June 2018 O&P News by AOPA

JUNE 2 01 8

THE ORTHOTIC & PROSTHETIC COMMUNITY NEWS SOURCE

Boosting Business Practices PG.10 A Study of Socket Materials and Clinical Outcomes PG.14

R&D TAX CREDIT:

What You Need To Know PG. 4

O&P VISIONARY:

Wendy Beattie, CPO, FAAOP PG. 20

WWW.AOPANET.ORG

Improving Efficiencies in the Lab PG. 26

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Vol. 27 • No. 6 | June 2018

Departments & Columns 22 State by State A monthly column dedicated to

the most important state and local O&P news.

23 Classified Ads 24 Ad Index 25 Meetings & Courses

COVER STORY

R&D Tax Credit: What You Need To Know Many O&P facilities may be able to take advantage of the Research & Experimentation Tax Credit. Learn the four basic requirements associated with “qualified research activities,” and find out which activities are disallowed under the Internal Revenue Code. By Yelena Mazur

FEATURES

Boosting Business Practices In today’s rapidly evolving and financially challenging healthcare landscape, O&P facilities must take a proactive approach to streamlining efficiencies and managing risk. Business owners and managers should review contracts, identify areas to reduce spending, adhere to budgets, and remove barriers to accepting payments. By Daniel Heidemann, MBA

26 Tech Tips How updating technology and implementing lean business practices in the lab can improve workplace culture.

20 O&P Visionary Wendy Beattie, CPO, FAAOP, advocates for increasing financial support for O&P students, updating the residency model, developing sabbaticals for clinician researchers, and more.

Research & Presentations 14

A Study of Socket Materials and Clinical Outcomes By Garrett Hurley, CPO; Jesse Williams, PhD; Jon Smith, CPO; Brad M. Isaacson, PhD, MBA, MSF; and David Rothberg

O&P News | June 2018

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Randall Alley, CP, BSc, FAAOP

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O&P News | June 2018

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COVER STORY

R&D TAX CREDIT:

What You Need To Know

Examine your business practices to determine whether your facility may qualify for the Research & Experimentation Tax Credit and a deduction of federal tax liability By Yelena Mazur

O&P News | June 2018

COVER STORY

erhaps you’ve already heard about the Research & Experimentation Tax Credit and have either cringed and backed away slowly—or found yourself curious but didn't know the next step. Whether you’re utilizing the credit or not, you and your practice should at least be familiar with what it is and understand how it could impact your facility. Knowledge is power, and seeking more information on the tax credit presents new possibilities. The Research & Experimentation Tax Credit, frequently called the R&D Tax Credit, is a dollar-for dollar credit against the taxpayer’s federal income tax liability. The credit can be up to 20 percent of the cost of the taxpayer’s research and experimentation activities, including the cost of labor, over a calculated base amount. Taxpayers who claim the credit benefit from the deduction in the year the expenditure is paid or incurred (or subsequent amortization expenditure in the event the taxpayer elects to capitalize research costs for federal income taxes); by claiming the tax credit, taxpayers may see a dollar-fordollar reduction of federal tax liability. The tax was originated in 1981, mainly utilized by pharmaceutical companies that were the first in the industry to present a “new product.” The law has evolved since then; as of 2003, a company does not have to be the first in its industry to produce a new product or device—if it is new to your company, it counts. Currently, 35 states match the federal guidelines to determine R&D credits.

What does this mean for the O&P industry? O&P labs that are designing new, innovative, custom products for each individual patient could potentially qualify for the R&D tax credit. Jill Neuvirth, JD, is Monetek's co-founder and President. Her major initiative is assisting O&P professionals in capturing their innovation and due diligence through the R&D tax credit process. Neuvirth, an above-knee amputee of 33 years, offers a unique, well-rounded perspective with first-hand experience as an amputee patient and someone who has worked closely with prosthetists to readily

Jill Neuvirth, JD

understand the vast hours, determination, and creativity that feeds into the process of administering a device for each specific individual. Neuvirth says that “people may get hung up on the idea that a new prosthesis has to be new to the industry; however, each time you make a new prototype, each one is unique and thus this may qualify as a new innovative product. Test sockets are never really an end product because multiple factors, such as activity level, weight, and alignment for gait purposes, add to the complicated and constant differing variables.” One of the many roles Monetek assumes is communicating the existence and plausibility of this program to O&P facilities.

O&P News | June 2018

COVER STORY

Adam J. Herman, CPA/ABV/CFF, CVA, ASA, CFE, of Monetek explains that the credit is designed to award companies for coming up with new, innovative products and techniques. These new products help to increase functionality and performance while remaining thoroughly unique to each individual. There are four basic requirements for research to qualify: • Qualified research activities are defined as the development or improvement to a business component, which is defined as a product, process, technique, formula, invention, or software. • The research must be technological in nature. That is, the process of experimentation used to discover the information fundamentally relies upon the physical or biological sciences, engineering, or computer science. Furthermore, companies may use existing technologies and may rely upon existing principles to satisfy this requirement. • Elimination of the technical uncertainty must be accomplished through a process of experimentation, including systematic trial and error, modeling, or simulation. • The research must be intended to eliminate uncertainty concerning the development or improvement of a business component. Uncertainty exists if the capability or method for developing the business component is unknown, or if the appropriate design of the business component is unknown.

O&P News | June 2018

Qualified research projects may contain nonqualified research activities. The Internal Revenue Code and its regulations disallow the following activities: • Research after the taxpayer has proved the functionality of a new product or process • Adaptation of an existing business component to a particular customer’s requirements or need where the research is not aimed at improving the business component’s functionality, quality, performance, or reliability • Duplication or reverse engineering of an existing business component • Surveys, studies, market research, routine data collection, or routine quality control • Research conducted outside of the United States • Research in the social sciences, arts, or humanities • Research funded by contracts or grants regardless of research outcome.

