November December 2023 O&P Almanac

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FUTURE DELIVERY of CARE The entire healthcare market is changing rapidly. But what does that mean for O&P? 18


The Magazine for the Orthotics & Prosthetics Profession



Join us September 12–15, 2024, for an ideal combination of top-notch education and entertainment at the 107th AOPA National Assembly in Charlotte, NC.

Exhibits. Education. Networking. FOLLOW US @AmericanOandP


AOPA National Assembly



At Hersco, we pride ourselves on being on the leading edge of technology. We have mastered the art of accepting scans and 3D printing to bring you precise orthotics every time. Our team works to deliver custom orthotics tailored to each individual’s needs and specifications. We also keep an exact digital record of each patient’s foot orthotics for ease of reproduction.













November/December 2023 | Vol. 72, No. 10 FEATURES



24 GLOBAL AWARENESS Conflicts in Ukraine and Gaza and natural disasters in other areas are driving up amputation numbers across the globe, spurring a need for greater humanitarian O&P intervention. Experts discuss supply and demand disparities, and explain why traveling to meet patients in need should be a priority for governments, nongovernmental organizations, and volunteers.

How will the delivery of O&P patient-care evolve to meet the changing needs of the healthcare market, O&P patients, and payors? Experts in the industry weigh in with their thoughts on patient-centered and evidence-based care, telehealth, niche facilities, clinicians as “technology managers,” and more.







Reviewing the three C’s in O&P

Opportunity to earn up to two CE credits by taking the online quiz.

30 Transformations

30 Transformations SECOND CHANCES

Meet Jon Holmes, PT, CP, LP, and find out how he successfully treated a police officer who lost his leg in a roadside accident—beginning with a traditional socket and transitioning to a direct-attachment prosthesis after osseointegration surgery.


O&P Almanac November/December 2023


Views From AOPA Leadership Building bridges together

36 Marketplace

AOPA Contacts

39 Calendar

How to reach staff


35 Welcome New Members

Happenings Research, statistics, and industry news

13 People & Places Transitions in the profession

35 AOPA News AOPA announcements, member benefits, and more

Upcoming meetings and events

39 Ad Index 40 State By State Updates from Indiana, Nevada, and Ohio

Managing Partial Foot Amputations • Limb Preservation • Gait Restoration • Propulsion with Proximal Stability

Carbon footplate



Studies have shown destructive forces are distal to the residuum using BlueROCKER®, thereby preserving the residual foot.

Views From AOPA Leadership


Building Bridges Together

reetings to all! Given this issue of the O&P Almanac spans both of our terms, this column is jointly written by your AOPA presidents. As you may recall, AOPA’s leadership changes every Dec. 1, with movement of members on and off both the AOPA Board of Directors and the Executive Committee. The change is virtually seamless, in part because of AOPA’s governance, but in larger part because of the commitment and engagement of the board, with most of the strategic initiatives continuing from one year to the next. Another reason there is such continuity from year to year is the fact that the Nominating Committee works hard to ensure that the board is representative of all O&P voices. AOPA would not be as successful an organization if it did not represent the vast community of O&P professionals. This year, Kimberly Hanson, CPRH, joins the Executive Committee as vice president. She has served on the board for many years, and, in this capacity, she will move through the Executive Committee chairs and serve as AOPA president in a few years. We also welcome Adrienne Hill, MHA, CPO, LPO, who fills an at-large board seat. Their diverse viewpoints will add to the current mix and will help AOPA continue to support all of its members. The strategic focus in 2024 will continue to be centered on patient care and AOPA’s vision: A world where orthotic and prosthetic care transforms lives. To do this, we will focus on bridge building, building off the stability of and trust in AOPA. Using stability and trust, AOPA has helped increase the standing of O&P as professionals. In the past several years, we have worked to prove our value as experts, and we have shared our collective industry voice on the regulatory and legislative fronts, at both the state and federal levels. We have spent time and infrastructure building relationships with decision makers, payors, and allied healthcare professionals. Although it may not always feel like it, more and more of these individuals see us as important healthcare professionals and respect the good work we do. In addition to this, the common stakeholders we have—the patients—also have gained a lot of ground with partners inside and outside the profession. You don’t have to look far to see individuals who use a prosthesis or orthosis in television commercials or other media. Collaborative partnerships are important, and it is easier to engage with external forces when we have the entire profession working together. This has been very evident in the So Every BODY Can Move initiative. In joining together as a profession, we have seen four states enact this legislation, and many more are working to follow suit in 2024. We need this alignment to continue, and, where possible, we should look to combine resources to further the profession and improve the lives of our patients. Because of its established stability and trust, AOPA is the organization to preserve the integrity and viability of our profession. AOPA is the organization to provide you with the tools you need to run your business so you can focus on providing quality patient care. The AOPA Board of Directors takes pride in our role representing our members and, in turn, the profession. But to truly be successful in achieving our mission, we all must strive to be bridge builders, connecting lives, ideas, and aspirations. So, as 2023 ends, we want to thank each of you for your continued support of AOPA and for entrusting both of us with the responsibility of serving as president. On behalf of AOPA’s board and staff, we want to let you know just how much we appreciate all you do for AOPA and, more importantly, for the patients we are all privileged to serve. We look forward to continuing the good work and to building bridges together in 2024.

Teri Kuffel, JD, ended her term as AOPA president Nov. 30, 2023. Mitchell Dobson, CPO, FAAOP, begins his term as AOPA president Dec. 1, 2023.


A world where orthotic and prosthetic care transforms lives.

O&P Almanac November/December 2023

Board of Directors OFFICERS President Mitchell Dobson, CPO, FAAOP Hanger Clinic, Austin, TX Immediate Past President Teri Kuffel, JD Arise Orthotics & Prosthetics, Spring Lake Park, MN President-Elect Rick Riley O&P Boost, Bakersfield, CA Vice President Kimberly Hanson, CPRH Ottobock, Austin, TX Treasurer Chris Nolan Össur, Foothills Ranch, CA Executive Director/Secretary Eve Lee, MBA, CAE AOPA, Alexandria, VA

DIRECTORS Adrienne Hill, MHA, CPO(L), FAAOP Kennesaw State University, Kennesaw, GA Arlene Gillis, MEd, CP, LPO International Institute of Orthotics and Prosthetics, Tampa, FL John “Mo” Kenney, CPO, LPO, FAAOP Kenney Orthopedics, Lexington, KY James Kingsley Hanger Clinic, Oakbrook Terrace, IL Lesleigh Sisson, CFo, CFm Prosthetic Center of Excellence, Las Vegas, NV Linda Wise Fillauer Companies, Chattanooga, TN Shane Wurdeman, PhD, CP, FAAOP(D) Research Chair Hanger Clinic, Houston Medical Center, Houston, TX




AOPA Contacts Our Mission AOPA staff and volunteers are committed to our mission of being a trusted partner, advocating for and serving the orthotic and prosthetic community by: Fostering relationships with decision makers to ensure equitable access. Providing education that promotes professional excellence. Supporting research that informs innovative care. Advancing equality to strengthen the orthotic and prosthetic profession and improve the lives of patients.

• • • •


Our Vision

A world where orthotic and prosthetic care transforms lives.

AMERICAN ORTHOTIC & PROSTHETIC ASSOCIATION (AOPA) 330 John Carlyle St., Ste. 200, Alexandria, VA 22314 AOPA Main Number: 571-431-0876 | AOPA Fax: 571-431-0899 |

EXECUTIVE OFFICES Eve Lee, MBA, CAE, executive director, 571-431-0807, Akilah Williams, MBA, SHRM-CP, director of finance and strategic operations, 571-431-0819,

HEALTH POLICY AND ADVOCACY Joe McTernan, director of health policy and advocacy, 571-431-0811, Devon Bernard, assistant director of coding and reimbursement services, education, and programming, 571-431-0854, Sam Miller, manager, state and federal advocacy, 571-431-0814, Susannah Engdahl, PhD, manager, health policy and research, 571-431-0843,

MEETINGS & EDUCATION Tina Carlson, CMP, senior director, education and meetings, 571-431-0808, Kelly O’Neill, CEM, senior manager of meetings and exhibition, 571-431-0852, Kristen Bean, digital meetings specialist, 571-431-0876,

MEMBERSHIP & COMMUNICATIONS Joy Burwell, director of communications and membership, 571-431-0817, Betty Leppin, senior manager of member services, 571-431-0810, Nicole Ver Kuilen, manager of public engagement, 571-431-0836, Madison McTernan, coordinator of membership and communications, 571-431-0852, AOPA Bookstore: 571-431-0876 Reimbursement/Coding: 571-431-0833,

O&P ALMANAC Eve Lee, MBA, CAE, executive director/publisher, 571-431-0807, Josephine Rossi, editor, 703-662-5828, Catherine Marinoff, art director, 786-252-1667, Bob Heiman, director of sales, 856-520-9632, Christine Umbrell, editorial/production associate and contributing writer, 703-662-5828,


O&P Almanac November/December 2023

SUBSCRIBE O&P Almanac (ISSN: 1061-4621) is published monthly, except for combined issues in June/July and November/ December, by the American Orthotic & Prosthetic Association, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314. To subscribe, contact 571-431-0876, fax 571-431-0899, or email Yearly subscription rates: $59 domestic, $99 foreign. All foreign subscriptions must be prepaid in U.S. currency, and payment should come from a U.S. affiliate bank. A $35 processing fee must be added for non-affiliate bank checks. O&P Almanac does not issue refunds. Periodical postage paid at Alexandria, VA, and additional mailing offices.

ADDRESS CHANGES Postmaster: Send address changes to: O&P Almanac, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314. Copyright © 2023 American Orthotic and Prosthetic Association. All rights reserved. This publication may not be copied in part or in whole without written permission from the publisher. The opinions expressed by authors do not necessarily reflect the official views of AOPA, nor does the association necessarily endorse products shown in the O&P Almanac. The O&P Almanac is not responsible for returning any unsolicited materials. All letters, press releases, announcements, and articles submitted to the O&P Almanac may be edited for space and content. The magazine is meant to provide accurate, authoritative information about the subject matter covered. It is provided and disseminated with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice and/or expert assistance is required, a competent professional should be consulted.

ADVERTISE WITH US Share your message with AOPA membership— approximately 9,000 orthotic and prosthetic professionals, facility owners, and industry personnel. Contact Bob Heiman at 856-520-9632 or email Learn more at


Not just a 3.0 Redefining the Ankle Experience It actually feels like you have a leg. Feels a

lot lighter, very comfortable. When I stand still, I balance very easily.

It’s like a part of you and you’re not scared.”

Francisco M.

Retired Car Salesman



For the first time in all the different prostheses and feet I have tried, and

I have tried so many, it felt like I had my leg back again. The Kinterra is life changing. It has inspired me.”

Tarsha N.

Behavioral Therapist


Transradial Amputee Has First-ofIts-Kind Bionic Hand Function

A 50-year-old Swedish woman with transradial amputation has undergone osseointegration to connect a bionic hand directly to her neuromusculoskeletal system. The patient, named Karin, had been suffering from pain in using a prosthesis as well as “excruciating” phantom limb pain for more than 20 years. Before surgery, Karin said she “felt like I constantly had my hand in a meat grinder.” Now, her pain has decreased, and she has much better control over her prosthesis. Doctors and engineers at the Center for Bionics and Pain Research, an international multidisciplinary collaboration founded by Max Ortiz-Catalan, PhD, attached an advanced prosthesis to Karin’s nervous systems as well as to her muscle and bone. The bionic hand is self-contained; surgeons embedded a wrist-shaped battery unit and mechatronic coupler to connect the neuromusculoskeletal interface, which enables function of the device without a large battery or processing unit. “Karin was the first person with below-elbow amputation who received this new concept of a highly integrated bionic hand that can be used independently and reliably in daily life,” said Ortiz-Catalan in a press release. “The fact that she has been able to use her prosthesis comfortably and effectively in daily activities … is a promising testament to the potential life-changing capabilities of this novel technology for individuals facing limb loss.” “By combining osseointegration with reconstructive surgery, implanted electrodes, and AI, we can restore human function in an

In 2023, more than half of Medicare’s 60 million beneficiaries who have both Medicare parts A and B are enrolled in a Medicare Advantage plan. SOURCE: AARP BULLETIN, SEPTEMBER 2023.



unprecedented way,” added Prof. Rickard Brånemark, research affiliate at MIT and chief executive officer of Integrum, who led the surgery. “The below-elbow amputation level has particular challenges, and the level of functionality achieved marks an important milestone for the field of advanced extremity reconstructions as a whole.” The proof-of-concept study was published in October in Science Robotics.

