October 2014 Almanac

The Magazine for the Orthotics & Prosthetics Profession

O CTO B E R 2014

E! QU IZ M EARN

VA Changes—The Aftermath of Scandal

4

BUSINESS CE

CREDITS P.20 & 42

P.18

2014 National Assembly Highlights P.30

Tips for Preparing for an FDA Inspection

The Just In: Executive Think Tank Planned for January 2015 P.22

P.40

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contents

OCTOB E R 2014 | VOL. 63, NO. 10

FEATURES

DEPARTMENTS | COLUMNS

COVER STORY

24

President’s View....................................... 4

Insights from AOPA President Anita Liberman-Lampear, MA

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

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

At-a-glance statistics and data

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

Research, updates, and industry news

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

Transitions in the profession

Reimbursement Page..........................18

VA Changes—The Aftermath of Scandal

24 | To Be First Elizabeth Bailey-Smith, 65, is the first patient to undergo osseointegration surgery in the United States.

Meet the team of practitioners who made it possible as they discuss the procedure, recovery, and the future for osseointegration in O&P.

By Meghan Holohan

22 | This Just In

P. 30

Tackling the Future

Compliance Corner.............................. 40

Can the FDA ‘Shut Down’ My Business?

How to prepare your business for an FDA inspection

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

Member Spotlight................................ 44 n n

30 | Action and Evolution

iFIT Prosthetics Prosthetix Shop

AOPA News............................................... 48

AOPA meetings, announcements, member benefits, and more

national

AOPA O&P PAC .......................................57

assembly ’14

Marketplace.............................................. 58

Careers........................................................ 60

Professional opportunities

Calendar...................................................... 62

Upcoming meetings and events

P. 44

Advertise with Us! For advertising information, contact Bob Heiman 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

CREDITS

O&P executives are invited to convene at an upcoming leadership conference and share ideas about the future O&P.

By Don DeBolt

More than 2,200 O&P AOPA’s professionals and nearly 200 exhibitors gathered at the Mandalay Bay Hotel & Casino in September to “Experience the ENGERY” of AOPA’s 2014 National Assembly. Read the highlights from some of the more than 100 educational sessions and a thriving exhibit hall that made this year’s event the premier show for O&P.

Significant changes ahead for private prosthetic provider contracts

Ad Index....................................................... 63

Ask AOPA...................................................64 Expert answers to your questions about business associate agreements

O&P ALMANAC | OCTOBER 2014

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PRESIDENT’S VIEW

Amplifying Our Patients’ Voices

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

T

HE OLD BUSINESS SUCCESS adage rested on three truths: “Location, location, location.” Perhaps it’s time to embrace the three obvious truths in pressing our advocacy agenda: “Patients, patients, patients.”

That point was driven home by the recent success in mobilizing patient voices in opposing two separate CMS proposed rules. First, CMS’s prior authorization proposal was likely to delay and limit amputee patient care as lower-limb prostheses were singled out for an additional layer of claims processing. Just one month later, CMS proposed limiting who could provide custom-fit orthotic care and eliminating orthotic fitter involvement. This would have automatically classified any device provided by fitters as an off-the-shelf (OTS) device.

In both cases, AOPA preprinted postcards addressed to CMS, which were signed by individual patients with messages of concern. This strategy drew a barrage of patient comments to CMS: 292 on prior authorization and 185 on the OTS issue.

These patient comments—plus the comments from members of the profession (442 prior authorization comments and 368 OTS definition comments)— made a much stronger case for O&P’s position on both issues.

All told, the effort to mobilize patients was an eye-opening exercise for our advocacy strategies. It’s a strategy that deserves more focus in the future when any legislative or regulatory proposal harbors potential harm to patients. Our integrity continues to rest on providing the best possible patient care, and when any legislative or regulatory proposal threatens that ability, the patient call to action will probably deliver a more potent and persuasive voice than any other approach.

At last year’s World Congress in Orlando, I brought my Harry Potter wand and promised to do my best to help banish the problems O&P faces. But I did warn you that it will take far more than a magic wand to fix all of our problems. And while we did much good this past year, it occurred to me that the patient voice may well be the “magic wand” we are looking for. That and you, the providers, taking the time to respond and participate. That is really the magic wand in O&P. Here’s hoping you attended the 97th National Assembly in Las Vegas because there were so many exciting takeaways for everyone’s needs. Chris Nolan and the Assembly Planning Committee injected some truly great innovations into our traditional way of doing things. While all of them seemed to hit the mark, leaving Sunday purely for education and giving exhibitors more unopposed face-time with their customers and clients on Friday and Saturday seemed to be the biggest home run. Thanks also to the wonderful folks who made the 7th Annual Wine Tasting and Auction such a success for the Political Action Committee and Capital Connection—a $31,991 success! And congratulations to the winners of all of the contests—the Thranhardt and the Hamontree lectures, posters, student papers, technical fabrication, and the many exhibitor-sponsored giveaways.

The stage was set for returning to the Mandalay Bay Resort and Casino for AOPA’s centennial celebration in 2017, which will also be billed as the 2nd World Congress sponsored by AOPA and its growing list of co-sponsors.

If you weren’t able to join us in Las Vegas, we do hope you’ll read the wrap-up story in this issue of the O&P Almanac. It will give you a glimpse of what you missed and whet your appetite for San Antonio next year, October 7-10, 2015.

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 4

OCTOBER 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

O&P ALMANAC

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

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

Don DeBolt, chief operating officer, 571/431-0814, ddebolt@AOPAnet.org

Josephine Rossi, editor, 703/662-5828, jrossi@contentcommunicators.com

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 Stephen Custer, communications manager, 571/431-0810, scuster@AOPAnet.org Lauren Anderson, manager of membership services, 571/431-0843, landerson@AOPAnet.org Betty Leppin, project manager, 571/431-0876, bleppin@AOPAnet.org AOPA Bookstore: 571/431-0865 GOVERNMENT AFFAIRS

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 Stephen Custer, production manager, 571/431-0810, scuster@AOPAnet.org Lia K. Dangelico, contributing writer, ldangelico@contentcommunicators.com

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OCTOBER 2014 | O&P ALMANAC

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

Advertise with Us!

Joe McTernan, director of coding and reimbursement services, education and programming, 571/431-0811, jmcternan@AOPAnet.org Devon Bernard, assistant director of coding reimbursement, programming and education, 571/431-0854, dbernard@AOPAnet.org

Advertising Sales RH Media LLC

MobilitySaves.org MobilitySaves.org

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 http://bit.ly/aopa14media for advertising options!

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PROFESSIONAL LIABILITY | GENERAL LIABILITY | PROPERTY

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NUMBERS

AOPA Assembly Wins Big in Vegas 2014 National Assembly draws thousands for education, advancement of O&P

AOPA’s

national

LOTS TO SEE

assembly ’14 Last month, more than 2,200 O&P professionals gathered in Las Vegas for the 97th Annual AOPA National Assembly Sept. 4-7, 2014. Business owners, practitioners, and a variety of related health-care professionals united during education sessions and networking events, each adding to the collective O&P voice advancing the profession.

LOTS TO LEARN

CE

36 Credits

Conference-goers had the opportunity to earn up to 36 CE credits in five dedicated education tracks.

4 Days

Attendees partook in four days of orthotic, prosthetic, and pedorthic education.

100+ Sessions Attendees had the chance to take part in their choice of 110 educational sessions and 32 manufacturer workshops.

2,200+

More than 2,200 O&P professionals took part in the 2014 AOPA Assembly.

160 Exhibits

One hundred and sixty exhibitors took over the trade show floor in Vegas, showcasing the latest and greatest in orthotic and prosthetic devices and related supplies.

Nicole Gibson of the University of Michigan designed the winning device in the 3rd Annual Technical Fabrication Contest by designing a lower-extremity device with a theme of “energy.”

$5,000

Erin Cammarata of CBS Billing & Consulting LLC won the $5,000 cash giveaway.

$31,991

The AOPA Political Action Committee and Capital Connection received nearly $32,000 during the 7th Annual Wine Tasting and Auction.

Thursday, Sept. 4

2.5 Hours

Friday, Sept. 5

8.5 Hours

OCTOBER 2014 | O&P ALMANAC

Two individuals became the first graduating class of AOPA’s Business Certificate Program: Jennifer Porter and Sarah Marich of Northeast Orthotics & Prosthetics.

$500

EXPANDED EXPO HOURS

8

Class of 2014

LOTS TO WIN

Participants Browsed the Expo Hall for 19 Total Hours

Saturday, Sept. 6

FIRST GRADUATES

8 Hours

“The Planning Committee injected some truly great innovations into our traditional way of doing things at this year’s Assembly.

While all of them seemed to hit the mark, leaving Sunday purely for education and giving exhibitors more unopposed face-time with their customers and clients on Friday and Saturday seemed to be the biggest home run.”

—Anita Liberman-Lampear, MA, AOPA President

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NEW Knit-Rite Ease by Therafirm® Gradient Compression Hosiery • Made with ultra stretchy yarns for ease in pulling on • Very innovative, yet affordable, premium line • Super soft, breathable material offers superior comfort for all-day wear • Moisture wicking CoolMax® fibers provide dry comfortable coolness • Delivers lab-tested true gradient compression to promote better blood flow, prevent mild to moderate swelling, and relieve tired, achy legs and feet

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Happenings PII SECURITY

O&P ON THE RUNWAY

Health Care Accounts for 23% of Data Breaches While data breaches are becoming increasingly challenging for consumers in any industry, new research offers a snapshot of how breaches related to health-care exchanges fit in the mix.

Between April and June of this year, 237 total data breaches occurred, according to SafeNet’s Breach Level Index for the second quarter of 2014.

More than 175 million customer records of personal and financial information worldwide were compromised due to those breaches.

Health care incurred 23 percent of those incidents, but only accounted for less than 1 percent of all records stolen during that time period.

Individuals With Limb Loss Strut Their Stuff Fashion Week 2014 made headlines this year when two amputeesturned-models showcased their abilities on the runways.

Karen Crespo became the first quadruple amputee to walk the runway at New York Fashion Week in September. Crespo lost her arms and legs following a bout with bacterial meningitis three years ago. She was invited to participate in a fashion show

by Carrie Hammer, a New York Citybased designer. Hammer prefers to use “role models, not runway models” in her shows. Hammer also assisted Crespo in getting new prosthetic arms after her previous arms were stolen; Hammer reached out to Hanger Orthopedic

Group, who agreed to make her new arms in time for her runway walk.

During Mercedes Benz Fashion Week, retired Marine Cpl. Alex Minsky wore a UNYQ fairing with swimwear during his appearance. Minsky was injured in 2009 in Afghanistan when his Humvee ran over a roadside bomb. His bottom jaw was broken in four different places, his arm injured, and his right leg was amputated below the knee.

Despite doctors’ predictions, Minsky survived and found a positive way to cope by hitting the gym—where a photographer “discovered” him. Minsky now models UNYQ’s covers, among other items, and he helped design the fairing he wore during Fashion Week.

DIABETES DOWNLOAD

DATA BREACHES

Total Contact Casting Proven Effective for Foot Ulcers

23% Health Care

Retail and Other

77% 10

OCTOBER 2014 | O&P ALMANAC

Diabetic patients with foot ulcers suffered significantly fewer foot amputations a year after being treated via total contact foot casting versus other methods of treatment, according to Texas researchers.

A team led by Caroline Fife, MD, of the University of Texas Medical School at Houston, studied a wound care registry with more than 11,000 patients who had 25,000 diabetic foot ulcers. The researchers studied outcome measures, including whether the ulcers were healed, amputation, percent of offloading, percent use of total contact casting, and infection rates.

Offloading was documented in 2 percent of 220,000 visits over six years.

Of those, 37 percent were offloaded

via postoperative shoe and 16 percent were offloaded via total contact casting. There were significantly more amputations within a year for those with diabetic foot ulcers who did not have total contact casting when compared with those who did.

“Total contact casting is vastly underutilized in diabetic foot ulcer wound care settings, suggesting that there is a gap in practice for adequate offloading,” the researchers concluded. Though total contact casting can be expensive and time-consuming, many health-care professionals believe it to be the most successful technique for healing.

See full study results in the July issue of Advances in Skin & Wound Care.

HAPPENINGS

O&P ATHLETICS

Kayakers Prepare for Paralympic Debut in Rio

PHOTOS: John King, CP, (ret.)

Paddlers with physical disabilities made a strong showing during the U.S. Canoe Association (USCA) Nationals in Lock Haven, Pennsylvania, in August. Despite the rain, Bob Balk took first place in the 500-meter V1 race, and Nolan Yesh took first place in the K1 solo kayak race.

The paddlers will continue to face tough competition as they compete for a spot in the 2016 Paralympic Games to be held in Rio. Kayak racing for individuals with disabilities will make its debut during the Games.

(Bottom, from left to right) Nolan Yesh, Derrick Mertowski, Jan Whitaker, Colin Gooley, and Bob Balk took part in the U.S. Canoe Association Nationals in Lock Haven, Pennsylvania.

VA VIEWPOINT

Revised Prosthetic Limb Contract Template Available The Veterans Administration (VA) has released a contract template that will govern the provision of prosthetic limbs to veterans by private contractors. The new template, which will be mandatory for use by all VA contracting officers, will replace existing contract templates as their terms expire.

Revisions to the contract template include the following: • Contractors will be required to be accredited by either the American Board for Certification in Orthotics, Prosthetics, and Pedorthics or the Board of Certification.

• Prosthetic services must be provided by properly certified and trained individuals.

• Contractors must prove that they have received specific education and training to fit certain devices that represent technology that may only be provided with

• •

•

•

training and education offered by the manufacturer of the device.

Changes to the prosthetic prescription must be authorized by the VA contracting officer.

The VA may prescribe and authorize the provision of a utilization and function monitoring device for purposes of data collection. Contractors must provide data collected to the VA. Contractors will be required to provide semi-annual service for each prosthetic limb they provide to a veteran. These service visits will be compensated and providers may bill for up to four units (60 minutes total) of the prosthetic labor code (L7520) for these visits.