Adam J. Herman, CPA/ABV/CFF, CVA, ASA, CFE

The R&D Tax Credit is quite broad in scope. Both Neuvirth and Herman stress the importance of a phase one analysis, which Monetek conducts without cost to potential clients. When visiting an O&P facility, a full credit estimate and utilization analysis is assessed. Questions are reiterated to establish transparency and

the nature of qualified research activities. Is your lab coming up with new business components, products, techniques, processes, and/or formulas? This first test evokes the essence of “newness,” weeding out the atypical nuances from traditional processes. A second test seeks to determine whether there is some sort of uncertainty in the capability method or design. The third test identifies the process of examination with test sockets, prototypes, the various castings and materials, and whether CAD/CAM was utilized. The fourth test is the simplest, which is determining whether the entire process was related to the general sciences, such as the nature of the biology and chemistry through formulations. This initial analysis is purposefully detailed because it determines the basis of whether a facility truly has a case or whether its practices remain fixed within a more traditional model. Either way, it’s worth the time or assessment to gauge the actual qualified research activities conducted at your facility. Brandon Sampson, CP, of Limb Lab, based in Rochester, Minnesota, can attest to the thoroughness and tenacity of hiring consultants to establish credibility for the credit. Sampson, with his 20 years in the O&P industry, along with his business partner and chief executive officer, Marty Frana, reached out to various consultants after being in business for five years to assess Limb Lab’s current practices. Sampson prides himself on establishing and maintaining a constant innovative approach. “The truth is that when you’re in it, you just do it. When you step away and have a consultant look at your framework, it’s actually not the same thing every day; it’s unique custom solutions for people on a daily basis by improving upon traditional approaches,” he says. Sampson applauds the efforts of companies such as Monetek, because they are able to gauge the purview of a business from a complete outsider’s perspective, sans biases or scripts. Either your lab or

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COVER STORY

facility falls into the scope of innovation, or it doesn’t. Either you invest in creation and new design, or you stick to a well-practiced and basic approach. It can be difficult to determine this on your own, hence trusting the assessment to a knowledge-based entity. Sampson and his business partner presented a short list of what they felt could potentially qualify for a credit, including two new patents: one for a new universal digit for partial hand amputees and one for a new socket design, which Sampson spent hundreds of hours inventing and developing. Three to four days were spent onsite in conducting lengthy interviews with every individual involved with processes in examining their day-to-day activities and the time spent thinking outside the box. A thorough calculation was determined based on these interviews. Sampson also credits Limb Lab’s professional accounting team and in-house counsel, who were equally involved with the process from day one. Sampson notes that an O&P practice can’t do everything on its own and can only provide optimal patient care with the tools available to them. “There’s not a lot of time to think outside the box,” he says. “The companies that relate to innovation, they’ll probably find more opportunities without knowing it.” Sampson understands that there’s fear in the O&P industry since his business came into fruition during the height of the Recovery Audit Contractor (RAC) audits. However, his new business was built around efficiency and immaculate thoroughness, with pre-audit checks and detailed claims. “We didn’t have the fear of a new business because we didn’t have suboptimal compliance,” he says. “Know the rules, play by the rules.” Monetek offers its services to help O&P companies gauge and determine whether they meet the general standards for the R&D tax credit. Herman stresses that there are some grey areas and uncertainty when companies try to go through the process

O&P News | June 2018

themselves, with no expert aid. Monetek has worked with Congress and agents of the U.S. Internal Revenue Service (IRS) who want innovation to happen in America, but who need to see a balanced approach. To qualify for the credit, an O&P business needs to commit to explaining not only why it qualifies for a credit but also why it does not. A company may have a CPA; however, that individual may not have a technical background and may not be critically aware of the processes of an O&P lab. Neuvirth adds that some CPAs from a health-care or nonprofit background have no understanding or guidance from a manufacturing standpoint; hence, you cannot rely on one entity alone because you miss the full picture.

Brandon Sampson, CP

Companies like Monetek proceed with a transparent and educational approach. They have created specific employee activity sheets for the O&P industry that make it simpler and easier to understand what qualifies and what does not qualify for a credit, and which daily activities qualify. Typically, O&P labs have excellent records for supplies used in the conduct of research. Maintaining thorough documentation is essential. Both Herman and Neuvirth believe that the benefits of taking the R&D Tax Credit usually outweigh the costs, but activities must be examined at each facility to make a final determination. “Since we are able to go back to all open tax years, usually three years if the statute is still open, it takes additional efforts on the part of the O&P lab and our firm when the initial study is performed,” says Neuvirth. “Therefore, certain practitioners, technicians, and clinicians

need to make themselves available for interviews, which typically last 30 to 45 minutes. Also, supporting documentation needs to be compiled and reviewed. In addition, the IRS audit risk goes up slightly by filing an amended return, from a 1 percent chance to about a 5 percent auditing chance.” As with any new endeavor, companies must do their due diligence and research. There are reliable resources that can be helpful in learning the ins and outs of the R&D Tax Credit. The online portal of the IRS is a good place to start, along with the CPA Association. Talking with a local CPA could also help you grasp the technical aspect and breakdown of the credit. The fact is that research-related tax credits are not mainstream in the O&P environment. If you yell out, “RAC audits!” in a room full of O&P professionals, heads will frantically turn. If you shout out, “R&D tax credits!” you may be met with blank faces. How you choose to conduct your business affects the outcomes of your patients, and patient care will always prove tantamount to any specific practice. However, innovation should not be ignored or minimized. We need to support and encourage innovation in this profession to meet the needs of a diverse population. Whether you choose to explore the R&D Tax Credit or bypass it altogether ultimately depends on the general scope of your business practices. This material is not intended, and should not be relied on, as legal advice. AOPA members should consult with their own CPAs and counsel about their 2018 taxes. Yelena Mazur is communications specialist at AOPA.