Rotational Wrist Modules Improve Prosthesis Function



A Swedish woman became the first person with transradial amputation to receive a highly integrated bionic hand via osseointegration.

Given the large array of hand sizes, most partial hand prostheses lack rotational wrists movements. Researchers in Korea are exploring the benefits of a prosthetic hand with a wrist rotation module. They hypothesized that partial hand amputees using the new design would achieve more natural upperlimb movement muscle synergy and motion analysis compared to a control group. The researchers created the prototype then compared a control group of individuals with partial hand amputation, both with and without the wrist rotation module prototype. They conducted muscle synergy analysis through non-negative matrix factorization (NMF) using surface electromyography and motion analyses employing a motion capture system while participants performed reach-to-grasp tasks.

O&P Almanac November/December 2023

During motion analysis, the researchers observed a statistically significant difference between the group using the prosthetic hand with the wrist rotation module and the group with no wrist rotation module. They also found a greater improvement in score of the Jebsen-Taylor Hand Function Test among subjects using the wrist rotation module. “Integrating a wrist rotation module in prosthetic hand designs for partial hand amputees restores natural upper-limb movement patterns, reduces compensatory movements,” and prevents secondary musculoskeletal issues, reported the authors in the October issue of Journal of NeuroEngineering and Rehabilitation. “This highlights the importance of this module in enhancing overall functionality and quality of life.”


Prosthetic Foot Prototype Targets Long Residual Limbs Mark Geil, PhD, associate dean at Kennesaw State University (KSU), has partnered with the National Institutes of Health’s (NIH’s) Small Business Innovation Research Program to refine and test a new prosthetic foot designed to enhance function for individuals with long residual limbs. Geil is working with students in the university’s master’s O&P program, along with Little Room Innovations in Atlanta, to test a less rigid foot prototype foot that leverages a triangular keel inspired by the suspension used in pickup trucks. The keel is designed to increase flexibility and versatility. “We believe the new device opens up an entirely new category of foot material compliance for users with long residual limbs or users whose components take up space necessitating a low-profile foot, without sacrificing strength,” explained Geil. “The process of this NIH grant will be to take the prototype and put it on people who have a long residual limb and use the current low-profile foot that we think is too stiff,” Geil said. “Along with the stairs and slope, we’ll test the foot in the biomechanics lab to make sure people can move efficiently with the flexible foot.” At this time, the researchers have developed a working prototype, which has been tested on one individual with limb loss. “We are currently completing construction of stairs and ramps in the biomechanics laboratory, and then we’ll be able to see our first subject as part of the new NIH study,” said Geil. “We will use this Phase 1 NIH

Kennesaw State University researchers, led by Mark Geil, PhD (far right), are refining and testing a prosthetic foot for long residual limbs. PHOTO CREDIT: KENNESAW STATE UNIVERSITY

project to make any necessary improvements to the foot design. After that, the foot could be ready for market toward the end of next year with the right commercial partner, or it’s also possible that the modified design will be tested much more broadly in a Phase 2 trial.” Details are available on the KSU website.

Increased Activity Reported Among Patients With Implants

Carbon-Fiber AFOs Produce Favorable Outcomes

Individuals with bone-anchored lower-limb prostheses spent more time engaging in daily activity and daily walking after 24 months with implants, according to a new study published in Acta Orthopaedica. Researchers from Rotterdam, Netherlands, conducted a retrospective case series, measuring activities of daily living (ADLs) among study participants at four points in time: before surgery and at six, 12, and 24 months after undergoing osseointegration. The subjects, who were between 18 and 99 years old and had either transfemoral or transtibial amputation, were assessed using the Timed Up and Go (TUG) Test and the Six-Minute Walk Test (6MWT). Prior to receiving bone-anchored prostheses, study subjects’ total daily activity averaged 1.6 hours; postsurgery, daily activity increased to 2.1 hours at six months, 1.7 hours at 12 months, and 2.7 hours at 24 months. Participants also increased their total walking time: Prior to receiving an implant, daily walking time averaged 1.3 hours; postsurgery, walking time increased to 1.8 hours at six months, 1.7 hours at 12 months, and 2.0 hours at 24 months. Objective measurements on ADLs, including TUG and 6MWT results, “positively changed in patients with bone-anchored prostheses,” reported the researchers. “This effect was also seen in mobility and walking ability at 24 months.”

Because carbon fiber is becoming more commonplace in the construction of ankle-foot orthoses (AFOs), researchers from the University of Iowa conducted a qualitative systematic review to characterize the effects of carbon-fiber AFOs in individuals with impairments. Researchers studied 78 articles that discussed devices with unique designs and associated with specific populations, including individuals with hemiplegia, stroke, and cerebral palsy. The research demonstrated that each device produced favorable outcomes—for example, increased walking speed, reduced pain, or improved balance—in their respective populations of interest. “The mechanical characteristics and designs of carbon-fiber AFOs improve outcomes in the populations in which they are most studied,” noted the researchers. The study was published in October in Prosthetics and Orthotics International.

November/December 2023 O&P Almanac





Robotic Prosthesis Named a 2023 Best Invention


In a survey of more than 400 O&P professionals, 29% were at “high risk of burnout” and 8% were at “levels of burnout that are affecting their mental and physical health.”




An observational study from China suggests that individuals who drink tea regularly, particularly dark tea, may improve their blood glucose levels and decrease insulin resistance. Tea drinkers had a 15% lower risk for prediabetes and a 28% reduced risk for type 2 diabetes compared with non-tea drinkers. SOURCE: MEDICAL NEWS TODAY, OCT. 4, 2023.



Powered Orthoses and Exoskeletons Defined as ‘Braces’



The Utah Bionic Leg made the 2023 list of Best Inventions by Time magazine, honored within the “Experimental” category. The prosthesis was developed by Tommaso Lenzi, PhD, director of the HGN Lab for Bionic Engineering at University of Utah. The lab recently partnered with Ottobock to license the technology behind the leg to bring the prosthesis to more individuals with lower-limb amputations. The Utah Bionic Leg, which features a suite of motors, sensors, and controllers, was designed to better replicate the biomechanics of the human knee, ankle, and toe. “In contrast to other active prostheses, which rely on triggering movements and preprogrammed functions for specific activities like standing up from a seated position or climbing stairs, the Utah Bionic Leg uses a continuous adaptation approach,” Lenzi explained.

CMS released its annual final rule Nov. 1 that established 2024 payment rates for the Medicare Home Health Prospective Payment System. Provisions relating to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) finalized in the rule include the following: Codification and expansion of the Medicare definition of the term “brace” to include powered orthoses and exoskeletons Creation of a new benefit category and payment for compression garments used to treat lymphedema Changes to the methodology used to calculate Medicare fee schedules based on rates established through competitive bidding Modifications to supplier enrollment processes designed to further control Medicare fraud and abuse Codification of existing policy regarding documentation requirements for DMEPOS refills.

• • • • •

The inclusion of powered orthoses and exoskeletons in the brace benefit category for Medicare coverage and payment purposes will likely have the greatest impact on O&P. This represents a reversal of the longstanding CMS position that powered orthoses and exoskeletons should be classified as durable medical equipment as they generated motion across a joint without necessarily supporting a weakened joint or body member. AOPA and its O&P Alliance partners submitted detailed comments on this proposed provision, and AOPA is pleased that CMS included this provision in the final rule.

O&P Almanac November/December 2023

CONSUMERS REPORT COVERAGE ISSUES “A majority of insured adults (58%) say they have experienced a problem using their health insurance in the past 12 months, such as denied claims, provider network problems, and preauthorization problems.” SOURCE: “KFF SURVEY OF CONSUMER EXPERIENCES WITH HEALTH INSURANCE,” JUNE 2023.




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Centuries-Old Prosthesis Discovered in Germany The skeleton of a man wearbones indicate that four fingers ing a partial prosthetic hand may have been amputated, but was uncovered during pipea thumb bone was found on the line construction in Freising, corroded metal prosthesis. The Germany, in October. The grave prosthetic fingers were slightly contained a skeleton of a man curved and lay parallel to each who died between 1450 and other, similar to a natural resting 1620, aged between 30 and position for a hand. 50, whose left hand had been According to an article in replaced with a metal prosthe- The prosthetic hand prior to Archaeology, the discovery restoration work sis featuring four individually suggests medicine at the time formed, immobile fingers. was concerned with the well-being of amputees The prosthesis had been at least partially and found solutions to make life easier post-limb covered in leather and attached to the man’s hand loss. During the time period of the man’s death, with bandages. Pieces of gauze found on the prosmilitary conflicts were underway in the surroundthesis indicate the device may have been padded to ing area, which “likely heightened the demand for protect the residual limb. Marks on the man’s hand prosthetics in and around Freising.”

The skeleton discovered during pipeline work in Freising


O&P By the Numbers New Study Finds High Rates of Dissatisfaction With Prostheses Researchers from Louisiana State University and Auburn University conducted an online survey of 1,736 individuals with lower-limb amputation, publishing the results in the October issue of Prosthetics and Orthotics International. Given these findings, O&P clinicians should check in with their own patients to ensure satisfaction with prostheses and service.

M A J O R I T Y PA R T ICIPA N T D E M O G R A P HIC S Male participants

60% 67%

Trauma as leading cause of amputation Unilateral amputation

86% 39%

Below-knee amputation



Reported a low level of functional performance



O&P Almanac November/December 2023


Reported dissatisfaction with their prosthetic device


Reported dissatisfaction with prosthetic service

People & Places



Greg Packer of U.S. Rehab has announced his retirement as president, effective at the end of 2023. Packer will maintain his relationship with VGM & Associates on a consulting basis through 2024 and will maintain his position as the current president of the National Coalition for Assistive & Rehab Technology. Greg Packer Packer joined VGM in 2009 and has been an integral part of U.S. Rehab as president, contributing to the growth and success of the complex rehab industry. His has been responsible for several projects, services, and tools during his tenure at U.S. Rehab, including the development of the Functional Mobility Assessment outcomes program. Tyler Mahncke, current vice president of U.S. Rehab, will take over leading U.S. Rehab effective Jan. 1, 2024. “We are extremely pleased to have Tyler Mahncke take over U.S. Rehab,” said Jeremy Stolz, president, VGM & Associates. “Tyler brings an exciting new perspective while staying true to what Greg and others before him Tyler Mahncke have built.” Nerrolyn Ramstrand, PhD, BP&O (Hons), has been awarded a $60,000 grant from the National Commission on Orthotics & Prosthetics Education, in coordination with the O&P Foundation, to lead a study to advance O&P education. The single, two-year study is designed to identify and unpack core principles to determine different levels of understanding for O&P students.

