February 20, 2017.

Woodley DT, Peterson HD, Herzog SR, et al. Burn wounds resurfaced by cultured epidermal autografts show abnormal reconstitution of anchoring fibrils. JAMA. 1988;259(17):2566-2571.

Wound Source. DermACELL. [Wound Source Web site]. Available at: http://www.woundsource.com/product/dermacell-advanced-decellularized-dermis. Accessed February 20, 2017.

Yim H, Cho YS, Seo Ch, et al. The use of Alloderm on major burn patients: Alloderm prevents post-burn joint contracture. Burns.2010;36(3):322-328.

Zelen C. An evaluation of dehydrated human amniotic membrane allografts in patients with DFU’s. J Wound Care. 2013;22(7):347-351.

Zelen C, Serena T, Fetterolf D. Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: a long term follow-up study. Wound Medicine. 2014;4:1-4.

Zelen C, Serena T, Snyder R. A prospective randomized comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers. Int Wound J. 2013;10(5):1-14.

Zelen CM, Gould L, Serena TE, et al. A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. Int Wound J. 2015;12(6):724-32.

Zelen CM, Orgill DP, Serena T, et al. A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers. Int Wound J. April 12, 2016. [Epub ahead of print]

Zelen CM, Poka A, Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study. Foot Ankle Int. 2013;34(10):1332-9.

Zelen CM, Serena TE, Denoziere G, et al. A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcer. Int Wound J. 2013;10(5):502-507.

Zelen CM, Snyder RJ, Serena TE, et al. The use of human amnion/chorion membrane in the clinical setting for lower extremity repair: a review. Clin Podiatr Med Surg. 2015;32(1):135-46.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

15150, 15151, 15152, 15155, 15156, 15157, 15271, 15272, 15273, 15274, 15275, 15276, 15277, 15278


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

C5271 Application of low cost 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

C5272 Application of low cost 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)

C5273 Application of low cost 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

C5274 Application of low cost 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)

C5275 Application of low cost 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

C5276 Application of low cost 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)

C5277 Application of low cost 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

C5278 Application of low cost 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)

C9363 Skin substitute (Integra Meshed Bilayer Wound Matrix), per square cm

Q4101 Apligraf, per sq cm

Q4102 Oasis wound matrix, per sq cm

Q4103 Oasis burn 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

Q4108 Integra matrix, per sq cm

Q4110 PriMatrix, per sq cm

Q4111 GammaGraft, per sq cm

Q4113 GRAFTJACKET XPRESS, injectable, 1cc

Q4114 Integra flowable wound matrix, injectable, 1 cc

Q4115 AlloSkin, per sq cm

Q4117 HYALOMATRIX, per sq cm

Q4118 MatriStem micromatrix, 1 mg

Q4121 TheraSkin, per sq cm

Q4122 DermACELL, per sq cm

Q4123 AlloSkin RT, per sq cm

Q4124 OASIS ultra tri-layer wound matrix, per sq cm

Q4126 MemoDerm, DermaSpan, TranZgraft or InteguPly, per sq cm

Q4127 Talymed, per sq cm

Q4128 FlexHD, Allopatch HD, or Matrix HD, per sq cm

Q4132 Grafix core and grafixpl core, per sq cm

Q4133 Grafix prime, grafixpl prime, stravix and stravixpl, per square centimeter

Q4134 HMatrix, per sq cm

Q4135 Mediskin, per sq cm

Q4136 E-Z Derm, per sq cm

Q4137 Amnioexcel, amnioexcel plus or biodexcel, per square centimeter

Q4139 AmnioMatrix or BioDMatrix, injectable, 1 cc

Q4140 BioDFence, per sq cm

Q4141 AlloSkin AC, 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

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

Q4158 Kerecis omega3, 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, 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 sq cm

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 sq cm

Q4176 Neopatch, 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 square centimeter

Q4184 Cellesta, per square centimeter

Q4185 Cellesta flowable amnion (25 mg per cc); per 0.5 cc

Q4186 Epifix, per square centimeter

Q4187 Epicord, per square centimeter

Q4188 Amnioarmor, per square centimeter

Q4189 Artacent ac, 1 mg

Q4190 Artacent ac, per square centimeter

Q4191 Restorigin, per square centimeter

Q4192 Restorigin, 1 cc

Q4193 Coll-e-derm, per square centimeter

Q4194 Novachor, per square centimeter

Q4195 Puraply, per square centimeter

Q4196 Puraply am, per square centimeter

Q4197 Puraply xt, per square centimeter

Q4198 Genesis amniotic membrane, per square centimeter

Q4200 Skin te, per square centimeter

Q4201 Matrion, per square centimeter

Q4202 Keroxx (2.5g/cc), 1cc

Q4203 Derma-gide, per square centimeter

Q4204 Xwrap, per square centimeter


THE FOLLOWING CODE IS USED TO REPRESENT BIOBRANE, EPICEL, INTEGRA MESHED BILAYER WOUND MATRIX, AND ORCEL

Q4100 Skin substitute, not otherwise specified


EXPERIMENTAL/INVESTIGATIONAL

A6460 Synthetic resorbable wound dressing, sterile, pad size 16 sq. in. or less, without adhesive border, each dressing

A6461 Synthetic resorbable wound dressing, sterile, pad size more than 16 sq. in. but less than or equal to 48 sq. in., without adhesive border, each dressing



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Wound Care: Skin Substitutes for the Treatment of Burns and Chronic, Non-Healing Wounds
Description: Skin substitutes and their approved indications.




