GAITHERSBURG, MD, September 18, 2013 -- 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/.
Cytomedix management and advisors also held a meeting with CMS to explain more fully the resource requirements for AutoloGel use and why the requested change to APC 0135 is appropriate. CMS is expected to announce final regulations in November, and the coding and reimbursement determinations in the final regulations will take effect January 1, 2014.
Reimbursement for AutoloGel in physicians' offices is covered by a separate proposed rule issued by CMS in July, which reaffirms CMS's current payment policy in this care setting. This proposed rule allows Medicare Administrative Contractors to determine the payment amount for AutoloGel for claims submitted from physician offices. Historically, Medicare contractors have paid these types of claims based on product invoices presented by the healthcare provider.
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.
Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds and the Angel® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood or a mixture of blood and bone marrow, into red cells, platelet poor plasma ("PPP") and PRP in surgical settings. For additional information please visit cytomedix.com.
Safe Harbor Statement - Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, and thereafter, to successfully negotiate with physician offices as anticipated and to realize the anticipated sales growth from such treatments; to meet its stroke trial enrollment rates, to successfully realize sales of the Angel Technology resulting in the royalty stream to the Company, the Company's ability to successfully integrate the Aldagen acquisition, the Company's ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company's expectations of favorable future dialogue with potential strategic partners, and its ability to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes", "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2012, as amended to date, and other subsequent filings. These filings are available at www.sec.gov.
Chief Executive Officer
Steven A. Shallcross
EVP/Chief Financial Officer
LifeSci Advisors, LLC
SOURCE: Cytomedix, Inc.