Final inspection of new prosthetic limbs and socket replacements by the VA amputee clinic will be required.

• Approved miscellaneous codes (L5999 and L7499) will be reimbursed at 150 percent of the contractors’ purchase price minus any contractually negotiated discount.

Sources at the VA have indicated that the award of new contracts using the revised template will continue to be based on a competitive model using the proposed contractual discount as only one of several factors in determining the award. Other factors include the quality of care provided, the ability to service the veteran community, and the ability of the VA to provide services within its own facilities.

For more information, please read this issue’s Reimbursement Page on page 18.

O&P ALMANAC | OCTOBER 2014

11

HAPPENINGS

#ICYMI

DME MACs Clarify Rules on Proof of Delivery Documentation The four Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have published a joint article on their websites that provides clarification regarding who may enter the date on proof of delivery documentation. While the signature must be personally applied by the beneficiary or their designated representative, the date may be entered by the beneficiary, his or her representative, or the supplier of the item(s).

The clarification also indicates that “auto-filling” of the date, where the date is automatically applied to the proof of delivery document, is acceptable for documentation purposes.

The DME MACs reminded suppliers that, however the date is applied, it must match the actual date of delivery of the completed item(s).

CMS Announces Limited Restart of RAC Activities Existing contracts with the current recovery audit contractors (RACs) have been modified to allow them to restart recovery activities on a limited basis, according to CMS. RAC auditors were previously notified that, in order to ensure a smooth transition as the term of the original RAC contracts expired, no new additional documentation requests were to be sent to providers after Feb. 28, 2014. In addition to facilitating a smooth transition of contract responsibilities, CMS also stated that the pause in RAC activities would allow CMS to continue to refine and improve the Medicare recovery audit program.

The modification of the existing

Jurisdiction B Publishes Results of Prepayment Reviews National Government Services (NGS), the Jurisdiction B DME MAC, has released results for its prepayment review of high error rate claims for durable medical equipment, prosthetics, orthotics, and supplies, for the second quarter of 2014. The overall error rate for this review, which includes O&P claims, was 60 percent. This error rate was lower than during the first quarter review (68 percent), but NGS will continue its review based on the current error rate of 60 percent.

While the report did not identify the specific error rate for O&P claims, it did highlight the main reasons for denials of the O&P claims that were part of the review: • No medical records were submitted.

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OCTOBER 2014 | O&P ALMANAC

contracts to allow RAC auditors to restart recovery activities using the same flawed processes that were addressed in a bipartisan letter to former Secretary Kathleen Sebelius from 111 members of Congress in February of 2014 appears to be in direct conflict with CMS’s stated goal of continuing to improve and refine the Medicare audit recovery program. While the recent announcement states that RAC activities will be limited and focus mainly on automated reviews, CMS indicated that a limited number of complex reviews of topics selected by CMS will be conducted by RAC auditors.

• No required documentation was included to justify the medical need of the item billed.

• This service was included in a claim that had been previously billed and adjudicated.

While a lower error rate is a positive development, AOPA members are reminded to make sure all documentation requirements outlined in the local coverage determinations and policy articles have been met prior to submission of claims to the DME MAC. The only way to stop the prepayment review process is to reduce the error rate to a level that warrants removal of a product category, such as O&P items, from the high error rate category.

HAPPENINGS

CMS Issues New K Codes CMS has announced the release of two new K codes, effective Oct. 1, 2014, to be used to describe off-the-shelf (OTS) versions of custom-fitted knee orthoses currently described by L1843 and L1845.The two new K codes and there descriptors are as follows: K0901: Knee orthosis, single upright, thigh and calf, with adjustable flexion and extension joint (unicentric or polycentric), medial-lateral and rotation control, with or without varus/valgus adjustment, prefabricated, off-the-shelf.

K0902: Knee orthosis, double upright, thigh and calf, with adjustable flexion and extension joint (unicentric or polycentric), medial-lateral and rotation control, with or without varus/valgus adjustment, prefabricated, off-the-shelf.

The creation of these two new K codes expands the current list of “split codes” that describe the same product

that is delivered either on a customfitted or OTS basis from 23 to 25. A larger concern is the fact that CMS has issued new OTS codes for knee orthoses that were previously acknowledged publicly by CMS as always requiring the expertise of a properly trained individual to ensure the proper fitting of the orthoses. As part of its response to comments received on the initial CMS proposed list of orthotic codes subject to competitive bidding, CMS agreed with AOPA’s comment that products described

by L1843 and L1845 should never be delivered in an OTS environment.

AOPA has discussed this issue during several conversations with Sean Cavanaugh, the CMS deputy administrator and director. AOPA will continue to use all available resources to challenge the issuance of these new codes.

GAO Report Criticizes Medicare Postpayment Review Process postpayment reviews, the database was not designed to provide information on all possible duplications, and the data itself is not considered reliable as not all Medicare contractors consistently report information regarding their postpayment reviews.

The report recommended that “CMS take actions to improve the efficiency and effectiveness of contractors’ postpayment review efforts, which include providing additional oversight and guidance regarding data, duplicative reviews, and contractor correspondence.”

The Department of Health and Human Services concurred with the GAO recommendations and indicated it will improve its oversight and guidance efforts to avoid duplicative postpayment reviews.

Prosthetic Sock Changes Less Frequent on Weekends Researchers at the University of Washington have published their findings on the use of prosthetic socks among persons with transtibial amputations. Krittika D’Silva and Brian Hafner, PhD, who led the research, investigated prosthetic sock use with a customized self-report questionnaire. Participants reported number, thickness, and timing of socks over a 14-day period.

On average, socks were changed less than once per day and ply increased over the day. Subjects wore prostheses significantly longer and changed socks significantly more often on weekdays compared to weekends. Subjects generally added socks to account for volume loss over the course of the day.

The full article is published in the August 2014 issue of Prosthetics and Orthotics International.

O&P ALMANAC | OCTOBER 2014

PHOTO: Courtesy of Hanger

The U.S. Government Accountability Office (GAO) recently released a report titled “Medicare Program Integrity: Increased Oversight and Guidance Could Improve Effectiveness and Efficiency of Postpayment Claims Reviews.” The report focused on the lack of sufficient oversight and guidance efforts by the CMS to reduce the number of duplicative postpayment reviews among its various contractors, including the DME MACs, comprehensive error rate testing contractors, and recovery audit contractors.

The GAO criticized the systems that CMS currently has in place to prevent duplicate postpayment reviews of Medicare claims by different contractors. While the GAO report indicated that Medicare maintains a database designed to prevent duplicative

JOURNAL JUST IN

13

PEOPLE & PLACES PROFESSIONALS TRANSITIONS

Asif Ahmad has been elected a director of the Hanger board. Ahmad is chief executive officer and a director of Anthelio Healthcare Solutions Inc., an independent provider of health-care information technology and business process services. He will serve as an independent director.

Team USA’s Richard Browne ran a new Paralympic world record in the 200-meter race at the AG Insurance Memorial Van Damme.

With a time of 21.62, he shaved three-tenths of a second off the world record he had previously set.

Richard Browne

Kim De Roy

Aaron Holm

Doug Petek

Thomas Kiraly

14

Kim De Roy, Ossur’s vice president of sales and marketing and education, prosthetics, set a world record when he competed in his first marathon in August. With a time of 2:57:06, De Roy, 37, ran the fastest time by a below-knee amputee in his category during the Reykjavík Marathon in Iceland. His performance represented a 38-second improvement over the prior record, which had been set by master runner Rick Ball of Canada.

Aaron Holm has joined Ottobock as manager of consumer marketing and engagement. The newly created position was designed with the goal to impact product development processes and patient outcomes through the strengthening of Ottobock’s connection with the people who use its products.

Doug Petek has been named director of business development for PEL LLC. Petek will manage sales and customer service functions and will lead the business development strategies and initiatives for both short-term and long-term revenue growth for the company.

Thomas Kiraly has been named an executive vice president of Hanger Inc., and will become the orthotics company’s chief financial officer in the fourth quarter of this year. Kiraly is the former executive vice president, chief financial officer, and treasurer

OCTOBER 2014 | O&P ALMANAC

of Sheridan Healthcare Inc. The move is coming about due to the retirement of current Hanger Chief Financial Officer George McHenry, effective December 31.

Mark Vukov, CPO

Chris Wintenburg

Mark Vukov, CPO, has joined College Park Industries as the company’s clinical education manager. He will lead the education department, providing clinical education to customers and teaching the company’s Mastering Prosthetics Technology workshops.

Chris Wintenburg has joined Ottobock as the new director of e-commerce and inside sales for North America. Wintenburg is responsible for managing the company’s e-business relationships and driving online sales in North America.

IN MEMORIAM George Edward “Ed” Snell Sr., CPO George Edward “Ed” Snell Sr., CPO, passed away at his home near Little Rock, Arkansas, on September 5 at the age of 99. In 1945, he was released from his job at a defense George Edward “Ed” Snell Sr., CPO contractor and relocated his young family to take over the management of the Little Rock branch of the Snell Artificial Limb Company owned by his uncle, R.W. “Pop” Snell. After a six-week internship with his cousin, Jim Snell in Shreveport, Louisiana, he took the reins in Little Rock, purchasing the location for himself a year later. By 1950, he had expanded the business to include orthotics and renamed it Snell Limb and Brace Company. In 1976 it would receive its current title, Snell Prosthetic and Orthotic Laboratory.

For over 40 years, Ed actively served the needs of the O&P population of Arkansas. He was among the first to attend the initial formal education classes for O&P practitioners at University of California—Los Angeles in the 1950s and at Northwestern University in the 1960s. He served as an examiner for the American Board for Certification in Orthotics, Prosthetics, and Pedorthics in the 1960s and 1970s, and was prosthetic exam chairman in 1973. Throughout his career he was always striving to upgrade the profession and increase its respect in the medical community. Snell’s legacy lives on through his son Frank Snell, CPO, LPO, FAAOP, and grandchildren Brant Snell, MA, RPA, LP, COA, and Melissa Snell, MBA, CFM, who continue Snell Laboratory with its 10 facility locations in Arkansas.

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PEOPLE & PLACES BUSINESSES TRANSITIONS

BCP Group has acquired ownership of Baker Orthotics & Prosthetics in the Dallas-Fort Worth area, and will provide operational support and practice resources to support Baker O&P’s continued growth. Gordon Stevens, CPO, who will continue to serve as president of Baker O&P, has become an equity partner in BCP. The Challenged Athletes Foundation is accepting applications for its annual Access for Athletes grant though December 5. The grant, intended to remove financial impediments for participation in sports, provides funding for equipment, as well as resources for training and competitions. Visit www.challengedathletes.org.

OPIE Software, Gainesville, Florida, has announced that it is merging with Futura International, Clearwater, Florida, under its corporate umbrella. Jon Shinn, the previous chief operating officer of OPIE Software, has been named president of the combined software organization.

OPIE Software also introduced the OPIE Choice Network to bring together independent patient-care facilities to collaborate and work collectively.

Ottobock has announced the winners of the June and July competitions 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 June winner, David Berling of Avondale, Arizona, was David Berling an active-duty Air Force captain when he lost both legs above-the-knee in a private plane crash in 2007. His C-legs have allowed him to resume his passion for flying; Berlin’s winning photos depicts him standing in front of his Cessna Cardinal.

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OCTOBER 2014 | O&P ALMANAC

Ottobock’s main workshop in the Athletes Village at the Rio 2016 Paralympic Games will be similar to the one at the London 2012 Paralympic Games.

In addition, Ottobock has announced that it will be providing technical service for the Rio 2016 Paralympic Games.

Ottobock will have a team of 90 prosthetists, orthotists, wheelchair technicians, and welders who will provide technical service in the Paralympic Villages as well as sport and training venues. More than 15,000 spare parts and 13 tons of equipment will be set up in two days to prepare for the workshops to open on August 28. The Rio 2016 Technical Service Team will draw on Ottobock Paralympic expertise from all over the world, to work alongside colleagues from Brazil and Latin America.

The Pennsylvania O&P Society has announced the availability of licensure applications. The applications, which comply with the new amendment (HB104), are available on the Pennsylvania Board of Medicine website. Licensure without exam is available until March 2015. Orthotists, prosthetists, pedorthists, and orthotic fitters who have been certified by the American Board for Certification in Orthotics, Prosthetics, and Pedorthics or the Board of Certification will qualify during the licensing-without-exam period based solely on certification and not years of experience or education.

PHOTO:Courtesy of Harry Engels/Getty Images for Ottobock

The American Board for Certification in Orthotics, Prosthetics, and Pedorthics (ABC) has launched two videos specifically for candidates of the ABC Clinical Patient Management (CPM) exam. Available on the ABC website and YouTube, the videos provide an overview of the ABC CPM exam experience, and demonstrate how ABC’s experienced examiners perform live evaluations of candidates’ patient management skills and ability to formulate a treatment plan.

The July winner, Mike Hodges of Eden Prairie, Minnesota, lost his left leg abovethe-knee as a result of being electrocuted by power line; he now works as a prosthetic technician. Hodges’ photo was taken as he played in a charity golf tournament in California: The photo demonstrates the C-leg’s stability as Hodges offers a Mike Hodges piggy-back ride to actor Will Ferrell.

Ottobock also celebrated the 15-year anniversary of the C-leg during the AOPA National Assembly, during a party on Friday evening during the event.

REIMBURSEMENT PAGE

By JOE MCTERNAN

VA Changes—The Aftermath of Scandal

E! QU IZ M EARN

2

BUSINESS CE

CREDITS P.20

Revised contracting process to promote consistency while increasing competition

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

CE

W

ITH THE RECENT NEGATIVE

publicity surrounding the veterans’ health-care system, it should come as no surprise that the Veterans Administration (VA) recently announced significant changes regarding how it will handle contractual relationships with private providers of prosthetic services.

