November 2014 O&P Almanac by AOPA

The Magazine for the Orthotics & Prosthetics Profession

N OV E M B E R 2014

E! QU IZ M EARN

7 Steps To End 2014 on a High Note

BUSINESS CE

CREDITS P.18

P.16

Fighting Back Against the Next Pandemic P.30

2014 Buyersâ&#x20AC;&#x2122; Guide to Foot Care P.46

O&P in 3D WWW.AOPANET.ORG

Is this open-source technology a friend or foe to the profession?

This Just In: Tennesseans Plant a Seed for the Nation P.20

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NOVE M B E R 2014 | VOL. 63, NO. 11

contents

FEATURES

DEPARTMENTS | COLUMNS President’s View....................................... 4

Insights from AOPA President Anita Liberman-Lampear, MA

AOPA Contacts............................................6

COVER STORY

How to reach staff

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

At-a-glance statistics and data

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

Research, updates, and industry news

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

Transitions in the profession

22 | O&P in 3D At a recent event, 3D printing was used by individuals outside of traditional O&P to create prosthetic hands for children, touching off a heated debate in the profession. Some see it as a disruptive technology with many limitations, while others consider it a solution for underserved populations. O&P Almanac investigates. By Christine Umbrell

20 | This Just In

46 | 2014 Buyers’ Guide to Foot Care Our annual guide is back with the foot-care products and services you need to meet your patients’ needs.

Brunswick Orthotics & Prosthetics LIM Innovations

AOPA News................................................ 38

AOPA meetings, announcements, member benefits, and more

P. 30

Welcome New Members .................. 43

Milestones................................................. 44

Celebrating 60 Years at Dankmeyer Prosthetics and Orthotics Inc.

Careers........................................................ 50

Professional opportunities

Calendar...................................................... 52

P. 46

BUYERS’ GUIDE to

Upcoming meetings and events Contents 46 Custom Fabrication 47 Custom Foot Orthotics

The annual one-stop resource for O&P foot-care products and services

47 Lower-Limb Devices

CAD/CAM Casting and Fabrication Amfit, Inc.

Vancouver, WA 98665 360/573-9100 www.amfit.com

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Advertise with Us! For advertising information, contact Bob Heiman

46 NOVEMBER 2014 | O&P ALMANAC

Ad Index....................................................... 55

46 CAD/CAM Casting and Fabrication

FOOT-CARE

at 856/673-4000 or email bob.rhmedia@comcast.net.

CE Opportunity to earn up to 2 CE credits by taking the online quiz.

CREDITS

30 | The Next Global Pandemic With 592 million cases expected worldwide by 2030, diabetes is a global health emergency. But with a better understanding of the disease and a standard in preventative and ongoing foot care, practitioners can fight back against this deadly disease. By Katia Langton, DC, CPed

Prepping for 2015

Seven steps to end 2014 on a high note

Member Spotlight................................. 34

P. 20

Tennesseans Plant a Seed for the Nation This summer, the O&P community partnered with state leaders to defeat a reimbursement reduction in the Volunteer State and elevate the profession in the eyes of state payers. By Greg Armstrong, BSPO, CPO/L

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

47 Liners

47 Pediatric Orthoses

Ask AOPA................................................... 56 Expert answers to your questions about verification by PDAC contractors

Central Fabrication Amfit, Inc.

Vancouver, WA 98665 360/573-9100 www.amfit.com

Central Fabrication You need to save time. You also want to save money. Trust Amfit with fabrication of custom foot orthotics and free up lab time for bigger projects. A5513 approved Diabetic program is as low as 3/$60 (shipping included). 5 EVA styles, polypropylene, and carbon fiber options round out the options. Foam box orders are shipped in 3-5 business days, Amfit digital records in 2 business days. Our primary focus for nearly 30 years has been custom foot orthotics and orthotic technology. Amfit. Where Technology Fits...Perfectly.

COVER Photo: Jen Owen

O&P ALMANAC | NOVEMBER 2014

PRESIDENT’S VIEW

Reflecting on the Past Year

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

HANK YOU ALL FOR the support and attendance at the National Assembly in September. The “This Just In” sessions drew a standing-room-only crowd in Las Vegas for good reason. Attendees there were looking for helpful guidance that could bolster their ability to survive the mountain of challenges being thrown our way. However, it was clear from the very positive energy that permeated the meeting that O&P is back in high gear and ready to find ways of coping with all the current and coming waves of regulatory challenges. While serving as your president for the past 12 months, it has never ceased to amaze me how our organization, with the combined will of our members and leadership, could come up with so many responses to so many issues. No, we didn’t solve all the problems. We didn’t make audits go away, and we certainly didn’t transform Medicare’s way of doing business so we could better serve our patients. But, we did make some headway. It’s a fair observation that our litigation effort may have had some impact even though our lawsuit was dismissed. Our basic claim was that CMS didn’t follow the rules on making a major policy change when it merely published on its website the “Dear Physician” letter as a done deal. It should have gone through a proper notice published in the Federal Register allowing for a comment period in a process mandated by the Administrative Procedure Act. Since then, CMS has properly followed the rules on proposing the two major changes involving prior authorization on lower-limb prosthetics and OTS definitions. That’s a good thing regardless of how it turns out. (See page 18 —Late Breaking News) What this past year has really meant to me has been the nearly daily exposure to the threats affecting what we do and how we deliver patient care. It never occurred to me before becoming active in AOPA’s leadership that an association like AOPA has so many “buckets” to deal with at the same time. Fighting for our very survival on Capitol Hill, dealing with Medicare, conducting another big annual meeting, or just responding to everyday member queries can be pretty daunting tasks. But for me, it has been one terrific opportunity to give back to an organization and the O&P community that has become my life’s work. And so much has been learned from my colleagues these past eight years on the board and executive board that will serve that life’s work well in the coming years. I guess I was pretty accurate when I said in my acceptance speech in Orlando in 2013 that even my favorite Harry Potter wand wasn’t going to be much help. However, a lot of hard work and commitment to you and AOPA has hopefully accomplished a lot in one year! I really liked Charlie Dankmeyer’s remarks at the Annual Business Meeting when he accepted his role as president. He said, “There are three fundamental things—secure our service turf, qualified provider recognition, and payment for services.” Then he asked the audience, “Do you want those three things?” Of course, the answer was a resounding “Yes.” Next he asked for your help. And so do I. As Charlie said, “Let’s get it done!” and I hope you will support him as you have supported me as he takes the reins in December. Thank you all for a wonderful and memorable year.

Board of Directors OFFICERS

President Anita Liberman-Lampear, MA University of Michigan Orthotics and Prosthetics Center, Ann Arbor, MI President-Elect Charles H. Dankmeyer Jr., CPO Dankmeyer Inc., Linthicum Heights, MD Vice President James Campbell, PhD, CO Becker Orthopedic Appliance Co., Troy, MI Immediate Past President Tom Kirk, PhD Member of Hanger Inc. Board, Austin, TX Treasurer James Weber, MBA Prosthetic & Orthotic Care Inc., St. Louis, MO Executive Director/Secretary Thomas F. Fise, JD AOPA, Alexandria, VA DIRECTORS Maynard Carkhuff Freedom Innovations, LLC, Irvine, CA Jeff Collins, CPA Cascade Orthopedic Supply Inc., Chico, CA Alfred E. Kritter Jr., CPO, FAAOP Hanger, Inc., Savannah, GA Eileen Levis Orthologix LLC, Trevose, PA Ronald Manganiello New England Orthotics & Prosthetics Systems LLC, Branford, CT Dave McGill Össur Americas, Foothill Ranch, CA Michael Oros, CPO Scheck and Siress O&P Inc., Oakbrook Terrace, IL Scott Schneider Ottobock, Minneapolis, MN

Anita Liberman-Lampear, MA AOPA President

NOVEMBER 2014 | O&P ALMANAC

Don Shurr, CPO, PT American Prosthetics & Orthotics Inc., Iowa City, IA

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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

Our Mission Statement The mission of the American Orthotic & Prosthetic Association is to work for favorable treatment of the O&P business in laws, regulation and services; to help members improve their management and marketing skills; and to raise awareness and understanding of the industry and the association.

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

EXECUTIVE OFFICES Thomas F. Fise, JD, executive director, 571/431-0802, tfise@AOPAnet.org Don DeBolt, chief operating officer, 571/431-0814, ddebolt@AOPAnet.org MEMBERSHIP & MEETINGS Tina Moran, CMP, senior director of membership operations and meetings, 571/431-0808, tmoran@AOPAnet.org Kelly O’Neill, CEM, manager of membership and meetings, 571/431-0852, koneill@AOPAnet.org Lauren Anderson, manager of communications, policy, and strategic initiatives, 571/431-0843, landerson@AOPAnet.org Betty Leppin, manager of membership services and operations, 571/431-0876, bleppin@AOPAnet.org

O&P ALMANAC Thomas F. Fise, JD, publisher, 571/431-0802, tfise@AOPAnet.org Josephine Rossi, editor, 703/662-5828, jrossi@contentcommunicators.com Catherine Marinoff, art director, 786/293-1577, catherine@marinoffdesign.com Bob Heiman, director of sales, 856/673-4000, bob.rhmedia@comcast.net Christine Umbrell, editorial/production associate and contributing writer, 703/662-5828, cumbrell@contentcommunicators.com Lia K. Dangelico, contributing writer, ldangelico@contentcommunicators.com

AOPA Bookstore: 571/431-0865 GOVERNMENT AFFAIRS Joe McTernan, director of coding and reimbursement services, education and programming, 571/431-0811, jmcternan@AOPAnet.org Devon Bernard, assistant director of coding and reimbursement services, education, and programming, 571/431-0854, dbernard@AOPAnet.org 6

NOVEMBER 2014 | O&P ALMANAC

Advertising Sales RH Media LLC Design & Production Marinoff Design LLC Printing Dartmouth Printing Company 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 almanac@AOPAnet.org. Yearly subscription rates: $59 domestic, $99 foreign. All foreign subscriptions must be prepaid in U.S. currency, and payment should come from a U.S. affiliate bank. A $35 processing fee must be added for non-affiliate bank checks. O&P Almanac does not issue refunds. Periodical postage paid at Alexandria, VA, and additional mailing offices. ADDRESS CHANGES POSTMASTER: Send address changes to: O&P Almanac, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314. Copyright © 2014 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.

Reimbursement/Coding: 571/431-0833, www.LCodeSearch.com

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Reach out to AOPA’s membership and 15,000 subscribers. Engage the profession today. Contact Bob Heiman at 856/673-4000 or email bob.rhmedia@comcast.net. Visit bit.ly/aopa14media for advertising options!

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NUMBERS

U.S. Diabetes Rates Level Off— But Not for Minorities CDC shows rising incidence of the disease among Blacks, Hispanics, and Native Americans Approximately 9 percent of the U.S. population has diabetes, according to the latest research published in the CDC’s “The National Diabetes Statistic Report, 2014” and an article in the Journal of the American Medical Association titled “Prevalence and Incidence Trends for Diagnosed Diabetes Among Adults Aged 20 to 79 Years, United States, 1980-2012.” These numbers indicate that while the incidence of diabetes is not increasing overall, the disease is becoming more prevalent among certain demographics.

28% OF DIABETES CASES GO UNDIAGNOSED

1.7 MILLION NEW CASES EACH YEAR

PERCENTAGES INCREASE WITH AGE

371,000 3.6% of people ages 20-44 are diagnosed annually.

892,000

12% of people ages 45-64 are diagnosed annually.

400,000

11.5% of people ages 65 and older are diagnosed annually.

21.0 Million

60%

8.1 Million

Nearly two thirds of the 70,000 nontraumatic lower-limb amputations among adults in 2010 occurred in people with diagnosed diabetes.

More than 20 million people currently have diagnosed diabetes.

Another 8 million people with diabetes have gone undiagnosed.

Ages 20-44 4% of people ages 20 to 44 have diabetes (4.3 million).

Ages 45-64

16% of people ages 45 to 64 have diabetes (13.4 million).

Ages 65+ 26% of people older than 64 have diabetes (11.2 million).

INEQUITIES AMONG THE DEMOGRAPHICS Percentages of People in the U.S. Ages 20 or Older With Diagnosed Diabetes By Race/Ethnicity, 2010-2012 Non-Hispanic Whites 7.6% Asian Americans 9.0% Hispanics 12.8% Non-Hispanic Blacks 13.2% Native Americans/Alaska Natives 15.9% 8

NOVEMBER 2014 | O&P ALMANAC

“In light of the well-known excess risk of amputation, blindness, end-stage renal disease, disability, mortality, and health-care costs associated with diabetes, the doubling of diabetes incidence and prevalence [among minority groups] ensures that diabetes will remain a major public health problem that demands effective prevention and management programs.” —Linda S. Geiss et al., Division of Diabetes Translation, CDC, in “Prevalence and Incidence Trends for Diagnosed Diabetes Among Adults Aged 20 to 79 Years, U.S., 1980-2012”

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Happenings LATEST ON LICENSURE

Alabama Introduces Online Licensure Renewal The Alabama State Board of Prosthetists and Orthotists has launched an online licensure renewal service. The organization has partnered with Alabama Interactive to implement the service, which allows O&P practitioners to renew their licenses online with just a few steps. From Oct. 1, 2014, through Jan. 31, 2015, prosthetists, orthotists, assistants, licensed fitters, and orthotic suppliers can renew their licenses online, including their facility’s accreditation. Licensees can visit www.alabamainteractive.org and search for “licensure renewal,” or visit www.Alabama.gov and visit the “Professional” section. For more information about the Alabama State Board of Prosthetists and Orthotists, visit www.apob.alabama.gov.

DIABETES DOWNLOAD

Breakthrough Treatment for Type 1 Diabetes Stem cell researchers from Harvard University have announced a breakthrough in their quest to find an effective treatment for Type 1 diabetes. Using human embryonic stem cells, Douglas Melton, PhD, and his team were able to produce, in mass quantity, human insulin-producing beta equivalent to normally functioning beta cells. The findings are a culmination of 15 years spent researching a recipe for making beta cells—the cells that sense the level of sugar in the blood and keep it in a healthy range by making precise amounts of insulin. Melton and his team say they have pioneered a technique to grow, by the billions, the insulin-producing cells that are lacking in people who have diabetes. The next step will be using this information to identify new ways to treat the disease. Laboratories will be able to use the cells to test drugs

and learn more about how diabetes occurs, according to the researchers. “This is part of the holy grail of regenerative medicine or tissue engineering, trying to make an unlimited source of cells or tissues or organs that you can use in a patient to correct a disease,” says Albert Hwa, director of discovery science at the Juvenile Diabetes Research Foundation International, a New York-based diabetes advocacy group that funded the research. For more information, see the October 9 issue of Cell journal.

INSURANCE INSIGHT

Miami Has Highest Uninsured Rate in U.S. Cities with the highest rates of uninsured residents have been identified in a new study, and Miami tops the list, with close to 25 percent uninsured. The information comes from 2013 U.S. Census data featuring the 25 most populous metro areas sorted by percent uninsured. Also high on the list are Houston, Dallas, Los Angeles, and San Antonio. These cities tend to have higher numbers of undocumented workers, 10

NOVEMBER 2014 | O&P ALMANAC

who are ineligible for Medicaid or other coverage, according to the study. By contrast, Boston has the lowest uninsured rate, at less than 5 percent. The overall numbers are expected to trend downward as the Affordable Care Act takes effect and more people sign up for coverage, although undocumented workers will continue to lack coverage. For more information, visit www.census.gov/acs.

