Policy title: Application of Bio-Engineered Skin and Soft Tissue Substitutes

Policy number: MA 1.158

Effective date 7/1/2026

Política

Breast reconstructive surgery using allogeneic acellular dermal matrix products may be considered medically necessary:

• When there is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required;
• When there is viable but compromised or thin postmastectomy skin flaps that are at risk of dehiscence or necrosis; or
• The inframammary fold and lateral mammary folds have been undermined during mastectomy and reestablishment of these landmarks is needed.

Treatment of dystrophic epidermolysis bullosa using the following tissue-engineered skin substitutes may be considered medically necessary:

• For the treatment of mitten-hand deformity when standard wound therapy has failed and when provided in accordance with the humanitarian device exemption [HDE] specifications of the U.S. Food and Drug Administration [FDA].

Treatment of second- and third-degree burns using the following tissue-engineered skin substitutes may be considered medically necessary:

• Epicel^® (for the treatment of deep dermal or full-thickness burns comprising a total body surface area ≥30% when provided in accordance with the HDE specifications of the FDA).

For guidance on lower extremity ulcers, please refer the latest version of Medicare Local Coverage Determination (LCD).

All other uses reviewed herein of the bioengineered skin and soft tissue substitutes listed above are considered investigational as there is insufficient evidence to support a conclusion concerning the general health outcomes or benefits associated with this procedure.

Directrices de la política

A failed response is defined as an ulcer or skin deficit that has failed to respond to documented appropriate wound-care measures, 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).

Wound healing is impaired by the systemic use of tobacco. Therefore, ideally patients who have smoked will have ceased smoking or have refrained from systemic tobacco intake for at least 4 weeks during conservative wound care and prior to planned bioengineered skin replacement therapy.

Esta política médica se aplica a los planes Medicare Advantage ofrecidos por Capital Blue Cross y sus subsidiarias.

Cross-references:
MA 1.167 Products of Bio-Engineered Skin and Soft Tissue Substitutes
MA 1.159 Amniotic Membrane and Amniotic Fluid
MA 4.028 Wound and Burn Care and Specialized Treatment Centers

Descripción/Antecedentes

Skin and Soft Tissue Substitutes

Bioengineered skin and soft tissue substitutes may be either acellular or cellular. Acellular products (e.g., dermis with cellular material removed) contain a matrix or scaffold composed of materials such as collagen, hyaluronic acid, and fibronectin. Acellular dermal matrix (ADM) products can differ in a number of ways, including as species source (human, bovine, porcine), tissue source (e.g., dermis, pericardium, intestinal mucosa), additives (e.g., antibiotics, surfactants), hydration (wet, freeze-dried), and required preparation (multiple rinses, rehydration).

Cellular products contain living cells such as fibroblasts and keratinocytes within a matrix. The cells contained within the matrix may be autologous, allogeneic, or derived from other species (e.g., bovine, porcine). Skin substitutes may also be composed of dermal cells, epidermal cells, or a combination of dermal and epidermal cells, and may provide growth factors to stimulate healing. Bioengineered skin substitutes can be used as either temporary or permanent wound coverings.

Solicitudes

There are a large number of potential applications for artificial skin and soft tissue products. One large category is nonhealing wounds, which potentially encompass diabetic neuropathic ulcers, vascular insufficiency ulcers, and pressure ulcers. A substantial minority of such wounds do not heal adequately with standard wound care, leading to prolonged morbidity and increased risk of mortality. For example, nonhealing lower-extremity wounds represent an ongoing risk for infection, sepsis, limb amputation, and death. Bioengineered skin and soft tissue substitutes have the potential to improve rates of healing and reduce secondary complications.

Other situations in which bioengineered skin products might substitute for living skin grafts include certain postsurgical states (e.g., breast reconstruction) in which skin coverage is inadequate for the procedure performed, or for surgical wounds in patients with compromised ability to heal. Second- and third-degree burns are another indication in which artificial skin products may substitute for auto- or allografts. Certain primary dermatologic conditions that involve large areas of skin breakdown (e.g., bullous diseases) may also be conditions in which artificial skin products can be considered as substitutes for skin grafts. ADM products are also being evaluated in the repair of other soft tissues including rotator cuff repair, following oral and facial surgery, hernias, and other conditions.