The relationship between the VA and its prosthetic contractors has generally been positive over the years, and the VA has stated that it remains committed to building strong relationships with providers outside of the VA system to ensure full access to quality prosthetic care for veterans. The recently announced changes, which will be phased in as existing contracts expire, will focus on a more competitive process for obtaining VA business, ensuring better outcomes for veterans, and creating consistency among the regional Veterans Integrated Service Networks (VISNs) when negotiating contracts with private providers.

While prosthetic contractors may not welcome all of the changes with open arms, the changes appear to be based in ensuring that veterans continue

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OCTOBER 2014 | O&P ALMANAC

to have access to quality prosthetic care provided by properly trained, educated, and credentialed providers.

This month’s Reimbursement Page will highlight the major changes to the VA contracting process and what they mean to private O&P providers.

Increased Competition

While the recently released contract template, which all VA contracting officers will be required to use going forward, does not specifically add language relative to increased competition within the marketplace, it does require the contracting officer to perform a detailed analysis of the number of prostheses as well as repairs to prostheses that were provided to veterans during the previous fiscal year(s) identified in the request for proposal (RFP). This analysis must be provided on an aggregate basis for all of the VA Medical Centers (VAMCs) identified in the RFP, as well as for each individual VAMC identified in the RFP. VA officials have stated that this analysis will allow the contracting officer to identify the anticipated need for prosthetic services outside of the VA system during the contract period, thereby helping them to determine the correct number of contracts that need to be awarded to ensure that veterans have proper access to prosthetic services. While the VA has stated that price will not be the sole factor in determining who is awarded a contract, they have indicated that providers should expect the contracting process to be more competitive than it has been in the past as the award of contracts will be limited by the

anticipated need for prosthetic services to veterans who choose not to receive their care directly from the VA system.

Education and Training Requirements

The revised VA prosthetic limb contract template places renewed emphasis on specific education, training, and credentialing requirements that potential contractors must meet to be eligible for contract award. Contractors must have a full-time prosthetist certified by the American Board for Certification in Orthotics, Prosthetics, and Pedorthics (ABC) or the Board of Certification (BOC), in good standing, at each service location identified in their proposals.

All contractor facilities included in the proposal also must maintain current accreditation through either ABC or BOC and must notify the VA of any changes to a facility’s accreditation status within 15 days of the change.

In addition, in order to provide prosthetic services that require specific education or training through the manufacturer of the device, contractors must provide those services under the supervision of a prosthetist who has completed the required productspecific training. The VA reserves the right to determine which, if any, specific services or devices require additional training or education in order to be provided to veterans.

Changes to the Prosthetic Prescription

As has always been the case, contractors are expected to limit the provision of a prosthesis or prosthetic components to only those items that are listed in the

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prescription provided by the VA amputee clinic team. The revised contract template states that the provision of any components or services that are not specifically identified on a veteran’s prescription must be approved, in writing, by the contracting officer in consultation with the VA amputee clinic team.

Pricing for Unlisted Procedure Codes

The revised contract template significantly changes the way the VA reimburses contractors for the provision of prosthetic components that are not described by existing L codes. Prior to the release of the revised contract template, reimbursement for unlisted procedure codes was determined on an individual consideration basis and could vary between VISNs. The revised template includes a consistent reimbursement methodology for approved unlisted codes that must be used by all contracting officers. The reimbursement methodology outlined in the revised contract template is 150 percent of the contractor’s acquisition cost minus any contractually negotiated discount as part of a contract award.

The establishment of a consistent reimbursement methodology for unlisted procedure codes allows the contractor to make an informed decision regarding the economic viability of providing prosthetic services described by unlisted procedure codes.

Outcome Monitoring and Utilization Data

The revised contract template includes a provision that the VA may prescribe and authorize the provision of an automated prosthetic utilization and function monitoring device that will be used to collect data for new prosthetic limbs. Data collected will include gait symmetry information, daily step counts, cadence variability, peak performance information, functional level assessment capability, and measurement of socket load during gait. Contracted providers who are authorized to provide these monitoring devices will be required to generate “veteran outcome reports” that will be provided to the VA for 20

OCTOBER 2014 | O&P ALMANAC

purposes of monitoring utilization and performance outcomes of the prosthesis. The contract language is clear that not all veterans will be authorized to receive the monitoring devices, but for those who are, providers must comply with VA data collection and analysis requirements.

Semiannual Service Visits

A requirement for semiannual service visits has been included in the language of the revised contract template. Contracted providers will be required to provide these service visits to any veteran for whom they are managing prosthetic limb care.

A semiannual service visit is defined as a follow-up visit for inspection of the prosthetic limb and evaluation for fit and function of any VA-approved prosthetic limb the patient owns and is actively wearing. Contractors will be paid up to four units (60 minutes total) of the prosthetic labor code (L7520) to perform the semiannual service visits and must obtain written authorization from the contracting officer before providing a service visit for the veteran.

Loaner Units, Recalls, and Final Inspection

Under the terms of the new contract template, prosthetic contractors must provide loaner units to patients who require them while their prosthesis is being repaired by a manufacturer.

While the contract template states that the cost of loaner units will not be reimbursed by the VA, labor associated with the removal, repair, and replacement of the original component remain covered under the prosthetic repair provisions of the contract template.

Contractors will be responsible for notifying all VAMCs and contracting officers of any manufacturer recalls

involving prosthetic components provided to veterans. In the event of a recall, the contractor must comply with all of the manufacturer instructions regarding the recall, including potential replacement of the component.

For new prosthetic limbs and all socket replacements, prior to submitting a final invoice for payment to the VA, the VA amputee clinic team that prescribed the prosthesis must perform a final “checkout.” Once this occurs, contractors must submit their final invoice to the VA within 30 days of delivery of the completed prosthesis.

While some of the upcoming changes to the VA contracting process will create challenges for potential contractors, the fact that consistency will be required throughout the entire VA system regarding the provision of prosthetic limbs is certainly a welcome change. For years, prosthetic providers have been dealing with different policies created by individual contracting officers within the VA system. While increased competition may exclude some providers from being awarded contracts for VA work, it will ultimately result in better outcomes and higher quality care for VA patients, a result that is sorely needed after the recent scandal surrounding the treatment of veterans within the VA health-care system.

Copies of the revised prosthetic limb contract template and statement of work that will be used going forward by VA contracting officers are available for review on the AOPA website at www.aopanet.org.

Joe McTernan is AOPA’s director of coding and reimbursement services, education, and programming. Reach him at jmcternan@aopanet.org.

Take advantage of the opportunity to earn two CE credits today! Take the quiz by scanning the QR code or visit http://bit.ly/OPalmanacQuiz.

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This Just In

Tackling the Future CEOs/COOs of every AOPA member company, or a top exec who they specifically designate, receive invitation to share challenges, big ideas, and to shape agenda for leadership conference

By DON DEBOLT

T

HE CHALLENGES FOR TODAY’S

AOPA President-Elect Charles H. Dankmeyer Jr., CPO, and AOPA President Anita Liberman-Lampear, MA

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OCTOBER 2014 | O&P ALMANAC

O&P practices are profound and ever-changing. Even in a very competitive environment, leaders in the O&P profession need to take stock of the environment, and exchange ideas with others knowledgeable about orthotic and prosthetic patients and the current business climate.

High-level O&P professionals will get an opportunity for just such interaction in January, when AOPA will convene the “O&P, Its Leadership, and Its Future” conference. This event is open to international and domestic owners, chief executive officers, chief operating officers of AOPA member companies (or a specific top executive they request) who have received an invite from AOPA. Letters and emails were distributed September 18 inviting executives to the January 9-11, 2015, conference at the EAU Palm Beach Resort & Spa in Palm Beach, Florida. The invitations were addressed to specific recipients; if an invitee is unable to attend, he or she may submit an alternative candidate to receive the invitation.

One notable departure from the typical O&P leadership gathering is the effort to harness the thinking of those invited to help shape the

AOPA has done much to advance a series of strategic initiatives and survival imperatives to help AOPA members prosper and, yes, survive in this turbulent healthcare environment. content of the specific topics and format for the conference.

To help flesh out the specific major areas of concern and opportunities for the future, four questions were included in the invitations.

These questions will help shape the content and the agenda for the January conference: • What is the most pressing challenge that faces your business, and potentially O&P more generally?

• What is the most promising growth, advancement, and/or profit opportunity that you perceive in today’s O&P world?

• How do you believe the world of O&P/health care will look decidedly different five years from now?

• What types of talents, skills, and expertise will be indispensable prerequisites to taking advantage of the opportunities of the future in O&P, and how can we ensure that persons to fill those needs are attracted to the O&P profession?

AOPA has done much to advance a series of strategic initiatives and survival imperatives to help AOPA members prosper and, yes, survive in this turbulent health-care environment. An overview and assessment of the initiatives will be critical background for all attendees.

O&P leaders will likely want to discuss the direction and priorities O&P research should be taking in the years ahead. The $10 million in funding approved in the Department of Defense budget devoted to O&P research is just the tip of the iceberg in terms of what really may be needed to chart the direction of specific devices and treatment protocols that will help ensure better patient outcomes

and better demonstrate effectiveness.

Some of these same research projects showing results of O&P intervention may assist in the continued effort to have the profession’s patient-care contributions fully recognized by payers as important. The research also may play a part in ensuring O&P providers are recognized as “qualified” allied health-care providers whose expertise and notes deserve recognition in patient treatment and payment decisions.

The “O&P, Its Leadership, and Its Future” conference is intended to be a different type of gathering than previous leadership conferences. This event will not attempt to undertake strategic

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planning for the profession or aim at any specific desired end point (though one might certainly emerge).

Rather, AOPA leaders planning the session believe that tackling key questions and identifying trends will help the attending executives find takeaways that can lead their planning, actions, and business success in 2015 and beyond.

Focusing on the future and what’s needed to embrace that future is the hallmark. With a set agenda, programming, and expert speakers identified based on priorities established by the people attending, this conference will truly be a “big picture think” event. Such a gathering holds the promise of shared ideas about the future O&P being a driver in how that future can be harnessed for the best outcomes for all: patients, payers, and O&P professionals.

Don DeBolt is AOPA’s chief operating officer. Reach him at ddebolt@ aopanet.org.

Interchange or Disconnect

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Model A5

Model F5

Model P5

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

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

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Model FA5

Model FF5

Model FP5

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Model T5

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

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

The unit is waterproof and has a traction base pad.

O&P ALMANAC | OCTOBER 2014

23

COVER STORY

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OCTOBER 2014 | O&P ALMANAC

PHOTO: AOPA

(From left to right) Ed Dolegowski, PT (front left); Danny Tatum, BOCP, CTP (back left); Elizabeth Bailey-Smith; Ronald Hillock, MD

COVER STORY

To Be

By MEGHAN HOLOHAN

s

Meet the first osseointegration patient in the United States—and the O&P team who made it possible

NEED TO KNOW: • Osseointegration is a two-part procedure that gives patients access to a prosthesis that allows for a normal gait, reduces secondary problems, and provides osseoperception. This tactile sensation is “key to energy conservation and fluid gait,” says Ronald Hillock, MD. • The procedure requires multiple steps. First is the amputation, which takes about a year to heal.

Later comes the insertion of the stem into the bone and creation of a stoma. Finally, the stem is coupled to an abutment device that allows for the pairing of the stump to the prosthetic limb.

• By studying successful osseointegration surgeries in Europe and Australia, Hillock believes he can offer a best-in-class procedure in the U.S. for a fraction of the cost. But funding is needed to perform more surgeries and gather enough data to present insurance companies.

• Much of the componentry selection and design was based on functionality with traditional prostheses. But, prosthetists need to take into consideration the stem’s connection to the skeleton as well—for example, designing the prosthesis with two rotators, for more flexibility.

F

ROM THE AGE OF 16, Elizabeth Bailey-Smith experi-

enced tumors in her right knee. Doctors would remove the chondrosarcomas, and they’d return. After decades of surgeries, she finally had a knee replacement. Yet, she felt no relief. The pain behind her knee intensified. Then, in 2012, her foot dropped. The 65-year-old Las Vegas area nurse was talking to one of her patients who recommended she visit Ronald Hillock, MD. Hillock informed Bailey-Smith that her leg needed to be amputated. But he offered what he thought was an exciting option—osseointegration, an amputation where the prosthesis is connected to a stem that is surgically inserted in the patient’s bone. Popular in Europe and Australia for four decades, the two-part procedure gives patients access to a prosthesis that allows for a more normal gait, reduces secondary problems such as arthritis or skin breakdown, and provides osseoperception, the ability to “feel” the prosthetic leg as if it were the patient’s biological leg.

Despite the advantages, Bailey-Smith balked. She wanted to keep her leg. She left Hillock’s office determined to find a doctor who would help her do that.

“In this day and age, I thought they could save my leg,” she says.

She visited another doctor for a second opinion. He also recommended amputation. A few weeks later, she returned to Hillock’s office at Nevada Orthopedic & Spine Center in Las Vegas, and they scheduled the procedure.

“When you get a diagnosis of cancer, you want to be healthy again,” says Bailey-Smith. “We just had to do it.”

O&P ALMANAC | OCTOBER 2014

25

COVER STORY

The Surgery

While Bailey-Smith is the first person in United States to have an osseointegration completed for a prosthetic limb, physicians in Europe and Australia have been conducting them for years with great success. The first procedures date back to the early 1900s, but osseointegration did not become viable until the latter half of the 20th century.

OCTOBER 2014 | O&P ALMANAC

PHOTOS: Ronald W. Hillock, M.D. and Nevada Orthopedic & Spine Center, AOPA

26

Osseointegration is frequently used by dentists to give patients dental implants. For Bailey-Smith’s surgery, the concept is similar: The metal implant, pounded into the bone, functions like her biological leg because it is integrated with her musculoskeletal system. The process requires multiple steps. First is the amputation, which takes about a year to heal. Later comes the insertion of the stem into the bone and creation of a stoma, which has a small pocket to collect drainage.

