October 2018 O&P Almanac by AOPA

The Magazine for the Orthotics & Prosthetics Profession

O CTO B E R 2018

Setting Your Participation Status P.20

Underwater Research With Wounded Warriors P.38

Ready, Set,

Startup

TIPS FOR BRINGING NEW PRODUCTS TO MARKET

P.28

Leveraging Efficacy Trials To Improve Prosthetic Interventions P.44

Reducing Errors on Dispensing Orders and DWOs P.48

This Just In: The True Cost of Providing Veterans With Advanced Technologies P.24

E! QU IZ M EARN

BUSINESS CE

WWW.AOPANET.ORG

CREDITS P.22, 50

YOUR CONNECTION TO

EVERYTHING O&P

AOPA Coding Experts Are Coming to

Las Vegas

November 12-13

ATLANTA

FEB. 26-27 | 2018

AOPA MASTERING MEDICARE:

ESSENTIAL CODING & BILLING TECHNIQUES SEMINAR Join AOPA November 12-13 in Las Vegas to advance your O&P practitioners’ and billing staff ’s coding knowledge. Join AOPA for this two-day event, where you will earn 14 CEs and get up-to-date on all the hot topics.

EARN 14 CEs

AOPA experts provide the most up-todate information to help O&P practitioners and office billing staff learn how to code complex devices, including repairs and adjustments, through interactive discussions with AOPA experts, your colleagues, and much more. Meant for both practitioners and office staff, this advanced two-day event will feature breakout sessions for these two groups, to ensure concentration on material appropriate to each group.

Don’t miss the opportunity to experience two jam-packed days of valuable O&P coding and billing information. Learn more at bit.ly/2018billing.

The Tropicana Las Vegas 3801 S Las Vegas Blvd Las Vegas, NV 89109 Book your hotel by October 24 Individuals can book online through bit.ly/codingvegas.

Top 10 reasons to attend: 1.

Get your claims paid.

Increase your company’s bottom line.

Stay up-to-date on billing Medicare.

Code complex devices

Earn 14 CE credits.

Learn about audit updates.

Overturn denials.

Submit your specific questions ahead of time.

Advance your career.

10. AOPA coding and billing experts have more than 70 years of combined experience. Find the best practices to help you manage your business.

Participate in the 2018 Coding & Billing Seminar!

For more information, email Ryan Gleeson at rgleeson@AOPAnet.org. .

www.AOPAnet.org

contents

OCTOB E R 2018 | VOL. 67, NO. 10

28 | Ready, Set Startup Traditional manufacturing companies continue to roll out new orthotic and prosthetic technologies—but individual O&P innovators and startups are making their marks as well. Find out how creative clinicians and researchers have developed new products to fill a void or meet patients’ particular needs, learn tips for bringing new devices to the marketplace, and find out about company acquisitions and partnership opportunities. By Christine Umbrell

24 | This Just In

A new report from the U.S. Department of Veterans Affairs (VA) details overpayments for prostheses—but the numbers don’t tell the whole story. AOPA is working to educate the VA and policymakers regarding problems with the coding and product verification processes, as well as the adverse impact these problems can have on new product development.

OCTOBER 2018 | O&P ALMANAC

PHOTO: Idee Belau/CWVC

Veteran Access to Advanced Technology

PHOTO: Ottobock

COVER STORY

FEATURES

38 | Diving Into O&P Research Researchers at the University of Hartford have partnered with the Combat Wounded Veteran Challenge to study wounded warriors with amputations as they take part in an annual Scuba Challenge in Florida. The unique underwater setting enables the researchers to dive alongside their subjects and collect data to improve the design of underwater prostheses and aid individuals with limb loss in their recreational pursuits. By Christine Umbrell

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contents

PRINCIPAL INVESTIGATOR

DEPARTMENTS Views From AOPA Leadership......... 6

Jason Kahle, MSMS, CPO, LPO.............................................................................44

Mitchell Dobson, CPO, FAAOP, urges adherence to a company compliance plan

Meet a researcher who has devoted much of his career to performing efficacy trials and proving that O&P intervention benefits individuals living with limb loss.

AOPA Contacts.......................................... 8 How to reach staff

Numbers...................................................... 10 At-a-glance statistics and data

Happenings................................................12

COLUMNS

Research, updates, and industry news

Reimbursement Page........................ 20

Gearing Up for 2019

Is it time to change your Medicare participation status? CE Opportunity to earn up to two CE credits by taking the online quiz.

CREDITS

Compliance Corner.............................. 48

Points of Order

P.16

Tips for accurate dispensing orders and detailed written orders

People & Places........................................19 Transitions in the profession

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

CREDITS

AOPA News...............................................56

Member Spotlight................................. 52 n

Priority Footwear

Spinal Technology

P.20

AOPA meetings, announcements, member benefits, and more

PAC Update............................................... 57 Welcome New Members................... 57 Careers.........................................................58 Professional opportunities

Marketplace............................................. 60 Calendar..................................................... 62 Upcoming meetings and events

Ad Index......................................................63 Ask AOPA.................................................. 64 P.52

OCTOBER 2018 | O&P ALMANAC

P.54

When and how to use the new Medicare ID cards

Boo! New products around every corner

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VIEWS FROM AOPA LEADERSHIP

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

MBER 4-10, 2 VE 0

The Importance of a Compliance Plan

Mitchell Dobson, CPO, FAAOP, is a member of AOPA’s Board of Directors.

OCTOBER 2018 | O&P ALMANAC

ce me

a Aw

RECENTLY CAME ACROSS AN old map of the area where I live and was taken CORPORATE COMPLIANCE aback by the thought of the last time I used & ETHICS WEEK a paper map to get where I was going. In this age of GPS, we often rely on “turn-by-turn” ne ss , or directions. There is nothing inherently wrong inf Re c o g n i t i on , R e with that, but we lose a bit of the big picture when we travel by GPS. If you were to liken your business operations to a journey, it seems to me that operating an O&P business can cause you to focus more on the turn that is right ahead of you, instead of focusing on understanding the regulatory or government enforcement landscapes that are in play. Continuing this illustration, your policy and procedure manual could be viewed as your GPS. It would give you step-bystep directions on how to execute on great clinical service, outcomes, claims submission, payment, and appeal efforts. In contrast, a good compliance plan could be likened to a road map, which shows you the pitfalls and areas of risk that often lie outside the view of your headlights. A compliance plan should reflect and build upon the efforts you have already undertaken. If you manage your business well, a compliance plan should not be arduous to create or implement. It should be complementary to your workflow and processes. While it should be based in the government’s guidance, it also should be a living document, changing to reflect the constant fluctuations in the O&P business and regulatory environment. Maybe you don’t have a functioning compliance plan. Let me encourage you to spend time developing yours. It can tangibly assist during an external investigation of your business by the government—an ever-increasing risk. Many enforcement organizations will include a request of your compliance plan in any investigation they may perform. Not having one could be detrimental. AOPA has great resources to assist you in creating and implementing a solid O&P-based compliance plan. Additionally, AOPA will be partnering with the Health-Care Compliance Association (HCCA) again this year to promote Health-Care Compliance and Ethics week, November 4-10. This might be a great time to release or promote your compliance plan. The “road map” of your compliance plan will help you get where you are going. And unlike those pesky maps, you won’t even have to worry about trying to fold it back up when you are done.

Board of Directors OFFICERS President Jim Weber, MBA Prosthetic & Orthotic Care Inc., St. Louis, MO President-Elect Chris Nolan Ottobock, Austin, TX Vice President Jeffrey Lutz, CPO Hanger Clinic, Lafayette, LA Immediate Past President Michael Oros, CPO, FAAOP Scheck and Siress O&P Inc., Oakbrook Terrace, IL Treasurer Jeff Collins, CPA Cascade Orthopedic Supply Inc., Chico, CA Executive Director/Secretary Thomas F. Fise, JD AOPA, Alexandria, VA DIRECTORS David A. Boone, MPH, PhD, BSPO Orthocare Innovations LLC, Edmonds, WA Jeffrey M. Brandt, CPO Ability Prosthetics & Orthotics Inc., Exton, PA Mitchell Dobson, CPO, FAAOP Hanger Clinic, Grain Valley, MO Traci Dralle, CFM Fillauer Companies, Chattanooga, TN Teri Kuffel, JD Arise Orthotics & Prosthetics Inc., Blaine, MN Dave McGill Össur Americas, Foothill Ranch, CA Rick Riley Thuasne USA, Bakersfield, CA Brad Ruhl Ottobock, Austin, 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 Thomas F. Fise, JD 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.

Printing Sheridan

EXECUTIVE OFFICES

REIMBURSEMENT SERVICES

SUBSCRIBE O&P Almanac (ISSN: 1061-4621) is published monthly by the American Orthotic & Prosthetic Association, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314. To subscribe, contact 571/431-0876, fax 571/431-0899, or email ymazur@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.

Thomas F. Fise, JD, executive director, 571/431-0802, tfise@AOPAnet.org

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

ADDRESS CHANGES POSTMASTER: Send address changes to: O&P Almanac, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314.

Devon Bernard, assistant director of coding and reimbursement services, education, and programming, 571/431-0854, dbernard@AOPAnet.org

Copyright © 2018 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.

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.

Tina Carlson, CMP, chief operating officer, 571/431-0808, tcarlson@AOPAnet.org MEMBERSHIP & MEETINGS Kelly O’Neill, CEM, manager of membership and meetings, 571/431-0852, kelly.oneill@AOPAnet.org

SPECIAL PROJECTS

Betty Leppin, manager of member services and operations, 571/431-0810, bleppin@AOPAnet.org

Ashlie White, MA, manager of advocacy, outreach, and special projects 571/431-0812, awhite@AOPAnet.org

Yelena Mazur, communications specialist, 571/431-0835, ymazur@AOPAnet.org

O&P ALMANAC

Ryan Gleeson, CMP, assistant manager of meetings, 571/431-0836, rgleeson@AOPAnet.org

Thomas F. Fise, JD, publisher, 571/431-0802, tfise@AOPAnet.org

Kristen Bean, membership and meetings coordinator, 571/431-0876, kbean@AOPAnet.org

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AOPA Bookstore: 571/431-0876

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Design & Production Marinoff Design LLC

OCTOBER 2018 | O&P ALMANAC

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 11,800 subscribers. Engage the profession today. Contact Bob Heiman at 856/673-4000 or email bob.rhmedia@comcast.net. Visit bit.ly/almanac18 for advertising options!

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NUMBERS

Consumers Seek Greater Transparency Research sheds light on patients’ priorities and pain points relating to their health-care expenses

SURPRISES REGARDING BILLS THOUGHT TO BE COVERED BY INSURANCE

29 Percent 28 Percent 25 Percent Understanding basic medical costs

PERCENT

Received unexpected bills for physician services

Received unexpected bills for laboratory tests

Prefer digital solutions when checking health information

PERCENT

Received unexpected bills for hospital or health-care facility charges

68 Percent

Received unexpected bills for prescription drugs

PERCENT

69 Percent

Prefer digital solutions when shopping for a health plan

Consumers Express Concerns Over Health-Care Expenses Percent Concerned About General Expenses

Health insurance/health care Routine medical expenses

46% 34%

Percent Concerned About Nonroutine Expenses Catastrophic expenses Long-term care expenses End-of-life care expenses Chronic condition care expenses SOURCE: “Health-Care Consumerism 2018: An Update on the Journey,” McKinsey & Co.

OCTOBER 2018 | O&P ALMANAC

Comprehending their medical bills

PREFERENCE OF DIGITAL OPTIONS OVER PHONE OR IN-PERSON SOLUTIONS

PERCENT

Determining whether a treatment will be covered

51%

“Health insurers and providers have an opportunity to better inform patients about the potential cost of care. Consumers who can understand both the total cost of care and the fraction of those costs they will be responsible for are in a better position to decide what types of care they need and which health plans would best provide the needed coverage.”

49% 41% 41%

—“Health-Care Consumerism 2018: An Update on the Journey,” McKinsey & Co.

SOURCES: “2017 Consumer Health Insights Survey,” “Health-Care Consumerism 2018: An Update on the Journey,” McKinsey & Co.; 2018 Survey from University of Chicago’s NORC Research Institute

SOURCES OF FRUSTRATION

O&P professionals seeking to better understand their patients’ cost concerns can look to recent health-care consumer research. Studies from McKinsey and Co. and University of Chicago’s NORC Research Institute, conducted among consumers with individual insurance, demonstrate that health-care consumers continue to be concerned with rising costs and confusing bills. Given this information, O&P facilities should seek to provide accurate and transparent pricing and insurance reimbursement information.

Happenings RESEARCH ROUNDUP

Studies Signal Progress in Paralysis Therapies Researchers from the University of Louisville have developed an experimental combination therapy that has enabled several people with spinal cord injuries to stand, take steps, and—in two cases—walk without assistance. The treatment involves epidural stimulation of the spinal cord via a medical device implanted below the site of the injury, used in conjunction with locomotor training, which aims to retrain the spinal cord to “remember” the pattern of walking by repetitively practicing standing and stepping. The researchers worked with four study participants who were living with traumatic, motor complete spinal cord injury. After being treated with epidural stimulation paired with daily locomotor training, all four study subjects achieved trunk stability when using the stimulation and maintaining their mental focus, and two achieved over-ground walking. “This research demonstrates that some brain-to-spine connectivity may be restored years after a spinal cord injury as these participants living with motor complete paralysis

were able to walk, stand, regain trunk mobility, and recover a number of motor functions without physical assistance when using the epidural stimulator and maintaining focus to take steps,” said Susan Harkema, PhD, associate scientific director of the Kentucky Spinal Cord Injury Research Center at the University of Louisville. “The basis of this work is that the spinal circuitry is sophisticated and really has the same properties that the brain does in many ways, and in the context of this study, really what is shown is it has the capability of relearning to walk in the right conditions.” The researchers published their study in a recent issue of New England Journal of Medicine. They plan to conduct further clinical research with larger cohorts. In a related study, researchers at the Mayo Clinic have reported that one patient with spinal cord injury was able to take steps and walk with trainer assistance after epidural electrical stimulation and intensive physical therapy. That study has been published in Nature Medicine.

Amputees can be convinced that their prosthetic hand belongs to their own body, according to researchers participating in a scientific collaboration led by the Ecole Polytechnique Federale de Lausanne (EPFL) in

OCTOBER 2018 | O&P ALMANAC

Switzerland. The scientists led a study that combined virtual reality (VR) and artificial tactile sensations to “trick the amputee’s brain into feeling what it sees, inducing embodiment of the prosthetic hand with an additional effect that the phantom limb grows into the prosthetic one,” according to Giulio Rognini, PhD, of EPFL’s Laboratory of Cognitive Neuroprosthetics. The scientists worked with two study participants who completed an experiment requiring the patients to passively observe two sensations on the fingertip. The researchers provided artificial tactile sensations at the tip of the phantom limb’s index finger by stimulating the patient’s nerve in the residual limb. The

patients wore VR gloves that showed the index finger of the prosthesis glowing in synchrony with the administered touch sensations. These activities enabled the study participants to feel as though the prosthetic hand belonged to their own body, according to the researchers. Both patients also reported feeling as though their phantom limb had extended into the prosthetic limb. The VR setup developed at EPFL is portable, and the researchers have suggested leveraging the technology as a therapy to help patients embody their prosthetic limb permanently. Details of the approach were described in the Journal of Neurology, Neurosurgery, and Psychiatry.