Miami has close to 25% uninsured residents

HAPPENINGS

VA R&D

Pregnancy Prosthesis? The Department of Veterans Affairs is working in conjunction with Disabled American Veterans (DAV) to develop a prosthetic leg for pregnant women. Designing a prosthesis geared toward pregnant amputees is one of the recommendations made by the DAV, a veterans advocacy and assistance group, in its recently released report, “Women Veterans: The Long Journey Home.” Nearly 20 women lost all or part of a leg or legs while on duty in Iraq or Afghanistan, including Rep. Tammy Duckworth (D-Illinois), who is due to give birth in December.

“Pregnant women with limb loss experience increased wear on prosthetic components, need for realignment, and frequent modifications depending on socket and suspension,” according to the DAV report. “In addition, for women with above-knee amputations who need a caesarian section, a higher abdominal incision should be planned to avoid irritation by the socket brim.” No release date has been given for when a specialty prosthesis for pregnant amputees will be available, but the research is underway. Read more at www.military.com.

Military Service Members Who Suffered Amputations in Iraq and Afghanistan LIMB LOSS

Women Men Total

Single Lower-Extremity Single Upper-Extremity Double Lower-Extremity Double Upper-Extremity Double Upper-Extremity and Lower-Extremity Triple Upper-Extremity and Lower-Extremity Quadruple Upper-Extremity and Lower-Extremity TOTAL

15 933 948 3 186 189 4 410 414 1 9 9 — 32 32 — 51 51 — 5 5 23 1,626 1,649

Source: DoD-VA Extremity Trauma and Amputation Center of Excellence Registry, August 2014.

O&P ATHLETICS

U.S. Team Takes Gold in Paraclimbing Championship An American team of 14 men and women collected seven medals in the finals of the Paraclimbing World Championships, held in Gijón, Spain. The paraclimbing competition took place in conjunction with the International Federation of Sport Climbing lead and speed climbing world championships, held every two years. The following U.S. team members took home medals:

• Men, Leg Amputees: Ronald Dickson, second place; Craig DeMartino, third place • Women, Leg Amputees: Christa Brelsford, first place • Men, Arm Amputees: Ryan Snyder, first place • Women, Arm Amputees: Maureen Beck, first place • Women, Seated: Chloe Crawford, first place; Julia Sikut, second place.

Milwaukee Hosts First Swing Clinic A full-day First Swing Learn to Golf event was held in Waukesha, Wisconsin. The clinic offered teaching and hands-on instruction through the National Amputee Golf Association. The morning session, attended by area therapists, golf teaching pros, and O&P professionals, featured classroom instruction in methodology, terminology, adaptive devices, and Americans with Disabilities Act compliance for those with physical challenges. Students were then taken to the driving range and challenged to hit a golf ball with one arm, standing on one leg, from a seated position in a wheelchair, and with closed eyes. During the afternoon session, amputees, spinal cord injury patients, and stroke or brain injury survivors learned or relearned the game of golf. Participants had one-on-one time with therapists to work on driving, chipping, and putting. This event was made possible through the financial underwriting of the Ed Halperin Memorial Golf Outing held each year. Halperin, a bilateral below-knee amputee and avid golfer, was a patient of Kempfer Prosthetics Orthotics in Greenfield, Wisconsin.

O&P ALMANAC | NOVEMBER 2014

HAPPENINGS

#ICYMI

O&P OUTCOMES AWARDS

2015 Medicare Premiums and Deductibles Announced

$8.9 Million in Grant Funding Available

CMS has announced the Medicare premium and deductible rates for 2015. The monthly Medicare Part B premium will begin at $104.90, the same as the 2014 premium. The Medicare Part B deductible for 2015 has not increased and will remain set at $147; the Medicare Part B coinsurance remains at 20 percent of the Medicare allowed charge. The Medicare Part A deductible for 2015 is set $1,260, which represents a $44 increase over the 2014 amount. The daily co-insurance amount for days 61 to 90 is $315, and the lifetime reserve days rate is set at $630. The skilled nursing facility Part A extended care days (days 21 to 100) will be $157.50 for 2015.

Grant opportunities available through the Orthotics & Prosthetics Outcomes Research Award (OPORA) have been posted. These grant funds were part of the Department of Defense Omnibus Appropriations Bill at the direction of Sen. Richard Durbin (D-Illinois), whose office worked with AOPA’s research funding consultant Linchpin Strategies and its president Catriona Macdonald in directing the funding to be used for O&P research needs. The funding is intended to support research that evaluates the comparative effectiveness of and functional outcomes associated with prosthetic and orthotic clinical interventions and/or other rehabilitation interventions for service members and veterans who have undergone limb salvage or amputation. Closing date for grant proposals is Jan. 20, 2015. The goal of this program, whose funding is currently at $8.9 million, is to improve understanding of and ultimately advance the implementation of the most effective prescriptions for prosthetic and orthotic devices, treatment, rehabilitation, and secondary health effect prevention options for patients, clinicians, other caregivers, and policymakers. Proposed projects should be designed to provide outcomes data regarding O&P devices, and/or related clinical interventions, and must include the anticipated effect on patient-care metrics. Collaboration with military researchers and clinicians is encouraged, as are joint Department of Defense/ Department of Veterans Affairs studies, including longitudinal outcome studies. Studies also may be proposed that consider outcome factors related to health-care delivery and clinical decision making such as cost, accessibility, adoption of medical policy, and patient preferences. Studies should have a clinical focus and may include methodologies and designs

MEETING MASHUP

Going to Madrid: AOPA Collaborates With ORTO Medical Care’s 2014 Meeting AOPA has signed on to assist organizers at the ORTO Medical Care’s 2014 Meeting in preparing an agenda (scientific and touristic) geared specifically toward American professionals. Scheduled for November 20-21, the meeting’s organizers have designated the United States of America as the official guest country of the meeting. View a list of exhibitors at www.ortomedicalcare.com/expositores_en.htm. Contact Cristina Mora for more information, ortho2014@fedop.org, or visit www.ortomedicalcare.com.

NOVEMBER 2014 | O&P ALMANAC

such as surveys, retrospective data analyses, simulation modeling, longitudinal observation, cross-sectional observation, case control, or qualitative research study designs. Research proposed under the OPORA may include small- to largescale projects and be at different stages of idea and research development, including efficacy studies, effective comparison studies, human use, observational studies, and clinical trials. Two different funding levels, based on the scope of the research, are available. Clinical research and clinical trials will be considered for both funding levels. It is the responsibility of the principal investigator to select the funding level that is most appropriate for the proposed research project. The following are general descriptions of the scope of research projects that would be appropriate to propose under each funding level: • Funding Level 1: Research that is already supported by preliminary data and has the potential to make significant advancements toward clinical translation. • Funding Level 2: Advanced translational studies that have the potential for near-term clinical investigation. For details, visit www.grants.gov/ view-opportunity.html?oppId=268008.

HAPPENINGS

RAC REPORT

Providers Appealed 31 Percent of Initial Claims in FY 2013 CMS has released its FY 2013 report on the Medicare fee-for-service Recovery Audit Program. The report found that recovery audit contractors (RACs) identified and corrected $3.75 billion in improper payments during FY 2013. Moreover, there were $3.65 billion collected in overpayments and $102.4 million in identified underpayments paid back to providers. CMS also found that in FY 2013, providers initially appealed 500,629 claims, which constituted 30.7 percent of all claims with overpayment determinations. Providers appealed 836,849 claims throughout all levels of appeal, but of the total claims appealed, 18.1 percent of claims were overturned with decisions in the provider’s favor. Just 9.3 percent of all RAC determinations were challenged and later overturned on appeal in FY 2013, according to CMS. “The mission of the Recovery Audit Program is to identify and correct Medicare and Medicaid improper payments through the efficient detection and collection of overpayments made on claims for health-care services provided to Medicare and Medicaid beneficiaries, and the identification of underpayments to providers, so that CMS and states can implement

actions that will prevent future improper payments,” CMS explained in its report. “Compared to overall fee-forservice expenditures, the amount collected by recovery auditors is relatively small,” CMS states. “Recovery auditors collected less than 1 percent of the more than $481 billion that Medicare pays in Part A and B benefits in FY 2013.”

PHOTO:RAC Report:Courtesy of Hanger; Tech Update: Jen Owen

2015 Amounts in Controversy Thresholds Released The new amounts in controversy thresholds required to obtain appeal rights at the administrative law judge (ALJ) and judicial review levels for 2015 have been released. The current amount that must remain in controversy for ALJ requests to be filed is $140. For requests made on or after Jan. 1, 2015, the amount in controversy must be at

least $150. The current amount that must remain in controversy for a judicial review to be processed is $1,430. This amount has increased to $1,460 for all judicial review appeals made on or after Jan. 1, 2015.

TECH UPDATE

Prosthetists Get Education in 3D-Printing Technology Prosthetists were invited to attend the inaugural e-NABLE Conference in Baltimore in September, “Prosthetists Meet Printers: Mainstreaming OpenSource 3D Printed Prosthetics for Underserved Populations.” The event was designed to introduce attendees to the development process of the 3D-printed e-NABLE hand, a simple artificial hand made using open-source designs on printers using downloadable computer code. Engineers, medical professionals, prosthetists, children with limb loss, and their patients attended the Baltimore event. Over the course of a 14-hour day, 25 children helped engineers and medical professionals design their hands, which were then 3D printed and presented to the children. The e-NABLE organization, which was started 18 months ago by Jon Schull, PhD, of the Rochester Institute of Technology, matches individuals in need of simple prosthetic hands with individuals who have access to 3D printers. Schull is seeking to include more prosthetists in the organization to benefit from their expertise. For details, visit the organization’s Facebook page at www.facebook.com/enableorganization. See more information in the feature story on page 22 of this issue of the O&P Almanac.

O&P ALMANAC | NOVEMBER 2014

PEOPLE & PLACES PROFESSIONALS ANNOUNCEMENTS AND TRANSITIONS

Hugh Herr, PhD, has been named Innovator of the Year by R&D Magazine. Herr heads the biomechanics research group at the Massachusetts Institute of Technology Media Lab, and his research has focused Hugh Herr, PhD on creating bionic limbs that emulate the function of natural limbs. He has designed a bionic foot and calf system, the BiOM, and led the development of dancing legs for Boston bombing survivor Adrianne Haslet-Davis. (For more information, see the September 2014 issue of the O&P Almanac.)

Russell Hornfisher

Russell Hornfisher has joined Orthotics Holdings Inc. as the company’s O&P channel manager for the business development team. Hornfisher, who previously worked for Becker Orthopedic, also previously served on AOPA’s board of directors for eight years. Brian Lagana has resigned from his position as executive director and director of government affairs for the Pedorthic Footcare Association.

Brian Lagana

Susan Stout

The Amputee Coalition board of directors has appointed Susan Stout as president and chief executive officer (CEO) of the organization, effective Nov. 1, 2014. Stout joined the Amputee Coalition in 2011 and has held several positions in the organization, including chief communications officer and chief policy and programs officer, as well as being appointed interim president and CEO since September 2013.

Matt Swiggum has been named Ottobock’s new executive vice president of sales for North America. In his new position, Swiggum serves as the leader for the Ottobock sales representatives across all business units with Matt Swiggum the goal to expand the region’s selling skills, share best practices, and ensure that all customers get consistent experiences when working with the company.

NOVEMBER 2014 | O&P ALMANAC

IN MEMORIAM

Becky Porter-Spiares, CFm Becky Lynne Porter-Spiares, CFm, passed away September 10. PorterSpiares was an account and national education executive for Nearly Me Technologies, Waco, Texas, a provider of mastectomy and fashion products, and was a member of AOPA and the American Association of Breast Care Professionals. Porter-Spiares was born August 15, 1960, in Fort Hood, Texas. She was preceded in death by her husband, Jeffrey Dwayne Spiares, who passed away November 2013, her father, and sister. She is survived by her mother, two sons, two granddaughters, two brothers, and several other family members.

Fred Cato, CPO, LPO Fred Cato, CPO, LPO, passed away August 14 at the age of 62. Born in Las Cruces, New Mexico, Cato joined the Army in 1973. He subsequently attended the University of Washington School of Rehabilitation, graduating in 1978 with a bachelor of science degree in orthotics and prosthetics. Cato practiced O&P in the Tacoma and Seattle areas of Washington State. In 1995, Cato started Preferred Orthotic and Prosthetic Services. He provided all levels of O&P care, and specialized in the orthotic treatment of scoliosis. He also served as an examiner and committee member for prosthetic and orthotic national board exams. Cato was beloved by many patients as well as his family.

R. Douglas Turner R. Douglas Turner passed away October 30 after a long battle with cancer. Turner was director of international marketing and sales at Becker Orthopedic. A graduate of Lake Forest College in Chicago, Turner held many positions with Becker during his 28 years at the company. He is survived by his wife, Maryann Devanas, and daughter, Genevieve. A memorial service is being planned in Michigan.

HAPPENINGS

BUSINESSES ANNOUNCEMENTS AND TRANSITIONS

Fillauer Orthotics and Prosthetics made headlines when one of its devices was showcased on the NBC crime drama “The Blacklist” in September. A villain known as “Berlin” was portrayed as an upper-extremity amputee and was introduced to the plotline wearing a hook. The device was made in Fillauer’s Chattanooga, Tennessee, facility.

Ottobock also served as an official technical service provider for the Invictus Games, held September 10-14 in London’s Queen Elizabeth Olympic Park and Lee Valley Athletics Centre. More than 400 competitors from 14 nations participated, with teams coming from the armed forces of nations that have served alongside each other. In addition to conducting repairs to wheelchairs and prostheses damaged in competition, Ottobock was also a supporter of the British Armed Forces team for the games.

Össur has created the Össur Women’s Leadership Initiative, a group that seeks to encourage and support independent O&P practitioners by providing a forum for discussion and education with the goal of developing and strengthening the leadership skills of female O&P practitioners. The initiative hopes to increase the volume of female leadership within the O&P industry, encourage fairness and equality in the workplace, and eliminate conscious or unconscious gender biases in the workplace. The group is planning to unveil a blog and hold educational webinars in 2015. Look to the January 2015 O&P Almanac for more information. Ottobock has announced the winner of the August competition for the company’s C-Leg 15-Year Anniversary Photo Contest. The contest asks users of C-legs or other prostheses to submit photos or videos showing how their devices have changed their lives. The August winner, Hilbert Potter, is a military veteran who lost his leg in Iraq in 1991 while serving in the U.S. Army. Potter, currently a physical therapist, works with soldiers in the Warrior Transition Unit at Fort Knox, Kentucky. He has twice completed the Kentucky Derby Festival Mini-Marathon. The winning photo was taken at the PGA Championship recently held in Louisville, where he walked the entire 18-hole course for three straight Hilbert Potter days as part of his volunteer duties.

Ottobock at the Invictus Games with Prince Harry

U.S. competitor being treated by an Ottobock prosthetist at the Invictus Games

O&P ALMANAC | NOVEMBER 2014

REIMBURSEMENT PAGE

By DEVON BERNARD

Prepping for 2015 Follow these seven steps to end 2014 on a high note and prepare for the new year

Editor’s Note—Readers of CREDITS Reimbursement Page are now eligible to earn two CE credits. After reading this column, simply scan the QR code or use the link on page 18 to take the Reimbursement Page quiz. Receive a score of at least 80 percent, and AOPA will transmit the information to the certifying boards.

HE END OF THE year can be a very hectic and stressful time. You are busy preparing for the holidays, closing out outstanding patient accounts, and thinking about what needs to be done before year’s end. This month’s Reimbursement Page offers suggestions on some of the things you may be thinking about, and provides information on some of the things you may have forgotten to think about—all of which can lead to a successful and slightly less hectic new year.