Finally, the stem is coupled to an abutment device that allows for the pairing of the stump to the prosthetic limb.

While the multistep procedure takes time, Hillock believes it can revolutionize how prosthetic devices are fitted in the United States.

He says he can perform the surgery for a fraction of the price that his European counterparts are charging.

Bailey-Smith’s procedure cost less than $50,000 and was covered by her insurance. The same procedure in Europe costs about 140,000 Euros (roughly $177,647).

But not everyone qualifies for osseointegration. People with diabetes, peripheral

vascular disease, and ongoing infectious disease are not candidates because these conditions make it difficult for them to heal properly.

Hillock first became familiar with osseointegration when he worked as a doctor in the U.S. Army, during the early part of his career. When he was deployed to Bosnia, Kosovo, Macedonia, Iraq, and other areas, he often had to perform surgery in harrowing conditions, amputating a limb on the side of the road or removing a bullet in a surgical theater without electricity or running water. Seeing so many soldiers living as amputees convinced him there must be a better way to provide prosthetic limbs.

“I want OI for battle amputees,” he says. “Pain-free, fluid, and effective gait pattern. What’s not to like?”

After hearing about osseointegration, he sought out doctors who performed the procedures to learn more. He even dug into the history. After interviewing doctors, prosthetists, physical therapists, and patients, Hillock says that he understood the strengths and limitations of the procedure. He learned from other’s mistakes.

While he believed that osseointegration provides better mobility and health for lower-limb amputees, no U.S. insurers initially seemed interested in funding an experimental therapy. And, he also needed to find a patient who

COVER STORY

Elizabeth Bailey-Smith

was young and healthy enough to experience a two-part surgery. Not everyone has enough bone left after an amputation to be able to withstand the metal implant. Although Bailey-Smith suffered from chondrosarcoma in her leg, there was no sign that it would return after the amputation.

After she agreed to the surgery, Hillock began working with Signature Orthopedics, an Australian-based medical device company, and AmPro Orthotics and Prosthetics to design Ronald Hillock, MD

PHOTOS: AOPA

the stem. He knew from talking with other patients that the stem sometimes breaks, which seemed to him like a design flaw.

“We cherrypicked the best features,” Hillock says. Based on his research, he selected qualities to make the strongest stem and implant. He included an external breaking point, for example, so that if the implant broke, another surgery would not be required to replace it.

Hillock believed the stem should be permanent. To create a lasting one, he started by taking a CT-scan of BaileySmith’s limb. This allowed engineers to manufacture a stem that fits her perfectly; it’s not an off-the-shelf option.

Signature used the CT-scan to create a 3D rendering, then plugged that into CAD software to create plans for the stem. Engineers in Australia designed the stem and sent it to Hillock, and he marked it up and returned it to them. The stem is titanium, with machined texturing.

While Hillock admits that he probably “over-designed” the product, he did so because it was vitally important that the first procedure was correct.

In the future, Hillock plans on providing all of his osseointegration patients with custom parts, like he did for Bailey-Smith. While patients frequently approach him for the procedure, he has not been able to accommodate them because these patients’ insurance will not cover the procedure, and they often cannot afford the expenses out of pocket. After hearing more about osseointegration, BaileySmith’s insurance company, United Healthcare, believed it had therapeutic

Danny Tatum , BOCP, CTP

value and agreed to fund it. Hillock would like to be able to conduct about 19 more of these procedures to have enough data for publication, which could convince insurance companies to cover it, he says.

The Recovery

While the engineers focused on designing the abutment, Bailey-Smith focused on physical therapy, strengthening her core and hip so that when the prosthesis was coupled, she’d be able to put her weight on her new leg.

“Physical therapy started out kind of scary,” she says. “I didn’t know how much weight I would be [able to support].”

Ed Dolegowski, PT

But Bailey-Smith’s physical therapist, Ed Dolegowski, PT, of Matt Smith Physical Therapy in Las Vegas, had worked with limb-loss patients before and found that an aggressive approach helped people recover faster. He needed Hillock’s input to understand how aggressive he could be.

“The sky’s the limit,” Hillock told him. But, it wasn’t easy.

“She was inactive for 18 months, completely de-conditioned her hip flexor,” says Hillock.

O&P ALMANAC | OCTOBER 2014

27

COVER STORY

And, Bailey-Smith feared putting too much weight on her leg, and often held back.

“That was the hardest,” she admits.

As the prosthetic leg was being designed and her body healed, she completed physical therapy with what Dolegowski calls a “stubby,” a short attachment that connected to the stem and had a flat bottom. Bailey-Smith would practice balancing on it on a table. She had to be able to put half of her weight on it before she was ready for the new prosthesis.

Even as Bailey-Smith was strengthening her body, she still struggled with

life without her leg.

“Once I had the amputation, I thought I was fine,” she says. “[But,] I went through quite an emotional time … I didn’t feel like me.”

She slept poorly, fearing she wouldn’t wake up. She tried medication, but didn’t like the side effects.

But then she was able to talk to someone else who had the procedure, and sharing her experiences helped Bailey-Smith to feel better.

During that time, she also wrote in a journal where she expressed her emotions, in “colorful language,” helping her to cope. Along with the support of her husband, Dwayne Smith, she began to feel better and more like herself.

Bailey-Smith discusses gait and balance with Danny Tatum, BOCP, CTP, (left) and Robert Gailey, PhD, PT, at the 2014 AOPA National Assembly 28

OCTOBER 2014 | O&P ALMANAC

PHOTOS: Ronald W. Hillock, M.D. and Nevada Orthopedic & Spine Center, AOPA

Bailey-Smith demonstrates changing the battery in her Plié 2 knee

COVER STORY

As Bailey-Smith worked on building her physical and mental strength, Danny Tatum, BOCP, CTP, of AmPro needed to decide what foot and knee would work best for her. For the most part, he relied on products that he often used with other patients, which he believed yielded the best results.

“First and foremost, the knee had to be battery [powered] and not [have] a cord, and it [needed to be] waterproof,” he wrote via email. “The Endolite foot allows for movement in all planes.”

Tatum selected Freedom Innovations’ Plié 2 knee because of its fast processors and its ability to function after being completely submerged in water. It also had a battery available at any retail store.

“A lot of [the componentry selection choices] just came from years of using [different parts],” Tatum explains. “I over-built the thing. It’s better to have too much than not enough.”

While he relied on his past experience to guide his decisions, the unique nature of the procedure did mean that he needed to take other factors into consideration.

“This is a part of [a patient]… it is connected to the skeleton,” says Tatum.

This meant he had to design the prosthesis with two rotators, for example, to give Bailey-Smith more flexibility. For more traditional prostheses, he generally only uses one, he explains.

“The biggest difference, honestly, has been the alignment. With traditional prosthetics, we have to offset couplers,” he says.

The Mobility

PHOTO: AOPA

It’s now 10 months since her surgery, and when Bailey-Smith walks, she does not limp. It appears impossible to tell which leg is the prosthetic one and which is her biological leg.

While providing a natural and painfree gait means that osseointegration offers a huge advantage, it is perhaps osseoperception that makes the biggest difference for patients. Bailey-Smith can feel in her hip when she steps on the ground—not the jarring feeling that traditional prostheses cause. She

describes the sensation as feeling like it did when she walked with her own knee and foot.

“When I put my foot on the floor, I feel everything,” she says.

Hillock elaborates: “She feels up into her hip … with this she gets the tactile sensation. It’s key to energy conservation and fluid gait. She doesn’t have to throw herself through the world.”

He suspects that Bailey-Smith’s cerebellum even functions in the same way it would if she had not had her leg amputated.

Over three months, Bailey-Smith has taken 100,000 steps. When she’s at the grocery store she might only

be able to walk for about 10 minutes before she feels too tired. But, she walks around her house quite well, and she can even walk backward and up a hill backward—two tasks that people wearing traditional prostheses often struggle to do.

While she originally felt shocked that the prosthesis would be connected to her bone, and she would have “a part sticking out” of her body, Bailey-Smith now feels comfortable with life with her new leg.

“It’s a part of me.”

Meghan Holohan is a contributing writer to O&P Almanac. Reach her at meghan.e.holohan@gmail.com.

O&P ALMANAC | OCTOBER 2014

29

AOPA’s

national

assembly ’14

ACTION and EVOLUTION The O&P community unites for need-to-know education, networking, and partnerships at the 2014 AOPA National Assembly

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OCTOBER 2014 | O&P ALMANAC

F

ROM SEPTEMBER 4 TO 7, 2,200 O&P professionals and 160 exhibitors gathered at the Mandalay Bay Hotel & Casino to “Experience the ENGERY” as part of AOPA’s 2014 National Assembly. Attendees had the chance to participate in 110 educational sessions that provided O&P professionals with the most up-to-date information and best practices for success in a challenging health-care environment.

Participants could feel the energy and the themes of action and evolution resonating throughout the sessions. One of the biggest calls to action was for members to improve how they tell their stories, often through research and reporting.

“I made the plea last year, which I am going to repeat. We must look outward. Like Mobility Saves, we must find tools to make sure that the outside world knows the good we have accomplished for our fellow humans,” said AOPA President Anita Liberman-Lampear, MA, during the annual business meeting.

AOPA President Anita Liberman-Lampear, MA

O&P ALMANAC | OCTOBER 2014

31

AOPA’s

national

AOPA President-Elect Charles H. Dankmeyer Jr., CPO

assembly ’14

AOPA Executive Director Thomas F. Fise, JD

She also urged participants to encourage their colleagues to participate in AOPA to make the organization a stronger advocate for the industry and to help professionals tell the story behind the importance of O&P interventions.

“We provided the hard evidence that O&P timely intervention in the long run saved money for Medicaid and insurance,” she said. “We were really preaching to the choir. So the challenge became: How could we possibly get the truth to the audiences who need to know?”

AOPA Executive Director Tom Fise, JD, echoed the sentiment that research will ultimately help the field—and patients: “We do know for certain our efforts must be on cost-effective research to help produce and substantiate better outcomes,” he said. “Mobility Saves—it saves lives and money.”

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OCTOBER 2014 | O&P ALMANAC

Evolving for the Future

As the health-care environment presents O&P professionals with everchanging demands, many of the general sessions focused on what experts can do to demonstrate their vital role in the overall health-care landscape.

Sessions focused on the Affordable Care Act, how to combat claims of fraud in the industry, how to use assessment measures to justify decisions, 10 ways to grow a practice, and the importance of research and reporting in emphasizing the change in the O&P environment.

For example, during his symposium, “The Impact of Current Research and Outcomes on the Future of Amputee Care and Your Practice,” Robert Gailey, PhD, PT, University of Miami School of Medicine, stressed the need for professionals to conduct assessments of their patients and how they are performing

Speaker Susan Spaulding, MS, CPO

with the recommended treatments.

“This means you just have to show that one knee or one foot is better than the other,” he said.

His comments dovetailed with an earlier presentation by Susan Spaulding, MS, CPO, during the Thranhardt Lectures, where she was one of four researchers selected as the “best of the best” from the series, which honors the memory of Howard R. Thranhardt, CP. Spaulding’s presentation looked at a study where they evaluated how O&P professionals measure use and comfort with various assessment tools including the Amputee Mobility Predicator (AMP) and the Timed Up and Go (TUG). She found that while many people reported being familiar with these assessment tools, few actually used them to evaluate whether they fitted patients with limbs that helped them improve.

“There’s a lack of awareness of outcomes in general. Hospital reimbursements are tied to outcomes,” she said, noting that with extra training,

Speakers Jason Highsmith, DPT, PhD, CP, FAAOP, and Jason Kahle, MS, CPO, FAAOP

practitioners can gain the confidence needed to use assessment tools more efficiently.

Just as assessments play a pivotal Getting Inspired role for O&P professionals to thrive in Although many of the presentations focused on the challenges O&P professionthis new environment, so will research, als face in an evolving climate, keynote speaker Adrianne Haslet-Davis’s story of as the field communicates its goals and surviving the Boston Marathon bombings and coping with the loss of her lower successes to the world. Consequently, left leg and foot highlighted how valuable O&P interventions are to the patients several sessions focused on research who need them the most. that provides hard data about the “When I hear about the struggles of what each and every one of you face in effectiveness of certain prostheses or caring for us to be able to dance, to be able to walk, or to be able to even move interventions. around our own bedrooms or apartments, I feel that there is nowhere else I During the presentation need to be except in this ballroom to tell you my story,” she said.

“Differences in Energy-Storing and Only a week after her Shock-Adapting Prosthetic Feet amputation, the professional Keynote Speaker Adrianne Haslet-Davis in High-Performing Transtibial ballroom dancer declared on Amputees: A Randomized Control CNN that she would dance Trial,” Jason Highsmith, DPT, PhD, again. Hugh Herr, PhD, heard CP, FAAOP, and Jason Kahle reported her story and designed a leg, on the results of their double-blind based on BiOM technology, randomized test of three different which allowed her to dance high-performance feet. Former again. While that leg is still members of the military completed a prototype, that experience, a SWAT obstacle course using one along with the support of her of three different feet randomly and husband, Adam Davis, and blindly assigned and compared to a family, played an important control group of SWAT members. role in allowing her to return While the feet provided compato the dance floor. With her prosthetic leg she has been rable results, the Elite Blade came dancing up to eight hours a up on top by a slight margin, with day.

Reflex Rotate and Veriflex coming “I am now using my regular in second and third, respectively. prosthesis and I hope to Because many military amputees inspire other… amputees that already perform at a high level, only have access to that prosmany at K4, pairing them with the right foot can make their transition thesis,” Haslet-Davis said. back to work even smoother.

