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This policy contains information which Homemade mature wife swap orgy clinical in nature.

The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the Dermal substitute breast reconstruction policy of a Wellmark member's health Dermal substitute breast reconstruction policy plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional.

If you would like to request an accessible version of this document, please contact customer service at Benefit determinations are based on the applicable contract language in effect at the time the services were rendered.

Exclusions, limitations or exceptions may apply. Benefits may Dermal substitute breast reconstruction policy based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable.

This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program. This Medical Policy 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 will be reviewed regularly and be updated as scientific and medical literature Dermal substitute breast reconstruction policy available. A wide variety of wound care products are available for clinicians to choose from when treating chronic wounds and during breast reconstruction. Many of these products are said to mimic or substitute for some aspect of the skin's structure and function to promote healing and wound closure.

The materials Dermal substitute breast reconstruction policy to produce these products may be derived from human or animal tissue and may undergo extensive or minimal processing to make the finished product.

The extent of processing and the source of the material used in the product also determines what regulatory pathway may be required before the product can be marketed. For individuals who are undergoing breast reconstruction who receive allogeneic ADM products, the evidence incudes randomized controlled trials RCTs and systematic reviews.

Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. A systematic review found no difference in overall complication rates with ADM allograft compared with standard procedures for Dermal substitute breast reconstruction policy 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.

The evidence Dermal substitute breast reconstruction policy sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have diabetic lower-extremity ulcers who receive skin substitues, the evidence includes several RCTs. Relevant outcomes are disease-specific survival, symptoms, change in disease status, morbid events, and quality of life. RCTs have demonstrated the efficacy of products over the standard of care. Studies are needed to further define the population who might benefit from this treatment with various products. Additional studies with a larger number of subjects is needed to evaluate the effects compared with current SOC or other advanced wound therapies.

For individuals who have lower-extremity ulcers due to venous insufficiency who receive certain products, the evidence includes RCTs. RCTs have demonstrated the efficacy over the standard of care for certain products.

For individuals who have dystrophic epidermolysis bullosa who receive certain products, the evidence includes only case series. Relevant outcomes are symptoms, change in disease status, morbid events, and quality of life. 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 small series eg, 5 patients. The evidence is insufficient to determine Dermal substitute breast reconstruction policy effects of the technology on health outcomes. For individuals who have deep dermal burns who receive bioengineered skin substitutes, the evidence includes RCTs.

Relevant outcomes are disease-specific Dermal substitute breast reconstruction policy, symptoms, change in disease status, morbid events, functional outcomes, quality of life, and treatment-related morbidity.

Overall, few skin substitutes have been approved, and the evidence is limited for each product. For information regarding the use of amniotic patches for ophthalmologic use, Dermal substitute breast reconstruction policy fluid, and amniotic fluid injectable products please see policy Use of skin substitues specifically to make the reconstructive procedure more convenient in the absence of the above conditions is considered not medically necessary.

Treatment of chronic, non-infected, partial or full-thickness lower extremity skin ulcers Brad pitt naked sunbathing to venous insufficiency utilizing the following specific products:.

Treatment of dystrophic epidermolysis bullosa wounds 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 FDA:. Treatment of children with recessive epidermolysis bullosa who are undergoing reconstructive hand surgery using the following tissue-engineered skin substitute may be considered medically necessary:.

Treatment of second and third degree burns using the following tissue-engineered skin substitutes may be considered medically necessary:. Treatment of fresh, clean, split-thickness donor site wounds in burn victims using the following tissue-engineered skin substitute may be considered medically necessary:.

If any of the following characteristics are not met, the use of a skin substitute does not have an ideal environment for success. The use of a skin substitute will be denied as not medically necessary. Repeat applications of skin substitutes are not indicated when previous applications were unsuccessful.

Unsuccessful treatment is defined in this situation as increase in size or depth of a wound or ulcer, or no change in baseline size or depth and no sign of improvement.

Retreatment in this scenario is considered not medically necessary. Sexy milf mom short dress Response — 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 i. Repeat use of any skin substitute when treatment has been unsuccessful is considered not medically necessary.

Unsuccessful treatment — defined as increase in size or depth of an ulcer or no change in baseline size or depth and no sign of improvement or indication that improvement is likely such as granulation, epithelialization or progress towards closing for a period of 4 weeks past start of therapy.

All other uses of the bio-engineered skin and soft tissue substitutes are considered investigationalincluding but not limited to:. The literature is inadequate and frequently biased for the studies that do exist. There is an inability to define the success of one product vs another in many of the conditions listed. In spite of their Tamil actress sehan nude pics efficacy in some clinical trials, there remains a paucity of good quality randomized controlled trials RCTs contributing to the evidence based use of skin substitutes and even fewer studies comparing products to each other.

The evidence of efficacy is insufficient and therefore, these indications are considered investigational. Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice.

Wellmark medical policies contain only Dermal substitute breast reconstruction policy partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot Dermal substitute breast reconstruction policy any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating Dermal substitute breast reconstruction policy are solely responsible for medical advice and treatment of members.

Our medical policies may be updated and therefore are subject Dermal substitute breast reconstruction policy change without notice.

Benefit Application: Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Description: A wide variety of wound care products are available for clinicians to choose from when treating chronic wounds and during breast reconstruction.

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 Dermal substitute breast reconstruction policy treatment of full-thickness skin and soft tissue loss.

Most are biodegradable and disappear after 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. All are proposed to promote healing by the creation of localized intensification of an array of hormonal and enzymatic activity Dermal substitute breast reconstruction policy accelerate closure by migration of native dermal and epithelial components, rather than function as distinctly incorporated tissue closing the skin defect.

Breast Reconstruction For individuals who are undergoing breast reconstruction who receive allogeneic ADM products, the evidence incudes randomized controlled trials RCTs and systematic reviews. Diabetic Lower-Extremity Ulcers For individuals who have diabetic lower-extremity ulcers who receive skin substitues, the evidence includes several RCTs.

Lower-Extremity Ulcers due to Venous Insufficiency For individuals who have lower-extremity ulcers due to venous insufficiency who receive certain products, the evidence includes RCTs. Dystrophic Epidermolysis Bullosa For individuals who have dystrophic epidermolysis bullosa who receive certain products, the evidence includes only case series. Burns For individuals who have deep dermal burns who receive bioengineered skin substitutes, the evidence includes RCTs. AND The ulcer must extend through the dermis but not expose tendon, muscle, joint capsule, or bone.

AND There must be adequate blood supply as evidenced by a palpable pedal pulse or by an ankle-brachial index ABI of 0.

AND Repeat application without improvement of the wound is considered not medically necessary. Improvement must be evidenced by measurements and additional documentation. Repeat Application Repeat applications of skin substitutes are not indicated when previous applications were unsuccessful. Doumentation Requirements Medical record documentation must clearly document the medical necessity of the bioengineered skin substitute application.

This would include wound measurements and evidence Dermal substitute breast reconstruction policy prior ineffective wound care, or for repeat application prior care with skin substitute that demonstrates success. Documentation must confirm and Dermal substitute breast reconstruction policy characteristics of the ulcer, the presence of qualifying or disqualifying conditions, and the nature of and the duration of pretreatment conservative treatment.

Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care Feb;24 2 Streit M, Barathen LR. Apligraf-a living human skin equivalent for the treatment of chronic wounds. International Journal of Artificial Organs Dec;23 12


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