April 2021 O&P Almanac by AOPA

The Magazine for the Orthotics & Prosthetics Profession

AP R I L 2021

How To Use the Competitive Bidding Modifiers P.16

Medical Advancements Impacting Future O&P Patient Care P.34

Studying Motion in Elite Athletes P.40

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Educate lawmakers on key issues important to YOU and your PATIENTS

N E P O N O I T A R T S

REGI

APRIL 20-22

APRIL 27-29

SCHEDULE The 2021 Virtual Policy Forum

April 20:

Lobbying 101 (10am – 1pm ET) and Senate Meetings

April 21:

Senate Meetings

April 22:

Senate Meetings and Wrap-Up Session/ Virtual Happy Hour (4 – 5pm ET)

April 27:

Legislative Updates (10am – noon ET) and House Meetings

opportunity to educate members

April 28:

House Meetings

of Congress on the needs of the

April 29:

House Meetings and Wrap-Up Session (4 – 5pm ET)

is your opportunity to learn about the latest legislative and regulatory issues and how they will affect you, your business, and your patients. It is also your

O&P profession.

NOTE: Participants will only need to be available for one Lobbying 101, their Senate and House Meetings, and Wrap-Up Sessions – you do not need to be available all six days

Our voices are louder together, ATTEND the 2021 Virtual Policy Forum! Register online at www.AOPAnet.org.

www.AOPAnet.org

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APR I L 2021 | VOL. 70, NO. 4

contents

FEATURES

DEPARTMENTS | COLUMNS

COVER STORY

22 | Additive O&P Advances in scanning technologies, materials strength, and 3D-printing machines have prompted some prosthetists and orthotists to adopt additive manufacturing as one more option to create specific solutions for some patients. From partial hands and fingers, to prosthetic covers, to sockets and more, find out what types of devices O&P facilities are 3D printing, and learn what’s new in terms of scanning and printing technologies. By Christine Umbrell

Views From AOPA Leadership......... 4 Building relationships

AOPA Contacts............................................6 How to reach staff

Numbers........................................................ 8

At-a-glance statistics and data

Happenings............................................... 10

Research, updates, and industry news

People & Places........................................ 14

Transitions in the profession

Reimbursement Page.......................... 16

Modifier Matters

34 | Accelerating Acceptance In the not-too-distant future, individuals with amputation may benefit from several promising medical advancements. Learn how neural technologies being used in conjunction with osseointegration will enable more precise and intuitive prosthetic control, and preview a multiphase study to convert residual limb skin into volar-type skin for enhanced use of prosthetic devices. By Josephine Rossi

Review new and commonly used modifiers to ensure proper claim submissions Opportunity to earn up to two CE credits by taking the online quiz.

Member Spotlight.................................46 n

Prosthetic & Orthotic Designs

Naked Prosthetics

AOPA News............................................... 50

AOPA announcements, member benefits, and more

PRINCIPAL INVESTIGATOR Alena Grabowski, PhD................................................40 Meet an associate professor at the University of Colorado Boulder who studies motion as it relates to competitive and elite athletes. Alena M. Grabowski, PhD, has conducted investigations of key importance in decisions by the International Association of Athletics Federations and the Court of Arbitration in Sports.

APRIL 2021 | O&P ALMANAC

Welcome New Members.................... 51 Marketplace.............................................. 52 Ad Index....................................................... 55 Careers......................................................... 56

Professional opportunities

Calendar...................................................... 58

Upcoming meetings and events

State By State.......................................... 60

Florida, New York, North Carolina, and Oklahoma

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VIEWS FROM AOPA LEADERSHIP

The Value of AOPA’s Relationships

CONSISTENT THEME in my professional life, both in my day job at Fillauer and

in my role as president of AOPA, is relationships and communication. They are essential to moving initiatives forward. I think it is safe to say that most of us feel like the relationship between payors and providers is often adversarial from the providers’ perspective. This is due in large part to providers’ struggle to get paid while scrambling to keep up with payors’ ever-changing policies. But it does not have to be this way; relationships and communication can improve the dynamic and ultimately lead to mutually beneficial policies. Over the past several years, the AOPA staff and Board of Directors have invested time, energy, and resources into relationships with the influencers of O&P policy, including payors. Most recently, I hope you received the communications that, after feedback from AOPA, the durable medical equipment Medicare administrative contractors (DME MACs) are no longer requiring brand name product selection for Medicare prior authorization. On this issue, AOPA engaged the DME MAC medical directors in very constructive and positive dialogue regarding the need for flexibility in product selection to best meet patients’ clinical needs. While we did not challenge the concept of Medicare prior authorization, we respectfully requested that the DME MACs reconsider the decision to require product selection as part of the process. And they did. This was not the first conversation we have had with the DME MAC medical directors; staff and leadership have been in dialogue with them for years, working to build this trusted and respectful relationship. In addition to this accomplishment, we have been engaging with state payors regarding coverage criteria, such as a state Medicaid’s prosthetics and orthotics coverage policy. Our relationships and communication have led to successful engagement and response to medical review requests to increase access for patients with both the five-state BCBS/HCSC review of cranial remolding orthoses medical policy and review of lower-limb prosthesis, including microprocessor, medical policy. To help with the development and fostering of these relationships as well as to encourage and empower the membership to do the same, AOPA invested in Gov Predict as a resource to help you track legislative developments in your states. These developments are posted to AOPA’s Co-OP and disseminated via email as appropriate. If you are looking to get engaged and stay up-to-date on your state’s policies, read the State by State column in O&P Almanac each month (see page 60). Finally, the relationships AOPA has established on Capitol Hill are what led to the introduction of the Medicare O&P Patient-Centered Care Act in the U.S. House of Representatives last month. Senate introduction is expected this month (and will hopefully have happened by the time you are reading this). If you have not yet, I encourage you to help get this bill passed by participating later this month in the 2021 Virtual Policy Forum. Your relationships and communication of your needs are what will get this vital piece of legislation passed. These are just some examples demonstrating how important relationships and communication are for influencing policymakers and payors, and how AOPA is leveraging them to help improve policy and reimbursement for you and your patients. Traci Dralle, CFm, is president of AOPA.

APRIL 2021 | O&P ALMANAC

Specialists in delivering superior treatments and outcomes to patients with limb loss and limb impairment.

Board of Directors OFFICERS President Traci Dralle, CFm Fillauer Companies, Chattanooga, TN President-Elect Dave McGill Össur Americas, Foothill Ranch, CA Vice President Teri Kuffel, JD Arise Orthotics & Prosthetics, Spring Lake Park, MN Immediate Past President Jeffrey Lutz, CPO Hanger Clinic, Lafayette, LA Treasurer Rick Riley O&P Boost, Bakersfield, CA Executive Director/Secretary (Nonvoting) Eve Lee, MBA, CAE AOPA, Alexandria, VA DIRECTORS Jeffrey M. Brandt, CPO Ability Prosthetics & Orthotics Inc., Exton, PA Mitchell Dobson, CPO, FAAOP Hanger, Austin, TX Elizabeth Ginzel, MHA, CPO Baker O&P, Fort Worth, TX Kimberly Hanson, CPRH Ottobock, Austin, TX John “Mo” Kenney, CPO, LPO, FAAOP Kenney Orthopedics, Lexington, KY Linda Wise WillowWood, Mount Sterling, OH James O. Young Jr., LP, CP, FAAOP Amputee Prosthetic Clinic, Tifton, GA Shane Wurdeman, MSPO, PhD, CP, FAAOP(D) Research Chair Hanger Clinic, Houston Medical Center, Houston, TX

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AOPA CONTACTS

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 www.AOPAnet.org

Publisher Eve Lee, MBA, CAE Editorial Management Content Communicators LLC Advertising Sales RH Media LLC

Our Mission Statement Through advocacy, research, and education, AOPA improves patient access to quality orthotic and prosthetic care.

Our Core Objectives AOPA has three core objectives—Protect, Promote, and Provide. These core objectives establish the foundation of the strategic business plan. AOPA encourages members to participate with our efforts to ensure these objectives are met. EXECUTIVE OFFICES

REIMBURSEMENT SERVICES

Eve Lee, MBA, CAE, executive director, 571/431-0807, elee@AOPAnet.org

Joe McTernan, director of coding and reimbursement services, education, and programming, 571/431-0811, jmcternan@AOPAnet.org

Tina Carlson, CMP, senior director, membership, education, and meetings, 571/431-0808, tcarlson@AOPAnet.org Akilah Williams, MBA, SHRM-CP, senior manager for finance, operations, and HR, 571/431-0819, awilliams@AOPAnet.org GOVERNMENT AFFAIRS Justin Beland, director of government affairs, 571/ 431-0814, jbeland@AOPAnet.org COMMUNICATIONS, MEMBERSHIP & MEETINGS Joy Burwell, director of communications and membership, 571/431-0817, jburwell@AOPAnet.org Betty Leppin, senior manager of member services, 571/431-0810, bleppin@AOPAnet.org Kelly O’Neill, CEM, manager of membership and meetings, 571/431-0852, kelly.oneill@AOPAnet.org Ryan Gleeson, CMP, assistant manager of meetings, 571/431-0836, rgleeson@AOPAnet.org Kristen Bean, membership and meetings coordinator, 571/431-0876, kbean@AOPAnet.org AOPA Bookstore: 571/431-0876

APRIL 2021 | O&P ALMANAC

Devon Bernard, assistant director of coding and reimbursement services, education, and programming, 571/431-0854, dbernard@AOPAnet.org Reimbursement/Coding: 571/431-0833, www.LCodeSearch.com

STRATEGIC ALLIANCES Ashlie White, MA, director of strategic alliances, 571/431-0812, awhite@AOPAnet.org O&P ALMANAC Eve Lee, MBA, CAE, executive director/publisher, 571/431-0807, elee@AOPAnet.org

Design & Production Marinoff Design LLC Printing Sheridan SUBSCRIBE O&P Almanac (ISSN: 1061-4621) is published 10 times per year by the American Orthotic & Prosthetic Association, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314. To subscribe, contact 571/4310876, fax 571/431-0899, or email info@aopanet.org. 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 © 2021 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.

Josephine Rossi, editor, 703/662-5828, jrossi@contentcommunicators.com Catherine Marinoff, art director, 786/252-1667, catherine@marinoffdesign.com Bob Heiman, director of sales, 856/673-4000, bob.rhmedia@comcast.net Christine Umbrell, editorial/production associate and contributing writer, 703/6625828, cumbrell@contentcommunicators.com

Advertise With Us! Reach out to AOPA’s membership and more than 11,400 subscribers. Engage the profession today. Contact Bob Heiman at 856/673-4000 or email bob.rhmedia@comcast.net. Visit bit.ly/AOPAMedia2021 for advertising options!

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NUMBERS

ABC Certification and Accreditation During the pandemic year, ABC continued its credentialing and accreditation activities

The American Board for Certification in Orthotics, Prosthetics, and Pedorthics (ABC) recently released the “ABC 2020 Annual Report,” which summarizes the organization’s activities during the pandemic last year. “Even with all the chaos surrounding the year, we still managed to serve our constituents and meet the needs of the profession,” noted the report authors.

2,175

4,361

Total number of examinations completed

Accredited facilities

714

1,057

Individuals certified by ABC

TYPES OF ABC CERTIFICATION ACHIEVED IN 2020

Onsite surveys

TYPES OF ABC-ACCREDITED FACILITIES IN 2020 370

Practitioners 130

Orthotic Fitters

Pharmacy

Therapeutic Shoe Fitters

Mastectomy

Pedorthists

Pedorthics

Mastectomy Fitters

Technicians

2,944

Comprehensive O&P

Assistants

ABC ACCREDITATIONS RECOGNIZED IN 2020

ABC EXAMINATIONS CONDUCTED IN 2020

Central fabrication Ocular

949 270 169 20 9

Current ABC-Certified Clinicians, Male/Female Breakdown

APRIL 2021 | O&P ALMANAC

Female

Total

1,208

448

1,656

1,035

239

1,274

CPO

2,297

981

3,278

TOTAL

4,540

1,668

6,208

SOURCE: Data provided by ABC

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Happenings RESEARCH ROUNDUP

Lower-Extremity Amputation Rates Rise Among Veterans Researchers at the Department of Veterans Affairs (VA), St. Louis Health Care System, examined the medical records of 6.5 million veterans from the 2008-2018 time period to study the temporal trends of lower-extremity amputation. Led by Ziyad Al-Aly, MD, the research team leveraged VA data to estimate incidence rates of lower-limb amputation among veterans using VA services. Rates of lower-extremity amputation increased from 12.89 per 10,000 persons to 18.12 per 10,000 persons between 2008 and 2018, representing a net increase of 5.23 per 10,000. Toe amputations increased by 3.24 per 10,000; transmetatarsal amputations increased by 1.54 per 10,000; belowknee amputations increased by 0.81 per 10,000; and above-knee amputations

decreased by 0.37 per 10,000. Factors associated with increased risk of lower-limb amputation included Black race or another non-white race (i.e., Asian, Latino, or other), obesity, diabetes, smoking, cerebrovascular disease, cardiovascular disease,

dementia, hypertension, and peripheral artery disease. Changes in demographic composition (an increase in women veterans) and lower smoking rates were associated with a reduction in lower-extremity amputation incidence rates, but these reductions were more than offset by increased rates of diabetes, peripheral artery disease (PAD), and chronic kidney disease (CKD), according to the researchers. To help decrease amputation rates in the future, the researchers concluded that “focused attention at the individual and population levels to address risk factors, including smoking, diabetes, PAD, and CKD, may help alleviate the burden of amputation among veterans.” The study was published January 22 in the Journal of the American Medical Association Network Open.

Study Ties Mental Health to Higher Physical Functioning Among Amputees Researchers from Leidos in San Diego and the Naval Health Research Center have completed a study examining the relationships between patient-reported outcomes, mental health screening status, and quality of life. Led by research epidemiologist Susan Eskridge, PhD, the researchers recruited service members with combat-related lower-extremity amputations and participants in the Wounded Warrior Recovery Project to take part in the study. The research team compared participants’ patient-reported outcomes of physical functional status, post-traumatic stress disorder (PTSD), depression screening status, and quality of life. They leveraged linear regression analysis to assess relationships between physical functional status and quality of life.

