GAITHERSBURG, MD -- (Marketwire) -- 03/18/13 -- Cytomedix, Inc. (OTCQX: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that the Center for Medicare & Medicaid Services (CMS) has issued reimbursement coding and claims payment instructions to its regional contractors for the use of autologous PRP in chronic non-healing wounds. The assignment of a Healthcare Common Procedure Coding System (HCPCS) code establishes the reimbursement mechanism for physicians and other providers submitting claims for services provided to Medicare beneficiaries. A new HCPCS code, G-0460, has been assigned for:
"Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment."
Martin Rosendale, Chief Executive Officer of Cytomedix, commented, "The assignment of a HCPCS code for the use of AutoloGel is another critical element to the near term clinical treatment of chronic non-healing wounds with commercial reimbursement. We recently received protocol approval under the Coverage with Evidence Development (CED) program, and detailed coding and payment instructions have now been issued to CMS' regional contractors and fiscal intermediaries. Our interaction with CMS continues to be productive and appropriately collaborative. We are enthusiastic that Medicare beneficiaries will soon be treated with AutoloGel and look forward to this opportunity to improve the health outcomes of patients dealing with non-healing chronic wounds."
The assigned "G" code is a temporary code that will be used for the coverage of both the service and product initially. In addition to the "G" code, all Medicare claims submissions for treatments using the AutoloGel System will include an identification number that is specific for AutoloGel and the appropriate protocol. Medicare contractors have been instructed to pay claims in the following care settings: hospital outpatient departments, skilled nursing facilities, rural health clinics, comprehensive outpatient rehabilitation facilities, federally qualified health centers, and critical access hospitals. Claims processing will begin with an implementation date of July 1, 2013 for claims with dates of service after August 2, 2012.
About The AutoloGel System
The AutoloGel System utilizes a proprietary unique technology that enables the rapid isolation and activation of PRP from a patient's own blood. The PRP is subsequently processed to produce a bioactive gel for application to the wound bed, re-establishing a balance needed for natural healing to occur. In normal healing, platelets migrate from the blood into the wound site where they serve as the primary source of growth factors for effective wound healing. In chronic wounds, blood supply may be impaired and the delivery of platelets is impeded, disallowing adequate concentrations of growth factors.
The AutoloGel System is used at the point-of-care and is the only PRP system cleared by the U.S. Food and Drug Administration for use on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and for the management of mechanically or surgically-debrided wounds. Cytomedix's clinical studies have shown that AutoloGel rapidly and more effectively improved healing compared with control-treated wounds. This has been demonstrated in a variety of clinical studies including a systematic review of 21 comparison studies and a number of other observational and case series publications as well.
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