PHOTO: Copyright: Scuole Superiore Sant’Anna / Luca Rossini - Rossini Photography

Researchers Leverage VR To Aid in Prosthetic Hand Acceptance

HAPPENINGS

FASTK2 Study Demonstrates Value of Microprocessor Knees for Limited Community Ambulators A new study focusing on transfemoral amputees classified as limited community ambulators demonstrates that use of microprocessor-controlled prosthetic knees in this population results in fewer falls, increased activity, and greater satisfaction. The study, “Functional Assessment and Satisfaction of Transfemoral Amputees With Low Mobility (FASTK2): A Clinical Trial of Microprocessor-Controlled Versus Nonmicroprocessor-Controlled Knees,” led by Kenton R. Kaufman, PhD, PE, Kathie A. Bernhardt, and Kevin Symms, CO, BOCPO, has been published in Clinical Biomechanics. The findings of the study, which was partially funded by AOPA as part of the Prosthetics 2020 initiative, indicate that, despite current medical policy restricting access to microprocessor-controlled knees to unlimited community ambulators, the technology

may offer benefits to those amputees with some mobility challenges. The study was performed in collaboration with Hanger Clinic and involved studying 50 experienced above-knee amputees, most of whom were classified as Level K2 ambulators by their prosthetists. All study participants were at least 55 years old, had previously used only nonmicroprocessor-controlled knees, and were able to ambulate without a gait aid. At the outset of the study, the participants were tested using their nonmicroprocessor-controlled knee, then fit with a microprocessorcontrolled knee and allowed 10 weeks of acclimation before being assessed as to their function in the free-living environment using triaxial accelerometers. They also were evaluated four weeks later, after switching back to their nonmicroprocessor knees. The transfemoral amputees, who

had a mean age of 69, demonstrated improved outcomes when using the microprocessor-controlled knee, experiencing a significant reduction in falls, less time sitting, and increased activity levels. “The increased activity resulted in a greater exposure to fall risk, but that risk was moderated by the advanced technology,” according to the researchers. Subjects also reported improved ambulation and appearance, as well as greater utility, using the microprocessor-controlled prostheses. FAST FACTS

JNER Publishes O&P-Themed Edition AOPA has partnered with the Journal of Neuroengineering and Rehabilitation (JNER) in publishing “Advancements in Prosthetics and Orthotics: Selected Articles From the Second World Congress Hosted by AOPA,” a supplement to the journal. During last year’s AOPA World Congress, several papers were identified for possible inclusion in the supplement, which was co-funded by AOPA and the American Board for Certification in Orthotics, Prosthetics, and Pedorthics. The authors of those high-quality papers were invited to submit their full manuscripts to JNER for rigorous peer review and consideration for inclusion in the special edition. The goal of the O&P-themed

publication is to afford the scientific and clinical communities the opportunity to take a “deeper dive” into the detail of the top presentations at the World Congress. Seven articles are included in the supplement, which was edited by M. Jason Highsmith, PT, PhD, CP, FAAOP; Michael Orendurff, PhD; and Andreas Kannenberg, MD. Topics in the supplement range from exercise testing and cardiovascular events in patients with limb loss, to gait assessment and novel therapies, such as use of a virtual environment during rehabilitation. Economic evaluations for O&P devices also are addressed. Visit bit.ly/AdvancementsinOP to view the supplement.

Prosthetics Sales Account for Greatest Portion of Gross Sales at O&P Facilities Percent of Gross Sales/Billings by Category

Durable Medical Equipment Pedorthics

Other

4% 3%

40%

Orthotics

49% Prosthetics

Source: “2018 AOPA Operating Performance Report,” AOPA.

O&P ALMANAC | OCTOBER 2018

HAPPENINGS

LEGAL UPDATE

Congress Reaches Agreement on Opioid Legislation The U.S. House of Representatives and Senate have reached an agreement on measures to address the opioid epidemic. Approximately 72,000 people died of drug-related overdoses in the United States between March 2017 and March 2018, according to the U.S. Centers for Disease Control (CDC)—a 5.1 percent increase over the preceding year. Following the June passage of a bill in the House, the Senate passed the Opioid Crisis Response Act of 2018 in August, authored by Sen. Lamar Alexander (R-Tennessee). The House and Senate announced on September 26 that both bodies had

approved a 653-page compromise bill. Provisions in the final bill would require the U.S. Postal Service to take additional measures to prevent the flow of drugs illegally imported by mail; allow more nurses to prescribe medication for opioid addiction; and make it easier for Medicaid recipients to access inpatient care for substance abuse, among other provisions. Members of Congress were awaiting a final vote as of publication. The White House praised the pending legislation as a “whole-of-government” approach to combating the opioid crisis, and it is expected that President Donald Trump will sign the bill into law.

PATIENT REGISTRY

National Repository Will Collect and Store Information on Individuals With Limb Loss

OCTOBER 2018 | O&P ALMANAC

Development (NICHD). “The information housed in this database will be vital to preventing limb loss, improving amputation surgeries, refining rehabilitation approaches, and guiding the development of devices for people with limb loss.” NICHD has awarded a five-year contract, capped at $5 million, to the Mayo Clinic to develop and launch the registry. Registry data will include electronic health records of U.S. adults and children. Researchers studying diseases and conditions that can contribute to limb loss, such as vascular disease and diabetes, will have access to the registry, according to Cernich. Researchers will be able to sort the data by age, gender, and type of limb loss, according to NIH.

DoD will be involved in development of the registry in an effort to improve the quality of care for active military personnel, veterans, and civilian members of the population. “The joint effort between federal agencies allows us to collect data that will inform research and improve the lives of all citizens coping with limb loss,” Cernich said.

PHOTO: Getty Images

The National Institutes of Health (NIH) and the Department of Defense (DoD) have partnered to develop a Limb Loss and Preservation Registry. Debuting in 2020, the registry is being designed to establish the number of people in the United States living with limb loss and provide insight on their challenges and needs. The goal is to collect data that will improve prevention, treatment, and rehabilitation efforts for the O&P patient population, according to NIH. “The Limb Loss and Preservation Registry addresses a significant public health knowledge gap,” said Alison Cernich, PhD, director of the National Center for Medical Rehabilitation Research within NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human

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HAPPENINGS

AMPUTEE ATHLETICS

Athletes Compete at World Para Athletics European Championships

Louisville Community Takes Part in First Stride Training and Clinic

The Center for Orthotic & Prosthetic Care recently hosted an OPAF First Stride Training and Clinic for facility patients, their referral sources, and the community in Louisville, Kentucky. The event was held at Norton’s Orthopaedic and Hand Center and led by First Stride instructor Jim Scharf, PTA.

OCTOBER 2018 | O&P ALMANAC

Approximately 700 athletes from 35 countries recently took part in the 2018 World Para Athletics European Championships, a track-and-field competition for athletes with a disability, open to countries within Europe affiliated with the International Paralympic Committee. Ten medals were awarded to members of Team Össur over the course of the seven-day competition, held August 20-26 in Berlin, Germany. Paralympian Marie-Amélie Le Fur made history as the first parathletic woman to perform a long jump greater than 6 meters, while Paralympian Markus Rehm set a new world record in the men’s long jump T64, with a distance of 8.48 meters. Both Le Fur and Rehm are Össur Ambassadors and Paralympic athletes. Other winning performances from Team Össur members included double Gold-medalist Daniel Wagner, who won both the men’s 100-meter T63 sprint and men’s long jump T63, and bilateral amputee runner and multiple-time Paralympian Richard Whitehead, who took Gold in the men’s 200-meter T61.

Marie-Amélie Le Fur became the first parathletic woman to perform a long jump greater than 6 meters. In addition, Helgi Sveinsson took Bronze for his performance in men’s javelin F64, and Jean-Baptiste Alaize was the Bronze medalist in men’s long jump T64. Stef Reid also took Bronze in the women’s long jump T64. “We congratulate all of the athletes for their extraordinary performance during the European IPC championships,” said Jon Sigurdsson, Össur president and chief executive officer.

PHOTOS: Courtesy of Össur

PHOTOS: Center for Orthotic & Prosthetic Care

More than 25 therapists, practitioners, and patients attended the morning session, focusing on outcomes measures and how they relate to introduction to gait training for the lower-limb amputee. The three-hour classroom education session, which provided CEUs for both therapists and practitioners, covered prosthetic componentry as well as proprioception. During the afternoon session, several lower-limb amputees participated in a series of exercises and demonstrations to improve walking as well as balance and core strength. Patients were given handouts of exercises to do at home to improve their walking and activity level.

Markus Rehm set a record in the men's long jump T64.

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HAPPENINGS

COMMUNICATION STATION

O&P News Goes Digital AOPA has created an online presentation and platform for O&P News, whose mission is to educate and inform health professionals who serve the greater limb loss community and those living with mobility challenges. The new platform features an efficient website and click-ready flipbook. As of September 2018, O&P News is longer available via print edition but may be accessed via digital access across all device platforms. Advertisers continue to express interest in an integrated advertising approach of print and digital ads. This can now be accomplished through the print platform of O&P Almanac and the digital platform of O&P News. Advertisers should contact Bob Heiman at 856/6734000 or bob.rhmedia@comcast. net to secure a placement. Visit bit.ly/OPNSubscribe to sign up for a digital subscription.

Subscribe Today! FAST FACTS

U.S. Diabetes Incidence Rates A significant portion of American adults have either diagnosed or undiagnosed diabetes: SOURCE: CDC Annual Report, 2017.

OCTOBER 2018 | O&P ALMANAC

CODING CORNER

Jurisdiction D Releases Quarterly TPE Results Noridian, the durable medical equipment Medicare administrative contractor (DME MAC) for Jurisdiction D, published quarterly results of its Target, Probe, and Educate (TPE) audits for therapeutic shoes for persons with diabetes. The audit results, based on claims for code A5500 reviewed between April and June 2018, show an overall claim potential improper payment rate of 33 percent. The top denial reasons for the TPE results during this period included the following: • Documentation does not support basic coverage criteria. • Detailed written order (DWO) was not received. • Documentation was not received in response to the additional documentation request (ADR) letter. • Medical record documentation was not received. Noridian also published quarterly results of the TPE program for some orthotic claims audited or reviewed during the April to June 2018 timeframe, with the following results: • Ankle-foot orthoses/knee-anklefoot orthoses (L4360, L4361, L4386, and L4387) had an overall claim potential improper payment rate of 34 percent. This was an

increase over the previous quarter’s overall claim potential improper payment rate of 19 percent. • Knee orthoses (L1810, L1812, L1830, L1832, L1833, L1843, L1845, and L1852) had an overall claim potential improper payment rate of 57 percent. This was a decrease from the previous quarter’s overall claim potential improper payment rate of 77 percent. • Spinal orthoses (L0625, L0626, L0627, L0630, L0631, L0637, L0641, L0642, L0643, L0648, and L0650) had an overall claim potential improper payment rate of 51 percent. This was an increase over the previous quarter’s overall claim potential improper payment rate of 34 percent. Common denial reasons for TPE results included the following: • Documentation does not support basic coverage criteria. • DWO is incomplete or missing elements. • Documentation was not received in response to the ADR letter. • Claim is the same or similar to another claim on file. • Documentation does not include verification that the equipment was lost, stolen, or irreparably damaged in a specific incident.

4% 17%

Ages 18-44

Ages 45-64

25%

Ages 65 and Older

PEOPLE & PLACES PROFESSIONALS ANNOUNCEMENTS AND TRANSITIONS

Marlies Beerli Cabell, CPO, a clinician at Ability Prosthetics & Orthotics, has been named to “Leading Women 2018” by the Daily Record in Baltimore, Maryland. The honor recognizes women 40 and under who have made tremendous accomplishments in their careers. Nominees were judged on professional experience, community involvement, and a commitment to inspiring change.

2018 AOPA Coding Products Get your facility up to speed, fast, on all of the O&P Health-Care Common Procedure Coding System (HCPCS) code changes with an array of 2018 AOPA coding products. Ensure each member of your staff has a 2018 Quick Coder, a durable, easy-to-store desk reference of all of the O&P HCPCS codes and descriptors. • 2018 Coding Suite (includes CodingPro single user, Illustrated Guide, and Quick Coder): $350 AOPA members, $895 nonmembers • 2018 CodingPro CD-ROM (single-user version): $185 AOPA members, $425 nonmembers • 2018 CodingPro CD-ROM (network version): $435 AOPA members, $695 nonmembers • 2018 Illustrated Guide: $185 AOPA members, $425 nonmembers

OPGA President Todd Eagen presents Karen Edwards with the 2018 O&P Woman of the Year award. Karen Edwards has been selected as the O&P Woman of the Year, awarded by Orthotic Prosthetic Group of America (OPGA) during the company’s member and supplier reception at the Vancouver Convention Center during the 2018 AOPA National Assembly. Edwards, who is director of the Össur Women’s Leadership Initiative (ÖWLI) and a senior area manager with Össur in Arizona and Utah, was one of four finalists for the award. She has been involved in the O&P profession for more than 12 years, and has overseen ÖWLI since its inception in 2014. “I am honored and thrilled to win this award,” said Edwards. “To me, this award validates that advocating for women and gender equality is meaningful and important to all of us, and that what we do in the Össur Women’s Leadership Initiative matters to the profession.” The award was developed by OPGA, a division of VGM Group Inc., and was open to all women who work in the O&P industry. A selection committee of five industry professionals reviewed the 27 nominations and selected the finalists by considering the nominees’ contributions throughout their careers to patients, community, and the profession.

• 2018 Quick Coder: $30 AOPA members, $80 nonmembers. Order at www.AOPAnet.org or call AOPA at 571/431-0876.

THE LIGHTER SIDE

O&P ALMANAC | OCTOBER 2018

REIMBURSEMENT PAGE

By JOSEPH MCTERNAN

Gearing Up for 2019 Preparing for a new calendar year, with Medicare participation changes and gift-giving in mind

E! QU IZ M EARN

BUSINESS CE

CREDITS P.22

S WE APPROACH THE end of 2018,

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 22 to take the Reimbursement Page quiz. Receive a score of at least 80 percent, and AOPA will transmit the information to the certifying boards.

CREDITS

it is natural to start thinking about what 2019 will bring. New Health-Care Common Procedure Coding System (HCPCS) codes, fee schedule increases or decreases, closing out outstanding accounts, and other housekeeping matters may be on your mind as you prepare your business for a new year. In addition to looking ahead, now is the time to review your Medicare participation status for 2019 and consider whether making any changes might benefit your business. It also is the start of the holiday season, and you may be considering providing gifts to some of your most loyal and longtime patients and regular referral sources. This month’s Reimbursement Page offers a quick primer on Medicare participation and the rules for providing acceptable gifts to Medicare beneficiaries and referral sources.

Which Participation Status Is Best for Your Business?

Participation status with Medicare is valid for one year and can only be changed during the open enrollment period. At the start of each open enrollment period, typically around mid-November, the National Supplier Clearinghouse (NSC) will send all Medicare-enrolled suppliers a letter reminding them of their current participation status. The letter also will inform 20

OCTOBER 2018 | O&P ALMANAC

Participation status with Medicare is valid for one year and can only be changed during the open enrollment period.

suppliers that if they wish to change their current participation status, they must do so before December 31, the close of the open enrollment period. If your organization has a current participation agreement in effect for 2018 and you wish to be nonparticipating for 2019, you must submit written notice to NSC explaining that you no longer wish to be a participating provider. There is no standard form for this written notice; you must simply write

REIMBURSEMENT PAGE

a letter informing NSC of your desire to change your participation status. The letter must be printed on your official company letterhead and signed by one of your company’s authorized representatives. The authorized representative must be the same person who is on file with NSC as an authorized individual—most likely a chief executive officer, chief financial officer, president, or board member. If you are unsure who is on file as the authorized individual for your company, review your most recent Medicare enrollment application, the CMS 855S form; authorized officials are listed in section 15. The letter must be received by NSC no later than Dec. 31, 2018. The letter may not be postmarked by December 31 and arrive at a later date—it must arrive on or before the end of the year. Be sure to factor in mailing time, and consider setting an artificial deadline of a week earlier to allow for mailing time. Send the letter to the following address: National Supplier Clearinghouse P.O. Box 100142 Columbia, SC 29202-3142 If your company is currently enrolled as a nonparticipating provider and you wish to change your company’s status to participating, the process is a bit more formal. Your company must complete an official Medicare Participation Agreement for 2019, or the CMS 460 form, a copy of which can be found at www.cms.gov/Medicare/CMS-Forms/ CMS-Forms/downloads/cms460.pdf.