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BOOSTING

Business Practices Facilities should be proactive in managing risks in an ever-changing health-care climate By Daniel Heidemann, MBA, Kenney Orthopedics

10 O&P News | June 2018

Daniel Heidemann, MBA, is the chief financial officer for Kenney Orthopedics. Prior to joining the Kentucky-based O&P practice, he was a business partner senior specialist at University of Kentucky HealthCare. He received a bachelor’s of science in finance and a master’s of business administration from the University of Kentucky. He is currently pursuing his CPA license. Here, Heidemann shares guidance on preparing an orthotics and prosthetics practice for an unpredictable future and the inevitable instability caused by a changing health-care landscape.

ealth care is a dynamic, everchanging industry. There has been a great deal of focus on the costs of health care in the United States as compared to the rest of the world. States are combatting ballooning deficits and leaving no stone unturned in their search for savings. There is no telling what the future will hold or what changes to health care are lurking around the corner. What is certain, however, is that O&P practice owners need to prepare their businesses for inevitable changes to our health-care system. These are exciting and rewarding times to be part of the prosthetic and orthotic profession. The revolutionary, life-changing technologies that are being developed are restoring motion and empowering the lives of those individuals who receive O&P care from qualified practitioners. It is important

to remember that the O&P industry is about people. Every day we interact with patients, family members, practitioners, referral sources, suppliers, insurance representatives, and employees, with the ultimate goal of providing O&P care to improve patients’ lives. Stephen Covey’s The Seven Habits of Highly Effective People provides an excellent framework for how to pursue optimal outcomes during these interactions. In particular, practices should adopt Habit 1 of The Seven Habits and “be proactive” in taking steps to manage the type and degree of risk to which the practice is exposed. There are certain systematic or market risks, such as Medicare reimbursement rates, that are out of an owner’s control. However, there are other unsystematic risks that the practice owner can mitigate through capital structure decisions and diversification.

O&P News | June 2018

Revenue Practices that have not reviewed their third-party payor contracts for some time should consider doing so. If your contracted rate does not provide a tolerable profit margin, reach out to your provider relations representative to renegotiate the contract. Be sure to communicate the value of prosthetic and orthotic care to the third-party payor and its provider relations representatives during this process. During the January AOPA Leadership Conference, Jason Altmire, who served as a U.S. Representative for Pennsylvania’s 4th congressional district from 2007 until 2013, explained that third-party payors want to improve their loss ratio. Recent studies by Dobson-DaVanzo and RAND Corp. are valuable resources demonstrating that prosthetic and orthotic care reduces costs while resulting in better outcomes, thereby achieving that objective. Practices also should seek out new third-party payor contracts. Again, be

sure not to accept a less-than-tolerable profit margin, and negotiate for better rates than the practice is receiving on existing contracts. This will drive additional patient volume while diversifying the practice’s payor mix and reducing the risks associated with over-reliance on one or a few payors. If a facility does not have the time or resources to dedicate to new insurance applications and contract negotiations, outsourced provider network outsourcing services are another option. In terms of patient care, practices should schedule their prosthetic patients for a six-month follow-up visit at delivery of the prosthesis and continue to do so for the life of care. This is both good patient care and good for the financial health of the practice.

Expenses Practice owners should review spending with suppliers annually and reach out to supplier representatives to discuss

opportunities for better pricing. They also should consider participating in a group purchasing organization (GPO). GPOs have greater purchasing power and may be able to negotiate better discounts than a practice would otherwise be able to obtain on its own. If the practice has fewer locations, outsourced billing may be a good fit. There are billing companies that will handle a facility’s billing at a cost between 4 and 8 percent of collections—which may make sense, given the alternative of investing in a billing department. If an O&P company fabricates its own sockets, it can consult with a CPA about the Research & Experimentation Tax Credit. The credit is available for the direct costs associated with wages, raw materials, or subcontract labor in the development of prototypes. (See the article “R&D Tax Credit: Friend or Foe?” on page 4.) Staffing costs typically represent the biggest expense for a practice. Companies can utilize benchmarking information, such as the AOPA Operating Performance and Compensation Report, to compare staffing levels and mix against those of other practices of various sizes and locations. This annual benchmarking report provides a wealth of information and is free for survey participants; the report also may be purchased at a discounted rate for members. In addition, facilities should take the time to develop a budget for the practice. A budget is a great tool and point of reference for informed decision making.

Cash Flow Management An O&P practice must monitor its days sales outstanding (DSO). This metric indicates how long, on average, it takes for the practice to collect on its accounts receivable. The goal is to minimize DSO, or collect faster, while maximizing days payables outstanding (DPO). There are several tactics a practice can employ to minimize DSO and accelerate

12 O&P News | June 2018

collections. One is to sign up for electronic funds transfer (EFT) payments. Doing so reduces the amount of time it takes to receive payment by eliminating the time associated with processing, mailing, and depositing a check. Second, a facility can remove barriers to receiving patient payments. In this era of high-deductible health plans, patient responsibility represents a greater percentage of the total claim; as patient balances age, the likelihood of collecting those balances declines. Work with third-party service providers to accelerate collections by accepting online patient payments and offering financing. Finally, if a facility receives a denial from an insurance company, it can educate patients on how to properly advocate for themselves using the Amputee Coalition’s Amplify platform. This resource was introduced at AOPA last year and provides a tool for patients to advocate directly to insurance companies on their own behalf.

While it’s important to focus on minimizing DSO, it’s also a good idea to try to extend a practice’s DPO. One way to do so involves collaboration with supplier partners to establish extended payment terms. Such an arrangement will greatly assist the practice in bridging the gap between cash going out and cash coming in. Second, a facility should examine interest-free loan products (i.e., credit cards). This will help the practice hold on to its cash for another 30 to 45 days. A cash-back card would offer the added benefit of reducing cost of goods sold by another 1 to 2 percent in the form of a cash-back rebate. Shop around to find the best product for your needs, and make sure these are paid down each month. Otherwise, interest charges on balances will negate any benefits of using these products. Lastly, facility managers should meet with their bankers to discuss opening a line of credit for the business. These products

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Risk Management Another way O&P companies can manage risks is by reviewing the practice’s insurance coverage annually and working with an agent to ensure the policy is up to date and coverages are sufficient. In addition, facilities should stay up to date with accreditation standards from the American Board for Certification in Orthotics, Prosthetics, and Pedorthics, and pursue accreditation if they have not done so. Finally, O&P practices should seek a legal resource with O&P experience. Attorneys with this expertise are hard to find but a valuable resource when needed.