Twenty-seven O&P providers have been honored with a 2023 Freedom Award from Orthotic and Prosthetic Group of America (OPGA) in recognition of their exceptional care of military personnel. These awards are open to all facilities in the O&P profession who are part of the OPGA membership community and serve veterans. Recipients of the 2023 Freedom Award received a framed award to showcase in their patient-care facility. “We’re proud to recognize these O&P providers for the exceptional care they provide to those who have sacrificed for our freedoms,” said Adam Miller, president of OPGA. “The Freedom Award highlights their dedication to the distinguished veterans they treat, and to our nation’s armed forces.” The following AOPA members are among the 2023 Freedom Award recipients: Advanced Prosthetics LLC, Columbia, South Carolina Allegheny Orthotics and Prosthetics, Altoona, Pennsylvania Central Brace and Limb Co., Indianapolis Leimkuehler Inc., Cleveland Mobility Prosthetics, Murray, Utah NovaCare Prosthetics & Orthotics, Fond du Lac, Wisconsin Orthotics and Prosthetics One, Waterloo, Iowa Rehability, Spring Hill, Florida Tillges Orthotics & Prosthetics, Maplewood, Minnesota Todd Bullock dba Sierra Prosthetics-Orthotics, Grass Valley, California

• • • • • • • • • •

Nerrolyn Ramstrand, PhD, BP&O (Hons)


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November/December 2023 O&P Almanac


Reimbursement Page


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Coding, Compensation, and Coverage The value of the three C’s in orthotics and prosthetics


nnovation is not a new concept in orthotics and prosthetics. From myoelectric prostheses to microprocessor integration to exoskeletons to osseointegration, O&P has always been at the forefront of innovation and technological advances. One of the biggest hurdles to innovation and advancement remains the challenge of translating innovation into marketability. If you want a new product to be successful, it must be financially feasible when it arrives on the market. This is where the three C’s come into play: coding, compensation, and coverage. For a new technology or product to be viable in the marketplace, all three must be addressed. Failure in just one of the three areas can render a product unmarketable, and major investments in research and development and technology can be rendered useless. 14

O&P Almanac November/December 2023

This month’s Reimbursement Page examines each of the three C’s, what they mean for product marketing, and how to build a strategy to ensure they are addressed in a way that creates the most favorable environment for product success.


One of the keys to product success is accurate and appropriate coding. The Healthcare Common Procedure Coding System (HCPCS) Level II coding system is very hierarchical and organized. Incorrect classification of a product into an incorrect code set can not only be detrimental to the marketing of the product, it also can be very difficult to change. There have been several recent instances where O&P products, which are traditionally described by L codes, were classified under

a different benefit category and assigned codes outside of the L-code system. One recent innovation was initially classified as exercise equipment by CMS, and providers were instructed to use E codes to describe it when billing Medicare. This created significant confusion among O&P providers, who were unfamiliar with these codes and unsure if they were even permitted to bill E codes to Medicare and other payors. Even when there is no confusion about benefit category, coding can remain a challenge. The CMS HCPCS Workgroup has the responsibility and authority to issue new HCPCS codes to describe products that are not described by existing codes. The application process for a new HCPCS code requires significant information regarding the product in question, including detailed sales date, product information, and an PHOTO CREDIT: ADOBE STOCK

Reimbursement Page

explanation on how the product differs from others already classified into existing codes. The HCPCS Workgroup reviews HCPCS code applications twice a year, and there is no guarantee that an application will result in the issuance of a new HCPCS code. Obtaining a new HCPCS code can sometimes take several years—and there is no guarantee that a new code will ultimately be issued. When a product is not described by an existing or new HCPCS code, a provider’s only option is to use a miscellaneous HCPCS code to describe the product. While the coding system is designed to utilize miscellaneous codes for this exact purpose, providers are often reluctant to use products that rely on miscellaneous codes due to the uncertainty that comes with their use. Ironically, one of the ways to encourage CMS to consider a new code for an emerging product is to establish a claim

submission pattern that uses miscellaneous codes with consistent descriptions. This often is an important step in the development of new HCPCS codes. While coding is an essential piece of the overall puzzle, without compensation and coverage, it is usually not enough to drive a new and innovative product to market success.


Compensation is another important piece of the puzzle when talking about the three C’s. Compensation usually goes hand-inhand with coding as CMS controls both the HCPCS Level II coding system and the Medicare fee schedule. When CMS, through its HCPCS Workgroup, issues a new HCPCS code, it typically will assign the code to an established Medicare benefit category and also publish a preliminary average Medicare fee schedule

amount. This was not always the case, but recently passed regulations require the HCPCS creation process to be more transparent, including holding public meetings and being more transparent regarding pricing development. The proposed pricing may be challenged by the HCPCS code applicant or any member of the public. Once any challenges are addressed and resolved, the preliminary average fee is finalized and then used to establish a Medicare fee schedule for the code. Compensation is obviously crucial to the marketability of a product as it must be fair and equitable for providers. HCPCS codes do not differentiate compensation for the physical object that is being provided from the clinical care necessary to provide it. The single fee schedule amount represents the total compensation, covering both the item itself and the professional services

November/December 2023 O&P Almanac


Reimbursement Page

of the provider. If a fee schedule is not adequate to not only cover the cost of the device but also provide equitable compensation for the professional services of the provider, it will significantly hinder the viability of the product within the marketplace. While obtaining an equitable fee amount is a challenge, the process of getting there in the first place creates additional issues that must be considered when bringing a product to market. Federal regulations require CMS to sometimes use a process known as “gap filling” when establishing Medicare fees for new products. Gap filling uses a complex mathematical formula to reach a final fee schedule amount, but the process can be summed up as follows: When determining the fee schedule for a new HCPCS code, CMS gathers publicly available pricing information to establish a base fee amount. This amount is then deflated backwards to 1986 rates by reducing it according to the change in the Consumer Pricing Index for Urban Areas (CPI-U) for each year. This amount is then reinflated to the current year by applying the annual percentage change to the Medicare fee schedule. The result of the gap filling process is a net reduction in the Medicare fee schedule since the comprehensive annual Medicare update from 1986 to the present is less than the cumulative change to the CPI-U for the same period. 16

O&P Almanac November/December 2023

Adequate compensation for new products is crucial to their success but is no more important than the other two C’s, coding and coverage.


Coverage is usually the last of the three C’s to be addressed when a new product is introduced to the market, but it is no more or no less important than coding and compensation. It usually just takes a bit longer. Coverage of a new product to the market can be negatively impacted primarily in one of two ways: It can be deemed “noncovered no benefit” or “not medically necessary.” Either of these scenarios can render a product essentially unmarketable and may be the death knell of a good product. If something is deemed noncovered no benefit, it means that it is not covered for any patient in any circumstance because it does not meet the definition of an established benefit category. An example of this from a Medicare perspective is orthopedic shoes that are not an integral part of a brace. The designation of noncovered no benefit is not a judgment on whether a product is effective or not; it is simply a statement of fact. In the case of orthopedic shoes that are not an integral part of a brace, Medicare simply does

not offer coverage of them as a benefit of the program. A product that is determined to be not medically necessary is one that is typically covered as a plan benefit but in certain circumstances is not considered medically necessary for a particular patient or under a predetermined set of circumstances. For Medicare, medical necessity guidelines are established through the development of formal policy, known as a Local Coverage Determination (LCD). LCDs are complex and often confusing, but when followed and understood, they create a useful guideline regarding coverage of products. Providers should not be surprised if something is deemed not medically necessary as LCDs are usually very detailed regarding what conditions must be met in order for a product to be deemed medically necessary. For Medicare, the durable medical equipment Medicare administrative contractors have the authority and responsibility to create the LCD and Policy Articles that together comprise the medical policy for O&P products. The policy development process takes time and can be frustrating for manufacturers and providers alike. It is important, however, that the process is done well as changing an LCD is often more difficult than creating one. Fair and equitable coverage of O&P products makes them much more marketable and can contribute to their success.

Combined Value

The three C’s are equally important to the success of a product. One does not carry any more weight than the others, but failure of just one of them can severely hamper product viability. Understanding the combined value of coding, compensation, and coverage will help create a path to success for new products.

Joe McTernan is director of health policy and advocacy at AOPA. Reach him at

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O&P Almanac November/December 2023



As the pace of technological change intensifies, O&P patient-care must evolve


y 2035, healthcare will be hyper-personalized, digitized, and AI-enabled, with healthcare solutions seamlessly integrated into daily life.” That prediction is according to PwC’s “Future of Health” study, which suggests that medical facilities of the future “will need to optimize care within and beyond their walls.” They will do that with tight integration with independent physician networks, connections to post-acute care, remote patient monitoring, virtual care platforms, use of dataenabled real-world evidence for research, and remote care teams. Right now, experts across the United States are seeing significant changes in the delivery of patient care. Given a proliferation of technological innovations, an increasing push to reduce spending, and consumers’ involvement in decision making, it’s clear that general healthcare in the

United States is changing. But do these trends affect the O&P market, and what do they mean for the future provision of O&P care? Most importantly, how should clinicians and facilities begin preparing for change?

Virtual Care and Remote Patient Monitoring “Healthcare is changing—and changing rapidly,” says Alberto Esquenazi, MD, the John Otto Haas chair and professor in the Department of PM&R; chief clinical officer at Jefferson Moss-Magee Rehabilitation; and director of the Gait & Motion Analysis Laboratory and Regional Amputee Center. Esquenazi believes virtual care will continue to grow in general medical care, enabled by technology for video examinations and remote patient monitoring. He predicts virtual O&P options also will expand.


f Medical facilities of the future

are predicted to evolve, becoming more robust evidence-based care providers, more tightly integrated with independent physician networks, and more heavily reliant on remote patient monitoring and virtual care.

f In O&P specifically, many of these

trends will affect the ways in which facilities provide patient care. For example, as O&P devices become more complex and sensor-driven, there will be more opportunities for

multidisciplinary care and remote appointments, as well as clinical decision making driven by community stepcount and ambulation data.

f As outcome measures become

increasingly important, greater access to O&P data may lead to more personalized care. But O&P facilities will need to consider what information they’re collecting, how they are using the information, and how effective it is in driving optimal outcomes.

f O&P clinicians are the experts

in O&P technologies, functional requirements, and material properties. They should emphasize those skills while enhancing their business competencies to prepare for the future of healthcare.

f As new technologies and

opportunities become available, O&P stakeholders should take into account reimbursement implications and patient preferences, and adopt new processes and advancements in a strategic manner.

November/December 2023 O&P Almanac


Cover Story

“As we get more complex [prosthetic or orthotic systems], there will be more opportunities” for remote patient-care appointments, says Esquenazi, who also is a member of AOPA’s Medical Advisory Board. For example, a patient in need of a custom-made leg orthosis may start with a virtual appointment to answer questions from the orthotist and submit photos of their leg. “Then the patient comes in the office for delivery of the brace and adjustments,” Esquenazi posits. Video or audio follow-up visits could occur to determine whether the patient is satisfied, supplemented by step-count data with the new device. “Orthotists and prosthetists will be able to make judgments based on real-life data, rather than from just a few Alberto Esquenazi, MD steps taken in the clinic,” he says. But O&P will need to proceed with caution and consider reimbursement and patient preference for telemedicine: “O&P is often based on our personal interactions and engagement with patients,” says J. Chad Duncan, PhD, CRC, CPO, LPO, chair/program director of O&P at Salus University. “Efficiencies in telemedicine” can be helpful, he says, “but you have to consider what it’s ideal for. And how do we standardize it so we know we’re meeting a standard of care” while considering the regulatory and insurance requirements that may enable or hinder web-based care? At Hanger Clinic, “we will continue to assess the need to expand utilization of virtual care,” says Jason Warren, CO, vice president of operations. “This platform not only enables us to care for patients in their homes, but allows us to leverage a national footprint of resources so that we no longer need everyone in the Jason Warren, CO same location to ensure the most optimal outcome for patients. “We can also use virtual platforms to reach areas where it has historically been difficult to recruit clinicians,” adds Warren. “This expands patient access to care, particularly in underserved communities, as well as access to specialized care without having to travel far distances.” One innovation that may facilitate expanded use of virtual care is sensor technology: “We see it in research, and in entities evaluating the necessity of O&P products,” says Duncan, “but it’s still in its infancy.” With sensors enabling some remote monitoring of patients, “we can deploy outcome measures virtually today, and based on those responses, we can identify scenarios where patients may need to be seen sooner than the original treatPhil Stevens MEd, ment plan dictated,” says Phil Stevens CPO/FAAOP MEd, CPO/FAAOP, vice president of clinical affairs for Hanger Clinic. “Alternatively, we can confirm that a patient is doing well with the current plan of care and modify the in-office follow-up schedule. 20

O&P Almanac November/December 2023

“The larger construct of mobility across a range of walking environments is also very important to consider,” Stevens adds. “We do not want to limit our monitoring to only things like step count if we are going to have the full picture of the patient’s status.” The proliferation of sensors and smart technology may enable more patients to facilitate their own care, adds Esquenazi. For example, more prosthetic sockets may feature embedded sensors that not only collect data, but also have the ability to make adjustments throughout the day as residual limb volume fluctuates, he says. “This would be done automatically, via a sensor that adjusts the girth of the socket, based on the shape of the leg at that instant,” he says.