O&P ALMANAC | OCTOBER 2014

33

AOPA’s

national

assembly ’14 Lifetime Achievement Award: Karl Fillauer, CPO

Award Winners Shine BEST OF SHOW

Thranhardt Lecture Series Awards: (Left) Andreas Hahn, PhD, MSc—Evaluation of 1200+ C-Leg Test Fittings in Germany and (right) Nicoleta Bugnariu, PT, PhD—Functional Performance and Evaluation of Dynamic Response Feet

Otto & Lucille Becker Orthotic Abstract Poster Award: Lauren Levey, MSPO, of Georgia Tech—Lateralization of Motor Control in the Lower Extremity Edwin & Kathryn Arbogast Prosthetic Abstract Poster Award: Steven Siebert of Georgia Tech—A Wireless Instrumented AFO To Quantify Ankle Stiffness and Range of Motion

Third Annual Technical Fabrication Contest: Nicole Gibson of the University of Michigan 34

OCTOBER 2014 | O&P ALMANAC

$5,000 Cash Giveaway presented by Arizona AFO: Erin Cammarata of CBS Billing & Consulting LLC

AWARD WINNING

2014 Sam E. Hamontree Award: Mike Mallaro, CFO, CPA—Build a Stronger Business: Megatrends Impacting Your O&P Practice and What You Need To Do Now To Optimize Your Business

Hugh Herr, PhD, and Mike Corcoran, CPO, presented results from their research on a powered ankle

by BiOM during their presentation of “Design and Clinical Impact of a Powered Ankle Prosthesis.”

“A traditional prosthesis uses more energy than with BiOM,” said Herr.

They found that people who used the BiOM device were able to walk with a normal gait and feel less exhausted than those who used a traditional prosthetic device.

As much as research will help tell the story about how timely O&P interventions save, understanding how to succeed in an ever-changing environment will help the profession grow.

During a presentation on emerging business trends, Mike Mallaro, CFO, CPA, provided ways to improve one’s business during a presentation called “Build a Stronger Business: Megatrends Impacting Your O&P Practice and What You Need To Do Now To Optimize Your Business.”

“I’ve got a little different perspective than you do and my real mission in the next half hour or so is to provoke your thinking,” he told attendees. First, Mallaro identified several megatrends influence the O&P industry including: the aging of America, soaring obesity rates, increased cases of diabetes, European money flooding the industry,

MISSED THE ASSEMBLY? You Can Still Learn How Mobility Saves!

Attendees of the 2014 AOPA National Assembly were among the first to learn about Mobility Saves and received a copy of the important Dobson-DaVanzo study, which confirms that O&P intervention and services save money for payers, and more importantly, help preserve or regain mobility for patients.

If you didn’t make it to Vegas for the meeting, you can download a copy of the cost-effectiveness study, plus a host of other tools to help you spread the word to practitioners, payers, and referral sources.

Visit MobilitySaves.org for more information.

Speakers Thomas Kirk, PhD; Ashlie White; and Anthony Potter

deteriorating health in America, lowered reimbursements, consolidating of health-care firms, personalized and patient-centered care, and big data changing reporting practices.

By recognizing these trends, practices can improve. He urged clinicians to focus on expanding their businesses, improving operations, making contracting a priority, embracing new business technology, understanding business numbers, aligning with the changes in health care, improving cash-based operations, and leveraging assets to be more efficient.

“If we refuse to change… we’re going to be left behind,” Mallaro said.

Understanding the Affordable Care Act and its role in the O&P industry remained another important theme in many sessions.

Speakers Mike Corcoran, CPO, and Hugh Herr, PhD

“There are a couple of fundamental things that are underpinning … the Affordable Care Act,” said Anthony Potter, director of marketing at Hanger during a presentation called “Trends and Implications for the O&P Industry.”

These underlying trends associated with the Affordable Care Act—the aging population, the need to use better technology, big data playing a role in determining care, the desire for valueadded treatments instead of volume, increasing competition, and the choices created by health exchanges—mean the industry must ask itself an important question, he said.

“How do we create higher quality care at lower costs that meet the consumer’s changing needs? … It’s really about focusing on answering that question,” Potter said.

As time passes, he believes that the industry will evolve and come to the answers, which will benefit both the O&P field and its patients.

Dan Ignaszewski, director of government relations at the Amputee Coalition, addressed what the Affordable Care Act means for patients.

He outlined how his organization, along with AOPA, lobbied hard for orthotic and prosthetic devices to be covered under essential health benefits.

When these devices fall under essential health benefits, insurance companies cannot deny patients access to such

Speaker Dan Ignaszewski

devices or put a cap on them.

States that require coverage of orthotics and prosthetics see tangible reduction in health-care costs, he explained. A study in Colorado—which looked at health-care costs before and after Medicaid covered orthotics and prosthetics—found striking results.

“The independent study in Colorado found that by covering custom orthotics and prosthetics the state was able to reduce health-care costs by half a million dollars … because [patients] were able to get the device that they needed when they needed it,” Ignaszewski explained.

His comments highlighted the importance of advocacy, echoing Liberman-Lampear’s sentiments that inviting O&P professionals to join AOPA and support its advocacy work remains a vital function for all members.

O&P ALMANAC | OCTOBER 2014

35

AOPA’s

national

assembly ’14

Jay Martin, Martin Bionics Innovations

UNYQ: (Left to right) Daniel Seeff, Katherine Taylor, Travis Ricks, Katherine Crawford, Bob Bradly, and CEO Eythor Bender

Progressing Products and Services

This year’s exhibit hall opened up with a reception fit for a king, and there were no shortages of kings at the event.

Several Elvis Presley impersonators roamed the hall as guests enjoyed refreshments. In between photo ops, attendees had the chance to talk to their favorite manufacturers, and meet many new vendors. iWalk—which gained a lot of press coverage when Harrison Ford used the crutch to recover from a broken ankle while filming the latest Star Wars movie—was a new addition to the exhibition hall, and guests enjoyed strapping Modeling the iWalk it on and trying it out. The novel crutch, which supports a user’s entire body weight while the lower leg rests, allows people to walk without the inconvenience and discomfort of crutches.

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OCTOBER 2014 | O&P ALMANAC

“It’s easy to use, pain-free, and stable,” said Brad Hunter, director of business development at iWalk Free.

“You’re putting [your weight] where you always do.”

Another new exhibitor joining the National Assembly was Martin Bionics Innovations. The company offers several fabric-based products that provide additional comfort for people who need either hip socket socks or shoulder socks.

“We need to have a socket interface that is dynamic,” said Jay Martin, founder and president of the company.

He also has been working with NASA and the U.S. armed forces to provide technology to wear under exoskeletons and the proposed Iron Man suit.

UNYQ (pronounced “unique”) displayed the latest in prosthetic covers, which are custom-created and allow people to show off their own personal style. Founded by Eythor Bender, former president of Ossur Americas, and Manuel Boza, manager of Ossur’s Southern European sales, UNYQ aims to provides 3D printed covers for artificial limbs that allow wearers to feel as if they are an extension of them.

These covers even ensure that jeans

and slacks fit better, creating a more natural look.

Another new exhibitor on the block this year, LIM Innovations, also uses 3D printing to provide its Infinite Socket that fits wearers better and reduces clinical time.

While the exhibitors often showed off what was new and exciting, there was also time to celebrate the past.

Among many receptions, Fillauer commemorated 100 years of developing, manufacturing, and distributing O&P products. Meanwhile, Ottobock hosted a “Party Like It’s 1999” event to celebrate the 15th anniversary of the introduction of its C-leg, the microprocessor powered knee that more than 40,000 people use.

“It truly is a collaborative effort between the private clinician and the manufacturer…a team effort to get people up and going to do extraordinary things,” said Lacey Henderson, Ottobock patient model and user of the C-leg.

Lacey Henderson, Ottobock model and patient

The King Is in the Building

O&P ALMANAC | OCTOBER 2014

37

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COMPLIANCE CORNER

By LARRY R. PILOT, ESQ.

Can the FDA ‘Shut Down’ My Business?

Prevent an interruption in operations by preparing for an FDA inspection

Editor’s Note: Readers of Compliance Corner are now eligible to earn two CE credits. After reading this column, simply scan the QR code or use the link on page 40 to take the Compliance Corner quiz.

Receive a score of at least 80 percent, and AOPA will transmit the information to the certifying boards.

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40

OCTOBER 2014 | O&P ALMANAC

ALL DEVICE ESTABLISHMENTS— both those registered with the Food and Drug Administration (FDA) and those the FDA believes should be registered—are subject to unannounced inspections by FDA inspectors. These inspectors are authorized, upon presentation of credentials, to inspect facilities at “reasonable times within reasonable limits and in a reasonable manner.” These basic criteria have been applicable for decades through the explicit language contained in the federal Food, Drug, and Cosmetic Act (the Act).

The Act identifies three categories of devices, Class I, II, and III, for which different regulatory requirements apply to provide to the user/patient

a reasonable assurance of device safety and effectiveness through compliance with these requirements.

Numerous general controls apply to those who manufacture Class I devices, including registration, listing, specific reporting requirements, Good Manufacturing Practice (GMP/QSR) regulations in whole or in part, inspection, etc.

Class II (Special Controls/Standards) and Class III (Premarket Approval) devices must comply with all of the requirements applicable to Class I devices and those aforementioned unique to their class. However, manufacturers of Class II and Class III devices, through provisions of the Act, are to be inspected biannually.

COMPLIANCE CORNER

No One Is Exempt

For orthotic and prosthetic facilities, the situation is somewhat confusing because most O&P devices are Class I, and most of those Class I devices have been granted exemptions from one or more of the so-called general controls under Class I. For example, many O&P devices are exempted from premarket notification, or exempted from all aspects of GMPs except complaint files under 21 CFR 820.198. Some individuals in the O&P field have erroneously concluded that these exemptions mean that their devices are free of FDA regulation—that is a false and incorrect conclusion. If you manufacture a Class I device that enjoys these exemptions, you may still be inspected by FDA under the portion of the GMP regulations that relate to your complaint records or other records and reports required under Section 518, or for broader violations constituting adulteration or misbranding of the device. In short, FDA inspections are relevant to and can be conducted at any FDA-regulated facility, including O&P facilities that enjoy exemptions for some of the Class I general controls.

The result of an inspection by the FDA is the most prevalent factor under the Act to support an allegation of violation that could lead to a possible interruption or “shut down” of a device business in whole or in part. Thus, basic knowledge of the inspection process from the beginning to the end and possible consequence—including the remote possibility of a shut down—are essential to the knowledge of device industry executives regardless of business size or device type.

The ABCs of the FDA

Approximately 20 FDA district offices are spread throughout the United States, and each is managed by a district director whose staff consists of a director of inspections and compliance director. The inspectors are directed to inspect a facility as part of scheduled routine inspections or special assignments through FDA Headquarters, for which the director of the Office of Inspections supervises and reviews

the work of the inspector. The district director has the flexibility to determine whether to notify the manufacturer in advance of the intent to inspect.

Each inspection, which can be conducted by one or more inspectors, begins with a presentation of credentials, which includes issuance of the federal Form FDA 482 describing applicable provisions of law and signed by the inspector. It is advisable to assign a knowledgeable employee who is familiar with company policy and provisions of law to accompany the inspector.

The inspection may be completed within a few hours or may take up to several days, during which required documents are to be reviewed and copied if necessary. If the inspection becomes unreasonable, management does have an opportunity, generally on advice of counsel, to seek modifications.

Once the inspection is complete, one of two results is possible and is discussed with company executive personnel through what the FDA describes as a “management conference.”

Management may decline to participate in a management conference, but this is rarely helpful because the inspector may not have any findings to converse about the inspection.

The other possibility is that there are “observations of objectionable conditions,” which are to be presented on a federal Form FDA 483 for discussion and to be signed whether a discussion occurs. The option to discuss is

an opportunity to understand and/ or correct statements before formal presentation. Management is not required to express any opinion about decisions but does have the opportunity to provide a written reply for the administrative record.

The inspector is obligated to prepare a narrative of the inspection, which is referred to as the Establishment Inspection Report (EIR). If the inspections director believes that the EIR supports possible allegations of violation of the Act and/or regulations (e.g., GMP/QSR), the director will refer the EIR to the compliance director, whose office will determine whether to make a recommendation to the district director for some type of enforcement communication or action. The possible actions range from issuance of a warning letter to seizure of devices or civil/criminal penalties.

Any recommendation accepted by the district director must be reviewed

by FDA Headquarters. The most common form of notice is a warning letter recommended by the district director, which must be approved for clearance by the CDRH, Office of Commissioner (Regulatory Affairs), and FDA Office of General Counsel.

The recipient of a warning letter is given the opportunity to respond and hopefully avoid any internal civil money penalty or eventual federal court-ordered seizure, injunction, or misdemeanor/ felony conviction. These latter possibilities must be enforced with permission of either the Department of Justice (DOJ) or the applicable Office of the U.S. Attorney for the district. The FDA is not authorized to initiate any federal litigation because it is a client of the DOJ, which decides whether to proceed with litigation. The FDA, however, does have limited authority to administratively “detain” devices from entering into interstate commerce as well as seek civil money penalties without the assistance or approval of the DOJ.

The Threat of Shut Down

What is a shut down, and what does the FDA have to do to accomplish this objective?

O&P ALMANAC | OCTOBER 2014

41

COMPLIANCE CORNER

The procedure for a shut down requires that the FDA collect verifiable direct and indirect evidence for presentation to the FDA Office of Chief Counsel. If the Office of Chief Counsel is satisfied with the evidence to support a claim for “injunctive relief” in federal court, the FDA will recommend to the DOJ Civil Division that such action be undertaken. If the Civil Division agrees, the DOJ procedures begin with a contact to the counsel, if known, for the manufacturer/company. The notice to counsel or other representative serves to announce the intent of the FDA to proceed with a formal complaint or provide the option for a mutually acceptable “consent decree” to be filed with the appropriate federal court. The consent decree may include a possible temporary or permanent shut down, but this would be the decision of the potential defendant.