Situación reglamentaria

The FDA does not refer to any product or class of products as "skin substitutes." However, products commonly described as "skin substitutes" are regulated by FDA under one of the four categories described below depending on the origin and composition of the product.

Human Cells, Tissues, and Cellular and Tissue-Based Products - Cells and tissues taken from human donors and transplanted to a recipient are regulated under 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). The Center for Biologics Evaluation and Research is responsible for regulating biological and related products including blood, vaccines, allergens, tissues, and cellular and gene therapies. Establishments producing HCT/Ps must register with FDA and list their HCT/Ps. HCT/Ps establishments are not required to demonstrate the safety or effectiveness of their products and FDA does not evaluate the safety or effectiveness of these products.

Premarket Approval - Premarket approval (PMA) by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Before Class III devices can be marketed, they must have an approved PMA application. Therefore, wound care products regulated under the PMA process will require evidence that they promote wound healing before they are approved for marketing.

510(k) Submissions - According to FDA documents a 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent (SE), to a legally marketed device [21 CFR 807.92(a)(3)] that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. Unlike PMA, 510(k) confers reasonable assurance of safety and effectiveness via demonstration of substantial equivalence to a legally marketed device that does not require premarket approval. Therefore, wound care products regulated under the 510(k) process will not typically require clinical evidence to establish effectiveness in wound healing, as compared with products regulated under the PMA process in which substantial clinical evidence is always required.

Humanitarian Device Exemption (HDE) - An HDE is similar in both form and content to a premarket approval (PMA) application but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market. Humanitarian Device Exemption approval is based on evidence of probable benefit in a disease population occurring at a frequency of less than 4,000 patients per year in the United States.

Human Amniotic Membrane (HAM)

HAM consists of two conjoined layers, the amnion, and chorion, and forms the innermost lining of the amniotic sac or placenta. Cuando se prepara para su uso como aloinjerto, la membrana se extrae inmediatamente después del parto, se limpia, se esteriliza y se criopreserva o se deshidrata. Se están estudiando muchos productos disponibles que utilizan el amnios, el corion, el líquido amniótico y el cordón umbilical para el tratamiento de diversas afecciones, entre ellas las úlceras crónicas de espesor completo en las extremidades inferiores causadas por la diabetes, las úlceras venosas, la artrosis de rodilla, la fascitis plantar y las afecciones oftálmicas. Los productos se formulan en forma de parches, que pueden aplicarse como cubiertas para heridas, o como suspensiones o partículas, o extracciones de tejido conjuntivo, que pueden inyectarse o aplicarse por vía tópica.

La membrana amniótica fresca contiene colágeno, fibronectina y ácido hialurónico, junto con una combinación de factores de crecimiento, citocinas y proteínas antiinflamatorias, como el antagonista del receptor de interleucina-1. Existen pruebas de que el tejido tiene propiedades antiinflamatorias, antifibroblásticas y antimicrobianas. La HAM se considera no inmunógena y no se ha observado que provoque una respuesta inmunitaria significativa. It is believed these properties are retained in cryopreserved HAM and HAM products, resulting in a readily available tissue with regenerative potential. In support, one HAM product has been shown to elute growth factors into saline and stimulate the migration of mesenchymal stem cells, both in vitro and in vivo.

Use of a HAM graft, which is fixated by sutures, is an established treatment for disorders of the corneal surface, including neurotrophic keratitis, corneal ulcers, and melts, following pterygium repair, Stevens-Johnson syndrome, and persistent epithelial defects. Recientemente se han investigado productos de membrana amniótica que se insertan como lentes de contacto para el tratamiento de trastornos de la córnea y la superficie ocular. Los parches de membrana amniótica también se están evaluando para el tratamiento de otras afecciones, como heridas cutáneas, quemaduras, úlceras en las piernas y prevención de la adhesión de tejidos en procedimientos quirúrgicos. Otras indicaciones estudiadas en modelos preclínicos incluyen tendinitis, reparación de tendones y reparación de nervios. La disponibilidad de la HAM abre la posibilidad de la medicina regenerativa para una amplia gama de afecciones.

