Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products in orthopedics, sports medicine and wound care, announced today that, on November 27, 2013, the Centers for Medicare and Medicaid Services (CMS) released their proposed ruling for the reimbursement of skin substitutes in the hospital outpatient setting. CMS decided to package the reimbursement for products used in advanced wound care with the related surgical procedure into a two-tier system.
The proposed ruling means that the current payment methodology for Grafix® will not immediately be impacted by the changes described in the proposed ruling. Grafix will maintain its current transitional pass-through status and that may continue until late 2015. Grafix will be exempt from the current rule and available to patients in the Hospital Outpatient Department and Ambulatory Surgical Center settings under the current Ambulatory Payment Classification payment system. Once the transitional pass-through status expires, Osiris expects Grafix to be reimbursed as a part of a packaged rate in the higher tier of the two-tier system.
"We are very well-positioned to gain market share in the chronic wound market place," said Frank Czworka, General Manager of Wound Care for Osiris. "The overwhelming efficacy demonstrated in the controlled, randomized, multicenter study, combined with our multiple size offerings of Grafix, provides clinical and cost-effective solutions for our patients, physicians and payers."