Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and commercializing products to treat medical conditions in inflammatory, cardiovascular, orthopedic, and wound healing markets, announced today that it has received transitional pass-through status from the Center for Medicare & Medicaid Services (“CMS”), with C-Codes being designated for Grafix®. Further, the product has been assigned pass-through status under Medicare's outpatient prospective payment system (“OPPS”), effective July 1, 2012. These codes will assist in facilitating reimbursement when Grafix products are used to treat Medicare patients with acute and chronic wounds in the hospital outpatient department and ambulatory surgical center settings.
“We are very pleased with CMS, and their decision to assign pass-through codes for our Grafix line of Biosurgery products,” said Frank Czworka, Executive Director, Wound Care of Osiris Therapeutics. “This step will allow more Medicare patients and their providers to have greater access to these next-generation regenerative medicine products."
CMS also issued a preliminary positive decision for the assignment of permanent Healthcare Common Procedure Coding System (HCPCS) Q-codes for Grafix. If the decision is made permanent, it is anticipated that the Q-codes would be available starting in January 2013. The assignment of unique Q-codes will assist in facilitating reimbursement in the physician office setting, offering additional access for Medicare patients.
Non-healing wounds remain a serious unmet medical need and result in over 100,000 amputations each year in the United States alone. Current treatment options include growth factors and bioengineered dressings. However, when chronic wounds fail to respond to current standards of care, new advances are needed. Research shows that mesenchymal stem cells (MSCs) in normal skin play a critical role in the wound healing process. Grafix is the only commercially available product that provides viable, endogenous MSCs together with growth factors and an optimal tissue matrix, making it well suited to promote active dermal healing.