The CMS 460 form is only one page in length and simple to fill out. While anyone may fill out the form, it must be signed by an authorized individual. The completed form also must be received by Dec. 31, 2018, and if it is not received by then, your participation status will remain nonparticipating for 2019. If you are satisfied with your current Medicare participation status and do not wish to make any changes for 2019, simply do nothing and your status will remain the same. Also remember that your participation status is tied to your tax identification (ID) number and not to the physical location of your facility, and any changes you make will not take effect until the start of the next calendar. If you have several locations operating under the same tax ID, you may not have some locations be nonparticipating and other locations be participating—it is all or nothing. Since your Medicare participation decision has far-reaching effects on all your locations, it’s good to understand the differences between a participating provider and a nonparticipating provider. The term “participating provider” does not relate to the fact of whether or not you wish to be enrolled in the Medicare program; by the act of completing a Medicare enrollment application and obtaining a Medicare supplier number, you are part of the Medicare program. Your participation status instead relates to your

agreement with Medicare to automatically accept assignment for all Medicare claims—or to not accept assignment on claims. In short, your decision to be a participating or a nonparticipating provider in the Medicare program hinges primarily on how you wish to handle the assignment of Medicare claims; and the choice to accept assignment only relates to the amount of money you may collect from the patient and where Medicare will send the check. When you elect to be a participating provider with Medicare, you agree to accept assignment on all Medicare claims; and you agree to accept the Medicare allowable for any given item or service as payment in full—and you do not have the ability to balance bill a patient. This means that Medicare will forward its payment, 80 percent of the approved allowed amount, directly to you, and you may then collect the remaining 20 percent coinsurance directly from the patient. Besides having payments sent directly to you by Medicare, there are a few other advantages of being a participating provider. First, your company’s name and contact information will be listed in the Medicare provider directory, and second, any claims involving a Medigap supplement policy will be automatically crossed over by the durable medical equipment Medicare administrative contractors (DME MACs). A nonparticipating provider, on the other hand, is not automatically tied to accepting assignment, and will have the option to make a claim-byclaim decision on whether to accept assignment. The decision to accept or not accept assignment, however, must be made on a claim-by-claim basis; you cannot accept assignment on one claim line and then not accept assignment on another claim line. Also, when a nonparticipating provider elects not to accept assignment, that provider has the ability to collect its usual and customary charge from the patient, or balance bill the patient, and does not have to accept Medicare’s allowable as payment in full at the time of service. There are some risks associated O&P ALMANAC | OCTOBER 2018

REIMBURSEMENT PAGE

with not accepting assignment for a claim. First, you are required to submit the claim on the patient’s behalf and Medicare will make payment directly to the patient, and the patient is not obligated to use the Medicare payment to pay you. Most importantly, not accepting assignment does not relieve you from meeting Medicare policy criteria or eliminate your financial liability should the claim be denied. There may be a few other considerations when it comes to making your final participation decision. Be sure to review existing and future contracts with outside private payors; some contracts may require you to be a participating member with Medicare, so if you choose to become a nonparticipating member, the contract may be voided or may have to be renegotiated. There is no right or wrong decision regarding Medicare participation status. Review the options and possible ramifications and make the choice that is best for you and your company—and remember you will not have another chance to change your status until the next open enrollment period, a year from now.

Which Gifts Are Accepable?

The giving of gifts to Medicare patients and referral sources is acceptable and allowed—but some restrictions and provisions must be followed. These provisions mainly relate to providing a gift

OCTOBER 2018 | O&P ALMANAC

as an inducement to encourage patients to choose you; or to encourage referral sources to provide you with business. If these provisions are not followed, your gifts could land you in some serious trouble. In August 2002, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published a special fraud alert that created three guidelines, which are still in effect, and must be followed in order for gifts provided to Medicare beneficiaries to be considered acceptable. First and foremost, gifts of cash or cash equivalents (gift certificates or gift cards) of any type are strictly prohibited. Second, the use of nonmonetary gifts is acceptable as long as the gifts are of nominal value. OIG has stated that the value of gifts should not exceed $15 per gift, with a $75 aggregate per calendar year. This means that you can offer your Medicare patients a maximum of five gifts valued at $15 in any calendar year. Finally, there may not be terms or strings associated with a gift. For example, you cannot require that a patient come in for an evaluation in order to receive his or her gift, or that the patient can only receive the gift if they choose to receive a particular service or item. When considering gifts to referral sources, understand that, as with gifts to beneficiaries, gifts of cash or cash equivalents of any kind (gift certificates, gift cards, and even free samples of products) are prohibited, but nonmonetary gifts are allowed— under very limited circumstances. First, the value of the gift may not be tied to the volume of referrals received from a physician’s office. For example, you may not provide a gift of higher value to your regular referral sources than you do to practices that only refer patients periodically. While you do not have to offer the same gift to all of your referral sources, you cannot base your decision on the number of referrals you receive. Second, gifts may not be directly solicited by referral sources. If a referral

requests a specific gift and you provide it, this could be construed as an inducement and a violation of federal antikickback statutes. Finally, there is a limit to the amount of money that may be spent on gifts for referral sources. This gift limit is not a fixed sum, and it fluctuates from year to year as the limit is set and adjusted according to the increase in the Consumer Pricing Index. For 2018, there is an aggregate limit of $407, so any gift or gifts provided to a referral source in 2018 may not exceed $407. The annual $407 aggregate is a limit, not an entitlement. When dealing with gifts for your patients and your referral sources, it is always a good idea to consult with your attorney, or the OIG, if you have any doubts, as it can be easy to slip over the line from an acceptable to a nonacceptable gift, or from compliance to noncompliance. Joseph McTernan is director of reimbursement services at AOPA. Reach him at jmcternan@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:

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This Just In

Veteran Access to Advanced Technology New report on VA payments for prosthetics describes overpayments but fails to address problems with coding and product verification systems

N AUG. 27, 2018, the Department of Veterans Affairs’ (VA’s) Office of Inspector General (OIG) issued a report regarding VA overpayments for prosthetic devices described by nototherwise-classified procedure codes. A key paragraph in the report addresses purported overpayment by the VA to prosthetic providers of $7.7 million from October 2014 through July 2017. The paragraph reads as follows:

OCTOBER 2018 | O&P ALMANAC

PHOTO: Ottobock

“The VA OIG substantiated allegations received in January and February 2016 alleging the Veterans Health Administration (VHA) was overpaying for prosthetic items because it incorrectly used nototherwise-classified (NOC) codes to classify the items for payment to vendors. Incorrectly using an NOC code can result in an overpayment because the payments are not based on pre-established reimbursement rates. For example, the Touch Bionics I-Limb, when classified with the correct code, costs VHA about $27,000. However, VHA paid vendors as much as $61,702 for the same item when classified using an NOC code. The OIG found that VHA overpaid vendors about $7.7

million from October 2014 through July 2017. The OIG found prosthetists incorrectly used NOC codes to classify prosthetic items when existing codes adequately described the items. Prosthetists incorrectly used NOC codes because they were either unaware of the existing codes or because they allowed vendors to classify the items with NOC codes. The incorrect use of NOC codes to classify some prosthetic items was not detected because the Prosthetic and Sensory Aids Service lacked a process to monitor the use of NOC codes. Because prosthetists incorrectly used NOC codes to classify prosthetic items for reimbursement, VHA paid more for the items. The OIG made five recommendations, including determining which codes are appropriate to classify prosthetic items for reimbursement and issuing revised guidance, establishing an oversight and reporting structure that defines the roles and authorities to approve recommendations for the use of codes to classify specific prosthetic components, developing processes to monitor the use of NOC codes, and implementing processes to establish

This Just In

pricing guidance that ensures VA pays a fair price for items classified using an NOC code.” Fundamentally, the OIG’s critique is based on the errant assumption that the Medicare code/Health-Care Common Procedure Coding System (HCPCS) process and the pricing, data analysis, and coding (PDAC) verifications are working appropriately. If that were true, the OIG conclusions in the report might be at least partially correct. But the assumption is false, and so the OIG criticism is wrong, missing the point. The situation reflected in the VA OIG report represents a clear, but unfortunate, choice: Will veteran amputees receive a high quality of care, which virtually everyone in America says they deserve, or will their access to advanced technology be limited due to an outdated and ineffective coding system? If the VA had followed the limitations of the Medicare-based HCPCS coding system and product verification, it is unlikely that amputee veterans would have gained access

to, and received the benefits of, these new technologies. Knowing this, key leaders within the VA prosthetics leadership identified a way to make sure amputee veterans could receive these newer devices—by providers using the NOC codes. Unfortunately, the CMS-based coding system, also generally used by the VA, is broken. AOPA recently attempted to explore whether the current coding process/system, and the related assignment of pricing for new prosthetic and orthotic products, serves as an impediment to investment in innovative technologies that could benefit Medicare beneficiaries. Research and development (R&D) for health care—whether in pharmaceuticals or in devices—represents a substantial capital commitment of resources. Companies commit to R&D based on their expectation that the increased benefits and value of new, improved technologies will be recognized via higher, justified pricing and reimbursement. If pricing is locked regardless of increases in

The Source for Orthotic & Prosthetic Coding

value, companies and their investors will refrain from substantial resource commitments that offer no return on the investment. This is a basic business concept and not hard to understand. The group with proper authority for overseeing new code requests—Medicare’s HCPCS Workgroup—presents profound challenges that severely discourage the introduction of new orthotic and prosthetic technology to market, and this disincentive is reinforced by an outdated pricing policy currently under examination. In an era of unparalleled technological innovation, where records from the U.S. Food and Drug Administration demonstrate that 98 percent of the new medical device applications it processes are approved as to their safety and effectiveness, the number of applications to the HCPCS Coding Workgroup has decreased. Over the past five years, O&P manufacturers have submitted only 24 applications for new products, a nearly 50 percent decline when compared to the preceding five years (49 applications).

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O&P ALMANAC | OCTOBER 2018

This Just In

During the same five-year period, the HCPCS Coding Workgroup has approved only two new O&P codes, one of which—a powered ankle-foot system for lower-extremity amputees— Medicare’s contractors later designated as noncovered for all Medicare beneficiaries. This tells the story that only 4 percent of HCPCS code applications submitted over the last five years have resulted in a new device gaining access to Medicare beneficiaries, and less directly, to VA patients. These numbers suggest that the obstacles to both obtaining a code and maintaining coverage for it are stifling prosthetic and orthotic innovation. Below are a few examples of significant new technologies where both patient access and manufacturer return on investment have been severely hampered by regulatory actions that short-changed Medicare’s recognition of significant advances because coding and pricing authorities were excessively locked into ensuring that there be no increase in payment commensurate in any way with either increased value or manufacturer R&D investment needed to bring the product to market. • Össur Pro-Flex was introduced as a new, highly dynamic foot design— yet it was classified according to predicate products that shared its basic design features even though the performance characteristics of the new product were very different from the predicate products it was classified as being similar to. • Bionix’s powered ankle/foot, a relatively new product, was issued a new HCPCS code (L5969) but with an unreasonable reimbursement amount. After four months, the durable medical equipment Medicare administrative contractors (DME MACs) indicated that there was “insufficient information to demonstrate that the item meets the Medicare standard to be considered reasonable and necessary” and that claims for L5969 will be denied as not reasonable and necessary. The Medicare fee schedule for this code 26

OCTOBER 2018 | O&P ALMANAC

was subsequently eliminated. A code without any Medicare allowable is not a viable code that anyone will use. After years of effort by the manufacturer, it appears this inequity may be poised to be addressed and rectified. • With the Genium knee, mentioned specifically in the OIG report, the manufacturer did not seek a new code, planning to await some research and clinical results with the product. The DME MACs took the initiative to assert that the device was not experimental and assigned the new device the identical allowable reimbursement as the preceding C-leg device, despite significantly advanced product performance largely attributable to advances in software. CMS has locked into hardware only, ignoring the valuable software advances that deliver better performance.

Turning to another dimension of coding and pricing policy for new orthotic and prosthetic technologies, the standards upon which the PDAC evaluates coding verification applications and the rationales underlying its decisions are not publicly available in any format. To the extent that industry experts can assess the reasoning behind the PDAC’s coding decisions, they note that these determinations appear to rest only on the device’s appearance, not its performance characteristics—that is, what that same device actually does for the patients who need them, instead of whether it looks like the original “predicate” product, which may have been on the market for 30 years. (Does today’s automobile look exactly like cars built 30 years ago, or operate exactly the same way?) As a result,

O&P manufacturers almost universally decline to voluntarily submit coding verification requests to the PDAC, a process that itself lacks transparency. AOPA has tried for the past year to activate discussion, via a roundtable or joint hearing, whereby the House VA Health Subcommittee and the House Ways and Means Health Subcommittee could gain a greater understanding of the many problems with the coding and product verification processes, and the adverse impact these can have on new product development. AOPA also wishes to convey the adverse impact this has on both Medicare-covered amputees and amputee veterans seeking access to technology demonstrated in a recent report by the RAND Corp. to reduce serious falls, and deaths from falls, by 450 percent. The HCPCS coding system and CMS coding verification are at best marginally functional, and at worst dysfunctional. We cannot address whether either the percent of the markups or reimbursements paid that are mentioned in the VA OIG report were appropriate. What we can say is that VA personnel, the VA Coding Committee, and the private-sector contractors who serve the amputee veteran community were faced with the dilemma of how to try to keep the care for amputee veterans current with new technology, and ensure that veterans who had sacrificed a limb in the service of their country received timely access to improved mobility, despite the profound problems with the coding and product verification systems used by Medicare. Perhaps they could have done a better job, which may have saved the VHA money, but the steps these parties took undoubtedly improved veterans’ access to quality care and improved mobility. Access the full report issued by Department of Veterans Affairs’ Office of Inspector General regarding payments for prosthetics at bit.ly/vaoigprosthetics.

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COVER STORY

Ready, Set,

STARTUP By CHRISTINE UMBRELL

O&P entrepreneurs share their startup stories and offer tips for bringing new products to market

Tamarack Flexure JointÂ® (TFJ)

OCTOBER 2018 | O&P ALMANAC

COVER STORY

NEED TO KNOW • Many O&P professionals are innately creative individuals who design solutions for their patients on a regular basis—so it comes as no surprise that some clinicians are developing innovative orthotic and prosthetic components and equipment. In addition, some O&P researchers are inspired to develop prototypes to fill voids or augment their investigations. • Individuals who are considering developing an O&P product or getting involved in a startup should begin by conducting market research, building a working model, and researching the legal aspects regarding ownership of the product. • It’s also important to identify sources of funding, which may be available via government or private organizations. Contacting local business incubators or accelerator programs also may be helpful.

• O&P professionals should consult with business experts when bringing their products to market; consultants with experience in the world of O&P commerce can assist with pricing and distribution questions. • Once a startup has reached sustainability, selling the company to a larger organization may be an option, as startups and legacy companies that find a good fit can pursue mutually beneficial relationships and configurations. But there are several considerations before making the decision to sell or partner, including pricing, personality fit, and next steps. • As new materials and technologies emerge, traditional manufacturing companies will continue to roll out advanced orthotic and prosthetic designs to aid the O&P patient population in achieving a higher quality of life. But there also will be plenty of room for O&P innovators and startups.

CROSS THE COUNTRY, STARTUP

businesses and individuals are disrupting many industries. In O&P, increasingly advanced orthotic and prosthetic devices and componentry continue to be introduced by traditional manufacturing companies with expansive research and development departments. However, individuals and teams are making their mark with research-driven innovations that fill niche needs. Innovation among O&P professionals is nothing new—individuals drawn to the profession are innately creative people, according to Martin “Marty” Carlson, CPO(E), FAAOP, founder and president of Tamarack Habilitation Technologies and an AOPA Inventor Award honoree. “Practicing orthotists, prosthetists, and rehab technologists are inventing new solutions all the time,” he explains. “What gets more notice are the inventions that result in mass-produced, sometimes patented, products.” The current O&P climate allows a lot of room for creativity, according to Carlson, who is responsible for the teamwork leading to the invention of the Tamarack Flexure Joint® (TFJ) as well as a metal clevis-type joint, ShearBan low-friction interface patch

material, and other O&P components. He notes that materials research, for example, is an area of significant growth, leading to opportunities to develop O&P devices that are even lighter and more durable. Goeran Fiedler, PhD, an assistant professor in the Department of Rehabilitation Science and Technology at the University of Pittsburgh (Pitt), also sees the O&P space as ripe for invention, and has been involved in two startups of his own. “Given that there are a lot of yet unsolved clinical challenges, there certainly appears to be room for creativity, and I believe practitioners in our field are, by nature, ingenious in coming up with individualized solutions,” he says.

Research-Driven Innovation

Fiedler is a prime example of an O&P researcher who has developed technology to fill a need. He has been involved in developing several new prototypes— most notably a prosthesis alignment sensor. “Designing … research protocols, I often found myself faced with the difficulty of making accurate alignment angle changes in the common pyramid adapter system, say, if I wanted to investigate the effects of increasing plantarflexion by exactly 2 degrees.” O&P ALMANAC | OCTOBER 2018

COVER STORY

In 2014, Fiedler teamed with Jonathan Akins, a postdoctoral researcher at Pitt, to develop a device to electronically measure pyramid adapter alignment angles. “It became quickly clear that such a thing would be useful beyond the realm of prosthetic research, to help clinicians with documentation, quality control, and training,” recalls Fiedler. With the support of the university, Fiedler and Akins filed for a patent and started a company— APO Technologies—that is currently working on refining their prototypes into a consumer-ready product.

