AMA and CMS Issue Final Physician Codes and Payment for DERMAGRAFT 2012
November 21, 2011
Westport, Conn. – November 21, 2011
Changes to streamline coding and reimbursement process for providers
Advanced BioHealing, Inc., Shire plc’s regenerative medicine business, today announced the American Medical Association (AMA) has assigned two new procedure codes for the application of DERMAGRAFT®, an FDA-approved living cell product for the treatment of diabetic foot ulcers.
The new Current Procedural Terminology (CPT) codes, which include CPT 15275 and 15276, are assigned a 0-day global period. These codes have no impact on DERMAGRAFT’s FDA-approved indication for treatment of diabetic foot ulcers, but will streamline the reimbursement process for providers and contractors, enabling physicians to receive appropriate compensation from Medicare and other insurers for each application of DERMAGRAFT, in accordance with its FDA-approved indication and directions for use of up to eight weekly applications over a twelve-week period.
“Diabetes is a growing epidemic and its complications, including diabetic foot ulcers, place a significant burden on patients and the U.S. healthcare system,” said Kevin Rakin, President of Regenerative Medicine for Shire. “Streamlining access to medical products like DERMAGRAFT will help improve the quality of care and reduce the costs to both the Medicare system and beneficiaries.”
The DERMAGRAFT product code (HCPCS Q4106) will remain unchanged.
The new CPT codes are:
- 15275—Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq. cm.; first 25 sq. cm. or less wound surface area
- 15276—Each additional 25 sq. cm. wound surface area, or part thereof (List separately in addition to code for primary procedure)
More than one 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.
Payment policies and rates adopted in the final rule will be effective for services on or after January 1, 2012.
These new codes, which will impact the application codes for all tissue cultured allogeneic skin or dermal substitute products, were established in the 2012 CPT Book from the AMA and were also included in the final Physician Fee Schedule ruling released by the Centers for Medicare and Medicaid Services (CMS) on November 1st, 2011.
For more information on the final ruling, please visit pages 511-513 and 549 at the following link: http://www.ofr.gov/OFRUpload/OFRData/2011-28597_PI.pdf.
About DERMAGRAFT®
DERMAGRAFT is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. DERMAGRAFT should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
DERMAGRAFT is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. DERMAGRAFT is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution.
About Advanced BioHealing, Inc.
Advanced BioHealing (ABH), became Shire’s regenerative medicine business following its acquisition in June 2011. ABH specializes in the development and commercialization of regenerative medicine treatments. ABH currently manufactures and markets DERMAGRAFT®, a bio-engineered skin substitute approved by the FDA for the treatment of diabetic foot ulcers. DERMAGRAFT contains fibroblasts that secrete human dermal collagen, matrix proteins and growth factors. The Company maintains its corporate office in Westport, Conn. with additional sites in San Diego, Calif. and Nashville, Tenn. To learn more about ABH, please visit www.ABH.com.
About Shire plc
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company’s website: www.shire.com.
“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.
