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07/31/2024 Jonathan Moore, DPM, PhD, MS
Balance Braces
In 2009, I introduced the Moore Balance Brace, which was initially manufactured by Arizona AFO. Following OHI's acquisition of Arizona AFO, I began a long-standing collaboration with OHI, primarily through the leadership of Jason Kraus, OHI’s former CEO. Under Jason’s guidance, numerous studies were conducted using my design, including biomechanical, clinical, and peer-reviewed research published in journals such as Geriatrics and JAPMA.
From the beginning, I advocated for a multidisciplinary fall prevention program. As the AFO gained widespread clinical use and demonstrated significant success, many DME companies started copying my basic design to replicate its clinical benefits and financial rewards. To differentiate the Moore Balance Brace from these imitations, I withdrew my intellectual property and involvement from OHI and once again collaborated with Orthotica’s CEO, Jason Kraus. Our goal was to create a better AFO with enhanced features to improve balance, reduce postural sway, and offer a comfortable, sleek design that fits into a shoe.
Together with Orthotica’s partners, Jason and I developed the first lower extremity fall risk management program, "Life in Balance," based on the CDC’s STEADI document. This program helps podiatric physicians recognize at-risk individuals and implement an evidence-based algorithm, starting with a standardized, reimbursable fall risk assessment.
Jason and I also introduced podiatry’s first reimbursable web/app-based platform that not only identifies patient risk factors but also supports clinical intervention pathways, including physical therapy/exercise, AFO/DME, and additional procedures to improve patient functional independence.
An AFO designed to enhance balance should not be used as a stand-alone approach to fall prevention. The Life in Balance Fall Risk Management program aims to make fall risk reduction evidence-based and clinically effective. Moreover, not all AFOs marketed as Balance AFOs possess the necessary design features for effective biomechanical control and balance enhancement. An appropriately designed Balance AFO should not restrict sagittal plane motion but should allow normal sagittal movement. The design, incorporating a posterior leaf spring, supports the arch, prevents shuffling, and addresses sagittal plane weakness if present. The Moore Balance Brace (MBB) permits normal sagittal plane motion, preventing seniors from dragging or shuffling their feet, thereby reducing the risk of forward falls.
Jonathan Moore, DPM, PhD, MS, Somerset, KY
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04/24/2019 Paul Kesselman, DPM
Balance Braces for Elderly Patients (Fall Prevention) (Dennis Shavelson, DPM)
From a purely utilization standpoint, those who dispense bilateral AFOs on the same date of service, stand out on the right end of the bell curve. Now mind you, being on the right side of the bell curve or being an "outlier" is not necessarily a bad thing. But if you are going to be a "pioneer" be prepared for lots of potential negative push back from carriers, simply because you are not in step with your peers. And by your peers, I mean all providers of AFOs, not just podiatrists. Currently, the data simply is not in line with bilateral dispensing of AFOs.
As for the time period mentioned by Dr. Shavelson, I believe he was referring to the Same or Similar issue, which somewhat precludes a new AFO within a 5 year (not 3-5 as mentioned in his LTE). While the Same or Similar period can be overcome through appealing to your DMEMAC and meeting the requirements stipulated in the LCD (new diagnosis, change in anatomy, physiology, etc.), it's no slam dunk to a successful appeal. If your appeal fails, you may get stuck paying for an expensive brace without reimbursement.
As for the clinical efficacy of external or internal bracing for fall prevention, we are a far cry from any verdict on any of this. There are a few recent papers which I was fortunate to review, which do provide some positive feedback regarding the use of balance bracing and fall prevention. These papers suggest some evidence that AFOs prevent falls, but there still is a wide gap between suggestion, preliminary data and clear evidence-based medicine (EBM) to stipulate that AFOs prevent falls. Simply put, there are so many etiologies for falls in the elderly, it will take quite a bit of studies to draw any positive conclusion that balance bracing can prevent falls due to each and every fall etiology.
From the perspective of external AFOs vs. internal AFOs, external (E) AFOs do offer quite a number of advantages. Most are light weight and one I've become familiar with can easily be removed from one shoe and placed on another. Others are more limited to use on one shoe. Easy removal and donning is no doubt a great advantage for the elderly, as is not taking up any room in the shoe, thus allowing patients to wear a more normal appearing shoe. Unfortunately many EAFOs also have fewer clinical applications than their internal counterparts.
From a reimbursement perspective, there are very few preventative programs in Medicare available for the podiatrist to provide. The ones most recognizable to podiatrists include routine foot care, LOPS and Therapeutic Shoe Program for Patients with Diabetes. AFOs used when the primary intent is for fall prevention are currently not a covered service. Disguising claims for fall prevention devices with other diagnosis, in particular when dispensed bilaterally, is ill advised.
Paul Kesselman, DPM, Woodside, NY
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