Goeran Fiedler, PhD

OCTOBER 2018 | O&P ALMANAC

Driven To Help Others

Like Fiedler, Jessica Zistatsis is another O&P innovator who is bringing a device to market after identifying a need in the O&P patient population. Zistatsis was part of a team at the University of Washington that developed a working prototype for a passive pediatric exoskeleton to improve walking ability for children with neuromuscular disorders. “My team spoke with pediatric physical therapists, children with cerebral palsy, and their caregivers to understand the current market options for assistive walking devices,” Zistatsis says. “We found that children with neuromuscular disorders don’t get enough walking practice outside of therapy, and the walking practice they get in the community is with devices like walkers and crutches.” Zistatsis’s team found that these devices improve mobility, to the extent that the community provides accessible pathways, but they do not provide rehabilitation or encourage a biomechanically efficient walking pattern. “Our device needed to

be low profile, adjustable for children’s rapid growth, tune-able to each child, and applicable for community use,” Zistatsis says. The team partnered with local pediatric physical therapists for input on design specifications, then designed and built a working prototype. The team received grant funding and was awarded prize money from business plan competitions to support product development and market research. To demonstrate to clinicians that the

Jessica Zistatsis

patent-pending exoskeleton could improve walking ability, Zistatsis conducted a case study to evaluate muscle activation patterns and joint kinematics. During the case study, the device was tested with typically developing children and children with hemiparesis. “My research team saw altered lower-limb muscle activation patterns and improved kinematic symmetry for children with hemiparesis.” The device is still in the research and development stage, and Zistatsis, who is now working as a mechanical engineer at Orthocare Innovations LLC, intends to conduct a longitudinal study with children wearing the device in the community to evaluate the exoskeleton’s rehabilitation potential before licensing the intellectual property (IP).

PHOTO: Getty Images

Fiedler also helped develop a prosthetic gait training system while serving as the primary dissertation advisor for Krista Kutina, a physical therapist, three years ago. “We combined our expertise to develop a wearable system that provides visual real-time feedback to people who learn to walk better with a prosthesis,” he says. “This addresses a great clinical need, as the amount of classical gait retraining that new prosthesis users receive is almost inevitably limited by the logistics and costs of needing an actual therapist around.” Kutina has spent the last few years refining the technology and method, which has yielded a patent application and several conference presentations. “We are currently exploring the best commercialization options,” Fiedler says. Fiedler has been part of one additional startup, GuentherBionics. He worked closely with Michael Guenther, a fellow student at University of Wisconsin—Milwaukee during their graduate studies, and developed a Milwaukee socket for transfemoral prosthetics, a brimless socket design, after being inspired by patient data from a stereofluoroscopy study. Fiedler and Guenther observed that the presumed “bony lock” in

ischial containment sockets is not as effective as commonly believed. “Instead, we concluded it must be the muscles that predominantly stabilize the connection and support the weight bearing. Accordingly, much of the discomfort that patients often report with the ischial containment may be unnecessary.” Guenther built a socket prototype that embraced this concept and tested it successfully in a number of patients. “We published about the technology, and it has since become the cornerstone of” GuentherBionics.

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INNOVATION

Success Story

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For those who are considering developing an O&P product or getting involved in a startup, experienced inventors offer words of encouragement and caution. First, Zistatsis warns that market research is essential. It’s important to evaluate the market need and competition, she explains. “Perhaps the problem you’re thinking of solving is actually symptomatic of a deeper problem and an invention is needed for that root problem, or perhaps an existing product you weren’t originally aware of solves the problem,” she says. Under such circumstances, “take time to discuss your idea with potential stakeholders: patients, family members or caregivers of patients, payors, investors, etc. Make sure the stakeholders are interested in your idea and find it valuable. Determine the size of the market.” Collaboration with people who can provide additional expertise is key, Zistatsis adds. “As an engineer, I partner with clinical experts to inform device specifications and to assist with clinical studies. Then my role is to convert those specifications into a robust and viable product design. Throughout the initial proof-ofconcept prototyping and testing, it’s important to think of the long-term goal for your device idea: Will you create a startup to sell your device? Will you patent the idea and license the IP [intellectual property] to an existing organization? The extent of the research and development process will be informed by the long-term goal and funding contracts.” The next step is to build a largescale working model of the device that is relatively simple to allow features of the device to be easily prototyped, iterated, and tested for function and efficiency, says Zistatsis. “Once the features are determined to meet the design specifications, the device design can be made compact and optimized for affordability and efficiency.” Of course, O&P professionals who create new devices need to understand all of the legal factors regarding whether they “own” the product, if they

PHOTO: Getty Images

When speaking of O&P innovators, one of the most successful names in recent O&P history always comes to mind—Van Phillips, winner of a 2017 AOPA Inventor Award. Phillips holds approximately 70 U.S. and international patents, but his most famous invention is the Flex-Foot, an energy-storing carbon graphite foot that stores kinetic energy, allowing the wearer to run and jump. “When I developed the Flex-Foot, with a team of two other guys, there was nothing like it on the Van Phillips market,” recalls Phillips, who not only designed the device but also was the first to test it, having lost his leg below the knee at age 21 as the result of a motorboat accident. He worked with a carbon graphite supply representative and an aerospace engineer, pooling their resources and setting up a lab in Phillips’ basement to bring the idea to reality. Creating the first prototype was just a two-week process, he recalls, and when he tried the prosthesis, “it allowed me to run for the first time” since his amputation. It took another two years to refine and perfect the component. The Flex-Foot Co. was founded in 1983, and the product was a hit almost immediately—in particular demand among Paralympic athletes. To market the original Flex-Foot, “we made a lot of videos demonstrating the product”—a novel approach at the time. Phillips sold Flex-Foot to Össur in 2000, devoting time to other activities, including developing additional products and establishing a nonprofit foundation, Second Wind, to help amputees who do not have the means to help themselves. Given his experience, Phillips says, “it’s one thing to have an idea of something that will work. It’s another to have to make it work”—to develop a proof of concept and an actual prototype. He recognizes how innovative the Flex-Foot was. “We paved the way with vertical shock, split toe, air-driven prosthetics,” he says. “Now the market is flooded, so it’s become harder” to come up with an innovative product and then market it successfully. Phillips believes that bringing new products to market today requires creative approaches to raise awareness of inventions. “You may not have to go the standard marketing route—you may be able to go directly to amputees,” he says. He plans to take a creative approach with the product he is currently developing—a prosthetic foot for landmine survivors, designed to be high-tech and exceptionally durable as well as affordable. The new prosthesis is the “highest performing foot” he’s ever created, says Phillips. Developing a product that will potentially help thousands of amputees worldwide at an affordable rate keeps Phillips motivated. “Part of why I’m driven is because I know what it feels like to have pain, and I know what freedom it is to get a foot that’s light and has vertical shock—that you can run and dance on,” he says.

Getting In on the Action

COVER STORY

Martin “Marty” Carlson, CPO(E), FAAOP

PHOTO: Getty Images

Fiedler suggests conducting research to identify sources of funding; he points to “an entire ecosystem” dedicated to the commercialization of innovations. “In many places, government and private organizations are eager to support entrepreneurs and, while it still takes a lot of determination and diligent work, it is usually quite easy to find the contacts and the information needed to get into this ‘game,’” he says. “I would look for and apply to local business incubator and/ or accelerator programs. This will bring connections to people with the experience and skill set to successfully navigate the journey to commercialization.” There also are resources for the development of business plans and

“

Plan very carefully how much funding and time it will take

“

are employed by a company at the time they are developing a new product. “The individual with the idea must consult an attorney with IP experience as early as practical,” Carlson advises. A few questions that have a bearing on ownership include the following, according to Carlson: What is the full span of the employer’s business activities? What are the employee’s job duties and responsibilities? Whose tools, materials, space, and time were used to develop and/or document the device? And is there a pre-employment document regarding IP? Once a product is ready to go, Carlson says that launching and growing a startup can take a lot of time and money. “Plan very carefully how much funding and time it will take to reach profitability. Then add another 50 percent” to each estimate, he suggests. “Remember that positive cash flow lags behind profitability; sometimes far behind. Some startups fail because they arrive at a point where they don’t have sufficient funds or credit necessary to pay employees, utilities, or materials in spite of beginning to show a profit on paper.”

to reach profitability.

Then add another 50 percent. —Martin “Marty” Carlson, CPO(E), FAAOP

elevator pitches, says Fiedler. “I would not recommend using one’s own funds to finance a startup— not just because it is cheaper not to, but because it means missing out on a lot of very helpful feedback,” Fielder adds. “Shipping an idea around in search of funding can be disappointing. But if a number of experienced investors cannot be convinced that an idea is worth investing in, chances are that the idea is simply not good enough to succeed. Finding this out early can help save a lot of time and money.” Carlson also advises O&P professionals to consult with business experts when bringing their products to market. “Most clinician-technologists are not the best people to realistically figure out commercialization of their invention,” he says. Inventors should engage someone in the world of O&P commerce early on to help them with pricing and distribution questions.

Growing a Company

What happens to startups once their products become recognized and other companies begin expressing interest in acquiring them? These situations can be challenging for innovators, who may not have experience in acquisition or company sales. Carlson suggests that O&P innovators with startups that have reached

sustainability ask several questions when determining how to proceed if selling is an option: Do you like what you are doing? Do you and your employees, as a team, have all of the abilities to improve the design, manufacture, and grow sales? Is somebody offering a price for your business that allows you to be free to do something you enjoy/value more highly? Is age or succession a factor? What is your opinion of the potential acquirer? The answers to these questions should point entrepreneurs in the right direction. “If the balance tips toward selling, there are several accounting formulas or professional appraisers that can help you evaluate an offer,” Carlson adds. Inventors who are thinking about selling also should consider how larger O&P manufacturers perceive startups. “Unless an innovative new product really ‘sparkles’ and fits neatly into present billing codes with obvious profit potential, it will be a tough sell,” says Carlson. “Most large companies would rather invest in internal incremental design or manufacturing improvements where it is easy to calculate return on investment. Large companies tend to favor purchasing after the new technology or product has demonstrated potential in the marketplace. That allows mid-level management in large companies to advocate a purchase with less career risk.” O&P ALMANAC | OCTOBER 2018

COVER STORY

PHOTOS: Danae Prosthetics

O&P Interests Drive

STUDENT STARTUPS W

OCTOBER 2018 | O&P ALMANAC

Rivera and Calvin Leung, the team decided to enter the contest as “Artemus Labs” and focus the O&P sector. An electronics engineering technology student, Rivera had worked in a lab with prosthesis users, and says the team recognized there were opportunities for creativity in the prosthetics space. She and her colleagues interviewed several local amputee support groups and consulted with area prosthetists, learning that many amputees were dissatisfied with their liners, which may entrap heat and sweat.

PHOTO: Artemus Labs

ITH AN INCREASING FOCUS on technology and innovation at today’s educational institutions, increasing numbers of students are participating in startup competitions—and many are choosing O&P themes to drive their participation. Winston Frazer, a 25-year-old graduate of the Maryland Institute College of Art (MICA), entered the O&P space by accident. Though he studied photography, painting, and sculpture at MICA, he was drawn to O&P during a junior-year studyabroad program to Sao Tome and Principe, an island nation in the Gulf of Guinea, where—as he travelled the island to draw Winston Frazer the locals—he was struck by the number of individuals with limb loss. Once back in the States, Frazer explored different ways to combine his love of art into improving life for amputees, and started a senior thesis to make a 3-D-printed prosthetic hand. But he soon switched gears and began designing artistic prosthetic covers, creating a “pitch” proposal centered around the idea, and entering an Up/Start entrepreneurial contest. His idea was one of five winners in the 2017 contest, and he received $20,000 in winnings. He used that money—along with additional funds he has raised and investments from a local business accelerator—to start Danae Prosthetics, a company that allows lower-limb amputees to take part in designing and creating 3-D prosthetic covers. The covers are made out of Nylon-12 and feature a novel locking mechanism for ease of taking on and off. The company offers an app and desktop interface users can employ to upload the shape and dimensions of their prostheses and then personize the cover with a unique design. Danae Prosthetics is still in its early stages, with the first products delivered just last month. While prosthetic covers remain Frazer’s central focus, he continues to ruminate about new ways to leverage 3-D printing for O&P. “We want to empower clinicians to use additive manufacturing in the best way possible,” he says. On the other side of the country, six undergraduate students at California State University—Long Beach recently designed a new prosthetic liner and took part in their school’s 2018 Innovation Challenge, an annual competition designed to cultivate useful ideas and bring end results to the market. Led by students and co-chief executives Rae Jillian

Prosthetic Covers, Danae Prosthetics

From left, Artemus Labs’ Calvin Leung, Rae Jillian Rivera, Kimberly Ventura, Nikki Escobar, and Anna Maria del Mundo They used this information to develop their “Python” device, a temperature-sensitive prosthetic liner made of silicone that uses body heat and stresses user comfort—“a more breathable liner that is also more visually appealing,” according to Leung. The Artemus team took an interdisciplinary approach to design, including team members from business, engineering, and design majors to create a design that is both useful and visually appealing. They learned in April that they beat out 40 other teams to be named the winner in the university’s Innovation Challenge. They have been awarded $10,000 in seed money and an additional $40,000 worth of business essentials, including office space, legal services, marketing assistance, and accounting services to be used over the next year. The startup is currently working on testing its product and has partnered with some individuals at California State University—Dominguez to finalize the design. The team also is pursuing an Institutional Review Board certificate, seeking insurance information, and laying out plans for the future. “We’re just about ready to validate everything with our design,” says Rivera. Rivera predicts the liner will be available one year from now—and after that, “we have other biotech designs in mind,” she says.

COVER STORY

Carlson also warns that established O&P manufacturers “certainly do not welcome new startups that basically copy established products with a new ‘wrinkle’ and ad claim.” On the other hand, authentically new innovations that demonstrate a profitable start “are, of course, welcomed into a larger established company as an acquisition.” Startups and legacy companies that do find a good fit can pursue mutually beneficial relationships in various configurations. “Innovative entrepreneurs often lack some of the talents needed to promote and distribute products, or to grow a business,” says Carlson. “A legacy company may be willing to purchase or pay a royalty to use the patented IP of a startup. The legacy company may act as the distributor of things manufactured by the startup. There are all kinds of ways to build a satisfying, successful business. Strong, enduring business relationships are possible when business ethics are compatible and both sides benefit.”

Finding a Niche

Christine Umbrell is a contributing writer and editorial/production associate for O&P Almanac. Reach her at cumbrell@contentcommunicators.com.

DRIVE INNOVATION HANGER AND AT&T CREATE NETWORK-ENABLED DEVICE FOR LOWER-LIMB PROSTHESES

&P INNOVATION IS SOMETIMES driven

by key collaborations. Such was the case in the recent development of a prototype standalone, network-connected device that attaches to lower-limb prostheses and allows for connectivity, enabling a patient’s prosthesis to “talk to” the patient’s clinician. The prototype, Mohamed Mohamed shows Andrew DiBello and developed via a Hanger Aaron Flores, PhD, the prototype mobile app. Inc./AT&T partnership, syncs directly to the cloud via AT&T’s network. The device will enable clinicians at Hanger Clinic to monitor data about the prosthesis and proactively contact patients to address potential issues impacting prosthesis usage, such as fit and comfort, to in turn increase mobility. The device has been designed to attach to all types of lower-limb prostheses, both below-knee and above-knee, according to Aaron Flores, PhD, vice president, Hanger Clinic. “The device contains many types of sensors and has the ability to track many gait parameters, wear time, and more,” says Flores. “The data could be used by clinicians during patient interactions, helping to increase patient mobility, and could also tie into Hanger’s robust research and outcomes measures program.” Designers at the AT&T Foundry worked closely with Hanger in designing the prototype, which combines an accelerometer, gyroscope, magnetometer, and LTE-M modem into a compact device. They also prototyped an iOS app equipped with patient and clinician portals. The app will allow patients to view their day-to-day progress, such as number of steps taken, and includes a video calling feature. Clinicians can view their patients’ activity levels, with patients’ permission, and contact those whose user data shows low activity or irregularities. For prosthetists, “being able to monitor their patients’ activity in near real time may allow clinicians to proactively intervene when they see a possible issue, and to adjust goals to help patients continue on a path to greater mobility,” says Andrew DiBello, leader of manufacturing process and systems at Hanger Clinic. With a prototype in place, Hanger is currently trialing five devices with existing patients. The developers intend to refine the device and associated communication programs, incorporating input from those testing the prototype. In the future, Hanger may collaborate with groups and institutions to further validate outcomes studies. “It is too early in the program to determine whether the device will be available outside the Hanger network,” says DiBello.