Policy History

Revisions from 11.08.20s:
01/01/2019The following HCPCS codes have been added to the policy as medically necessary: Q4183, Q4184, Q4185, Q4186, Q4187, Q4188, Q4189, Q4190, Q4191, Q4192, Q4193, Q4194, Q4195, Q4196, Q4197, Q4198, Q4200, Q4201, Q4202, Q4203, Q4204

The following HCPCS codes have been added to the policy as experimental/investigational: A6460, A6461

The following code was deleted: Q4131, Q4172


Revisions from 11.08.20r:
01/01/2018This policy has been identified for the HCPCS code update effective 01/01/2018.

The following HCPCS codes have been added to this policy: Q4176, Q4177, Q4178, Q4179, Q4180, Q4181

Transcyte has been removed from the list of medically necessary skin substitutes that are to be reported using NOC code Q4100 and is replaced by HCPCS code Q4182.

The following HCPCS narratives have been revised in this policy: Q4132, Q4133, Q4148, Q4156, Q4158, Q4162, Q4163

Revisions from 11.08.20q:
12/01/2017POLICY SECTION

Chronic Non-Healing Wounds
  • Criteria was revised in the policy section regarding Chronic Non-Healing Wounds.
  • Language defining chronic wounds and non-healing wounds was moved from the policy section to the Guidelines section.

Deep Second-Degree (Partial-Thickness) Burns and Third-Degree (Full-Thickness) Burns
  • Integra Omnigraft Dermal Regeneration Matrix was added as Medically Necessary for burn wounds when medical necessity criteria in the policy are met.
  • Language was removed from the policy section regarding all other uses of the Integra Dermal Regeneration Template.

Experimental/Investigational
  • The following Experimental/Investigational language was removed:
      The following skin substitutes, which are represented by a specific HCPCS code, are considered experimental/investigational for all wound-care uses and, therefore, are not covered because the safety and/or effectiveness of these products cannot be established by review of the available published peer-reviewed literature; this list may not be all inclusive:

      and replaced with:

      Skin substitutes that are FDA approved to treat conditions other than burns and chronic, non-healing wounds are considered experimental/investigational for the treatment of burns and chronic, non-healing wounds and, therefore, are not covered because the safety and/or effectiveness of these products cannot be established by review of the available published peer-reviewed literature.
  • AlloPatch HD and Matrix HD were removed from the list of Experimental/Investigational skin substitutes because they are considered Medically Necessary.
  • Alloderm, Allowrap Dry/Allowrap DS, Arthroflex, BioDFence DryFlex, Cymetra, FlexHD Acellular Dermal Matrix, Repriza, Strattice Tissue Matrix, and XCM Biologic Tissue Matrix were removed from the list of Experimental/Investigational skin substitutes because they are used to treat conditions other than burns and chronic, non-healing wounds, which is out of scope for this policy.

Billing Requirements
  • Under billing requirements, the following skin substitutes were added to the list of skin substitutes in which application codes are not to be reported: AmnioBand Particulate, Amniogen-A, Amniogen-C, AmnioPro Flow, BioRenew Flow, BioSkin Flow, Interfyl, MatriStem MicroMatrix, PalinGen Flow, PalinGen SportFlow, ProMatrX ACF, and WoundEx Flow.

GUIDELINES SECTION
  • Language defining standard wound therapy was added to the Guidelines section.

Benefit Applications
  • Under Benefit Applications, AlloPatch HD and Matrix HD were removed from the Experimental/Investigational statement because they are considered Medically Necessary.
  • Under Benefit Applications, Alloderm, Allowrap Dry/Allowrap DS, Arthroflex, BioDFence DryFlex, Cymetra, FlexHD Acellular Dermal Matrix, Repriza, Strattice Tissue Matrix, and XCM Biologic Tissue Matrix were removed from the Experimental/Investigational statement because they are used to treat conditions other than burns and chronic, non-healing wounds, which is out of scope for this policy.

CODING
  • The following statement was added to ICD-10 Diagnosis Codes: Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.
  • The following HCPCS codes were removed from this policy: Q4112, Q4116, Q4125, Q4130, Q4138, Q4142, Q4143, Q4150
  • HCPCS code Q4128 was moved from Experimental/Investigational to Medically Necessary in the coding table.

REVISIONS TO ATTACHMENT A
  • The following skin substitutes were added to Attachment A:
    AlloPatch HD, AmnioBand Particulate, Amniogen-45, Amniogen-200, Amniogen-A, Amniogen-C, AmnioPro, AmnioPro Flow, Architect Px Extracellular Collagen Matrix, Architect Fx Extracellular Collagen Matrix, Artacent Wound, Bio-ConneKt Wound Matrix, BioRenew, BioRenew Flow, BioSkin, BioSkin Flow, Cygnus, Cytal Wound Matrix, EpiCord, Helicoll, Integra Dermal Regeneration Template (DRT), Integra Omnigraft Dermal Regeneration Matrix, Interfyl, Keramatrix, Matrix HD, Miroderm, PalinGen Flow, PalinGen SportFlow, PalinGen Membrane, PalinGen XPlus Membrane, Plurivest, ProMatrX ACF, TruSkin, WoundEx, WoundEx Flow
  • The following skin substitutes were removed from Attachment A:
    MatriStem Burn Matrix (now know as Cytal Wound Matrix), MatriStem Wound Matrix (now know as Cytal Wound Matrix), Unite Biomatrix (product is no longer available)


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 01/04/2019
Version Reissued Date: N/A

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