Increased Data Capture and Outcome Measures

Over the past 10 years, the adoption of outcome measures and a recognition of their importance within O&P facilities has accelerated, partially because more clinicians have O&P master’s degrees and take a more science-based approach, says Silvia Ursula Raschke, PhD, editor-in-chief of Canadian Prosthetics and Orthotics Journal and retired faculty from BCIT Applied Research: MAKE+. “Even though we have outcome measures and more evidencebased practice, I’m still not sure how effectively those in clinical practice are using them,” Raschke says. “Are you applying them only in a reactionary way due to insurance requirements, or are you using them proactively to inform your care?” O&P clinicians need to consider what they are collecting, how they are using that information, and how effective it is in ensuring optimal outcomes. It will be critical in the future that O&P clinicians “use outcome measures— not just to say you’re doing it,” but to actually improve your practice. She encourages clinicians to investigate which measures make a noticeable and useful difference in their professional lives, and how the use and analysis of those measures affect patients as well as insurers. “As a field, we need to move toward an emphasis on the best possible patient outcomes rather than just device delivery,” says Stevens. “We provide thoughtfully designed prostheses and orthoses, but we don’t always know the extent to which these devices are integrated into our patients’ lives. The potential use of remote monitoring may open the door to better awareness of things like physical activity levels after device delivery, so that we can know when we might need to reach out to a patient postdelivery to facilitate their best outcomes.” Esquenazi believes amassing more data will one day lead to “more tuning of the device to the patient.” He predicts that clinicians may eventually consider a series of data points—patient age, height, and weight; cause of amputation; activity level prior to amputation and expected activity level in the future; environment; and more—to determine specific componentry recommendations based on what’s needed for a particular patient.

Clinicians As “Technology Managers”

With technology ever evolving, “prosthetists and orthotists have a lot to offer … on the technology human interface side,” says Raschke. She encourages O&P professionals to embrace their roles as “technology managers,” suggesting that clinicians consider

Cover Story

how new technologies can influence profitability in the process of providing prosthetic care. Most prosthetists and orthotists prioritize the clinical aspect of their job, “but what makes O&P professionals unique within the greater care team is the technical side of things,” Raschke explains. Clinicians look at functional requirements and material properties, and consider factors such as likelihood of skin breakdown and diabetes management, to determine the most appropriate prosthesis or orthosis for an individual patient, says Raschke. These are important responsibilities that “already make us ‘technology managers,’” she says, “but we don’t capitalize on that.” She believes O&P master’s programs should include education about the O&P business landscape to prepare them to compete.

“Graduates need to see themselves as making decisions about which technology to use within the provision process that’s best for the patient,” Raschke explains, “while taking into consideration the fee schedule, reimbursement, as well as materials and componentry selection.” Because some allied health professionals with higher levels of education may be encroaching on some O&P tasks, it’s important to emphasize the technical skills specific to orthotists and prosthetists, adds Raschke. For example, physiotherapists are trained to analyze gait—but they are unable to change trimlines on an orthosis or change the fit of a socket. “The one skillset O&P has that makes us unique and is our competitive advantage is our role as prosthetic or orthotic technology managers.

Embracing a Patient-Centered Approach to Care


o prepare for the future of O&P care—given the challenges of market disruption by direct-to-patient services, technological innovations, and the device-centric reimbursement model—the O&P profession needs a more sustainable and proactive strategy for services, says Christopher Hovorka, PhD, CPO, FAAOP, an Established Scientist Fellow in the Department of Rehabilitation Medicine at Center for the Intrepid, Brooke Army Medical Center, with a background in O&P clinical education. “Rather than continue our legacy as ‘device-centric providers,’ O&P clinicians face substantial challenges that require a new strategy, such as considering a systematic patient-centered approach to care,” says Hovorka. This approach would enable O&P to offer more informed solutions that meet the needs and priorities of patients and third-party payors, he suggests. “For example, the O&P profession has undergone substantial penetration” by entities representing engineering, automated manufacturing, and allied healthcare, says Hovorka. “With digital scanning and 3D printing emerging as new options for device design and production, non-O&P entities” Christopher Hovorka, PhD, are creating and delivering devices CPO, FAAOP for consumers, including adjustable sockets with modular components. “But there is opportunity for the O&P profession, because many disruptors possess limited clinical perspectives needed to inform successful person-centered care, which includes device design and integration,” Hovorka says. “The O&P profession has opportunity to further define itself through a ‘patient-centered

holistic approach to care provision.’ This would distinguish O&P professionals as the patient-care experts, as opposed to devicecentric providers.” This pivot would require O&P practitioners to add attention to physiological, psychological, and behavioral dynamics that are interrelated to the biomechanical challenges of individuals who require O&P services, he explains. “If done properly, this approach can enable O&P professionals to more clearly identify the factors that influence the person’s need for O&P services and better-informed solutions for improved clinical outcomes,” he says. “Preparing the next generation of O&P care providers with updates to the curriculum and training can enable the profession to continue to clarify its identity and value to address the patients’ and payors’ needs for cost-effective care that provides meaning and value. “The market is changing and will continue to demand evidence for outcomes and the value of care. We can get ahead of this by updating curriculum and training that further integrates use of emerging digital technologies to improve efficiency in the device design and manufacturing process. In turn, this would enable the clinician to include attention toward the patient and payor, which are two key stakeholders in the care delivery process,” Hovorka explains. “Looking ahead toward long-term outcomes, evidence-based patient-oriented care can help build the knowledge of O&P intervention effectiveness by potentially reducing long-term costs for care. To achieve this, we need to collectively embrace data-driven approaches by better equipping clinicians who are providing care now so that they can inform our future.”

November/December 2023 O&P Almanac


Cover Story

“Providing devices is not a simple thing; it takes a long time to get it right,” adds Raschke. O&P clinicians should learn to improve their productivity, both technically within the production process chain as well as by taking the right outcome measurements, to “lean the entire provision process out”—which would mean fewer fittings to achieve the correct device and fit. “Be strategic about which measurements to take, and which ones are most useful with Silvia Ursula Raschke, PhD respect to your decision making about what to provide” to patients.

Specialization, Collaboration, and Opportunities Specializations within—or adjacent to—traditional O&P pose another opportunity to modernize care delivery in O&P. Duncan predicts “highly focused care on specific etiologies. “We have evolved as a profession, and we have to evolve our business plan concepts,” explains Duncan. “We have a lot of capabilities for expanding our practices into boutique care, with fun and revenue-generating ventures,” he says. “We have the concepts needed” for some other opportunities and should not be afraid to try new things. Some facilities may choose to focus on areas within O&P that require expanded knowledge—such as upper-limb care, suggests Duncan. Many clinicians are not comprehensively versed in all of the nuances of upper-limb care—but he foresees O&P students or new clinicians pursuing fellowships or residencies that specialize in particular areas. Adaptive services is another area of potential opportunity. “The assistive tech arena—why can’t we get into the realm of being active on trikes, bikes, athletic J. Chad Duncan, PhD, CRC, performance, adaptive skis, ice skates?” CPO, LPO asks Duncan. “We can dive into those areas. We can implement our knowledge of human anatomy and the concepts we study every day” to improve adaptive technologies for individuals with disabilities. “Be more open to these new ideas and try new things,” Raschke says. That means O&P professionals will need to look outside the box and take on new roles and responsibilities. For example, O&P facilities should adopt a collaborative approach to care as orthoses and prostheses become more technologically advanced and more complicated, according to Esquenazi. For implantable devices, “we’ll see increased interaction between O&P providers and other care providers,” he says. “More complex gadgets will require collaborative, multidisciplinary care.” Exoskeletons that are motorized, which were recently defined as “braces” by CMS, “will require orthotists to set up and tune the powered devices,” Esquenazi says. “Orthotic and prosthetic facilities that may be interested in providing physiologically controlled devices [devices controlled by muscles or the brain] will need to work closely” with the healthcare providers who implant 22

O&P Almanac November/December 2023

sensors, as well as physical therapists and other allied health professionals. In addition, as various competing entities bring new products to market, O&P clinicians should be part of the product development process—partnering with engineers as well as end users in the early stages of development, says Raschke. “Startups are disrupting O&P with new products and approaches to provide new solutions to fill existing gaps within the market,” she says. “We need to start filling those gaps ourselves.” Of course, developments in artificial intelligence (AI) and machine learning will impact the provision of O&P care. “AI and machine learning for predictive analyses—those can be very powerful in O&P,” says Duncan. “O&P professionals may not truly be ready for how [AI and machine learning] can affect how we provide care,” he says. “It’s a true challenge: How do we embrace it and manage it in the future?”

The growth of AI will mean “we’ll have information at hand that we’ve never had before—more evidence and research to support and add to our knowledge that we have from our training and certifications,” adds Duncan, which will lead to better patient management. “That could be very powerful—but dangerous” as other professions could attempt to creep into O&P and provide equivalent care based on data and analytics—but without the training and education of certified clinicians. Raschke says that as sensors, wearables, and remote patient monitoring facilitate data collection in the future, “O&P facilities have to figure out how to capitalize on that … and leverage the data we collect and organize to develop better-focused, more efficient, and less costly solutions for O&P problems.” The O&P community will need to survey healthcare trends outside of O&P that may influence the provision of O&P care. For example, “advances in diabetes care could impact both prosthetics and orthotics, as could the aging population and osseointegration,” Raschke says. “You need to monitor these types of broader trends so you can pivot if needed; and do the strategic planning to be ready for these advances—even if they don’t come to fruition.” “All of the pieces are interconnected,” Duncan says. “We will need to consider the standards of care in place to protect patients, and we have to make ourselves irreplaceable.” Christine Umbrell is a contributing writer to O&P Almanac. Reach her at

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The state of international O&P care and why experts urge assistance on the ground in areas with growing limb loss populations


f Humanitarian crises in conflict-ridden f During the World Health Assembly countries, and natural disasters that impact thousands, can be “catalysts” that raise awareness of individuals in need of prostheses and orthoses and focus the O&P world on areas of greatest need.

f Some non-governmental

organizations and nonprofits are committing more resources to the most hard-hit locations—but others, like the International Committee of the Red Cross, are reducing their budgets.


