November/December 2018 O&P News

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N OV EM B ER/D ECEMBER 2 01 8

Repositioning Therapy or a Cranial Orthosis?

It’s a Clinical Decision PG. 4

Brachycephaly—More Than Just a ‘Flat Head’

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CASE STUDY: What in the ‘Heel’ Do They Feel?

Glimpse Into Emerging Technologies PG.24

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O&P VISIONARY: 7

Frank Bostock, MBA, CPO7 PG.187

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Vol. 27 • No. 10 | Nov./Dec. 2018

Departments & Columns 22 State by State

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The most important state and local O&P news.

23 Meetings & Courses 23 Classifieds 24 Tech Tips

COVER STORY

04 08

Steve Hill, CO, BOCO, offers a glimpse into emerging technologies.

16

Repositioning Therapy or a Cranial Orthosis? It’s a Clinical Decision Several recent studies suggest that cranial remolding orthotic (CRO) treatment is more effective than repositioning alone for infants who have a diagnosis of a deformational head shape. Learn about the recommended age for CRO intervention, results from CRO treatment when implemented at various ages, challenges related to compliance and insurance coverage, and more.

By Tiffany Graham, MSPO, CPO, LPO

18 O&P Visionary

Plus, O&P professionals share their challenges and successes with providing and securing reimbursement for CROs.

Research & Presentations 10

Brachycephaly—More Than Just a ‘Flat Head’

16

CASE STUDY: What in the ‘Heel’ Do They Feel?

Frank Bostock, MBA, CO, says that today’s O&P profession must create a new paradigm that places a greater emphasis on the patient-care and rehabilitative services provided by certified orthotists and prosthetists for their patients, and not just on the products provided.

By Timothy R. Littlefield, MS

By Megan Smith, CO

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COVER STORY

Repositioning Therapy or a Cranial Orthosis?

It’s a Clinical Decision Examining the factors that influence whether an infant would benefit from cranial remolding orthotic treatment

By Tiffany Graham, MSPO, CPO, LPO

T

ypically, if a patient comes to your office with a prescription for an orthosis or a prosthesis, the patient will eventually leave your office with an orthosis or prosthesis.

However, this may not be the case for infants with the diagnosis of a deformational head shape. Studies have shown repositioning therapy to generally be an effective treatment for deformational head shapes, reporting that up to 77 percent of cases achieve correction to the cranial shape.1 However, several studies, as well as a systematic review of the evidence published in 2016 by the Congress of Neurological Surgeons (CNS), support that cranial remolding orthotic (CRO) treatment is more effective than repositioning alone. That being said, in its guidelines for the treatment of deformational head shapes, CNS recommends that affected infants undergo a course of conservative treatment prior to pursuing a cranial remolding orthosis. This guideline is endorsed by the American Academy for Pediatrics (AAP) and the

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O&P News | November/December 2018

COVER STORY

American Association of Neurological Surgeons (AANS).2 Therefore, when evaluating a patient for the first time, an orthotist has the additional challenge of first determining if the patient has been repositioning. If not, the practitioner needs to instruct the caregivers on repositioning techniques as well as determine if repositioning is likely to improve the infant’s cranial deformation. This can be a challenge for orthotists who are inexperienced with cranial reshaping.

The recommended age at which CRO intervention should occur for deformational head shapes varies among physicians and in the literature. However, generally speaking, repositioning therapy should be started from the moment the deformation is noted. The AAP recommends that pediatricians screen their patients for deformational deformities at the one-month, two-month, four-month, six-month, nine-month, and 12-month well-child visits.3 Most physicians are trained to instruct caregivers at the time of observation in repositioning techniques, and some may refer their patients directly to a specialist to screen for fusion of the cranial sutures (craniosynostosis) or other common comorbidities, such as torticollis (a tightening of the sternocleidomastoid that causes a preferred tilt and turn of the head). Based on the literature, repositioning therapy is more effective in very young infants. Specifically, Mortenson’s study in 2012 showed that repositioning is most effective prior to four months of age. 4 After a systematic review of the literature, CNS published the recommendation that patients undergo a course of conservative treatment as the first intervention for a deformational head shape2 but did not specify how long a “course” of conservative treatment may be. Most insurances require two or three months of repositioning therapy prior to covering a CRO, but some may require up to six months of repositioning.

CDC Growth Chart: United States Series 11, No. 246 [ Page 25

Figure 7. Individual growth chart 3rd, 5th, 10th, 25th, 50th, 75th, 90th, 95th, 97th percentiles, birth to 36 months: Boys head circumferencefor-age

Mortenson Skull Shapes

Mortenson Skull Growth

O&P News | November/December 2018

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COVER STORY

PERSPECTIVES FROM THE PROFESSION:

Delivery of Care Challenges and Successes With Cranial Remolding Orthoses Several O&P professionals discuss their experiences with treating patients in need of cranial remolding orthoses and share challenges related to reimbursement.

Reimbursement Roadblocks Bill Gustavson, Vice President of Business Development at Orthomerica

One of the major challenges with coverage/reimbursement stems from the fact that the S1040 does not have a universal fee schedule like Medicare L codes. CMS made this decision since this is a pediatric product only and therefore does not apply to Medicare beneficiaries. As a result, coverage/ reimbursement is decided on a carrier and state-by-state basis for Medicaid.

Orthomerica works closely with its customers regarding policy and reimbursement issues. This past year, we were successful working with the Michigan Orthotic & Prosthetic Association to get an increase from $904.40 to $1,684.61

Steinberg

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O&P News | November/December 2018

for cranial remolding orthoses billed under S1040. It took us two years, but it was well worth the efforts. Other states that recently received Medicaid fee schedule increases include Minnesota and Washington.

The key to getting reimbursement increased for cranial remolding orthoses is to work with your state O&P association as well as AOPA and the American Academy of Orthotists and Prosthetists because payors don’t want to hear from manufacturers as they don’t perceive us as “vested stakeholders.” As a result, we have put together a comprehensive reimbursement package to assist our customers regarding these policy and pricing decisions.

AOPA’s Orthotics 2020 initiative provides us with a proactive approach to addressing some of these key issues as we all remember the BMJ study and how it negatively impacted coverage and reimbursement for CROs.

As practitioners, we must use our clinical judgment to assess the efforts of the parents prior to the infant’s first visit with us to decipher how long the infant has actually been repositioning, although this information may already be notated in the referring physician’s clinical documentation. Steinberg’s study published in 2015 reported that a course of conservative treatment (i.e., repositioning therapy) does not preclude a patient from getting benefit from a CRO.1 However, the amount of correction seen with CRO treatment is growth dependent; therefore, CRO treatment also is more effective at younger ages, and, clinically, we need to decide if the infant should to transition to CRO treatment in order to achieve cranial correction.

If the infant has not been repositioning, we need to educate our patients’ families on proper repositioning techniques and have the patients return

in an appropriate timeframe to reassess the cranial deformation to see if there has been significant improvement.

Although there is not a specific recommendation in the literature for the timeframe between cranial measurements for patients who are repositioning, the author’s clinical experience is that four to six weeks is typically adequate to have enough cranial growth to determine if changes to the head shape are occurring. This is where measurements, photography, and scanning can play a large role in the clinical assessment of cranial shape changes. This documentation also can be used to justify use of a CRO, if lack of improvement is noted or the severity of the condition is such that a CRO is indicated.

CRO treatment initiation age is regulated by the U.S. Food and Drug Administration (FDA) to be between three months and 18 months of age.5

COVER STORY

Examples of Deformational Head Shapes

PERSPECTIVES FROM THE PROFESSION:

Delivery of Care Challenges and Successes With Cranial Remolding Orthoses Several O&P professionals discuss their experiences with treating patients in need of cranial remolding orthoses and share challenges related to reimbursement.