Review Your Medicare Participation Status. The end of the year, usually between November and December, is the only time of the year you may make a change in your Medicare participation status—from participating to nonparticipating or vice versa. If you currently are a participating provider and you want to be nonparticipating, you must notify the National Supplier Clearinghouse (NSC) in writing that you have decided to be a nonparticipating provider for the upcoming calendar year. If you choose to switch and become a participating provider, you must complete and sign a participation agreement form, available on the Medicare website www. cms.gov/cmsforms/downloads/cms460. pdf. If you choose to make a switch in your participation status, it must be done prior to December 31 and will become effective Jan. 1, 2015. There is no wrong decision when it comes to Medicare participation. The decision you make should take into account what is in the best interest of your company. Just remember that the decision is tied to your tax

E! QU IZ M EARN

BUSINESS CE

CREDITS P.18

NOVEMBER 2014 | O&P ALMANAC

identification number, so it may be a companywide decision, and it is not related to location or National Provider Identifier (NPI) or Provider Transaction Access Number (PTAN). The decision is binding for the upcoming year. For more information about the pros and cons of Medicare participation and how to make changes, see the Reimbursement Page in the October 2014 issue of the O&P Almanac. Submit a Medicare Claim for Each Office. As a Medicare-enrolled supplier, you are required to submit claims at least once within four consecutive quarters, or at least one claim a year, to maintain billing privileges, in compliance with the NSC. Since each location where you treat and see Medicare beneficiaries is required to be enrolled separately and have its own NPI and PTAN number; be sure each office submits at least one claim each year. It is a common misconception that it is acceptable to use one location as a central billing site and use that location’s NPI and PTAN numbers for all billing purposes. While this is true for a majority of the year, you are required to submit at least one claim per year using the NPI and PTAN numbers of each of your offices. What can happen if you don’t submit at least one claim from each of your locations? It is possible the NSC could deactivate your supplier number for that location, meaning that your billing privileges for that location also would be deactivated. To reinstate or reactivate your billing number, you would have to reapply with the Medicare program

REIMBURSEMENT PAGE

(i.e., complete a Medicare application, pay the application fee, etc.), which could take more than two months. Alternatively, you could challenge the deactivation and demonstrate that you did submit at least one claim during the timeframe in question. Just remember that you will not be able to see or treat patients at a location until the supplier number is reinstated and reactivated. To prevent such problems, submit a claim from each of your offices—the main centralized office and the satellite offices—at the start of the year. Then you will have met the Medicare quarterly billing requirement, and you will not have to worry about one of your offices having its PTAN number deactivated for inactive billing.

to send a letter or postcard to your patients, especially those you have not seen in a while, inviting them to come to your office for a consultation, or to check out a new product. What methods of contact are not acceptable? There is a slight prohibition on contacting patients via the telephone. You may not cold call former patients, unless you have provided a Medicare-covered item or service to that patient within the past 15 months. So, if you review your charts and you have seen a patient within the past 15 months—let’s say, for diabetic shoes—you could call that patient to see if he or she is ready for more inserts. In addition to contacting your patients with postcards and/or phone calls, follow up with your patients when they come into your office. The beginning of the year is a good time to verify with patients that all of their information is current and up to date. Most importantly, make sure patients have not switched insurance carriers or insurance plans. Thank Patients. With the holiday season upon you, you may be thinking of showing your gratitude and appreciation to your patients by providing them with gifts. The giving of certain gifts to Medicare patients is acceptable, but it can easily become a jumbled mess, as there are several provisions that limit gift giving. These provisions mainly relate to providing a gift as an inducement to encourage patients to choose you over other providers in your area. What should you keep in mind when shopping for and providing gifts to your patients? First and foremost, gifts of cash or cash equivalents of any kind (e.g., gift certificates or gift cards) are strictly prohibited. The use of nonmonetary gifts is acceptable as long as the gifts are of nominal value. The Office of Inspector General (OIG) has stated that the value of gifts should not exceed $10 per gift, with a $50 aggregate per calendar year. This means that you can offer your Medicare patients a maximum of five gifts valued at $10 each in any calendar year. The OIG

Follow Up With Patients. Whether you choose to do it at the beginning of the year to start off strong, or if you do it at the end of the year to close out on a big note, or to clear the books, reviewing your patient files and identifying who may require additional services is a good business move. If you choose to contact your patients, be sure to abide by the Supplier Standards, Standard 11 in particular. What methods of contact are acceptable? There are currently no prohibitions on mailing information about new products or services to patients. It is completely acceptable

also has stated that there cannot be terms or strings attached to the gift: You cannot require that the patient come in for an evaluation to receive a gift. To learn more about the prohibitions on providing gifts to patients, review an August 2002 OIG Special Advisory Bulletin on the OIG website, www.oig.hhs.gov. Thank Referral Sources. While providing gifts to Medicare beneficiaries may be challenging, giving gifts to referral sources should be approached with even greater caution and scrutiny. As with gifts to beneficiaries, monetary gifts of any value to referral sources are completely prohibited. 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 cannot provide a gift of higher value to your regular referral sources than you do to practices that only refer patients periodically. Second, gifts may not be directly solicited by referral sources. If a referral specifically requests a specific gift and you provide it, this could be construed as an inducement and a violation of federal antikickback statutes. Finally, the gift limit to a physician referral source has an aggregate limit of $385 for 2014, so any gifts provided to a referral source in 2014 may not exceed $385. It is important to note that the annual $385 aggregate is a limit, not an entitlement. To learn more about the legality and ethics of providing gifts to referral sources, purchase a copy of the November AOPAversity webinar available at the AOPA website. You also may review the federal antikickback provisions on the OIG website.

Update Fee Schedules. Make sure that all of your fee schedules are updated at the start of the year. If you don’t update your fee schedules in a timely manner, you could see a loss in revenue due to under-billing for the services

O&P ALMANAC | NOVEMBER 2014

REIMBURSEMENT PAGE

you provide. Typically, if private insurance fees are tied to the Medicare fee schedule, then those fee schedules should automatically increase by the same amount; however, you will want to verify that the private insurance companies are updating their fees. While it is not official (at the time this article was written), the estimated Medicare O&P Fee Schedule for 2015 is expected to increase by 1.5 percent.

When updating/checking your fee schedules, review existing contracts to determine if they are approaching their expiration dates, or if they have clauses that automatically renew the contracts at year’s end, and what you have to do to renegotiate the contract (if you choose to do so). Remember, everything is negotiable, and you should try to obtain the best contracts for your company’s future.

Late Breaking News! CMS Defers Action on Expanded OTS Definition and Orthotic Fitter Role

N OCTOBER 31, CMS released the massive final rule covering

end-stage renal disease payments and a host of other topics, but CMS withdrew from any action on the off-the-shelf (OTS) orthotics proposed rule issued July 2. This represents a step back by CMS by not enacting the provision that limited certified orthotic fitters to OTS orthotic devices only. Also deferred was language that would have expanded the statutory definition of “minimal self-adjustment,” which AOPA has steadfastly opposed since CMS first began expanding the definition in 2007. CMS provided no explanation as to why it suspended any action on the OTS orthotics proposal. While AOPA is pleased the proposal—which would have expanded the number of orthotic devices deemed eligible for competitive bidding—was not enacted, there is a price. The July 2 proposal did a good thing in intervening to stop individuals (e.g., manufacturers’ reps) who are not physicians, nurse practitioners, therapists, or certified orthotists from providing custom-fitted orthoses, and so a major disappointment is that CMS drawing back has impaired the hard-fought and carefully crafted effort to refine the CMS language that would have “outed” unlicensed/uncertified providers from providing custom-fitted devices in physicians’ offices. Why did CMS reverse fields in deferring action? Was it the sheer volume of more than 500 comments opposing the changes from AOPA members and their patients? Or did the recent Grassley-Harkin letter to the CMS administrator force top levels in CMS to apply the brakes? Did the October 21 O&P Alliance meeting with CMS Chronic Care Director Laurence Wilson turn the tide? Or was it the data from Medicare’s own records analyzed by AOPA’s consultant, Dobson DaVanzo, showing that 19 percent of Medicare beneficiaries who receive a Medicare-provided OTS orthotic device also subsequently receive a Medicare custom-fitted device that gave pause to the underlying economic principles of CMS action? We are left to speculate, but AOPA plans to maintain a high alert on these orthotic issues, hopefully leading to a sounder, more lasting treatment of orthotic devices by the Medicare program.

Update Your Policy and Procedures Manual. The beginning of the year, or the very end of the year, is a good time to pull out your company’s policy and procedures manual and make sure it is still up-to-date. Things change throughout the year, and 2014 was no exception. For example, in 2014, you should have updated your policies and procedures in regard to the Health Insurance Portability and Accountability Act. Also, your policies and procedures for documenting and providing custom-fitted and off-theshelf orthoses should have been revised. Some of the new policies can be found in the updated Appendix C of the Medicare Quality Standards on the CMS website. This also is a good time to make sure that your current insurance information and business licenses are accurate and up-to-date. While it is important to have a policy and procedures manual, it is even more important that the information within it is followed. Use this time to examine whether everyone’s training is up-to-date and complete, and make sure everyone understands the policies. The rules and regulations are constantly changing, so an annual review to ensure that the policies and procedures you follow is a good way to remain compliant.

Spending a few moments now or at the start of next year reviewing these topics could save you some headaches and lost revenue, which may lead to a more productive and successful 2015, and beyond. Devon Bernard is AOPA’s assistant director of coding reimbursement, programming, and education. Reach him at dbernard@aopanet.org. Take advantage of the opportunity to earn two CE credits today! Take the quiz by scanning the QR code or visit bit.ly/OPalmanacQuiz. Earn CE credits accepted by certifying boards:

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NOVEMBER 2014 | O&P ALMANAC

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This Just In

Tennesseans Plant a Seed for the Nation Follow the lead of the O&P community in the Volunteer State, which partnered with state leaders to defeat a reimbursement reduction By GREG ARMSTRONG

T IS HAPPENING IN Tennessee right now and has national implications. Until a group of tenacious professionals convinced them otherwise, Blue Cross Blue Shield of Tennessee (BCBST) intended to drastically cut reimbursements to virtually all of the state’s O&P and durable medical equipment providers by 30 percent (to 75 percent of Medicare allowables), effective July 1. The cut applied to all commercial, Medicare replacement, and TennCare (the state’s Medicaid program) products. But what began as a battle soon became a partnership between the insurance giant and the O&P community of Tennessee. Immediately after the BCBST letters of resolution declaring the cuts went out, a single email on the O and P listserve prompted a response. This led to the formation of a taskforce that later evolved into a committee by resolution of

NOVEMBER 2014 | O&P ALMANAC

the Tennessee Society for Orthotics and Prosthetics (TSOP). The committee, which includes Jim Rogers CPO/L, FAAOP; Joe Huntsman MBA, MA; Michael Fillauer, CPO/L; Richard Mason, CPO/L; and myself, also benefitted from the expertise of consultant Scott Williamson, CAE, of Quality Outcomes. The committee made several attempts to speak directly with BCBST to discuss the reduction decision, but these attempts failed as BCBST refused to have a meaningful dialogue. Fortunately, the committee made headway in late June, when Rep. Tilman Goins (R-10th district) set up a meeting between the committee and Laurie Lee, executive director for state employee benefits, and Lisa Jordan, assistant commissioner of insurance in charge of TennCare. Because she is responsible for all of the state’s employees, Lee has a vested interest in this matter. Jordan has the

This Just In

responsibility of making certain the TennCare beneficiaries also have access to care. They both listened carefully to committee members who explained that access to quality care was in great jeopardy by the potential devastation of an entire profession in the state. The committee cited the Dobson DaVanzo study to show the cost efficacy of appropriate O&P intervention over a 12- to 24-month time period. When Lee learned that BCBST was not responding to requests to meet, she commented, “They will listen to me. We spend $800 million per year on our self-funded health plan, and half of it goes to Blue Cross.” Jordan explained that TennCare requires the letters are sent certified mail with a 30-day period to respond. Tennessee providers began filing complaints with her office shortly after that meeting. These actions pressured BCBST to sit down with the TSOP committee and have meaningful dialogue. In late August, the company’s principal executives— Scott Pierce, chief executive officer of TennCare MCO, and Marc Barclay, vice president of Provider Network Contracts—came to the table, along with other officials and legal experts. Though participants in the meeting were initially prepared for debate, the tone of the room changed. The dialogue grew engaging and meaningful, with Blue Cross officials even assuming that O&P providers were paid for our time using CPT coding. The committee explained the differences between a certified/ licensed practitioner and a licensed fitter and suggested that reducing overutilization through reduction of underqualified providers would save much more than a fee reduction and would not adversely affect the care of beneficiaries. Blue Cross officials voiced strong concern that the networks retain quality providers and that the level of care available not diminish. Participants discussed the following topics:

• The episode of care differences between an O&P provider and DME providers. • The cost in dollars and administrative time it sometimes requires to receive payment after delivery of a device. • The fact that approximately 38 percent of orthoses in this country are provided by credentialed O&P professionals. • The difference between the professional clinical care provided by O&P professionals and commoditized care provided by DME suppliers. By the end of the meeting, there was talk of a partnership. Participants said they hoped to change the dynamic between the O&P community and BCBST by helping officials identify qualified and unqualified providers and helping them eliminate overutilization of care and unnecessary expenditures while retaining a high quality standard. The committee discussed the use of outcomes measures that can be used as a tool for measuring the quality of care and metrics to define quality providers within the networks. At

the end of the meeting, Pierce and Barclay indicated that they could not immediately rescind the cuts, but they promised they would discuss it quickly with other officials within the insurer’s hierarchy. One week later, Dockery called each member of the committee with the news that the carrier was immediately rescinding the cuts to TennCare. A few weeks passed, and the decision to make any changes to the reduction on commercial and Medicare plans was tabled, with the caveat that the O&P community keep its word of working with BCBST to help implement cost-saving measures. In the coming weeks, representatives from the O&P community will meet with BCBST’s chief medical officers to begin discussing these many concepts. According to BCBST officials, once the new measures are in place, BCBST will endeavor to pay for quality care. It is our hope that those payments are reasonable and recognize the full scope of the care provided by Tennessee’s certified and licensed professionals. Over the last decade or more, our profession has allowed payers to negotiate the costs of care based on the device, eliminating the scope of care being provided from the equation. If we are to survive as a profession this perspective must change and the metrics used must be upgraded from the cost of a device based on an obsolete fee schedule to a continuum of care that provides valuable clinical and economic contributions to the rehabilitation of individuals and ultimately lowers costs by eliminating the costs associated with care provided by lesser qualified individuals. Here in Tennessee, we have planted a seed that may grow national opportunities to elevate our profession to a higher standard in the eyes of our payers. Greg Armstrong BSPO, CPO/L. Reach him at txgreg61@gmail.com. O&P ALMANAC | NOVEMBER 2014

COVER STORY

O&P in With 3D-printing technology and events now open to the public, how is the profession reacting?

By CHRISTINE UMBRELL

NOVEMBER 2014 | O&P ALMANAC

COVER STORY

N RECENT YEARS, APPLICATIONS for 3D printing have been spreading throughout the medical community. From surgical instruments to medical implants and surgical guides, 3D-printed objects are adding to the proliferation of health-care products designed as cost-effective solutions to medical problems. Several O&P manufacturers are embracing the technology as a small part of their design process, as 3D-printed parts can aid in research and testing of prototypes. Many of the orthoses and prostheses on today’s market contain parts that were 3D printed “at some stage in prototyping or early modeling,” says Troy Farnsworth, CP, FAAOP, vice president of upper-extremity prosthetics at Hanger Clinic. “The technology already is being used to speed up development cycles.” Health-care professionals in many countries are experimenting with 3D-printing technologies in developing ankle-foot orthoses, shoe inserts, and braces for cerebral palsy patients. More recently, the technology has been adopted by individuals outside of the traditional O&P health-care arena to create entire devices—artificial hands for children, using a design developed by nonpractitioners and posted online as open-source for anyone to download and “print.” Some see these hands, which have been the subject of heated discussion throughout the O&P community, as an additional tool in the O&P toolbox. But a thorough understanding of 3D printing in general, and the community that is facilitating the distribution of 3D-printed hands, is needed before deciding how the technology can best be incorporated into the health-care realm.