Amniotic Fluid

Amniotic fluid surrounds the fetus during pregnancy and provides protection and nourishment. In the second half of gestation, most of the fluid is a result of micturition and secretion from the respiratory tract and gastrointestinal tract of the fetus, along with urea. The fluid contains proteins, carbohydrates, peptides, fats, amino acids, enzymes, hormones, pigments, and fetal cells. Use of human and bovine amniotic fluid for orthopedic conditions was first reported in 1927. Amniotic fluid has been compared with synovial fluid, containing hyaluronan, lubricant, cholesterol, and cytokines. Injection of amniotic fluid or amniotic fluid-derived cells is currently being evaluated for the treatment of osteoarthritis and plantar fasciitis.

Amniotic membrane and amniotic fluid are also being investigated as sources of pluripotent stem cells. Pluripotent stem cells can be cultured and are capable of differentiation toward any cell type. The use of stem cells in orthopedic applications is addressed in evidence review MP 2.080.

Situación reglamentaria

The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation, Title 21, parts 1270 and 1271. In 2017, the FDA published clarification of what is considered minimal manipulation and homologous use for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

HCT/Ps are defined as human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. Si un HCT/P no reúne los criterios que se indican a continuación y no cumple los requisitos para ninguna de las excepciones establecidas, el HCT/P será considerado para la reglamentación como un medicamento, dispositivo y/o producto biológico, por lo que se aplicarán las normas correspondientes y se requerirá una revisión previa a la comercialización.

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) includes all layers of the skin. Although autografts are the optimal choice for full thickness wound coverage, areas for skin harvesting may be limited, particularly in cases of large burns or venous stasis ulceration. Harvesting procedures are painful, disfiguring and require additional wound care.

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, but they must later be replaced by an autograft or the ingrowth of the patient’s own skin.

Bioengineered skin / cultured epidermal autografts (CEA) are autografts derived from the patient’s own skin cells grown or cultured from very small amounts of skin or hair follicle. Production time is prolonged. One such product is grown on a layer of irradiated mouse cells, bestowing some elements of a xenograft. Widespread usage has not been available due to limited availability or access to the technology.

Bioengineered Skin Substitutes or Cellular and Tissue Based Products (CTPs), referred to as Skin Substitutes by CMS, the Current Procedural Terminology (CPT) and the Healthcare Common Procedure Coding Manuals, have been developed in an attempt to circumvent problems inherent with autografts, allografts and xenografts. These constitute biologic covers for refractory wounds with full thickness skin loss secondary to 3rd degree burns or other disease processes such as diabetic neuropathic ulcers and the skin loss of chronic venous stasis or venous hypertension. The production of these biologic skin substitutes or CTPs varies by company and product but generally involves the creation of immunologically inert biological products containing protein, hormones or enzymes seeded into a matrix which may provide protein or growth factors proposed to stimulate or facilitate healing or promote epithelialization. A variety of biosynthetic and tissue-engineered skin substitution products marketed as Human Skin Equivalents (HSE) or Cellular or Tissue-Based Products (CTP) are manufactured under an array of trade names and marketed for a variety of indications. All are procured, produced, manufactured, processed and promoted in sufficiently different manners to preclude direct product comparison for equivalency or superiority in randomized controlled trials. Sufficient data is available to establish distinct inferiority to human skin autografts and preclude their designation as skin equivalence.

Bioengineered skin substitutes or CTPs are classified into the following types:

• Human skin allografts derived from donated human skin (cadavers)
• Allogeneic matrices derived from human tissue (fibroblasts or membrane)
• Composite matrices derived from human keratinocytes, fibroblasts and xenogeneic collagen
• Acellular matrices derived from xenogeneic collagen or tissue

Human skin allografts are bioengineered from human skin components and human tissue which have had intact cells removed or treated to avoid immunologic rejection. They are available in different forms promoted to allow scaffolding, soft tissue filling, growth factors and other bioavailable hormonal or enzymatic activity.

Allogeneic matrices are usually 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 implantation.

Composite matrices are 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 are derived from other than human skin and include the majority of bioengineered skin substitutes. All are composed of allogeneic or xenogeneic derived collagen, membrane, or cellular remnants proposed to stimulate or exaggerate the characteristics of human skin. All propose 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.