APRIL 2021 | O&P ALMANAC

Eskridge’s team found that physical functioning was associated with patient-reported outcomes, including quality of life and mental health screening. Participants who screened positively for PTSD or depression were found to have worse self-reported physical function. “The current study shows that physical functioning in participants with combatrelated amputation is related to the amputation level, quality of life, and mental health symptom screening,” reported the authors. “Good mental health is crucial to optimal functioning, as presence of adverse mental health symptoms may exacerbate physical functional limitations among those with combat-related amputations.” The study was published in December in Disability and Rehabilitation.

HAPPENINGS

O&P OUTREACH

CODE L5986

Donate Prosthetic Componentry The Range of Motion Project (ROMP), with the help of its clinical partners, has organized the “largest prosthetic component recycling month ever” in recognition of Limb Loss Awareness Month in April. ROMP has set a goal to collect 5,000 pounds of components this spring from both clinics and individuals, which could help 500 people get prosthetic care over the next year. The organization accepts entire prosthetic limbs, feet, knees, modular components, liners, prosthetic socks, supplies, and other tools. After ROMP receives donations, the organization disassembles full limbs and strips them for parts. ROMP staff and volunteers clean and test parts in the ROMP warehouse in Denver before dispatching them out. Neary 100 clinics have already donated componentry through the organization. ROMP’s clinical partners include Hanger Clinic, Ability Prosthetics & Orthotics, and Scheck & Siress. The organization accepts donations all year long.

Visit the ROMP website at rompglobal.org or contact ROMP at info@rompglobal.com for more information, including how to donate components.

CODING CORNER

DME MACS Provide New Coding Guidelines for L5968 and L5986 The durable medical equipment Medicare administrative contractors (DME MACs) released a revised version of the Lower-Limb Prostheses Policy Article (PA) on March 18. The updated PA includes new coding guidelines for two Healthcare Common Procedure Coding System codes, the L5968 (addition to lower-limb prosthesis, multiaxial ankle with swing phase active dorsiflexion feature) and L5986 (all lower-extremity prostheses, multiaxial rotation unit, “MCP” or equal). The new guidance follows: • L5968 describes a product that is used as an addition to L-code foot systems for lower-limb prosthesis construction. The product provides multiaxial motion in the coronal

and sagittal plane from articulating components. At transition of stance phase to swing phase, the product will increase the ankle’s dorsiflexion angle and maintain it throughout swing phase. The product provides an accommodation of changing heel heights without the user’s input. The predicate product is the Rincoe R-Hab Ankle. • L5986 describes a product that is used as an addition to L-code foot systems for lower-limb prosthesis construction. The product provides multiaxial motion in all three planes of motion, sagittal, coronal, and transverse. This code does not describe the multiaxial motion achieved from the inherent

CODE L5986

CODE L5968

flexibility of the prosthetic keel or a split keel/heel prosthetic foot design. The predicate product is a device that was manufactured by Medical Center Prosthetic, which is represented in the coding narrative by “MCP.” O&P ALMANAC | APRIL 2021

HAPPENINGS

CORPORATE SOCIAL RESPONSIBILITY

FAST FACT

Manufacturer Commits to Carbon Neutral Operations

Congenital Limb Loss Each year, about 1,500 U.S. babies are born with upper-limb reductions (about 4 of every 10,000 babies), and about 750 are born with lower-limb reductions (about 2 of every 10,000 babies). —“Birth Defects: Upper- and Lower-Limb Reduction Deficits,” Centers for Disease Control and Prevention

Össur has announced the company will be carbon neutral in 2021, its 50th anniversary year. Össur has been actively working toward a carbon neutral operation in recent years. This year, the company will be carbon neutral for energy and fuel consumption, waste generation, business travel, transportation of goods, and electricity consumption of finished goods suppliers. This represents direct and indirect emissions (Scope 1 and 2) and selected Scope 3 emissions, according to the Greenhouse Gas Protocol. “We care about the environment and take our responsibility seriously. We have been actively working on establishing a good overview of the company’s carbon footprint and are proud to commemorate the company’s 50th anniversary by becoming carbon neutral,” said Jon Sigurdsson, president and CEO of Össur. “As part of our larger commitment to sustainability, we are contributing to

THANK YOU

to our 2021 AOPA Supplier Plus Members for their continued support of the association.

AOPA 2021 SUPPLIER PLUS MEMBERS

SUPPLIER PARTNER

For more information, contact Kelly O’Neill at 571/431-0852 or kelly.oneill@AOPAnet.org. FOLLOW US @AmericanOandP

APRIL 2021 | O&P ALMANAC

www.AOPAnet.org

the United Nations (UN) Sustainable Development Goals, and climate action is one of four UN Sustainable Development Goals we have chosen to focus on.” According to Sigurdsson, Össur will continue to reduce emissions, improve energy efficiency, source all electricity from renewable sources, and offset remaining emissions by supporting emission reduction projects. The company has partnered with First Climate, a leading service provider of carbon emissions management, to achieve carbon neutrality in 2021. “As a company, Össur remains focused on supporting a better quality of life for all, not only through excellent products and services but also through our contribution to social responsibility and sustainable development,” Sigurdsson said. “As much as we have already accomplished over the past 50 years, we aspire to do even more as we continue to help people live a life without limitations.”

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PEOPLE & PLACES PROFESSIONALS

BUSINESSES

ANNOUNCEMENTS AND TRANSITIONS

Marc C. Lundeberg has been appointed chief executive officer (CEO) and regional president of Ottobock’s North America operation. Effective Feb. 1, 2021, Lundeberg succeeds Brad Ruhl, who will remain on as non-executive Marc C. chairman until he transitions to retirement after Lundeberg a more than 30-year tenure with Ottobock. Lundeberg joins Ottobock North America from Amplifon, where he held the position of CEO and president for North America. “After careful consideration, the board concluded that Marc was the right leader to take the reins from Brad, who has led the region to record profitability and expanded Ottobock’s footprint across the United States and Canada,” said Philipp Schulte-Noelle, Ottobock global CEO. “Marc brings a tremendous amount of expertise and a distinguished track record of strategic, operational, and people leadership to our growth path. I am delighted to welcome Marc to the Ottobock Family.” “I am thrilled to join a global leader in its field and help Ottobock continue setting new standards in the pursuit of its mission to help people maintain or regain their freedom of movement,” said Lundeberg.

Hanger Inc. has established the Hanger Institute for Clinical Research and Education (Hanger Institute), a collection of resources and experts dedicated to advancing clinical practice and improving patient outcomes. Focusing on leading-edge clinical research, evidence-based care, and professional education, the Hanger Institute will serve as a platform to collaborate with top-tier medical and academic institutions and industry experts. Visit www.HangerClinic.com/Institute for details.

IN MEMORIAM

Walter Joseph Gorski III Walter Joseph Gorski III, who worked as director of legislative affairs for AOPA from 2001 to 2006, passed away on March 10 in Fairfax, Virginia. At AOPA, Gorski’s range of responsibilities included lobbying Congress and CMS, managing PAC activities, coordinating state association and grassroots initiatives, and building coalitions. After attending the University of Richmond, Gorski was appointed to the staff of the Ways and Means Committee of the U.S. House of Representatives. He later worked on healthcare issues at Black, Kelly, Scruggs, Healey LLP and at Price Waterhouse LLP, before joining AOPA’s staff. He left AOPA in November 2006 to serve as vice president of government affairs at the American Association for Homecare. The family asks for donations to the American Heart Association.

APRIL 2021 | O&P ALMANAC

Hanger Clinic has established a network of cranial remolding specialists to help parents find expert care for babies with plagiocephaly and similar conditions. The Cranial Asymmetry Remolding Experts (CARE) Network includes more than 200 certified orthotists from 260 clinics with extensive experience correcting babies’ head shapes using custom cranial remolding orthoses. Hanger Clinic developed the first clinical practice guidelines for treating plagiocephaly, which are used to evaluate the severity of a baby’s cranial asymmetry and educate parents about their care options. “At Hanger Clinic, we harness clinical research and data to drive successful patient outcomes,” said James Campbell, PhD, Hanger’s chief clinical officer. “To ensure optimal care for our littlest patients, our certified orthotists collaborate with referring physicians and meet rigorous annual continuing education requirements. They also leverage their knowledge of musculoskeletal conditions and pediatric anatomy, and the experience of their peers in the CARE Network, to provide personalized, high-quality care for every patient.” Össur has been recognized by the World Intellectual Property Organization (WIPO) for its intellectual property leadership in conventional mobility assistive technology. The “WIPO Technology Trends Report 2021: Assistive Technologies” is the first study to systematically investigate patenting and technology trends across assistive technology at scale, analyzing data on patent filings from 1998-2019. Key findings in the report show that Össur ranks second in the world for top patent applicants in conventional mobility assistive technologies, following only Toyota and ranking among such other global leaders as Panasonic, Honda, and Stryker. Össur also is listed among the top applicants in patent filings for advanced prosthetics and exoskeletons, and ranks 12th in the world among top patent applicants for emerging mobility assistive technologies.

HAPPENINGS

“We are honored by WIPO’s acknowledgment of our company’s contributions to new innovations that can help more people achieve greater mobility,” said Jon Sigurdsson, Össur president and CEO. “Receiving this acknowledgment during our 50th anniversary gives us one more thing to celebrate, and also inspires us to continue raising the bar even further as we continue progressing as a company.” WillowWood Global has been awarded a Department of Defense (DOD) grant to utilize the company’s Alpha SmartTemp® platform to research material additives and improve the thermal properties of prosthetic socket technology. WillowWood Global’s liner platform was specifically designed to address issues associated with excessive perspiration. By using a blend of proprietary materials with heat absorption properties, this technology allows the liner to absorb and store heat from a residual limb and delay the onset of sweat. The liner then releases the stored heat as the body cools down, stabilizing the skin temperature to keep an amputee comfortable all day. With the reduction of sweat within the liner, chafing and skin breakdown may be reduced while suspension strength of the prosthesis may be improved. The vision of this project is to develop a solution

that addresses the issue of heat and perspiration within the socket using learnings from this liner without adding complexity, weight, bulk, or significant cost to the overall system. “We are really excited that the DOD has awarded us this grant to continue building upon our Alpha SmartTemp technology platform,” said Daniel Rubin, chief operating officer. “We are focused on improving limb health and achieving the best clinical outcomes for amputees.”

THANK YOU

TO OUR 2021 SPONSORS BRONZE

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Our voices are louder together, ATTEND the 2021 Virtual Policy Forum! Register online at www.AOPAnet.org.

www.AOPAnet.org O&P ALMANAC | APRIL 2021

REIMBURSEMENT PAGE

By DEVON BERNARD

Modifier Matters Review both commonly used and recently added modifiers to ensure proper claim submissions

Editor’s Note—Readers of Reimbursement Page are eligible to earn two CE credits. After reading this column, simply scan the QR code or use the link on page 21 to take the Reimbursement Page quiz. Receive a score of at least 80 percent, and AOPA will transmit the information to the certifying boards.

E! QU IZ M EARN

BUSINESS CE

CREDITS P.21

APRIL 2021 | O&P ALMANAC

ODIFIERS ARE A VITAL piece

of a compliant claim; missing or incorrectly used modifiers may result in improper payments, denials, or slowdowns in the adjudication process of your claims. This month’s Reimbursement Page reviews some of the more common modifiers, some of the modifiers you are likely using on a daily basis, and some modifiers you may have just started using—those related to the COVID-19 public health emergency (PHE) and competitive bidding Round 2021.

Policy-Directed Modifiers: KX and CG

Each of the Medicare Local Coverage Determinations (LCD) and Policy Articles (PA) provides specific information regarding which modifiers are required for a claim to be processed, as well as how the modifiers are to be used. The information in the LCDs and PAs touches on the basic modifiers, RT and LT, but also may explain when a specific modifier is required. Two examples include the use of functional/K-level modifiers explained in the Lower-Limb Prostheses LCD and the AW modifier explained in the Surgical Dressing LCD. In this article, we will examine the KX and the CG modifiers, which inform Medicare that requirements in policy have been met (KX) or policy criteria have been applied (CG). Medicare has stated that devices constructed primarily of elastic or other stretchable/flexible materials are not always rigid enough to provide sufficient support, not meeting the definition of

a brace, and therefore are considered noncovered. Within the code set, several codes describe flexible orthoses that can be used to describe devices that are elastic in nature and devices that are flexible but not made of elastic materials or have components that may make them rigid. Since these styles of braces remain eligible for coverage, suppliers have been directed to use the CG modifier to identify flexible braces not made of elastic material. Currently, the only LCD that requires use of the CG modifier is the Lumbosacral Orthosis/ Thoracolumbosacral Orthosis Policy. If you are providing a spinal brace described by L0450, L0454, L0455, L0621, L0625, or L0628 and it is primarily constructed of inelastic material (e.g., canvas, cotton, or nylon) and/or has stays or panels, providing the required support, then include the CG modifier. In addition, the Pricing, Data Analysis, and Coding contractor and the durable medical equipment Medicare administrative contractors have directed suppliers to use the CG modifier when billing for the L3923. The KX modifier means that the coverage and medical necessity requirements specified in a policy have been met. Currently, only four O&P policies require the use of a KX modifier: Ankle-Foot Orthosis/KneeAnkle-Foot Orthosis (AFO/KAFO), Knee Orthosis (KO), Orthopedic Shoes, and Therapeutic Shoes for Persons With Diabetes. The KX is not required for claims outside of these

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four policies. Remember that when you include the KX modifier on your claim, you are attesting that everything required by policy is in place—do not simply add the KX modifier because you know it will get your claim paid. How the KX modifier is used and applied depends on the policy, so before using it, review current medical policies—the LCD and the PA—to ensure that the policy criteria for medical necessity have been met, that the KX modifier is required, and that specific requirements of the KX modifier usage have been met. For example, in the PA for KOs, under “Policy-Specific Documentation Requirements,” the following statement is included: “Suppliers must add a KX modifier … if all of the coverage criteria … have been met and evidence of such is retained in the supplier’s files.” Thus, the documentation supporting the use of the KX modifier must be physically present in your files; if you don’t have this documentation, do not attach the KX modifier.