Need to Know:

PHOTOS: Jen Owen

Recently, 3D-printing technology has been adopted by individuals outside of traditional O&P—using a design developed by nonpractitioners and posted online as open-source—to create artificial hands for children.

Those involved say the 3D-printed hands lack the sophistication, capabilities, and fit of the traditional manufacturers’ upperextremity prostheses and should be viewed as low-cost “beginner” devices for children who otherwise go without any device.

Some adults in the United States also are seeking 3D-printed hands as backup devices to avoid damaging their primary myoelectric devices or because they have avoided prostheses for a long time and have learned to cope without them.

Some see 3D printing as “disruptive technology and a disruptive model of service” with limitations that need to be addressed, including product liability issues and FDA classification. (See sidebar on page 24 for AOPA’s response.)

Some practitioners envision a point in the future when an established supplier joins the 3D-printing realm—an entity that can print the devices in a consistent manner, meeting an established standard, with testing in place to prove the devices are being distributed correctly.

O&P ALMANAC | NOVEMBER 2014

COVER STORY

AOPA Responds to Liability and FDA Compliance Issues What obligations are those who manufacture or fabricate these 3D-printed prosthetic devices under, and how will these devices stack up in terms of well-established FDA compliance responsibilities? AOPA responds…

HERE IS LITTLE DOUBT that

—TOM FISE, JD, AOPA, Executive Director 24

NOVEMBER 2014 | O&P ALMANAC

Threat or Opportunity?

“People tend to be afraid of what they don’t know,” says Farnsworth. He was a speaker at “Prosthetists Meet Printers: Mainstreaming Open-Source 3D Printed Prosthetics for Underserved Populations,” the first conference held by e-NABLE, a group of more than 1,500 members worldwide who “create and design 3D-printed assistive hand devices for those in need.” The September 28 event, held in Baltimore, brought together the inventors of the 3D-printed e-NABLE hand, engineers, medical professionals, prosthetists, children with limb loss, and their parents. The conference was designed to spark interest among prosthetists and related health-care professionals in 3D-printing technology and its applications for crowdsourced e-NABLE designs—simple artificial hands made

Troy Farnsworth, CP, FAAOP

Albert Chi, MD

using open-source designs on printers that use downloadable computer code. During the event, dozens of children with upper-extremity limb loss met with 3D-printing experts, designers, and prosthetists to help select colors and designs for new hand or partial hand prostheses. The devices were made on-site that day—enabling the children to return home that evening with a new hand. Representatives of the e-NABLE community taught attendees how to assemble the devices step-by-step, so they can consider putting them on patients, at a cost of less than $100 for materials. “The reality is, 3D printing is just a different manufacturing technique,” says Farnsworth. And the 3D-printed hands are filling a void: providing simple prostheses for children who would otherwise go without any device.

PHOTOS: Jen Owen

these these 3D-printed hands for children affect the structure or www.AOPAnet.org function of the human body and, therefore, are medical devices in terms of the Food and Drug Administration (FDA). At some point, someone may submit a request to the FDA under 513(g) of the Medical Device law, inquiring as to the classification status of the device and method of “manufacture”/application of Quality System Regulation. Everyone else who brings a new product to market has to satisfy FDA requirements (most have an easy path because many O&P devices are exempt from 510(k) notifications), but nonetheless they must go through the hoops. Some will assert that this is a new type of medical device—unlike anything on the market currently—and its safety and effectiveness have not been established by the FDA. As such, this type of device could be identified by the FDA as a Class III device requiring premarket approval, and is being marketed prematurely and in violation of the FD&C Act. These devices are not 510(k) eligible, and individuals are distributing them without any notice to or reaction by the FDA. The FDA’s medical device laws and regulations look at patient safety and effectiveness of devices and require that anyone who is going to come onto market with new medical devices or distribute them in any way must go through the necessary processes with FDA—be that 510(k) or premarket approval, which involves clinical testing prior to marketing.

COVER STORY

Manufacturers Respond to 3D-Printing Evolution 3D printing is not new to the O&P industry. Many of the current products were developed using 3D-printed pieces during the research phase, and some even contain parts that were 3D printed. Here, manufacturing experts reflect on the current and future applications of 3D technology to the O&P industry:

“We are always interested in the application of new technology to medical devices. Balancing the need for a custom fit together with the potential ability to quickly produce small quantities of high-quality components is one of the manufacturing challenges for everyone involved in prosthetics, and it is exciting to see options like 3D printing in play. Our field has been so focused for so long on the use of CAD (computer-aided design) to help create positive models for use in fabricating check sockets. Now comes the real opportunity to truly combine it with CAM (computer-aided manufacturing) in the manufacturing of definitive components—real CAD/CAM. 3D printing as a disruptive technology has the potential to revolutionize the field.” —BRAD RUHL, President & CEO, Ottobock US Healthcare

“Regarding the use of 3D printing , I think the applications for lower extremity would be mainly cosmetic at this point. Lower-extremity prosthetics go through rigorous testing. At this point I don’t think there is enough quality control over any structural components 3D printing would make to allow them to be fitted on amputees. “There are plenty of applications for rapid prototyping in the R&D stages of product design; however, for the complex nature of feet and knees, I feel there would be a loss of product integrity. As the technology begins to develop further and the material science behind it has been confirmed through extensive testing, this may change. 3D printing is technology that we will continue to stay close to for lower-extremity prosthetics. “For some high-end componentry, there are some applications where 3D printing does have some application whereby it is more accurate and efficient for internal components used to secure cables and connectors. Cosmetic foot shells are another area where 3D printing holds promise. And in the future, there may be applications for metal components, but at this point that technology is still a bit off in the future.” —CHRISTOPHER J. NOLAN, Vice President & General Manager, Endolite

NOVEMBER 2014 | O&P ALMANAC

“WillowWood believes that 3D printing can be used effectively to complement other manufacturing processes that are already being used to produce prosthetic devices. 3D-printing technology is quickly developing, which presents increased opportunities to apply 3D printing to prosthetic and orthotic devices. WillowWood’s first major effort to apply 3D printing to prosthetic devices began in 2008, and resulted in the development of an extremely durable and functional 3D-printed transtibial socket. Since then, we have continued to develop applications for 3D printing in prosthetics and orthotics. “WillowWood has found 3D printing to be an effective manufacturing method to supplement our many other manufacturing techniques. We currently use 3D printing to print parts for manufacturing equipment, prototype devices, and production devices. These 3D-printed parts are combined with parts made with more traditional manufacturing methods to produce the finished devices. We expect that our use of 3D printing will increase as 3D-printing technology and materials continue to evolve.” —JIM COLVIN, MSBME, Director of R&D, WillowWood

“It’s an amazing time for 3D printing . [3D printers] have helped us in product design. To give you an example, I thought of a part on the way to work. I was able to draw it in SolidWorks by 10 a.m. and in a few minutes it was printing. The part was small so it only took 30 minutes to print. By having the 3D-printed part in my hand, I could see the flaws in the design. After four more iterations of the part, it was ready for machining. The final part took two weeks for the machine shop to produce. In the past, each iteration would have taken two weeks, 10 weeks in total. Most of the parts that we produce from the FormLabs 3D printer are strong enough to try out. “As for the 3D-printed hands and prosthetics, I don’t think we are there yet. ... The hand kits that are 3D printed may stand up for a while but the material is not strong enough for long-term use. That’s one of the differences: The products that a prosthetic manufacturer produces have to survive ISO testing, plus the device needs to be fit by a prosthetist that can design the socket interface to the patient.” —CRAIG MACKENZIE, CP, RTP(c), Managing Director of Evolution Industries, an Össur company

COVER STORY

Recognizing the Limitations

PHOTOS: Jen Owen

AOPA President-Elect Charles Dankmeyer Jr., CPO, attended the e-NABLE meeting in Baltimore, and his facility, Dankmeyer Prosthetics and Orthotics, was a gold sponsor of the event. He was overwhelmed by the excitement and engagement among attendees. “I have never attended a program where the attendees were more engaged, excited, and attentive than the people at this program.” He describes the typical 3D-printed hand as “a partial hand-gripper system that people can put together themselves, almost like a Lego system. The concept and design are elegantly simple.” He was most impressed by the global network of dedicated volunteers who are committed to printing the devices. Dankmeyer says that using such a 3D-printed system may help patients learn to grip and prepare them for a more advanced prosthesis down the road: “These devices can help children develop bimanual skills instead of relying only on one side,” he says. With low-cost hands, children “learn to value being able to grasp on both sides.” But Dankmeyer also points to the limitations of the e-NABLE hands. “The devices are not made to be unique to each presentation, but are scaled to various sizes. The actual fitting of the device to the patient is not very sophisticated, but generally sufficient for limited function. Should a more customized fit be required, that would be the role of a prosthetist.” “Many prosthetists would say the 3D-printed devices are too big, and they don’t fit properly,” adds Farnsworth. But children seem to be accepting the devices because

they participate in their design—that involvement “overcomes all of the other obstacles.” Jon Schull, PhD, who founded the e-NABLE movement and planned the Baltimore event, recognizes 3D-printed hands lack the sophistication and capabilities of the traditional manufacturers’ upper-extremity prostheses. He sees 3D-printed hands as an addition to the market, rather than an alternative.

Chi highlights the role healthcare professionals should play as the technology becomes more widespread: “It’s imperative that the medical community get involved so we can do this safely,” he says. “We need to involve the prosthetist and therapist to make sure the devices fit well.” He also points to the opportunity the 3D hands provide: Many of the first children fit with the e-NABLE hands are congenital patients, who often choose to forgo more expensive upper-extremity prostheses and manage with one hand. The e-NABLE hand is cost-effective enough that parents are willing to purchase materials, and “fun” enough— offering custom color and design choices—to interest the children. Like Dankmeyer, Chi also describes the 3D-printed hand as a “beginner” prosthesis: “It’s a beautifully basic design that can prepare children for more advanced prosthetics when they are teenagers,” he explains. In fact, learning to use a 3D-printed hand improves children’s range of motion, according to research conducted by Jorge Zuniga, PhD. Zuniga and his team at Creighton University examined the strength, muscle morphology, and functionality of the devices among nine patients who used 3D-printed hands beginning in March 2014. In his findings, Zuniga wrote: “The main finding thus far was that the prosthetic device has a great potential in positively impacting the quality of life, daily usage, and can be incorporated into several activities at home and in school.”

Jon Schull, PhD

A Minimal Design

The low-cost body-powered hands built at the e-NABLE event are designed to be easy to use and attractive to children, but they are very simple devices. “They are highly functional and provide indescribable psychosocial benefits for children,” says Albert Chi, MD, a trauma surgeon and medical director of the targeted muscle reinnervation program at Johns Hopkins Medicine. Chi offered the opening speech at the conference and led a session titled “With Great Hands Comes Great Responsibility.”

Albert Chi, MD O&P ALMANAC | NOVEMBER 2014

COVER STORY

How Does 3D Printing Work?

Not Just for Children

The focus of the e-NABLE conference was on fitting children with devices, but 3D-printed hands also are being embraced by the volunteer community treating patients in developing countries. While they don’t offer the same close fit and options of manufactured hands, they give a “grip” to adults in countries where there is little money for upper-extremity devices. In addition, some adults in the United States are seeking 3D-printed hands as a backup—for use when they don’t want to damage their primary myoelectric devices. Chi cites an adult patient who uses a 3D prosthesis when participating in extreme sports so he doesn’t have to use his regular

NOVEMBER 2014 | O&P ALMANAC

device. “3D-printed devices create options,” he says. Schull points to adult consumers who have avoided hand prostheses as a potential market for the 3D-printed hands. “Many adults who have gone without prosthetics for a long time don’t want upper-extremity devices because they have learned to cope without them,” he says. If those individuals try low-cost 3D-printed devices, then “they will be better patients when they’re ready for the Cadillacs”—the high-end prostheses currently on market, he says.

Proceeding With Caution

There are both risks and rewards inherent in new technology such as 3D printing , says Mark Hopkins, PT, CPO, another speaker at the e-NABLE event. Hopkins, who is chief executive officer and president of Dankmeyer Prosthetics and Orthotics, sees the 3D-printing model as a different model than traditional O&P patient care. The e-NABLE conference “represents disruptive technology and a disruptive model of service. It represents a change to business as usual,” Hopkins says. Hopkins believes both models have their place—the collaborative e-NABLE service model and the established service model within the regulated health-care arena. And he hopes the individuals within each service

PHOTO: Jen Owen

Mark Hopkins, PT, CPO

PHOTO:Thinkstock

3D printers make use of a process called “additive manufacturing.” The process starts with a blueprint created in a 3D digital-modeling program, which is programmed into the printer. The printer then builds the desired object by laying down super-thin layers of the materials—which can range from metal to plastic and more. 3D printers range widely in price, with simple models retailing at $2,000 and industrial models costing $100,000 or more.

model can learn from each other for the ultimate benefit of patients: “If we are going to take advantage of the disruption, the challenge is to make real and lasting change for the benefit of the entire community, and to enrich the lives of all those we serve.” But Hopkins and Farnsworth also note that while it’s exciting to see a growing sector of the upper-extremity patient population accepting prostheses, it’s important to recognize the 3D-printing world is, to some extent, unchartered territory. “I’m excited about all of this, but there are some issues we have to deal with,” says Farnsworth. What classification will the FDA designate for these devices? And what are the product liability issues? Take the example of an individual wearing a 3D-printed device while driving a car, who gets into an accident—possibly because something goes wrong with the mechanism, or a digit breaks. Who will the insurance companies hold responsible? “If I create something on a 3D printer, what’s the liability risk?” adds Hopkins. “We, as practitioners, will have to deal with this.” He emphasizes the clear distinction in liability between a 3D-printed device and a traditional O&P custom device: “All of the manufacturers have rigorous testing procedures in place,” he notes. The 3D-printing community “will have to be careful about this.” Licensure issues also may pose a problem for individuals who help fit patients with these devices. “Some states have very strict laws about the products we provide, for patient safety,” says Farnsworth. Some practitioners envision a point down the road when an established supplier joins the 3D-printing realm— an entity that can print the devices in a consistent manner, meeting an established standard, with testing in place to prove the devices are being distributed correctly. While it’s still uncertain how the FDA will react to 3D-printed devices, and many questions about liability and licensure remain unanswered,

COVER STORY

e-NABLE Facilitates Open-Source Artificial Hand Distribution Ivan Owen

it’s important to keep the channels of communication open. “We need to discuss these challenges—overcoming them is not an insurmountable task,” says Farnsworth.

