Navigation Links
Apligraf Reimbursement to Benefit from New CMS Codes
Date:11/10/2010

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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Apligraf® Approved by Saudi Food and Drug Authority for Treatment of Chronic Wounds
2. UK Pharmaceutical Market Overview - Pricing and reimbursement challenges dampen future growth
3. Uroplasty Inc. Announces CPT® Category I Code and Associated Reimbursement Value for Posterior Tibial Nerve Stimulation
4. Local Chinese Government Authorities Approve Pricing and Reimbursement for NeoStems Licensed Adult Stem Cell Treatments for Orthopedic Applications in China
5. Medical Technology, Funding & Government Experts Address Business, Investment, Reimbursement, Compliance, Innovation, Regulatory and Legal Issues at AdvaMed 2010
6. Concentric Medical Announces Product and Procedure Reimbursement as Well as Full Commercialization of the Merci Retriever® in Japan
7. WATCHMAN® Receives German Reimbursement Coverage
8. Will MHLW Changes in Reimbursement Drive Japanese Physicians to Increase Usage of Chronic Dialysis Catheters?
9. Millennium Laboratories, Inc. Urges Medicare to Reconsider the 2010 Physician Reimbursement for Point-of-Care Urine Drug Screen Devices
10. Dr. Robert J. Rubin to Join Halt Board as Reimbursement Advisor
11. Schwarz Pharma Pays $22 Million to Settle False Claims Allegations Concerning Reimbursement for Unapproved Drugs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... -- Global Hospital Linen Supply and Management Services Market: ... supply and management services market presents a comprehensive analysis ... regional level. The study provides historic data of 2015 ... 2024 based on revenue (US$ Bn). The drivers and ... their impact on demand during the forecast period have ...
(Date:12/7/2016)... Dec. 7, 2016  Palatin Technologies, Inc. ("Palatin") ... on a previously disclosed underwritten public offering of ... acted as sole book-running manager, Roth Capital Partners ... acted as co-manager for the offering. ... in net proceeds, allowing us to continue advancing ...
(Date:12/7/2016)... 2016  Northwest Biotherapeutics (Nasdaq: NWBO ... company developing DCVax® personalized immune therapies for solid ... has not accepted the Company,s plan of remediation ... and the Company has notified Nasdaq of its ... from listing on Nasdaq.  Upon withdrawal from Nasdaq, ...
Breaking Medicine Technology:
(Date:12/7/2016)... Valley, CA (PRWEB) , ... December 07, 2016 , ... ... be used in several ways to restore a more youthful appearance to the face. ... now offer Sculptra, along with a variety of other treatments, to rejuvenate and renew ...
(Date:12/7/2016)... ... ... When it came time to blow out his candles on his 14th birthday, Estefano Reano ... Transplant team at Joe DiMaggio Children’s Hospital surprised his family with a phone call ... recipient. , “He was playing at home, when we got the phone call telling ...
(Date:12/7/2016)... ... December 07, 2016 , ... Augustine Insurance Agency, ... families and business owners in the greater Dallas metropolitan area, is announcing a ... Officer Foundation. , Established in 2009 by active police professionals in the Dallas ...
(Date:12/7/2016)... , ... OCTOBER XX, 2016 (PRWEB) (PRWEB) December ... ... another mystery. A new study entitled “Canine Filamentous Dermatitis Associated with Borrelia ... occur in dogs. The study was published in the prestigious Journal of Veterinary ...
(Date:12/7/2016)... Phoenix, Arizona (PRWEB) , ... December 07, 2016 , ... ... Juvederm®, Just in Time For The Holiday Party Season. Save Up To 33% Off ... and Laser Salon is providing the Phoenix Valley with Delightful Deals on ...
Breaking Medicine News(10 mins):