Payor Requirements Cassandra Delgado, MSPO, CO Deformational Plagiocephaly

Deformational Brachycephaly

Measurement Location

Measurement Location

Diagonal Measurements

Studies have suggested a wide variety of preferred initiation ages, ranging from as early as four months of age6 and prior to seven or eight months of age.1 CNS did not define a recommended treatment initiation age in its published guidelines and instead noted that “the most appropriate time window in infancy for

The challenges that I often face are the various requirements that each insurance carries. Some insurances ask no questions and only want a prescription. Others, like MVP (a Medicaid plan), have many, many stipulations that cause a delay in coverage and treatment time.

For example, in New York, MVP requires, at a minimum, the following: • Prescription from physician (standard) • Measurements from certified individual showing need for helmet (standard) • Photos of child • Letter written by the parents stating they have performed a repositioning program • Physical therapy (PT) or occupational therapy (OT) notes (they have no specific requirements on what the PT/OT notes have to say, or even what they should be evaluating; they just physically have to get a PT/OT to evaluate them) • Evaluation by a neurosurgeon (the evaluation cannot be conducted by a neurologist, but must be completed by a surgeon).

The last requirement—evaluation by a neurosurgeon—is the hardest part because many parents struggle to find pediatric neurosurgeons in their area, and it takes a long time to get an appointment.

It’s hard for the parents because they have to schedule more appointments and have their treating physician write more prescriptions to be seen by more healthcare providers. Each of these extra steps takes valuable time that they could be receiving treatment.

Sometimes it feels as though these extra steps and stipulations are put in place to make it harder for patients to get the coverage that they need. For example, PT and OT visits were a new requirement this past year. Previously, a child could be seen by just a neurologist, but now the child must be seen by a neurosurgeon. Of course, there are potential benefits for each of these requirements. PT/OT evaluations can provide additional information to the parents about more optimal ways for their child to grow and strengthen. A neuro consult is a sure way to rule out any cranial synostosis.

However, with performing cranial remolding treatment, we look for these areas.

When I treat children with low tone or delayed milestones, I will typically discuss or recommend being evaluated by a PT/OT and will discuss this possibility with their prescribing physician.

Additionally, if there is any cranial shape that is outside of the standard textbook appearance for positional plagiocephaly, I will request that the patient receive a neuro consult prior to beginning treatment.

O&P News | November/December 2018

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COVER STORY

PERSPECTIVES FROM THE PROFESSION:

Delivery of Care Challenges and Successes With Cranial Remolding Orthoses Several O&P professionals discuss their experiences with treating patients in need of cranial remolding orthoses and share challenges related to reimbursement.

Increasing Medicaid Reimbursement in Minnesota Charles Kuffel, MSM, CPO, LPO, FAAOP

The great state of Minnesota has two O&P member groups: the Northern Plains Chapter of the American Academy of Orthotists and Prosthetists (NPC AAOP) and the Minnesota Society of Orthotics, Prosthetics, and Pedorthics (MSOPP). For the most part, we all get along and come together to advance local and national O&P initiatives.

With regard to Minnesota Medicaid, for the past 10 years we have created and fostered relationships with some of the individuals who control the coverage criteria for O&P claims and reimbursements. The last three managers have held regular DMEPOS meetings, and the most recent manager started holding quarterly O&P calls to discuss concerns and revise O&P prior authorization policies. Several local O&P providers have contributed to the conversations.

Each year, we invite our Minnesota Medicaid managers and their teams, and they regularly attend, our annual

Diagonal Measurements

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O&P News | November/December 2018

NPC AAOP chapter meetings. They are receptive to learning about O&P through the various business and clinical educational presentations and enjoy walking the tables of the O&P devices set up by the manufacturers. We answer questions and let them know we are available to be a resource in the future.

On a scheduled call last spring, I added an item to the agenda asking for a review of the reimbursement for S1040, cranial remolding orthoses. I explained that the current reimbursement, at $1,100, was simply not sufficient to cover expenses incurred with fitting, delivering, and following up with these particular patients. We shared an in-depth clinical conversation, and I spoke specifically to the time, effort, energy, and numerous follow-up visits required of this particular device. The manager asked for more literature and promised to conduct a review. About two months later, we received notice that the reimbursement for S1040 was increased from $1,100 to $2,782.80 and would be retroactive to claims dated Jan. 1, 2018. We expressed our gratitude for the increase in reimbursement and for being provided the opportunity to be part of the process.

the treatment of positional plagiocephaly with a helmet remain[s] elusive.”2 Many studies also have documented that earlier CRO intervention provides more favorable results.1,2,4,6,7 Ultimately, this is a clinical decision based on the individual patent’s age, growth potential, and physical presentation. Since correction with a CRO is only achieved through skull growth, the patient must have an adequate expectation of growth. Growth charts can be a handy tool to estimate a patient’s growth potential, especially if you are able to get a history of the patient’s cranial circumference growth pattern from the patient’s pediatrician or if you have seen the patient several

COVER STORY

times already to measure his or her cranial circumference. Orthomerica (the manufacturer of the STARband) has observed that most infants with moderate to severe deformities require two to three centimeters of circumferential cranial growth to achieve nearly full or full correction. It is important to note that patients can still benefit from CRO treatment when they have a lesser growth potential, but parental expectations should be managed based on expected growth.

Additionally, caregiver compliance is key to the success of CRO treatment.

Infants should wear the orthosis 23 hours per day. If a patient is not wearing the orthosis the prescribed amount of time, he or she is at increased risk for skin irritations, CRO treatment failure, and outgrowing the orthosis before treatment is completed. Similarly, the orthosis must be cleaned by the caregiver at least once daily to minimize risk to the infant. If you suspect compliance with daily cleaning or the wear schedule would be questionable, this may factor into your clinical decision about whether or not to recommend CRO treatment.

Other contraindications for CRO treatment outlined by the FDA include

craniosynostosis and hydrocephalus. The FDA also warns that patient skin should be inspected at frequent intervals and gives the example of every three to four hours in its published regulations.5 If you have made the clinical decision to recommend CRO treatment to your patient, you still may encounter complications with insurance coverage guidelines, even if the patient’s policy typically covers CRO treatment. One complication is that the infant must have completed the insurance-recommended duration of repositioning therapy, which must have been documented in his or her medical records. Another complication is that most insurances base their coverage on one or more two-dimensional measurements of the cranium, which has three-dimensional deformation. As practitioners, we need to make sure that the measurements we report accurately reflect the patient’s clinical presentation. Occasionally, this occurs at slightly different locations for each patient. For example, a cranial vault asymmetry (or diagonal difference) may be more appropriately taken at 45 degrees or 30 degrees off the midsagittal line. Photography and scans also can aid in producing an accurate representation of a patient and can be used in the future to show the changes seen with intervention.

When used appropriately, the CRO can provide excellent correction to a deformational head shape. However, as described, there are several factors that influence whether an infant would benefit from CRO treatment. Our clinical education and experience are important.

Ultimately, we are practitioners, not “prescription-fillers.” We need to make a judgment call for every cranial patient we see and communicate our reasons for this decision with the caregivers and referring physician.

Tiffany Graham, MSPO, CPO, LPO, is an instructor at the Prosthetics-Orthotics Program at the University of Texas Southwestern Medical Center.