Embracing the Future

PHOTOS: Jen Owen

The O&P practitioners who made the trek to Baltimore were impressed with the “mind-blowing” atmosphere, says Chi. Participants built a total of 100 hands at the e-NABLE event, 25 of which were presented to children in attendance. “The prosthetists were very excited about the future,” he says. “And they had so many suggestions for improvements. This was really an open forum for brainstorming.” The crowdsourcing aspect of the 3D design is “amazing and unique,” says Farnsworth. “Different people with different backgrounds take the design, download it, and then suggest improvements. And then they post the new version back online.” That collaborative spirit is what drove the design of a new device unveiled during the conference, the e-NABLE 2.0, or “Raptor,” which is in its formative stages. This device is being billed as “the world’s first crowdsourced, crowd-developed prosthesis that incorporates the collective intelligence, learning, and experiences and e-NABLE’s online global community.” Ivan Owen, co-creator of the original e-NABLE hand and one of the developers of the Raptor, explains that the new design was developed based on feedback from previous device users, advice

HE FIRST E-NABLE HAND was developed in January 2013 as a collaboration between two individuals on opposite sides of the world: puppeteer Ivan Owen in Washington State and partial hand amputee Richard Van As in South Africa. After seeing a YouTube video of a giant puppet hand Owen had built, Van As emailed Owen and asked if they could work together to help build mechanical finger prostheses. Owen and Van As collaborated via Skype, eventually meeting in person and creating a hand with the help of a 3D printer. Their solution was open-sourced and posted online for others to view. One of the browsers who stumbled across their design was Jon Schull, PhD, at the Rochester Institute of Technology. Realizing that a lot of people could benefit from the design, Schull created a custom Google map and linked a comment geared toward individuals with 3D printers: “If you’re willing to receive inquiries from people who need an assistive device, put yourself on this map. Crowdsource the distribution network.” He also asked people in need of a prosthetic hand to pin the map. Within six weeks, there were 70 pins on the map. The community continued growing about 10 percent per week, with the community today numbering more than 2,000. The e-NABLE movement was built “on a tremendous amount of goodwill,” says Owen. “We’ve been a zero-budget organization—all research and development have been done through a volunteer network.” Since e-NABLE started, many hands have been built with donated materials for free, or for materials costs. The organization’s first conference, held September 28 in Baltimore, brought together more than 500 people associated with the organization or interested in learning about the technology. Schull was glad to see a number of prosthetists in attendance: “Gaining their expertise in the design process is important,” he says. He is hoping that prosthetist involvement will lead to more adaptations of the device for noncongenital amputees.

and guidance from the medical community and prosthetists, and researchers at Creighton University. Owen encourages prosthetists to learn more about 3D-printed devices, to get a greater understanding of their advantages and limitations. “Individuals who jump in now will be getting into an industry that can grow quite a bit,” he says. “If practitioners try to hide from

this, they’ll be looking from the outside in,” says Farnsworth. And he reminds O&P professionals of the ultimate goal: “We might have to change the way we do things—but we won’t have to change our focus on patient care.” Christine Umbrell is a staff writer and editorial/production associate for O&P Almanac. Reach her at cumbrell@ contentcommunicators.com. O&P ALMANAC | NOVEMBER 2014

The Next Global

PANDEMIC

Diabetes, ulcers, and amputations are poised to overwhelm nations and cripple health-care budgets By KATIA LANGTON, DC, CPed

Need to Know: • The number of diabetes cases is skyrocketing worldwide and is predicted to hit 592 million by 2030. In addition, the five-year mortality rate of a diabetesrelated lower-extremity amputation is as high as 80 percent, second only to lung cancer. • Type 2 diabetes is no longer a disease of affluence isolated to Western culture. China and India now have the highest incidence of diabetes, far surpassing the U.S. diabetic population of 24 million. • Practitioners need to be examining patients’ feet earlier, more regularly, and in more detail. Most patients do not fully understand peripheral neuropathy and the impact of unmanaged blood sugars on their peripheral nerves, and many have never had proper foot care or comprehensive foot check-ups. • A critical paradigm shift in treating the diabetic foot is necessary to prepare for the increasing incidence and severity of the disease and its complications. Putting the money upstream in preventative care, preventative devices, and devices that will close the ulcers more quickly will reduce overall costs and make health care sustainable in the future as the disease progresses on a global level.

NOVEMBER 2014 | O&P ALMANAC

N 2009, INTERNATIONAL DIABETES

Federation (IDF) President Jean Claude Mbanya voiced his concerns about the global threat of diabetes: “…The epidemic is out of control. We are losing ground in the struggle to contain diabetes. No country is immune, and no country is fully equipped to repel this common enemy.” At that time, there were 300 million diabetes cases worldwide, up from 30 million in 1985, according to the IDF. Mbanya was trying to sound the alarm to world health leaders on the diabetes epidemic as a global health emergency because most countries’ health-care systems are not equipped to handle the extent of the threat. Diabetes and its complications will overwhelm and cripple most nations’ health-care budgets. In 2009, diabetes cases around the world were predicted to grow to 435 million by 2030. In 2014, the number of cases is now predicted to hit 592 million by 2030, according to the World Diabetes Foundation. One can only wonder if, in the next five years, another 160 million will be added to the 2030 predictions? We have nothing short of a global pandemic on our hands, an epidemic that has crossed international borders and is affecting many, if not all, countries of the world at the same time. But with a better understanding of the disease and a global standard in preventative and ongoing care, practitioners are in a position to fight back against this deadly disease.

How Did We Get Here?

Diabetes is a metabolic disease. Although it affects every part of the body, it tends to strike the feet first, leading to complications such as foot ulcers and eventually amputations. These complications, resulting mainly from diabetic peripheral neuropathy, are extremely problematic and lead to very high mortality and morbidity rates. The five-year mortality rate of a diabetes-related lower-extremity amputation is as high as 80 percent, according to Diabetes UK. That is, up to 80 percent of these patients will not be alive in five years. This staggering statistic is second only to lung cancer, which has a fiveyear mortality rate of 86 percent, and it is higher than the five-year mortality rates of breast, colon, and prostate cancers, according to the Southern Arizona Limb Salvage Alliance. This disease and its menacing complications are now represented as a percentage of the population in every country in the world, and the numbers are increasing in almost every country. Type 2 diabetes, which represents 95 percent of diabetes cases, is no longer a disease of affluence isolated to Western culture. China and India now have the highest incidence of diabetes, far surpassing the U.S. diabetic population of 24 million. China has 98 million diabetics, and India has 65 million, according to the IDF. The obesity epidemic may be fueling the diabetes pandemic in the Western world, but in the East, the number of new Type 2 diabetes cases

PHOTOS: Top center column and top left column: Katia Langton, DC, CPed

is exploding for multiple reasons. One is the link between undernutrition in utero and early life, combined with overnutrition in later years, according to American Diabetes Association. In response to fetal undernutrition, the body develops insulin resistance, which serves people well in times of scarcity of food and limited glucose availability. However, with increasing economic development and rapid urbanization in these countries, people now have increased access to fast foods, sugars, animal fats, polished rice, refined wheat, and low-energy foods. When these same people are exposed to a nutritionally rich environment later in life, the insulin resistance that they developed at a young age in response to inconsistent food supply will substantially elevate their risk for developing Type 2 diabetes as adults.

Implications for Practitioners

Those of us on the ground treating the diabetic foot and its complications need to be examining patients’ feet earlier, more regularly, and in more

detail. We should expect to see more patients who are undiagnosed, prediabetic, or diabetic—all exhibiting various stages of diabetic foot disease. That means more patients with foot deformities, stiffened feet, and peripheral neuropathy—all of which elevate their risk of ulcerations and amputations. To complicate matters, most patients do not fully understand peripheral neuropathy and the impact of unmanaged blood sugars on their peripheral nerves, and many have never had proper foot care or comprehensive foot check-ups. For these and many other reasons, we have a perfect storm brewing, and it is going to be a big one. Consider the following: • It is costly to treat diabetes and its complications. In 2012, $471 billion USD was spent due to diabetes, according to the IDF. As 80 percent of the cases are in low- to middle-income countries (70 percent of that 80 percent are in low-income countries), this has the potential to devastate the healthcare systems of many nations as they are not equipped to deal with this disease and its impacts in such staggering numbers. • Complications from peripheral neuropathy and the loss of protective sensation happen without warning. Persistent hyperglycaemia damages the microvascular circulation, which damages the small nerves in the foot. As the sensory nerves die, protective sensation disappears. Once patients have lost protective sensation, the simple act of walking puts them at risk. With normal protective sensation, when our feet are sore, we rest, get off our feet, and change our footwear. Without this feedback mechanism, patients put task over body and power through normal activities such as walking the dog, mowing the lawn, or pressure washing

the driveway. The task takes precedence, as the body is silent and gives no warning of the damage occurring. • The clear relationship among limited foot joint mobility, peripheral neuropathy, and peak pressures in the feet increases risks for ulcers. In the diabetic foot, glucose reacts with the collagen in the connective tissue in a process called glycosylation. This leads to the formation of AGEs (advanced glycosylated end products), which increase collagen crosslinking, causing both inelasticity and toughness in the foot’s connective tissue. This subsequently weakens the muscles and stiffens the joints, reducing mobility. This affects the patient’s ability to adapt to terrain, absorb shock at heel strike, and dissipate peak pressure during the gait cycle. The degradation of this function allows peak pressures to develop in the feet that are highly predictive of diabetic foot ulcers. Healthy skin is tough and can withstand up to 500 pounds of pressure per square inch. In rat pad studies conducted by Paul Brand, MD, and published in Pain: The Gift Nobody Wants, researchers anaesthetized rats and strapped a mechanical device to their foot fat pads, applying a steady rhythmic force to constantly tap the feet while they slept. Brand found that a pressure as low as one pound per square inch would damage the plantar surface of the foot if it was consistent and persistent. If he

O&P ALMANAC | NOVEMBER 2014

PHOTO: Katia Langton, DC, CPed/ Lower Extremity Amputation Prevention

Diabetic Foot Screen

paused the tapping, a callus would form, but if the machine kept on tapping, an ulcer would eventually open up. This study mimics the lack of response to the repetitive stress of walking for the patient with the insensate foot. Limited joint mobility in the foot, coupled with lack of adaptation to areas of peak pressure due to poor protective sensation, can lead to tissue breakdown and, subsequently, the development of foot ulcers. • The general public and healthcare providers have little understanding of diabetic peripheral neuropathy. We are dealing with predictable patterns and predictable outcomes once the foot becomes insensate. This is tricky for most patients to understand, but many health-care providers don’t fully understand it either. Neuropathy strikes the most distal nerves first. Sensory neuropathy destroys the ability to protect the foot from injury. Motor neuropathy deforms the foot into the “intrinsic minus” foot that further increases areas of peak pressure, which increases risk. Concurrently, autonomic neuropathy decreases the ability of the skin to sweat, leading to epidermal dryness and increase risk of fissuring—a potential open pathway for bacteria. 32

NOVEMBER 2014 | O&P ALMANAC

We need to better educate our patients on how to best protect their insensate feet. Health-care providers and patients must understand how to manage simple foot problems and how to use off-loading devices to increase surface area to decrease peak pressure areas. • We lack systematic adherence to best practice guidelines at a global level. Research indicates that patient outcomes and how the patient is treated (off-loading devices, modalities, medication, or amputation) are determined by location and by chance. The chance is based on the clinician’s interest and understanding of the assessment, appropriate treatment, and preventative off-loading of the diabetic foot. Individual clinicians with a special interest and specific training in treating the diabetic foot can greatly influence the amputation rate. If a few individuals can make a difference, consider the difference we could make if a larger proportion of the global health-care community treated the diabetic foot in accordance with proven best practice guidelines. A critical paradigm shift in treating the diabetic foot is necessary now to prepare for the increasing incidence and severity of this disease and its complications. All diabetic patients need access to regular foot screening exams, including strength tests; assessments for physical deformities and evaluations of nail structure; footwear assessments; range of motion tests in

the foot; and pulse checks. The most important assessment, however, is to test for light pressure sensation using a 5.07 monofilament exerting 10 grams of pressure.

Looking to the Future

Diabetic foot screening needs to become a fully funded service in all health-care systems to remove barriers for all people with diabetes, so that they can be seen regularly based on their risk category for ulceration. Diabetes UK has a well-organized, comprehensive program with highly trained foot protection teams that focus on prevention. They triage and stratify patients based on international risk categories and then refer high-risk patients to multidisciplinary teams for thorough treatment. This approach is needed in all countries. We need funding support for off-loading and pressure redistribution devices. Putting the money upstream in preventative care, preventative devices, and devices that will close the ulcers more quickly will reduce overall costs and make health care sustainable in the future as this disease progresses both in our backyard and on a global level. It behooves all of us to better understand diabetic foot disease and pass that knowledge on to the general population, health-care providers, and policy makers alike. The diabetic foot and the consequences of peripheral neuropathy must be more universally understood and managed effectively. When we all truly understand the predictable complications and serious outcomes, we will all be treating these patients in a systematic and standardized manner so that no one falls through the gaps in diagnosis and treatment. Katia Langton, DC, CPed, is the owner of Island Pedorthic FootCare in British Columbia, Canada. She is a frequent speaker and educator on the topic of high-risk feet due to diabetic neuropathy. Reach her at islandpedorthicfootcare@gmail.com.

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ADO Indications

WHO Mid-foot/Walking Indications

• As a stage two device when daytime ambulation is desired

• Wagner 1+ ulceration of the heel. (Can be constructed to accommodate malleolus and forefoot wounds.)

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• Used in conjunction with the ADO night time orthosis • Used as a post-operative walking orthosis

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MEMBER SPOTLIGHT

Brunswick Orthotics & Prosthetics

By DEBORAH CONN

Small and Flexible Brunswick O&P emphasizes patient-first care in the Peach State

HANNON THOMPSON, CPO, WORKED for large O&P

NOVEMBER 2014 | O&P ALMANAC

Shannon Thompson, CPO, works with patient.

FACILITY: Brunswick Orthotics & Prosthetics LOCATION: Brunswick, Georgia OWNER: Shannon Thompson, CPO HISTORY: 14 years

The facility includes three patient-care rooms and a gait room with parallel bars alongside a sunken area that allows clinicians to view the patients’ prostheses at eye level. “That’s a big benefit to the practitioner,” says Thompson, who saw a similar setup in a Minneapolis clinic and decided to adopt it when he built his own facility. Brunswick O&P sees patients of all ages and provides orthotic and prosthetic services of all kinds. “We do see a lot of spinal patients for being a small clinic,” says Thompson.

In addition to seeing patients in Brunswick, Edwards also travels one day each week to clinics and rehabilitation facilities throughout the area—often covering up to 200 square miles—to evaluate patients, who then come to the

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

PHOTOS: Brunswick O&P

patient-care companies after graduating from Memphis State University in 1988—specifically Hanger, NovaCare, and Atlanta’s Scottish Rite Hospital. But in 2000, he decided to open his own facility in his home state of Georgia. Thompson knew he had the clinical knowledge to provide patient care, but he consulted an expert—his father—in setting up his business. “My father had recently retired from running a multimillion-dollar company and started a consulting firm to provide financial advice to small businesses,” explains Thompson. “He told me, ‘You know the medical field, let me help you with the business plan.’ So we had the two most important elements. My father continues to come down for three or four days a month to look at profit-and-loss statements and other issues. His help along with a great team effort by our front-office staff and management team has helped us prosper, even in difficult financial times.” Brunswick Orthotics & Prosthetics, located on the coast, serves an area of about 300 square miles in the southeastern part of the state. The facility has seven employees, including five administrative workers and two clinicians—Thompson and Ken Edwards, BOC, who has been with Brunswick O&P for 13 years. In fact, most of the employees have been with the company for 10 years or more.

Brunswick facility for fitting. Thompson relies mainly on word of mouth and education to promote his services. “A former boss once told me to let our work speak for itself,” he says. The facility stays in touch with referrers, often providing one-on-one educational sessions to demonstrate a new device. Thompson brings in sales representatives from manufacturers and offers on-site training at a hospital or private clinic as well as in the Brunswick facility. In addition, the company’s website includes videos of patients using their prosthetic limbs, as well as a glossary of relevant terms and downloadable forms for new patients. Thompson is content with the size and reach of his facility. “I like to stay relatively small. The bigger you grow, the more headaches you have,” he says. “We had other offices, but we were getting spread out too far. I closed them so we could concentrate our efforts right here in Brunswick.” The result is more control, less turnover, and better patient care, he says. For Thompson, the principal strength of his facility is in putting patients first. “We listen to what they actually need,” he says, “The prescription may be close, but it’s important to hear what the patient has to say. And the doctors have been helpful. If the outcome is good, they support our decisions.”