O&P Almanac November/December 2023

in May, 194 countries ratified a landmark resolution to develop and strengthen rehabilitation in their health systems; the resolution sets out nine actions for governments, including increasing access to artificial limbs and braces.

f Innovative socket manufacturing technologies, including digital fabrication and direct-casted sockets, are rapidly emerging and are expected to boost

access to prostheses—but some designs and manufacturing techniques are substandard.

f Most experts agree the need for

localized training in low-income countries is even greater than the need for supplies. Some volunteers fill the void via virtual training sessions; others schedule trips to developing nations to train local healthcare providers.

At the Cambodian School of Prosthetics and Orthotics in Phnom Penh, (left) a lecturer discusses socket fit issues with a student; (right) an O&P trainee assesses her work at first fitting; and (below) a student adjusts the alignment of a prosthesis under the direction of an instructor.


he global need for orthotics and prosthetics care is skyrocketing, fueled by wars, diseases, and natural disasters. But as the world economy sputters under inflation and high interest rates, funding for humanitarian assistance is stretched thin, compounding the challenge of providing O&P care for the rapidly growing ranks of individuals with limb loss around the world. Global health organizations are urging national governments to acknowledge that basic mobility services are an essential human right, and that public health spending on orthotics and prosthetics should be boosted accordingly. Non-governmental organizations (NGOs) and nonprofits that provide O&P care, including some in the United States, are committing more resources to O&P training on the ground where it’s needed most, with an eye to the provision of long-term care. Still, global turmoil is driving the need for O&P services ever higher.

Recent Conflicts, Natural Disasters

In Ukraine, public and private health officials estimate 25,000 to 50,000 soldiers and civilians have lost limbs—or multiple limbs—in the two years since Russia began its attacks on the former Soviet bloc country. Artillery and missiles caused most amputations early in the conflict. Now, landmines along the 600-mile front line are claiming even more Ukrainian limbs and lives. Meanwhile, Israel’s widespread bombing of the Gaza Strip, in retaliation for the Oct. 7 Hamas attacks that resulted in the deaths of more than 1,200 Israelis, created an untold number of new amputees—including hundreds of children. Exact amputation numbers are not yet available, but the humanitarian need for O&P care in Carson Harte Gaza will be immense, based on reports from the Palestinian Health Ministry. Brutal conflicts weren’t the only tragedies driving amputations higher in 2023. Catastrophic earthquakes rocked Turkey and Syria, necessitating hundreds of amputations that compounded the global need for O&P devices and care.


“In general, a humanitarian crisis like a war or an earthquake can be a catalyst to focus the O&P world on the need—and the current conflicts are clearly creating a lot of amputees,” says Carson Harte, founder and CEO of U.K.-based Exceed Worldwide. The organization has nearly 200 employees in five southeast Asian nations, including Cambodia, where three decades of war have resulted in amputations among more than 40,000 individuals. Exceed Worldwide has worked with partners since 1989 to establish five specialist orthotic and prosthetic schools. These institutions train local professionals to international standards and operate clinics that provide high-quality O&P devices and treatment to people with disabilities on a charitable basis. Randy Titony, executive director of the Oklahoma City-based Limbs for Life Foundation, which provides functional and free prosthetic devices to those who cannot otherwise afford them, also senses a growing need for O&P care around the world, based on evidence landing in his organization’s email inbox with increasing frequency. With just five full-time staffers and a robust national and international network of O&P provider partners, Limbs for Life has provided thousands of prostheses to amputees around the world. “Virtually every day, we get a very powerful and moving email from someone in Ecuador, or Kenya, or Egypt, or India, who lost their leg in an accident,” Titony explains. “The international requests on a personal level are increasing. Even in areas where people are very, very low income, they’re finding ways to reach out to us.” November/December 2023 O&P Almanac


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That’s in part because medical advancements are helping people survive traumatic battlefield, workplace, and other injuries that previously may have resulted in death instead of amputation. “We’re not getting healthier; we’re just living with disease longer,” says Titony. “Across the globe, diabetes, peripheral vascular disease, cancer, trauma—these things are lending itself to increasing the risk of an amputation.”

Need Recognition

The escalating demand for O&P intervention comes at a time when the International Committee of the Red Cross (ICRC)—a major funder of humanitarian medical care—is reducing its initial 2024 budget forecast to $2.4 billion, down 13% compared to 2023. The cutback means Randy Titony ICRC delegations will have considerably less capacity to assist those in need. “The ICRC is highly concerned about the impact that reduced humanitarian assistance will have on people living through armed conflict and violence,” the organization said in a September statement. “We are therefore working to reduce costs, create organizational efficiencies, and maximize resources to deliver our core work.” The steep ICRC budget cuts will mean less money for training logistics of supportive care—and could result in more people discharged from hospitals without prostheses. It’s not all bad news, however. The U.N.’s 2015 adoption of Sustainable Development Goals (SDGs), with full support from the International Monetary Fund, has proven a major catalyst in raising awareness of O&P need, changing societal views of individuals with limb loss, and encouraging state funding for assistive technologies, including O&P devices and related care. 26

O&P Almanac November/December 2023

Growing rates of diabetes have driven the shift. The U.N. estimates the rate of people living with diabetes—a major contributor to limb loss—has more than doubled since 1980, with more than 422 million people now diagnosed with the disease. Rates of lowerlimb amputation are 10 to 20 times higher for people with diabetes compared to those who do not have the disease. Harte notes that U.N.’s Millennium Development Goals, which predated the SDGs, “did not mention disability in any shape, or form.” “The SDGs quite clearly state that about a billion people have some form of impairment, so there’s a lot more interest in that,” Harte explains. “The World Health Organization (WHO) has also made a number of very positive statements making sure that physical rehabilitation and assistive technology is now within healthcare. That’s a big thing—a big push forward.” WHO’s establishment of Global Cooperation on Assistive Technology (GATE) in 2014 is helping improve access to high-quality affordable assistive technology for all people, regardless of geographic location, income level, or socioeconomic status. The GATE initiative is a proactive response to the U.N. Convention on the Rights of Persons With Disabilities, the SDGs, and calls for universal health care in all nations. In May, the World Health Assembly advanced the O&P agenda again when it gathered in Geneva and took decisive action in support of expanded O&P care across the globe. At the assembly, 194 countries ratified a landmark resolution committing, for the first time, to develop and strengthen rehabilitation in their health systems. David Constantine, the U.K.-based president of the International Society of Prosthetics and Orthotics (ISPO), says the new focus on assistive care worldwide is a warning to nations that have long neglected such needs: “What they’re saying is governments need to wake up to the fact that there’s going to be an explosion of funding requirements to provide this stuff to their populations.” The WHO resolution—the highest level of international commitment—sets out nine actions for governments, including an increase in physical and occupational therapy services and training, and expanded access to artificial limbs and braces. The new global framework is designed to spur government investment in rehabilitation services, which has historically been a major, historical barrier to encouraging private donors to open their wallets, as well. “We know that nothing can change unless there is political will, a strong commitment to make things happen,” says Valentina Pomatto, inclusive development advocacy manager at Humanity and Inclusion, which has worked internationally to improve the lives of individuals with limb loss for decades. “This resolution at the 2023 World Health Assembly is a document that fixes this commitment into words and holds those in charge of delivering on this commitment accountable.” PHOTO CREDITS: LIMBS FOR LIFE FOUNDATION

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A young boy takes his first steps with his new prosthesis.

Santos Lara, a prosthetist with CAMO, treats a young patient.

Supply and Demand Disparities

Despite the growing recognition of the need for expanded O&P services and devices across the world, many areas remain in dire need of providers and equipment to treat individuals with limb loss. An estimated 65 million people worldwide live with amputation, and the need for prosthetic services is expected to double worldwide by 2050, WHO reports. Globally, an estimated 1.5 million people undergo amputations (mostly lower limb) every year, most of whom would benefit from access to prosthetic services. This need is rising fastest in lowand middle-income countries, according to WHO. It’s a long-established fact that a quality prosthesis can improve quality of life and reduce mortality for amputees, but the WHO estimates that only 5% to 15% of amputees who need prostheses in these Valentina Pomatto areas have access to them. In the absence of government investments, NGOs have developed service capacities—largely in response to emergencies—that sometimes work side-by-side with government systems. Just a few major players dominate the worldwide prosthetic components industry, and the market is geared heavily to customers who can afford technologically advanced solutions. Innovative socket manufacturing technologies, including digital fabrication and direct-casted sockets, are rapidly emerging and expected to boost access to prostheses, but some designs and manufacturing techniques are substandard. In some instances, misguided or unscrupulous O&P device “inventors” travel to developing nations aiming to test their experiments without taking appropriate considerations and precautions, essentially turning unsuspecting and sometimes desperate individuals with limb loss into human guinea pigs, according to Harte. 28

O&P Almanac November/December 2023

ISPO—the global governing body for O&P—addressed this issue in a March 2021 position paper: “Testing technology involving human subjects or participants creates ethical concerns that are under-explored and become a critical issue for prosthetists, orthotists, researchers, and their clients, especially those in the low and middle-income countries,” the policy says in part. “We created an ethical guideline for this within [ISPO] because there are some who thought trying [unproven O&P technology and devices] on poor people was a good idea,” Harte explains. Constantine says it’s a constant struggle to ensure that humanitarian O&P equipment and care delivered to low-income or developing regions is up to modern standards. “You can do as much provision as you want, but if it’s not the right kind of provision, and not working to the guidelines, then it’s not good enough,” he says. “Many organizations, especially faith-based ones that [operate under] a charity model, say, ‘Well, something’s better than nothing.’ Well, I say, ‘No.’ Morally, that may be a hard thing to argue against, but just because someone’s poor, or hasn’t got the money, doesn’t mean” they deserve crap, or hand-me downs from other countries or inappropriate products just because they’re not needed in that country anymore.” While the latest and greatest O&P technology doesn’t come cheap, new commercial suppliers from China, Turkey, India, and other countries are emerging in the global market and offering affordable O&P products to address the growing need in developing nations. But their track record is unclear because of limited transparency regarding quality and performance. Harte and others who specialize in meeting the humanitarian need for O&P care say the emerging new supply could lead to broader access to affordable and appropriate prosthetic components, but increased accountability from device developers and a more responsive supply chain are required to establish better credibility.