Daniel Heidemann, MBA, is chief financial officer for Kenney Orthopedics.

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Research & Presentations

A Study of Socket Materials and Clinical Outcomes By Garrett Hurley, CPO; Jesse Williams, PhD; Jon Smith, CPO; Brad M. Isaacson, PhD, MBA, MSF; and David Rothberg

Introduction As the joke goes, “You will never meet the second best prosthetist in the world because every prosthetist will tell you that they are the best in the world.” Likewise, just about every prosthetist believes that they use the secret recipe of materials for the best socket fabrication. Prosthetists also may use add-on billing codes for materials used in the prosthetic sockets they deliver. However, little research has been done to validate, quantify, or better understand material properties and corresponding clinical results. Regardless of the differences in options, we should be prepared to justify reimbursement for sockets and materials used with material testing data and corresponding outcome measures. The industry has defaulted to making prosthetic sockets that are very rigid. It is understandable that prosthetists have gravitated toward making rigid sockets, given that sockets need to be exceptionally strong and durable (in both fatigue and peak stress) while also being low profile, adjustable, lightweight, and easy to use in order to meet the needs of prosthetic users.

14 O&P News | June 2018

While these needs are certainly important, we also should consider the fact that we are interfacing with the human body, which is much softer and less rigid than typical socket materials. Fitting rigid sockets on relatively soft and pliable residual limbs may be a large contributor to the high incidence of ulcers, pain, discomfort, and prosthetic abandonment.1-5 Logic derived from the laws of physics also would suggest that a more rigid socket would be better at efficiently transferring movements of the residual limb and biomechanical forces between the socket and the residual limb. This logic also would postulate that more rigid shoes, like clogs, would more effectively transfer forces between the foot and the shoe—and yet the vast majority of shoes sold today are considerably less rigid than clogs. The logic of rigid interfaces for improved biomechanical control does not factor the user’s subjective experience into the equation. This may explain why so many users walk with a high degree of symmetry in the clinic but use compensatory movements to dampen forces between the socket and the residual limb outside the clinic.

Research & Presentations

This is not to say that biomechanical control is not important; rather, that it is one important consideration to be included, along with other important considerations. Other important considerations include elastic modulus of materials and finish construction; durometer; surface area; trim lines; shape; force dampening; force transitions; type of adjustment; cold flow and regionally selective pressure distribution per residual limb length, user weight, user height, and user activity; and other user needs. There are many factors of prostheses that could affect clinical results. This study aims to better understand the relationship between socket rigidity and clinical results.

Figure 1

The socket rigidity testing apparatus used to test socket rigidity

Methods In this study, we used a compression testing machine to test and quantify the rigidity of two different socket types. Hanspal Socket Comfort Scores and functional outcome measures of volunteer participants who were fit with those same two socket types were recorded as outcome measures. Material Testing Methods

Material properties of four standard-ofcare conventional laminated sockets and two Infinite Sockets or dynamic modular sockets were studied and measured. The four conventional laminated sockets were comprised of two transfemoral suction sockets and two transtibial pin-lock sockets fabricated by two different reputable and independent central fabrication facilities. These sockets included vacuum-formed flexible inner liners and carbon fiber with thermoset acrylic resin composite frames. They were ordered with a request for standard fabrication for a 200-pound user with moderate activity level. The two dynamic modular sockets tested consisted of one Infinite Socket TF C1 with suction suspension and one Infinite Socket TT with pin-lock suspension from LIM Innovations.

These dynamic modular sockets were engineered to have an appropriate modulus of elasticity that was derived from extensive stress testing and user testing. The orders for the Infinite Sockets were requested to accommodate a 200-pound user with moderate activity level. The same CAD file was made to order all of the transfemoral sockets and all of the transtibial sockets, respectively. Overall socket rigidity or socket compliance was measured with a socket rigidity testing apparatus that included a testing jig, mold, and compression testing machine. The compression testing

machine is able to apply forces while measuring and recording resultant forces. The testing jig, which was made to isolate the rigidity of the sockets being tested, included a ½-inch-thick steel plate, a ½-inch steel chain, a steel pulley wheel, and a ½-inch stainless steel cable. The same transfemoral and transtibial molds were used across all different socket types. The molds were made with plaster and reinforced with steel and a 2-inch square steel mandrill. The molds were made such that the roll-on gel liners were included and pin-lock and suction suspension were respectively achieved.

O&P News | June 2018

Research & Presentations

Figure 2 One of the conventional laminated sockets in the socket rigidity testing apparatus

Figure 3 The Infinite Socket TF C1 that was tested in the socket rigidity testing apparatus

Forces were applied to the sockets in four different directions (anterior, posterior, medial, and lateral) and at different maximum loads between 20 pounds and 150 pounds. Socket materials testing also included testing of individual materials included in the sockets. These materials were tested for their durometer, modulus of elasticity, tensile modulus, and flexural modulus. Tests like the three-point bend test with the compression testing machine were used to measure the results. Materials tested include thermoset composites, thermoplastic composites, thermoplastics, 3-D-printed polyurethane plastic, urethane foams, and various textile materials. Outcome Measures Methods

Outcome measures were collected from amputees using the same types of prosthetic sockets that were measured in the material testing: Infinite Sockets

16 O&P News | June 2018

or dynamic modular sockets compared to conventional laminated sockets. There were 177 amputees who volunteered to participate in this associated study. The volunteer participants were fit at 30 different independent prosthetic service providers. Users included for this study used the same distal components for both socket types. The outcome measures data were statistically analyzed and written up by independent researchers. Â Outcome measures were scheduled to be collected immediately after fitting, at two weeks after fitting, and at six months after fitting, but the reporting intervals did vary per user availability and compliance. Participants reported Hanspal Socket Comfort Scores and were tested for functional outcome measures at intervals after being fit with the different socket types. The functional outcome measures used were the L-test, the two-minute walk test, and the four-square step test.