Liability Modifiers: GA and GY

Liability or payment modifiers are typically included on your claims to denote that the items/services you are providing should be considered a Medicare benefit, considered medically necessary, or are a noncovered item/service; whether the items/services should be paid; and who will be responsible for the payment. The liability modifiers include GA, GY, GZ, GK, GL, and to some extent KX, but let’s focus on the GA and GY. The GA (waiver of liability statement issued as required by payor policy) modifier informs Medicare that you expect the claim or claim lines in question to be denied as not medically necessary (i.e., same/similar, documentation is missing, you are not a contracted supplier under competitive bidding, etc.); you have discussed this possibility with the patient; and the patient has signed a properly issued advanced beneficiary notice (ABN). The ABN notifies the patient that Medicare may deny the claim as not medically necessary, and the patient agrees to assume financial 18

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GA GY

liability for the codes in question should Medicare deny the claim. Without a GA modifier, Medicare assumes that financial liability remains with you—the provider—if the claim is denied. The GY modifier is used to indicate that the item or service you are providing is statutorily excluded from Medicare coverage, meaning there is no Medicare benefit and Medicare will never pay for the item or service. The GY modifier is most commonly associated with claims involving orthopedic shoes that are not attached to a brace, but it also may be used with AFOs used solely for off-loading and for diabetic shoes and inserts that exceed the number of allotted services in a year, as well as for compression garments. The GY is not used when an item does not meet coverage criteria and will be denied as not medically necessary.

PHE Modifiers: CR and DR

When CMS declares an emergency, it may temporarily modify, waive, or update certain policy guidelines, as it did with the COVID-19 pandemic on March 13, 2020; when this occurs, CMS implements CR and DR modifiers. These modifiers mean “catastrophe/

DR disaster-related,” and their use, along with the waivers, ensures there are no delays in care for patients affected by the emergency. The DR modifier is used for Part A institutional/facility claims, and CR is used for Part B billing and claims. Under the PHE for COVID-19, CMS issued a significant number of waivers; however, only a handful require the use of the CR modifier, and only a few apply directly to O&P claims. The two that have most likely impacted your business are the waivers for patient signatures on a proof of delivery (POD) and the relaxation of face-to-face requirements. You also may have been impacted by the relaxation of telehealth rules; however, claims related to telehealth visits don’t require the use of a CR modifier. If you have or had a patient who refused to sign a POD out of fear of COVID-19 or who could not sign due to COVID-19 precautions, you would still be able to submit your claim. However, you must document in your records when the delivery occurred and that an appropriate signature could not be obtained as a result of COVID-19. You would include the CR modifier on your claim, and write “COVID-19” in the narrative field.

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CMS has stated that “requirements for face-to-face or in-person encounters for evaluations, assessments, certifications, or other implied face-to-face services would not apply during the COVID-19 PHE.” But this waiver of face-to-face encounter requirements only applies to policy-based requirements—those found in the LCDs—and therefore does not apply to face-to-face encounter requirements that are enforced elsewhere, specifically those that are part of the Quality Standards for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) or the Social Security Act. For example, under the Therapeutic Shoe Policy, the certifying physician is required to have a face-to-face visit with the patient, and you are required to have a face-to-face visit with the patient at the time of delivery.

The physician would no longer be required to have the face-to-face visit to certify the medical necessity, but you still would be required to perform an in-person evaluation at the time of shoe selection and an in-person fitting of the shoes at delivery as these are addressed in the DMEPOS Quality Standards. Telehealth-based physician encounters also will meet any face-to-face visit requirements that are incorporated into existing Medicare policies. So, if an LCD requires a face-to-face encounter, and it is only mandated by the LCD, and one could not occur as a result of the COVID-19 PHE, you must include the CR modifier on your claim. Once again, you must document in your records why the encounter did not occur and write “COVID-19” in the narrative field of the claim. If you accidently applied a CR modifier to a claim when it was not required

or appropriate, that is OK as your claims will still be processed and should not be denied. If you forgot to include the CR modifier, that is OK as well; and if your claim is affected, you may resubmit your claim with the CR modifier.

Competitive Bidding Modifiers: KT, KV, J4, and J5

Four modifiers are associated with billing for DMEPOS items subject to competitive bidding—KT, KV, J4 and J5—but you most likely will use only the KT modifier. The remaining three modifiers are provider-specific and relate to established exceptions under the competitive bidding rules. As a quick reminder, as of Jan. 1, 2021, claims for off-the-shelf (OTS) spinal braces (L0450, L0455, L0457, L0467, L0469, L0621, L0623, L0625, L0628, L0641, L0642, L0643, L0648, L0649, L0650, and L0651) and OTS

Scenarios for Delivering an Off-the-Shelf Brace Under Competitive Bidding

Patient’s Permanent Address Is in a…

Patient Is…

Who Must Deliver the OTS Brace?

Do You Have To Accept Assignment?

Reimbursement Is Based on…

Does the Claim Require the KT Modifier?

CBA

Traveling to a CBA

A supplier with a competitive bid contract

Yes

The SPA in the patient’s CBA

Yes

CBA

Traveling to a non-CBA

Any eligible Medicare supplier

Yes

The SPA in the patient’s CBA

Yes

Non-CBA

Traveling to a CBA

A supplier with a competitive bid contract

Yes

The fee schedule amount for the patient’s permanent address

Non-CBA

Traveling to a non-CBA

Any eligible Medicare supplier

The fee schedule amount for the patient’s permanent address

CBA

Not traveling

A supplier with a competitive bid contract

Yes

The SPA in the patient’s CBA

APRIL 2021 | O&P ALMANAC

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knee braces (L1812, L1830, L1833, L1836, L1850, L1851, and L1852) in competitive bidding areas (CBA) will be denied if submitted by a supplier who doesn’t have a competitive bidding contract, unless an ABN has been properly issued and signed by the patient. This is straightforward, but since the CBA is based on the patient’s permanent address—and not the address of your facility—things can get confusing if the patient is traveling and needs care. That is where the KT modifier (beneficiary resides in a CBA and travels outside that CBA and receives a competitive bid item) comes into play. When you encounter a patient who is traveling, there are three things to remember so you understand when you are able to provide and bill for one of the OTS knee or spinal braces, and how much you are able to bill and collect from the patient. Medicare payment is always based on the beneficiary’s permanent residence. So, if the patient

lives in a CBA, then the single pricing amount (SPA) for that CBA is the amount you would be reimbursed. • Who may provide the OTS brace will be determined based on where the patient receives the item. For the purposes of the competitive bidding program, traveling is not necessarily defined by a set distance, but rather where the patient will initially use the item provided. So, if a patient lives in a CBA and elects to receive care from a supplier not in a CBA, and then immediately returns to their permanent address, this would not be considered traveling. • If the patient travels to another CBA, then the patient may only receive care from a contracted supplier. If the patient travels to a non-CBA, then any eligible Medicare supplier may furnish the item. • The supplier who provides the OTS brace must accept assignment, unless the patient’s permanent address is not in a CBA and the patient travels

to a non-CBA. Please see the chart on page 20 for some examples. Understanding the modifiers discussed here is critical and could mean the difference between payment and nonpayment for your services. To learn more about the proper use of modifiers, review the Medicare policies prior to claim submission. Devon Bernard is AOPA’s assistant director of coding and reimbursement services, education, and programming. Reach him at dbernard@AOPAnet.org. Take advantage of the opportunity to earn two CE credits today! Take the quiz by scanning the QR code or visit bit.ly/OPalmanacQuiz. Earn CE credits accepted by certifying boards: www.bocusa.org

O&P ALMANAC | APRIL 2021

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ADDITIVE

O&P

More O&P facilities incorporate 3D-printing technologies into their practices for specialized and specific purposes By CHRISTINE UMBRELL

APRIL 2021 | O&P ALMANAC

COVER STORY

NEED TO KNOW • Some O&P facilities are taking advantage of recent advances in stronger materials, updated scanning technologies, and higher-end 3D printers to create unique parts and componentry. • O&P facilities are leveraging the technology to complement, rather than replace, traditional manufacturing—by 3D printing prototypes, prosthetic covers, unique terminal devices, test sockets, fabrication tools, and more. • Several O&P facilities house fused deposition modeling printers on site; some outsource 3D printing to facilities that house higher-tech printers; and a few do both. • Those facilities that choose to test 3D-printing solutions should do their research, learn proper scanning techniques, and reach out to experts for information and guidance. • As with any O&P solution, patient safety comes first.

VER THE PAST 10 YEARS,

3D-printing technologies have exploded throughout the medical community. In O&P specifically, some prosthetists and orthotists are taking advantage of recent advances in stronger materials, updated scanning technologies and software, and highertech printers to create unique parts and componentry. “3D printers have historically been considered a prototyping tool, due to the limitations of parts produced having anisotropic mechanical properties—variations in strength along different orientations, similar to wood grain,” explains Antonio Dias, director of engineering at Hanger Fabrication Network. However, recent advancements in 3D-printing technology “have greatly improved the quality of printed parts with the ability to print materials and parts with isotropic properties—uniform strength in all directions,” as well as greater precision and sufficient strength to meet the safety and functionality requirements for some device fabrication customized to patient needs, says Dias. Given these advances, 3D-printing experts believe the technology will continue to grow in popularity as one

more option to create O&P solutions. “This is a supplemental form of manufacturing,” explains Renee Lewis, CO, CPA, director of clinical solutions for Friddle’s Orthopedic Appliances. 3D printing “will not take the place of traditional fabrication and the technician’s job,” but will serve as one more tool to meet patients’ needs, according to Lewis. 3D printing offers the ability to fabricate devices of variable thicknesses and the ability to create unique solutions in a quick, cost-efficient manner, according to those who have embraced the technology. But those benefits are only possible if O&P professionals are properly educated on the scanning technologies and relevant software, as well as the various materials and types of 3D printers. As with any O&P solution, patient safety should come first, says Joe McTernan, AOPA’s director of reimbursement services. “Regardless of what process is used to manufacture a device, remember we are part of the professional allied health system,” he says. “CPOs need to make sure what they are fitting on patients will meet their medical need and not harm them. It still comes down to delivering effective patient care.” O&P ALMANAC | APRIL 2021

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At Handspring Clinical Services, one area is designated for scanning and modifying in preparation for 3D printing: From left to right, a scanner on a custom-made rotating scanning stand; a computer with Geomagic Freeform Plus being used to make a transradial, external powered prosthesis forearm; a haptic input device used to manipulate and modify a 3D model; and a can of scanning spray.

Upper-Extremity Options

Some facilities that care for significant upper-limb populations have come to appreciate additive manufacturing. “3D printing lends itself to high complexity and low volume, which is exactly what’s involved in upper-extremity prosthetics,” says Chris Baschuk, MPO, CPO, FAAOP(D), regional clinic manager for Handspring Clinical Services. “3D printing allows us to conceptualize beyond what is offered by traditional manufacturing,” and integrate 3D-printed components into traditionally manufactured devices. Baschuk’s location houses a low-cost FDM printer—a machine his facility purchased, then customized. “We can print very fine if we need to, or fast and large,” he says. While Baschuk and his team make 3D-printed prototypes in-house, they 24

APRIL 2021 | O&P ALMANAC

send files for definitive devices to an outside facility that uses a Multijet Fusion printer, which is believed to bond materials better, producing stronger end products. He and his team make some partial hands and partial fingers, as well as custom sockets for the upper limb, says Baschuk. He appreciates the time savings: “When you talk about a partial hand, traditional wet lamination doesn’t translate well to small pieces,” and requires hours of lab time. By contrast, scanning and 3D printing a partial hand on an FDM printer can take just 20 minutes to prep and a Staff at Hanger Fabrication Network recently created a passive 3D-printed pediatric arm, using an HP Multijet Fusion printer.

PHOTOS: Upper right, Chris Baschuk, MPO, CPO, FAAOP(D), Handspring Clinical Services; lower left, Hanger

As more O&P facilities purchase fused deposition modeling (FDM) printers for on-site use and outsource advanced printing needs to fabrication facilities that house higher-tech FDM printers, HP Multijet Fusion printers, or EOS machines, industry professionals are learning which types of components best lend themselves to this type of fabrication.

few hours to print, he says. “It’s not laminated or made of carbon fiber, so it’s a little bulkier [than traditionally manufactured components], but it’s sufficient.” Plus, if the component cracks or requires a minor alignment change, it can be printed again, quickly and cost-effectively. Hanger has focused mainly on upper-extremity prosthetics when it comes to 3D printing, including creating partial-hand prosthetic devices for adults and developing a 3D-printed passive hand for pediatric patients, according to Dias. “While we have tried a variety of printing technologies, we primarily utilize our HP Multijet Fusion industrial 3D printer, as it is able to print parts of sufficient strength, and also prints many components in a given fabrication cycle,” he says. Jeff Erenstone, CPO, owner and head clinician at Mountain Orthotic & Prosthetic Services in Lake Placid, New York, keeps a lower-cost 3D printer on-site. “I recently 3D-printed a finger for a partial hand,” for a patient to use in conjunction with a traditionally manufactured myoelectric hand.

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Covers and Unique Components

Erik Schaffer, CP, founder and chief executive officer of A Step Ahead Prosthetics, leverages a customized 3D printer at his main facility in Hicksville, New York, to perform many functions. “We use it all day long, every day … for research and development, for prototyping, for tools,” and more, he says.

The technology is of particular value when designing handmade silicone prosthetic covers, which Schaffer crafts via “silhouetting”: He scans a patient’s natural limb on the side without amputation to create an anatomically correct prosthesis that is a mirror-like image of patient’s natural limb. “We can make a synthetic cover [using 3D printing] with realistic freckled skin in the front and a ‘cyborg’ look in the back,” he says. He also uses the 3D printer to digitally conceptualize and make models of new designs. In addition, he 3D prints replacements for maxillofacial areas, such as ears and noses, and makes adaptive devices—cost-effective custom attachments for upper-limb prostheses or swimming attachments for lower-limb devices. The company makes its own custom tools on the printer, too. For example, “we made a tool to drag along silicone rubber to make an edge,” Schaffer says. He has made a cookie cutter to press out a tool for a project; created special stamping devices for an experiment; and made stands and clips to use as fasteners.