Localized Care

With so many people in need of O&P care worldwide, properly trained O&P caregivers are in high demand. A report delivered by the Clinton Health Access Initiative under the UK-funded AT2030 program found that training prosthetists to ISPO standards helps expand service capacity, improves prosthetic and orthotic service delivery, bolsters clinical leadership, and spurs development of professional O&P communities everywhere, regardless of income levels. PHOTO CREDITS: CENTRAL AMERICAN MEDICAL OUTREACH (CAMO)

The need for localized training in developing or low-income countries that lack O&P industry infrastructure is even greater than the need for supplies, according to Harte and other humanitarian experts. “I strongly believe in building infrastructure in-country,” says Jeff Erenstone, CPO, founder and CEO of Operation Namaste, an organization based in Lake Placid, New York, that provides low-cost technology, collaboration tools, and training for O&P caregivers in the developing world and conflict zones. Jeff Erenstone, CPO In 2022, Erenstone traveled with several colleagues to war-torn Lviv, Ukraine, and trained local practitioners on the types of technology that can provide O&P care quickly. For example, the Operation Namaste Limbkit is a compact mobile lab that can be transported in a small truck or van to provide comprehensive transtibial prosthetic care in regions with significant numbers of amputations. Operation Namaste also has developed a Collaborative Care Network that facilitates training of caregivers in low-resource areas via remote prosthetics specialists, and offers computer-assisted design software to customize prosthetic devices. This approach eliminates the cost and logistics of in-person training and enables design, fabrication, and delivery of advanced prosthetic devices and care, regardless of location. “These virtual labs just allow us to improve the education and break down those education barriers because that’s one of the biggest problems in low-income countries,” Erenstone explained a in 2022 interview. Remote training opportunities provide for more sustained care than one-time fittings, according to Erenstone. He and some other humanitarian experts believe the U.S. media tends to focus on stories of U.S. practitioners providing limbs or other devices and a fitting—and many times that’s the end of the commitment. He cites examples of news coverage showcasing Ukrainian soldiers who lost limbs in battle being transported to the United States for O&P care, then returning to Ukraine. “It’s a really good feel-good story,” Erenstone says, “but who’s going to do the follow-up care?” Even preliminary provision of devices and fittings is appreciated and essential, but it’s also exorbitantly expensive to finance and scale, whereas a team of trained O&P experts could spend a week or two on-site in a developing nation and train others to provide basic care that could help far more people. “What we encourage, and what we embrace enthusiastically, is people coming out to teach and deliver a course, or people coming out to help write material— people coming out to train the trainers, or people coming out to share an appropriate new technology,” says Harte. Exceed Worldwide relies largely on private donations, including upwards of $60 million from Japan’s Nippon Foundation since its founding in 1989. Kathy Tschiegg, RN, a former Peace Corps nurse and founder and executive director of Central American Medical Outreach (CAMO) Honduras, agrees that providing O&P training and resources in-country is far more effective and economical than transporting patients to and from the U.S for care, or traveling abroad simply

Help Make a Difference O&P professionals willing to share their expertise in developing nations—or make a donation—have ample opportunities. The organizations interviewed for this article welcome help from the profession. Exceed Worldwide accepts volunteers with specific skills, says Carson Harte, founder and CEO: “It would be a matter of discussion and agreement with the team, before arrival, to identify skills and talents and set goals for the volunteering session.” Those interested should contact the London-based headquarters at +44 (0)7394 499333, or email office@ Exceed also has a donor page at Operation Namaste also welcomes volunteers. The organization makes “annual trips to Nepal to teach local practitioners modern clinical care techniques,” says founder Jeff Erenstone, CPO. Anyone interested should email info@operationnamaste. org or visit Central American Medical Outreach (CAMO) seeks volunteers in the U.S. and Central America. The organization is seeking experienced professionals who can volunteer in the group’s Orrville, Ohio, warehouse to help disassemble prosthetic limbs that will be shipped to Honduras. CAMO also is “in great need of” supplies including prosthetic feet, knees and tubes, and endoskeletal components for lower-limb prostheses. Those interested in volunteering internationally should contact the U.S. office at 330-683-5956. Although the Limbs for Life Foundation doesn’t facilitate volunteers, the organization partners with domestic O&P clinics to assist low-income clients, as well as clinicians who travel abroad to do international mission work. Limbs for Life accepts donations of prosthetic limbs (but not orthoses), as well as monetary contributions. For more information, visit the website, call 1-888-235-5462, or email

to do a few fittings. With six employees at its U.S. office in Orrville, Ohio, and a staff of 38 in Honduras, CAMO procures medical supplies, materials and equipment, and monetary donations for its medical programs—including an orthotic/prosthetic lab. CAMO has entered into contracts with 14 city governments and three NGOs to provide care for their citizens. In 2021-2022, the organization fit more than 700 Central Americans with prostheses. “It costs much less money” to provide O&P and other medical services on the ground, Tschiegg says. “If we take care of the issue where it is, instead of paying the plane fares [for patients] and doing the [medical care and housing patients] here in the United States, we give people hope where they live.” Michael Coleman is a contributing writer to O&P Almanac.

November/December 2023 O&P Almanac



Second Chances Houston prosthetist has treated many osseointegration patients— including a police officer who lost his leg helping others

Jon Holmes, PT, CP, LP, has treated more than 30 patients who have undergone osseointegration.

In each issue of O&P Almanac, the Transformations column features the success story of an O&P clinician who has worked with an inspiring or challenging patient. This month, we speak with Jon Holmes, PT, CP, LP, about a patient who initially wore a socket prosthesis but eventually underwent osseointegration.


Michael Huffman, a police officer who lost his leg in a roadside accident, wore a traditional socket for several years before undergoing osseointegration.


O&P Almanac November/December 2023

or police officer Michael Huffman, having Jon Holmes, PT, CP, LP, as his prosthetist has been an integral part of his rehabilitation journey—a journey that began with a traumatic amputation, led to a few years wearing a traditional socket, and eventually resulted in a trip to Australia for osseointegration surgery. In April 2013, Huffman and another off-duty police officer were driving home from a hunting trip when they stopped to assist with a multi-car crash on the side of the road. They retrieved their medical kits and went to the scene; while they were helping, an 18-wheeler drove into the accident scene, Huffman’s colleague lost his life, and Huffman sustained life-threatening injuries.

Recovery and Work Physicians amputated Huffman’s left leg above the knee. His right leg was fractured in several places, including in the tibia-fibula and right femur, and his pelvis was broken. He also had several broken ribs, broken vertebrae, and a broken humerus. “Rehabilitation was quite extensive,” Huffman recalls. “I was in the ICU for about 20 days.” Once stabilized, Huffman was transferred to TIRR Memorial Hermann Rehabilitation Center in Houston, where he met Holmes, founder of Holmes Prosthetic Center (HPC). Holmes recalls noticing the extensive damage to Huffman’s lower body during their first meeting: “He was an above-knee amputee—but his residual limb had lots of PHOTO CREDITS: JON HOLMES, PT, CP, LP/MICHAEL HUFFMAN


A 3D scan of Huffman’s heterotopic ossification, taken in Australia

scars and lots of heterotopic ossification, in addition to the tib-fib fracture on the right side,” he says. He initially fit Huffman with a traditional socket and an Ottobock Genium X3 leg, and the two began a patientpractitioner relationship that has lasted a decade. Huffman returned to the force—first in a wheelchair, then with his prosthesis. While he had spent 23 years of his career on the SWAT team, he had more recently been working at the police range as an instructor, and his prosthesis allowed him to continue that work. Huffman wore the socket for more than three years, but he frequently developed painful sores and blisters. One day, he met a patient at Holmes’ facility who had an implant—and he approached Holmes about the possibility of osseointegration for himself.

MBChB, FRACS, FAOrthA, an orthopedic surgeon and chairman of OGA. “That patient was the 99th in the entire world” to undergo osseointegration, Holmes recalls. Over the next few years, Holmes learned more about implant surgery; he followed advances worldwide and participated in an educational course presented by Al Muderis in Houston. “Then, three more of my patients went to Australia to have the procedure done—so I went with them,” Holmes says. He spent two weeks at OGA, meeting with surgeons, therapists, prosthetists, and patients in various stages of recovery. “It was all new at the beginning,” he recalls. “My first patients were risk takers, so I said, ‘Let’s figure this out together.’” To date, more than 30 of Holmes’ patients have undergone osseointegration—some at OGA, and others in the United States via the OPRA implant system or in correlation with the U.S. Department of Veterans Affairs. That means Holmes has fit prostheses for approximately 1.5% of all individuals worldwide who have undergone osseointegration— which he estimates to be approximately 2,000 people. Holmes sees many benefits of osseointegration, but he cautions patients to understand the “risks as well as rewards.” Because osseointegration patients are susceptible to infections and are warned against activities such as running, jumping, and swimming, the procedure is only recommended for patients who can’t tolerate a socket, according to Holmes. In addition,

patients who smoke or who are out of shape are not advised to have the procedure. For Huffman, who was extremely physically fit and did not smoke or drink alcohol, osseointegration was an option given the pain he experienced with his socket He contacted OGA and submitted to both psychological and physical prescreening to determine his mental and physical fitness and ensure he didn’t smoke or have diabetes. He ultimately traveled to OGA in Australia in May 2017 and underwent surgery to receive an implant. Huffman paid out of pocket for the procedure, but was reimbursed by his home city because he was considered injured in the line of duty. Huffman spent six weeks in Australia, where he received the implant—which easily attached to his X3 prosthesis—and underwent initial rehabilitation. Then he returned home on two crutches as he continued to rehab in Texas, transitioning to one crutch and finally graduating to walking without crutches. During the process, he had several appointments with Holmes. “There were lots of angular adjustments, and adjustments for alignment,” recalls Holmes. The experience was “life-changing” for Huffman. “I’ve had zero infections in seven years,” he says. “I’m pretty active, but osseointegration has some fail-safe features” designed in to prevent catastrophes in case the implant is damaged. “I’ve broken some pins and have had to replace some parts, but I’ve not had phantom pain or sensations” since receiving the implant.


Implant Exploration

For a patient considering osseointegration, Huffman was in the right facility. Holmes, who worked with A.L. Muilenburg for 23 years before launching HPC in Houston in 2006, has treated many patients who have undergone surgery to have an implant attached to their bone. Nine years ago, the first of Holmes’ osseointegration patients travelled to Australia to have the procedure done at the Osseointegration Group of Australia (OGA), led by Munjed Al Muderis, PHOTO CREDITS: JON HOLMES, PT, CP, LP/MICHAEL HUFFMAN


X-rays of Huffman’s leg pre-osseointegration with a socket (left) and post-osseointegration with an implant

November/December 2023 O&P Almanac



Huffman visits Holmes Prosthetic Center on a regular basis for alignments, adjustments, and componentry replacement.

“Osseointegration has made me more active,” adds Huffman. “With the socket, I had to take it off several times a day” due to discomfort and the need to clean it. Now, “I don’t sleep with the leg—but I get up at 5 a.m. and keep it on all day.” In addition, “walking is a lot easier now that I don’t have to carry a big, heavy socket around.” In fact, because Huffman’s right leg is still damaged from the 2013 accident, “the osseointegration leg [with the prosthesis] is in better shape,” he says. He underwent a right knee replacement a year ago and successfully relied on his left leg and prosthesis as he rehabilitated.

Huffman continued his work as an instructor at the police range for several years post-osseointegration.


O&P Almanac November/December 2023

Huffman continued his work as a police officer for several more years postosseointegration. He officially retired from full-time duty in June after 38 years on the police force, but he continues to work for the force part-time.

Learning Curves

As Holmes’ osseointegration patient base has expanded, so, too, has his knowledge of how best to treat this demographic. He is adept at the precise alignment required for implant patients, and he has learned to keep the necessary replacement parts on hand. “Early on, I didn’t stock all of the parts, so patients would have to wait three days for missing pieces,” Holmes says, recalling several times when Huffman would have to use crutches or a wheelchair while waiting for a part. In addition to his home patient base, Holmes works immediately post-surgery with some patients who travelled to Houston to undergo osseointegration from a nearby surgeon who specializes in implant procedures. “Then we send them back to their local prosthetist” to continue their rehabilitation. Because he has treated so many implant patients, Holmes has a good understanding of which patients are appropriate candidates for the procedure. “If a patient has a perfect residual limb, or doesn’t have medical issues, then I steer them away,” he says. If a patient has a short or hard-to-fit limb or has trouble with the socket, he will recommend the procedure, as long as the patient is physically fit and meets the guidelines.

Not all of his patients have fared as well as Huffman post-osseointegration. Several patients have battled infections for long periods of time, and two patients have had their implants removed due to discomfort and infection, says Holmes. Overall, though, results have been positive. Holmes believes more people will undergo osseointegration in the next few years—as more implants gain approval from the U.S. Food and Drug Administration, and as more people become aware of the procedure. “Now we have to get the insurance companies on board,” he says. Prosthetists who have not yet fit prostheses on patients with implants should learn about osseointegration now to prepare to see patients in the future, according to Holmes. “Learn the connectors that attach to the leg; learn the alignment; do your homework,” he says. “It’s in your Scope of Practice” as defined by the American Board for Certification in Orthotics, Prosthetics, and Pedorthics. He also cautions prosthetists to understand the patients for whom implants will be a benefit: “Not everyone is a candidate,” he says—but those who are may one day, as Huffman did, share their own “life-changing” experiences. DO YOU HAVE A TRANSFORMATIVE PATIENT-CARE EXPERIENCE YOU’D LIKE TO SHARE WITH O&P ALMANAC READERS? Contact Editor Josephine Rossi,, with your story to be considered for an upcoming profile.


