MARIETTA, Ga., March 13, 2014 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that Medicare contractor, First Coast Service Options, Inc. ("FCSO"), has confirmed that the Company's wound care allograft, EpiFix®, has been approved for coverage when applied in the hospital outpatient and ambulatory surgery center settings.
The coverage from FCSO is effective immediately, and it completes the nationwide coverage of EpiFix from all Medicare Administrative Contractors (MACs) having jurisdiction within the United States. The FCSO jurisdiction is the State of Florida, Puerto Rico and the U.S. Virgin Islands.
In November 2013, the Centers for Medicare and Medicaid Services ("CMS") issued its Hospital Outpatient Prospective Payment System (OPPS) Final Rule, regarding the packaging of the reimbursement for certain products used in advanced wound care with the related surgical procedure. This change in methodology by CMS was effective January 1, 2014. FCSO also retired its local coverage determination ("LCD") for Hospital Outpatient Department and Ambulatory Surgery Center Setting – Part A Coverage, effective January 1, 2014. FCSO has confirmed that EpiFix is now covered in Florida based on "reasonable and medically necessary" clinical use. As such, EpiFix coverage is approved by FCSO for the product use as prescribed by the physician when the reasonable and medically necessary threshold is met.
"We are very pleased that we now have successfully secured EpiFix coverage from all of the MACs," said Parker H. "Pete" Petit, Chairman and CEO. "We know that being awarded MAC coverage is largely dependent upon the body of clinical evidence demonstrating the clinical effectiveness of the product or service. We are gratified by the fact that the excellent results from our randomized controlled clinical studies have contributed to the coverage adoption by the MACs."
Bill Taylor, President and COO, commented, "We are continuing to aggressively focus on state Medicaid Programs and commercial health plans. We are approaching these health plans with the same concentrated effort as we applied in securing the coverage awards from the MACs. We expect to see a sizable number of additional regional and national commercial health plans and state Medicaid programs replicate the coverage decisions put forth by the MACs."
Petit added, "At this stage, we have secured EpiFix coverage and are receiving reimbursement from approximately 100 commercial health plans and state Medicaid Programs. EpiFix is covered for the Blue Cross and Blue Shield members in 23 states and coverage is provided for the members in more than 65 additional commercial health plans. EpiFix also has coverage from 16 state Medicaid Programs. During the past week, EpiFix coverage was confirmed from four of the above commercial plans and two of the 16 state Medicaid Programs."
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include AmnioFix® and EpiFix®, our tissue technologies processed from human amniotic membrane that is derived from donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® process, to produce a safe and effective implant. MiMedx® is the leading supplier of amniotic tissue, having supplied over 200,000 allografts to date for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the clinical effectiveness of EpiFix® and the prospect of additional reimbursement approvals from a sizeable number of commercial health care plans and state Medicaid programs, and the opportunities presented by the additional coverage determinations. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that other commercial plans and state Medicaid programs will not approve EpiFix for reimbursement coverage or that the conditions to coverage or the reimbursement rate will be less favorable than anticipated, that we will be unable to capitalize on the opportunity for expanded sales of our EpiFix allografts, that EpiFix will not prove to be as clinically and cost effective as anticipated or will not gain acceptance as anticipated in the medical community, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2013. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.
SOURCE MiMedx Group, Inc.