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Issue Date: March 16, 2022 |
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ANNOUNCEMENTS
Big news this week as we introduce a new surgeon CMO and some new products launches. Also, we will begin to uncover the details of the upcoming CMS Amnio Clawback. The full story on reimbursement reversal is far from being understood, but we wanted to layout what we think we know at this point in the game. Once more details are presented, we will be sure to follow up on them.
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As always, we are very grateful for all of our FAN’s. Thanks you very much for reading and continue to contact us anytime at footandanklenews@gmail.com
Have a great day,
Big Foot
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This week we have:
- Golden Sawbone of the Week - Social Media
- Xtremity Medical Hires Steven Haddad, MD as CCO
- New Product Announcements: Arthrex | Carbon 22/Novastep
- CMS Amnio Clawback is Coming!
- Access Past FAN Newsletters
- PodiatryMeetings.com Calendar of Events
- AOFAS Meetings Updated Listing
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GOLDEN SAWBONE OF THE WEEK
Social Media Edition
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This week, the award goes to a man dedicated to foot and ankle, with an Instagram handle and post portfolio to match. His account includes a massive collection of F&A cases with multiple images and follow-up shots. To be worthy of a Golden Saw Bone you need to be dedicated, not having a single family photo or dog picture or really anything other than foot and ankle is award worthy!
Congrats to:
Daniel Patton, MD
Our featured post looks at a patient with bilateral allograft total ankles. The patient is almost 4 years out on his right side and closing in on 3 years on the right. Amazing case, with outstanding reported results up to this point.
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Follow FAN on LinkedIn!
https://www.linkedin.com/company/footandanklenews/
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XTREMITY MEDICAL HIRES
STEVE HADDAD, MD AS CCO
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The Lyons Brothers, who sold their former company Blackstone Medical to OrthoFix for $333 million in 2006, appear to have seriously reengaged and are looking to make a move in the F&A market. |
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By hiring Haddad as the Chief Clinical Officer, they have added a respected innovator who will push for the creation of difference making products and help shape corporate strategy moving forward. Haddad is well known in the development industry, having been pivotal in the creation of Stryker/Wright's total ankle arthroplasty line after he joined them as a design surgeon in 2008.
How exactly XM will become relevant is unknown right now, as they have a few issues to tackle. The first is expanding distribution and finding solid partners to push their product line. Right now, they have a mixed bag of products (XM PRODUCT LINE) that are definitely not a collection of “me too” devices. However, they do not offer anything game changing, and as a result XM has never broken through as a true threat in foot and ankle. Xtremity Medical has some name recognition and newly motivated founders, but they will need more than that to boost revenue and enter the acquisition picture.
One way to start creating and moving product is to assemble a team of surgeons to help innovate. Word on the street is that Haddad is working with XM to engage four top-tier foot and ankle surgeons as a Surgeon Advisory Board: Chris DiGiovanni, William McGarvey, David Thordarson, and Paul Fortin. Those are some heavy hitters who can help relaunch XM and get them back in the game quickly.
Haddad, know for being a thought leader in ankle arthroplasty, is now one of four members of the Wright/Stryker TAR development team who have gone onto being CCO/CMO’s at extremity driven, foot and ankle companies. The others: Tom Lee, MD at Novastep, Greg Berlet, MD first at Medshape and now at Ossio, and finally Hodges Davis, MD now at Stryker. We only need one more to make a solid starting 5. Paging Bob Anderson.
Overall, this is a great move for XM and the industry. Time will tell if the hiring of Haddad pays off, but it looks like the Lyon’s boys are ready to play for real in F&A.
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NEW PRODUCT ANNOUNCEMENTS |
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Arthrex – OsteoAuger
Arthrex has launched a nice little adjunct line for bone graft harvesting with their OsteoAuger product. With more and more elective cases moving to ASC’s, the use of expensive allograft products is not cost effective for most patient’s insurance.
The OsteoAuger system can be used at common harvesting sites, including the iliac crest, calcaneus, distal and proximal tibia, and distal radius. The system is available in 6 mm, 8 mm, and 10 mm diameters to accommodate the various harvest sites and desired graft volume.
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The OsteoAuger provides a quick, minimally invasive way to bolster fusion procedures using the gold standard of all biologics - autograft. Another bonus, the surgeon gets paid for the harvest. Good one keep coming from the team down in Naples. |
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Carbon22 /Novastep - Apollo Ankle Fracture System
The team at Carbon 22 received 510k clearance for an Ortholucent Ankle Fracture Plating system, their third product. The Ortholucent Technology is a combination of thin-walled titanium injected with PEEK which allows for visualization of bone integration, alignment, and healing useful both intra and post-operatively.