References 1. Steinberg JP, Rawlani R, Humphries LS, Rawlani V, Vicari FA. “Effectiveness of Conservative Therapy and Helmet Therapy for Positional Cranial Deformation,” Plastic and Reconstructive Surgery. 2015; 135(3):833-842.

2. Tamber MS, Nikas D, Beier A, et al.

“Congress of Neurological Surgeons Systematic Review and EvidenceBased Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly,” Neurosurgery. 2016; 79(5).

3. American Academy of Pediatrics.

Bright Futures Tool and Resource Kit, 2010. Adapted from: Hagan JC, Shaw JS, Duncan PM, eds.

Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 2008. 3rd Ed. Elk Grove Village, IL: American Academy of Pediatrics.

4. Mortenson P, Steinbok P, Smith D. “Deformational Plagiocephaly and Orthotic Treatment: Indications and Limitations,” Childs Nervous System.

2012; 28(9):1407-1412.

5. Jacobson ED. Department of Health and Human Services Food and Drug Administration. Medical Devices: Neurolgical Devices; Classification of Cranial Orthosis. 1998; 21 CFR Part 882, Docket No. 98N-0513. Washington, DC. 6. Fish D, Lima D. “An Overview of Positional Plagiocephaly and Cranial Remolding Orthoses,” JPO Journal of Prosthetics and Orthotics. 2003; 15(2):37-45.

7. Kluba S, Kraut W, Reinert S, Krimmel M, Krimmel M. “What Is the Optimal Time To Start Helmet Therapy in Positional Plagiocephaly?” Plastic and Reconstructive Surgery. 2011; 128(2):492-498.

O&P News | November/December 2018

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Research & Presentations

Brachycephaly—More Than Just a ‘Flat Head’

By Timothy R. Littlefield, MS

A

parent is often the first to notice that the shape of an infant’s head doesn’t look “quite right.”

Just yesterday it seemed fine, yet tonight, in the bath, there it is—a notable flatness to the back of the infant’s head. At the first available moment, the parent slips away to a computer, and, although unfamiliar with the medical lingo, he or she Googles “flat head.” To the parent’s surprise, hundreds of resources discussing a medical condition known as “plagiocephaly” pop up, including a specific subtype known as “brachycephaly.” In looking at photos and reading descriptions, the parent wants to speak to a doctor right away.

The day of the appointment, the parents are anxious, yet relieved to be taking action; however, the reaction they receive isn’t quite what was expected. The physician acknowledges the parents’ concerns and explains that deformation or flattening of the cranium can occur in young infants as the result of having very soft and malleable heads.

However, in an attempt to allay fears, the parents are assured that it’s nothing to worry about, that as the baby grows and starts to be able to independently hold his or her head up and/or crawl, the shape will round out on its own. An anecdotal statement that, “We don’t see this in adults,” may be offered as a reassurance, or that since it is brachycephaly (i.e., a symmetric type of deformity), it’s a cosmetic issue anyway. Conversations

10 O&P News | November/December 2018

with family members may fare no better, yet parental intuition suggests something isn’t right, it doesn’t seem “normal,” and—as we’ll discuss—it is certainly more than just a “cosmetic” issue.

Causes of Brachycephaly In 1992, the American Academy of Pediatrics (AAP) introduced the “Back To Sleep” campaign, which, in an effort to reduce the incidence of Sudden Infant Death Syndrome (SIDS), 1 encouraged parents to sleep infants on their backs rather than their stomachs.

As part of the campaign, it was also advised that no soft bedding materials (blankets, toys, pillows) should be placed in the crib due to fear of asphyxiation. Infant mattress firmness also was increased due to the same concerns.

This was one of the most successful campaigns ever launched by the AAP, and by the mid-1990s, more than 70 percent of the U.S. population had switched to back sleeping, with SIDS rates dropping by over 50 percent.2 Despite the success with reduction in SIDS, being such a successful campaign has had unintended consequences.

Frequent media coverage had parents so afraid of SIDS that they never allowed their infant to spend any time on their stomach. One recent study confirmed that following the Back To Sleep campaign, infants were averaging 23.5 hours on their backs or with their head lying against a firm surface.3

Research & Presentations

Figure 1

Female infant starting treatment at four months of age; initial cephalic index: 98.5; exit cephalic index: 89.3; treatment time: 2.75 months.

The AAP quickly responded, changing its program to “Back To Sleep— Tummy To Play,” and encouraged parents to provide plenty of supervised “tummy time.”4 Unfortunately, by then the incidence of plagiocephaly had jumped from what was 1 in 300, to 1 in 60—a 500 percent increase.5 During this time, the term plagiocephaly had begun to be used generically to describe any cranial deformity, although three distinct types exist (see “Definitions” sidebar).

Although the Back To Sleep campaign is often cited as the reason for the “epidemic” increase in plagiocephaly,

another behind-the-scenes factor also was contributing: devices of convenience.

By the late 1980s, every state had passed legislation requiring the use of car seats. Early devices were little more than a booster seat that allowed a seatbelt to be held across a child’s lap.

However, throughout the 1990s, these devices evolved into the combination carriers/car seats seen today. In these devices, the carrier snaps into a cradle in the back seat for transportation.

When the destination is reached, the infant carrier is removed, and, in some cases, it may be directly snapped into a

stroller. Often, whether in the doctor’s office, hair salon, or car dealership, the infant remains in the carrier, and when we arrive home we transfer the infant to a swing or bouncy seat. What we as parents were never made aware of is that these devices apply a uniform, constant pressure across the back of the head and have contributed to the significant increase in brachycephalic deformities seen today. 6,7 The AAP now advises parents to limit the time infants spend in devices of convenience and recommends that car seats be used only for transportation purposes.4

O&P News | November/December 2018

11

Research & Presentations

Figure 2

Male infant entering treatment at eight months of age; initial cephalic index: 102.9; exit cephalic index: 91.1; treatment time: 9.5 months.

Other Considerations For many years, brachycephaly has been given far less attention in the medical literature due to the mistaken belief that it is somehow a less significant deformity than plagiocephaly. This belief arises from two main sources. First, the asymmetry of the ears, jaw, and face seen in plagiocephaly is more obvious than the more symmetric deformity seen in brachycephaly. Second, concerns about the potential functional implications (e.g., ocular, auditory, malocclusion)8-13 of such asymmetry were immediately concerning, while it was assumed that a symmetric deformity like brachycephaly would not have as many functional implications. However, when one studies the anatomical changes that occur as a head becomes brachycephalic, it is quickly realized that this is not the case.

A significant amount of research into the relationship between head shape and function has been documented by D.H. Enlow, MD, and colleagues over the past 25 years in a series of papers, book chapters, and presentations. In these studies, Enlow has demonstrated

12 O&P News | November/December 2018

how symmetrical flattening of the back of the head leads to changes in the skull base, affecting how the jaw articulates and potentially leading to Class III malocclusion (under-bite).14-17 Changes to the skull base also may impact the soft tissue of the upper airway, narrowing that passage and potentially increasing the risk of obstructive sleep apnea.19-20 Slightly pinching the top of a straw while drinking demonstrates how small changes in shape may impact air/ fluid movement.21 It is now beginning to be suspected that the higher incidence of apnea seen in certain cultures may be attributed to cranial shape rather than genetics.

Concerns regarding potential developmental issues associated with head shape also are now beginning to be expressed. Anatomical textbooks will show that the center of mass of the head is supposed to lie above and slightly behind the ear. When the back of the head is flattened, as in brachycephaly, the mass of the head is moved anterior and superior, which impacts an infant’s ability to hold his or her head in an upright

position. This forces the infant into a constant state of flexion, though to the lay observer it appears as if the infant has tucked his or her chin to his or her chest.