Results Material Testing Results

Socket compliance results showed the Infinite Socket to be significantly less rigid than the standard-of-care conventionally laminated sockets tested. Testing for individual materials with the different sockets tested showed a larger variation in elastic modulus or stiffness and a greater number of elastic modulus increments for the Infinite Sockets as compared to the conventionally laminated sockets.Â The individual materials tested were consistent with the testing results of the entire socket in that the materials in the Infinite Socket were generally less rigid than those of conventional laminated sockets. The quantities of overall socket rigidity and individual material properties are proprietary to LIM Innovations, but we can see from Figures 4 and 5 that there is a significant difference in rigidity between socket types.

Research & Presentations

The inherent compliance of the mold with respect to the socket is expected to affect results in the lower portion of the force versus displacement curve. After the mold settles into maximum yield position, the flat portion of the force versus displacement curve demonstrates the socket rigidity. Outcome Measures Results

Volunteer participants reported significantly better Hanspal Socket Comfort Scores for the less stiff Infinite Socket as compared to conventionally laminated sockets (7.64 ± 2.00 vs. 4.52 ± 2.22, p<0.0001). Additional Socket Comfort Score results: • 2.4 percent of participants gave their conventional laminated socket a Hanspal Socket Comfort Score greater or equal to 8 out of 10, compared to 35.4 percent when wearing the Infinite Socket.

• 46.5 percent of participants rated their conventional laminated sockets less than or equal to 4 out of 10 compared to 5.5 percent for the Infinite Socket. Twenty-six of the volunteer participants performed functional outcome measures in both conventional sockets and the Infinite Socket. For the 26 participants who performed functional outcome measures, results were improved for the two-minute walk test (108.80 ± 31.28 vs. 101.53 ± 33.96, p=0.007) and the four-step square test (17.01 ± 12.14 vs. 21.57 ± 18.52, p=0.005). There was no statistically significant difference in the L-test (30.98 ± 27.51, 36.31 ± 45.64, p=0.246). The number of participants who performed functional outcome measures was low relative to the number that reported Socket Comfort Scores. We believe that the relatively low participation in functional outcome measures was due to the added time required to

Figure 4

Force versus displacement with a posteriorly directed force on the socket. The two standard-of-care conventionally laminated sockets that were tested are in blue and red. The Infinite Socket tested is in grey. The maximum load in this case was 150 pounds.

perform these tests and the limited availability of the users and/or prosthetist.

Conclusions The Infinite Socket is significantly less rigid than the conventionally laminated sockets that were tested. Clinical outcome measures for the Infinite Socket were superior to those of conventionally laminated sockets for the population of amputees that volunteered to participate in the study. More specifically, Hanspal Socket Comfort Scores improved significantly while maintaining or improving functional outcome measures with use of an Infinite Socket as compared to a conventional laminated socket. There are many quantifiable differences between the Infinite Socket and the conventional laminated sockets tested, and between other socket types as well. Therefore, these results do not prove that lower rigidity correlated with better clinical outcomes. That being said, we believe that standard-of-care

Figure 5

Force versus displacement with a medially directed force on the socket. The two standard-of-care conventionally laminated sockets that were tested are in blue and red. The Infinite Socket tested is in grey. The maximum load in this case was 80 pounds.

O&P News | June 2018

Research & Presentations

Figure 6

Figure 7

Socket comfort scores reported by the volunteer participants for their standard-of-care conventional laminated socket

conventional laminated sockets are more rigid than they need to be. The results of this study support the possibility that users could benefit from the Infinite Socket or sockets engineered to have more optimized rigidity. Further research should be conducted by independent researchers to validate or invalidate these findings.

Significance Whether ordering a socket or fabricating a socket, prosthetists should closely consider and study the optimal materials and amount of rigidity within the prosthetic sockets they make for their patients. Providing prosthetic sockets that are durable (in both fatigue and peak stress), adjustable, low profile, lightweight, and easy to use, and have the optimal amount of rigidity, is certainly not an easy task. Additionally, foot selection and knee programming should take into account socket construction and additional components. It’s a good thing that we are all

18 O&P News | June 2018

Socket comfort scores reported by the volunteer participants for their Infinite Socket

the “best prosthetists” in the world so that we may evolve past the current standard of care. Garrett Hurley, CPO; Jesse Williams, PhD; and Jon Smith, CPO, are the material analysis authors of this article and work at LIM Innovations in San Francisco, California. Brad M. Isaacson, PhD, MBA, MSF, is an outcomes research author and is affiliated with the Center for Rehabilitation Sciences Research, Department of Physical Medicine and Rehabilitation, Uniformed Services University of Health Sciences, Bethesda, Maryland, as well as the Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland. David Rothberg is an outcomes research author and is with the Department of Orthopedics at the University of Utah in Salt Lake City, Utah.

References 1. Pasquina CP, Carvalho AJ, Sheehan TP. Ethics in Rehabilitation: Access to Prosthetics and Quality Care Following Amputation. AMA J Ethics. 2015; 17(6):535-546.   2. Sanders J. Stump-Socket Interface

Conditions. Pressure Ulcer Research. 2005; 129-147.   3. Isaacson BM, Brown AA, Brunker LB, Higgins TF, Bloebaum RD. Clarifying the Structure and Bone Mineral Content of Heterotopic Ossification. J Surg Res. 2011; 167(2):e163-170. 4. Isaacson BM, Potter BK, Bloebaum RD, Epperson RT, Kawaguchi BS, Swanson TM, Pasquina PF. Link Between Clinical Predictors of Heterotopic Ossification and Histological Analysis in Combat-Injured Service Members. J Bone Joint Surg Am. 2016; 98(8):647-657.   5. Isaacson BM, Stinstra JG, MacLeod RS, Pasquina PF, Bloebaum RD. Developing a Quantitative Measurement System for Assessing Heterotopic Ossification and Monitoring the Bioelectric Metrics From Electrically Induced Osseointegration in the Residual Limb of Service Members. Ann Biomed Eng. 2010;38(9):2968-2978.

