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CMS Proposes Updated Dermagraft Coding for 2011

Proposed coding to streamline reimbursement process for Medicare providers


Westport, Conn. – July 6, 2010 – Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced that the Centers for Medicare and Medicaid Services (CMS) has proposed to create a new G-code for the application of Dermagraft® with a 0-day global period for calendar year 2011. This proposal was included in the Medicare Physician Fee Schedule Proposed Rule released on Friday, June 25, 2010.

Dermagraft, a bio-engineered skin substitute approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetic foot ulcers, is indicated for up to eight weekly applications over a twelve-week period.

In the proposed rule, CMS noted the importance of “ensuring that skin substitutes are properly utilized for Medicare beneficiaries who will benefit from that treatment.”

“ABH has been actively working with CMS officials to advocate for the creation of G-codes for Dermagraft to be consistent with the FDA-approved use of the product and to allow appropriate payment with the least administrative burden for Medicare providers and contractors. This proposed rule is a significant step in that direction,” said Kevin Rakin, Chairman and Chief Executive Officer for ABH. “Diabetes and diabetic foot ulcers continue to be an epidemic in the U.S. and around the world, so anything that can be done to streamline access to advanced therapies like Dermagraft will help reduce the need for lower extremity amputation and subsequent additional health care costs for both Medicare and beneficiaries.”

More than 1 million physicians and health care professionals are paid under Medicare’s fee schedule, and its rules cover more than 7,000 types of services in physician offices, hospitals and other health care settings.

CMS will accept comments on the proposed rule until August 24, 2010, and will respond to them in a final rule to be issued by November 1, 2010.  Payment policies and rates adopted in the final rule will be effective for services on or after January 1, 2011.

This proposed rule impacts only the application code for Dermagraft; the product code (HCPCS Q4106) will remain unchanged.

For more information on this proposed change, please visit page 226 at the following link:
http://federalregister.gov/OFRUpload/OFRData/2010-15900_PI.pdf

About Advanced BioHealing, Inc.
Advanced BioHealing develops and commercializes living cell therapies that repair damaged human tissue and enable the body to heal itself. A privately held company, Advanced BioHealing maintains its corporate office in Westport, Conn. with additional sites in La Jolla, Calif. and Nashville, Tenn. To learn more about Advanced BioHealing, please visit the Company’s web site at www.ABH.com.

About Dermagraft®
Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial in subjects with venous leg ulcers (VLUs) to assess the product’s safety and efficacy in the promotion of healing VLUs. To date, more than 200,000 applications of Dermagraft have been administered in over 1,000 wound care centers and outpatient clinics nationwide. For videos of Dermagraft in action, case studies, research and more, visit www.Dermagraft.com.

Media Contacts:

  • Lindsey Hart
    • Advanced BioHealing
    • lhart@abh.com
    • Direct: (773) 697-3838
    • Cell: (206) 335-0114
  • Mike Lizun