Two implications of this behavior are its impact on the airway (e.g., tuck your chin and observe the change) and how the infant accommodates by changing his or her posture, arching the back to bring the head upright.

One of the most immediate consequences of brachycephaly is its impact on the fit of protective gear. In brachycephaly, the head is disproportionally wider, shorter, and often taller than the average head shape. It is not uncommon for parents to report having to purchase adult-sized helmets in an attempt to accommodate for the increased width of the child’s head, but then discovering that the helmet tends to fall into the child’s face. When considering the number of athletic and recreational activities that now require the use of protective helmets, this is no small consideration and impacts not only the children’s participation, but also how well they are protected.

Research & Presentations

Prevention and Treatment As in all areas of medicine, prevention of illness and injury is the goal. Over the past 20 years, significant efforts have been launched by organizations, including AAP, American Academy of Family Practice, American Physical Therapy Association, and American Occupational Therapy Association, to educate parents about the importance of supervised “tummy time” and limiting the time an infant spends on his or her back. By limiting the time an infant spends with a force on the back of the head, normal growth and development may ensue.

When conservative, preventive measures are unsuccessful, a physician may prescribe the use of a cranial helmet that gently holds cranial width and encourages growth into the flatted occiput, restoring a more normal length-to-width ratio and rounding out the back of the head. While parents may initially express hesitation, physicians may quickly dispel any concerns by explaining that the “force” applied by these devices is very mild and may be thought of as “equal but opposite” to those that originally led to deformity. Cranial helmets for treatment of brachycephaly have been cleared by the U.S. Food and Drug Administration and effectively used since 1998.21 Cranial Orthosis Treatment In a study presented at AOPA’s National Assembly in Vancouver, and recently published in Global Pediatric Health,23 we presented the results of our fiveyear investigation into the treatment of brachycephaly with the cranial orthosis.

When evaluating treatment outcomes for brachycephaly, three measurements are required. These are the cranial length, cranial width, and an index known as the cephalic index (a measure of proportionality of the head): • Cranial width: Measured from Euryon (Eu) to Euryon (Eu) in the coronal plane.

• Cranial length: Measured from

Figure 3

Mean treatment time by group (with one standard deviation bars).

Figure 4

Mean change in cephalic index by group (with one standard deviation bars).

•

Glabella (g) to Opisthicranium (Op) in the sagittal plane.

Cephalic index: CI = (Cranial width / Cranial length)*100.

In the normal population, the cephalic index will typically range from the low to mid 80s. A head often is characterized as brachycephalic when it reaches a value of 90 or higher.

Sample Population & Statistical Analysis

Over the five-year period, all infants who entered treatment with the cranial

orthosis (DOC Band®, Cranial Technologies Inc., Tempe, Arizona) in one of 30 treatment centers nationwide were included into the study. Threedimensional images22 (DSi®, Cranial Technologies Inc., Tempe Arizona) were acquired at consult, entry, and exit from treatment. These images were processed through a proprietary program that identifies all cranial anthropometric landmarks, calculates key cranial metrics, and saves the results in a SQL database for further analysis. This database was then filtered to include only infants who presented with isolated

O&P News | November/December 2018

13

Research & Presentations

DEFINITIONS PLAGIOCEPHALY: Asymmetrical deformation of the cranium where roughly half of the back of the head appears flat, the ear and forehead on the same side are “pushed forward,” and the opposite forehead appears flat.

Common Causes: Congenital muscular torticollis, intrauterine constraint, positional preference.

BRACHYCEPHALY: Characterized by the uniform flattening of the back of the head, but without the asymmetry seen in plagiocephaly. The head becomes nearly as wide as it is long, and when viewed from the front the head simply looks “big.” From the side, it often appears as if the back of the infant’s head is flat rather than curved.

Common Causes: Sleeping on back without frequently changing position, low tone, devices of convenience (i.e., car seats, swings, carriers, and bouncy seats).

DOLICHOCEPHALY: The near opposite of brachycephaly. The head takes on a long, narrow appearance.

Common Causes: Prematurity, intrauterine constraint.

brachycephaly; in other words, they had wide, short head shapes with minimal to no asymmetry and no other confounding medical conditions (e.g., synostosis, syndromic, hydrocephalus).

This resulted in a final sample size of 4,205. Statistical analysis showed statistically significant improvement in head shape with an improvement in cephalic index (proportionality of the head) from 95.0 to 89.4. Mean treatment time was 3.3 months. Treatment results are shown in Figures 1 and 2.

By further dividing this sample into categories based upon age the patients entered treatment, it was also possible to demonstrate that overall correction was better, and treatment time was shorter, if the infants started at an earlier age, and these results are seen graphically in Figures 3 and 4. These results confirm

14 O&P News | November/December 2018

the findings of many other previous studies in the literature.24-28

Summary Due to its symmetric appearance, deformational brachycephaly is sometimes incorrectly dismissed as being less concerning than plagiocephaly.

It has even sometimes erroneously been reported that treatment of this condition is either unwarranted, or that it cannot be successfully treated with the cranial orthosis.

When considering the mechanics of how a cranial orthosis works (i.e., holding the prominences and redirecting brain growth in the adjacent flattened areas), as well as a basic understanding of normal craniofacial growth patterns, it may be recognized that treatment of deformational brachycephaly in many

ways is no different than treatment of deformational plagiocephaly. All that has changed is the direction in which corrective forces are applied. The rest is accomplished by growth of the brain and proper adjustment of the device by the treating clinician.

The results of this investigation demonstrate that the cranial orthosis is successful in the treatment of deformational brachycephaly and confirmed that entrance age is a critical variable in the overall effectiveness of treatment.

Consistent with other studies, these results demonstrated that earlier intervention results in improved outcomes and shorter treatment durations; however, satisfying results may still be achieved well into the second year of life.

Timothy R. Littlefield, MS, is a biomedical engineer who has specialized in the treatment of abnormal head shape for 23 years. He is the author of over 20 peer-reviewed medical articles and has served as reviewer for several prominent medical journals, the National Institutes of Health, and the insurance industry.

Research & Presentations

References 1. American Academy of Pediatrics, Task Force on Infant Positioning and SIDS: Positioning and SIDS. Pediatrics. 1992; 1120-1126.

2. Persing JA, et al. American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Plastic Surgery and Section on Neurological Surgery. “Prevention and Management of Positional Skull Deformities in Infants,” Pediatrics.

200; 199-202.

3. Davis BE, Moon RY, Sachs HC, Ottolini MC. “Effects of Sleep Position on Infant Motor Development,” Pediatrics. 1998; 102(5):1135-1140.

4. American Academy of Pediatrics, Task Force on Infant Sleep Position and Sudden Infant Death Syndrome. “Changing Concerns of Sudden Infant Death Syndrome: Implications for Infant Sleeping Environment and Sleep Position,” Pediatrics. 2000; 650-656.

5. Kane AA, et al. “Observations on a Recent Increase on Plagiocephaly Without Synostosis.” Pediatrics.

1996; 702-704.

6. Littlefield TR, et al. “Car Seats, Infant Carriers, and Swings: Their Role in Deformational Plagiocephaly,” Journal of Prosthetics and Orthotics. 2003; 102-106.

7. Pomatto JK, et al. “A Study of Family Head Shape: Environment Alters Cranial Shape,” Clinical Pediatrics. 2006; 55-63.

8. Fredrick D, et al. “Ocular Manifestations of Deformational Frontal Plagiocephaly,” Journal of Pediatric Opthalmology Strabismus. 1993; 92-95.