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O&P Visionary

Wendy Beattie, CPO, FAAOP Experienced educator suggests easing the financial burdens associated with O&P master’s and residency programs

was recently approached by AOPA Executive Director Thomas F. Fise, JD, who offered me the opportunity to describe changes I would make to O&P if I could “wave a wand.” O&P is the best profession in the world. It is rewarding on every level— intellectually, emotionally, and (sometimes) financially. It is filled with bright, creative, problem solvers—people who want to make the world a better place by helping individuals improve their lives. But it is not perfect. What would I do if I could change our profession in an instant?

20 O&P News | June 2018

Education I would like to start my perfect O&P world at the entry point into the profession: school. As educational requirements have increased, the financial burden to students also has increased. Our new clinicians are entering the profession with staggering debt. In the past, state and federal funding supported our public universities and our low- and middle-income students, respectively. While higher education has a positive impact on individual socioeconomics, it has a larger impact on well-being at the local, state, and even national levels. Formerly the world leader in higher education, the United States currently has an education gap compared to several other countries. This has disproportionately impacted people of color, and, partially because of this decreased funding, O&P clinicians do not reflect the diversity of the populations we serve. Some cities and states have recognized this disparity and are attempting to narrow this gap with such programs as the Kalamazoo Promise and New York State’s recent Excelsior Scholarship, which eliminate the cost barrier to higher

education. My first change would be to increase financial support for students attending our master’s programs.

Residency Next, I would focus on altering our residency model. Residency is a bottleneck for entry into the profession. Many facilities, concerned with decreases in productivity and increases in costs from educating these residents, choose not to have residencies. Students and recent graduates face a haphazard system for procuring the limited number of existing residencies, with no defined application period or deadline. Resident candidates may be asked to pay fees, pay for their own residency, or work for paltry sums for certain sites. The U.S. Department of Health and Human Services (HHS) recognizes the cost burden of residencies and supports physician residencies by covering part of the direct costs (e.g., salaries) and indirect costs (e.g., extra tests) associated with having residents. This also allows the government to direct residents to underserved areas, which helps prevent issues with access to care. My second change would be to alter

O&P Visionary

the O&P residency model. Applications would be centralized, with all students learning of their “match” similar to the medical model. HHS would help subsidize the costs of residency, based on the number of Medicare patients treated at the facility.

Clinical Rotations Change comes naturally to O&P clinicians—as professionals, we each strive to make changes to how we practice on a routine basis, evaluating what we have done, reflecting on successes and failures, and modifying our practices accordingly. But this is gradual change. Many practitioners work in relative isolation, unable to bounce ideas off of others or gain exposure to new methods and alternative practices. While publications and meetings can help provide us with new knowledge and techniques for innovation, it is difficult to translate these directly into our own practices. Change is hard, and, in the absence of initial success, we may choose to abandon initial attempts to alter our practices and stay with what has worked with us before. However, when we interact directly with other professionals, the ability to change is accelerated as we can avoid some of the mistakes made previously by those from whom we are learning. In light of this, I propose the profession implement continuing education credits for visiting colleagues, and organize this type of exchange of ideas and techniques. This would promote lifelong learning, prevent practitioner burnout, and improve patient care. Sabbaticals for Research and Publication As a profession, we lament the lack of research and the paucity of publications produced by our profession. The reality is there are barely more than a handful of individuals who work solely in research and have the time and resources to conduct research and

Rep. Mike Bishop (R-Michigan) and Wendy Beattie, CPO, FAAOP

disseminate the information to the larger O&P community. I propose sabbaticals for clinician researchers to provide sufficient time for these important activities.

Spreading the Word It is a constant source of amazement— and, on bad days, irritation—to see how little is known or understood about what we do as orthotists and prosthetists by the rest of society. Although there is a myriad of commercials highlighting those who benefit from our services, there is virtually no mention of the people behind the work. Even those in related health-care fields seem unaware of the scope of our profession. As a result, our services are underutilized. If my time in clinical practice is any indicator, it is not uncommon for us to be the first person to suggest orthotic intervention to those in dire need of our services. Caregivers, incidentally in our offices with horrendous limps, are shocked to learn of potential solutions—solutions no one else has ever mentioned. We need to “market” our profession better. We offer outreach to high school students to encourage more applicants to our programs. This has been effective in increasing applicants. Now we need to

address the referral sources. What if each resident were to give a presentation at an area social work or nursing program? Or, what if we developed a spreadsheet of such programs and provided incentives (such as continuing education credits) for practitioners to spend an hour describing the value of our work to those who could be referral sources if they knew?

Parting Thoughts What else? Assure that O&P is considered an essential benefit, that custom orthoses are removed from the diagnosis-related groups to allow for timely delivery in hospitals and skilled nursing facilities. Limit physician-owned entities to provide for a free market, have O&P professionals provide input on future CMS Local Coverages of Determination, limit noncompete agreements, and ensure parity for O&P. What would each of you advocate to improve our profession as we strive to make the world a better place for our patients? Wendy Beattie, CPO, FAAOP, is clinic and program director of the Orthotic and Prosthetic Master’s Program in the School of Health Promotion & Human Performance at Eastern Michigan University.

O&P News | June 2018

STATE NEWS

State by State

The latest news from California, Connecticut, Kansas, and Michigan

Each month, we talk to O&P professionals about the most important state and local issues affecting their businesses and the patients they serve. This column features information about medical policy updates, fee schedule adjustments, state association announcements, and more.

California The California Orthotic and Prosthetic Association (COPA) is undergoing an effort to increase the Medicaid/MediCal reimbursement through a fee schedule increase. Over the past 16 years, reimbursement for 75 codes has decreased by an average of $50, while 517 codes have remained unchanged in that same period. The current fee schedule reimburses at a rate significantly below the Medicare allowable.

One third of Californians depend on Medi-Cal, with that percentage increasing in the pediatric population to one half. Matthew Garibaldi, MS, CPO, president of COPA, says, “The association’s position regarding this effort highlights that such a disparity in reimbursement results in subpar and

22 O&P News | June 2018

inadequate prosthetic and orthotic care for Californians with Medi-Cal coverage and threatens long-term access to O&P care for this vulnerable population.”

