Apligraf Reimbursement to Benefit from New CMS Codes

CANTON, Mass., Nov. 10, 2010 /PRNewswire/ -- Organogenesis, Inc. announced today that Apligraf®, the only product with FDA approval for the treatment of both diabetic foot ulcers and venous leg ulcers, will have two new procedure codes assigned by the Centers for Medicare & Medicaid Services (CMS) as of January 2011. The new codes will enable physicians to receive appropriate reimbursement for each application of Apligraf in accordance with its FDA labeling criteria, which includes weekly assessment and up to 5 applications as needed.

The new Healthcare Common Procedure Coding System (HCPCS) codes will include site preparation and debridement and 0-day global billing period. The new codes are:

• G0440 (Application of tissue cultured allogeneic skin substitute or dermal substitute; for use on lower limb, includes the site preparation and debridement if performed; first 25 sq cm or less) and;
• G0441 (Application of tissue cultured allogeneic skin substitute or dermal substitute; for use on lower limb, includes the site preparation and debridement if performed; each additional 25 sq cm).

As part of its annual rulemaking process, CMS reviewed feedback from key stakeholders, noting that:

"…some stakeholders believe that the current coding and payment provides a financial incentive for the selection of one tissue cultured product over another, rather than facilitating clinical decision-making based solely on the most clinically appropriate product for the patient's case."

The new codes were created to address inconsistencies in valuing the use of bioengineered skin substitutes for the treatment of chronic wounds. For example, some application codes allowed for separate billing of site preparation and debridement, whereas Apligraf's application codes already included site preparation and debridement.

"Under the new codes, physicians will be reimbursed fairly for each application of Apligraf as directed by our FDA labeling, based on our pivotal clinical trials," stated Geoff MacKay, CEO of Organogenesis. "The new codes, together with a 0-day global billing period, will eliminate unequal financial incentives in the selection of products for the treatment of chronic wounds as well as help ensure that physicians make their treatment decisions based solely on clinical benefit."

Apligraf is the first bio-engineered living cell-based product to have received FDA approval for treatment of diabetic foot ulcers and venous leg ulcers. Clinical studies of Apligraf application were based on up to 5 treatments, comprising weekly assessments and/or applications, over a 12-week period. Over 350,000 Apligraf units have been shipped to date, reaching patients around the world.

About Apligraf

Apligraf contains two layers of human living cells: a layer of differentiated keratinocytes and a layer of fibroblasts in a collagen matrix. When placed on a wound previously unresponsive to treatment, Apligraf provides cells, collagen matrix and other proteins that provide a covering that has been demonstrated to promote healing. In multiple controlled clinical studies, Apligraf has been shown to be an effective and safe wound care treatment, superior to conventional treatments.

About Organogenesis, Inc.

Having pioneered the field, Massachusetts-based Organogenesis, Inc. is a leading regenerative medicine company focused in the areas of bioactive wound healing, oral tissue regeneration and bio-surgery. The company's mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care. For more information, visit www.organogenesis.com.   

SOURCE Organogenesis, Inc.