Theramend

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Theramend, 2x2cm

TheraMend is a patch product made from minimally processed, dehydrated amniotic membrane obtained from donated human tissue and is sterilized via gamma irradiation. It is an allogeneic matrix cellular and tissue-based skin substitute for wound healing.

INTENDED USES: Indications for use include topical wound covering or barrier for acute or chronic wounds.

CLAIMED BENEFITS: TheraMend is for single patient, one-time, homologous use only. TheraMend is applied directly to the wound and can be meshed or fenestrated as needed for drainage. The decision to alter the product for wound drainage is to be made by the healthcare practitioner and done in such a way to maintain sterility of the product. TheraMend is intended to be applied to the moist wound environment and can be hydrated with sterile saline if the healthcare practitioner deems it necessary for appropriate application. TheraMend may be applied for the duration of the wound or in an interval approved by the health care practitioner. The dose or sizing of the selected TheraMend is dependent on the wound size. TheraMend is packaged in single, one-time-use pouch, which is heat sealed to maintain a secure barrier and sterilized by gamma irradiation to meet a sterility assurance level of 10-6. Once opened, TheraMend should be used immediately or discarded to prevent contamination. TheraMend can be stored in the sealed packaging at ambient temperature.

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=3893

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.