The alternative to a shut down consent decree, when the DOJ is unwilling to demonstrate flexibility, is litigation. This type of occurrence is rare because the federal court could

authorize a preliminary or permanent injunction disabling the defendant from doing business unless appeals to the circuit and/or supreme court reverse the lower court decision. However, if the defendant elects to litigate, it is the burden of the DOJ to file a complaint in federal court and prove through the preponderance of the evidence that the FDA deserves to prevail. Meanwhile, the manufacturer continues with business and has the opportunity to undertake complete discovery of FDA performance, including access to all FDA internal documents/communications that are not attorney/client privileged or attorney-directed work product; completion of interrogatories; admissions; and under oath depositions of FDA employees and experts.

It may take several years for the matter to be litigated in federal court, during which at any time the parties may come to an agreement before a decision from the trial court. Thus, any ‘”threat” by any FDA representative is likely to take a period of years before the government can accomplish a shut

down. To the extent that there is any exception to this process, this would necessitate a clear and supportable danger to health for which it is more likely than not that the Tort Bar will be more successful in accelerating the death of such a device company.

One of the rare handful of examples where a target of a DOJ effort to shut down a device manufacturer was a failure for the FDA: The United States of America v. Utah Medical Products et. al. The specifics of this case are available at 404 F. Supp. 2d 1315.

Larry R. Pilot is an attorney at law based in Arlington, Virginia.

Take advantage of the opportunity to earn two CE credits today! Take the quiz by scanning the QR code or visit http://bit.ly/OPalmanacQuiz.

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OCTOBER 2014 | O&P ALMANAC

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O&P ALMANAC | OCTOBER 2014

43

MEMBER SPOTLIGHT

iFIT Prosthetics

By DEBORAH CONN

From Physiatrist to O&P Manufacturer Rehab physician develops lower-limb prosthesis with immediate fit in mind

P

HYSIATRIST TIM DILLINGHAM, MD, worked with a

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OCTOBER 2014 | O&P ALMANAC

FACILITY: iFIT Prosthetics LOCATION: Pewaukee, Wisconsin OWNER: Timothy Dillingham, MD HISTORY: 4 years

“In our changing healthcare environment, insurers are increasingly unwilling to pay for high-cost devices, or they are limiting the care patients can get,” says Dillingham. “It makes sense to have another alternative.”

A potentially large secondary market consists of patients who use standard prostheses but would like a second device “to kick around in, without worrying about breaking it,” he says. “Many people would like to be more active on the beach or in the mountains but are afraid of damaging their conventional devices.

“I also wanted to create something for people in impoverished countries. My vision was a prosthesis in a box, something that could be mass produced, airlifted to remote or war-torn countries, and fit to patients with a minimum of tools and without prosthetic labs,” he says.

Dillingham says he is looking to partner with other manufacturers and prosthetists to join the company’s distribution and fitting network.

“We are seeking forwardlooking prosthetists to partner with us and bring this new device to patients. We envision a network of providers, trained and certified by iFIT, who can fit devices to patients across the country,” says Dillingham.

“We encourage companies who share our vision for such a product to speak with us.”

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

PHOTOS: iFIT Prosthetics

number of patients with amputations during his years at the Walter Reed Army Medical Center (then located in Washington, D.C.), Baltimore’s Johns Hopkins Hospital, and the Medical College of Wisconsin, where he was chair of the department of physical medicine and rehabilitation.

“During this time, it struck me that prosthetic technology was not keeping up with what persons with limb loss needed,” he said. “We spend considerable effort trying to make a hard socket fit a changing limb.”

Dillingham decided to use his experience in rehabilitation, as well as a background in engineering and biomechanics, to develop a better lower-limb prosthesis. He began to work with the Milwaukee engineering firm Advanced Design Concepts on a new socket design and, in 2010, he founded iFIT Prosthetics in Pewaukee, Wisconsin, to create a new device. Much of the work was funded by small-business technology transfer grants from the National Institutes of Health and the National Center for Medical Rehabilitation Research.

That work came to fruition this year, as the company launched the new iFIT Prosthetic System at AOPA’s 2014 National Assembly in Las Vegas last month.

The device is made of highstrength, flexible polymers, says Dillingham, which are lighter than metal and stronger than aluminum, and can be mass produced, making it less expensive to manufacture than conventional

components. The patented system includes a socket with a flexible outer shell, a rigid inner structure, and a connector and buckle system that allows for a highly adjustable fit. It uses a standard silicone pin suspension system and is compatible with most commercially available prosthetic feet and liners.

Dillingham believes the system offers patients a more comfortable fit at the outset, as well as the ability to adjust the device themselves during the day to account for any swelling that might occur. “This is a consumercentered technology that puts the user in control of the prosthetic fit,” he says. “Our device is quite useful as a preparatory prosthesis when the patient’s limb changes in size during the first six months post-surgery.”

It can serve as the definitive device as well, and can be particularly useful for patients with heart and kidney diseases who experience volume changes in their residual limbs over the course of a day, says Dillingham.

Even though the system can be mass produced, Dillingham notes, the socket type and appearance of the device can be customized for each individual patient. Different sizes and colors are available, and the patient can choose on which side to place the buckles. Prosthetists will find it easy to fit using a minimal number of hand tools, he says.

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This 96-page comprehensive resource provides information about how prosthetics are covered, dealing with appeals and denials, and how to advocate for yourself.

&

A Publication of the

~Jeffrey Cain, MD

How to Be Your Own Advocate

A publication of the Amputee Coalition 2014 Edition

2014 edition

For ordering information, call 888/267-5669 or order at amputee-coalition.org/order-guide

Order Copies Today For Your Patients!

MEMBER SPOTLIGHT

Prosthetix Shop

By DEBORAH CONN

Giving Awards, Getting Rewards Two-year-old facility grows business through patient-centered care and community engagement

O

WNING HIS OWN PROSTHETICS facility was always

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OCTOBER 2014 | O&P ALMANAC

Aaron Moles, L/CP

FACILITY: Prosthetix Shop LOCATION: Cincinnati, Ohio OWNER: Aaron Moles, L/CP HISTORY: 2 years

is such a custom thing. Everyone is so different. I think you really need to be able to fabricate devices yourself.”

Moles plans to add additional offices and is scouting for appropriate locations in the Cincinnati metropolitan area.

He has a close relationship with local physicians and often is called upon to consult on amputation surgeries to improve the ultimate fit of a prosthesis. Moles is a champion of the Ertl procedure, a reconstructive surgery that builds a bridge between the tibia and fibula to create a more viable limb for the prosthesis. “It promotes better vascularity in the residual limb, improves muscle tone, and allows the patient to distally bear weight, improving the functional outcome and eliminating discomfort,” he says.

Moles credits Jordan with the successful launch of his facility as well as continuing effective marketing activities.

“The three ‘As’ of marketing are awareness, acceptance, and action,” says Jordan. “Because Aaron had worked as a prosthetist in the community long before opening his own business, he already had acceptance. We had to build awareness that Prosthetix Shop was his new facility.”

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

PHOTOS: Prosthetix Shop

part of the plan for Aaron Moles, L/CP, who opened Prosthetix Shop in Cincinnati, Ohio, in December 2012. Moles, who graduated from the prosthetics and orthotics program at Northwestern University in 2004, believed he would be able to give back to his community more effectively if he had his own business.

Moles enjoys the freedom that comes with being a business owner—for example, choosing to provide pro bono work to those who need it. Earlier this year, Prosthetix Shop partnered with Rehab Resources, a local rehabilitation facility, to offer the Mobilizing Amputees with Prosthetics, or MAP, Award—a free prosthesis and follow-up physical therapy—to an underinsured or noninsured amputee nominated by a health-care provider, relative, or friend. Moles expects to repeat the award program periodically.

Moles’ facility occupies three suites in a commercial building on the east side of the city. He has three full-time employees, including business manager Nicole Jordan, a prosthetic assistant/ technician, and an administrative secretary. But, he says, as a small business, “everyone wears all of the hats.”

Moles works with upper- as well as lower-extremity amputees, although upper extremity accounts for only about 10 percent of his business. Prosthetix Shop fabricates many of its own devices, but does turn to central fabrication when things get busy.

“Ultimately, we plan to do everything in-house,” says Moles. “It

Jordan uses a mix of traditional marketing strategies, including in-person “lunch and learn” sessions with referrers, to convey the message that Moles can be a valuable resource for them.

She employs a full range of social media, including Facebook and LinkedIn, a blog, videos, personal stories from patients, and media interviews. Moles offers free educational sessions with nurses and physical therapists on such topics as how to wrap a newly healing amputation.

Moles believes Prosthetix Shop differs from its competitors in several ways. First, he says, “we do extremely thorough assessments of our patients to find out exactly what they need. What are their functional needs? That means we don’t just do range of motion, we do an amputee mobility predictor test, a timed up-and-go test, a distance-walk test. It might take longer, but we get a much better idea of what each patient requires.”

Developing a personal relationship with patients also is paramount. Moles even spends time outside of the facility with some patients, and in doing so, is able to understand their environments.

“I took a boat ride with one patient and was able to see the challenges he ran into while operating the boat,” says Moles.

“You can ask a million questions, but until you really connect, you won’t get the answers.”

The result, he says, is that “we have very functional patients.

They are successful with their prostheses.”

The O&P Business Management Certificate Program addresses skills that are fundamental to the success of an O&P business.

O&P Business Management: This unique leadership learning experience will provide business owners, managers and practitioners an opportunity to experience fresh insights, new tools and proven techniques as a pathway for developing better business practices, while creating ongoing returns for your company.

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AOPA NEWS

THE AOPA BULLETIN

Unified OTS Opposition AOPA, O&P Alliance, AAHomecare, and ‘NOMA provide similar input during CMS comment period

T

HE TWO FLASH POINTS in

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.

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the recently proposed regulations by CMS that directly affect O&P providers and patients were provisions to further expand the definition of “minimal self-adjustment” in describing off-the-shelf (OTS) orthotic devices eligible for competitive bidding and a new limitation of the credentialed/licensed orthotic fitter’s role in providing custom-fitted orthoses.

The deadline was Sept.

2, 2014, and comments were abundant—not only from AOPA, its members, and patients of its members, but from other groups as well. The total comments flowing through AOPA for delivery to CMS was 581, including 203 postcards from patients and 378 letters from members, plus a 10-page statement filed by AOPA. In addition to AOPA and O&P patient comments, CMS received comments and concerns from a number of other organizations.

Fortunately, their comments buttressed the basic position AOPA took in urging CMS to stick to the statute’s definition of “minimal self-adjustment,” which limits OTS orthotic devices strictly to those devices that can be utilized without risk solely through patients doing the adjusting. CMS went beyond this definition in 2007 by ignoring the statutory word “self” and expanding the definition to allow the “caretaker for the

OCTOBER 2014 | O&P ALMANAC

Fortunately, their comments buttressed the basic position AOPA took in urging CMS to stick to the statute’s definition of “minimal self-adjustment,” which limits OTS orthotic devices strictly to those devices that can be utilized without risk solely through patients doing the adjusting. beneficiary, or supplier of the device” to also undertake adjustments that do not require the services of a certified orthotist.

One major emphasis of AOPA member comments was the need for CMS to “correct the serious deficiencies and excesses of this regulatory definition. CMS must revise this definition to incorporate the plain meaning of the statute, so that minimal selfadjustment references only those orthoses that are actually adjustable by the user him- or herself.”

AAHomecare, the primary association for durable medical equipment providers, joined the conversation by saying, “Congress chose to protect beneficiaries under competitive bidding by limiting orthoses subject to bidding to those that required minimal self-adjustment by the patient. Congress understood that competitive bid items would likely be drop-shipped or

provided to beneficiaries without the proper adjustments or instructions.”

The National Orthotic Manufacturers Association (NOMA) approached the “minimal self-adjustment” issue by criticizing the CMS proposal’s limitations as to who is considered to have special training, saying, “This proposal would hinder beneficiary access to timely, convenient, and appropriate bracing and would dramatically and needlessly disrupt orthopedic practices.”

NOMA also pointed out inherent conflicts with state laws on qualified providers.

The O&P Alliance weighed in by saying it “continues to believe that CMS’s definition of ‘minimal self-adjustment’ is contrary to the plain language of § 1847(a)(2) of the Social Security Act. CMS has exceeded its statutory authority in redefining OTS orthotics.”

Extraordinarily significant findings show Medicare data proves the value of an O&P intervention based on economic criteria.

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O&P CARE IS COST EFFECTIVE—It is a SAVER, not an expense to insurers!

O&P professionals have learned the positive outcomes from the Dobson DaVanzo study, which proves that timely O&P intervention results in fewer co-morbidities and lower healthcare costs for both patients and payers. Share this significant news by using the educational tools provided at MobilitySaves.org.

Dobson DaVanzo’s study commissioned by the Amputee Coalition, funded by AOPA and publicly released August 27, 2013, makes the cost effective case for O&P intervention and proves that “Mobility Saves.” O&P professionals knew that intuitively and now Medicare’s own costs and figures prove it irrefutably:

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New!

O&P ALMANAC Because of the highly PER MODULE educational content of the O&P Almanac’s Reimbursement Page and Compliance Corner, O&P Almanac readers can now earn two business continuing education (CE) credits each time they read these articles and pass the accompanying quiz.

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Read and learn from O&P Almanac’s monthly reimbursement column and quarterly compliance corner—you will now not only gain knowledge, but also can earn CE credits by taking a short quiz and receiving a passing grade of 80 percent or higher. AOPA will automatically transmit the information to the certifying boards on a quarterly basis.

The print version of the O&P Almanac is delivered to all AOPA members, ABC certified practitioners, BOC certified practitioners as well as subscribers. Additionally the electronic version of O&P Almanac is available online at www.aopanet.org/publications/digital-edition/.

Learn more at: www.aopanet.org/publications/op-almanac-magazine/

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AOPA’s video learning library PER VIDEO offers many different types of high-level education—clinical, business, motivational, and more.

Many of the videos have been approved for CE credits. After viewing the educational video in its entirety, complete and submit the quiz continuing education (CE) credits. AOPA will automatically transmit the information to the certifying boards on a quarterly basis for those with passing grades of 80 percent or higher. Those not passing the quiz will be notified.