PHOTO: Hanger Inc.

Given the current market conditions, full of new technologies and scientific advancements, combined with the diverse needs of a growing O&P patient population, the orthotics and prosthetics space offers plenty of opportunity for creative minds to develop useful solutions. While traditional manufacturing companies will continue to roll out new orthotic and prosthetic technologies to aid the O&P patient population in achieving a higher quality of life, there will be plenty of room for O&P innovators and startups. “Developing technology for orthotic and prosthetic patients is an incredible opportunity,” says Zistatsis.

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INTO

Diving O&P RESEARCH

The University of Hartford takes to the water to study prosthetic use and optimization among wounded warriors

NEED TO KNOW • The University of Hartford Department of Rehabilitation Sciences has partnered with the Combat Wounded Veteran Challenge (CWVC) in carrying out a research project centered around studying amputees’ performance with and without their prostheses in an underwater scuba-diving setting. • Each year, veterans and wounded service members with amputations take part in a week-long CWVC Scuba Challenge below the coast of Looe Key, Florida; for the past three years, researchers Duffy Felmlee, MSPO, CPO, and Michael McCauley, MSPO, CPO, have joined the dives.

OCTOBER 2018 | O&P ALMANAC

• To date, CWVC and University of Hartford have seen “overwhelming positive results” and are finding that most divers prefer to wear their prostheses while diving. The team plans to increase the sample size in the coming year; they hope to triple the trials in 2019. • The ultimate goal of the research is to be able to recommend best practices related to suspension, knee, foot/ankle, and fin combinations—information that prosthetists could share when assisting patients who want to participate in scuba.

PHOTO: Idee Belau/CWVC

• The research methodology relies on an array of inertial sensors and video recording, which allow the researchers to evaluate kinematic data in real time during the data collection and also review the data more thoroughly, with the assistance of other University of Hartford researchers, in the lab.

• Working with the wounded warrior population in an underwater setting poses some challenges, such as ensuring electronic sensors are not damaged in the water, assisting participants in achieving neutral buoyancy while using their prosthesis, and communicating with subjects while submerged.

A researcher adjusts a wrist-mounted heartrate monitor on a combat wounded veteran in the test environment.

ODAY’S O&P ACADEMICIANS AND

clinicians are taking research to new heights, investigating many aspects of orthotic and prosthetic intervention to determine the efficacy of various devices and treatment protocols. But researchers at the University of Hartford have taken their research to new depths—to the bottom of the sea. Scuba diving can be challenging for amputees—but it’s an activity that can serve both recreational and rehabilitative purposes. For the past several years, veterans and wounded service members with amputations have taken part in an annual week-long Scuba Challenge, hosted by the Combat Wounded Veteran Challenge (CWVC). Participants learn to improve their diving skills, with or without their prostheses, and spend time “giving back” by planting corals along Florida’s decaying barrier reef.

Three years ago, the University of Hartford was invited to partner with CWVC and conduct research during the annual Scuba Challenge. “CWVC was in search of an institutional partner to help them complete one of its mission objectives of ‘research and innovations in field-based assessments/treatment of orthotics and prosthetics,’” explains Duffy Felmlee, MSPO, CPO, assistant professor in the university’s Department of Rehabilitation Sciences. In response, Felmlee became one member of a team of researchers—which also includes Michael McCauley, MSPO, CPO; Kristamarie Pratt, PhD, MEng; and Matthew Parente, MS, PT, CPO, FAAOP—that has been formulating innovative field protocols and data analysis “for the immediate and future benefit of combat wounded veterans,” says Felmlee.

A Giant Stride

The CWVC’s annual Scuba Challenge, which takes place below the coast of Looe Key, Florida, is an ideal setting for the University of Hartford team to conduct investigations regarding underwater swimming in amputee subjects. The challenge is “the flagship event for CWVC, as it combines all of the major tenets of the organization into a high-impact, seven-day event” that offers camaraderie, research, and community, says Felmlee. Participants also benefit from instruction provided by Scubanauts International, an organization that trains junior scuba divers to participate in the sport and offers information about oceanographic preservation and research. O&P ALMANAC | OCTOBER 2018

Researcher Michael McCauley, MSPO, CPO, adjusts a buoyancy control mechanism on a transfemoral swim prosthesis.

A researcher evaluates the functionality of a knee unit while combined with a buoyancy control mechanism in open water trials.

Wounded Veterans Benefit From

Undersea Adventures T HE COMBAT WOUNDED VETERAN Challenge

OCTOBER 2018 | O&P ALMANAC

PHOTOS: Idee Belau/CWVC

scars” that can be alleviated, to an extent, by scuba diving with other wounded veterans (CWVC) sets itself apart from and their families—while other organizations develalso participating in reef oped to improve the lives of restoration and working wounded or injured veterans by with University of Hartford including a research directive researchers in discovering in its mission. Participants with Captain better ways of propulsion. amputations, post-traumatic Dominic Gorie Participants spend the stress, and traumatic brain first couple of days being injury can turn to a variety of fit for gear and being evaluated to organizations to take part in athletic ensure everyone is fully prepared activities, but, with the added research for diving. They spend rest of the component, participants “feel a contrip diving two or three times daily, nection to something greater—to make sometimes going as far as 100 feet life better not just for themselves, but underwater. They devote part of for others” who may experience simitheir diving time to planting corals to lar injuries, explains Captain Dominic help rebuild the reef near the Looe Gorie, a retired Naval aviator and Key Sanctuary Preservation Area in astronaut and a director on the CWVC Board of Directors. CWVC offers physically and Combat wounded divers, prosthetic researchers, and aquatic environment researchers participate psychologically demanding extreme in coral restoration projects to restore damaged outdoor events throughout the year, sections of coastal Florida. which have included activities such as hiking, mountaineering, and sailing, but the annual week-long Scuba Challenge has become the organization’s most successful challenge, says Gorie. “We invite families to take part so the participants can have a whole family experience.” After getting away from their everyday routines in a relaxed beach setting accompanied by spouses or children, participants go home in a much better frame of mind, according to Gorie. “Wounded veterans have emotional and mental

Florida, in conjunction with Mote Marine Laboratory and Scubanauts International. Last summer, they helped plant 300 coral fragments. The University of Hartford research team studying amputees in the underwater environment dives alongside the veterans, many of whom have been fit with electronic sensors to collect kinematic data for their investigation. They also observe the amputees as they take part in the coral reef planting event. “From the researchers’ perspective, we value the opportunity to observe the veterans using or not using the prostheses in real-world environments,” says Duffy Felmlee, MSPO, CPO, assistant professor in the Department of Rehabilitation Sciences. “As the users focus on tasks unrelated to swimming, we are able to make note of how the prosthesis or residuum is used to assist in remaining in a stationary position, which is not easy in the best open water conditions.” Scuba diving is “a perfect activity for veterans with missing limbs,” explains Gorie. Both unilateral and bilateral amputees have taken part in the challenge. “In a couple of cases, veterans with no limbs below the hips” have participated, he says. These individuals have tried a mega-fin, or mermaid fin, as a means of propulsion, with the researchers studying how best to help both bilateral lower-limb amputees and individuals with muscular dystrophy or lower-extremity paralysis navigate the water. “When veterans realize they are part of this much larger goal [to design better underwater prostheses for both amputees and individuals with other health-care challenges], it excites them and opens them up to the awareness that life is not as limiting as they thought,” says Gorie. “And that’s our goal. These veterans sacrificed for our country, and we owe them, to try to return them to a fully functioning body and mind.” Concludes Gorie: “When you combine a challenging adventure with a research component, it re-energizes the wounded vets and makes it all worthwhile.”

PHOTOS: Idee Belau/CWVC

Conducting research in the underwater setting allows for data collection that will improve the design of underwater prostheses and aid individuals with limb loss in their recreational pursuits. “It is in the interest of amputee advocacy to promote activities that encourage Michael equality with minimal accomMcCauley, modations to participate,” MSPO, CPO explains Parente. “Scuba can be very physically equalizing due to buoyancy and the team approach required to participate in the sport safely. As divers are trained, it is most apparent that the primary means of propulsion is achieved through symmetrical strokes of bilateral lower extremities.” But lower-extremity amputees have a disadvantage to symmetrical stroke length or limb leverage, depending on the “sidedness and level of the amputation,” says Parente. The initial goal for the project was to establish a methodology to evaluate underwater swimming with lower-extremity amputation. “We have been able to develop a method [that] relies on an array of inertial sensors and video recording, which allows the researchers to evaluate kinematic data in real time during the data collection and also be able to review the data more thoroughly in the lab,” explains McCauley. manner: The researchers have comWith more data collected each pleted three testing phases over the past year, the team’s methods have become three years. “Combined, we have now repeatable. “We are able to vary the tested greater than 22 subjects, unilatcomponents, knees, ankles, and fins eral transtibial and transfemoral,” as (split versus solid) and compare well as bilateral amputees, says Felmlee. what elements help to normalize the He and his team collect heart rate data propulsion patterns of our amputee using Polar Heart Rate monitors and divers compared to our controls,” Polar watches; they also use APDM McCauley adds. “Eventually, we inertial sensors to collect segmental would like to be able to recommend kinematic data. best practices related to suspension, “Our subjects have a sensor placed knee, foot/ankle, and fin combinaon each tibia, femur, and one on the lumbar spine as well the level of the tions, which prosthetists would be xiphoid,” Felmlee explains. The sensors able to recommend to patients that record the angular acceleration of each want to participate in scuba.” segment, which is then compared to the various trials of swimming with Waves of Data and without a prosthesis. “The field The annual nature of the Scuba Challenge makes it easy for the research observations give us the opportunity to see what the manifestations of the team to collect data in an organized

Left, A researcher adjusts the position of a swim foot prior to starting a round of testing environment trials. Below, Duffy Felmlee, MSPO, CPO, and Michael McCauley, MSPO, CPO, adjust inertial sensors prior to a swim trial in the test environment.

kinematic data quantifies,” he says. For example, one of the experienced divers who is a unilateral transfemoral amputee uses both lower extremities with a fairly symmetrical kick while using his prosthesis, but when the prosthesis is removed, “his swimming pattern moves to a porpoise style of propulsion, which requires a significant amount of trunk flexion and extension,” Felmlee says. “We are also able to observe in the pool and open water that a majority of the uninvolved limbs internally rotate—as we see with our controls—but the prosthesis will maintain a very linear motion in the sagittal plane; it is expected that this reduction in internal rotation is reducing the directional propulsion and requires our subject to compensate with the upper extremities.” O&P ALMANAC | OCTOBER 2018

A research participant undergoes a swim trial as a researcher records the limb and trunk movements.

High and Lows

The researchers enjoy being able to conduct O&P investigations in such a unique setting, especially knowing that their work has real-life implications 42

OCTOBER 2018 | O&P ALMANAC

Travelling to Florida to improve recreational and provides a welcome therapeutic activities for both change of pace from the wounded veterans and civilresearchers’ day-to-day ian amputees who may enjoy activities at the universcuba diving. “Our current subject pool is an impressive sity. “This field collection group of combat wounded is different than most veterans,” says Felmlee. “Our data collection trials in intention is that the research Duffy Felmlee, the sense of getting to MSPO, CPO gathered here would be able meet and work alongside to advance the current state subjects over an extended for activity-specific componentry period of time,” says McCauley. to allow veterans with limb loss to “These individuals become a motiparticipate in an activity [that] has vation to do more for the community significant physical, psychological, and and assist in improving the quality of social effects.” life for others.” To lead this research project, both While they enjoy conducting their Felmlee and McCauley had to become research, the team also is faced with divers themselves. “When I Iearned of challenges in the underwater setting. CWVC looking to do some scuba expe“Most electronics are not intended for use in the aquatic environment, so we ditions and they asked me to join, I have had to ensure that our sensors are thought, ‘Wow, how many prosthetists able to withstand the demands of data are scuba certified and have the desire collection and also be sure they are not to get into underwater prosthetic damaged due to moisture,” explains research? Probably not very many!’ Felmlee. This involves additional care, So I jumped on it and completed all with researchers carefully removing the my scuba requirements as soon as I sensors from their protective sleeves could prior to my first trip down to and docking them for data transfer after Key West,” recalls McCauley, who calls the dives have concluded. the experience “a dream come true.” The reduction in gravity also can Felmlee similarly completed scuba be difficult to adjust to, and some certification for the sole purpose of subjects experience issues regarding helping lead the investigations.

PHOTOS: Idee Belau/CWVC

The research is far from complete, but preliminary findings suggest prostheses are helpful to scuba divers with limb loss. “Debriefing questions have provided us the feedback that divers who have acclimated to the use of their swim prosthesis feel more balance and [are more] efficient when using their prosthesis compared to without and prefer to use [their prostheses] in every dive,” says Felmlee. Divers who are newly certified have tended to not use their prosthesis on the initial dives due to the additional equipment—“divers have a significant amount of gear to keep track of and know the proper function, [and] at times the prosthesis can seem cumbersome,” he explains. “But, once the diver has become accustomed to the dive gear and is placed in a controlled environment, such as a research pool, and allowed to compare the two trials of with and without prosthesis, the [general consensus] is the use of the prosthesis requires less effort to maintain a straight course or direction.”

orientation. “Neutral buoyancy is the goal of the diver, and this alone can be quite challenging to achieve due to some of the negative or positive buoyancy within the prosthesis,” Felmlee adds. In addition, communication while diving can be difficult. “Although hand signals are rehearsed top side, there is inevitably a task that will provide some additional communication between researcher and subject,” says Felmlee. “What would be an easy few words may take a little extra time communicating underwater. Some may say, ‘Just go to the surface and clarify,’ which is done in some cases—but achieving neutral buoyancy can be a time-consuming task, and once that is achieved, resurfacing would be less than ideal.”

SFC Billy Costello, U.S. Army (Retired), participates in open water field testing of prosthetic swim componentry.

Preparing for Ascent

PHOTOS: Idee Belau/CWVC

The university team plans to continue this research, and recently added faculty to the research team due to “the overwhelming positive results produced since the inception of this partnership,” says Parente. CWVC and the university have agreed to triple their trials in 2019. “CWVC has seen value in the research protocol and has increased the data collection trials from a single collection period to three separate challenges [during the year]—increasing our sample sizes significantly,” says Felmlee. “Now that our methodology has given us repeatable results, we will continue to field trial various combinations of componentry to find the best combinations for different amputation levels.” The team also plans to field-test new designs, based on observations and data from previous years. Assessing the componentry currently available, Felmlee notes that recent advances in O&P technology have led to significant improvements in allowing amputees to participate in aquatic activities—for example, with the use of noncorrosive materials and, in the case of ankles, allowing for plantarflexion when swimming. “As we look to improve upon these concepts, we have noted that allowing for a certain amount of motion at the knee

and ankle on the recovery stroke of a kick would be beneficial to the diver,” he notes. “Current locked components generate a power-propulsive stroke in both flexion and extension of the hip. This can lead to fatigue on the amputated side as well as asymmetrical propulsion, which requires the trunk and upper extremities to compensate.” Recommendations and analyses such as these should assist Felmlee and his team—and O&P professionals with patients who might enjoy scuba—in promoting the sport among active amputees. “The weightless environment of submerged swimming can be an equalizing factor for all. Although scuba can be physically demanding at times, there is the ability to perform the tasks in which the individual’s technique has a greater impact on the

result than that of physical ability with or without a prosthesis,” Felmlee says. “There are studies that show improved pulmonary function with the use of compressed air, commentaries that report on the improved socialization effect of swimming with a ‘dive buddy,’ and reports that encourage the use of aquatic therapy—these are all benefits that can be obtained by the interested individual.” “Research is not usually associated with having fun,” adds McCauley, “but working with these combat wounded men and women has not only been an honor but an absolute blast.” Christine Umbrell is a contributing writer and editorial/production associate for O&P Almanac. Reach her at cumbrell@contentcommunicators.com. O&P ALMANAC | OCTOBER 2018

PRINCIPAL INVESTIGATOR

Meaningful Investigations Jason Kahle, MSMS, CPO, LPO, almost didn’t get the opportunity to become a top O&P researcher

For 2018, O&P Almanac is introducing individuals who have undertaken O&P-focused research projects. Here, you will get to know colleagues and health-care 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.

