GAITHERSBURG, MD -- (Marketwired) -- 09/18/13 --
Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet technologies, today provided an update on recent progress in attaining appropriate reimbursement for AutoloGel™ in the Medicare Hospital Outpatient Prospective Payment System (HOPPS). The Company has filed public comments with the Centers for Medicare and Medicaid Services (CMS) on the previously announced proposed rules for HOPPS and recently held a direct meeting with CMS. Based on these interactions, Cytomedix believes that CMS now has all the information required to make a final and fully informed decision on AutoloGel reimbursement in the hospital outpatient setting.
Martin Rosendale, Chief Executive Officer of Cytomedix commented: "We have made significant progress in communicating our recommendations to CMS and we believe that we are moving in the right direction in terms of achieving adequate reimbursement for AutoloGel in the hospital outpatient setting. We have specifically requested the reassignment of AutoloGel to an appropriate Ambulatory Payment Classification (APC), which is used to determine Medicare hospital outpatient reimbursement. We believe that it is in line with CMS's wishes and overall purpose for the previously issued National Coverage Decision to be implemented successfully in all sites of care, and that CMS will agree to an appropriate APC assignment in their final decision later this year."
CMS agreed to provide reimbursement for AutoloGel™ for Medicare patients with chronic wounds under its Coverage with Evidence Development (CED) program in a National Coverage Determination (NCD) memo issued in 2012. In July this year, CMS issued a proposed rule that placed the reimbursement code for AutoloGel (G0460) in an Ambulatory Payment Classification (APC 0013) that, for the period July 1 to December 31 2013, provides limited reimbursement for use of the product in the hospital outpatient setting. Cytomedix has requested that this proposed rule be revised so as not to deny any Medicare beneficiaries' access to AutoloGel.
The public comments by Cytomedix have been submitted in the form of a detailed letter to CMS that makes the following points: 1) the coding and payment in the proposed CMS rule would result in Medicare hospital outpatient reimbursement for AutoloGel below the rate that any platelet-rich plasma product meeting the NCD's criteria can be produced, 2) the proposed APC 0013 bundle, which typically covers procedures relating to preparation of wound treatment, is inappropriate for AutoloGel and does not adequately reflect the complexity of treating patients with the product, and 3) AutoloGel should be permanently reassigned to APC 0135 (Level IV skin repair) thereby aligning it with procedures that have comparable clinical and resource requirements. Cytomedix's objective, in submitting these comments, is to achieve an APC assignment that will allow for reimbursement that is economically viable for hospitals. For the complete text of the letter, investors should refer to the Company's website at the following link: www.cytomedix.com/investors/investor-communications/.