Prosthetic Sockets

Mike Nunnery, CPO, LPO, owner of Nunnery Orthotic & Prosthetic Technologies in North Kingstown, Rhode Island, has embraced 3D printing for prototype parts and

Jeff Erenstone, CPO, recently 3D-printed a thumb for a patient to use in conjunction with a myoelectric hand.

sockets for diagnostic fittings as well as upper- and lower-limb socket prototyping. He considers 3D printing a natural extension of the digital workflow—the process of scanning the patient using appropriate software, downloading the scan, and fabricating from the file. Nunnery owns two FDM-type 3D printers, modified for his purposes. One of the printers can handle above-knee test sockets. For final sockets, “I use a local 3D-print service bureau; I upload the digital file” and the socket is fabricated on a Multijet Fusion machine. Because these printers use PA12, or nylon plastic, reimbursement works the same way as a traditionally manufactured socket, according to Nunnery. He does not laminate over the socket, so “from a reimbursement perspective, there’s no difference. It’s just fabricated by a different means.”

APRIL 2021 | O&P ALMANAC

PHOTOS: A Step Ahead Prosthetics

Erik Schaffer, CP, leverages 3D-printing technology to make tools, parts, handmade silicone prosthetic covers, and replacements for maxillofacial areas.

PHOTO: Jeff Erenstone, CPO

“The patient needed a simple, thin, lightweight thumb” to complement the device. “It took 45 minutes to print and cost about 50 cents.” Because of the low cost, Erenstone tests and redesigns as needed. “I’m on version four with the thumb, fine-tuning the length,” he says. Erenstone and his staff also regularly print diagnostic sockets, cosmetic covers for transtibial prostheses, and upper-extremity terminal devices, such as sports-specific additions.

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Many of the clinicians at EastPoint Prosthetics & Orthotics leverage 3D printing for prosthetic sockets, such as the one pictured here.

Solutions Head-to-Toe

Wright. In addition to O&P componentry, Additive America prints consumer goods, automotive parts, and aerospace pieces, using HP Multijet Fusion technology. The 3D-printed materials are durable and can be used “to create flexible and nonflexible areas for definitive sockets, at different thicknesses”—as thin as 1.75-mm thickness, says Wright. Additive America offers an open system that allows clinicians to submit designs created in a variety of software programs. Technicians can group O&P components with orders from other industries in one printing process, which takes 18 hours to complete, and another 18 hours to cool down. This outsourcing approach brings costs down, says Wright. Additive America has been asked to make everything from a full-on prosthesis, to an adaptive device, to a wrist-hand orthosis. But sockets are their most popular item, so the

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Nunnery believes 3D printing saves both time and money, used for the right purposes. “I can scan a patient, and within an hour, the printer is printing diagnostics,” he says. “Sometimes I modify the digital model with the patient sitting in the office.” At EastPoint Prosthetics and Orthotics in Raleigh, North Carolina, approximately 90 percent of the definitive prosthetic sockets are 3D-printed, says Brent Wright, CP, BOCO. EastPoint clinicians tend to fabricate via additive manufacturing unless the patient weighs more than 250 pounds, or the device is needed immediately, because 3D printing takes at least 36 hours. “Patients seem to really like” the 3D-printed devices. “We do a lot of customization—adding logos, or colorizing them to make them ‘fun,’” he says. EastPoint outsources to Additive America, a contract manufacturer of 3D-printed devices co-owned by

COVER STORY

company has been aggregating testing data on the sockets it makes—for example, data on when a device would be expected to fail. This data helps ensure the safety of patients, according to Wright.

Special Circumstances 3D printing can be useful outside of the traditional U.S. patient population. Nunnery leverages 3D printing for his “niche” business making face masks for patients with orbital or

nasal fractures, usually for university sports teams. “I scan in-office and send out to be Multijet Fusion printed,” he explains. “I have a lot of creativity with the design; it’s very cost-effective; and the masks come out phenomenally.”

Industry Committees Focus on Socket Strength A

OPA HAS LAUNCHED the AOPA Socket Guidance

PHOTOS: Getty Images

Workgroup, with stakeholder representation across the O&P industry, including prosthetists, materials engineers, 3D-printing experts, representatives from the International Standards Organization (ISO), and more. The group will first review existing research and determine evidence gaps to better understand the need for socket guidance, including but not limited to a possible ISO technical report or standard, according to Ashlie White, AOPA director of strategic alliances. The multistakeholder working group will work “to figure out strength standards for sockets in general,” says Jeff Erenstone, CPO, owner and head clinician at Mountain Orthotic & Prosthetic Services, and a member of the workgroup. While many believe that sockets made on high-end 3D printers, such as those made by HP or EOS, are strong enough for weight-bearing, “there’s no way to test [whether they are strong enough] because there is no standard for sockets yet,” says Erenstone. The workgroup is exploring whether such a standard might be beneficial. Eric Nickel, MS, senior biomedical engineer at the Department of Veterans Affairs (VA) Minneapolis Adaptive Design & Engineering Program, is involved in AOPA’s Socket Guidance Workgroup and also is a member of ISO/TC 168 Workgroup 3, which develops international testing standards for O&P. He is working with William Layman, CP, from the Southeast Louisiana VA, who is a member of the Veteran’s Health

Administration’s 3D-Printing Advisory Committee, to develop methods to assess “whether a clinician has mastered the skill set necessary to implement the new tools involved in 3D printing,” he says. “Our long-term goal is to develop a training program with integral structural testing, to train clinicians” in new scanning and 3D-printing technologies to ensure those individuals have acquired appropriate skill sets before working with patients. “Our group is excited about the potential ability to create socket designs” using 3D printing that allows for customization of regional mechanical properties in a single build,” Nickel says. “Our vision depends on the skill of a CP or CPO to apply the 3D-printing techniques to best serve each individual patient.” In a technical note published in Journal of Prosthetics and Orthotics last fall, Nickel and his team tested 24 transtibial prosthetic sockets using ISO 10328 loading conditions. They concluded an iterative design process with integral structural testing can result in strong, durable prosthetic sockets made using 3D-printing technology that may be robust to variations in limb size/shape and suspension type. But Nickel says it’s important for all fabricators to ensure that 3D-printed sockets are strong enough. “For companies that say they do 3D-printed definitive sockets, how do they know what they’re doing is good enough?” asks Nickel. “So much of it is opinion. “We need to develop a way to validate new technologies as they come out—and as new materials and more advanced printers come out,” says Nickel. “This is a multiyear process; we’re at the beginning.”

O&P ALMANAC | APRIL 2021

COVER STORY

Erenstone traveled to Nepal as part of Operation Namaste, where his team used 3D-printed molds to make transfemoral and transtibial silicone liners.

PHOTOS: Jeff Erenstone, CPO, LPO

Several clinicians volunteer overseas and deliver 3D-printed componentry during their visits. Erenstone, for example, is part of the development team at Operation Namaste, an organization that provides tools and support to O&P practitioners in underserved countries. He recently returned from a trip to Nepal, “where it’s very difficult to bring things into the country; they have a difficult customs situation, and they’re landlocked,” so importing supplies takes a long time. Most transtibial amputees in Nepal lack regular access to silicone liners and rely on old-fashioned PTB-style prostheses—which can be especially challenging to use in the mountainous

terrain, according to Erenstone. Through Operation Namaste, he and his colleagues use 3D-printed molds to make both transfemoral and transtibial silicone liners in five sizes—XS through XL—then rely on local labor to finalize the process. “As I design a mold, I email the digital file [to the local staff ], and they 3D-print the mold—so they’re completely sustainable,” Erenstone explains. “We regularly import silicone chemicals, which have a two-year shelf life. Even with labor costs, it’s only $40 or $50 per liner.”

Getting Started

Facilities that are considering adding 3D-printing capabilities should wait before investing in a printer, according to the sources. To successfully leverage 3D printing, “you really need to know how to scan accurately,” explains Nunnery, “and invest in high-end scanning tools.”

APRIL 2021 | O&P ALMANAC

PHOTO: Mike Nunnery, CPO, LPO

Mike Nunnery, CPO, LPO, 3D prints customized face masks for orbital and nasal fractures.

Understanding the digital ecosystem, from scanning a patient to CAD design, is a great place to start, says Dias. “Several software options are available to digitally modify scan files, and many are free to use,” he says. “Once the facility gains confidence in scanning and CAD design, they will then be able to test out their designs by working with a 3D print house to produce their parts without having to spend the money upfront to purchase a printer.” At Handspring Clinical Services, Baschuk says his facility did not purchase a printer “until we felt we had the CAD and digital skills in place” to do it correctly. Baschuk spent hours—often at night or on weekends—trying software packages, many of which offered 30-day free trials. His facility ultimately adopted Geomagic Freeform Plus, Rhinoceros 3D, and Fusion 360—“and we need all three” to meet patients’ needs, because “each one has its strengths,” he says. “Start by getting comfortable being able to make a shell that’s different thicknesses around your digital positive,” Baschuk says. “And get used to aligning the model in digital space, and cleaning up the model in digital space.” He encourages interested clinicians to experiment and collaborate. For example, LinkedIn hosts an active 3D-printing community to connect

BALDWIN BELT (shown on model)

COVER STORY

with other clinicians to see what they have printed. “Most of us are open and willing to talk about it,” Baschuk says. He also points to the younger generation of clinicians as potential resources: “A lot of today’s graduates have biomedical engineering degrees” and are already familiar with additive manufacturing, he says. O&P facilities also are turning to industry partners to explore different types of scanning technology. Comb O&P, for example, offers an app that

turns iPhones into O&P scanners. Aaron Naft, the company’s global director of sales and marketing, educates new customers on Comb’s technology and on the value of a digital workflow. “Scans are now essential to help with reimbursement,” he says. His company partners with several O&P facilities and c-fabs since the scanned file formats can be universally uploaded into most software platforms. Once clinicians are comfortable

with scanning, experts recommend facilities purchase a lower-end printer or consider partnering with one of the many 3D-printing companies across the nation. Friddle’s—a manufacturing and central fabrication facility—utilizes a variety of 3D-printed solutions, according to Lewis. On-site, Friddle’s houses a lower-end FDM printer to make donning tubes and for small batch printing, which is “less costly for smaller runs than injection molding,”

3D-Printing Research and Partnerships A

S 3D-PRINTING MATERIALS become stronger and

APRIL 2021 | O&P ALMANAC

The 3D-printed inlay uses a variable hardness metamaterial comprised of triangular pattern unit cells, which can be 3D-printed with walls of various thickness controlled by draft angles. The goal is to Ability Prosthetics and evaluate the additive manufacOrthotics is working with turing solution as a method of researchers at Clemson improving socket comfort for University in developing individuals with lower-limb loss. and testing 3D-printed socket inlays, designed The researchers “applied to fit within traditionally the advances of additive manufabricated sockets. facturing to achieve variable hardness within sockets to reduce pressure gradients,” says Brian Kaluf, BSE, CP, FAAOP, clinical outcome and research director at Ability P&O. Kaluf is working closely with Clemson’s John Desjardins, PhD, and graduate student Meredith Owen on this project, which is funded by the South Carolina Research Authority. They recorded socket comfort ratings via a questionnaire and socket pressure with a thin sensor system. While results are currently being analyzed, “we received positive feedback” from study participants, says Kaluf. Most participants “preferred the feel, especially over bony prominences, and wanted to keep their research socket” after the study had concluded. “By designing a variable hardness structure, which is only possible through 3D printing, we were able to design exactly what they needed.”

PHOTO: Brian Kaluf, BSE, CP, FAAOP

the machines more robust, healthcare entities and universities are experimenting with the technology and evaluating future uses. The Department of Veterans Affairs (VA), as represented by the VA Minneapolis Health Care System (HCS), and UNYQ, a company that offers 3D-printed wears, have entered into a cooperative research and development agreement for 3D-printed prosthetics, according to a press release published in February. The object of the collaboration is to introduce personalized products addressing specific needs of veterans with amputation, taking advantage of technology such as 3D printing, generative design, and app development. The aim of the VA/UNYQ partnership is to collaborate on launching products and to develop concepts together using 3D printing and other exponential technologies. “3D printing and personalization can solve needs unaddressed so far for the veterans with amputations,” says Andrew Hansen, PhD, director of the Minneapolis Adaptive Design & Engineering Program at the Minneapolis VA HCS. “Our team has been exploring and investing in the development of prototypes and advanced concepts. We are very excited to be partnering up with UNYQ to make this work finally available to clinics and end users, including veterans.” In another key partnership, Ability Prosthetics and Orthotics is working with researchers at Clemson University on a small-scale clinical trial and technology translation involving 3D-printed socket inlays, designed to fit within existing traditionally fabricated sockets for transtibial amputees.

COVER STORY

says Lewis. The company has made “one-off, in-house” designs, she says, including prosthetic covers. Friddle’s also partners with Extremiti3D LLC to provide 3D-printed componentry made on a more sophisticated 3D printer. In addition to test sockets, “we’ve seen a lot of interest in flexible inner sockets made via CAD design and 3D printed,” Lewis says.

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3D-printing advocates believe adoption will continue to grow. The technology will complement, rather than replace, traditional manufacturing, says Baschuk. Even though his facility 3D-prints some small parts, “we’ll continue to buy components from the manufacturers since some parts have to be traditionally manufactured for safety reasons,” he says. He would like to see manufacturers make available the digital files for the exterior shapes/outer surfaces of their components, or “digital fabrication dummies instead of the physical fabrication dummies that they already provide.” This would make it easier for patient-care facilities to integrate those components into their 3D-printed products. “We will need the manufacturers’ cooperation to keep using their components,” he says. “Those manufacturers who provide digital files will be the ones we’ll want to work with.” “There will be increased usage of 3D-printing technology going forward, not just for prosthetics, but also for orthotics,” says McTernan. “It’s growing as a viable and effective fabrication technique.” Five years from now, Wright believes 3D printing will be more widespread, especially because residents and young clinicians “are hungry for this,” he says. “It saves time—the new generation will reap the benefits of digital manufacturing and the efficiencies of 3D printing.” Christine Umbrell is a contributing writer to O&P Almanac. Reach her at cumbrell@contentcommunicators.com.