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THE AOPA BULLETIN

The role of fitters also stirred substantial concerns. The CMS proposal would eliminate the “certified orthotic fitter” as possessing specialized training and automatically define any device delivered by the fitter as off-the-shelf and eligible for competitive bidding.

AOPA and the O&P Alliance spoke with one unified voice on the issue of who should be able to provide custom-fitted orthotic devices in light of the CMS proposal to limit this role to physicians, nurse practitioners, therapists, and certified orthotists: “Unless the state’s licensure statute provides otherwise, those licensed or certified health-care professionals who regularly engage and/or assist in the care and treatment of patients with conditions requiring orthotic treatment (including certified orthotic fitters) that truly act under the supervision of a physician (or other individual who has specialized training) should be permitted to continue providing such services with respect to custom-fitted orthoses.”

AOPA pointed out Medicare data still to be explicated, that even before CMS expanded its list of OTS devices fully, 19 percent of Medicare beneficiaries who received an OTS orthotic device subsequently also received a Medicare custom-fitted or custom-fabricated orthosis. On expansion beyond the four categories of “persons with expertise” to provide custom-fitted orthotics, AOPA stated: “While the proposed rule discusses the fact that not all of the 17 states that currently require licensure in O&P either recognize and/or license orthotic fitters, the failure of CMS to comply with existing statutes in states that do offer licensure as an orthotic fitter is a violation of the Constitution as well as existing federal preemption statutes and case law. AOPA strongly supports the following clear criteria for both personnel and conditions that may (or may not) appropriately participate in provision of custom-fitted orthoses to Medicare beneficiaries, as stated in

the following excerpt of the comments on this proposed rulemaking by the Orthotic & Prosthetic Alliance.

“As noted above, CMS’s proposed rule precludes most unlicensed/noncertified personnel on the office staff in physician practices, therapy offices, or orthotic facilities from fitting and adjusting prefabricated/custom-fitted orthoses for Medicare beneficiaries.

The O&P Alliance agrees that the unlicensed/noncertified, nonclinical staff and persons who are in the health professional’s practice should not be permitted to provide such services.

“Unless the state’s licensure statute provides otherwise, those licensed or certified health-care professionals who regularly engage and/or assist in the care and treatment of patients with conditions requiring orthotic treatment (including certified orthotic fitters) that truly act under the supervision of a physician (or other individual who has specialized training) should be permitted to continue providing such services with respect to custom-fitted orthoses.”

NOMA also commented on the orthotic fitter issue: “NOMA recommends that CMS expand the list of ‘individuals with specialized training’; who can provide custom-fitted orthotics directly to include: licensed and/or

AOPA NEWS

certified athletic trainers, licensed and/ or certified orthotic fitters, certified orthopedic technologists, and certified orthopedic nurses.” NOMA also provided a fallback position in case its second recommendation isn’t adopted, saying “[those providers] should be permitted to provide custom-fitted orthotics under the supervision of an individual with specialized training.”

AAHomecare addressed it in this manner: “The standards contradict both the statutory language and FDA labeling for these products. CMS should withdraw the proposal to revise the definition of OTS and rescind the supplier quality standards.”

While not everyone is saying the same words, there is certainly much in common across the major commenters on this issue deeply affecting competitive bidding, OTS orthotic devices, and the role of certified/licensed orthotic fitters. These critical issues brought together a groundswell of patient, provider, manufacturer, and organizational viewpoints that consistently take CMS to task for regulatory overreach. As AOPA’s concluding statement said, “If this proposed rule were to advance in its current form, it would essentially harm all stakeholders—including orthotists, other care providers, and most importantly, Medicare beneficiaries.”

O&P ALMANAC | OCTOBER 2014

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AOPA NEWS

Mobility Saves Lives & Money at AOPA’s 2014 National Assembly

A

TTENDEES OF THE 2014

AOPA National Assembly were among the first to learn about Mobility Saves and the importance of the DobsonDaVanzo Study. During an Assembly presentation on September 7, Thomas Kirk, PhD, and Ashlie White discussed Thomas Kirk, PhD, how the study’s findings conand Ashlie White firm that O&P intervention and services save money for payers, and help preserve or regain mobility for patients.

Don’t worry—if you didn’t make it to Vegas for the meeting, you can still participate!

1. Go to MobilitySaves.org to learn and utilize the costeffectiveness study for both orthotics and prosthetics.

2. Follow Mobility Saves on Facebook, Twitter, YouTube, and LinkedIn. 3. Spread the word to practitioners, payers, and referral sources.

Ashlie White speaks at the AOPA 2014 National Assembly

Get Involved With the Major Public Relations Campaign

AOPA is continuously looking for content for inclusion in our O&P library of materials, which is made available to all AOPA members via Mobility Saves. If you have a video clip that you would like us to consider including in the campaign, please send the video to Tina Moran at tmoran@aopanet.org. In particular, AOPA is seeking compelling patient-centered stories highlighting O&P care and its impact on restoring function and independence.

Questions? Contact Steve Custer at 571/431-0876 or email scuster@AOPAnet.org.

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OCTOBER 2014 | O&P ALMANAC

AOPA Renews Partnership With Cailor Fleming Insurance

A

OPA AND CAILOR FLEMING Insurance announced the

renewal of their partnership effective Jan. 1, 2015, to serve the O&P profession with a wide range of custom-designed insurance products for O&P facilities and manufacturers.

Jim Weber, MBA, AOPA treasurer, and Thomas F. Fise, JD, AOPA executive director, announced they are “pleased with the result.” AOPA is extending the relationship with Cailor Fleming for another five years.

“Cailor Fleming brings over 20 years of experience and client growth to the O&P partnership,” said Jeff Michalenok, president of Cailor Fleming Insurance. “We are now the exclusively endorsed program of AOPA and the American Board for Certification in Orthotics, Prosthetics, and Pedorthics,” and the company has additional endorsements from other national and state-level O&P organizations.

“Because of the unique exposures the industry faces, we designed an insurance program specifically for these risks and offer comprehensive protection that helps your business succeed, whether it’s a patient-care facility, central fab, manufacturer, or distributor,” said Don Foley, a principal of Cailor Fleming Insurance and the manager of the firm’s O&P program.

Insurance coverage for AOPA members currently insured in the AOPA program will remain in force. The AOPA insurance program offers broad property, general, and professional liability. In addition, when needed, auto, umbrella and workers’ compensation can be written.

Contact Don Foley at dfoley@cailorfleming.com or 330/782-8068, or visit www.cailorfleming.com/OandP.asp.

Additional questions may be directed to Steve Custer, AOPA’s communications manager, at scuster@AOPAnet.org or 571/431-0876.

AOPA NEWS

Earn CE !

UIZ ME Q Credits by EARN 4 Reading the CREDITS O&P Almanac!

BUSINESS CE

P.21 & 42

Mastering Medicare: Advanced Coding & Billing Techniques Renaissance St. Louis Grand Hotel | October 20-21, 2014 | St. Louis, Missouri

J

OIN YOUR COLLEAGUES FOR AOPA’s Mastering Medicare: Advanced Coding & Billing Techniques seminar in October. AOPA experts will provide up-to-date information to help O&P practitioners and office billing staff learn how to code complex devices, including repairs and adjustments, through interactive discussions and much more. Meant for both practitioners and office staff, this advanced two-day event will feature breakout sessions for these two groups to ensure concentration on material appropriate to each group.

AOPA has reserved a block of hotel rooms at the Renaissance St. Louis Grand Hotel for the rate of $129 per night for reservations made before September 24, based on availability. For hotel reservations, call 800/468-3571.

Basic material that was contained in AOPA’s previous coding and billing seminars has been converted into nine one-hour webcasts. Register for the webcasts on AOPA’s homepage, www.aopanet.org.

Register online for the Mastering Medicare: Advanced Coding & Billing Techniques seminar in St. Louis at http://bit.ly/aopa2014stlouis.

Questions? Contact Devon Bernard at dbernard@aopanet.org or 571/431-0854.

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: • http://bit.ly/OPalmanacQuiz TheSeptember 2014 quiz is located at: • https://aopa.wufoo.com/forms/ op-almanac-september-2014-reimbursement-page/ Be sure to read the Reimbursement Page and Compliance Corner article in this issue and take the October 2014 quizes.

Take advantage of the opportunity to earn up to four CE credits today! Take the quiz by scanning the QR code or visit http://bit.ly/OPalmanacQuiz.

Earn CE credits accepted by certifying boards:

www.bocusa.org

O&P ALMANAC | OCTOBER 2014

53

AOPA NEWS

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.

AOPA Media on Facebook and Twitter— Follow us and we follow you!

A

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.

Welcome to AOPA Jobs AOPA’S ONLINE CAREER CENTER gives you

access to a very specialized niche. The Online Career Center is an easy-to-use, targeted resource that connects O&P companies and industry affiliates with highly qualified professionals. The online job board is designed to help connect our members with new employment opportunities.

JOB SEEKERS: Post your resume online today, or access the newest jobs available to professionals seeking employment. Whether you’re actively or passively seeking work, your online resume is your ticket to great job offers.

EMPLOYERS: Reach the most qualified candidates by posting your job opening on our Online Career Center. Check out our resumes and only pay for the ones that interest you.

RECRUITERS: Create and manage your online recruiting account. Post jobs to our site and browse candidates interested in your positions.

The AOPA Online Career Center is your one-stop resource for career information. Create an account and learn about opportunities as a job seeker, an employer, or a recruiter. Get started at http://jobs.aopanet.org.

In addition, take advantage of O&P Almanac’s Jobs section to post or browse an employment opportunity, and advertise to AOPA’s 2,000+ member organizations!

Regardless of your staffing needs or budget, we have an option that is right for you. For advertising, call Bob Heiman, Advertising Sales Representative at 856/673-4000 or email bob.rhmedia@comcast.net.

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OCTOBER 2014 | O&P ALMANAC

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 Steve Custer at scuster@AOPAnet.org or 571/431-0876 with social media and content questions.

AOPA NEWS

Log On for Free at the AOPAversity Online Meeting Place

If You’re Paying More Than 1.9%, You’re Paying Too Much AOPA has partnered with Bank of America Merchant Services to offer credit card processing rates as low as 1.9 percent to AOPA members.

Many members are paying more than 2.5 percent, and if you’re handling $500,000 a year in credit card transactions, the 0.6 percent savings is like getting a 200 percent return on your membership dues investment.

To enroll, contact 888/317-5402 or email tellmemore@ bankofamericamerchant.com. AOPA encourages members to request an audit of a recent processing statement to identify the savings they would enjoy.

UPS Savings Program 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 http://bit.ly/WebcastsAOPA.

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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!

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O&P ALMANAC | OCTOBER 2014

55

THE PREMIER MEETING FOR ORTHOTIC, PROSTHETIC, AND PEDORTHIC PROFESSIONALS.

Save the Date

OCTOBER 7-10, 2015 Mark your calendars for an ideal combination of top-notch education and entertainment at the 98th AOPA National Assembly in San Antonio, Texas. We look forward to seeing you in 2015!

For information about the show, scan the QR code with a code reader on your smartphone or visit www.AOPAnet.org.

AOPA O&P PAC

T

HE O&P PAC ADVOCATES for legislative or political interests at

the federal level that have an impact on the orthotic and prosthetic community. To achieve this goal, committee members work closely with members of the House and Senate to educate them about the issues, and help elect those individuals who support the orthotic and prosthetic community.

To participate in the O&P PAC, federal law mandates that you must first sign an authorization form. To obtain an authorization form contact Devon Bernard at dbernard@AOPAnet.org.

• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

John Allen, CPO Michael Allen, CPO, FAAOP Michael Angelico Ryan Arbogast Rudolf Becker III Vincent Benenati James Bernardino, CPO Frank Bostock, CO Luke Brewer, CPO Robin Burton Michael Burton Scott Buser Erin Cammaratta Jim Campbell, CO, FAAOP, PhD Charles Dankmeyer, CPO Mark Degroff Thomas Dibello, CO, LO, FAAOP Ted Drygas, CPO Susi Ebersbach Kristin Faircloth, CPO Jim Fitzpatrick Rick Fleetwood, MPA Steven Foy, CPO Michael Fulkerson, MSHA Arlene Gillis Marbee Gingras Richard Gingras, CPO Elizabeth Ginzel, CPO, LPO Melody Giralo, CPO Susan Guerra, RN, CFO William Gustavson Warren Hagen, CO, BOCO, C.Ped, PTA

• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Denise Hoffman David Johnson, CO Rosie Jovane Brian Kasprowicz, CO Jim Kingsley Thomas Kirk, PhD William Kitchens, CO Alfred Kritter, CPO, FAAOP Teri Kuffel, Esq. Jon Leimkuehler, CPO, FAAOP Alan Lett, CPO Eileen Levis Sam Liang Anita LibermanLampear, MA James Liston, CP, FAAOP Carlo Luetto Pam Lupo, CO Jeff Lutz, CPO Ronald Manganiello, CEO Ann Mantelmacher Brad Mattear, CPA, CFO Mark McDonald, CPO Jonathan Naft, CPO Chris Nolan Michael Oros, CPO, LPO J. Curt Patton III, BOCPO, CP Larry Powers, CP Paul Prusakowski, CPO Walter Racette, CPO Ricardo Ramos, CP, C.Ped, LP Tonja Randolph

Seventh Annual AOPA O&P PAC Wine Tasting and Silent Auction

• • • • • • • • • • • • • • • • • •

Rick Riley John Roberts Jr., CPO Bradley Ruhl Andreas Schultz Donald Shurr, CPO, PT C. William Teague, CP Chrissy Thomas Terry Thompson, CO Steve Tillges Robert Tillges, CPO, FAAOP Mike Vanek Bernie Veldman, CO John Wall, PT, CPO, FAAOP James Weber, MBA Jeff Wensman, CPO Ashlie White Eddie White, CP Pam Young

*Due to publishing deadlines, this list was created on Sept. 26, 2014, and includes only donations and contributions made or received between Aug. 8, 2014, and Sept. 26, 2014. Any donations or contributions made or received after Sept. 26, 2014, will be published in the next issue of the O&P Almanac.