The announcement indicates that the ankle fracture plates will be part of a comprehensive system we expect to address all aspects of the foot.
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Right now, Novastep is the distribution channel for the 2 other Carbon 22 products and they are currently in negotiations to represent this line as well. With an expected commercial release in the last spring of this year, it could be a nice addition to the Novastep bag.
Carbofix makes a carbon fiber line of radiolucent implants, including an ankle fracture system. One of the complaints is the inability to bend the plate to accommodate for unique anatomy. The posted video, clearly demonstrartes that this has been addressed with this technology. More to come from GLW, Carbon 22, and the Novastep team in the future. Different is marketable in foot and ankle, this falls in that bucket. Nice work!
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CMS AMNIO CLAWBACK IS COMING... |
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It is my understanding that Amniotic tissue is a CMS approved product for treating wounds and burns. Everything else, including injections for pain relief and inflammation, are listed in the Medicare Guidelines (LCDs) as experimental and not covered. Those pain indicated injections are at the center of the upcoming CMS Clawback that started in Florida last week and quickly escalated to the entire country. If it goes through, Medicare is going to be looking for a bunch of cash that was paid out on or after December 6th, 2019, to be returned back to them.
The Quick and Dirty
In-office amniotic injections were sold to physicians as reimbursable by a massive number of Regenerative Biologic Companies and Distributors. At the time of the sales pitch, physicians were provided Q Codes that they trusted were legitimate for Medicare Reimbursement. Patients were treated, physicians then got paid for their services and the product…but there is a problem. The products and the creative Q Codes, after CMS review, were not what was originally sold to Medicare and Amnio Injections were never approved for the indication of pain under CMS guidelines. Therefore, the claims that were submitted and paid are under review and subject to a Clawback.
Remember Pain Creams?
This is very reminiscent of the compounding craze that came to a crashing halt only a few years back. The difference this time, the doctors, who thought they were doing the right thing for their patients, are the ones who are going to have to potentially foot the bill.
I’m not sure if any of the major device players will be involved in the payback or not, as only a handful of them offer injectable amniotic products. The “Johnny Come Lately” companies who sold or distributed the products will either fold or have already disappeared, only adding to the confusion.
Dr. Centeno March 2022 Blog Posts
If you want to dig in, I am going to link a few blog articles, put together by Dr. Chris Centeno, MD. He is the Chief Medical officer for a company called Regenexx. He has been taking a stand against unscrupulous Amnio and Stem Cell providers for many years. Dr. Centeno’s articles below have the clearest explanation of any that I have found on the subject. I do not know his true angle: Is he is a hero or a guy trying to profit by taking down his competition? His passion for being on the right side of the fence is admirable and to be honest he seems very well informed, well researched and very passionate about advancing this area of medicine. His knowledge on this subject would crush me, so I will take his word for it until convinced otherwise. Here is a sequential list of relevant blogs to help fully understand how we got here.
9/18/2020
2/1/2021
3/4/2022
3/6/2022
3/7/2022
Final Thoughts
Regenerative medicine is still a very grey area. It is very expansive with so many different options that get created, manufactured, and pitched daily. Literature exists against and in support of lots of things being injected into patients in pain. My hope is that this thing gets sorted out fairly and does not crush good people for the actions of a few bad actors.
Full disclosure: I do not know anything about billing amnio, and the use of Q codes! This CMS CLAWBACK announcement is a developing story and this news is intended to inform the FAN community who potentially could be affected by the announcement. More information will continue to come in and we will make sure to report on it. If you, the Physician, reading this has an opinion or additional information that you would like to share, please send it our way.
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PodiatryMeetings.com Calendar
Looking for a meeting?
This resource has an extensive amount of information for meeting opportunities where you can earn your required continuing education credits.
Click below to access the extensive meeting calendar.
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AOFAS Upcoming Meetings & Courses |
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March 30, 2022 | 9-10pm EST
April 14, 2022 | 8-9:30pm EST
July 7-9, 2022
September 14-17, 2022 | Québec City, Canada
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About Foot and Ankle News & Contact Information
Foot and Ankle News is curated roundup of the most impactful news for Foot and Ankle Doctors, Rep’s, and Exec’s delivered weekly directly to your inbox.
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- Journal Reviews
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All of our posts from our weekly email newsletter can be found at www.footandanklenews.com. Our newsletter goes out to over 12,000 foot and ankle surgeons and industry professionals across the country. The articles are created by a group of volunteers and freelance industry insiders. If you you would like to contact us or have an article or topic you would like to share, please submit it to: footandanklenews@gmail.com
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