ASON KAHLE, MSMS, CPO, LPO,

OCTOBER 2018 | O&P ALMANAC

Defining Moments

Forty years ago, when Kahle was in second grade, he developed an unexplained black eye. His parents took him to a pediatrician and then an oncologist, who diagnosed him with aplastic anemia, a rare condition in which the body stops producing enough new red blood cells. Originally told there was no cure, his family learned that the University of Minnesota was offering an emerging treatment for the condition—a bone marrow transplant. Because his sister was a match, Kahle was able to undergo the 25th bone marrow transplant in the world—and became just the 13th person to survive the procedure. Kahle had total body radiation as part of the treatment and spent the following six months in isolation, spending his time watching television and drawing. During the ensuing years, he developed a deep appreciation for life and knew he wanted to find a way to help others. As a high school senior determining a career path, he considered

medical school, but he also was an accomplished artist and had earned a scholarship to a top art school. “When I was preparing my art portfolio by attending a class at the University of Michigan in medical illustration, I was introduced to the prosthetic profession,” he recalls. “I felt a connection with the art, creativity, and medicine. I have known I wanted to be a prosthetist since I was 17 years old.” After earning a Bachelor of Arts degree from Baldwin Wallace College in Ohio and then completing graduate certificates in orthotics and prosthetics at Northwestern University, Kahle spent the early part of his career as a clinician in private practice. Once certified, he spent seven years at Hanger P&O in San Diego. During that time, his interest in research grew quickly. “I always wanted to have a research side to my clinical career, and conducted and published two amputee journal articles in my first position in California,” he says. Kahle’s next position involved a move to Westcoast Brace & Limb in Tampa, where he served as director of lower-extremity prosthetics for 10 years. “In that position, I was able to negotiate an award from Ottobock comparing the C-leg to nonmicroprocessor knees,” he says. “I also began teaching O&P to physical therapy students at the University of South Florida (USF).”

PHOTO: Jason Kahle, MSMS, CPO, LPO

may be one of the best known names in O&P research. His accomplishments include a career in O&P spanning 25 years, millions of dollars in federal grant funding to research and improve prosthetics, and nearly 100 articles published in various journals and magazines. But his future was not always so certain. After battling what was considered a terminal illness at age 7 and undergoing a groundbreaking procedure to save his life, Kahle now believes “he was put on this earth and offered a second chance at this life for a reason.” Fortunately for the orthotic and prosthetic community, that “reason” is to be an important contributor to the O&P profession. Kahle, who currently is chief executive officer of OP Solutions

in Tampa, Florida, and also has a dual role as director of research/clinical prosthetist at Prosthetic Research and Design, says he lives every day like it’s his last and is always thankful for another. “My research projects and my company are my ‘kids.’ I’ve had a great life and am so thankful for it.”

PRINCIPAL INVESTIGATOR

OCTOBER 2018 | O&P ALMANAC

PHOTO: Jason Kahle, MSMS, CPO, LPO

he explains. “I try to focus on the He moved into an academic projects with clinical translation, setting as a research scientist/ or what is important to the staff prosthetist and subcontract prosthetist who just wants to know principal investigator/instructor which socket, knee, or foot [is most at USF, where he also attended appropriate for] their amputee an National Institutes of Health patients.” Kahle is co-principal (NIH) master’s level program in investigator with Highsmith medical science and earned his on a current project, funded MSMS, with a concentration in by DoD, looking at the use of a clinical and translational research distal sensor that communicates in 2012. Kahle worked closely with an amputee user’s smartwith M. Jason Highsmith, PhD, DPT, CP, in several research phone to add or take away a sock endeavors; they were awarded according to the distal pressure several large grants from the U.S. that is detected in real time. Department of Defense (DoD) Another significant project and the industry. Kahle and involves an award Kahle received Highsmith “really pushed each last year from DoD. Kahle himself other hard, and to this day are still is named as principal investigator, co-principal investigators on two and the prosthetic clinic he works ongoing grant awards,” Kahle says. in is the performing organization. Seven years ago, Kahle opened The study involves the Amputee his own firm, OP Solutions, a Coalition’s peer visitation program. company that offers clinical He also is in the process of dissemresources for the O&P industry. ination with Highsmith regarding “I decided to leave the university a DoD randomized clinical trial setting to start a company with of three different above-knee no limits to creativity,” Kahle sockets, and he presented prelimexplains. Among other solutions, inary research on this topic at last the company offers participamonth’s AOPA National Assembly. While many of Kahle’s studies tion in research opportunities Kahle still treats patients on a regular basis and have demonstrated the value of and assistance in translating uses his published studies to clinically translate O&P intervention—which could evidence into evidence-based the evidence to explain the benefits serve as useful outcomes data for practice—and he continues to of a particular prosthetic component. payors—his central focus is deterprioritize his research endeavors. “As an entrepreneur, I have mining whether an intervention is developed software tools including an “better” for the amputee user. “You have EHR [electronic health record] and a he explains. “The C-leg study [published to go into these projects with a hypothwebsite platform specifically for the in 2008 in the Journal of Rehabilitation esis, while eliminating bias,” he explains. “I O&P clinician. I use my past and ongoing Research and Development (JRRD)] only hope to play a role in payor considexperience with research and as a was our first significant clinical trial erations if what I reported on did, in fact, clinician to provide evidence-based tools publication,” and was one of several benefit the person living with limb loss. to help O&P clinics be more efficient studies at the time that helped change I am most concerned that the project policy—to secure reimbursement in I pick shows an effect, or a difference. and survive in today’s health-care certain cases for the advanced techThen I know the project was meaningful.” climate,” says Kahle. “As a researcher, Kahle’s studies have been funded I am a subcontractor on many past and nology by Medicare and private payors. by various sources throughout the present funded projects. I am involved Kahle considers some past publiyears, including DoD and AOPA, but as a principal investigative research cations and current projects related to he believes securing funds is becoming scientist and a clinical prosthetist.” socket research to be among his most increasingly difficult. “The RFPs are getsignificant accomplishments. Two of his articles compared ischial containProving the Value of ting more narrow and want larger patient populations, yet have limited budgets,” he ment (IRC) to subischial sockets and Prosthetic Intervention explains. “NIH gravitates towards ‘develwere published in 2013 (JRRD) and In terms of research focus, efficacy 2014 (Gait & Posture). “Any study that trials have played a central part in oping widgets,’ not clinical trials, when it clinically translates to help amputees Kahle’s contributions—“comparing one comes to funding, which leaves DoD as is important, and desperately needed,” thing—socket, knee, foot—to another,” the primary source for larger grants.”

PRINCIPAL INVESTIGATOR

Funds secured via manufacturing companies “are typically not as glamorous, especially if you work for a university, [but] they are important,” Kahle adds. He notes similarities with pharmaceutical companies funding medical research. “Drug companies have been paying for clinical trials since the 1980s. If industry funding is acceptable in drug trials—cancer, diabetes, heart disease—then it is certainly acceptable for our profession as well. Companies like Ottobock, which dedicate a significant amount of money year after year to research, should be applauded.” While O&P manufacturers are helping O&P clinicians prove the value in what they provide, Kahle concedes that identifying funding for and conducting O&P research is not an easy undertaking. “It takes approximately 150 hours to write a DoD proposal, and publishing can take 50 to 60 hours. Unless you have done it, it’s hard to appreciate how hard it is— and how rewarding it is when you ‘win.’”

Sharing Experiences

Despite the challenges, Kahle continues to dedicate a great deal of time and effort to research because he believes the value of O&P intervention must be substantiated. “Whether it’s sockets, knees, or feet—any project that helps justify our services is the most important right now,” he says. “The health-care climate has not been good for any provider in the last eight years. We have been particularly hammered. Value-based medicine is here; we are naive to think we will be excluded from that focus. Research should focus on the value of what we do.” Over the years, Kahle’s contributions have been recognized by various O&P organizations. He has received numerous awards, including several Thranhardt Awards for clinical presentations from both AOPA and the American Academy of Orthotists and Prosthetists, as well as a Hamontree Award for best business lecture at AOPA’s 2014 National Assembly. He also was honored with a Clinical Creativity Award from the Academy in 2015. In addition to his business and clinical responsibilities, Kahle serves

Notable Works

Jason Kahle, MSMS, CPO, LPO, has been involved in the publication of many important articles and papers over the course of his education and career. Some of his most impactful articles include the following: • Kahle J.T., Highsmith M.J., Hubbard S. “Comparison of Nonmicroprocessor Prosthetic Knee Mechanisms and the C- Leg in the PEQ, Stumbles and Falls, Walking Tests, Stair Descent, and Knee Preference.” Journal of Rehabilitation, Research, and Development 2008; 45(1): 1-13. https://www.ncbi.nlm.nih.gov/pubmed/18566922 • Kahle J.T., Highsmith M.J., Lunseth P., Kenney J.M., Ruth T., Ertl J.P. “Efficacy of the Transtibial Bone Bridge Procedure: A Systematic Review.” Prosthetics Orthotics International 2016. http://poi.sagepub.com/cgi/ reprint/0309364616679318v1.pdf?ijkey=vOAOGeF0sm4Vq47&keytype=finite • Kahle J.T., Highsmith, M.J., Schaepper J., Johannesson A., Orendurff M., Kaufman K. “Predicting Walking Ability Following Lower-Limb Amputation; An Updated Systematic Literature Review.” Technol Innov 2016; 18(2-3): 125-137. http://www. ingentaconnect.com/content/nai/ti/2016/00000018/f0020002 as a manuscript reviewer for several highly regarded peer-reviewed journals, including JRRD, Archives of Physical Medicine and Rehabilitation, Journal of Prosthetics and Orthotics, Journal of Rehabilitation Medicine, and Prosthetics and Orthotics International. Kahle attributes his success as a researcher partly to the beneficial partnerships in which he has been involved. He values the contributions of others— which may be big or small, but are always appreciated. “Getting input from someone smarter, with a higher-level degree and position than me, only helps my position,” he says. “I don’t think I have an ego, which helps because even though you may dedicate the most time on a project, one of your partners could make or break your study, even if they put in minimal time. You have to understand they have earned that respect and are successful and productive, with good reason. I also have been involved in many projects where I put in less effort, and am grateful for the opportunity to contribute and be included.” Kahle also finds serving as a mentor rewarding, especially to his research assistants. He is hopeful that others will get more involved in O&P research, and he encourages clinicians to consider reaching out to a known, respected

researcher. Kahle suggests choosing one who is well published and funded. “Ask how you can be part of the team and how can you significantly contribute. You have to be able to help them; the experience and knowledge is your reward.” He also counsels that clinicians should “be ready to volunteer hours— there are far more unpaid opportunities, but that is the best way to work yourself into a paid one. Especially if you come to a researcher with a creative idea.” Kahle—who also volunteers time working for a foundation that benefits veterans and low-income individuals— is eager to assist younger clinicians in achieving their research goals. “I would be willing to impart any knowledge and experience I have had to any young researcher who is ambitious about jumping into the game,” says Kahle. “I am always looking for someone [to whom] I can pass the torch.” Those young clinicians who seek to learn from Kahle will benefit not only from his extensive O&P knowledge base but also from his infectious positive attitude. “I live life every day like I’m lucky to live one more day,” Kahle says. And the O&P patient population is lucky to have Kahle—and dedicated O&P researchers like him— leading important O&P studies. O&P ALMANAC | OCTOBER 2018

COMPLIANCE CORNER

Points of Order The DME MAC CERT Outreach and Education Task Force clarifies requirements for dispensing orders and detailed written orders

Editor’s Note: Readers of Compliance Corner are now eligible to earn two CE credits. After reading this column, simply scan the QR code or use the link on page 50 to take the Compliance Corner quiz. Receive a score of at least 80 percent, and AOPA will transmit the information to the certifying boards.

CREDITS

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CREDITS P.50

This month’s Compliance Corner has been written by members of the Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Comprehensive Error Rate Testing (CERT) Outreach and Education Task Force. The task force shares its recommendations regarding different issues and questions affecting the orthotics and prosthetics community.

EMBERS OF THE DURABLE

Medical Equipment Medicare Administrative Contractor (DME MAC) Comprehensive Error Rate Testing (CERT) Outreach and Education Task Force analyze CERT data trends for different durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) categories. We continually notice that a consistent percentage of CERT errors in orthotics and prosthetics come from missing, invalid, or incomplete orders submitted to the CERT contractor. Understanding some important rules and requirements will assist O&P professionals with reducing errors related to dispensing orders and detailed written orders.

Who Can Order DMEPOS Items?

Let’s begin with a quick overview of the medical professionals who can write orders. Medicare’s Internet Only Manual (IOM) 100-8, Program Integrity Manual, Chapter 5, §5.2 -§5.2.4, “Rules Concerning Orders,” requires the following physicians or nonphysician practitioners to be enrolled in the Medicare program to 48

OCTOBER 2018 | O&P ALMANAC

be eligible to order/refer DMEPOS services for Medicare beneficiaries: • Doctor of medicine • Doctor of osteopathy (including osteopathic practitioner)— must be licensed to practice medicine and surgery • Doctor of dental surgery or dental medicine • Doctor of podiatry (for certain DMEPOS items) • Doctor of optometry • Physician assistant • Nurse practitioner • Clinical nurse specialist Once this requirement is met, the physician can write the dispensing order and detailed written order if he or she is treating the beneficiary for a condition that requires DMEPOS and if he or she has a valid National Provider Identifier (NPI). Each of the medical professionals listed above must be an entity legally authorized to practice by a state in which he or she performs this function as a physician. The services performed by a physician within these definitions are subject to any limitations posed

COMPLIANCE CORNER

by the state on the scope of practice. All claims for items billed to Medicare require an order (prescription). This order is not part of the Medicare beneficiary’s medical record, and any information on the order must be corroborated in the medical record.

Dispensing Orders

Most DMEPOS items billed by O&P suppliers can be provided based on a dispensing order. This dispensing order can be verbal or written and must contain the following: • Description of the item ordered • Medicare beneficiary’s name • Prescribing physician’s name • Date of the order • Prescribing physician’s signature (for a written dispensing order) or the supplier’s signature (for a verbal dispensing order) Suppliers may not dispense any item prior to receiving a verbal or written dispensing order. The date of the order

will either be the date the supplier is contacted by the prescribing physician (for a verbal order) or the date entered by the prescribing physician (for a written dispensing order). An example of a written dispensing order would be an order written on a physician’s prescription pad, as this document almost always has every element listed above. An example of a verbal dispensing order would be the physician’s nurse or office manager calling the supplier to request an orthosis for one of facility’s patients. The supplier would input the information on a template or directly into its system, and this would constitute the verbal dispensing order. The supplier would be required to use the date of the telephone contact to order the orthosis as the date of the verbal order.

Detailed Written Orders

Once a supplier has a dispensing order, it may provide the DMEPOS item to the Medicare beneficiary. However,

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the supplier is prohibited from billing the Medicare program until it receives a valid, signed detailed written order from the prescribing physician. Someone other than the physician (i.e., the supplier) can create and complete the detailed written order except for the signature and signature date (unless noted otherwise in policy instruction). A detailed written order must include the following: • Beneficiary’s name • Prescribing physician’s name • Date of the order • All items, options, or additional features that are separately billed or require an upgraded code; the description can be a narrative description—for example, “CROW walking boot”; a Healthcare Common Procedure Coding System (HCPCS) code; a HCPCS code narrative; or a brand name/model number • Prescribing physician’s signature • Signature date, if applicable (see below)

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COMPLIANCE CORNER

If the prescriber creates the detailed written order, only a single date—the “order date”—is required. This order date may be the date that the prescriber signs the document. If someone other than the prescriber (e.g., DME supplier) creates the detailed written order, then the prescription must be reviewed and personally signed and dated by the prescriber. In this scenario, two dates are required: an “order date” and a prescriber-entered “signature date.”

