Welcome!

News Feed Item

MiMedx EpiFix® Allograft Receives Medicare Coverage From The Final Medicare Contractor

EpiFix® Now Has Coverage From All Medicare Contractors In All 50 states

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."

About MiMedx

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.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
"We're focused on how to get some of the attributes that you would expect from an Amazon, Azure, Google, and doing that on-prem. We believe today that you can actually get those types of things done with certain architectures available in the market today," explained Steve Conner, VP of Sales at Cloudistics, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
As organizations shift towards IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. Commvault can ensure protection, access and E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his general session at 18th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Part...
Andi Mann, Chief Technology Advocate at Splunk, is an accomplished digital business executive with extensive global expertise as a strategist, technologist, innovator, marketer, and communicator. For over 30 years across five continents, he has built success with Fortune 500 corporations, vendors, governments, and as a leading research analyst and consultant.
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Archi...
"We're here to tell the world about our cloud-scale infrastructure that we have at Juniper combined with the world-class security that we put into the cloud," explained Lisa Guess, VP of Systems Engineering at Juniper Networks, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Hardware virtualization and cloud computing allowed us to increase resource utilization and increase our flexibility to respond to business demand. Docker Containers are the next quantum leap - Are they?! Databases always represented an additional set of challenges unique to running workloads requiring a maximum of I/O, network, CPU resources combined with data locality.
The current age of digital transformation means that IT organizations must adapt their toolset to cover all digital experiences, beyond just the end users’. Today’s businesses can no longer focus solely on the digital interactions they manage with employees or customers; they must now contend with non-traditional factors. Whether it's the power of brand to make or break a company, the need to monitor across all locations 24/7, or the ability to proactively resolve issues, companies must adapt to...
In his session at 20th Cloud Expo, Brad Winett, Senior Technologist for DDN Storage, will present several current, end-user environments that are using object storage at scale for cloud deployments including private cloud and cloud providers. Details on the top considerations of features and functions for selecting object storage will be included. Brad will also touch on recent developments in tiering technologies that deliver single solution and an end-user view of data across files and objects...
"Cloud computing is certainly changing how people consume storage, how they use it, and what they use it for. It's also making people rethink how they architect their environment," stated Brad Winett, Senior Technologist for DDN Storage, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settl...
"Venafi has a platform that allows you to manage, centralize and automate the complete life cycle of keys and certificates within the organization," explained Gina Osmond, Sr. Field Marketing Manager at Venafi, in this SYS-CON.tv interview at DevOps at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Digital transformation has increased the pace of business creating a productivity divide between the technology haves and have nots. Managing financial information on spreadsheets and piecing together insight from numerous disconnected systems is no longer an option. Rapid market changes and aggressive competition are motivating business leaders to reevaluate legacy technology investments in search of modern technologies to achieve greater agility, reduced costs and organizational efficiencies. ...
For far too long technology teams have lived in siloes. Not only physical siloes, but cultural siloes pushed by competing objectives. This includes informational siloes where business users require one set of data and tech teams require different data. DevOps intends to bridge these gaps to make tech driven operations more aligned and efficient.
Organizations planning enterprise data center consolidation and modernization projects are faced with a challenging, costly reality. Requirements to deploy modern, cloud-native applications simultaneously with traditional client/server applications are almost impossible to achieve with hardware-centric enterprise infrastructure. Compute and network infrastructure are fast moving down a software-defined path, but storage has been a laggard. Until now.