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By JOSEPHINE ROSSI

Accelerating

Acceptance Medical advances pave the way for increased prosthetic use and advanced control

S THE O&P PROFESSION makes dramatic technological

advancements for the limb loss community to regain and improve mobility, the medical community is debuting several promising techniques and advancements to help solve some of the biggest challenges for individuals who use prosthetics. Imagine the possibilities for amputees who have more precise prosthetic control, enhanced proprioception, less pain, and improved skin durability. That future is closer than we may think.

APRIL 2021 | O&P ALMANAC

Of Bone, Muscle, Nerve

The state of osseointegration (OI) in the United States has seen many advancements in the past five years or so, including Food and Drug Administration (FDA) approvals of the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA), the first OPRA implant surgery at University of California San Francisco (UCSF), and the first global osseointegration registry of implants, allowing for worldwide outcomes data collection. The main advancement, however, has been “the combination of direct skeletal connection for gross motor control and placement of extremity, and implantable neural control for reproducible, intuitive, and accurate fine-point motor function,” says Matthew Garibaldi, CPO, director of the Orthotic and Prosthetic Centers, and associate clinical professor in the Department of Orthopaedic Surgery at UCSF. The shift of focus from bone implant interface to the soft tissues has come a long way in the past five years, agrees Jonathan A. Forsberg, MD, PhD, an orthopedic oncologist at Johns Hopkins Medicine. “We’ve learned that taking a more proactive approach with the soft tissues, as well as the nerves, can achieve better results” in terms of volitional control of prosthetics. “In addition, I think that implanted electrodes will ultimately become the future of device control and sensory feedback,” continues Forsberg, who has completed several surgeries involving implanted electrodes to date. “I’m excited to be a part of that because transdermal bone-anchored surgery is unique. We have a conduit that exits the body and that provides us with an opportunity to transmit the signals directly from the peripheral nervous system out to the implant itself. I believe this is the natural next step in intuitive control of both upperand lower-extremity prosthetics.”

The combination of osseointegration and neural-controlled prosthetic applications has led to improved patient outcomes and has changed the prosthetist’s role in the multidisciplinary medical team, says Garibaldi, who was the first prosthetist in the United States to treat patients with the OPRA implant. “Historically, a significant amount of the prosthetist’s time has been focused on socket optimization. With OI, that time is reallocated to patient education, alignment, programming, training, and formation of rehabilitation guidelines,” he explains. “With the introduction of OI and neural implants in the United States, the prosthetist has become more integrated into the multidisciplinary medical team and is viewed as a key authority and decision-maker as it pertains to the long-term rehabilitation trajectory of these patients.” Among the multiple neural-controlled technologies and procedures, three are being tested in conjunction with osseointegration, according to Garibaldi and Forsberg. The latest research on each has demonstrated exciting results for the future of prosthetics: AMI. In February, researchers at the Massachusetts Institute of Technology’s Media Lab in collaboration with surgeons at Harvard University announced the results of a clinical study of a surgical technique, called agonist-antagonist myoneural

interface (AMI), which would give amputees better control of the residual muscle and prosthetic limb. The MIT Media Lab website describes the AMI surgical procedure as “made up of two muscles—an agonist and an antagonist—mechanically connected so that when the agonist contracts, the antagonist is stretched, and vice versa. The purpose of an AMI is to control and interpret proprioceptive feedback from a bionic joint. “When the AMI patient wishes to move his bionic limb, he contracts the AMI muscles associated with his intended joint motion. Muscle electrodes adjacent to the AMI muscles send electrical signals from the muscles to small computers on the prosthetic limb, which then use the muscle signals to control motion of the prosthetic joints in a natural way.” The study, which was published in the Proceedings of the National Academy of Sciences, compared 15 participants who received the AMI surgical procedure for a below-knee (BK) amputation to seven people who had traditional BK amputations. “… Our study shows that persons with an AMI amputation experience a greater phantom joint range of motion, a reduced level of pain, and an increased fidelity of prosthetic limb controllability,” said Hugh Herr, a professor of media arts and sciences, head of the biomechatronics group in the MIT Media Lab, and the senior author of the paper, in a press release. O&P ALMANAC | APRIL 2021

More specifically, the study revealed that AMI patients had “very similar” muscle activity in their amputated and intact limbs, and they were able to control the muscles of their amputated limb “much more precisely” than those who underwent traditional amputation procedures. “Our study wasn’t specifically designed to achieve this, but it was a sentiment our subjects expressed over and over again. They had a much greater sensation of what their foot actually felt like and how it was moving in space,” said Shriya Srinivasan, an MIT postdoctoral researcher and lead author of the study. “It became increasingly apparent that restoring the muscles to their normal physiology had benefits not only for prosthetic control, but also for their day-to-day mental well-being.” e-OPRA. Building on the success of the OPRA implant, inventor Max Ortiz Catalán, PhD, associate professor and head of the Bionics Research Unit at the Department of Electrical Engineering at Chalmers University of Technology, modified portions of the OPRA implant with “feedthrough connectors” to interact with several types of implanted electrodes. He and his fellow researchers studied the use of the technology, called enhanced-OPRA or e-OPRA, in patients following transhumeral amputation. They shared the results with the New England Journal of Medicine in April 2020. “In four patients who had an existing osseointegrated prosthesis with surface electrodes to control a prosthetic hand, we removed the coupling components within the fixture and abutment and replaced them with embedded electrical connectors,” the authors explained. “The connectors sealed the interface and provided bidirectional communication between the prosthesis and electrodes that we implanted in nerves and muscles, thereby creating a self-contained neuromusculoskeletal human–machine interface.” 36

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“With the introduction of OI and neural implants in the United States, the prosthetist has become more integrated into the multidisciplinary medical team and is viewed as a key authority and decision-maker as it pertains to the long-term rehabilitation trajectory of these patients.” —MATTHEW GARIBALDI, CPO

For prosthetic control via the neuromusculoskeletal interface, three of the four patients underwent nerve transfers “to extract neural signals related to the opening and closing of the hand through remnant muscles” at the residual end of the limb. The fourth used “natively innervated” triceps and biceps. The neural and muscular electrodes were then surgically placed for control and to provide sensory feedback to the osseointegrated arm prosthesis. “The prosthesis was effective during the performance of activities of daily living without supervision and allowed intuitive somatosensory feedback, thereby requiring no formal training,” the researchers reported. None of the participants suffered adverse side effects, while all experienced improvements in “precision in prosthetic control” and reported “greater trust” in their prosthesis.

“The relevance of the work presented here is not in the number of perceived and measured sensations but in the achievement of an integrated and fully self-contained prosthesis with implanted electrodes that can be used reliably in daily life, enabling intuitive control and somatosensory feedback of the hand,” the authors reported. A clinical trial is currently underway at MIT to evaluate the possibility of full neural control using the e-OPRA system on lower-limb amputees. RPNI. Last year, researchers at the University of Michigan (U-M) released the results of a study proving regenerative peripheral nerve interfaces, or RPNIs—small muscle grafts surgically wrapped around severed nerve endings—can serve as a “biologically stable bioamplifier of efferent motor action potentials with long-term stability in upper limb amputees,” according to the study abstract. The severed nerves grow into the muscle tissue, which not only prevents the growth of neuromas but also amplifies nerve signal. The RPNIs of two of the study participants were assessed via ultrasound, which showed “prominent contractions during phantom finger flexion, confirming functional reinnervation of the RPNIs.” Two other participants received electrodes implanted into their muscle grafts, and their RPNIs “produced electromyography signals with large signal-to-noise ratios.” The nerve signals were passed on to a prosthetic hand in real time. “This is the biggest advance in motor control for people with amputations in many years,” said Paul Cederna, MD, Robert Oneal Collegiate Professor of Plastic Surgery at the U-M Medical School, as well as a professor of biomedical engineering, in a press statement. “We have developed a technique to provide individual finger control of prosthetic devices using the nerves in a patient’s residual limb. With it, we have been able to provide some of the most advanced prosthetic control that the world has seen.”

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Because the nerve signals are strong, the researchers are able to translate them into fine gross motor intent in real time using machine learning algorithms. “This worked the very first time we tried it,” added Cindy Chestek, PhD, associate professor of biomedical engineering, who co-leads the research with Cederna. “There’s no learning for the participants. All of the learning happens in our algorithms. That’s different from other approaches.” The U-M team is currently exploring the use of finer electrodes for better nerve signal resolution and if RPNI can be used for prosthetic leg and foot control. The researchers also have proof that the RPNIs can send sensory data back to the brain and plan further study of the occurrence.

“When you inject cells, there are a lot of things you have to learn about—how well they’ll survive, where to put them, how much to use. A lot of what we’re figuring out now, will help [answer] questions” regarding limb regeneration. —LUIS GARZA, MD, PhD

Tougher Skin

Other soft tissue studies could lead to greater traditional prosthesis acceptance. Luis Garza, MD, PhD, associate professor of dermatology at the Johns Hopkins University School of Medicine, and his team have been working on a multiphase study to convert the identity of skin at the residual limb of amputees into thick, volar-type skin, which is more friction-resistant, to enhance their use of prosthetic devices. The goal is to transform skin that interacts with

APRIL 2021 | O&P ALMANAC

a prosthesis into volar skin that is thicker and structurally more complex, has increased sensory abilities, and is devoid of hair and sebaceous glands. Garza says the inspiration for the project came “around the time of Iraq and Afghanistan [wars]” to help wounded warriors who experience problems wearing their prostheses because of skin break-down, with the intention of translating these solutions for the civilian population.

Another motivation came from the team’s interest in cellular therapy, which holds the potential for regenerative medicine and long-term cures for many conditions. For example, the current treatment for high blood pressure is medication. “What if you had a cell that would just sense high blood pressure and then release the right hormone to decrease your blood pressure? That would be a cure,” Garza explains. Initial, proof-of-concept trials began by biopsying volar skin cells from the palms or soles of 30 healthy nonamputees and growing them in the lab over several weeks. The lab-grown cells were injected back into the same volunteers but at a new site on the body, usually the back of their leg. Two control groups received injections of either cells from another part of the body, such as the scalp, or simply the injection vehicle, a liquid containing no cells. Next, the team removed skin from the reinjection site at different intervals over two to five months for detailed study. The skin was separated down to single cells for RNA sequencing, which revealed tissue changes and promising results: “We could see that the cells we injected changed a lot of the cells around them,” says Garza. Published information also states that the volunteers “experienced more firm skin at the injection site.” In addition, the testing proved to be safe for the participants, according to Garza. Only a few experienced mild skin color changes at the injection site, and none suffered major rashes or systemic effects, paving the way for the next phase of the trial— testing on amputees. As of press time, the team was not fully approved to begin amputee testing at military treatments sites, including Brooke Army Medical Center, Naval Medical Center San Diego, and Walter Reed National Military Medical Center. However, they did have FDA approval to begin amputee studies at Johns Hopkins. In this current study, researchers will determine if “fibroblast injections

are safe and effective at increasing epidermal thickness and skin firmness at the stump site in below-the-knee amputees,” according to the published description. They will use noninvasive imaging and skin firmness testing devices and questionnaires to assess outcomes. “Our plan is to first prioritize amputees who have sores at their stump sites,” says Garza. The trial will require multiple injections of cells at the edges of the sores to “help the cells take over.” The study description explains that the team also will be looking for the most effective approach to “administering this intervention via injections to the entire stump and the safety and effectiveness of whole stump injections and their effects on prosthesis use, skin breakdown, quality of life, and activity level.” Garza anticipates the entire amputee study will take three to four

years to complete and is hopeful this kind of personalized cellular therapy will complement technological advances in prostheses. He envisions the therapy as means to offer more solutions to patients—with more skin resilience and less discomfort, they will be less apprehensive of trying new devices and will ultimately spend more time wearing their prosthesis. “So, the hope is we eventually make the tissue such that it’s as easy as putting on a shoe— there’s no discomfort or fear,” says Garza.

Even more remarkable, Garza says the work he and his colleagues are doing now likely will provide the baseline evidence for limb regeneration in the future. The group recently presented their cellular therapy work at an NIH-sponsored conference devoted to the idea of limb regeneration in humans. “When you inject cells, there are a lot of things you have to learn about—how well they’ll survive, where to put them, how much to use. A lot of what we’re figuring out now, will help [answer] those questions,” he explains. “The next step is trying to make the cells that we’re injecting not just change it into volar skin, but actually change into the type of skin that a baby had when it was growing its limb.” Josephine Rossi is editor of O&P Almanac. Reach her at jrossi@ contentcommunicators.com.

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O&P ALMANAC | APRIL 2021

PRINCIPAL INVESTIGATOR

Competitive Spirit Colorado researcher’s findings influence the world of organized sports

O&P Almanac introduces individuals who have undertaken O&P-focused research projects. Here, you will get to know colleagues and healthcare professionals who have carried out studies and gathered quantitative and/or qualitative data related to orthotics and prosthetics, and find out what it takes to become an O&P researcher.

HE CONTROVERSY surrounding

the use of running prostheses by Oscar Pistorius, a South African sprinter with bilateral leg amputations, served a positive purpose for Alena M. Grabowski, PhD: “It captivated me and got me involved in prosthetic research,” she says. Ten years ago, Pistorius achieved a time for the 400-meter sprint that qualified him to compete in the Olympics; however, he was initially denied the opportunity to compete by the International Association of Athletics Federations (IAAF, now

World Athletics), which claimed that prostheses provided an advantage to their user. At the time, Grabowski was part of a research team that concluded the opposite: that the use of prosthetic legs does not provide amputees with an advantage compared with elite nonamputee sprinters. “Our team’s research was used in the Court of Arbitration in Sport (CAS) to successfully appeal the IAAF’s decision,” and Pistorius was allowed to compete in the 2012 Olympic Games. Over the past decade, Grabowski—a runner herself—has been captivated by how devices such as prostheses and orthoses affect the physiology and biomechanics of people with physical disabilities and has pursued several groundbreaking research projects to better understand the use of these devices.

Studying Human Movement

APRIL 2021 | O&P ALMANAC

PHOTO: Patrick Campbell/University of Colorado

Alena Grabowski, PhD, works in the Applied Biomechanics Lab at University of Colorado Boulder.

The Pistorius prosthetic controversy ignited a career rich in movement research. Grabowski earned a bachelor’s degree in kinesiology from University of Colorado Boulder (UC Boulder) in 1998, followed by a doctorate degree from the same university in 2007. Grabowski completed postdoctorate work at the Massachusetts Institute of Technology’s Media Lab and at the Providence VA Center for Restorative and Regenerative Medicine in 2011.