Member Spotlight






Action Prosthetics

Karl Burk, CP

Troy and Greenville, Ohio

15 years

Service and Support Ohio prosthetic facility embraces a personalized approach to care

I Karl Burk, CP, owner of Action Prosthetics, with a patient

Molly Null, patient liaison/marketing director; a patient; and Pam Aukerman, office manager

The Action Prosthetics headquarters facility in Troy, Ohio


n college, Karl Burk, CP, planned on a career as a physical therapist. But all it took was one patient with a prosthesis for him to change his mind. “To see how someone could walk again was very moving,” Burk recalls, “and I liked to build and do engineering things when I was in high school.” He switched to pursuing a prosthetics career and never looked back. Burk graduated with a bachelor of science degree in rehabilitation in 1999 and earned his CP credential. After working for various employers, Burk opened his own facility, Action Prosthetics, in 2008. He and Pam Aukerman, the facility’s administrator, were the sole employees until 2016, when he hired Molly Null as a patient liaison and marketing manager. Action Prosthetics is based in Troy, Ohio, with a satellite office in Greenville. The Troy office features 14-foot-long parallel bars, mirrors, two fitting rooms, and a full-scale lab, where Burk fabricates about 90% of the devices his patients use. “I do outsource the initial test socket for transfemoral prostheses and modify it from there,” he says. The Greenville office includes a small lab for making adjustments and is located in a building with occupational, physical, and speech therapists. Burk and his patients can use the physical therapy gym there when needed. Most of Burk’s patients are higher-functioning adults, Medicare K levels 3 and 4, with amputations resulting from trauma, although he also sees some older individuals with vascular amputations and patients at the local veterans’ hospital. Many of Burk’s patients have sought him out after unsatisfying treatment elsewhere. “We tend to attract difficult cases, and we are able to help them,” he notes. Action Prosthetics is committed to an individual, personal approach to patients. “We truly treat each patient like a family member,” he says. Burk pays close attention to advancements in technology, including 3D scanning and printing, but he’s not ready to take the plunge just yet. “I really enjoy doing things by hand,” he says, “although I can see the benefits of the technology,

especially for larger facilities. I’m certainly not ruling it out. We keep up to date, attend AOPA meetings nearly every year, and stay on top of the newer products. But one reason I haven’t jumped on board is that I want to do this right for patients, not just faster—and so far, I feel like I have more control with hand casting.” Null is both a current employee and one of Burk’s successful patient-care cases: In 2008, soon after Burk launched his facility, Null lost two fingers and both her legs below the knee after strep throat caused fullblown sepsis. “I thought I’d have to travel much farther away, but I lived in Greenville and was able to visit the satellite office,” Null recalls. Hers was a difficult case because she had a short residual limb and significant scar tissue, but Burk was able to fit her successfully. “Karl is picky, and I’m glad he is!” she says. Null began running an amputee support group in 2009, and in 2016, Burk approached her with a job offer. “He wanted to hire someone to be a patient liaison and marketing manager,” says Noll, who had taught school prior to her amputation. Now, “my favorite part of my job is to educate new amputees, to guide them through their journey,” she says. “I am optimistically honest with them. [Amputation] is not an easy thing, but I was there, I got through it, and I am happily living my life.” Null continues to run a monthly support group and regularly updates the facility’s social media. After 15 years, Burk has no plans to expand. “I enjoy patient care so much,” he explains. “I don’t want expand to where I’m managing employees instead of actually treating patients.” Nevertheless, he might just bring on one more practitioner, at some point: His daughter, Mary, is finishing her senior year of college and has been accepted into an O&P graduate program. “We hope she’ll join us eventually,” Burk says. “And she will be certified in both prosthetics and orthotics, so if that is her passion, we might add orthotics to our services.” Deborah Conn is a contributing writer to O&P Almanac. Reach her at

November/December 2023 O&P Almanac


Member Spotlight






LIMBER Prosthetics and Orthotics

Joshua Pelz, PhD; Luca De Vivo, PhD; and Herbert Barrack, CPO

San Diego

Three years

Merging Engineering, Tech, and Prosthetics Startup company plans to market a 3D-printed transtibial leg

L The UniLeg has been fit on roughly 30 individuals in Ensenada and is part of a pilot program at a facility in San Diego.

A patient wearing the device


ike many innovative O&P startups, LIMBER Prosthetics and Orthotics was a spinoff of a university research project. This one was launched at the University of California (UC) San Diego, where Joshua Pelz, PhD, and Luca De Vivo, PhD, were part of a program centered on improving access to mobility devices, with a focus on prosthetics. Herbert Barrack, CPO, was brought in as a subject matter specialist. For the past 25 years, Barrack has participated in a quarterly prosthetic clinic in Ensenada, Mexico, a joint effort by the Coronado Rotary Club in San Diego and the Calafia Rotary Club in Ensenada. “It’s a weekend of intense work and clinical care, and there is never enough time to fabricate as many limbs as you want,” says Barrack. “This was the inspiration for us to create a single 3D-printed system.” Barrack, Pelz, and De Vivo developed a fully 3Dprinted prosthetic leg “that we thought could make a big difference, so we decided to form a company,” says Pelz. “We incorporated LIMBER in 2020. Our goal from day 1—and why we joined forces—has been to combine engineering and cutting-edge tech, like digital design and 3D printing, with conventional prosthetic understanding and fabrication methods.” Since then, the trio has been refining and testing the LIMBER UniLeg, a patent-pending completely 3D-printed transtibial prosthesis, and expects to bring it to market in early 2024. Printing the entire device, rather than just the socket, is unique to the industry, according to Pelz. “If you just 3D-print the socket, you lose out on many advantages: precision, turnaround time, flexibility of design, personalization. It’s no longer one size fits all, or small, medium, large—every device can be completely customized.” The company’s business model is to work with clinics to help practitioners improve efficiency and precision when producing a transtibial prosthesis. LIMBER uses a specific type of engineering-grade thermoplastics to increase strength and durability, subjecting it to high-cycle fatigue testing to ensure the prosthesis meets the same durability standards as conventional componentry.

O&P Almanac November/December 2023

The company also developed its own 3D printer. “It was hard to find one to print the entire leg because it is so large and we require special environmental controls during the process,” explains Pelz. “Now we have printing tech that is perfectly tailored to our process, and it takes 12 hours or less to print a leg.” LIMBER is testing the UniLeg in the United States and Mexico and conducted a pilot program in Ukraine last year. The company has fit roughly 30 individuals in Ensenada, including five with bilateral limb loss. After 20 months, all continue to function successfully wearing the device, with regular follow-ups. The company also is running a pilot program at ABI Prosthetics and Orthotics in San Diego, where Barrack previously worked as a prosthetist/orthotist. LIMBER has received approval to conduct a clinical trial on 30 individuals with limb loss, comparing outcome measures between the UniLeg and each individual’s conventional prosthetic device. “Participants will be mature, unilateral transtibial patients who have been successful with a conventional prosthesis,” Pelz says. “We’ll run outcome measures, fit them with the LIMBER leg, and repeat the outcome measures after one month.” The study will be conducted at UC San Diego, with faculty serving as principal investigators. LIMBER P&O recently moved to a new office in San Diego, where the owners are scaling up their design and manufacturing capabilities. In addition to the three directors—Pelz, De Vivo, and Barrack—the company has three full-time and two part-time employees, along with several independent contractors. “One of the tenets of our company is combining the minds of engineers with the minds of clinicians—you will lose out if you don’t do that,” says Pelz. “It’s the best way to get the best possible patient outcomes. Herb brings his specialized patient knowledge, and Luca and I—our expertise in materials and technology. We are excited to bring that to the U.S. market very soon.” Deborah Conn is a contributing writer to O&P Almanac. Reach her at



Visit AOPA’s Co-OP: The Compendium of O&P


n online reimbursement, coding, and policy resource, the Co-OP features a collection of detailed information with links to supporting documentation for the topics most important to AOPA members. A Wikipedia of all things O&P, the Co-OP incorporates a crowdsourcing component, which is vetted by AOPA staff, to garner the vast knowledge and experience of our membership. Visit AOPA’s website to sign in to your account. There’s also an app! Once you’ve signed up, download it to your mobile device. Enter as the domain, and enter your email and password from the Co-OP. Questions? Contact Sam Miller, AOPA’s manager of state and federal advocacy, at Scan the QR code to download the app.

New AOPA Members


COMPREHENSIVE GUIDE The Most Popular Orthotic and Prosthetic Illustrated Reference

2023 Illustrated Guide Updated Medicare Codes for Orthotics and Prosthetics

Purchase the Updated AOPA Illustrated Guide The 2023 Illustrated Guide is now available! Purchase this easy-to-use digital guide, featuring the Healthcare Common Procedure Coding System codes for orthotics, prosthetics, and shoes. The 2023 Illustrated Guide is a digital product; you will receive a PDF file to view digitally or print on your own. Prices are for $135 for members and $425 for nonmembers. Contact or visit My AOPA Connection for details.

Welcome New AOPA Members Alexander Prosthetics & Orthotics Inc. P.O. Box 351979 Los Angeles, CA 90035 310-621-9950 Majid Ashrafy, BOCP Patient-Care Facility The officers and directors of the American Orthotic & Prosthetic Association (AOPA) are pleased to present these applicants for membership. Each company will become an official member of AOPA if, within 30 days of publication, no objections are made regarding the company’s ability to meet the qualifications and requirements of membership.

November/December 2023 O&P Almanac




New Mini Dynamic Strut FREE Online CEUs & Partial Foot Illustrative Guide Available! Visit and earn 3(S) CEUs. Also available, our comprehensive 12-page guide for Management and Fabrication of Partial Foot Prosthesis. Reduce friction, shearing, and pressure, restore propulsion and limb length, and preserve residual limb. To request the guide, call 888-678-6548, email


Soft, Medium, and Rigid Flex


Designed for smaller patients Kit includes tooling & mounting Replacement struts available

Easy-Off Lock Robust Design

Deeply Discounted Fitting Kit Available Phone (208) 429-0026 |

Coyote’s New Mini Dynamic Strut Is Now Available This smaller version of our popular strut comes in soft, medium, and rigid flex. The strut flexes and moves with smaller patients, thus creating a more natural and comfortable gait. It works great with thermoformed braces, giving it more adjustability. Contact Coyote at 208-429-0026 or

The Original Preflexed Suspension Sleeve ESP created the Flexi family of suspension sleeves as a comfortable, durable, and cost-effective alternative to traditional suspension sleeves. Preflexed at 43 degrees for maximum comfort and natural unrestricted movement. For more information, call ESP LLC at 888-932-7377 or visit

Precision Fit With Mt Emey® Custom Shoes Embrace the comfort of custom-fit with Mt Emey ®’s Custom Shoe (Medical) Program. Our precise 3D scanning captures your unique foot contours, promising a perfect fit without the wait or waste. From stylish athletics to roomy comfort designs, our handcrafted shoes adapt to your needs. Satisfaction guaranteed before payment. Plus, qualified wholesale accounts receive a free 3D scanner. Step into the Mt Emey ® difference—where every shoe is made for you. For more information, call 1-888-937-2747 or visit


O&P Almanac November/December 2023

Hersco 3D Printing Hersco is delighted to offer HP’s advanced 3D-printing technology for custom orthotics. 3D printing has unique design capabilities not possible with other methods—reducing landfill waste by 90%! The accuracy of 3D is unparalleled, specs exceed direct-milled polypro, and manual plaster fabrication. Among the benefits: a 90% reduction in landfill waste, many new design possibilities for posting, and the ability to vary thickness and flexibility across the shell. The PA-11 polymer is a biobased renewable material that has been tested and proven in research and industry. Call today, 800-301-8275, for a free sample.