Connecticut An insurance fairness bill designed to ensure better prosthetic coverage for those living with limb loss in Connecticut has passed the state’s Senate and House of Representatives. The bill, titled An Act Concerning Health Insurance Coverage for Prosthetic Devices, S.B. 376, passed unanimously in the Senate on May 4, 2018, and unanimously in the House on May 9, 2018, just four hours before the end of session. On May 25, Gov. Dannel Malloy signed SB376/PA 18-69, An Act Concerning Health Insurance Coverage for Prosthetic Devices. Effective January 1, 2019, private health insurance plans in Connecticut will be required to cover prosthetic devices that are determined by the patient's health care provider to be medically necessary—including microprocessor devices—at a rate that is at least equivalent to Medicare. Kansas Limits on the Trump administration’s promise of flexibility to states in running their Medicaid programs were expressed this month when CMS rejected a proposal from Kansas to place a three-year lifetime cap on some adult Medicaid enrollees. According to Morning Consult, since Medicaid began in 1965, no state has restricted how long beneficiaries could remain in the entitlement program.

Michigan Blue Cross Blue Shield of Michigan (BCBSM) has issued a durable medical equipment/ prosthetic and orthotic (DME/P&O) Request for Proposals (RFP). According to the company’s website, the RFP was issued “to identify and evaluate DME/P&O vendor(s) who can help achieve DME/P&O benefit cost savings for the 2.4 million commercial PPO [preferred provider organization] members in Michigan.” Michigan Orthotics and Prosthetics Association (MOPA) sent a letter to BCBSM to request a meeting to learn more about the RFP. According to the letter, some MOPA members were not aware of the RFP while others received a direct communication from BCBSM. EDITOR'S NOTE: To submit an update for publication, please email awhite@aopanet.org. For up-to-date information about what’s happening in O&P in your state, visit the AOPA Co-OP and join the conversation in the AOPA Google+ Community.

CLASSIFIEDS

CERTIFIED PROSTHETIST/ ORTHOTIST (CPO) CERTIFIED PROSTHETIST (CP) Pittsburgh, Pennsylvania De La Torre Orthotics and Prosthetics is seeking a certified prosthetist/orthotist and a certified prosthetist to join our growing practice. The qualified candidate will see patients in our local clinical offices, various PT departments, and rehab facilities in the greater Pittsburgh area. Requirements: • ABC-certified is preferred • A minimum of two years of recent, successful patient-based experience • Must work well in a team environment • Excellent oral communication skills with patients and referral sources • Ability to learn and use an EMR system is necessary. De La Torre O&P offers competitive compensation and benefit packages including 401(k), medical, disability policies, and certification reimbursement and is an AAP employer.

De La Torre Orthotics and Prosthetics Email résumé to: drew@delatorreop.com Subject line: prosthetist/orthotist job opening

CLASSIFIEDS

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O&P News | June 2018

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SUBSCRIBE O&P News (ISSN: 1060-3220) 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 571/4310899, or email landerson@AOPAnet.org. Periodical postage paid at Alexandria, VA, and additional mailing offices.

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Copyright © 2018 American Orthotic and Prosthetic Association. All rights reserved. This publication may not be copied in part or in whole without written permission from the publisher. The opinions expressed by authors do not necessarily reflect the official views of the publisher, nor does the publisher necessarily endorse products shown in O&P News. The O&P News is not responsible for returning any unsolicited materials. All letters, press releases, announcements, and articles submitted to the O&P News may be edited for space and content. The magazine is meant to provide accurate, authoritative information about the subject matter covered. It is provided and disseminated with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice and/or expert assistance is required, a competent professional should be consulted. ADVERTISE Reach out to the O&P profession and more than 13,500 subscribers. Engage the profession today. Contact Bob Heiman at 856/673-4000 or email bob.rhmedia@comcast.net.

Make Your First Impressions Count With Customized Polo shirts, Scrub tops, and Lab Coats for your O&P staff

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POLO TS SHIR

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Meetings & Courses

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JULY 23-24 Mastering Medicare: Essential Coding & Billing Techniques. St. Louis. Register online at bit.

JUNE 13 AOPA Webinar: Audits: Know the Types, Know the Players, and Know the Rules. Register online

ly/2018billing. For more information, email Ryan Gleeson at rgleeson@ AOPAnet.org.

JULY 13 PrimeFair Eastâ&#x20AC;&#x201D;The Providence Nocturnal Scoliosis System. Downtown Hilton, Nashville, TN. 8:00 AM- 12:15 PM. This course instructs orthotists on the use of a nocturnal orthotic system for the nonsurgical treatment of adolescent idiopathic, juvenile, and neuromuscular scoliosis. The program will educate on how to

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AUGUST 8 AOPA Webinar: Outcomes & Patient Satisfaction Surveys. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

SEPTEMBER 12 AOPA Webinar: Medicare As a Secondary Payor: Knowing the Rules. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

SEPTEMBER 26-29 AOPA National Assembly.

patients via thorough review of

Vancouver Convention Center. For general inquiries, contact Ryan Gleeson at 571/431-0876 or rgleeson@AOPAnet.org, or visit www.AOPAnet.org.

innovative technology to optimize fit, comfort, and compliance while stopping curve progression in a

information, email Ryan Gleeson at

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satisfactorily address the needs of scoliosis principles and the use of

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online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

AOPA Webinar: Year-End Review: What Should You Do To Wrap Up the Year & Get Ready for the New Year? Register online

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Center, Oklahoma City. For more information, contact Tony Thaxton Jr.

NOVEMBER 14 AOPA Webinar: Evaluating Your Compliance Plan & Procedures: How To Audit Your Practice. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

DECEMBER 12 AOPA Webinar: New Codes, Medicare Changes, & Updates. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

at 404/875-0066, email thaxton.jr@ comcast.net, or visit www.iaapoc.org.

NOVEMBER 4-10 Health-Care Compliance & Ethics Week. AOPA is celebrating Health-Care Compliance & Ethics Week and is providing resources to help members celebrate. Learn more at bit.ly/aopaethics.