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Grabowski observes as a lower-limb amputee runs on the treadmill.

Left, Grabowski works with a study participant.

Impactful Studies

In recent years, Grabowski has studied the motion of competitive and even elite athletes. Her team conducted a systematic series of studies to establish how the use of runningspecific prostheses by athletes with 42

APRIL 2021 | O&P ALMANAC

unilateral and bilateral leg amputations affect performance. “First, we found that sprinters with leg amputations using running-specific prostheses have slower acceleration out of the starting blocks, slower curve-running speed, and slower maximum speed compared to nonamputees,” she says. However, the prosthetic configuration used by athletes with a leg amputation may affect their running and sprinting performance. “We determined the biomechanics, metabolic demands, and maximum speeds of athletes with unilateral and bilateral leg amputations each using 15 different prosthetic configurations: three models with three stiffness categories at one height, and two additional heights with the optimal stiffness category.” The optimal distance-running prosthetic configuration elicited the lowest metabolic cost, and the optimal sprinting prosthetic configuration maximized speed, according to Grabowski. “Athletes with unilateral leg amputations optimized distancerunning performance when they used a J-shaped model, and athletes with bilateral leg amputations optimized distance-running performance when they used J- or C-shaped models with lower-than-recommended stiffness,” she says. Sprinting speed was maximized when these athletes used J-shaped models but was not

affected by prosthetic stiffness or height. “We used the results from the most economical prosthetic configurations to hypothesize that, despite biomechanical differences between athletes with and without leg amputations, metabolic cost is within the same range,” she says. Thus, use of an optimal runningspecific prosthetic configuration can enhance the performance of athletes with leg amputations when compared to other configurations, but it does not normalize biomechanics or performance when compared to nonamputees. Grabowski also has led investigations focusing on jumping. “The long jump performances of Markus Rehm, a German athlete with a leg amputation, have generated speculation that use of a running-specific prosthesis and affected leg as the takeoff leg for the long jump provides an advantage compared to nonamputees,” she explains. Grabowski worked as part of an international research team to measure the biomechanics and performance of elite athletes with and without a leg amputation during maximum distance long jumps. “All of the athletes with a leg amputation used their affected leg, including their prosthesis, as their takeoff leg,” says Grabowski. The athletes had a slower run-up speed but an enhanced takeoff step technique for the long jump compared to performance-matched nonamputees.

PHOTOS: Glen Asakawa/University of Colorado Boulder

Today, Grabowski serves dual roles, as an associate professor at UC Boulder and as a research healthcare scientist with the Department of Veterans Affairs Eastern Colorado Healthcare System in Denver. At UC Boulder, Grabowski’s appointment is focused on research, but she also teaches biomechanics and is the director of the Applied Biomechanics Lab. She aims to improve the function and enhance the performance of people with and without physical disabilities, such as leg amputation, as they walk, run, cycle, sprint, and jump. To accomplish those goals, Grabowski and her team investigate how mechanical and robotic devices such as prostheses, exoskeletons, and sports equipment affect people’s ability to move. “We utilize different types of biomechanical equipment in the lab, such as force-measuring treadmills, motion capture, force platforms, electromyography to measure muscle activity, a materials testing machine to determine stiffness of prostheses and orthoses, and indirect calorimetry to measure metabolic rates,” she explains.

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Grabowski’s team is studying how use of running-specific prostheses affects the performance of Blake Leeper, a U.S. athlete with bilateral amputations.

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advantage compared to nonamputees,” she explains. “The IAAF did not allow Leeper to compete, and I served as an expert witness in the appeal of the IAAF decision in the CAS.” CAS ruled that the IAAF must have the burden of proof, but that Leeper is not allowed to compete because he did not abide by the International Paralympic Committee’s rule on the maximum allowable standing height (MASH). “The MASH rule is very controversial because it is based on people of Caucasian and Asian descent, but not on people of African descent,” Grabowski explains. “Moreover, MASH has not been used by the IAAF to regulate height of nonamputee athletes. Thus, the controversy surrounding the use of running prostheses remains, and we are conducting additional studies to determine how use of running-specific prostheses affect performance.”

Investigations Into Walking

While many of her studies have implications for elite athletes, Grabowski also devotes resources to walking-related investigations. “Over time, the design of leg prostheses has improved, but until recently, leg prostheses have been incapable of actively adapting to different walking speeds in a manner comparable to biological limbs,” she

More To Come

Grabowski plans to continue studying topics that are relevant to individuals with limb loss. For example, she and her team are determining how visual feedback of peak propulsive force affects the biomechanics and metabolic costs of people with a leg amputation using the BiOM. “We also are comparing how the interaction of prosthetic foot stiffness and ankle power affect

PHOTOS: Nathaniel Minor/CPR News

“Our results imply that use of a running-specific prosthesis has a neutral effect on long jump performance for athletes with a leg amputation compared to nonamputee athletes,” she says. However, the rule made by the IAAF regarding the use of running-specific prostheses states that athletes must prove that the use of a prosthesis does not provide them with an advantage compared to nonamputees. “Based on the neutral effect of athletes with a leg amputation using a prosthesis for the long jump, the IAAF did not allow Rehm to compete in sanctioned track and field events, including the Olympics,” she says. “The effects of using a runningspecific prosthesis on the performance of athletes with a leg amputation remains controversial,” Grabowski adds. Her team is currently involved in research to determine how use of running-specific prostheses affects the performance of Blake Leeper, a U.S. athlete with bilateral leg amputations who has attained a 400-meter time of 44.36 seconds, which is faster than the Olympic-qualifying time and Oscar Pistorius. “We have analyzed and compared Leeper’s performance metrics over 400 meters to those of nonamputees to address the IAAF rule that put the burden of proof on an athlete to show that the use of prostheses does not provide an

explains. “People with a leg amputation using passive-elastic prostheses require greater energy to move, walk at slower preferred speeds, and have asymmetric movements and forces during walking compared to nonamputees.” Grabowski conducted a series of studies analyzing the use of a bionic battery-powered ankle-foot prosthesis (BiOM) that emulates the function of a biological ankle during level-ground walking. People using the BiOM realized normative metabolic costs and biomechanics during level-ground walking over a range of speeds and dramatically improved their performance compared to using a passive-elastic prosthesis. She also has worked with her team on a series of studies analyzing and comparing the use of the BiOM to use of a passive prosthesis and to nonamputees during walking on uphill and downhill slopes. One study determined that, in nonamputees, the ankle’s contribution to the mechanics of the leg changes with speed and slope during walking, suggesting that a bionic powered prosthesis may need sophisticated control to normalize metabolic costs and biomechanics. Another study concluded that when people with a leg amputation used the BiOM, they reduced their metabolic cost and improved their biomechanics when walking uphill compared to using a passive-elastic prosthesis, but their metabolic costs and biomechanics did not change when walking downhill. “Use of a bionic battery-powered ankle-foot prosthesis has the potential to dramatically improve the physical function of people with a leg amputation during level-ground and uphill walking,” Grabowski concludes.

PRINCIPAL INVESTIGATOR

PHOTO: Patrick Campbell/University of Colorado

the biomechanics and metabolic costs of people with a leg amputation,” she says. Additional future projects include a study to optimize prosthetic configuration; bicycle fit in people with a leg amputation; and optimizing running-specific O&P components for military women with lower-limb salvage or amputation. “In future research, I hope to use results from all of my previous studies to design and develop lower-limb orthoses and prostheses that can improve the function of people with a disability during walking, running, jumping, bicycling, and sprinting,” she says. “I think it’s really important for researchers and clinicians to be able to understand each other and address the challenges in our field,” Grabowski adds. “I hope that my research contributes to better understanding how prostheses and orthoses affect the way that people with a disability move, be it walking or sprinting. I also hope that clinicians and O&P business owners are open to contributing to research and to adopting new and proven technology to support their patients’ mobility.”

Notable Works Alena M. Grabowski, PhD, is the author or co-author of dozens of peer-reviewed articles and conference presentations. Some of her most impactful contributions include the following: • Herr, H.M., Grabowski, A.M. “Bionic Ankle-Foot Prosthesis Normalizes Walking Gait for Persons With Leg Amputation.” Proceedings of the Royal Society B, 2012, 279: 457-464. http://royalsocietypublishing.org/ content/royprsb/early/2011/07/07/rspb.2011.1194.full.pdf • Weyand, P.G., Bundle, M.W., McGowan, C.P., Grabowski, A.M., Brown, M.B., Kram, R., Herr, H. “The Fastest Runner on Artificial Legs: Different Limbs, Similar Function?” Journal of Applied Physiology, 2009, 107: 903-911. http://jap.physiology. org/content/107/3/903 • Grabowski, A.M., McGowan, C.P., McDermott, W.J., Beale, M.T., Kram, R., Herr, H. “Running-Specific Prostheses Limit Ground Force During Sprinting.” Biology Letters, 2010, 6: 201-204. http://rsbl.royalsocietypublishing.org/content/6/2/201

Ferrier Coupler Options!

Grabowski holds a lower-limb prosthesis.

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.

O&P ALMANAC | APRIL 2021

MEMBER SPOTLIGHT

Prosthetic and Orthotic Designs

By DEBORAH CONN

Office Expansion Facility that opened in 2018 doubles in size

ON HESS, CPO, LPO, has

John Hess, CPO, LPO, works with a lower-limb patient.

been an O&P practitioner for 21 years—but that role follows a career as recreation therapist at Helen Hayes Hospital in West Haverstraw, New York. It was in that previous role that Hess was first introduced to patients with limb loss; he felt an immediate attraction to the hands-on nature of O&P work. Hess decided to go back to school at Northwestern University to study O&P, becoming certified in orthotics in 2000 and prosthetics in 2003.

FACILITY: Prosthetic and Orthotic Designs OWNER: Jon Hess, CPO, LPO LOCATION: Middletown, New York Hess works in the facility’s fabrication lab.

Hess worked for several facilities until 2018, when he decided to open his own practice. “It was a leap of faith,” he says, “but my instincts told me it was the right thing to do.” He never looked back. “I would not trade this experience for the world. I love making my own decisions, and I appreciate the financial benefits of owning my own practice.” Prosthetic and Orthotic Designs is located in Middletown, New York, not far from where Hess grew up. He is the sole practitioner, with another dedicated staff member—Iveliz Franceschi—managing the 46

APRIL 2021 | O&P ALMANAC

HISTORY: Three years

Jon Hess, CPO, LPO

company’s finance, accounting, billing, and HR functions, as well as the company’s administrative staff. Hess and his team are in the process of moving from a snug 1,300-square-foot office, where bumping elbows is an occupational hazard, to a facility that’s double the size—and right next door. “The only change to our address will be our suite number,” Hess says. The new space will better accommodate P&O Designs’ fabrication lab, where Hess and an independent technician build devices. While Hess has worked with computer-aided design, he prefers taking measurements and building sockets by hand. “In my experience, nothing is better than getting hands on the cast and making and relieving pressures,” he says. “In my opinion, when you create a relief or a pressure on a socket on CAD/CAM, you lose some of the intimacy of the shape. When I physically put plaster on a bony landmark, I know exactly how much pressure is going on.” Hess sees an even split of orthotic and prosthetic patients, providing head-to-toe orthotic treatments and primarily lowerextremity prostheses. Many of his patients have diabetes or arthritis.

Hess responded vigorously to the COVID-19 pandemic, encouraging Franceschi and office staff to work from home. He took advantage of both the Payroll Protection Program and a loan from the Coronavirus Aid, Relief, and Economic Security Act, which “absolutely helped us,” he says. Hess benefits from a solid cadre of referral sources and a network of therapists and former patients who knew his work from past positions. Aside from a company website and social media presence, Hess has not needed to market his services to create the volume he wants. Even so, he has retained someone to call new referral sources and plans to strengthen his internet marketing efforts. Before the pandemic, P&O Designs sponsored a local arthritis walk, and Hess has presented programs to a nearby amputee support group. Hess recognizes the ebb and flow of his business. “I am very busy right now,” he says, “and when I am that busy every single day, I’ll know it’s time to hire another practitioner and more office staff. That would be a good problem!” Meanwhile, Hess, Franceschi, and the administrative staff enjoy their work and have a genuine interest in the wellbeing of their patients. “Our commitment to providing the best care and being honest with our patients is why we’re succeeding,” says Hess. “We treat our patients like family, and we back up what we say. That goes a long way.” Deborah Conn is a contributing writer to O&P Almanac. Reach her at deborahconn@verizon.net.

3D-Printed Custom Insoles have arrived!

Amfit has added 3D -Printing technology to our central fabrication services, using the highest quality of SLS printing materials!

These are the first custom printed F/O’s that meets Amfit’s expectations for function and durability.

Call today for information on how you can provide your customers with the finest 3D-printed functional orthotics on the market!

800-356-3668

Powerful Foot Orthotic Systems | Designed for Professionals orders@amfit.com · AMFIT.COM · @AmfitInc

MEMBER SPOTLIGHT

Naked Prosthetics

By DEBORAH CONN

Function After Finger Loss Washington manufacturer offers choices to individuals with digital amputation

AKED PROSTHETICS, a maker

of functional, customized, body-driven prosthetic fingers, has developed several innovative devices over the years, all designed to restore function after finger amputation. The company’s original prosthesis, the PIP Driver, is designed for amputations just above the proximal interphalangeal joint (or PIP). The prosthesis is controlled by movement in the PIP joint and both restores function and protects the sensitive residual digit. In 2017, Naked Prosthetics released the MCP Driver (Gen 1), created for those with amputations through the proximal phalanx, the bone closest to the metacarpophalangeal joint, or knuckle, which drives the device. “The MCP Driver restores pinch, key, cylindrical, and power grasps,” says Bob Thompson, the company’s CEO. Next came the Thumb Driver, introduced in 2018, which enables users to make opposition grasps. The prosthesis is driven by the carpometacarpal (or CMC) joint, along with the MCP joint in the thumb. Naked Prosthetics’ most recent innovation is a grip lock device to address amputations through or just below the knuckles. Users can position the digit using a surface, such as their thigh or opposing hand, and then release it with a quick tap or by moving it to the full flexion release point. “These have totally changed the lives of people with finger amputations,” says Thompson. “Most digital amputations are the result

APRIL 2021 | O&P ALMANAC

A patient wears his Naked Prosthetics device to work with plants.