Smooth operator.

The Variable Speed Carver features a brushless motor and comes in a bench-top (shown) or floor model. Both models are height adjustable, and an optional lift assist is available for the floor carver for easy and safe adjustment. www.fillauer.com

MEMBER SPOTLIGHT

LIM Innovations

By DEBORAH CONN

Mission Possible At LIM Innovations, personalized sockets with reduced fitting and delivery time is the calling

TTENDEES AT THE 2014

NOVEMBER 2014 | O&P ALMANAC

Clinical Director Jon Smith, CPO, makes a quick adjustment to the Infinite Socket.

FACILITY: LIM Innovations LOCATION: San Francisco OWNER: Andrew Pedtke, MD, and Garrett Hurley, CPO HISTORY: 2 years

Co-Founder and Inventor, Garrett Hurley, CPO, checks the user-adjustable tensioning system.

materials not typically used in prosthetics and “feels like a comfy sneaker you’ve worn for years,” says Smith. “The socket is less restrictive, but is able to balance that comfort with stability.” Patients have the ability to adjust the fit of the socket to accommodate variations in residual limb volume. “For example, someone on an airplane flight can loosen the socket to make it more comfortable in the air and then tighten in back down when they land,” says Smith. The socket also is designed to improve clinical efficiency. “We can make really rapid modifications that don’t require machinery,” says Smith. “The clinician can loosen a couple of bolts to make a quick change, without needing to make laborious, time-consuming adjustments.” LIM has signed up a number of clinical partners who want to offer the Infinite Socket to their patients. They will take an impression of the patient’s residual limb and ship it to LIM,

which will customize the socket and send it back to the clinician. The company is working to reduce socket-fitting time and delivery of a finished socket to a patient down to three days. “The national average for transfemoral socket fitting is four to five weeks,” explains Smith. “We want to slash that time and do away with all the intermediate checksocket appointments, so that clinicians can go from evaluation to final fit in two appointments.” Faster turnaround time is a huge benefit to facilities, he says, because that can speed the billing process. “If a facility has to wait four to five weeks to fit a device, that’s four to five weeks they’ve invested clinical time without pay. The Infinite Socket is engineered to get to the billable event more quickly.” LIM sets itself apart from other device manufacturers by requiring feedback from clinicians on its products. “We listen to every single comment,” says Smith. “We want them to feel ownership in what we do. They are driving the next version of our product.” The Infinite Socket, which was featured in the October issue of Wired magazine, is just the start for LIM Innovations, according to Smith. The company is working on sockets for other amputation levels and has a few more products in development. “The way we work is to take a look at what O&P patients and clinicians need, and then do what it takes to provide it,” he says. Deborah Conn is a contributing writing to O&P Almanac. Reach her at deborahconn@verizon.net.

PHOTOS: LIM Innovations

AOPA National Assembly were present at the launch of a brand-new product, the Infinite Socket, developed by a brandnew company, LIM Innovations. The company was founded in 2012 with the express goal of developing prosthetic sockets based on users’ needs and clinicians’ demands that would be both comfortable and clinically efficient. The company is located in San Francisco, and all development and manufacturing activities take place in its offices. LIM Innovations was the outcome of discussions between Andrew Pedtke, MD, and Garrett Hurley, CPO, surfing buddies and colleagues at the University of California—San Francisco orthopedics department. They both believed that conventional sockets did not respond to changes in residual limb volume and were cumbersome to adjust. Their conversations inspired them to seek funding, found the company, and develop its first socket design. The Infinite Socket is a modular transfemoral socket system with four components, each customized for the user. “We can mass produce the sockets, making them less expensive, but clinicians can easily customize the fit for individual patients,” explains Jon Smith, CPO, director of sales and marketing. Smith likens a conventional socket to a rigid, unforgiving wooden clog and the Infinite Socket to a high-end running shoe that adjusts to changes in the residual limb and moves dynamically with the user. It is made of

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AOPA NEWS

AOPA Operating Performance Report

2014

(Reporting on 2013 Results)

THE AOPA BULLETIN

Numbers Don’t Lie The recent Operating Performance Report reflects the impact of reimbursement policy changes on the O&P community

HE 2014 OPERATING PERFORMANCE REPORT

In our quest to deliver maximum return on investment to you the reader and AOPA member, each issue of O&P Almanac will summarize recent actions AOPA has undertaken in making a difference in solving problems or meeting challenges faced by the O&P community and deliver a greater ROI on the AOPA investment for all of O&P.

(OPR), based on 2013 data, captured the financial facts from 99 companies representing 1,116 full-time facilities and 71 part-time facilities. The report shows an unsurprising drop in key performance data. Net profit as a percentage of sales before taxes eased to 5 percent for all respondents in 2013 compared with 6.4 percent in 2012 and 6.1 percent in 2011. Profit leaders—those in the upper quartile of performance—registered 13.7 percent in 2013, 18.3 percent in 2011, and 17.8 percent in 2010. The trend is clear from looking at net profit as a percentage of sales from data just five and six years ago when net profit registered 8.4 percent in 2008 and 10.3 percent in 2009. The net profit before taxes as a percentage return on total assets in 2013 also eased to 11.3 percent for all respondents compared with 14.9 percent in 2012 and 17.2 percent in 2011. Profit leaders (top 25 percent) also experienced diminishing returns—68.6 percent in 2013, down from 77.8 percent in 2012 and 113.4 percent in 2011. Consistent with anecdotal evidence we’ve all heard time and again, smaller companies with up to $1 million in sales took the biggest hit in net profit return on total assets, down from 61.6 percent in 2012 to 27.3 percent in 2013. Companies with more than $5 million in revenue dropped

NOVEMBER 2014 | O&P ALMANAC

from 18.4 percent in 2012 to 9.6 percent return on total assets in 2013. The 2013 survey mix of reporting companies was 20.2 percent reporting up to $1 million in revenue; 21.3 percent in the $1 to $2 million range; 30.9 percent in the $2 to $5 million range; and 27.6 percent in the more than $5 million range. Median sales for all respondents (one half had more and one half had less revenue) was $2,667,461, and the average of all respondents was $5,055,730 in 2013. The median sales for all respondents in 2008 was $2,000,000, and the average was $3,346,015. This indicates significant sales growth through organic or acquired growth in the five-year period. So what does this tell us about the relative health of the O&P community? First, keep in mind the results reflect the experiences of only these 99 companies and their 1,116 locations for 2013. However, the sample is large enough to have reasonable statistical relevance for the entire field, according to AOPA’s consultant Industry Insights, which has produced this

study for more than a decade. The decline in profit margins and the net percentage return on total assets are troubling statistics and certainly reflect the serious impact on cash flow and profitability that RAC audits and other reimbursement policy changes have imposed on the O&P community. The net profit on sales number dropped 41 percent from 8.4 percent for all respondents in 2008 to 5.0 percent in 2013. The same is true of net profit expressed as a percentage of total assets, which also dropped by more than 50 percent in the five-year period, from 22.8 percent in 2008 to 11.3 percent in 2013. To get a clearer picture of what’s happened in five years to the income statement for all respondents, cost of goods sold numbers help tell the story, with purchases comprising 28.6 percent of sales in 2008. By 2013, these costs had risen to 30.8 percent of sales. Total production/labor costs also rose from 21.3 percent in 2008 to 22 percent in 2013. Total cost of goods sold rose from 50 percent

AOPA NEWS

THE AOPA BULLETIN

Historical Comparisons

These tables summarize key information and trends for the past six years. Note that expenses, even more than revenue, can be the key to increased profitability.

Key Revenue by Product or Segment Information, All Respondents SOURCE OF REVENUE

2013

PROSTHETICS ORTHOTICS

2012

2011

2010

2009

2008

48%

46%

48%

49%

48%

41.5%

44.2%

44.9%

42%

40%

45%

DME

1.9%

1.4%

1.9%

PEDORTHICS

3.3%

5.5%

3.6%

OTHER

5.3%

2.8%

1.7%

Payer Source Trends, All Respondents SOURCE OF PAYMENT

2013

2012

2011

2010

2009

2008

MEDICARE

27.8%

28.4%

31.7%

28%

31%

32%

CONTRACTED PR. INSURANCE

31.4%

28%

26.5%

31%

30%

28%

MEDICAID

12.3%

13.2%

14.8%

16%

13%

12%

6.4%

4.6%

4.9%

5.5%

5.6%

5.9%

4.3%

4.7%

4.9%

4.5%

NONCONTRACT INSURANCE HOSPITALS/NURSING HOMES VA WORKERS COMP VOCATIONAL

0.7%

SELF-PAY

2.7%

5.5%

3.8%

OTHER

2.4%

1.5%

3.2%

Expense Trends, All Respondents EXPENSE

2013

2012

2011

2010

2009

2008

SALES/BILLINGS

100%

COST OF GOODS

30.8%

31.6%

29.8%

27.5%

28%

29%

22%

16.5%

16%

17.8%

19%

21%

42.2%

45.2%

47.4%

45.5%

42%

6.4%

6.1%

9.2%

11%

PRODUCTION/LABOR GEN/ADMIN OPERATING PROFIT

in 2009 to 52.8 percent in 2013. While the annual OPR does not dive as deep into employee productivity as the biannual Compensation and Benefits Report, the revenue per non-owner practitioner was $468,000 in 2008 for all respondents and $464,014 in 2013. Total revenue per employee for all employees was $160,000 in 2008 and $163,000 in 2013, which suggests little, if any, change in per-employee productivity. Taking into account modest inflation, it actually indicates a downturn in employee productivity.

In 2013, profit leaders reported $76,726 (compared with $67,028 in 2008) in total payroll and fringe benefits per employee, while all respondents reported $74,409 ($65,919 in 2008), maintaining just a small spread between the two groups. A similar spread existed between profit leaders and all respondents for revenue per employee when profit leaders reported $187,000 in 2013 per employee versus $163,000 for all respondents. In 2008, profit leaders reported $184,000 versus $160,000 for all respondents. Not

much change in the five-year period. These numbers will have differing importance for many AOPA members. Those reported here are just the tip of the iceberg of this highly detailed study that snapshots every possible angle from facility size to community size locations, revenue brackets, and much more. The OPR is now available through the AOPA bookstore for members at $85 for the electronic version and $185 for the hard copy. The electronic version is also available to nonmembers for $185 and $325 for the hard copy. O&P ALMANAC | NOVEMBER 2014

AOPA NEWS

AOPA’s 2015 Mastering Medicare Webinars Announced

ARK YOUR CALENDAR NOW for the 2015 AOPA Webi-

nars. These one-hour sessions come to you in the comfort of your office on the second Wednesday of each month at 1 p.m. EST. This series provides an outstanding opportunity for you and your staff to stay up-to-date with the latest hot topics in O&P, as well as gain clarification and ask questions on topics that you may not understand as fully as you would like to. You may access the webinars by phone or computer.

Buy the Series and Get Two FREE! • January 14: Fill In the Blanks: VA Contracting and the New Template • February 11: Find Success: Tips, Strategies, and Understanding the Appeals Process • March 11: Who Gets the Bill: A Complete Look at Medicare Inpatient Billing • April 8: Lower-Limb Prostheses Policy: Learn the Policy Inside and Out • May 13: The New Player in Town: Understand How the RAC Contract Works • June 10: Stay Out of Trouble: Building a Medicare-Approved Compliance Plan • July 8: Who’s on First? Medicare as a Secondary Payer • August 12: Off-the-Shelf vs. Custom Fit: The True Story • September 9: Prior Authorization, How Does It Work? • October 14: Understanding the LSO/TLSO Policy • November 11: How To Make a Good Impression: Marketing Yourself to Your Referrals • December 9: Bringing in the New Year: New Codes and Changes for 2016 Visit the AOPA website, buy the series, and get two free. Members pay just $990 and nonmembers pay $1,990. If you purchase all of the conferences, all conferences from months prior to your purchase of the set will be sent to you as CDs. Seminars are priced at just $99 per line for members ($199 for nonmembers). Questions? Contact Betty Leppin at bleppin@AOPAnet.org or 571/431-0876. 40

NOVEMBER 2014 | O&P ALMANAC

Mastering Medicare Webinar:

Gifts: Showing Appreciation Without Violating the Law November 12, 2014

EDICARE HAS VERY SPECIFIC rules about what you can and cannot do. Find out what is and what is not considered a kickback and how to acknowledge referral sources without getting into trouble. Subject matter experts also will discuss other types of activity that can be interpreted as kickbacks. The following topics will be covered:

• • • •

When gifts to referral sources are acceptable When gifts to patients are acceptable Federal antikickback regulation prohibitions Doing something nice versus doing something illegal.

The cost of participating is $99 for AOPA members ($199 for nonmembers), 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. Contact Devon Bernard at dbernard@AOPAnet.org or 571/431-0854 with content questions. Register online at bit.ly/aopa2014audio, and contact Betty Leppin at bleppin@ AOPAnet.org or 571/431-0876 with registration questions.

AOPA NEWS

AOPA Media on Facebook and Twitter—

AOPA Provides Disability, Life, Dental, Vision, Follow us and we follow you! Critical Illness, and Accident Insurance OPA IS ON FACEBOOK and Twitter. Follow us to keep

you and your office on top of the O&P community happenings! Signal your commitment to quality, accessibility, and accountability. Strengthen your association with AOPA by helping us build these online communities. • Like us on Facebook at: http://www.facebook.com/ AmericanOandP with your personal and your organization’s account. • Follow us on Twitter: @americanoandp and we’ll follow you, too.

Top 5 Reasons to Follow Us: • Be the first to find out about training opportunities, jobs and news from the field. • Build relationships with others working in the O&P field. • Stay in touch with the latest research, legislative issues, guides, blogs, and articles that are hot topics in the community. • Hear from leaders and experts. • Receive special social media follower discounts, perks, and giveaways! Contact Lauren Anderson at landerson@AOPAnet.org or 571/431-0843 with social media and content questions.

HROUGH AN AGREEMENT WITH Cailor-Fleming and

Keystone Insurers Group, AOPA is offering a new member benefits package that will provide AOPA member offices and facilities with access to disability, life, dental, and vision insurance benefits at competitive rates. Worksite marketing products such as accident and critical illness policies also will be offered. Owners and their employees can take advantage of competitive group dental and vision rates through convenient payroll deduction. Offering protection to employees from disability is something that more companies are looking to provide. Disabilities happen. In fact, the likelihood that a 40-year-old will be disabled for more than 90 days before age 65 is 45 percent. Fortunately, there is a way to help protect against the potentially devastating loss of livelihood resulting from disabling sicknesses and injuries. AOPA now sponsors convenient payroll-deductible short-term disability income protection. Employees can replace up to 60 percent of their salary if they are unable to work due to total or partial disability caused by illness or an off-the-job injury. Your AOPA membership will allow you to provide preferred underwriting on pre-existing conditions and partial disability benefits. Employees can choose from multiple options to decide what program is best to protect their income and their families. Employees also will have access to multiple life insurance, vision, and dental options on a preferred underwriting basis. Dental participants can access any dentist in the country and take advantage of large group rating discounts. “We are pleased that AOPA members will now be able to provide these valuable benefits to their employees,” says Jeff Michalenok of Cailor-Fleming. “In working with Keystone Insurers Group and VBA, we have been able to harness the power of large group benefits for each of AOPA’s members, regardless of their individual office size. In the vast majority of cases, the contracts and pricing are superior to what they can realize outside of AOPA.” More information will be forthcoming for employee enrollment and education. Open enrollments will begin this month for a December 1 effective date. Employers and employees will have several options including print, telephone, and web-based enrollment systems. O&P ALMANAC | NOVEMBER 2014

AOPA NEWS

Earn CE Credits by Reading the O&P Almanac!

