SYS-CON MEDIA Authors: Carmen Gonzalez, Sean Houghton, Glenn Rossman, Ignacio M. Llorente, Xenia von Wedel

News Feed Item

SI-BONE, Inc. Announces Medicare Palmetto Removes MIS SI Joint Fusion from Non-Coverage

SAN JOSE, Calif., Feb. 25, 2014 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System,® a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint, announced today that the Medicare Administrative Contractor (MAC) Palmetto GBA will begin covering MIS SI joint fusion, including when performed using the iFuse Implant System, effective today, on a case-by-case basis.  Specifically, Palmetto has removed the CPT® code, 0334T, which is used by physicians to report the iFuse procedure, from their list of non-covered services.  Palmetto is one of eight Part A/B MACs in the United States and the first to make this decision.  The change will enable Medicare beneficiaries to receive coverage for the iFuse procedure throughout the states of North Carolina, South Carolina, Virginia and West Virginia. This coverage decision by Palmetto was based on published clinical data demonstrating the safety, effectiveness and clinical value of the iFuse procedure.

"To ensure Medicare beneficiaries have access to the latest effective, evidence-based treatments, Palmetto GBA now allows access to MIS SI joint fusion for patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions who fail conservative therapy.  By removing the procedure from the non-coverage list, Palmetto confirms that the procedure is consistent with generally accepted standards of medical practice in the medical community and is safe and effective," said Michael Mydra, Vice President of Health Outcomes and Reimbursement.

SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System (then called the "SI Joint Fusion System") for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.

Clinical publications have identified the SI joint as a pain generator in up to 22% of low back pain patients.1 In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a low back pain generator in 43% to 61% of post-lumbar fusion, so-called "failed back surgery," patients.2 Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.

The iFuse Implant System is a commercially available device in the U.S. and Europe. The iFuse procedure uses a small incision for delivery and implantation of titanium implants.  The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and allow for biological fixation to support long term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures.  The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.  As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders.  The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology.  SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices.  SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2014 SI-BONE, Inc. All Rights Reserved.  8639.021014

1 Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.

2 DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732-9.

SOURCE SI-BONE, 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
What do a firewall and a fortress have in common? They are no longer strong enough to protect the valuables housed inside. Like the walls of an old fortress, the cracks in the firewall are allowing the bad guys to slip in - unannounced and unnoticed. By the time these thieves get in, the damage is already done and the network is already compromised. Intellectual property is easily slipped out the back door leaving no trace of forced entry. If we want to reign in on these cybercriminals, it's hig...
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
"ElasticBox is an enterprise company that makes it very easy for developers and IT ops to collaborate to develop, build and deploy applications on any cloud - private, public or hybrid," stated Monish Sharma, VP of Customer Success at ElasticBox, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
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 Internet of @ThingsExpo, James Kirkland, Chief Ar...
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using ...
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.