9. Di Francesco RC, et al. “Correlation Between Otitis Media and Craniofacial Morphology in Adults,” Ear

Nose and Throat Journal. 2007; 86(12):738-744.

10. Worley G, et al. “Evidence of a Relationship Between Head Shape and Prevalence of Middle Ear Effusion in Children,” Clinical Anatomy.

1994; 84-89.

11. Purzycki A, et al. “Incidence of Otitis Media in Children With Deformational Plagiocephaly,” Journal of Craniofacial Surgery. 2009; 1407-1411.

12. Balan P, et al. “Auditory ERPs Reveal Brain Dysfunction in Infants With Plagiocephaly,” Journal of Craniofacial Surgery. 2002; 520-525.

13. Cook JT. “Asymmetry of the Craniofacial Skeleton,” British Journal of Orthodontics. 1980; 33-38.

14. Enlow DH, et al. “Facial Morphology Associated With Head Form Variations.” Tweed Int. Found.

1984; 21-23.

15. Enlow DH. “Intrinsic Craniofacial Compensations,” Angle Orthodontia. 1971; 271-285.

16. Enlow DH, et al. “The Neurocranial Basis for Facial Form and Pattern,” Angle Orthodontia. 1973; 256-270.

17. Marton VD, et al. “Class I and Class III Malocclusion Subgroupings Related to Head Form Type,” Angle Orthodontia. 1992; 35-44.

18. Cakirer B, et al. “The Relationship Between Craniofacial Morphology and Obstructive Sleep Apnea in Whites and African-Americans,” American Journal of Respiratory Critical Care Medicine. 2001; 947-950.

19. Cheng MC, et al. “Developmental Effects of Impaired Breathing in the Face of the Growing Child,” Angle Orthodontia. 1988; 309-320.

20. Yu CC, et al. “Computational Fluid Dynamic Study on Obstructive

Sleep Apnea Syndrome Treated With Maixillomandibular Advancement,” Journal of Craniofacial Surgery. 2009; 426-430.

21. Littlefield TR, et al. “Food and Drug Administration Regulation of Orthotic Cranioplasty,” Cleft Palate Craniofacial Journal. 2000; 337-340.

22. Littlefield TR, et al. “Development of a New Three-Dimensional Cranial Imaging System,” Journal of Craniofacial Surgery. 2004; 175-181.

23. Kelly KM, Joganic EF, Beals SP, Riggs JA, McGuire MK, Littlefield TR. “Helmet Treatment of Infants With Deformational Brachycephaly,” Global Pediatric Health. 2018; 1-11.

24. Kelly KM, et al. “Importance of Early Recognition and Treatment of Deformational Plagiocephaly,” Cleft Palate Craniofacial Journal.

1999; 127-130.

25. Teichgraeber JF, Seymour-Dempsey K, Baumgartner JE, Xia JJ, Waller AL, Gateno J. “Molding Helmet Therapy in the Treatment of Brachycephaly and Plagiocephaly,” Journal of Craniofacial Surgery.

2004; 15(1):118-123.

26. Graham JM, et al. “Deformational Brachycephaly in Supine-Sleeping Infants,” Journal of Pediatrics. 2005; 253-257.

27. Seruya M, Oh AK, Taylor JH, Sauerhammer TM, Rogers GF. “Helmet Treatment of Deformational Plagiocephaly: The Relationship Between Age at Initiation and Rate of Correction,” Plast Reconstr Surg, 2013; 131(1):55e-61e.

28. Kluba S, Kraut W, Reinert S, Krimmel M. “What Is the Optimal Time To Start Helmet Therapy in Positional Plagiocephaly?” Plast Reconstr Surg. 2011; 128:492–498.

O&P News | November/December 2018

15

Research & Presentations

CASE STUDY:

What in the ‘Heel’ Do They Feel?

By Megan Smith, CO

“W

hy do we do the things we do?” I am very fortunate to be in a position to ask this question a lot. I ask it to myself, to my colleagues, and to providers across the country.

As members of a care team, what is the most dangerous answer to that question?

“Because we’ve always done it that way.”

This answer puts us in a place of complacency, which is not fair to our patients. They deserve for us to push ourselves and our profession, and to continue to strive for better results.

This study was an opportunity to challenge the way we’ve always done things.

Things were really great, and we were consistently seeing good results—but could we do better? That was the question we sought to answer.

Over the past few years, we have walked hundreds of children on a gait mat (Zeno Walkway, Protokinetics Software1) in various supramalleolar orthoses (SMOs) and ankle-foot orthoses

Figure 2

Figure 1

Location of plantar surface mechanoreceptors.

(AFOs). As we compared data—from barefoot condition, to shoes only condition, to shoes plus orthoses condition—we noticed trends. We saw increased step length, decreased base of support, improved center of pressure, and improved gross motor skills. But we also noticed that in orthoses, kids tended to be more anterior and have a faster transition from initial contact to foot-flat. These characteristics affect the achievement and quality of both gait and functional skills. We wondered if we could do better.

Our team discussed these observations and asked further questions. If kids are getting too far anterior too fast, are they strengthening their trunk extensors?

If they don’t get good eccentric contractions of their dorsiflexors in loading

Open heel modification on Surestep supramalleolar orthosis (SMO) and toe-walking SMO.

16 O&P News | November/December 2018

response and have too much knee and hip flexion, can they gain strength?

What are the effects of anterior weight lines on posture, gait, and function? Do we need to promote posterior weight shifts? And, perhaps most important, what do kids truly feel in their orthoses?

There are 104 mechanoreceptors on the plantar surface of the foot (see Figure 1).2 We see concentrations on the forefoot, lateral midfoot, and heel. The ability to feel changes in terrain and adjust posture to build a repertoire of motor and postural strategies is a vital part of typical development.3,4 With shorter footplates on many of our SMOs and AFOs, we are allowing the forefoot to feel the floor.

Could we allow the heel to feel the floor?

What are the effects of a heel post? And what can we do to make a difference?

Research & Presentations

Figure 3

Standard Surestep SMO with heel post and Surestep SMO with open heel modification.

Standard Surestep SMOs with heel post These questions and conversations led to the development of the open heel modification (see Figure 2). This modification adds a very thin inner boot to the orthosis and removes the heel post. The inner boot not only reduces irritation from the edges of the opening but, more importantly, helps ensure we have total contact and maintain circumferential compression.

In this study, we had 11 participants with an average age of 4.5 years old.

Patients were included in this study if they were receiving a new pair of orthoses (SMOs, toe-walking SMOs, or AFOs) from their certified orthotist and presented with anterior weight lines and/ or foot slap. Diagnoses of the participants included Down syndrome, autism, toe walking, hypotonia, and pronation.

Our goals were to promote more posterior weight lines, slow loading response, and improve proprioception while still controlling pronation.

What Did We Change?

Before analyzing the effects of the new modification on gait and function, we first had to evaluate foot position to ensure we were still controlling pronation. Patients stood in their standard Surestep SMOs with a heel post and in their Surestep SMOs with the open heel modification. There was no significant change in calcaneal position between devices (see Figure 3). The combination

Surestep SMOs with open heel

of the properties of the plastic, trim lines, and circumferential compression improved alignment and provided the dynamic stability necessary to control excessive pronation.

Patients also walked on the gait mat in barefoot condition, shoes only condition (when applicable), heel post orthoses condition, and open heel orthoses condition. The gait results included decreased velocity and increased time from initial contact to foot-flat with the open heel modification. Anterior weight lines tend to lead to increased velocity. Many of our participants struggled slowing down and walking with control.