E! QU IZ M EARN

BUSINESS CE

CREDITS P. 18

Coding Questions Answered 24/7 AOPA members can take advantage of a “click-ofthe-mouse” solution available at LCodeSearch.com. AOPA supplier members provide coding information about specific products. You can search for appropriate products three ways—by L code, by manufacturer, or by category. It’s the 21st century way to get quick answers to many of your coding questions. Access the coding website today by visiting www.LCodeSearch.com. AOPA’s expert staff continues to be available for all coding and reimbursement questions. Contact Devon Bernard at dbernard@AOPAnet.org or 571/431-0854 with content questions.

UPS Savings Program BECAUSE OF THE HIGHLY EDUCATIONAL content of the O&P Almanac’s Reimbursement Page and Compliance Corner columns, O&P Almanac readers can now earn two business continuing education (CE) credits each time you read the content and pass the accompanying quizzes. It’s easy, and it’s free. Simply read the Reimbursement Page column (appearing in each issue) and Compliance Corner column (appearing quarterly), take the quizzes, and score a grade of at least 80 percent. AOPA will automatically transmit the information to the certifying boards on a quarterly basis. Find the digital edition of O&P Almanac at: • http://www.aopanet.org/publications/digital-edition/ Access previous monthly quizzes at: • bit.ly/OPalmanacQuiz The October 2014 quizes are located at: • https://aopa.wufoo.com/forms/ op-almanac-october-2014-reimbursement-page/ • https://aopa.wufoo.com/forms/ op-almanac-october-2014-compliance-corner/ Be sure to read the Reimbursement Page article in this issue and take the November 2014 quiz. Take advantage of the opportunity to earn up to four CE credits today! Take the quiz by scanning the QR code or visit bit.ly/OPalmanacQuiz. Earn CE credits accepted by certifying boards:

NOVEMBER 2014 | O&P ALMANAC

www.bocusa.org

AOPA Members now save up to 30% on UPS Next Day Air® & International shipping! Sign up today at www.savewithups.com/aopa! Take advantage of special savings on UPS shipping offered to you as an AOPA Member. Through our extensive network, UPS offers you access to solutions that help you meet the special shipping and handling needs, putting your products to market faster. AOPA members enjoy discounts for all shipping needs and a host of shipping technologies. Members save: • Up to 30% off UPS Next Day Air® • Up to 30% off International Export/Import • Up to 23% off UPS 2nd Day Air® All this with the peace of mind that comes from using the carrier that delivers outstanding reliability, greater speed, more service, and innovative technology. UPS guarantees delivery of more packages around the world than anyone, and delivers more packages overnight on time in the US than any other carrier. Simple shipping! Special savings! It’s that easy!

www.savewithups.com/aopa

AOPA NEWS

Log On for Free at the AOPAversity Online Meeting Place EDUCATION DOES NOT GET ANY MORE CONVENIENT THAN THIS. Busy professionals need options—and

web-based learning offers sound benefits, including 24/7 access to materials, savings on travel expenses, and reduced fees. Learn at your own pace—where and when it is convenient for you. For a limited time, AOPA members can learn and earn for free at the AOPAversity Online Meeting Place: www.AOPAnetonline.org/education. Take advantage of the free introductory offer to learn about a variety of clinical and business topics by viewing educational videos from the prior year’s National Assembly. Earn continuing education credits by completing the accompanying quiz in the CE Credit Presentations Category. Credits will be recorded by ABC and BOC on a quarterly basis.

AOPA also offers two sets of webcasts: Mastering Medicare and Practice Management. Mastering Medicare: Coding & Billing Basics: These courses are designed for practitioners and office staff who need basic to intermediate education on coding and billing Medicare. Practice Management: Getting Started Series: These courses are designed for those establishing a new O&P practice. Register online by visiting bit.ly/WebcastsAOPA.

WELCOME 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 www.AOPAnet.org 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:

Level 1: equal to or less than $1 million Level 2: $1 million to $1,999,999 Level 3: $2 million to $4,999,999 Level 4: more than $5 million.

C-Pro Direct Ltd. 7A Enterprise Way Edenbridge, Kent TN8 6HF United Kingdom +44 (0)1732 860158 Category: International Member Stella Morrris Mid-Atlantic Prosthetics and Orthotics LLC North 2604 Kirkwood Highway, Ste. C Wilmington, DE 19085 302/691-7301 Category: Affiliate Member Parent Company: Mid-Atlantic Prosthetics & Orthotics, Alexandria, VA

San Antonio Prosthetics Corp. 11933 Network Blvd. San Antonio, TX 78249 210/616-0761 Category: Patient-Care Member Cellina Soria, CFm Swiftwick 7104 Crossroads Blvd., Ste. 123 Brentwood, TN 37027 615/370-8611 Category: Supplier Member Grant Castle

Is Your Facility Celebrating a Special Milestone in 2015?

O&P Almanac would like to celebrate the important milestones of established AOPA members. To share information about your anniversary or other special occasion to be published in a future issue of O&P Almanac, please email cumbrell@contentcommunicators.com. O&P ALMANAC | NOVEMBER 2014

MILESTONES

Congratulations to AOPA members

60-Year Anniversary: Dankmeyer Prosthetics and Orthotics Inc. O&P Almanac celebrates the important milestones being celebrated by established AOPA members in 2014

T ISN’T EVERY DAY that a

60-YEAR ANNIVERSARY: Dankmeyer Prosthetics and Orthotics HEADQUARTERS: Linthicum Heights, Maryland LOCATIONS: 4 facilities throughout Maryland, including a fullservice laboratory EMPLOYEES: 26, including 9 ABC-certified practitioners OWNERS: Mark Hopkins, PT, CPO, MBA, and Joseph DeLorenzo, CP

NOVEMBER 2014 | O&P ALMANAC

Facility History

Dankmeyer Inc., the largest O&P provider in Maryland, was founded in 1954 in Baltimore by Charles “Herb” Dankmeyer, a bilateral below-knee amputee, who was seeking an improved quality of life through better prosthetics. The first office was located in a corner building within a block of rowhouses in Baltimore. In 1969, he purchased property in Baltimore City and custom-designed the new facility to meet the needs of O&P patients. Herb Dankmeyer, who was certified as CPO Number 13, was known to be very progressive and is credited with several advances in the field. “My father was one of the first to use a hydraulic systems on above-knee amputees,” says Charles H. Dankmeyer Jr., CPO, Herb’s son and incoming AOPA president. Herb Dankmeyer played an important role in the research and development of the Muenster technique to fit short below-elbow amputees, and helped develop unique

specialty bracing for polio and fracture patients, using laminated plastics. In addition, he was involved in developing a variety of myoelectric signal systems to integrate into O&P devices. Dankmeyer P&O grew by venturing into remote areas as the need arose. “We always grew where people were asking us to be,” says Charles Dankmeyer Jr. In fact, the second location was opened in the mid 1970s, when Herb Dankmeyer had been treating patients 150 miles away in a Cumberland, Maryland, hospital. Recognizing the patient demand in the area, Herb Dankmeyer opened a clinic in cooperation with the hospital. Before long, Herb’s son Charles was making the drive to Cumberland instead of his father and a full-time facility was opened. Charles Dankmeyer Jr. officially took over leadership of the facility in 1974. In 1994 he moved facility headquarters to its current location in Linthicum Heights. In December 2012, two of the facility’s long-time employees took ownership of Dankmeyer P&O: Mark Hopkins, PT, CPO, MBA, and Joseph DeLorenzo, CP. Charles Dankmeyer Jr. remains a consultant for the facility, and a continued “family atmosphere” resonates among staff.

What Makes This Facility Successful

The staff at Dankmeyer P&O is committed to doing three tasks well: patient care, research, and education. “The staff has always been focused on taking care of people and

PHOTOS: Dankmeyer Prosthetics and Orthotics

respected O&P facility celebrates a 60th anniversary. But it also isn’t every day that a 60th anniversary is celebrated by the firm of a newly elected president of AOPA, Charles H. Dankmeyer Jr., CPO, who takes the helm at AOPA on December 1. O&P Almanac extends special congratulations to Dankmeyer Prosthetic and Orthotics Inc. Sixty years usually means second generation, and Dankmeyer P&O is no exception. Charles Dankmeyer’s father, Charles “Herb” Dankmeyer, a bilateral amputee, founded the original Dankmeyer patient-care facility in Baltimore in 1954. Patient care is now provided at four facilities in Linthicum, Baltimore, Cumberland, and Easton, Maryland. As we celebrate the milestone of Dankmeyer P&O, we also look to what Charles Dankmeyer Jr. will do in leading AOPA over the next year. He will be prioritizing needed research projects and steering AOPA as the organization plays an advisory role in the recently released grant announcements implementing $10 million in O&P research funding. We look forward to exciting futures for both AOPA and Dankmeyer P&O.

MILESTONES

Dankmeyer Prosthetics and Orthotics demonstrates “a commitment to the client.”

PHOTOS: Dankmeyer Prosthetics and Orthotics

making them feel welcome in the process,” says Charles Dankmeyer Jr. The facility has consistently demonstrated a “commitment to the client,” adds Hopkins, the facility’s CEO and president. “We take care of the patients we work with.” The facility has successfully positioned itself as part of the rehabilitation team. “We work with physicians, therapists, nurses, PTs, OTs, and patients and their families,” Hopkins says. The team approach has sustained the facility throughout the years: “We’ve got friends and the support of our community.” Practitioners at Dankmeyer P&O strive to stay on the cutting edge of the latest research and new technologies. The facility was the first in Maryland to produce plastic prostheses, endoskeletal prostheses, electronic prostheses, and plastic-molded orthoses for spine, lower limb, and upper limb. Dankmeyer teamed with the Johns Hopkins Applied Physics Laboratory in the development of powered upper-limb prostheses. The facility also has a residency program, which helps develop staff, and participates in local and national research programs. Charles Dankmeyer Jr. believes another key ingredient to the facility’s success is the administrative staff’s attention to detail: “We have justification and documentation for everything we do,” he says. “Any time we have faced scrutiny—be it

a Medicare audit, insurance inquiry, or disability claim—we always have the documentation in hand and ready.” Hopkins also credits a committed staff with keeping the facility running smoothly: “We have an awesome group of people who work here,” he says. “We maintain a family environment for our staff. We all get along well and are committed to the idea of taking care of our patients.”

How the Facility Will Thrive in the Future

In the years to come, Dankmeyer Prosthetics and Orthotics will “continue to put our clients first, and maintain our place on the rehab team,” says Hopkins. He also plans to research new technologies to incorporate into patient care, and to embrace the future: “We’ll take change as it comes while staying true to our mission,” he says. Charles Dankmeyer Jr. sees a sustained need for O&P practitioners, and a need for exceptional O&P facilities, for many years to come: “There are an increasing number of people who will require the services of orthotists and prosthetists,” he says. “We need to continue to demonstrate that we are the best people to provide that care. I think people will continue to find this a rewarding profession.”

MILESTONES Is Your Facility Celebrating a Special Milestone in 2015?

The O&P Almanac would like to celebrate the important milestones of established AOPA members. To share information about your anniversary or other special occasion to be published in a future issue of O&P Almanac, please email cumbrell@ contentcommunicators.com.

O&P ALMANAC | NOVEMBER 2014

BUYERSâ&#x20AC;&#x2122; GUIDE to

Contents 46

CAD/CAM Casting and Fabrication

Custom Fabrication

FOOT CARE

Custom Foot Orthotics

Liners

The annual one-stop resource for O&P foot-care products and services

47 Lower-Limb Devices

CAD/CAM Casting and Fabrication Amfit, Inc.

Vancouver, WA 98665 360/573-9100 www.amfit.com

CAD/CAM Systems Cast and manufacture custom foot orthotics quickly, accurately, and at a low cost per pair with an Amfit in-house fabrication system. Digital 3-D casting and milling on your schedule with two 3-D scanner options to create easily stored digital foot records. Choose Direct Digital 3-D Casting via the Contact Digitizer or foam box and positive model scanning with the Impress Scanner and Cad/Cam Mill to The Cad/ Cam Mill is as easy to operate as playing a disc. Rental, Lease, and Purchase programs include: Correct and Confirm orthotic design software, 2-year warranty, on-site training (in North America), and lifetime support. Â

NOVEMBER 2014 | O&P ALMANAC

48 Pediatric Orthoses

Central Fabrication Amfit, Inc.

Vancouver, WA 98665 360/573-9100 www.amfit.com

2014 Foot Buyers’ Guide

Custom Foot Orthotics

Liners PEL

Cleveland, OH 44135-2638 800/321-1264

Amfit, Inc.

Vancouver, WA 98665 360/573-9100

www.pelsupply.com

www.amfit.com

Custom Foot Orthotics You need to save time. You also want to save money. Trust Amfit with fabrication of custom foot orthotics and free up lab time for bigger projects. A5513 approved Diabetic program is as low as 3/$60 (shipping included). 5 EVA styles, polypropylene, and carbon fiber options round out the options. Foam box orders are shipped in 3-5 business days, Amfit digital records in 2 business days. Our primary focus for nearly 30 years has been custom foot orthotics and orthotic technology. Amfit. Where Technology Fits...Perfectly.

ALPSTM Guardian Suction Liner from PEL The ALPSTM Guardian Suction Liner features a high performance knitted fabric cover created by integrating ALPS proprietary in-house knitting techniques with GripGelTM technology. The resulting material increases functional improvement, ensures durability, and inhibits skin breakdown and surface discoloration. Features and benefits include: • Raised GripGel bands to prevent slippage or premature release • Low modulus GripGel bands stretch against the socket wall while the inner wall conforms easily to the residual limb • Suitable for both transtibial and transfemoral amputees • Rated for K2, K3, and K4 activity levels.

Fillauer

www.fillauer.com

Lower-Limb Devices

Chattanooga, TN 800/251-6398

Preformed TFC Foot Orthotics • Preformed for better fit on heel • 3/4 Length • May be easily customized to patient’s model • Re-moldable Carbon Composite • Extremely durable and tough

For more information, visit www.fillauer.com.

Contact PEL at 800/321-1264 or www.pelsupply.com.

Fillauer

Chattanooga, TN 800/251-6398 www.fillauer.com

COD Ankle Joint Fillauer’s Hosmer division offers the COD Self-aligning Ankle Joint, which allows for conversion of a rigid ankle foot orthosis (AFO) to an articulated AFO. The ankle joint allows four-way adjustments and continually variable range of motion in eversion, inversion, plantar flexion, and dorsiflexion. There is no need for structural changes or reworking of the stirrup. Just screen the connector in or out by detaching the upper ankle bar from the brace and turning it. The ankle joint is lubricated for life. For more information, visit www.fillauer.com.

O&P ALMANAC | NOVEMBER 2014

2014 Foot Buyers’ Guide

Fillauer

Chattanooga, TN 800/251-6398 www.fillauer.com Dynamic Walk • High quality dorsiflexion assist technology • Lightweight • High strength • Fits easily into normal or narrow shoes • Flexible for multi-plane action • Dynamic medial/lateral control • Enables athletic activity such as moderate running For more information, visit www.fillauer.com.

PEL

Cleveland, OH 44135-2638 800/321-1264 www.pelsupply.com

Nabtesco Symphony Knee from PEL The Nabtesco Symphony Knee is a six axis hydraulic knee that is bumper based with adjustable stance flexion. The unique design of the hydraulic cylinder allows for ease of inflection initiation and the knee provides a high level of safety due to the geometric knee lock until toe off is achieved. Features and benefits include: • Easy to access user adjustable manual lock • Low build height, comes in knee disarticulation version • User friendly 7 ¾ inch overall height.

Contact PEL at 800/321-1264 or www.pelsupply.com.

