Signature APatch

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Signature APatch, per square centimeter

Signature APatch is a cryopreserved, minimally manipulated amniotic membrane allograft for homologous use as a wound barrier (cover) or covering (physical barrier).

INTENDED USE: Signature APatch is a precision cut matrix, designed for application directly to acute or chronic wounds to establish a cover or barrier. This includes but is not limited to: venous leg ulcers, pressure ulcers, diabetic foot ulcers, surgical wounds, burns, and wounds with exposed tendon, muscle, and/or bone. It is directly applied to the wound weekly for up to 12 weeks or until the wound is closed as a part of a semi-wet dressing standard of care.

CLAIMED BENEFITS: The hexagon shape allows for coverage over many wound shapes and multi-directional expansion to cover unique wound sizes and morphology.

OPTION: Signature APatch is produced in a single size configuration: hexagon patch with 2.5 cm sides, measuring 5.0 cm in diameter, and a total surface area of 16 cm squared. Signature APatch is supplied as a cryopreserved tissue, prepared and packaged aseptically in a 15 mL cryovial. Signature APatch is thawed in a sterile gloved hand for 5 minutes, applied to a wound or injury site using sterile forceps following wound preparation. Signature APatch may be cut and shaped to appropriate size for application, may be used with tissue adhesives or semi-wet dressings to apply the allograft to the site if necessary.

Signature APatch, 2.5cm sides, 5.0cm diameter: Q4260

Product Information

The addition of Skin Substitutes or Cellular or Tissue Based Products (CTPs) to certain wounds may afford a healing advantage over dressings and conservative treatments when these options appear insufficient to affect complete healing, after at least a 30 day period of comprehensive conservative therapy. There are currently a wide variety of bioengineered products available for soft tissue coverage to affect closure. • Human skin allografts are derived from donated human skin (cadavers) • Allogeneic matrices are derived from human tissue (fibroblasts or membrane) • Composite matrices are derived from human keratinocytes, fibroblasts and xenogeneic collagen • Acellular matrices are derived from xenogeneic collagen or tissue

Pricing and Suppliers

Is it covered by Medicare Part B?

Medicare covers the application of Cellular and Tissue Based Products (CTPs) for chronic Wounds, which are defined as wounds that do not respond to standard wound treatment for at least a 30 day period during organized comprehensive conservative therapy. Medicare has guidelines that establish what is considered medically necessary and how often an item can be used.

How can I purchase this product?

For Medicare to cover this product, it needs to be ordered and applied by your clinician. A patient cannot purchase it directly from a Durable Medical Equipment (DME) store and receive reimbursement for it.

The table below shows highest and lowest Medicare pricing across the country

Description	Medicare DME co-payment Min / Max
	$0.00 / $0.00

Estimated out-of-pocket cost:

If your insurance does not cover this product, you can purchase it directly from any store. A list of online stores and prices is provided below for your convenience. For updated prices, find it on the internet at https://woundreference.com/app/product?id=3393

Other Stores

* Indicates whether store accepts Medicare or commercial insurance, but may not apply to this specific product. See coding, coverage and reimubursement for more information.

The information on this handout is for your convenience and educational purposes only. All product claims and specifications are those of the product suppliers. It does not constitute medical advice or a guarantee for reimbursement. Prices may have changed and suppliers may not have product in stock. Please confirm accuracy and appropriateness of information with insurance carrier and product supplier. Clinician and WoundReference assume no liability for inaccuracies or misstatements about products and insurance coverage.