They were essentially falling with every step as their trunk led their feet. By slowing down, they could work through eccentric contractions, gain strength, and work on posterior and lateral weight shifts. By increasing time from initial contact to foot-flat, we slowed down loading response and allowed the natural anatomy of the heel to work and control the mechanics, rather than the plastic heel post. This led to increased extension through the lower extremities and trunk as well as better mechanics when doing functional skills such as squatting.

Comments like, “I can feel my feet!” are coming from our patients, along with feedback from therapists and parents about how they felt proprioception improved. This feedback led us to believe that, along with the compression

of the orthoses, the dynamic tactile input through the forefoot and heel helped improve stability and sensory input.

These types of comments are what it is all about. This is the reason we strive to never answer the question, “Why do we do it this way?” with, “Because it’s the way we’ve always done it.”

For questions, or more information, please email megans@surestep.net or visit www.surestep.net/clinicians, where you can find our open heel modification FAQ sheet.

Megan Smith, CO, is director of clinical research for Surestep.

References 1. Kennedy PM, Inglis JT. “Distribution and Behavior of Glabrous Cutaneous Receptors in the Human Foot Sole,” J Physiol. 2002; 538(Pt. 3): 995-1002.

2. Protokinetics Software and Zeno Walkway. www.protokinetics.com.

3. Dusing SC, Harbourne RT. “Variability in Postural Control During Infancy: Implications for Development, Assessment, and Intervention,” Phys Ther. 2010; 90: 1838-1849.

4. Fetters L. “Perspective on Variability in the Development of Human Action,” Phys Ther. 2010; 90: 1860-1867.

O&P News | November/December 2018

17

O&P Visionary

Frank Bostock, MBA, CO

The O&P profession must be recognized for its unique body of knowledge that is supported by the educational preparation and the body of evidence of its certified clinicians

A

re certified orthotists and prosthetists product suppliers, or are they knowledge-based health-care professionals? Does it make a difference? A difference as it relates to how CMS, insurance payors, referral sources, and patients view certified orthotists and prosthetists?

I believe that it does. The perceptions of patients, payors, and referral sources of the O&P profession ultimately define our profession as it relates to the care we provide our patients and how we are compensated as health-care professionals. They are the ones that create the paradigm for our profession, and unfortunately it is a paradigm that currently defines O&P practitioners as suppliers, vendors, and product sales reps—providers of products.

Prior to this year’s change in the CMS “Dear Physician” prosthetic letter—which was a significant event for the O&P profession, and was led by the ongoing and tireless efforts of AOPA and the O&P Alliance—the previous CMS Dear Physician prosthetic letter stated the following: “The [durable medical equipment medical administrative contractors (DME MACs)] have jurisdiction for processing claims from prosthetists for artificial limbs. In the event

18 O&P News | November/December 2018

This year, I negotiated contracts with several hospitals, and in each of these contract negotiations we were always referred to as vendors, and listed as vendors in the contracts that the hospitals provided to us. of an audit, the Medicare contractor may request medical records to demonstrate that the prosthetic arm or leg was reasonable and necessary. Since the prosthetist is a supplier, the prosthetist’s records must be corroborated by the information in your patient’s medical record. If a supplier contacts your office to request additional clinical documentation, please partner with the supplier to establish what

clinical records are needed to support the services/item you ordered is medically necessary.” So, based upon how many times the letter refers to prosthetists as suppliers, CMS has documented what it believes prosthetists are—suppliers and providers of devices, and not knowledgebased health-care providers.

This supplier/vendor mentality is also prevalent within the hospital and insurance payor world. This year, I negotiated contracts with several hospitals, and in each of these contract negotiations we were always referred to as vendors, and listed as vendors in the contracts that the hospitals provided to us. Most hospitals and insurance payors view orthotists and prosthetists as people that sell products, and in their eyes orthotists and prosthetists are the same as any other product vendor with which they negotiate wherein the primary concern is on product pricing and not patient-care services.

In contrast, how do people generally define a health-care professional?

A good source for this definition is the American Medical Association (AMA). The AMA defines a healthcare professional as “a physician or other qualified health-care professional who is qualified by education, training,

O&P Visionary

licensure/regulation, and facility privileging who performs a professional service within his/ her scope of practice.” As you read this definition, do you believe that it appropriately describes certified orthotists and prosthetists?

The American Board for Certification in Orthotics, Prosthetics, and Pedorthics (ABC) defines ABC-certified orthotists and prosthetists as “health-care professionals specifically educated and trained to manage comprehensive orthotic and/or prosthetic patient care.” Under this definition, Frank Bostock, MBA, CO, speaking at the AOPA 2018 National Assembly there are not any references to the profession as vendors, the paradigm of O&P was still that of suppliers, product sales reps, or fitters of a provider of products, as the BIPA products. As such, if certified orthotists legislation defined who was qualified to and prosthetists are educated and trained provide Medicare patients with custom to provide comprehensive O&P care O&P products, rather than O&P prodto their patients, why is it that they do ucts and patient-care services. not bill for the care that they provide Under the 2000 BIPA legislation, to their patients? And why do other physicians and therapists were now health-care providers, such as physicians, deemed qualified to fit and bill O&P physical and occupational therapists, custom devices, along with certified optometrists, podiatrists, and athletic orthotists and prosthetists, but in additrainers, provide and bill for patient- tion to billing Health-Care Common care services and medical products, in Procedure Coding System (HCPCS) many instances including orthotic and codes for O&P custom devices, physiprosthetic devices—and certified ortho- cians and therapists also bill Medicare tists and prosthetists who also provide current procedural technology (CPT) patient-care services and medical devices, codes for patient-care services, including but only bill for the products and not the O&P-specific CPT patient-care services patient-care services that they provide to codes: CPT codes 97760, 97761, their patients? and 97763 used for O&P assessment, Throughout the history of O&P, management, and training for patients it was founded and defined from a needing or wearing orthotic and prosproduct perspective. With the federal thetic devices. Physicians and therapists government’s passage of the 2000 bill Medicare for both HCPCS and CPT Benefits Improvement and Protection codes for the products and services they Act (BIPA), certified orthotists and pros- provide, but as a recognized qualified thetists, along with physicians, physical provider, certified orthotists and prostherapists, and occupational therapists, thetists only bill Medicare and private were recognized as qualified providers payors HCPCS codes—and, again, the to provide custom O&P products to question is why? Why wouldn’t O&P Medicare patients. However, even with practitioners bill CPT codes for the the passage of the 2000 BIPA legislation, nonproduct patient care it provides to its

patients? Almost all health-care professionals routinely use CPT and HCPCS codes in the care they provide to their patients, so why is the O&P profession the only health-care provider that has not adopted the same coding practices?

One of the reasons that the O&P profession has not adopted CPT code billing practices is based upon what I believe is a false assumption that patientcare services are included in the L-code reimbursements. It is true that there is a labor component included in the reimbursements for L codes, but the labor reimbursement is tied directly to the delivery of a product and not patient care. In addition to the device being provided, L-code reimbursements include labor for collaborating with the prescribing physician in determining what product will be provided to the patient, labor in measuring the patient for the product, ordering or fabricating the product, fitting the product, and providing follow-up patient visits to ensure the product is fitting and functioning as intended. All labor activities included in the L-code reimbursements are product related and not patient-care related.

When other health-care professionals bill HCPCS codes, their billings also include the labor associated with delivering the product, and they do not concurrently bill O&P CPT codes with the HCPCS codes when they fit and bill for the orthotic or prosthetic device; and compliant protocols for billing O&P CPT and HCPCS codes have been established by groups such as the American Physical Therapy Association (APTA); however, independent of the labor associated with the delivery of the O&P device, other health-care providers do bill CPT codes for patients that have been provided O&P devices, but the care is independent of the O&P device provided.