NOVEMBER 12-13 Mastering Medicare: Essential Coding & Billing Techniques. Las Vegas. Register online at bit. ly/2018billing. For more information, email Ryan Gleeson at rgleeson@ AOPAnet.org.

nocturnal only setting. Presented by Barry McCoy, CPO, Spinal Technology Inc.

O&P News | June 2018

TECH TIPS

Implementing Lean Business Practices

How one facility revamped its processes to improve efficiencies in the fabrication lab and other spaces By Natalie Harold, MSOP When staff at Cornerstone Prosthetics & Orthotics decided to remodel the facility’s fabrication lab, the first and only goal was efficiency. Natalie Harold, MSOP, shares how the facility remodel optimized practice operations by incorporating a physical manifestation of lean business principles.

hen you walk through the front doors of Cornerstone Prosthetics & Orthotics, you may ask yourself why it is considered a “dream facility.” There is nothing that appears to set it apart from any other clinic or doctor’s office you may have visited in the past. The waiting room has a single TV monitor usually tuned in to

Figure 1

Inside one of the workbench drawers at Cornerstone’s lab, Kaizen foam is used to create a silhouette of each tool to quickly and efficiently determine if a tool is missing or out of place. Each tool is color coded corresponding to the drawer in which it belongs. This exemplifies the “point-of-use” principle, which states that only the tools that are needed should be placed exactly where they are needed.

26 O&P News | June 2018

the local news. There are plenty of chairs where patients can sit while they wait for their appointments to begin, and the racks are full of magazines to help pass time. But if you stop to consider the lean principles that went into the efficient use of each square foot, then you would begin to realize what sets this place apart. Nearly 17 years ago, Dave Hughes, CPO, LPO, owner of Cornerstone P&O since 1986, adopted the principles behind Toyota’s approach to lean manufacturing. These lean principles have been incorporated into every aspect of the Cornerstone clinic to help achieve continuous improvement. There was only one goal in mind when undergoing the clinic and fabrication lab remodel, and that was efficiency. We asked ourselves, “How can we improve efficiency in patient care, office work flow, and fabrication?”

TECH TIPS

When deciding how to best utilize space to maximize work flow efficiency in our fabrication lab, we consulted the Toyota lean team. Our technicians had recently moved out of the clinic to a larger space located just down the road. The consultants took one look inside the lab and said, “Move everything closer together.” To work efficiently, everything and everyone must be in close proximity.

A similar concept was applied to the layout of our new clinic space. “Point of use” is the principle that only the tools that are needed should be placed where they are needed. Just open one of the drawers in a patient fitting room and you will see this principle applied most literally. Every tool is located in each room, and its “place” is obvious—with the help of a silhouette cutout in a drawer lined in Kaizen foam.

Additionally, the decision was made to locate the stock room close to the patient fitting rooms to reduce the time practitioners spend traveling back and forth during appointments. Walls were knocked down in the office to create an open office environment for both the office and the practitioner staff. This remodel improved communication and work flow.

Figure 3

The Kanban Card Ordering System is used to maintain stock items. The cards are located in front of the minimum quantity item so that it must be pulled (and therefore reordered) prior to using the last item. Shown (top) is the inventory of orthotic componentry. Shown (bottom) is the inventory of prosthetic componentry.

Figure 2

The tool wall located in the lab space of Cornerstone's Everett office exemplifies the “point-of-use” concept. Each tool is kept orderly near the workbench in which it will be used.

O&P News | June 2018

TECH TIPS

To facilitate continuous improvement, Cornerstone holds morning meetings. Three days a week, all staff members join the meetings via video conference. These meetings ensure all staff members are moving in the same direction and provide an opportunity for employees to provide input on positive changes. Lastly, visual systems are utilized throughout the office to manage inventory using the Toyota Kanban Card Ordering System. The lab is a favorite space among most of the Cornerstone practitioners. Weâ&#x20AC;&#x2122;ve all seen our fair share of messy workbenches overflowing with tools and various projects. The lab space of Cornerstone is very organized. Every morning, 15 minutes is dedicated to cleaning and organizing. All workbenches are set up with point-of-use tools. The six workbenches are set up for specific jobs and are shared among all practitioners. If we were to do it all over, an even larger space would be shared by all office and practitioner staff to improve communication and work flow on an even greater level. When designing a new space or remodeling an existing office, we utilize employee-driven input to improve the design. We would like to add a gym in which a physical therapist could work simultaneously with our clinical staff for gait training. We also would love to add an outdoor area simulating real-world obstacles and terrains (e.g., gravel, grass, ramps, and stairs) in which patients could trial their devices during fitting appointments. We feel what makes Cornerstone a dream facility is not as much the facility layout as the culture we have created to promote continuous improvement. Our facility changes were made to enhance employee communication and allow all staff to contribute ideas on how to improve processes related to their specific jobs. Natalie Harold, MSOP, is an orthotic resident at Cornerstone Prosthetics & Orthotics in Everett, Washington.

28 O&P News | June 2018

Figure 4

The Kanban Card Ordering System is used in the stock room for every device that is part of the inventory as well as supplies used in the office. The red or yellow tab indicates the day the item was reordered so that duplicate orders are prevented.

Figure 5

Behind-the-scenes look at the lab space in the Cornerstone Everett clinic. These two shared workbenches are kept orderly for use among all practitioners. The drawers contain colorcoded tools necessary for the daily operation of the clinic to make repairs and adjustments to orthotic and prosthetic devices.

Weâ&#x20AC;&#x2122;ve all seen our fair share of messy workbenches overflowing with tools and various projects. The lab space of Cornerstone is very organized.

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RHEO KNEE

The perfect combination of stability and dynamics Combining both the safety and stability users need with the dynamic walking experience they want, RHEO KNEE automatically adapts with every step so users can walk their way.

NEW FOR 2018 • UPGRADED Össur Logic app with new user training tools featuring live feedback. • ENHANCED stability control. • MORE ROBUST exterior design with easier access to charging port.

Visit ossur.com/rheoknee or ask your Össur representative about RHEO KNEE today.

USA (800) 233-6263 WWW.OSSUR.COM

CANADA (800) 663-5982 WWW.OSSUR.CA