NOVEMBER 2014 | O&P ALMANAC

Pediatric Orthoses Cascade Dafo, Inc. Ferndale, WA 800/848-7332

bizdev@dafo.com www.cascadedafo.com

Cascade Dafo FlexiSport Strut Flexibility Options The DAFO FlexiSport is a customfabricated, two-part orthosis that combines full wrap-around foot control with a posterior upright that provides graded, leaf spring–like resistance to plantarflexion and dorsiflexion. This brace style is designed for larger, active patients who need moderate-to-strong ankle control and sturdy support. In response to customer requests, the DAFO FlexiSport can now be ordered with a choice of posterior strut flexibility—moderately flexible or semi-rigid—to meet your patient’s unique needs. Like all Cascade Dafo orthoses, the DAFO Flexisport is backed by a Full (90-Day) Warranty. For more information, visit www.cascadedafo.com or call 800/848-7332.

David Prince World Record Holder in the 4OOm

guardian Tel: 727.528.8566 Tel: 800.574.5426

www.easyliner.com

info@easyliner.com

AOPA NEWS

CAREERS

North Central

Northeast

CPO or Board-Eligible CPO

Certified Orthotist/Certified Prosthetist-Orthotist

Grand Rapids, Michigan We are seeking a motivated CPO or board-eligible CPO for our Grand Rapids location. Position will be focused upon orthotics with some travel to satellite locations. Candidate should be articulate and possess organizational and interpersonal skills. Teter O & P is a privately owned company with 20 locations in Michigan. We offer a competitive salary, good benefits, IRA plan, and paid continuing education. Please send resume to: Ladd Lorenz, CP 4024 Park East Court, Ste. B Grand Rapids, MI 49546 Fax: 616/949-4051 Email: laddl@teterop.com

Long Island, New York Wanted: CO/CPO for busy Long Island practice. Excellent pay and a comprehensive benefits package. Must be professional, knowledgeable, and caring. Upbeat practitioners need only apply. Apply by email: Email: mgpolab@gmail.com

The Source for Orthotic & Prosthetic Coding

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.

Morning, noon, or night— LCodeSearch.com allows you access to expert coding advice—24 hours a day, 7 days a week.

HE O&P CODING EXPERTISE the profession has come to rely on is available online 24/7! LCodeSearch.com allows users to search for information that matches L Codes with products in the orthotic and prosthetic industry. Users rely on it to search for L Codes and manufacturers, and to select appropriate codes for specific products. This exclusive service is available only for AOPA members.

Log on to LCodeSearch.com and start today. Need to renew your membership? Contact Betty Leppin at 571/431-0876 or bleppin@AOPAnet.org. www.AOPAnet.org

NOVEMBER 2014 | O&P ALMANAC

NEW

Manufacturers: for 2015! AOPA is now offering Enhanced Listings on LCodeSearch.com. Don’t miss out on this great opportunity for buyers to see your product information! Contact Betty Leppin for more information at 571-431-0876.

CAREERS

Opportunities for O&P Professionals Job location key: - Northeast - Mid-Atlantic

O&P Almanac Careers Rates Color Ad Special 1/4 Page ad 1/2 Page ad

Member $482 $634

Nonmember $678 $830

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

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

- Southeast - North Central - Inter-Mountain - 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 landerson@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.

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

Member Nonmember $80 $140

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

Discover new ways to connect with O&P professionals. Contact Bob Heiman at 856/673-4000 or email bob.rhmedia@comcast.net. Visit bit.ly/aopa14media for advertising options.

O&P ALMANAC | NOVEMBER 2014

CALENDAR

2014

November 15

Midwest Chapter AAOP—One-Day Fall Symposium. Hickory Hills, IL. For more information, visit www.mwcaaop. org/meetings-events.html or email mwcaaop@gmail.com.

November 5-7

New Jersey Chapter AAOP Educational Seminar. NEW LOCATION: Revel Atlantic City Resort Casino, NJ. For more information, visit www.njaaop.com or email director@njaaop.com.

November 6-7

COPA 2014 Northern California Educational Event. Hilton Garden Inn. Emeryville, CA. For more information, visit www.regonline.com/builder/site/?eventid=1567170.

November 10-15

ABC: Written and Written Simulation Certification Exams. ABC certification exams will be administered for orthotists, prosthetists, pedorthists, orthotic fitters, mastectomy fitters, therapeutic shoe fitters, and orthotic and prosthetic technicians in 250 locations nationwide. Contact 703/836-7114, email certification@abcop.org, or visit www.abcop.org/certification.

November 12

AOPA: Gifts—Showing Appreciation Without Violating the Law. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

Year-Round Testing BOC Examinations. BOC has year-round testing for all of its examinations. Candidates can apply and test when ready, receiving their results instantly for the multiple-choice and clinical-simulation exams. Apply now at http://my.bocusa.org. For more information, visit www.bocusa.org or email cert@bocusa.org.

www.bocusa.org

Calendar Rates Let us share your upcoming event! Telephone and fax numbers, email addresses, and websites are counted as single words. Refer to www. AOPAnet.org for content deadlines.

NOVEMBER 2014 | O&P ALMANAC

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 703/836-7714, email certification@abcop.org, or visit www.abcop.org/certification.

December 4-6

R.I.C.: Pediatric Gait Analysis: Segmental Kinematic Approach to Orthotic Management. Chicago. Elaine Owen. 21.50 ABC Credit application. Contact Melissa Kolski at 312/238-7731 or visit www.ric.org/education.

December 10

AOPA: New Codes and Changes for 2015. Register online at bit. ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

December 12-13

ABC: Orthotic Clinical Patient Management (CPM) Exam. Caruth Health Education Center, St. Petersburg College, FL. Contact 703/836-7114, email certification@abcop.org, or visit www.abcop.org/certification.

Online Training

Cascade Dafo Inc. Cascade Dafo Institute. Now offering a series of six free ABC-approved online courses, designed for pediatric practitioners. Visit www.cascadedafo.com or call 800/848-7332.

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

CREDITS

BONUS! Listings will be placed free of charge on the “Attend O&P Events” section of www.AOPAnet.org.

Words/Rate: Member Nonmember Color Ad Special: Member Nonmember 25 or less $40 $50 1/4 page Ad $482 $678 26-50 $50 $60 1/2 page Ad $634 $830 51+ $2.25/word $5.00/word

Send announcement and payment to: O&P Almanac, Calendar, P.O. Box 34711, Alexandria, VA 22334-0711, fax 571/431-0899, or email landerson@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.

CALENDAR

2015

May 14-16

January 9-11

O&P, Its Leadership, and Its Future. Palm Beach, FL. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org.

Western and Midwestern Orthotic and Prosthetic Association (WAMOPA) Annual Meeting. The best valued 24 CEUs in the industry. Visit www.wamopa.com for program and golf tournament updates. Peppermill Hotel Resort, Spa, and Casino. Reno, NV. Contact Sharon Gomez 530/521-4541, or Steve Colwell 206/440-1811.

June 10

January 14

Fill In the Blanks: VA Contracting Webinar Conference and the New Template. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org.

Stay Out of Trouble: Building a Medicare-Approved Compliance Plan. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

July 8

January 15-16

POMAC (Prosthetic and Orthotic Management Associates Corporation) Continuing Education Seminar. Shorebreak Hotel at Huntington Beach, CA. Contact John Shreter at 800/946-9170 x108 or email jshreter@pomac.com.

February 11

Find Success: Tips, Strategies, and Understanding the Appeals Process. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

March 11

Who Gets the Bill: A Complete Look at Medicare Inpatient Billing. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

April 8

Lower-Limb Prostheses Policy: Learn the Policy Inside and Out. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

April 30-May 2

2015 International African-American Prosthetic Orthotic Coalition Annual Meeting. Ocean Front Studio Suites, Virginia Beach, VA. Contact Michael Smith at 757/548-5656, email aopcnow@gmail.com, or visit www.iaaopc.org.

May 13

The New Player in Town: Understand How the RAC Contract Works. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

NOVEMBER 2014 | O&P ALMANAC

Whoâ&#x20AC;&#x2122;s on First? Medicare as a Secondary Payer. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

August 12

Off-the-Shelf vs. Custom Fit: The True Story. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

September 9

Prior Authorization, How Does It Work? Register online at bit. ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

October 7-10

98th AOPA National Assembly. San Antonio. Henry B. Gonzales Convention Center. For more information, contact AOPA Headquarters at 571/431-0876 or info@AOPAnet.org.

October 14

Understanding the LSO/TLSO Policy. Register online at bit. ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

November 11

How To Make a Good Impression: Marketing Yourself to Your Referrals. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

December 9

Bringing the New Year: New Codes and Changes for 2016. Register online at bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org. Webinar Conference

ADVERTISERS INDEX

Company

Page Phone

Website

ALPS South LLC

800/574-5426

www.easyliner.com

American Board for Certification in Orthotics, Prosthetics, & Pedorthics Inc.

703/836-7114

www.abcop.org

Amfit Inc.

800/356-3668

www.amfit.com

Board of Certification/Accreditation

877/776-2200

www.bocusa.org

Cascade Dafo

800/848-7332

www.cascadedafo.com

800/252-2828

www.daw-usa.com

800/251-6398

www.fillauer.com

7, 35

800/251-6398

www.fillauer.com

DAW Industries Dr. Comfort Fillauer Hersco

800/301-8275 www.hersco.com

Orthomerica

800/446-6770

Ottobock

800/328-4058 www.professionals.ottobockus.com

PEL

www.orthomerica.com

800/321-1264 www.pelsupply.com

Spinal Technology

800/253-7868

SPS

800/767-7776 www.spsco.com

www.spinaltech.com

Statement of Ownership, Management and Circulation (required by U.S.P.S. Form 3526) 1. Publication Title: O&P Almanac 2. Publication No.: 1061-4621 3. Filing Date: 9/26/14 4. Issue Frequency: Monthly 5. No. of Issues Published Annually: 12 6. Annual Subscription Price: $59 domestic/$99 foreign 7. Complete Mailing Address of Known Office of Publication (Not Printer): American Orthotic & Prosthetic Association, 330 John Carlyle St., Suite 200, Alexandria, VA 22314 8. Complete Mailing Address of Headquarters or General Business Office of Publisher (Not Printer): Same as #7 9. Full Names and Complete Mailing Addresses of Publisher, Editor, and Managing Editor: Publisher: Thomas F. Fise, address same as #7. Editor: Josephine Rossi, Content Communicators LLC, PO Box 223065, Chantilly, VA 20153. 10. Owner (Full Name and Complete Mailing Address): American Orthotic & Prosthetic Association, same as #7 11. Known Bondholders, Mortgagees, and Other Security Holders Owning 1 Percent or More of Total Amount of Bonds, Mortgages, or Other Securities: None. 12. The purpose, function, and nonprofit status of this organization and the exempt status for federal income tax purposes: Has Not Changed During the Preceding 12 Months. 13. Publication Name: O&P Almanac 14. Issue Date for Circulation Data Below: September 2014 Avg. No. Copies Each Issue Actual No. Copies of Single Issue During Preceding 12 Months Published Nearest to Filing Date 15. Extent and Nature of Circulation: a. Total number of Copies (Net Press Run) 13,356 12,905 b. Paid and/or Requested Circulation (1) Paid or Requested Outside-County Mail Subscriptions 12,916 11,634 (2) Paid In-County Subscriptions 0 0 (3) Sales Through Dealers and Carriers, Streeet Vendors, 0 0 Counter Sales, and other non-USPS Paid Distribution (4) Other Classes Mailed through the USPS 0 0 c. Total Paid and/or Requested Circulation 12,916 11,634 d. Free Distribution by Mail (1) Outside-County as Stated on Form 3541 0 0 (2) In-County as Stated on Form 3541 0 0 (3) Other Classes Mailed through the USPS 0 0 e. Free Distribution Outside the Mail 221 1,000 f. Total Free Distribution 221 1,000 g. Total Distribution 13,137 12,634 h. Copies Not Distributed 441 488 i. Total (Sum of 15g and h) 13,578 13,122 Percent Paid and/or Requested Circulation 98% 92%

O&P ALMANAC | NOVEMBER 2014

ASK AOPA

A Practical Guide to the PDAC Answers to your questions regarding verification by the Pricing, Data Analysis, and Coding contractor Are coding verifications made by the PDAC binding on Medicare providers?

S ATION

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PRIVATE

INSURER

TATBASE PDAC DA

Yes. Regardless of whether a request for PDAC verification is submitted voluntarily or as a mandatory submission as outlined in certain medical policies, once the PDAC has issued a coding verification, Medicare suppliers are required to bill Medicare using the Healthcare Common Procedure Coding System codes verified by the PDAC.

Is PDAC coding verification required for all O&P services billed to Medicare?

No. Mandatory coding verification by PDAC is limited to spinal orthoses, knee orthoses described by K0902 or L1845, diabetic shoe inserts described by A5512, ankle foot orthoses described by code L1906, and diabetic shoe inserts described by A5513 that are not fabricated within the lab of the individual supplier. L5969 is the only lower-limb prosthesis code that requires PDAC verification. For these items, PDAC coding verification is mandatory. In addition, any products that have been submitted voluntarily to PDAC and have received PDAC coding verification may only be billed using the codes indicated in the PDAC coding verification.

AOPA receives many questions from members regarding the role of the Pricing, Data Analysis, and Coding contractor (PDAC) in relation to billing Medicare for prosthetic and orthotic services. This month’s AOPA Answers reviews some common questions regarding the PDAC and its role as a Medicare contractor. If you would like to submit a question to AOPA for possible inclusion in the department, email Editor Josephine Rossi at jrossi@contentcommunicators.com.

NOVEMBER 2014 | O&P ALMANAC

How do I know if a product has had a PDAC coding verification?

The PDAC website has a searchable database of all products that have undergone the coding verification process. This database is searchable by manufacturer

name, product name, product number, or product category. Visit the PDAC database at www.dmepdac.com/ dmecsapp/do/search.

request?

Can O&P providers submit a PDAC coding verification

There are no restrictions regarding who may submit a PDAC coding verification request. However, based on the information the PDAC requires, product manufacturers are usually best suited to submit a request.

What if the PDAC database shows an “end date” for a specific product?

If the PDAC database lists an end date, the coding verification is not valid for claims with a date of service after that date. Products are usually end-dated if new information has been provided to the PDAC that results in a change to the product coding verification. Typically, the PDAC will end-date a coding verification and issue a new coding verification effective the same day.

insurers?

Are PDAC coding verifications binding on claims to private

No. The PDAC provides coding verification services only in its role as a Medicare contractor. Unless the private insurer has specific policy language that indicates that PDAC coding verification is binding on contracted suppliers, the PDAC coding verification applies only to claims submitted to Medicare.

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This night-time only brace works around the clock to let girls be kids too. Studies have shown that the Providence brace, a spinal orthosis worn only at night, is just as effective in the treatment of adolescent idiopathic scoliosis as full-time braces. That's important, because compliance increases when braces don't interfere with a child's everyday life. Spinal Technology is proud to be the exclusive manufacturer of the Providence. For more information on the Providence Nocturnal Scoliosis System contact your Spinal Technology Sales Representative or email us at info@spinaltech.com. 191 Mid Tech Drive West Yarmouth, MA 02673

800 253 7868

spinaltech.com

True-blue Hero One of the first to be fit with the C-Leg, Dr. Matt Bradley fought from an early age to gain greater mobility for himself. And now as an orthopedic surgeon he continues that fight—for his patients. Working on everything from rotator cuff injuries to amputation surgeries, Matt has relied on his Ottobock MPKs for true-blue stability during critical operations—and long, hectic days. In this 15th Anniversary year of the C-Leg, join us in applauding Matt as a C-Leg Hero. May he continue the fight for his—and your—mobility. Share a photo showing how the C-Leg or other Ottobock prosthetic product has changed your life at www.clegheroes.com.