Naked Prosthetics offers four finger prostheses: PIPDriver, MCPDriver, ThumbDriver, and GripLock Finger.

Patients with a transfemoral amputation place high importance on being able to complete functional tasks and activities of daily living. An independent study found that after 30 days of at-home use, patients identified five functional tasks as easier to complete with the PROTEOR QUATTRO MPK compared to their typical MPK. On average, subjects rated the following complex tasks statistically significantly easier with the QUATTRO: Walking backwards, walking sideways, walking over an obstacle of six inches in height, kneeling on their prosthetic knee, standing up, and swinging a golf club.


Read more about this study here:

The Xtern Line: A Step Up for Foot Drop By Turbomed Orthotics Turbomed has extended its line of AFOs to include three models: Xtern Classic, Summit, and Frontier. The Xterns will allow running, walking, and even hiking as long and far as you want without discomfort. Their unique design acts as an exoskeleton to the impaired limb, keeps the foot at 90 degrees, and provides the user with unparalleled levels of function. The Xtern Summit is lighter than the Classic, has more dorsiflexion power, and features a see-through design. The Xtern Frontier was designed for patients with reduced hand dexterity and requiring front leg support. Visit, and think outside the shoe!

Be Part of the




Join the AOPA Community Access to reimbursement experts and resources to help you get paid

Savings on all education, exhibit space, insurance, shipping, and products

Regular updates on happenings in O&P

Help growing your business

Visit for more information.

November/December 2023 O&P Almanac


Ferrier Coupler Options! Interchange or Disconnect The Ferrier Coupler provides you with options never before possible:

Enables a complete disconnect immediately below the socket in seconds without the removal of garments. Can be used where only the upper (above the Coupler) or lower (below the Coupler) portion of limb needs to be changed. Also allows for temporary limb replacement. All aluminum couplers are hard coated for enhanced durability. All models are interchangeable.

Model A5

Model F5

Model P5

The A5 Standard Coupler is for use in all lower limb prostheses. The male and female portions of the coupler bolt to any standard 4-bolt pattern component.

The F5 Coupler with female pyramid receiver is for use in all lower limb prostheses. Male portion of the coupler features a built-in female pyramid receiver. Female portion bolts to any standard 4-bolt pattern component. The Ferrier Coupler with an inverted pyramid built in. The male portion of the pyramid is built into the male portion of the coupler. Female portion bolts to any 4-bolt pattern component.

Model FA5

Model FF5

Model FP5

NEW! The FA5 coupler with 4-bolt and female pyramid is for use in all lower limb prostheses. Male portion of coupler is standard 4-bolt pattern. Female portion of coupler accepts a pyramid.

Model T5

NEW! The FF5 has a female pyramid receiver on both male and female portions of the coupler for easy connection to male pyramids.

NEW! The FP5 Coupler is for use in all lower limb prostheses. Male portion of coupler has a pyramid. The Female portion of coupler accepts a pyramid.

The Trowbridge Terra-Round foot mounts directly inside a standard 30mm pylon. The center stem exes in any direction allowing the unit to conform to uneven terrain. It is also useful in the lab when tting the prototype limb. The unit is waterproof and has a traction base pad.

Statement of Ownership, Management and Circulation (required by U.S.P.S. Form 3526) 1. Publication Title: O&P Almanac 2. Publication No.: 1061-4621 3. Filing Date: 10/3/23 4. Issue Frequency: Monthly, except for combined issues printed June/July and November/December 5. No. of Issues Published Annually: 10 6. Annual Subscription Price: $59 domestic/$99 foreign 7. Complete Mailing Address of Known Office of Publication (Not Printer): American Orthotic & Prosthetic Association, 330 John Carlyle St., Suite 200, Alexandria, VA 22314 8. Complete Mailing Address of Headquarters or General Business Office of Publisher (Not Printer): Same as #7 9. Full Names and Complete Mailing Addresses of Publisher, Editor, and Managing Editor: Publisher: Eve Lee, address same as #7. Editor: Josephine Rossi, Content Communicators LLC, PO Box 938, Purcellville, VA 20132. 10. Owner (Full Name and Complete Mailing Address): American Orthotic & Prosthetic Association, same as #7 11. Known Bondholders, Mortgagees, and Other Security Holders Owning 1 Percent or More of Total Amount of Bonds, Mortgages, or Other Securities: None. 12. The purpose, function, and nonprofit status of this organization and the exempt status for federal income tax purposes: Has Not Changed During the Preceding 12 Months. 13. Publication Name: O&P Almanac 14. Issue Date for Circulation Data Below: August 2023


O&P Almanac November/December 2023

15. Extent and Nature of Circulation:

Average No. Copies Each Issue During Preceding 12 Months

No. Copies of Single Issue Published Nearest to Filing Date



8,515 0 0

8,508 0 0

9 8,524

9 8,517

0 0 0 367 367 8,891 139 9,030 96%

0 0 0 1,326 1,326 9,843 198 10,041 87%

0 8,524 8,891 96%

0 8,517 9,843 87%

a. Total number of Copies (Net Press Run) b. Paid and/or Requested Circulation (1) Paid or Requested Outside-County Mail Subscriptions (2) Paid In-County Subscriptions (3) Sales Through Dealers and Carriers, Street Vendors, Counter Sales, and other non-USPS Paid Distribution (4) Other Classes Mailed through the USPS c. Total Paid and/or Requested Circulation d. Free Distribution by Mail (1) Outside-County as Stated on Form 3541 (2) In-County as Stated on Form 3541 (3) Other Classes Mailed through the USPS (4) Free or Nominal Rate Distribution Outside the Mail e. Total Free or Nominal Rate Distribution f. Total Distribution g. Copies not Distributed h. Total i. Percent Paid and/or Requested Circulation 16. Electronic Copy Circulation: a. Paid Electronic Copies b. Total Paid Print Copies (Line 15c) + Paid Electronic Copies (Line 16a) c. Total Print Distribution (Line 15f) + Paid Electronic Copies (Line 16a) d. Percent Paid (Both Print & Electronic Copies) (16b divided by 16c x 100)



2023 November 1–30, December 1–31

ABC: Application Deadlines, Exams Dates, O&P Conferences, and More! Check out ABC’s Calendar of Events at for the latest dates and event details, so you can plan ahead and be in the know. Questions? Contact us at or visit

2024 January 11, January 25


The Goralign Advantage: A Webinar for Certified Prosthetists. Improve your understanding of the Goralign Self-Adaptive Prosthetic Ankle and earn 1.25 CEU credits by attending our upcoming ABC-approved webinar. “Understanding the Goralign Self-Adaptive Prosthetic Ankle” will be offered virtually on January 11 and 25, 2024 from 1-2 PM ET. Register now at

September 12–15

AOPA National Assembly. Charlotte, NC. For more information, visit

• Explore new career opportunities for FREE! • Click on any websites, emails, and videos to learn more. • Download the guide to look back on organizations and opportunities that appeal to you.

AOPA- Program Book Ad.indd 1

Live and Online/On Demand CEs

The Pedorthic Footcare Association: Diabetic Wound Prevention, Management, and Healing Program. 10-session online education program series. Approved CEs by ABC and BOC, monthly classes are 1.5 hours each. For more information and to register, visit

8/7/23 9:49 PM

Share Your Calendar Event

Advertise O&P events for maximum exposure with O&P Almanac. Contact Bob Heiman at or learn more at Announcement and payment may also be sent to O&P Almanac, Calendar, P.O. Box 34711, Alexandria, VA 223340711 or emailed to along with VISA or MasterCard number, cardholder name, and expiration date. Make checks payable in U.S. currency to AOPA. Note: AOPA reserves the right to edit calendar listings for space and style considerations.

Advertisers Index A large number of O&P Almanac readers view the digital issue— If you’re missing out, visit to view your trusted source of everything O&P. Scan the QR to start advertising in the O&P Almanac or visit





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November/December 2023 O&P Almanac


BECOME AN AOPA STATE REPRESENTATIVE If you are interested in participating in the AOPA State Reps network, email

State By State

Fee Schedules and Regulations Updates from Indiana, Nevada, and Ohio

Indiana The Indiana Medicaid fee schedule will be updated in January 2024 to index to 2023 Medicare rates. Codes for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) that do not have a Medicare rate will receive an inflationary index increase. To read the full bulletin from Indiana Medicaid, visit the Indiana page of AOPA Co-OP.


The Nevada State Board of Pharmacy has proposed regulations that would allow medical product providers to hold an inventory of ambulatory aids at a hospital for delivery to patients upon their discharge. As used in this proposed legislation, “ambulatory aids” include “mobility-enhancing equipment, prosthetic devices, orthotic appliances, ambulatory casts, and other braces, supports, and casts for human use.” To read the full rule, visit the Nevada page of the AOPA Co-OP.


Several new regulations related to O&P have been proposed in Ohio. The Ohio Occupational Therapy, Physical Therapy, and Athletic Trainers Board has proposed new rules that would update the state’s licensure by endorsement policy to allow out-of-state applicants to obtain an Ohio license if they hold a substantially similar license or private certification from another state. In addition, Ohio Medicaid has proposed regulations that would update several DMEPOS coverage policies, including repairs, foot orthoses, and cranial remolding orthoses, as well as the overall fee schedule. For more information on these proposed regulations, check out the Ohio page of the AOPA Co-OP. Interested in getting involved? Email to learn more.


O&P Almanac November/December 2023

The Latest From So Every BODY Can Move Massachusetts’ So Every BODY Can Move legislation, formerly known as HD 4491, has officially been given a bill number: H 4096. The bill, introduced in late July, would require that state commercial plans, public employee plans, and Massachusetts Medicaid provide coverage for activity-specific O&P care. Since its introduction, H 4096 has garnered 14 cosponsors, or about 1 in 10 members of the Massachusetts House of Representatives, with more than a year remaining in the 2023-2024 session.

Get Ahead of the Holiday Rush It’s never too early to start prepping for peak shopping and shipping season. Whether you’re sending gifts, time-sensitive goods, or want to ensure your business operates smoothly during this busy time – UPS® can help manage your shipments so they arrive to their destination on time and intact.

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To start saving, visit: Or call: 1.800.MEMBERS (1.800.636.2377) to speak to a Member Care Specialist. Insurance coverage is underwritten by an authorized insurance company and issued through licensed insurance producers, including UPS Capital Insurance Agency, Inc. (“UPSCIA”), a subsidiary of UPS Capital Corporation (“UPS Capital”). The insurance company, UPSCIA and its licensed affiliates reserve the right to change or cancel the program at any time. You may be offered the opportunity to insure eligible shipments under a policy of insurance (the “Policy”) issued: (i) directly to you; (ii) to UPS Capital; or (iii) to the sender/ publisher of this communication. Where the Policy is issued to UPS Capital or such sender/ publisher, such Policy extends coverage to your eligible shipments, but you are neither an insured nor an additional insured under such Policy. In the event of a loss covered under such Policy, any resulting claim payment shall be directed to you as a loss payee. This information does not in any way alter or amend the terms, limitations or exclusions of the applicable Policy and is intended only as a brief summary. Insurance coverage is not available in all jurisdictions and coverage is governed by the terms, conditions, limitations and exclusions set forth in the applicable Policy. © 2023 United Parcel Service, UPS, UPS Capital, InsureShield, the UPS brandmark, and the color brown are trademarks of the United Parcel Service of America, Inc. All rights reserved. 3/23 Visit: <<>> for an Explanation of Flexible Parcel Insurance Program Coverage.


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