COMPANY: Naked Prosthetics OWNER: Privately held LOCATION: Olympia, Washington HISTORY: 10 years

Bob Thompson, CEO

Dulcey Lamotte, chief marketing officer

of construction and industrial accidents, and we can get people back to work, making a living and supporting their families.” All Naked Prosthetics devices are 3D-printed and customized to each user. They can be worn in any combination, making it easy to address the individual needs of each patient. The devices are designed to act like fingers, not look like them, says Dulcey Lamotte, chief marketing officer. Their open design allows the hand to breathe, and they can be cleaned with soap and water. All styles are available in a variety of color options. According to Lamotte, finger amputations receive far too little attention in the prosthetics arena. “Myoelectric arms and hands are big newsmakers, but 94 percent of upper-limb amputations happen at the digital and metacarpal level,” she says. “The degree of impairment in performing ADLs [activities of daily living] after finger amputation is high. According to the American Medical Association, losing the index and middle fingers

midmetacarpal creates a 40 percent impairment of the hand, 36 percent impairment of the upper extremity, and 22 percent impairment of the whole body. If you’re missing four fingers, it’s equivalent to a leg amputation or the loss of an eye in total impairment.” Naked Prosthetics occupies a former lumber storage facility in Olympia, Washington, built in 1920. The 20,000-squarefoot building features areas for production, engineering, administration, marketing, customer care, and clinical activities. The company sells only to prosthetists, but works to educate all members of the hand community: surgeons, rehabilitation centers, hand therapists, physical and occupational therapists, and emergency room doctors. “We want these professionals to reassure amputees that there is something out there to help them,” says Lamotte. “Losing part of a hand can be devastating to people who think they can never return to work. Just knowing we can help them regain function is sometimes literally a lifesaver.” Naked Prosthetics’ clinical team works closely with prosthetists in both evaluating and fitting patients, primarily through Zoom since the pandemic began. “We are here to support them throughout the process,” says Thompson. The company also serves as a billing resource for practitioners. Thompson is confident that the market will grow for digital prosthetics. “This won’t be a niche; there are more finger amputations than below-knee, and I believe that upper-limb prosthetics will approach lowerlimb in dollars spent within 20 years,” he says. “Prosthetists can add an enormous amount to their bottom line just treating a few patients a month.” Deborah Conn is a contributing writer to O&P Almanac. Reach her at deborahconn@verizon.net.

Think outside the shoe® A game changer solution for foot drop The XTERN is the only dynamic AFO for foot drop totally affixed outside the shoe to maximize comfort, prevent skin breakdown and rubbing injuries to the foot. Its flexibility helps keep maximal ankle range of motion and calf muscle strength.

Amazing energy return

No skin contact

Adaptable

Versatile

Lightweight, sleek design

Symmetrical design

Virtual training sessions available during Winter 2021!

Contact training.turbomed@gmail.com for Level 1 and Level 2 availabilities.

PDAC Validated (L1951) USA turbomedusa.com

AOPA NEWS

Webinars

OIN AOPA EXPERTS FOR the most up-to-date information on specific topics

during these one-hour webinars, held the second Wednesday of each month at 1 p.m. ET. One registration is all it takes to provide the most reliable business information and CE credits for your staff at a single office location. Visit www.AOPAnet.org/ education/monthly-webinars for details and registration information.

WEDNESDAY

MAY 10

Policy Updates & Changes: What Are You Missing?

Medicare updates the Local Coverage Determinations (LCDs) and Policy Articles on a regular basis. Are you aware of the most recent changes, and do you know how they may impact your billing and coding? Review the latest updates to the LCDs and Policy Articles, and learn how to locate and identify the changes.

UPCOMING WEBINAR

WEDNESDAY

JUNE 9

Documentation: Working With Your Referral Source

Documentation is key to reimbursement, and missing documentation from your referral sources is often the primary reason for denial. Learn some tips and strategies to ensure you are getting the documentation you require from your referral sources—in a timely manner.

UPCOMING WEBINAR

WEDNESDAY

JULY 14

Prior Authorizations: What We Have Learned, and What You Need To Know

Why are prior authorization requests being denied? Learn the steps you can take to avoid common errors. Access the latest details released by CMS and the durable medical equipment Medicare administrative contractors about the prior authorization process.

UPCOMING WEBINAR

Don’t Sleep on the Latest AOPA Member Resource

RE YOU UTILIZING YOUR AOPA MEMBERSHIP?

Attend the upcoming live tutorial to learn about one of the best resources available for O&P practices, the AOPA Co-OP. A Wikipedia for all things O&P, the Co-OP is a one-stop resource for information about reimbursement, coding, and policy. This searchable database provides up-to-date information on developments in Medicare policy, statespecific legislation, private-payor updates, and more. Members can access detailed information on everything from modifiers to product-specific L codes and associated policies. Register for the next Co-OP Live Tutorial hosted by AOPA Director of Strategic Initiatives Ashlie White, who will

APRIL 2021 | O&P ALMANAC

Co-OP

demonstrate how to use the Co-OP and answer all of your questions. Any employee of an AOPA member firm is welcome to join this free tutorial. Learn more at www.AOPAnet.org/resources/co-op.

Tutorial Webinars Co-OP Live on Friday at Noon ET • May 14 • June 4

• July 2

NEW MEMBERS

Welcome New AOPA Members

New Horizons Orthotics & Prosthetics 5609 1st Avenue, Ste. A-2 Kearney, NE 68847 308/698-0500 Patient-Care Facility Sandi Olsen www.newhorizonsoandp.com

HE 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. Baker Boot, Co. & Orthopedic LLC 211 W. Kansas Avenue Garden City, KS 67846 620/275-4712 Patient-Care Facility Jolene Baker, CFts www.bakerbootco.com

Doctor in the House/dba The Upper Extremity Institute 1515 DeKalb Pike Blue Bell, PA 19422 610/277-1990 Patient-Care Facility Scott Fried, MD www.docinthehouse.com; www.nervepain.com

Tropical Sky Orthotics & Prosthetics 50 W. Oak Street Kissimmee, FL 34741 407/897-2112 Patient-Care Facility Michael Newymyer www.tropicalskyoandp.com

Welcome to AOPA Connection, the one-stop-shop for all things AOPA. Logging into AOPA Connection you will instantly have access to all your AOPA benefits, including: • AOPAversity • Your Membership Record • Your Individual Profile • Event Calendar • Bookstore • Co-OP But, it doesn’t stop there! We are pleased to introduce a new benefit accessible through AOPA Connection, My O&P Community. In this online community of your O&P colleagues you can get guidance, share advice, have one-on-one and group conversations, and access resources.

MyAOPAConnection.org O&P ALMANAC | APRIL 2021

MARKETPLACE

Feature your product or service in Marketplace. Contact Bob Heiman at 856/673-4000 or email bob.rhmedia@comcast.net. Visit bit.ly/AOPAMedia2021 for advertising options.

Allard USA Central Fabrication Allard USA provides fastening solutions with a newly developed line of central fabrication supplies and accessories, keeping your needs in mind. Accessories like chafes, straps, and buckles are made to last. • Nylon, Dacron®, and leather straps available with or without eyelets • Straps have sewn in or heat welded cut lines to stop fraying • Rolls of Velcro® and padded strap material • Multiple lengths and widths • Chafes made to last. Call 888/678-6548 or email info@allardusa.com to receive our Central Fabrication Supplies & Accessories Catalog.

Apis

Apis custom programs offer practitioners best options and services for patient compliance. All products are covered under risk-free guaranteed-fit promise. We stand firmly behind our words. Call us at 1-888/937-2747.

Boston Orthotics & Prosthetics eLearning Center

The ALPS Superior Performance (SP) Prosthetic Gel Liner The ALPS Superior Performance (SP) prosthetic gel liner is ideal for active amputees. The SP liner features a new black fabric that allows for comfort and stability. We make this liner with high-performance fabric, for less vertical stretch and increased control of the prosthesis. We offer our SP liner with high-density (HD) or grip gel. The HD-gel version is ideal for active amputees and patients transitioning from a silicone liner to a gel liner. This liner is notable with its high, circumferential stretch to assist with form fitting. Call us or visit www.easyliner.com for more information.

Becker GEO™ (Gait Evaluation Orthosis) The Becker GEO™ is a prefabricated, carbon composite evaluation orthosis used to assess the benefit of an ankle-foot orthosis on ankle and knee stability. Please contact our customer service department today for more information. Visit BeckerOrthopedic.com.

APRIL 2021 | O&P ALMANAC

Boston Orthotics & Prosthetics eLearning Center is pleased to offer six online courses. You can take advantage of this new training option from anywhere, including your home. With our new eLearning Center, you can stay connected with the most up-to-date technology and techniques with Boston O&P. Students, residents, certified orthotists, physical therapists, and other allied health professionals are welcome to register for our courses. CEUs are provided upon completion of the course. Questions? Contact Jim Wynne, CPO, FAAOP, at jwynne@bostonoandp.com. To gain access to our eLearning courses, simply use the following link: https://www.bostonoandp.com/ for-providers/education-and-training/online-training.

MARKETPLACE A Breakthrough in Functional Prosthetics BrainRobotics is building products that will make a true and lasting difference for millions of people around the world. With the introduction of our revolutionary, yet affordable, technology to the upper-limb prosthetics market, now truly any transradial prosthesis user can explore all the possibilities of what they can do in the world around them. Our award-winning EMG-controlled prosthetic hand mimics the functionality of a human hand with groundbreaking precision through the help of our proprietary electrodes. The goal with our BrainRobotics prosthetic hand is to make it more accessible without sacrificing functionality or innovation. The BrainRobotics hand is due to launch in late spring, 2021. For more information, visit www.brainrobotics.com.

Coyote QUIK GLUE

QUIK GLUE

50 cc or 220 cc Nowavailable available inin Now 30, 60-, 60 & 9090-second second 30-, and set times set times

50 cc or 220 cc Now available in 30-, 60-, and 90-second set times. • Great for attaching componentry • Multiple repair uses • Very quick set with no sag. They ship nonharzardous and are safe with no odor. For more information, contact Coyote at 208/429-0026 or visit www.coyote.us.

LEAP Balance Brace Hersco’s Lower-Extremity Ankle Protection (LEAP) brace is designed to aid stability and proprioception for patients at risk for trips and falls. The LEAP is a short, semirigid anklefoot orthosis that is functionally balanced to support the foot and ankle complex. It is fully lined with a lightweight and cushioning Velcloth interface, and is easily secured and removed with two Velcro straps and a padded tongue. For more information, call 800/301-8275 or visit www.hersco.com.

Naked Prosthetics Naked Prosthetics designs and manufactures high-quality prosthetic devices specifically for finger loss. Our mission is to assist people with digit amputation(s) and positively impact their lives with fully articulating, custom finger prostheses. Our product aims to restore the ability to perform most tasks, supporting job retention and an active lifestyle. Our customers have lost fingers to power tools, equipment malfunctions, injury in the line of military service, random accidents, and infections; in some cases, multiple digits have been lost. NP provides a viable functional prosthesis, as opposed to a passive cosmetic solution. Our design mimics finger motion and utilizes the remainder of an amputee’s digit to power the device. For more information, visit www.npdevices.com.

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 www.wearesp.com. O&P ALMANAC | APRIL 2021

MARKETPLACE EZ-APO Dynamic Carbon Fiber AFO A dynamic, pre-preg carbon fiber AFO (PDAC approved L1932) that was clinically designed and tested in conjunction with leading COs at the Atlanta Prosthetic & Orthotic facility in Atlanta, Georgia. The first and only anterior spiral AFO with tuberosity tibia relief built right in. Ensures noncontact in critical pressure points, does not excessively push out the shoe, structurally reinforced in high stress areas with a trimmable footplate. Has a deep, high-gloss finish. One-year warranty included. Part of our O&P Solidarity Program, which means huge savings to the independent O&P facility. For more information, call 800/922-5155 or visit our website at www.oandp.solutions.

RUSH ROGUE® The PDAC-approved RUSH ROGUE® provides the most realistic and dynamic foot and ankle motion available. The Vertical Loading Pylon (VLP) provides vertical shock relief while offering +/- 8 degrees of torsion, allowing the user to push the foot and themselves to the limits. The RUSH ROGUE is made of our advanced fiberglass composite, which is three times more flexible than conventional prosthetic feet. The roll-through characteristics of the foot provide exceptional energy return with no “dead spot.” The RUSH ROGUE is also available in the EVAQ8 elevated vacuum and H2O models. #goROGUE

Introducing Agilium® Forte Knee OA Brace From Ottobock Meet Agilium Forte, a rigid low-profile, wraparound knee brace designed to provide lasting pain relief for patients with moderate to severe unicompartmental osteoarthritis. Key features: • Patented dynamic Y force strap unloads the knee with a single pull • Lightweight rigid shells for increased stability • Adjustable upright and trimmable sleeves reduce inventory to only three sizes. With the addition of Agilium Forte, Ottobock completes its portfolio of knee braces for OA, which includes the Agilium Vantage, Agilium Reactive, and Agilium Freestep 2.0. Provide your patients less pain and more life with the Agilium Family. For more information, call 800/328-4058 or visit professionals.ottobockus.com.

Myo Plus: The Newsest Advancement in Upper-Limb Prosthetics From Ottobock Myo Plus pattern recognition system represents a new paradigm in the control of a myoelectric prosthesis. Uniting artificial intelligence with the intuitive and innate EMG signals of the user, Myo Plus adapts to their natural movements versus requiring the user to adapt to the system. A sophisticated app provides a unique, patented EMG graphical interface that gives both the clinician and the user a window into the prosthesis. Offering direct, convenient control of the prosthesis without requiring any switching mechanisms and the ability to fine-tune adjustments via the app, the Myo Plus system was designed with both the user and prosthetist in mind. • • • •

Compatible Terminal Devices: bebionic Hand by Ottobock SensorHand Speed MyoHand VariPlus Speed System Electric Greifer DMC VariPlus. For more information, call 800/328-4058 or visit professionals.ottobockus.com.

APRIL 2021 | O&P ALMANAC

MARKETPLACE Spinal Technology Inc.