O&P News | November/December 2018

19

O&P Visionary

The CPT code set is a medical code set that is copyright protected by the American Medical Association, and it describes medical, surgical, and diagnostic services, not products. CPT codes are designed to provide uniform information about medical services and procedures; however, the most important thing to remember about CPT codes is that although there are CPT codes established for use by physicians and nonphysicians, they are not profession specific. Any qualified health-care professional can utilize CPT codes as long as the code’s description fits the procedure or service the professional is providing and it is within the profession’s scope of practice. Subsequently, as a qualified health-care professional, as acknowledged by the 2000 BIPA legislation and O&P licensure in many states, certified orthotists and prosthetists could use CPT codes for patient-care services that they provide to their patients that are not included and billed in the labor components reimbursed under the HCPCS L codes.

Examples of CPT codes that describe patient-care services that are included within the ABC scope of practice and provided by certified orthotists and prosthetists are the following: • Patient evaluations • Muscle strength • Range of motion • Posture, balance, and proprioception evaluations • Pain management • Wound management • O&P-related gait training and therapy • Patient education and training • Physical performance test or measurement • Assistive technology assessment.

Even though certified orthotists and prosthetists are recognized as qualified health-care professionals and licensed in many states, and there are CPT codes that cover patient-care services

20 O&P News | November/December 2018

Today, as health-care providers, certified orthotists and prosthetists assist their patients in improving the quality of their lives not through selling them products, but rather through knowing what products and patientcare services combined will provide them with increased mobility and independence, and the best possible cost effective outcomes.

that certified orthotists and prosthetists routinely provide to their patients that are included within the ABC Scope of Practice for Certified Practitioners, it does not mean that Medicare or insurance payors will automatically pay for CPT billings submitted by certified practitioners. Initially, O&P will encounter billing challenges as it creates a new paradigm for the profession as a patientcare provider that also provides O&P devices just as physicians, therapists, and podiatrists do; however, certified orthotists and prosthetists need to join the ranks of other qualified health-care providers who bill and are reimbursed for both HCPCS and CPT billings for patient care.

Why is it important for the O&P profession to include CPT patient-care billings in their practices for the patientcare services that they provide that are within their scopes of practice? Because if the O&P profession does not have access to billing CPT codes, then the O&P profession will remain in its product paradigm in the eyes of its payors, referral sources, and patients. As a supplier of O&P products, O&P professionals now find that many of the products

that they provide in their practices have now become commodities and are now readily available on the Internet through nontraditional suppliers and providers.

Recently, there was an article published in U.S. News and World Report and posted online, titled, “How 3-D Printing Will Revolutionize Prosthetics”—the article states that 3-D printing technology will revolutionize prosthetics by significantly lowering costs and delivery times. The availability of O&P products through nontraditional and non-O&Pindustry delivery models will provide patients and payors alternative sources for purchasing O&P products, including the Amazons of the world, wherein through a smartphone app a patient can take a picture of his or her leg and send it to an online provider who will fabricate a custom knee brace and have it at the patient’s doorstep in a matter of days, with online fitting and care instructions.

As such, certified orthotists and prosthetists will find their roles as product providers diminishing, and O&P will be challenged to survive in a productonly health-care delivery model. Today, as health-care providers, certified orthotists and prosthetists assist their patients

O&P Visionary

in improving the quality of their lives not through selling them products, but rather through knowing what products and patient-care services combined will provide them with increased mobility and independence, and the best possible cost effective outcomes.

The O&P profession has transitioned from a product manufacturing industry to a health-care profession comprised of knowledge-based health-care professionals; however, the product paradigm for the profession still exists in the eyes of many, and this product paradigm will not be changed to one that views certified orthotists and prosthetists as knowledge-based health-care professionals without educating referral sources, payors, patients, and ourselves. And this process will include the following: • Expanding the curricula at schools accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP),

•

•

with an emphasis on patient-care services and patient O&P rehabilitative care Strategic ABC updates and expansion of O&P’s Scope of Practice, with an emphasis on more rehabilitative and patient management services Educating payors on the cost savings and value of the patient-care services provided by certified orthotists and prosthetists to their patients.

Health-care professionals’ scopes of practice are ever-evolving, as exemplified by the APTA and optometry models, and with the current master’s level educational requirements, residency requirements, and examination process, the O&P profession needs to be defined and recognized for its unique body of knowledge that is supported by the educational preparation and the body of evidence that validates the value

orthotists and prosthetists provide to their patients.

Paraphrasing a quote attributed to both Robert Kennedy and George Bernard Shaw, “Some people see the O&P profession as it is and say, ‘Why?’ We need to see the O&P profession as what it can be and ask, ‘Why not?’”

Today’s story of O&P is about creating a new paradigm for the O&P profession that places a greater emphasis on the patient-care and rehabilitative services provided by certified orthotists and prosthetists for their patients, and not just on the products provided—a paradigm that no longer sees the profession solely through the lenses of a product bias, but rather one that sees and acknowledges certified orthotists and prosthetists as knowledge-based healthcare professionals.

Frank Bostock, MBA, CO, is Southwest Region vice president, Hanger Clinic, in Phoenix, Arizona.

NE

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O&P News | November/December 2018

21

STATE NEWS

State by State

The latest news from Idaho, Indiana, Michigan, Minnesota, and Vermont, plus a draft BCBS policy that could affect many

O&P News talks 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.

Multiple State Alert Blue Cross Blue Shield (BCBS) Illinois, BCBS Montana, BCBS New Mexico, BCBS Oklahoma, BCBS Texas, and Health Care Services Corp. (HCSC) issued a draft policy that would limit access to microprocessor-controlled prosthetic technology. AOPA and several other O&P organizations, including the O&P Alliance, issued comments on the draft policy, which was removed from the BCBS website on Monday, Oct. 1, 2018. A new policy has not been published as of Nov. 1, 2018. AOPA’s comments are available for review on the AOPA Co-OP, and AOPA will continue to monitor this issue.

Idaho O&P providers are preparing an effort to establish coverage for cranial remolding orthoses through Idaho Medicaid. Currently, Idaho

22 O&P News | November/December 2018

Medicaid does not cover cranial remolding orthoses, leaving an entire pediatric patient population without access to these needed services and devices.

Indiana O&P providers in Indiana have started to organize in preparation to launch an effort to introduce an O&P licensure bill. AOPA, with the help of AOPA state representatives Tim Ruth, CPO, and Curt Bertram, CPO, FAAOP, is working to organize Indiana O&P providers to discuss the plan moving forward, with a call scheduled for December 13. Additional information will be provided by AOPA.

an opportunity to present, via conference call, the latest research studies in support of less restrictive prosthetic policies to BCBS Minnesota’s medical director and medical policy team.

Arise O&P was supported in preparation for the meeting by Ottobock’s Kimberly Hanson. Charles Kuffel and Kenton Kaufman, PhD, PE, presented lower-limb information, and Andreas Kannenberg, MD, and Pat Prigge, CP, LP, FAAOP, presented the upper-limb information, during the one-hour, in-depth policy review.

Michigan Michigan O&P providers and the Michigan Orthotic & Prosthetic Association, with the help of Orthomerica, have been successful in receiving a Michigan Medicaid fee schedule increase from $904.40 to $1,684.61 for cranial remolding orthoses billed under S1040. “It took the group two years, but well worth the effort,” said Bill Gustavson.