Fundamentos

Resumen de la evidencia

Breast Reconstruction

For individuals who are undergoing breast reconstruction who receive allogeneic acellular dermal matrix (ADM) products, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life (QOL), and treatment-related morbidity. A systematic review found no difference in overall complication rates with ADM allograft compared with standard procedures for breast reconstruction. Reconstructions with ADM have been reported to have higher seroma, infection, and necrosis rates than reconstructions without ADM. However, capsular contracture and malposition of implants may be reduced. Thus, in cases where there is limited tissue coverage, the available evidence may inform patient decision making about reconstruction options. Las pruebas son suficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Tendon Repair

For individuals who are undergoing tendon repair who receive GraftJacket, the evidence includes an RCT. Relevant outcomes are symptoms, morbid events, functional outcomes, QOL, and treatment-related morbidity. The RCT identified found improved outcomes with the GraftJacket ADM allograft for rotator cuff repair. Although these results were positive, additional studies with a larger number of patients is needed to evaluate the consistency of the effect. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Surgical Repair of Hernias or Parastomal Reinforcement

For individuals who are undergoing surgical repair of hernias or parastomal reinforcement who receive acellular collagen-based scaffolds, the evidence includes RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, QOL, and treatment-related morbidity. Several comparative studies including RCTs have shown no difference in outcomes between tissue-engineered skin substitutes and either standard synthetic mesh or no reinforcement. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Diabetic Lower-Extremity Ulcers

For individuals who have diabetic lower-extremity ulcers who receive AlloPatch, Apligraf, Dermagraft, Integra, mVASC, or TheraSkin, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, and QOL. Randomized controlled trials reporting complete wound healing outcomes with at least 12 weeks of follow-up have demonstrated the efficacy of AlloPatch (reticular ADM), Apligraf and Dermagraft (living cell therapy), Integra (biosynthetic), mVASC, and TheraSkin over the standard of care (SOC). Las pruebas son suficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have diabetic lower-extremity ulcers who receive ADM products other than AlloPatch, Apligraf, Dermagraft, Integra, mVASC, or TheraSkin, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, and QOL. Results from a multicenter RCT showed some benefit of DermaCELL that was primarily for the subgroup of patients who only required a single application of the ADM. Studies are needed to further define those populations who might benefit from this treatment. Additional study with a larger number of subjects is needed to evaluate the effect of GraftJacket, DermACELL, Cytal, PriMatrix, and Oasis Wound Matrix, compared with current SOC or other advanced wound therapies. An RCT of Omega3 Wound (Kerecis) has been published and 2 larger RCTs are registered and reported as completed but have not been published. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Lower-Extremity Ulcers due to Venous Insufficiency

For individuals who have lower-extremity ulcers due to venous insufficiency who receive Apligraf or Oasis Wound Matrix, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, and QOL. Randomized controlled trials have demonstrated the efficacy of Apligraf living cell therapy and xenogeneic Oasis Wound Matrix over the SOC. Las pruebas son suficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have lower-extremity ulcers due to venous insufficiency who receive bioengineered skin substitutes other than Apligraf or Oasis Wound Matrix, the evidence includes RCTs. Relevant outcomes are disease-specific survival, symptoms, change in disease status, morbid events, and QOL. In a moderately large RCT, Dermagraft was not shown to be any more effective than controls for the primary or secondary endpoints in the entire population and was only slightly more effective than controls (an 8% to 15% increase in healing) in subgroups of patients with ulcer durations of 12 months or less or size of 10 cm or less. Additional studies with a larger number of subjects is needed to evaluate the effect of the xenogeneic PriMatrix skin substitute versus the current SOC. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Deep Dermal Burns

For individuals who have deep dermal burns who receive bioengineered skin substitutes (i.e., Epicel, Integra Dermal Regeneration Template), the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, functional outcomes, QOL, and treatment-related morbidity. Overall, few skin substitutes have been approved, and the evidence is limited for each product. Epicel (living cell therapy) has received U.S. Food and Drug Administration approval under a humanitarian device exemption for the treatment of deep dermal or full-thickness burns comprising a total body surface area of 30% or more. Comparative studies have demonstrated improved outcomes for biosynthetic skin substitute Integra Dermal Regeneration Template for the treatment of burns. Las pruebas son suficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have deep dermal burns who are treated with the ReCell autologous cell harvesting device, the evidence includes RCTs. One RCT evaluated ReCell as an adjunct to meshed autologous skin grafting and another compared ReCell head-to-head with skin grafting. Although the ReCell device was comparable to standard care on outcomes such as complete wound closure, confidence in the strength of the overall body of evidence is limited by individual study limitations and heterogeneity of populations, interventions, and outcome measures across studies. Additional RCT evidence in the intended use population is needed. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Dystrophic Epidermolysis Bullosa