The Xtern Foot Drop AFO by Turbomed Orthotics

Spinal Technology Inc. is a leading central fabricator of custom spinal and scoliosis orthoses. Our ABC-certified staff orthotists collaborate with our highly skilled, experienced technicians to provide the highest quality products and fastest delivery time, including weekends and holidays, as well as unparalleled customer support in the industry. Spinal Technology is the exclusive manufacturer of the Providence Nocturnal Scoliosis® System, a nocturnal bracing system designed to prevent the progression of scoliosis, and the patented FlexFoamTM spinal orthosis. For information, contact 800/253-7868 or visit www.spinaltech.com.

Think outside the shoe! This one-of-akind orthosis (AFO) is a game changer for foot drop patients: The Xtern is totally affixed outside the shoe to maximize comfort, and prevent skin breakdown and rubbing injuries. Its flexibility promotes maximal ankle range of motion and calf muscle strength. The Xtern allows running, walking, and even mountain hiking as long and as far as you want without any restrictions, and moves from sandals to boots flawlessly. Turbomed’s innovative products are designed in Quebec, Canada, sold in over 26 countries, and distributed by Cascade in the United States. Visit turbomedusa.com to get your life back!

AD INDEX

Advertisers Index Company

Page Phone

Allard USA 3 866/678-6548 ALPS South LLC 19 800/574-5426 Amfit 47 800/356-3668 Amputee Coalition C3 888/267-5669 Apis Footwear Company 21 888/937-2747 Becker Orthopedic 31 800/521-2192 Boston Orthotics & Prosthetics 27 800/262-2235 BrainRobotics 9 617/945-2166 ComfortFit Orthotic Labs Inc. 39 888/523-1600 Coyote 17 800/819-5980 ESP LLC 5 888/WEAR-ESP Ferrier Coupler Inc. 45 810/688-4292 Flo-Tech O&P Systems Inc. 33 800/356-8324 Hersco 1 800/301-8275 Naked Prosthetics 43 888/977-6693 O&P Solutions (formerly Spinal Solutions) 41 800/922-5155 Ottobock C4 800/328-4058 PROTEOR USA 7 855/450-7300 Spinal Technology Inc. 37 800/253-7868 Surestep 28 877/462-0711 The Bremer Group Company 25 800/428-2304 TurboMed Orthotics 13, 49 888/778-8726

Website www.allardusa.com www.easyliner.com www.amfit.com www.amputee-coalition.org www.apisfootwear.com www.beckerorthopedic.com www.bostonoandp.com www.brainrobotics.com www.comfprtfitlabs.com www.coyotedesign.com www.wearesp.com www.ferrier.coupler.com www.1800flo-tech.com www.hersco.com www.npdevices.com www.spinal.solutions www.professionals.ottobockus.com www.proteorusa.com www.spinaltech.com www.surestep.net www.bremergroup.com www.turbomedorthotics.com O&P ALMANAC | APRIL 2021

AOPA NEWS

CAREERS

Opportunities for O&P Professionals

WANTED! A few good businesses for sale.

Job Location Key: - Northeast

Lloyds Capital Inc. has sold over 150 practices in the last 26 years.

- Mid-Atlantic - Southeast - North Central

If you want to sell your business or just need to know its worth, please contact me in confidence.

- Inter-Mountain - Pacific

Hire employees and promote services by placing your classified ad in the O&P Almanac. Include your company logo with your listing free of charge.

Barry Smith Telephone: (O) 323/722-4880 • (C) 213/379-2397 Email: loyds@ix.netcom.com

Refer to www.AOPAnet.org for content deadlines. Ads can be posted and updated any time online on the O&P Job Board at jobs.AOPAnet.org. No orders or cancellations are taken by phone. Send classified ad and payment to: O&P Almanac, Calendar, P.O. Box 34711, Alexandria, VA 22334-0711 or email jburwell@AOPAnet.org 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. O&P Almanac Careers Rates Color Ad Special 1/4 Page ad 1/2 Page ad

Member $482 $634

Nonmember $678 $830

Listing Word Count 50 or less 51-75 76-120 121+

Member $140 $190 $260 $2.25 per word

Nonmember $280 $380 $520 $5 per word

ONLINE: O&P Job Board Rates Visit the only online job board in the industry at jobs.AOPAnet.org. Job Board 50 or less

Member $85

A large number of O&P Almanac readers view the digital issue— If you’re missing out, visit issuu.com/americanoandp to view your trusted source of everything O&P.

Connecting highly qualified O&P talent with career opportunities EMPLOYEE

• Research who is hiring • Apply online for job openings • Free résumé review.

Nonmember $280

For more opportunities, visit: http://jobs.AOPAnet.org. SUBSCRIBE

AOPA’s O&P Career Center

EMPLOYER

• Post your job in front of the most qualified group of O&P professionals • Search anonymous résumé database to find qualified candidates • Manage your posted jobs and applicant activity easily on this user-friendly site.

LOG ON TODAY! https://jobs.AOPAnet.org 56

APRIL 2021 | O&P ALMANAC

AOPA Member Benefit

AOPA’s Co-OP is

THE Compendium of O&P A confluence of coding, billing, and policy information, the AOPA Co-OP provides a cooperative space for collaboration among O&P colleagues. This easily accessible, online resource enables your organization to be successful in today’s everchanging healthcare environment.

Tutorial Webinars Co-OP Live on Friday at Noon ET May 14

June 4

July 2

Resources include: State-specific insurance policy updates L Code search capability Data and evidence resources, and so much more!

DOWNLOAD THE APP!

After creating your Co-OP account, Download to your mobile device at aopanet.atlassian.net.

We ARE AOPA

ADVOCACY | RESEARCH | EDUCATION

Learn more and sign up at www.AOPAnet.org/co-op.

www.AOPAnet.org

CALENDAR

June 1

ABC: Application Deadline for August Written & Simulation Exams. Applications must be received by June 1 for individuals seeking to take the August Written and Simulation certification exams. Contact 703/836-7114, email certification@ABCop.org, or visit ABCop.org/individual-certification.

June 3–5

ABC: Prosthetic Clinical Patient Management (CPM) Exam. ABC Testing Center, Tampa, FL. Contact 703/836-7114, email certification@ABCop.org, or visit ABCop.org/ individual-certification.

June 4

2021 April 20–22, April 27–29

AOPA Virtual Policy Forum. For more information, visit www.AOPAnet.org.

May 1

ABC: Practitioner Residency Completion Deadline for June Written & Simulation Exams. All practitioner candidates have an additional 30 days after the application deadline to complete their residency. Contact 703/836-7114, email certification@ABCop.org, or visit ABCop.org/individual-certification.

May 4–7

47th Academy Annual Meeting & Scientific Symposium. Virtual. For more information, visit www.oandp.org/ page/annual_meeting.

May 12

Policy Updates & Changes: What Are You Missing? 1 PM ET. For more information, visit www.AOPAnet.org. WEBINAR

May 14 WEBINAR

Co-OP Tutorial. Noon ET. For more information, visit www.AOPAnet.org.

May 20–22

ABC: Orthotic Clinical Patient Management (CPM) Exam. ABC Testing Center, Tampa, FL. Contact 703/836-7114, email certification@ABCop.org, or visit ABCop.org/individual-certification.

Co-OP Tutorial. Noon ET. For more information, visit www.AOPAnet.org.

WEBINAR

APRIL 2021 | O&P ALMANAC

June 7–12

ABC: Written and Simulation Certification Exams. ABC certification exams will be administered for orthotists, prosthetists, pedorthists, orthotic fitters, mastectomy fitters, therapeutic shoe fitters, orthotic and prosthetic assistants, and technicians in 350 locations nationwide. Contact 703/836-7114, email certification@ABCop.org, or visit ABCop.org/individual-certification.

June 9

Documentation: Working With Your Referral Source. 1 PM ET. For more information, visit www.AOPAnet.org. WEBINAR

June 25–26

PrimeFare East. Nashville Renaissance Hotel and Conference Center. In-Person Meeting. For more information, contact Cathie Pruitt at 901/359-3936 or email pruittprimecare@gmail.com, or Jane Edwards at 888/388-5243 or email jledwards88@att.net. Visit www.primecareop.com.

July 2 WEBINAR

Co-OP Tutorial. Noon ET. For more information, visit www.AOPAnet.org.

July 14

Prior Authorizations: What Have We Learned and What You Need To Know. 1 PM ET. For more information, visit www.AOPAnet.org. WEBINAR

August 11 WEBINAR

Prosthetics Clinicians Corner. 1 PM ET. For more information, visit www.AOPAnet.org.

CALENDAR

August 13–14

PrimeFare Central. Tulsa Renaissance Hotel and Convention Center. In-Person Meeting. For information, contact Cathie Pruitt at 901/359-3936 or email pruittprimecare@gmail.com, or Jane Edwards at 888/388-5243 or email jledwards88@att.net. Visit www.primecareop.com.

2022 January 9–11

U.S. ISPO Pacific Rim Conference. Waikoloa, Hawaii (Big Island). For more information, visit www.usispo.org.

September TBD WEBINAR

Hanger Live. Dallas, TX.

March 2–5

September 9–11, 16–18

AOPA National Assembly. The 2021 National Assembly will be held in Boston, September 9-11. In addition to the in-person Assembly, we will be offering all the education virtually. This content will be available a week after the Assembly, September 16-18. For more information, visit www.AOPAnet.org.

October 13 WEBINAR

January 30–February 3

AOPA Monthly Webinar. 1 PM ET. For more information, visit www.AOPAnet.org.

AAOP. Atlanta, GA. For more information, visit www.oandp.org/events/event_list.asp?DGPCrSrt=&DGPCrPg=2.

May 18–20

New York State Chapter of American Academy of Orthotists and Prosthetists (NYSAAOP) Meeting. Rivers Casino & Resort. Schenectady, NY. For more information, visit nysaaop.org/meeting.

Orthotic & Prosthetic Innovate Technologies Conference. Minneapolis, MN. For more information, go to http://cecpo.com/documents/OrthoAndProstheticTech_2022_1up.pdf.

November 1–4

ISPO 18th World Congress. Now virtual. For more information, contact the ISPO World Congress team at info@ispo-congress.com or call +49/341-678-8237.

September 29–October 1

November 10 WEBINAR

May 20–21

AOPA Monthly Webinar. 1 PM ET. For more information, visit www.AOPAnet.org.

AOPA National Assembly. San Antonio, TX. For more information, visit www.AOPAnet.org.

December 8 WEBINAR

AOPA Monthly Webinar. 1 PM ET. For more information, visit www.AOPAnet.org.

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O&P ALMANAC | APRIL 2021

STATE BY STATE

Policy and Legislation Updates from Florida, New York, North Carolina, and Oklahoma

Florida

Each month, State by State features news from O&P professionals about the most important state and local issues affecting their businesses and the patients they serve. This section includes information about medical policy updates, fee schedule adjustments, state association announcements, and more. These reports are accurate at press time, but constantly evolve. For up-to-date information about what is happening in your state, visit the Co-OP at www.AOPAnet.org/ resources/co-op.

NEW MEMBER RESOURCE ALERT

AOPA has invested in a new resource that allows us to track legislative and regulatory activity related to O&P in every state. We will be updating the state pages on the AOPA Co-OP with alerts as they arise.

APRIL 2021 | O&P ALMANAC

The International Institute of Orthotics and Prosthetics has secured the introduction of state legislation H 3503: “An act relating to the Appropriations Project titled International Institute of Orthotics and Prosthetics Sustainable Expansion.” AOPA is exploring opportunities for the introduction of similar legislation to support O&P schools across the United States.

New York

More than 275 letters have been sent through AOPA’s advocacy portal in support of O&P providers in New York and Assemblywoman Aileen Gunther’s (D, District 100) sign-on letter seeking a Medicaid fee schedule increase for O&P in the state. Also in New York, lawmakers recently introduced two pieces of legislation related to O&P. State Sen. Robert G. Ortt (R, District 62) introduced an Insurance Fairness Bill, S 3649. In addition, advocates have introduced a coverage bill for services and devices, including orthoses, for patients diagnosed with lymphedema (S 04867). Both pieces of legislation have companion bills in the Assembly. For timely updates regarding any of these efforts, visit the New York state page on the AOPA Co-OP.

Become an AOPA State Rep.

If you are interested in participating in the AOPA State Reps network, email awhite@AOPAnet.org.

North Carolina

AOPA and staff from the American Board for Certification in Orthotics, Prosthetics, and Pedorthics have been working with the Division of Health Benefits, Pharmacy, & Ancillary Services at the North Carolina Department of Health and Human Services to provide input for a policy review of the North Carolina Medicaid 5B Orthotics and Prosthetics Policy. O&P providers in North Carolina should expect a new policy to be published in the coming months.

Oklahoma

Legislation has been introduced, in accordance with the provisions in Oklahoma’s Sunset Law, that would recreate the Advisory Committee on Orthotics and Prosthetics under the State Board of Medical Licensure and Supervision. The proposed legislation includes details on the number of voting members and the duties of the committee. For additional information, visit the Oklahoma page of the AOPA Co-OP. Submit Your State News To submit an update for publication in the State by State department of O&P Almanac, email awhite@AOPAnet.org.

We are the National Limb Loss Resource Center® Where can you turn when you have questions about limb loss and limb difference?

At the National Limb Loss Resource Center®, we provide comprehensive information and resources free of charge to individuals. All of the information that we provide is reviewed by the Coalition’s medical/scientific advisory committee of experts in the field of limb loss, so you can count on the accuracy of the information.

Talk With an Information and Referral Specialist Our knowledgeable resource team is the place to turn when you have questions about your rights, resources, etc. You can reach them by calling toll-free 888-267-5669, emailing us at rc@amputee-coalition.org, or by visiting our website at amputee-coalition.org.

Browse Our Resources The Amputee Coalition has developed reliable resources to help answer your questions about living with limb loss and limb difference. Through our website, amputee-coalition.org, you can browse our entire collection of resources which includes fact sheets, videos, webinars, publications and articles covering a wide range of topics.

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April 2021 O&P Almanac

Articles inside

State By State

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Member Spotlight

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Welcome New Members

PRINCIPAL INVESTIGATOR

Views From AOPA Leadership

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AOPA News

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