New Order Requirements

New orders are required for five distinct reasons: • A new detailed written order is required any time a new DMEPOS item is purchased or there is an initial rental. • If there is a change in the order for the accessory, supply, drug, etc., a new order is needed. This is not a common occurrence in the O&P industry since most items are purchased and do not require refills on recurring supplies or accessories for them. An example of this scenario could be for a beneficiary who requires a different quantity of mastectomy bras than was indicated on the original order. • A new order is needed if it is required on a regular basis per policy guidelines. There are no Local Coverage Determinations (LCDs) in the O&P industry where this requirement is applicable. • A new order is required for the replacement of a DMEPOS item. This includes replacement of an orthotic or prosthetic device after the Reasonable Useful Lifetime (RUL) concludes or replacement due to theft, loss, or irreparable damage. All DMEPOS items have a five-year RUL unless otherwise noted in policy. Certain orthotic items have a one-, two-, or three-year RUL as outlined in the related Policy Article for the LCD. An example of replacement due to loss might be a house fire where the beneficiary’s prosthetic foot is consumed in the fire. Medicare will pay for the replacement of the foot due to the fire, but the supplier will 50

OCTOBER 2018 | O&P ALMANAC

need a new order before it can bill the program for the prosthesis. • A new order also is needed when there is a change in the DME supplier and the new supplier is unable to obtain a copy of a valid order and documentation from the original supplier. The DME MACs rarely see this from the O&P industry as changes in suppliers typically occur with beneficiaries and their capped rental items (i.e., a hospital bed or manual wheelchair), which does not include O&P.

hinged knee brace, lower-limb prosthesis, or a major component (socket, knee, or foot) of the DMEPOS item. Here’s an example: The area surrounding the socket on a Medicare beneficiary’s prosthesis is cracked and additional ultralight materials are needed to reinforce the socket defect to put the prosthesis back into working condition. The certified prosthetist/ orthotist (CPO) would bill Medicare for a repair to the prosthetic limb, and an order would not be necessary since there was no replacement of the main DMEPOS item—in this case, the socket.

Reminders

In closing, please remember a few key points from this article. Note the nuances between dispensing and detailed written orders; realize the supplier can create the detailed written order prior to the physician signing and dating the document; and understand that suppliers should never bill Medicare for an item until they have a signed detailed written order in their possession. Editor’s Note: Look for future articles written by the DME MAC CERT Outreach and Education Task Force to appear in the Compliance Corner department in 2019.

Repairs to O&P Items

There may be instances in which the beneficiary’s orthosis or prosthesis is in need of a repair. Medicare does not require new detailed written orders to repair a DMEPOS item. Medicare defines the term “repair” to mean fix or mend and put the item back in usable condition after damage or wear. “Replace” means the provision of an identical or nearly identical item and refers to the DMEPOS item, such as a

Disclaimer: This information is accurate as of Aug. 13, 2018. Suppliers are strongly encouraged to read the applicable Local Coverage Determination, related Policy Article, and Standard Documentation Requirements for All Claims Submitted to the DME MACs (A55426) for the most up-todate guidance on coverage, coding, and documentation requirements. 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:

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MEMBER SPOTLIGHT

Priority Footwear

By DEBORAH CONN

A Mission To Save Feet Therapeutic shoe and insole provider serves diabetic patients and collaborates with O&P facilities

RIORITY FOOTWEAR TRACES ITS history back

OCTOBER 2018 | O&P ALMANAC

A staff member digitally tunes a foot impression before sending it to the mill for manufacture.

Guido van den Bos, a senior pedorthist, fits a customer. have to turn patients away.” Priority is successful, Clarke says, because its workflow is COMPANY: finely tuned to manage paperwork, medical certifications, and Priority Footwear Medicare and private insurer docOWNER: umentation. “Other than clinical expertise, our biggest strength is Kevin Clarke the ability to manage the paperwork so we can stay in business.” LOCATIONS: Priority bases its marketing Seattle and Spokane, efforts on word of mouth and Washington; Eugene partnering with public clinics and Portland, Oregon; and retirement homes. “We with additional don’t want to be too aggressive satellite offices in in our marketing,” says Clarke. the Northwest “Most of it is just making people aware of our existence and HISTORY: that they have coverage under 17 years Medicare’s therapeutic shoe bill.” Priority Footwear is in the midst of converting all paper patient records—which literally line the walls, Clarke says—to electronic medical records. Representatives and clinicians An orthotic milling machine at work in the field have begun carrying

electronic tablets to capture patient information. While the company is still using crush boxes to capture foot impressions, plans are to move to digital scans by next year. Clarke’s company became an AOPA member company in January. “I joined because it’s difficult to make ends meet in this business unless you do it exactly right,” Clarke says. “A year ago Medicare came out with guidance on therapeutic footwear that would have killed our ability to serve our patients under the therapeutic shoe bill. AOPA jumped in and did an outstanding job of advocacy, and Medicare ended up revising the rule. When I saw [AOPA’s] work, I knew I had to be a member.” Looking ahead, Clarke plans to remain focused on the Pacific Northwest, where his company can do a better job of reaching out to patients and serving them efficiently. “I estimate that in this area, around 140,000 people need our services. Last year we served about 12,000 of them, and we expect that number to quadruple.” Clarke emphasizes that Priority Footwear is a missiondriven company. “We will be uncompromising in our care,” he says. “Our mission is to save feet. It makes a difference, and it’s very gratifying.” Deborah Conn is a contributing writer to O&P Almanac. Reach her at deborahconn@verizon.net

PHOTOS: Priority Footwear

to Pacific Footwear Company, founded in 2001 in Portland, Oregon, as a specialty shoe manufacturing company. The demand for diabetic and therapeutic shoes became clear, and by 2005, the entity began doing business as Priority Footwear, with a sole focus on the therapeutic market. Kevin Clarke acquired the company in 2015. “I entered into this about three years ago after a career in technology,” he says. “I realized that it was an opportunity to make a difference in many people’s lives very quickly. Between 70 and 85 percent of people who needed this service in our area were not being served, and the result can be premature death. We can help people get back on their feet and truly save lives.” Priority manufactures orthotic insoles and distributes shoes with appropriate billing codes from a variety of vendors. About two thirds of Priority’s 40 full-time employees are certified therapeutic shoe fitters or pedorthists, who often serve patients in their own homes. A large proportion of Priority’s patient base is low-income, and clinicians go into some very difficult home situations, says Clarke. The company is increasingly partnering with O&P facilities. “The reimbursement rate isn’t high enough for many facilities to make it worthwhile to offer therapeutic shoe services, so a number of them contract with us to handle diabetic shoes and inserts,” he notes. “They’d rather partner with us than

Realize the facts. O&P care improves quality of life and is cost effective! Learn more at MobilitySaves.org. The Study that Started MobilitySaves.org A major study, comparing patients using prosthetics versus patients without prosthetics had these findings: • They will have lower or comparable Medicare costs than patients who need, but do not receive, these services.

Reasons to visit MobilitySaves.org Find supporting data to get your device paid for

Learn about the study proving orthotic and prosthetic care saves money

• They will experience greater independence. • They can increase their physical therapy and become less bed-bound. • They will have fewer emergency room admissions and acute care hospital admissions. Share this significant news by using the educational tools provided at MobilitySaves.org. Mobility Saves Lives And Money!

See how amputees rallied when their prosthetic care was threatened

The Results Lower Limb Prosthetics Prosthetic patients experienced better quality of life and increased independence compared to patients who did not receive the prosthesis at essentially no additional cost to Medicare (or other payers).

O&P CARE IS A SAVER, NOT AN EXPENSE TO INSURERS! Visit MobilitySaves.org. Follow us on social media! “Search Mobility Saves” on Facebook, Twitter, and LinkedIn

MEMBER SPOTLIGHT

Spinal Technology

By DEBORAH CONN

Bracing for All Hours O&P fabricator adapts to customers’ schedules to provide spinal orthoses and more

OCTOBER 2018 | O&P ALMANAC

Spinal Technology President Jim Tierney reviews X-rays for brace design.

COMPANY: Spinal Technology OWNER: Jim Tierney LOCATIONS: West Yarmouth, Massachusetts, and Louisville, Kentucky HISTORY: 27 years

A CAD/CAM technician renders one of the company’s orthoses.

Technicians modify molds for various spinal orthoses.

scoliosis and pride ourselves in being versed in knowing and understanding the techniques applied in all the braces being used in the orthotic world,” he says. Tierney credits his success to some savvy business decisions early on. “When I first started with trauma bracing, most patients stayed in the hospital for two to four days after surgery, which allowed us time to make and deliver a device. We saw the trend moving to only one day in the hospital, and I knew we had to come up with a plan,” he says. Tierney met with representatives from UPS and FedEx and learned about their shipping processes. In 1996, after visiting the headquarters of both shippers, Tierney decided to build his second Spinal Technology facility in Louisville, Kentucky—home of UPS. “That gave me an edge” on trauma thoracolumbosacral (TLSO) braces, he says. The ability to ship overnight from Louisville meant that practitioners could order an orthosis as late as 9 or 10 p.m. EST at night and receive the finished product

Deborah Conn is a contributing writer to O&P Almanac. Reach her at deborahconn@verizon.net

PHOTOS: Spinal Technology

N 1975, JIM TIERNEY was 16 years old and attending a vocational high school welding program when he discovered and started working in the world of O&P. Tierney took part in the school’s cooperative educational program, which allowed him to alternately work full time for one week and after-school the next week. After graduation, Tierney spent 12 years in the idiopathic scoliosis clinics of Children’s Hospital of Boston—first as a technician and then as a clinician, working alongside physicians and physical therapists. “It was an enormous and vital education for me in understanding adolescent scoliosis,” he says. In 1991, Tierney decided to launch his own central fabrication company specializing in spinal deformities, making scoliosis and trauma braces. “Spinal Technology began as a small, boutique operation” in Massachusetts, he recalls, “but after we began attending regional O&P meetings, we started to expand. We only sell to CPOs, and a number of practitioners were already familiar with me and the quality of my work.” Today, the company, with 152 employees spread between its two locations, specializes in corrective scoliosis bracing. In addition to full daytime scoliosis bracing, Spinal Technology introduced a new device, the Providence Nocturnal Scoliosis® orthosis. Later, Tierney created the Flex Foam Body Brace®, for which he was granted a patent. “We realize there are more than just a few methods of managing adolescent

the next morning, especially if they were on the West Coast. “This was a great help to clinicians, too,” says Tierney. “Rather than having to drive to the hospital in the middle of the day, they could attend to their busy practice and swing by the hospital in the late afternoon or evening to serve trauma patients.” The result was a 50 percent expansion in Spinal Technology’s TLSO business. The company also embraced CAD/CAM early on. “A central fab facility is only as good as the number of molds you have,” says Tierney. “In 1994, I went to Europe and bought the largest carver I could find. We were able to increase our mold inventory from 900 to about 6,000.” Spinal Technology holds scoliosis education seminars at regional and national meetings and abroad, provides educational courses, and advertises in trade publications and on social media, says Bob Burns, director of marketing. The company also maintains a staff of certified practitioners and CAD/ CAM and other technicians to answer questions from customers. The company recently introduced a new bracing process, the SCT Modification SystemSM, which provides a precise and measurable analysis of rotational forces by considering the three planes of the body—the sagittal coronal, and transverse planes; and introduced a new program asking practitioners to send back in-brace X-rays of patients, so that Spinal Technology may more accurately assess and improve outcomes. “I come in every day trying to think up new ideas,” says Tierney. “Whether it’s a new manufacturing process or how we can support our customers better, there’s always room to grow.”

AOPA Celebrates Health-Care Compliance & Ethics Week November 4-10, 2018

HE SAVE T

DATE

10 NOV. 4-

2018

Save the Date!

Health-Care Compliance & Ethics Week Make plans to join your AOPA member colleagues in celebrating Health-Care Compliance and Ethics Week (HCEW), November 4-10. In its first year celebrating HCEW, AOPA energized more than 500 members of our community to participate in seminars, educate staff, and share their focus on ethical behavior with their patients and community. AOPA is organizing resources, education, prizes, and more to help your organization participate. With a week-long celebration of compliance and ethics, you have a great opportunity to introduce and reinforce your chosen themes. Your plans will rely in part on your organizationâ&#x20AC;&#x2122;s specific needs, but some basic goals may include:

AWARENESS of the Code of Conduct,

relevant laws/regulations, and other reporting methods, the organizationâ&#x20AC;&#x2122;s compliance and ethics staff, etc.

RECOGNITION of training completion,

compliance and ethics successes, etc.

REINFORCEMENT of a culture of compliance for which your organization strives.

AOPA has developed several free tools and resources to assist you. Visit our dedicated web page for tools, resources and more:

bit.ly/AOPAEthics

AOPA NEWS

AOPAversity Webinars NOVEMBER 14

DECEMBER 12

Evaluating Your Compliance Plan & Procedures: How To Audit Your Practice Proper preparation prevents poor performance—make sure your facility is fully prepared with an appropriate compliance plan. Participate in the November 14 webinar: • Review the elements of a compliance plan. • Learn how to test and evaluate the elements of a compliance plan. • Find out how to take action when compliance deficiencies are discovered. • Determine how and when to perform self-audits. • Learn how to create an in-house or self-audit.

Your source for advanced learning EARN CE CREDITS 56

OCTOBER 2018 | O&P ALMANAC

New Codes, Medicare Changes, & Updates Prepare for the new year by getting a head-start on the Health-Care Common Procedure Coding System (HCPCS) coding changes for 2019. Take part in the December 12 webinar, where you will:

• Learn about new HCPCS codes that will take effect Jan. 1, 2019 • Find out which codes will no longer be used as of Jan. 1, 2019 • Discuss verbiage changes to existing codes and how they may affect O&P businesses • Hear AOPA’s interpretation of why the changes are taking place • Look at other pertinent policy and legislative changes of which O&P facilities should be aware in order to succeed in 2019.

AOPA members pay $99 (nonmembers pay $199), and any number of employees may participate on a given line. Attendees earn 1.5 continuing education credits by returning the provided quiz within 30 days and scoring at least 80 percent. Register at bit.ly/2019webinars. Contact Ryan Gleeson at rgleeson@AOPAnet.org or 571/431-0836 with questions. Sign up for the entire series and get two webinars free. All webinars that you missed will be available as a recording. Register at bit.ly/2019webinars.

O&P PAC UPDATE

HE O&P PAC UPDATE provides infor-

mation on the activities of the O&P PAC, including the names of individuals who have made recent donations to the O&P PAC and the names of candidates the O&P PAC has recently supported. The O&P PAC would like to thank the following AOPA members for their contributions to the O&P PAC:

• Gerald Bernard Jr., CP • Jeffrey Brandt, CPO • Mitchell Dobson, CPO, FAAOP • Rick Fleetwood

• Michelle Hogan • Jon Naft, CPO • Michael Oros, CPO, FAAOP • Brad Ruhl

The purpose of the O&P PAC is to advocate for legislative or political interests at the federal level that have an impact on the orthotic and prosthetic community. The O&P PAC achieves this goal by working closely with members of the U.S. House of Representatives and Senate and other officials running for office to educate them about the issues, and help elect those individuals who support the orthotic and prosthetic community. To participate in, support, and receive additional information about the O&P PAC, federal law mandates that eligible individuals must first sign an authorization form, which may be completed online: bit.ly/pacauth.

NEW MEMBERS

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. At the end of each new facility listing is the name of the certified or state-licensed practitioner who qualifies that patient-care facility for membership according to AOPA’s bylaws. Affiliate members do not require a certified or state-licensed practitioner to be eligible for membership. At the end of each new supplier member listing is the supplier level associated with that company. Supplier levels are based on annual gross sales volume. Alchemy Orthotics and Prosthetics 12201 Industry Way, Ste. D Anchorage, AK 99515 907/562-0560 Patient-Care Facility Will Sundberg

American Limb & Orthopedic Company 201 E. Morthland, Ste 2 Valparaiso, IN 46383 219/531-7479 Patient-Care Facility Dagny Laur, CO, BOCP

Daily Medical 1289 N Air Depot Blvd. Midwest City, OK 73110 405/741-5666 Supplier Level 1 John O'Sullivan, BOCPO, LPO, CO

Kenney Orthopedics of Mt. Sterling 250 Foxglove Drive, Ste. 7 Mt. Sterling, KY 40353 859/498-1888 Patient-Care Affiliate Tom McIntosh

Kenney Orthopedics of Columbus 2525 California Street, Ste. B Columbus, IN 47201 812/214-4623 Patient-Care Affiliate Drew Wyant, CO, CPed

Kenney Orthopedics of Seymour 635 E. Tipton Street Seymour, IN 47274 812/271-1627 Patient-Care Affiliate Judy Myers

Kenney Orthopedics of London 100 Mt. View Drive, Ste. 300 London, KY 40741 606/862-9000 Patient-Care Affiliate Sandra Hensely Kenney Orthopedics of Morehead 220 Morehead Plaza Morehead, KY 40351 606/784-4255 Patient-Care Affiliate Keshia Owens

MUSC Prosthetic Orthotic Services LLC 135 Rutledge Avenue, 4th Floor, MSC 580 Charleston, SC 29425 843/876-7063 Patient-Care Affiliate Voxelcare SL Avda Universidad S/N PCE UMH Quorum III Elche 03202, Spain 34-545-2517 Supplier Level 1 Simon McClements

O&P ALMANAC | OCTOBER 2018

AOPA NEWS

CAREERS

Opportunities for O&P Professionals Job location key:

A few good businesses for sale.