Vermont BCBS Vermont announced that the Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses Policy has been reviewed and updated, effective Jan. 1, 2019. AOPA does not have access, currently, to pending policy. If you are an O&P provider in Vermont, you should have received a network bulletin and/or notice about the policy changes.

Please email co-op@aopanet.org if you have seen the policy language and have any concerns.

Minnesota Charles Kuffel, MSM, CPO, LPO, FAAOP, and Teri Kuffel, JD, facility owners of Arise O&P, requested a policy review to discuss the recent changes to BCBS Minnesota’s Upper-Limb and Lower-Limb Prosthetic Policies that have the potential to limit patients’ access. They were granted

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.

CALENDAR & CLASSIFIEDS

Meetings & Courses

2019 JANUARY 4-6 AOPA 2019 Leadership Conference. The Scott, Scottsdale, AZ. For more information, email Ryan Gleeson at rgleeson@ AOPAnet.org.

JANUARY 9 Understanding the Knee Orthoses Policy. Register online at bit.ly/2019webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

FEBRUARY 13 Patient Outcomes: Best Practices & How To Use Them. Register online at bit.ly/2019webinars. For more information, email Ryan

MAY 8

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Are You Compliant? Know the Supplier Standards. Register

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online at bit.ly/2019webinars. For

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Veterans Affairs Updates: Contracting, Special Reports, and Other News. Register online

more information, email Ryan

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at bit.ly/2019webinars. For more

Gleeson at rgleeson@AOPAnet.org.

Ryan Gleeson at rgleeson@

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rgleeson@AOPAnet.org.

JUNE 12 Documentation— Understanding Your Role. Register online at bit.

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

APRIL 10 Shoes, External Breast Prostheses, Surgical Dressings, and Other Policies. Register online at bit.ly/ 2019webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

Publisher Eve Humphreys, MBA, CAE Advertising Sales RH Media LLC Editing Services Content Communicators LLC Design & Production Marinoff Design LLC SUBSCRIBE O&P News (ISSN: 1060-3220) is published by the American Orthotic & Prosthetic Association, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314. To subscribe, contact 571/431-0876, fax 571/431-0899, or email ymazur@AOPAnet.org.

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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.

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O&P News | November/December 2018

23

TECH TIPS

Future Tech

A glimpse into emerging technologies

By Steve Hill, CO, BOCO

W

e live in the age of technology.

As it progresses, so too does the way we run our business. Billing and accounting software makes the financial side easier and more accurate. Patient management software makes organizing our patients’ information much easier, even to the point of ordering parts and suggesting L codes for us. We use infrared light to heat the plastic we use in thermoforming, another manufacturing technique we’ve hijacked. Materials like carbon fiber, aluminum, titanium, composite materials, and many others have given us a seemingly limitless variety of ways to create and customize our devices to adapt to any patient’s needs. But this technology usually comes to us from the outside.

As a relatively small and underfunded part of the medical field, O&P professionals have, by necessity, become a clever bunch, adapting technologies from other, much larger industries.

Although the O&P profession has one foot in the past with our “one-size-fitsone” custom work, we also keep another foot firmly planted in the promise of “new-and-better,” always looking for the next great technology that will make our jobs and our patients’ lives easier.

This creative and adaptive attitude is the point of this article. Yes, we will talk about some of the latest, greatest advances in technology and processes, but we do so with the understanding that we are always on the lookout for some technology that we can use in our own practice. If we keep our eyes peeled, an observant and creative person can find some new invention or innovation that can improve both our lives and our patients’ lives.

24 O&P News | November/December 2018

Embracing Technological Advances One new technology that has been essential to advancing the O&P profession is the ubiquitous smartphone. One of the first apps I ever downloaded was a clinometer. It gives, with a great deal of accuracy, the degree of angle in any given plane. This comes in very handy for setting up socket alignments and adjusting double-action ankle joints.

And if you’ve never used the AOPA 365 app during the national convention, you’re seeing the show and going to the classes the hard way.

One bit of tech that is new to O&P is 3-D printing. Although it has actually been around since about 1984 in the form known as stereolithography, new advances in electronics and software have allowed just about anyone to make use of it in a form known as “additive manufacturing” or “fused deposition modeling”—what most of us just call “3-D printing.”

Now a person can buy a small, usable 3-D printer for as little as $200 that can print some pretty useful things.

For about $1,000, you can find a unit that will print prosthetic sockets, arch supports, ankle-foot orthoses, and even many knee-ankle-foot orthoses. Add a scanner, take a few classes in CAD (computer-aided design), and you can make just about anything that you want to make.

Many people believe that you can only print with brittle, rigid plastic, but this is no longer the case. Not only are more flexible materials available in almost any durometer you want, but with multiple nozzle printers you can mix various materials to create devices with a variety of densities and material properties. Along with the polymers we have become used to, we can now even print with materials like carbon fiber, wood, color-changing or glow-in-thedark plastic, and cement (for houses).

And, if you really want to spend some

TECH TIPS

money, you can print with steel (known as “sintering”). And that is just the beginning.

In addition, 3-D printing is starting to become a viable format for making organs for transplant patients. An organ has been made by using a 3-D-printed scaffold coated in the patient’s own cells and grown in the lab. This was done back in 1999 when a patient was implanted with a bladder made in this way. The real beauty of growing organs using this method is that, since the patient’s own cells are used, there are none of the usual rejection problems that typically face such transplant patients. Similarly, cancerous cells are being harvested from patients and used to create multiple tumors used for testing of different chemotherapy treatments.

Clearly, 3-D printing has already started to make its way into the O&P lab, but it’s possible that before we know it, this technology will be used to make entirely new limbs for our patients using their own cells. But I don’t think that we will have to worry about for many years.

Other Emerging Technologies Another innovation that shows serious promise for O&P is what is currently known as “smart materials.” This class of materials has been designed to provide uses far beyond the obvious and can be activated by electric, chemical, thermal, or a variety of other inputs. There is a flexible glass, an amazing innovation with uses like innovative cell phones, unbreakable windshields, and a wide variety of medical applications.

In another neat adaptation, piezoelectric cloth can generate heat or electricity, which can then be sewn into clothing and used to power other materials, such as a cloth laced with smart metals. These metals could be one shape at rest, and another shape with the application of a few joules of energy. Perfecting these materials can result in the creation of pants that can walk for us, shirts that can lift things for us, and vests that can help

us breathe. Remember those self-tying shoes from the movie Back to the Future?

Expect to see something like those in a store near you some day.

Genomic therapy and stem cell therapy have the potential to revolutionize medicine to the point where you won’t recognize it 30 years from now. Nearly every genetic ailment or disease we might suffer, from cystic fibrosis to cancer, will be treatable by inserting a gene into the patient’s cell instead of surgical or

drug intervention or by introducing stem cells to rebuild damaged cells. A quadriplegic patient has already been treated in this way and has regained the ability to use his arms and hands. The promise of such treatments in the future will not only completely change the face of medicine as we know it, it will likely extend our life expectancies well past its current 100-year mark. What does your retirement portfolio look like? With the ability to cure any disease and grow replacement organs, you’re going to need to rethink your future plans. Again, this might well be far into the future, but it could also be right around the corner.

There are a multitude of emerging technologies that we might find helpful in the future, and many of them will appear to threaten our industry. Therefore, we must be able to identify these technologies and find ways to incorporate them if we are to be expected to control the future of our profession.

The only thing that never changes is change itself. We must stay in front of new technology in order not to be run over by it.

Steve Hill, CO, BOCO, is president and chief executive officer of Delphi Ortho and a founding board member of Orthotic Prosthetic Technological Association.

O&P News | November/December 2018

25

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