For individuals who have dystrophic epidermolysis bullosa who receive OrCel, the evidence includes a case series. Relevant outcomes are symptoms, change in disease status, morbid events, and QOL. OrCel was approved under a humanitarian drug exemption for use in patients with dystrophic epidermolysis bullosa undergoing hand reconstruction surgery, to close and heal wounds created by the surgery, including those at donor sites. Outcomes have been reported in a small series (e.g., 5 patients). Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definiciones

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) includes all layers of the skin. Although autografts are the optimal choice for full thickness wound coverage, areas for skin harvesting may be limited, particularly in cases of large burns or venous stasis ulceration. Harvesting procedures are painful, disfiguring and require additional wound care.

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, but they must later be replaced by an autograft or the ingrowth of the patient’s own skin.

Bioengineered skin / cultured epidermal autografts (CEA) are autografts derived from the patient’s own skin cells grown or cultured from very small amounts of skin or hair follicle. Production time is prolonged. One such product is grown on a layer of irradiated mouse cells, bestowing some elements of a xenograft. Widespread usage has not been available due to limited availability or access to the technology.

Bioengineered Skin Substitutes or Cellular and Tissue Based Products (CTPs), referred to as Skin Substitutes by CMS, the Current Procedural Terminology (CPT) and the Healthcare Common Procedure Coding Manuals, have been developed in an attempt to circumvent problems inherent with autografts, allografts and xenografts. These constitute biologic covers for refractory wounds with full thickness skin loss secondary to 3rd degree burns or other disease processes such as diabetic neuropathic ulcers and the skin loss of chronic venous stasis or venous hypertension. The production of these biologic skin substitutes or CTPs varies by company and product but generally involves the creation of immunologically inert biological products containing protein, hormones or enzymes seeded into a matrix which may provide protein or growth factors proposed to stimulate or facilitate healing or promote epithelialization. A variety of biosynthetic and tissue-engineered skin substitution products marketed as Human Skin Equivalents (HSE) or Cellular or Tissue-Based Products (CTP) are manufactured under an array of trade names and marketed for a variety of indications. All are procured, produced, manufactured, processed and promoted in sufficiently different manners to preclude direct product comparison for equivalency or superiority in randomized controlled trials. Sufficient data is available to establish distinct inferiority to human skin autografts and preclude their designation as skin equivalence.

Bioengineered skin substitutes or CTPs are classified into the following types:

• Human skin allografts derived from donated human skin (cadavers)
• Allogeneic matrices derived from human tissue (fibroblasts or membrane)
• Composite matrices derived from human keratinocytes, fibroblasts and xenogeneic collagen
• Acellular matrices derived from xenogeneic collagen or tissue

Human skin allografts are bioengineered from human skin components and human tissue which have had intact cells removed or treated to avoid immunologic rejection. They are available in different forms promoted to allow scaffolding, soft tissue filling, growth factors and other bioavailable hormonal or enzymatic activity.

Allogeneic matrices are usually 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 implantation.

Composite matrices are 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 are derived from other than human skin and include the majority of bioengineered skin substitutes. All are composed of allogeneic or xenogeneic derived collagen, membrane, or cellular remnants proposed to stimulate or exaggerate the characteristics of human skin. All propose 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.

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: Esta lista de códigos no es exhaustiva y puede cambiar de vez en cuando según lo permita la ley o las pautas clínicas aplicables. La inclusión de un código en esta sección no constituye una garantía de cobertura o pago. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Covered when medically necessary, associated procedures:

Covered when medically necessary for breast reconstructive surgery using allogeneic acellular dermal matrix products:

Covered when medically necessary for treatment of dystrophic epidermolysis bullosa:

Covered when medically necessary for treatment of second- and third-degree burns:

En fase de investigación:

Referencias

1. Snyder DL, Sullivan N, Margolis DJ, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Program Project ID No. WNDT0818. (Prepared by the ECRI Institute-Penn Medicine Evidence-based Practice Center under Contract No. HHSA 290-2015-00005-I) Rockville, MD: Agency for Healthcare Research and Quality. February 2020. Available at: https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/skin-substitute_0.pdf. Accessed March 25, 2025.
2. Administración de Medicamentos y Alimentos de Estados Unidos. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use. December 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal. Accessed March 23, 2025.
3. Administración de Medicamentos y Alimentos de Estados Unidos. Executive Summary Breast Implant Special Topics. March 2019. https://wayback.archive-it.org/7993/20201226003814/https://www.fda.gov/media/122956/download. Accessed March 24, 2025.
4. U.S. Food & Drug Administration. Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety Communication. March 2021. https://www.fda.gov/news-events/fda-brief/fda-warns-about-differing-complication-rates-acellular-dermal-matrix-type-surgical-mesh. Accessed March 25, 2025.
5. Davila AA, Seth AK, Wang E, et al. Human Acellular Dermis versus Submuscular Tissue Expander Breast Reconstruction: A Multivariate Analysis of Short-Term Complications. Arch Plast Surg. Jan 2013; 40(1): 19-27. PMID 23362476
6. Ng TP, Loo BYK, Yong N, et al. Review: Implant-Based Breast Reconstruction After Mastectomy for Breast Cancer: A Meta-analysis of Randomized Controlled Trials and Prospective Studies Comparing Use of Acellular Dermal Matrix (ADM) Versus Without ADM. Ann Surg Oncol. May 2024; 31(5): 3366-3376. PMID 38285304
7. Lee KT, Mun GH. Updated Evidence of Acellular Dermal Matrix Use for Implant-Based Breast Reconstruction: A Meta-analysis. Ann Surg Oncol. Feb 2016; 23(2): 600-10. PMID 26438439
8. McCarthy CM, Lee CN, Halvorson EG, et al. The use of acellular dermal matrices in two-stage expander/implant reconstruction: a multicenter, blinded, randomized controlled trial. Plast Reconstr Surg. Nov 2012; 130(5 Suppl 2): 57S-66S. PMID 23096987
9. Hinchcliff KM, Orbay H, Buse S BK, et al. Comparison of two cadaveric acellular dermal matrices for immediate breast reconstruction: A prospective randomized trial. J Plast Reconstr Aesthet Surg. May 2017; 70(5): 568-576. PMID 28341592
10. Mendenhall SD, Anderson LA, Ying J, et al. The BREASTrial Stage II: ADM Breast Reconstruction Outcomes from Definitive Reconstruction to 3 Months Postoperative. Plast Reconstr Surg Glob Open. Jan 2017; 5(1): e1209. PMID 28203509
11. Mendenhall SD, Moss WD, Graham EM, et al. The BREASTrial Stage III: Acellular Dermal Matrix Breast Reconstruction Outcomes from 3 Months to 2 Years Postoperatively. Plast Reconstr Surg. Jan 01 2023; 151(1): 17-24. PMID 36194057
12. Davison SP, Harbour S, Fassihi E. Comparison of Different Acellular Dermal Matrix in Breast Reconstruction: A Skin-to-Skin Study. Aesthet Surg J. Jul 15 2024; 44(8): 829-837. PMID 38377366
13. Keane AM, Chiang SN, Tao Y, et al. Cortiva versus AlloDerm in Prepectoral and Partial Submuscular Implant-Based Breast Reconstruction: A Randomized Clinical Trial. Plast Reconstr Surg. Oct 01 2024; 154(4S): 13S-26S. PMID 38085977
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Historial de políticas

• MA 1.158
  • 03/09/2026 Nueva política. Full adoption (in conjunction with MA 1.167).
  • Actualización administrativa del 06/05/2026. Added codes 1044T-1049T. Vigente a partir del 07/01/2026.

Plans issued by Capital Blue Cross and it's subsidiaries are independent licensees of the Blue Cross Blue Shield Association. Comunicaciones emitidas por Capital Blue Cross en su condición de administrador de programas y relaciones con los proveedores para todas las empresas.

Programas de beneficios de atención de la salud emitidos o administrados por Capital Blue Cross y/o sus subsidiarias, Capital Advantage Insurance Company^®, Capital Advantage Assurance Company^® y Keystone Health Plan^® Central. Licenciatarios independientes de Blue Cross BlueShield Association. Comunicaciones emitidas por Capital Blue Cross en su condición de administrador de programas y relaciones con los proveedores para todas las empresas.