- Northeast - Mid-Atlantic

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

- Southeast - North Central - Inter-Mountain

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

- Pacific

Hire employees and promote services by placing your classified ad in the O&P Almanac. When placing a blind ad, the advertiser may request that responses be sent to an ad number, to be assigned by AOPA. Responses to O&P box numbers are forwarded free of charge. Include your company logo with your listing free of charge. Deadline: Advertisements and payments need to be received one month prior to publication date in order to be printed in the magazine. 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. Submit ads by email to ymazur@AOPAnet.org or fax to 571/431-0899, along with VISA or MasterCard number, cardholder name, and expiration date. Mail typed advertisements and checks in U.S. currency (made out to AOPA) to P.O. Box 34711, Alexandria, VA 22334-0711. Note: AOPA reserves the right to edit Job listings for space and style considerations.

Color Ad Special 1/4 Page ad 1/2 Page ad

Member $482 $634

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

Member Nonmember $140 $280 $190 $380 $260 $520 $2.25 per word $5 per word

Nonmember $678 $830

ONLINE: O&P Job Board Rates Visit the only online job board in the industry at jobs.AOPAnet.org. Member Nonmember $85 $150

For more opportunities, visit: http://jobs.aopanet.org.

A large number of O&P Almanac readers view the digital issue— If you’re missing out, apply for an eSubscription by subscribing at bit.ly/AlmanacEsubscribe, or visit issuu.com/americanoandp to view your trusted source of everything O&P.

OCTOBER 2018 | O&P ALMANAC

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

Thank you to Our Supplier Plus Members

O&P Almanac Careers Rates

Job Board

WANTED!

AOPA Supplier Plus Partners Thank You to Our AOPA Supplier Plus Partners

AOPA Member

BENEFITS Contact AOPA to learn more about the benefits of membership today!

Get a competitive edge with exclusive face-to-face and distance learning opportunities on a variety of topics …plus valuable CEs!

It’s not just who you know, it’s who others know. Networking is powerful.

HAVE A VOICE Gain a say in what happens in government through AOPA’s advocacy efforts.

JOIN US!

LEARNING

NETWORKING

Call 571-431-0876 or email info@aopanet.org.

Why

JoOiPnA?

DISCOUNTS

Increase your purchasing power through members-only discounts on insurance, UPS, workplace apparel and credit card processing. B SCRU TOPS

VISIBILITY

Let your business stand out and get noticed by peers, patients, and your community. Mobility Saves Lives & Money.

CREDIBILITY

Improve documentation with coding, billing, and audit resources and research so you get fairly paid for services while providing excellent patient care.

Membership has its benefits:

BUILD A

Better BUSINESS WITH AOPA

Visit www.AOPAnet.org/join

Learn more at www.AOPAnet.org/join

MARKETPLACE

Feature your product or service in Marketplace. Contact Bob Heiman at 856/673-4000 or email bob.rhmedia@comcast.net. Visit bit.ly/almanac18 for advertising options.

ALPS ECO Liner Designed with the end user in mind, the ECO Liner is the newest seamless liner by ALPS. Featuring ALPS HD Gel, the firm nature of the gel provides active amputees with a great degree of control while still providing superior comfort. In addition, it utilizes a new distal construction with reduced stretch to control distal distraction. For more information, visit us at www.easyliner.com.

Central Fabrication Services Give us the opportunity to lessen the demands of your in-house fabrication team so your clinicians can devote more of their time to their patients and/or marketing new referral sources. Our highly trained technicians at Anatomical Concepts can provide a wide variety of custom-made lower-extremity orthoses, such as thermoplastic ankle-foot orthoses (AFOs), knee orthoses, and knee-ankle-foot orthoses (KAFOs), as well as functional and accommodative foot orthotics. Any of our AFOs from our prefabricated PRAFO® family can be implemented to any custom-made KAFO system due to their unique modular designs for exceptional stability and patient comfort. For more information, visit AnatomicalConceptsInc.com, call 800/837-3888, or email info@anatomicalconceptsinc.com.

“Itching” for a New Material?

• Nontoxic, noncarcinogenic, and inert alternative to carbon fiber. • Has little to no itch. • Made from basalt (lava rock), a 100 percent natural fiber. We found you can save at least 31 percent by using Coyote Composite compared to carbon fiber. For a list price and a more comprehensive list of reasons why you should switch to Coyote Composite, go to www.coyotedesign.com or call 208/429-0026.

OCTOBER 2018 | O&P ALMANAC

Make More Possible With the New 2018 ‘Crossover’ Knee The world’s first hybrid prosthetic knee that is user adaptable for walking, running, or sports. • Walking knee transforms into an activity knee • Mimics natural muscle function • Adjustable tendon durometers • Adjustable flexion range requiring no tools • Adjustable dampening and rebound • 275 lbs K2-K4+ activity • Use in any environment • Light and strong • Hybrid design. Call us about our evaluation program! Call 800/322-8324 or visit www.fabtechsystems.com.

NEXO™ by Fillauer® The Fillauer’s NEXO line provides simple, innovative alternatives for patients with transradial and transhumeral limb loss. NEXO’s PEEK rods are lightweight and strong. Because of their flexibility, they reduce rotational and perpendicular vibration and provide force damping to the residual limb. The rods may be trimmed to length and bent for alignment changes. NEXO provides two wrist options: the USMC-style quick disconnect wrist, previously only available for use in an exoskeletal system, and a lightweight friction wrist. All NEXO systems are easy to build and up to 50 percent lighter than existing prostheses. For more information, contact Fillauer at 423/624-0946 or visit www.Fillauer.com.

MARKETPLACE 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 ankle-foot 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.

Pro-Flex®—Less Load, More Dynamics™ Introducing Pro-Flex LP Align, which couples up to 2 3/4 inches of heel height adjustability with the mechanical power of the three-blade Pro-Flex design—so users can maintain proper alignment across a variety of everyday footwear, from sandals to sneakers to dress shoes. Visit ossur.com/pro-flex-family or ask your Össur representative about a Pro-Flex demo today.

New DVS Liner for Improved Sealing We know you’ve been waiting for this, and we’re pleased to announce that the new Ottobock 6Y94 DVS Partial Covered Liner is now available. With magnetic integration, this updated liner keeps an even better seal, while the DVS pump helps stabilize limb volume fluctuations creating a great connection through both swing and stance phases of gait. Ask your sales representative or visit professionals.ottobockus.com for details.

Ottobock’s WalkOn® Carbon-Fiber AFO WalkOn ankle-foot orthoses (AFOs) are prefabricated from advanced prepreg carbon composite material designed to help users with dorsiflexion weakness walk more naturally. WalkOn AFOs are lightweight, low profile, and extremely tough. Their dynamic design can help patients achieve a more physiological and symmetrical gait, offering fluid rollover and excellent energy return. WalkOn offers a full range of AFO sizes and designs, including the WalkOn Reaction Junior pediatric sizes. Fast and easy to fit, the WalkOn footplate is trimmable and can be shaped with scissors, often requiring only one office visit. Contact us at 800/328-4058 or professionals. ottobockus.com for details.

Spinal Technology Spinal Technology Inc. is a leading central fabricator of spinal orthotics, upper- and lowerlimb orthotics, and prosthetics. Our ABC-certified staff orthotists/ prosthetists collaborate with 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 Scoliosis System, a nocturnal bracing system designed to prevent the progression of scoliosis, and the patented FlexFoam™ spinal orthoses. For information, contact 800/253-7868, fax 888/775-0588, email info@spinaltech.com, or visit www.spinaltech.com.

O&P ALMANAC | OCTOBER 2018

CALENDAR

2018

November 1

October 10

Year-End Review: What Should You Do To Wrap Up the Year & Get Ready for the New Year? Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

ABC: Application Deadline for Certification Exams. Applications must be received by November 1 for individuals seeking to take the January Written and Written Simulation certification exams. Contact 703/836-7114, email certification@abcop.org, or visit www.abcop.org/certification.

WEBINAR

October 18–20

International African-American Prosthetic Orthotic Coalition Annual Meeting. Embassy Suites Downtown Medical Center, Oklahoma City. For more information, contact Tony Thaxton Jr. at 404/875-0066, email thaxton.jr@comcast.net, or visit www.iaapoc.org.

October 20

Advancements in Conservative Treatments of Scoliosis. San Mateo, CA. Schroth instructors, orthotists, and MDs from around the country will be joining us to discuss topics relating to conservative and surgical scoliosis treatment. Grant Wood, Align Clinic, and Beth Janssen, Scoliosis Rehab. For more information, visit www.align-clinic.com or email evaldez@align-clinic.com.

October 27

POMAC (Prosthetic and Orthotic Management Associates Corporation) Fall Continuing Education Seminar. LaGuardia Airport Plaza Hotel, New York. Contact Drew Shreter at 800/946-9170, ext. 101, or email dshreter@pomac.com.

November 1

ABC: Practitioner Residency Completion Deadline for Winter CPM 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 www.abcop.org/certification.

November 4–10

Health-Care Compliance & Ethics Week. AOPA is celebrating Health-Care Compliance & Ethics Week and is providing resources to help members celebrate. Learn more at bit.ly/aopaethics.

November 5–10

ABC: Written and Written 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 300 locations nationwide. Contact 703/836-7114, email certification@abcop.org, or visit www.abcop.org/certification.

November 7–9

NJAAOP. Harrah’s, Atlantic City, NJ. For more information, visit www.njaaop.com. Contact Brooke Artesi, CPO, LPO, with questions at Brooke@sunshinepando.com.

Apply Anytime!

Apply anytime for COF, CMF, CDME; test when www.bocusa.org ready; receive results instantly. Current BOCO, BOCP, and BOCPD candidates have three years from application date to pass their exam(s). To learn more about our nationally recognized, in-demand credentials, or to apply now, visit www.bocusa.org.

your next event!

Cascade Dafo Institute offers eight free ABC-approved online continuing education courses for pediatric practitioners. Earn up to 11.75 CE credits. Visit cascadedafo.com or call 800/848-7332.

CE For information on continuing education credits, contact the sponsor. Questions? Email ymazur@AOPAnet.org.

Calendar Rates Let us

Free Online Training

CREDITS

Phone numbers, email addresses, and websites are counted as single words. Refer to www.AOPAnet.org for content deadlines. Send announcement and payment to: O&P Almanac, Calendar, P.O. Box 34711, Alexandria, VA 22334-0711, fax 571/431-0899, or email ymazur@AOPAnet.org along with VISA or MasterCard number, the name on the card, 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.

OCTOBER 2018 | O&P ALMANAC

Words/Rate

Member

Nonmember

25 or less

$40

$50

26-50

$50 $60

51+

$2.25/word $5.00/word

Color Ad Special 1/4 page Ad

$482

$678

1/2 page Ad

$634

$830

CALENDAR November 12–13

2018 Mastering Medicare: Essential Coding & Billing Seminar Coding & Billing Techniques Seminars. Las Vegas. Register online at bit.ly/2018billing. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

November 14

Evaluating Your Compliance Plan & Procedures: How To Audit Your Practice. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org. WEBINAR

December 12

New Codes, Medicare Changes, & Updates. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org. WEBINAR

2019 January 9

November 28–30

New England Chapter AAOP. Please join us at Mohegan Sun in Connecticut for an outstanding ABC/ BOC continuing education program. Registration and more information at www.neaaop.org.

Understanding the KO Policy. Register online at bit.ly/2019webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org. WEBINAR

February 23–24

December 1

ABC: Practitioner Residency Completion Deadline for January 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 www.abcop.org/certification.

PrimeFare Central Regional Scientific Symposium 2019. Renaissance Hotel Tulsa, OK. Contact Cathie Pruitt at 901/359-3936, email primecarepruitt@gmail.com; or Jane Edwards at 888/388-5243, email jledwards88@att.net; or visit www.primecareop.com.

December 6–8

Shirley Ryan AbilityLab: Elaine Owen. Pediatric Gait Analysis and Orthotic Management: An Optimal Segment Kinematics and Alignment Approach to Rehabilitation (OSKAR). Chicago. 25.5 ABC credits approved. For more information, contact Melissa Kolski, call 312/238-7731, or visit www.sralab.org/academy/PedsGait18.

September 25–28

AOPA National Assembly. San Diego Convention Center. For general inquiries, contact Ryan Gleeson at 571/431-0836 or rgleeson@AOPAnet.org, or visit www.AOPAnet.org.

AD INDEX

Advertisers Index Company

Page

Phone

Website

ALPS

5 800/574-5426 www.easyliner.com

Amfit

31 800/356-3668 www.amfit.com

Anatomical Concepts Inc.

800/837-3888

www.anatomicalconceptsinc.com

College Park Industries

800/728-7950

www.college-park.com

Coyote Design

800/819-5980

www.coyotedesign.com

Custom Composite

866/273-2230

www.cc-mfg.com

Fabtech Systems LLC

1-800-FABTECH

www.fabtechsystems.com

Ferrier Coupler Inc.

810/688-4292

www.ferrier.coupler.com

Fillauer

51 800/251-6398 www.fillauer.com

Flo-Tech O&P Systems Inc.

800/356-8324

www.1800flo-tech.com

Hersco

1 800/301-8275 www.hersco.com

Naked Prosthetics

Össur

9 800/233-6263 www.ossur.com

Ottobock Spinal Technology Inc.

888/977-6693

www.npdevices.copm

36, 37, C4

800/328-4058

www.professionals.ottobockus.com

800/253-7868

www.spinaltech.com O&P ALMANAC | OCTOBER 2018

ASK AOPA CALENDAR

Proper ID Answers to your questions about the new Medicare ID cards, delivery records, and more AOPA receives hundreds of queries from readers and members who have questions about some aspect of the O&P industry. Each month, we’ll share several of these questions and answers from AOPA’s expert staff with readers. If you would like to submit a question to AOPA for possible inclusion in the department, email Editor Josephine Rossi at jrossi@contentcommunicators.com.

OCTOBER 2018 | O&P ALMANAC

When will all currently enrolled and newly enrolled Medicare patients receive the new Medicare identification (ID) cards with the Medicare Beneficiary Identifier (MBI) number instead of the old Health Insurance Claim Number (HCIN)? And when must we begin to use the MBI?

Any new Medicare enrollees should automatically receive a Medicare ID card with the MBI, and all currently enrolled Medicare patients should receive a new Medicare ID card and MBI by April 2019. Mandatory use of the MBI numbers begins in January 2020. You may begin using the MBIs as soon as your patients receive their new cards. There is a short transition period when you may use either the HCIN or MBI. During this transition period, Medicare will respond to your transactions with the identifier (HCIN or MBI) you used. For example if you submitted a claim with an HCIN, then the explanation of benefits/ remittance advice will use the HCIN. Note that using either identifier will only be allowed temporarily. Beginning on Jan. 1, 2020, you may no longer use the HCIN; you will be required to use MBIs for all Medicare-covered transactions—with a few exceptions. In the case of appeals, you may file using HCINs with dates of service prior to Jan. 1, 2020. Also, for any claim status inquiry with a date of service prior to Jan. 1, 2020, you may use either the HCIN or MBI.

When using a delivery service (UPS, FedEx, U.S. Postal Service, etc.) to deliver an item to a patient, what should we use as the delivery date in our records?

If you utilize a shipping service, your date of delivery/date of service becomes the date you mailed the item(s), and not the date or the anticipated date of delivery or when the patient actually receives the shipment.

Are we able to use the L-code descriptor on our proof of delivery forms?

Yes, it is acceptable to use the L-code descriptor on your proof of delivery forms as a means of describing the items you are providing. However, there is one caveat: You must use the full and complete descriptor, meaning you may not use an abbreviated version or just the code.

Are we allowed to provide gifts to our patients?

Yes, but you must keep some rules or restrictions in mind. First and foremost, gifts of cash or cash equivalents (gift certificates or gift cards) of any type are strictly prohibited. Second, the use of nonmonetary gifts is acceptable as long as they are of nominal value. (For details regarding gift-giving regulations, see the Reimbursement Page article on page 20.)

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