O&P ALMANAC | OCTOBER 2014

57

MARKETPLACE

Feature your product or service in Marketplace.

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

Visit http://bit.ly/aopa14media for advertising options.

New Genesee Metro Liner From College Park The new College Park Genesee liner provides the ideal benefits required of a gel liner in an affordable package.

Shaped for fit and flexibility with cushioning comfort and excellent limb-conforming properties, this durable liner accommodates a wide range of users. The unique fabric provides a superior fiber to gel bond, reduces pistoning, and eases donning. Shear forces are absorbed to prevent skin friction as the mineral oil provides continuous moisture over the entire lifespan of the liner.

• Mineral oil infused for continuous skin hydration • Retrofits with industry standard liners of like thickness and profile • Longer length for the perfect fit • Suitable for K1-K3 levels.

For more information, call 800/728-7950 or visit www.college-park.com/liners.

i-RUNNER i-RUNNER footwear is the lightest weight PDAC (diabetic) approved athletic/ fashion/comfort shoes. They feature a narrower, nonpistoning and high-stability heel and a wide and deep toe box. We are pleased to announce the addition of a highest rated slip resistance outsole. Dual purpose, these are also PDAC approved and available in black mesh to complement the line as well as an all leather shoe as required by OSHA for food, factory, and hospitality.

Contact I-RUNNER Shoes at 866/569-5462 or visit www.facebook.com/i.runnershoes.

RCAI Pediatric Wrist/Thumb Support From PEL The new Pediatric Wrist/Thumb Support from RCAI prevents unwanted flexion and extension of the wrist while providing compression, support, and warmth to the thumb. It also allows unrestricted motion of the fingers during use.

Features and benefits: • Made of a washable, breathable airprene material • Promotes patient comfort • Precontoured palmar stay bends for customization Contact PEL at 800/321-1264 or www.pelsupply.com.

Coyote Composite Coyote Composite is made from the melting of basalt (volcanic rock), which is then extruded into a filament that is braided to our proprietary specifications for use in prosthetics and orthotics.

Basalt has many applications in fields that demand extremely tough, lightweight material that retains flexibility, including the aerospace and hockey equipment industries.

• Noncarcinogenic and nontoxic • Because of the inert nature of basalt (the primary ingredient in Coyote Composite), it is not a carcinogen.

In addition, basalt fibers are too large to be inhaled.

• Less itch than carbon • Tough and durable • Basalt is extremely tough, more so than fiberglass, while still offering the lightweight strength and rigidity needed for prosthetics and orthotics.

• Lightweight • High saturation • Cost-effective • Easy to use for rigid or flexible lay ups • All prosthetic resins are fully compatible with basalt.

• Because of its superior saturation, Coyote Composite finishes as good or better than carbon laminations.

For more information, call 800/819-5980 or visit www.coyotedesign.com.

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OCTOBER 2014 | O&P ALMANAC

MARKETPLACE Coyote Lamination Coyote Composite is made from the melting of basalt (volcanic rock) which is then extruded into a filament that is braided to our proprietary specifications for use in prosthetics and orthotics.

Basalt has many applications in fields that demand extremely tough, lightweight material that retains flexibility, including the aerospace and hockey equipment industries.

• Noncarcinogenic and nontoxic • Because of the inert nature of basalt (the primary ingredient in Coyote Composite), it is not a carcinogen.

In addition, basalt fibers are too large to be inhaled.

• Less itch than carbon • Tough and durable • Basalt is extremely tough, more so than fiberglass, while still offering the lightweight strength and rigidity needed for prosthetics and orthotics.

• Lightweight • High saturation • Cost-effective • Easy to use for rigid or flexible lay ups • All prosthetic resins are fully compatible with basalt.

• Because of its superior saturation Coyote Composite finishes as good or better than carbon laminations.

For more information, call 800/819-5980 or visit www.coyotedesign.com.

AOPA’s 2014 Coding Products Are Available in the Bookstore 2014 Illustrated Guide

This easy-to-use reference manual provides an illustrated guide to the coding system in use for orthotics, prosthetics, and shoes, including HCPCS codes, official Medicare descriptors, and illustrations.

2014 Coding Pro

The Coding Pro is O&P’s comprehensive guide to Medicare codes, reimbursement, and medical policies.

This is the single-source reference for all of your coding needs!

The Coding Pro CD-ROM provides updated Medicare fee schedules for all 50 states and allows you to customize and import other fee schedules used by your office. Illustrations of the codes allow you to quickly sort codes. And writing prescriptions just got easier with the prescription writing tool. Network Version for use on multiple office terminals.

2014 Quick Coder

Stop searching through numerous pages to find a code! AOPA’s redesigned Quick Coder provides a speedy reference to the HCPCS orthotic, shoe, and prosthetic codes and modifiers. These laminated cards are durable, long-lasting, and convenient to store.

2014 Coding Suite

Save $50 when you purchase the newly updated Coding Suite, which includes all of the coding products discussed above: 2014 Illustrated Guide, 2014 Coding Pro (SingleUser CD Software), and the 2014 Quick Coder.

Go to the AOPA Bookstore and order your Coding Products today, visit http://bit.ly/BookStoreAOPA. O&P ALMANAC | OCTOBER 2014

59

AOPA NEWS

CAREERS

North Central

North Central

ABC-Illinois CPO

CPO

Orland Park, Illinois Earn as you would if you own your practice, without the hassle of paying the office cost. Growing practice located in Orland Park, Illinois, is looking for a licensed Illinois CPO to work as needed, which could turn into a full-time position. We offer 50 percent commission. Contact: Raul Georgescu Pro-Orthotics Inc. Cell: 708/674-3341 Office: 708/326-1554 Email: rgeorgescu@pro-orthotics.com

Chicago, Illinois The Ann & Robert H. Lurie Children’s Hospital of Chicago is committed to providing the highest level of patient care and has an open position for a CPO with pediatric experience. This environment includes inpatient and outpatient care for the greater Chicago area. At Lurie Children’s we take a team approach to orthotic/prosthetic care and work closely with other members of the medical team.

To access information about benefits and resume submission please visit www.Luriechildrens.org and go to the jobs link at the bottom of the page.

Southeast CPO or CO

Chattanooga, Tennessee Fillauer Companies Inc. is seeking a CPO or CO to join its team as the director of orthotics at its headquarters in Chattanooga, Tennessee. In this role, the qualified candidate will manage the product development and clinical education for Fillauer’s orthotic product lines.

Requirements: • Education minimum: Bachelor’s degree in O&P. Engineering degree and/or a master’s degree in O&P a plus.

• ABC certification, preferred.

• Minimum of five years of recent patient-care experience with emphasis on orthotics.

• Licensed or ability to be licensed in the state of Tennessee.

• If not currently living in Chattanooga or the surrounding area, candidate must be willing to relocate.

• Engineering experience preferred. Proficient in CAD and SolidWorks a plus.

• Must work well in a team environment.

• Excellent communications skills, including oral and written, are necessary.

• Must have the ability to travel up to 30 percent or as needed.

Fillauer Companies Inc. offers a competitive benefits package, including 401K and medical, dental, and vision insurance. Please apply at:

Website: Fillauer.com/careers 60

OCTOBER 2014 | O&P ALMANAC

CPO or Board-Eligible CPO

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

SUBSCRIBE

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

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 scuster@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 http://bit.ly/aopa14media for advertising options.

O&P ALMANAC | OCTOBER 2014

61

CALENDAR

2014

Bio-Mechanical Composites, Inc.

October 10

Fall 2014: Learning and Leisure—“Dynamic Response Orthotic System” Certification Course. Join us at the LaGuardia Airport Marriott in New York the day prior to the POMAC meeting. Workshop fulfills requirement for Phase I toward certification as a “Dynamic Response Systems Specialist.” 7.75 CEUs. For registration information, visit www. phatbraces.com. For more information, call 515/554-6132.

October 1-2

North Carolina Orthotic and Prosthetic Trade Association (NCOPTA) 2014 Annual Meeting. The Ballantyne Hotel & Lodge. Charlotte, NC. For more information, visit www.ncopta.org/ or contact info@ncopta.org.

October 8

October 11

AOPA: Medicare Enrollment, Webinar Conference Revalidation, and Participation. Register online at http://bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org.

POMAC (Prosthetic and Orthotic Management Associates Corporation) Continuing Education Seminar, co-sponsored with PEL. New York. LaGuardia Airport Marriott. Contact Drew Shreter at 800/946-9170 or visit www.pomac.com.

October 8-10

New England Chapter of AAOP 2014 Annual Meeting.

Radisson Manchester. Manchester, New Hampshire. For more information, visit www.neaaop.org or email jckndk@comcast.net.

October 9-11

Tennesee Society of Orthotics & Prosthetics 2014 Annual Meeting. Chattanoogan Hotel. Chattanooga, TN. For more information, visit https://www.regonline.com/builder/site/Default. aspx?EventID=1596170 or contact TSOPStaff@gmail.com.

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.

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OCTOBER 2014 | O&P ALMANAC

October 16-18

Virginia Orthotic & Prosthetic Association. Glen Allen, VA. Wyndham Virginia Crossings Resort & Conference Center. For more information, visit www.vopaweb.com or email vopainfo@gmail.com.

November 1

ABC: Application Deadline for Certification Exams.

Applications must be received by Nov. 1, 2014, for individuals seeking to take the January 2015 ABC certification exams for orthotists, prosthetists, pedorthists, orthotic fitters, mastectomy fitters, therapeutic shoe fitters, orthotic and prosthetic assistants, and orthotic and prosthetic technicians. 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 scuster@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 scuster@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 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.

December 4-6

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

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. The application deadline for these exams was Sept. 1, 2014. 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 http://bit.ly/aopa2014audio. For more information, contact Betty Leppin at 571/431-0876 or email bleppin@AOPAnet.org.

Webinar Conference

December 10

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

Webinar Conference

2015 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.

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.

ADVERTISERS INDEX Company

Page Phone

Website

Adaptec Prosthetics LLC

21

720/344-1212

www.adaptecprosthetics.com

ALPS South LLC

43

800/574-5426

www.easyliner.com

Amputee Coalition

45

888/267-5669

www.amputee-coalition.org

Cailor Fleming Insurance

7

800/796-8495

www.cailorfleming.com

Cascade Dafo

17

800/848-7332

www.cascadedafo.com

College Park Industries

C3

800/728-7950

www.college-park.com

Coyote Design

15

800/819-5980

www.coyotedesign.com

DAW Industries

1

800/252-2828

www.daw-usa.com

Dr. Comfort

5

877/713-5175

www.drcomfort.com

Ferrier Coupler Inc

23

810/688-4292

www.ferrier.coupler.com

Fillauer

19

800/251-6398 www.fillauer.com

Hersco

2

800/301-8275 www.hersco.com

Ottobock PEL SPS

C4 9 C2

800/328-4058 www.professionals.ottobockus.com 800/321-1264 www.pelsupply.com 800/767-7776

www.spsco.com O&P ALMANAC | OCTOBER 2014

63

ASK AOPA

BAAs, Part 2 Answers to your questions regarding the new rules for business associate agreements

Last month, the Ask AOPA column in the O&P Almanac explored how to determine who is considered a “business associate” for compliance with the HIPAA Omnibus Rule, which took full effect Sept.

23, 2014. This month, we address the requirements for new business associate agreements.

What elements are required to be included in a new business associate agreement (BAA)?

Q/

Each BAA you enter into should be tailored to meet your specific needs from the BA, but it should, at minimum, do the following:

A/

• Establish the uses and disclosures permitted by the business associate (BA).

• Establish that no other uses or disclosures of personal health information (PHI) are allowed unless granted by the BAA or as required by law.

• Require that at the termination of the BAA, the BA return or destroy all PHI. • Require the BA to ensure that any subcontractors it may engage on its behalf agree to the same restrictions and conditions that apply to the BA with respect to the PHI. • Provide the authority to terminate the BAA if the BA violates a material term of the BAA. Am I required to create a new BAA with my current BAs, or may I amend my current BAAs?

Q/

If you currently have a BAA in place that was compliant with previous HIPAA regulations, and the BAA allows you to amend the agreement, then you may amend the BAA. Below are some key items to include in your amended agreements.

A/

AOPA receives hundreds of queries from readers and members who have questions about some aspect of the O&P industry. Each month, we’ll share several of these questions and answers from AOPA’s expert staff with readers.

If you would like to submit a question to AOPA for possible inclusion in the department, email Editor Josephine Rossi at jrossi@contentcommunicators.com.

Q

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OCTOBER 2014 | O&P ALMANAC

• Require that the BA implement appropriate safeguards to prevent unauthorized use or disclosure of PHI. • Require the BA to report any uses or disclosures of PHI not provided for by its contract.

• Require the BA to assist with granting individuals access to their PHI, amending their PHI, and/or accounting of disclosures of their PHI. • To the extent the BA is to carry out a covered entity’s obligation under the Privacy Rule, the BA is to comply with the requirements of the Privacy Rule.

• Require the BA to make available its internal practices, books, and records relating to the use and disclosure of PHI and make PHI available to Medicare (or its contractors).

• Include a section that allows you to verify that the BA is in compliance with the HIPAA security and privacy regulations.

• Ensure the BA will report all breaches to you in a timely manner, and that these notifications will be done in a standard format.

• Ensure that subcontractors agree to the same restrictions and conditions you apply to the BA. • Require the BA to comply with the security requirements with regard to electronic PHI. • To the extent the BA is to carry out the covered entity’s obligation under the Privacy Rule, require the BA to comply with the same requirements of the Privacy Rule that apply to the covered entity in the performance of said obligations.

.

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800.728.7950 | 586.294.0067 | www.college-park.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.