Where Are They Now? SCO Technology Flourishes—But Usage Fades

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By Judith Philipps Otto
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When early versions of stance control orthoses (SCOs) began appearing in the 1980s and 1990s, they were hailed as an option for people who needed help with lower-limb deficiencies but who found their locked-knee KAFO designs cumbersome and frustrating. The SCO-with its free-swinging joint that allows the knee to bend and flex under the wearer's control rather than locking it into a fully extended, stiff-leg position-continues to offer an excellent solution for thousands of potential candidates who are identified annually. Evolving technology continues to present us with electronic and microprocessor stance control versions to serve patients in search of a more natural gait, yet SCOs cannot be said to be flourishing today as one might have anticipated a decade ago.

In "The Stance Control Orthosis: Has Its Time Finally Come?," published in the March 2008 issue of The O&P EDGE, the benefits to SCO users and the studies substantiating those benefit claims were enumerated by proponents hopeful that usage figures would rise with greater awareness and the 2005 L-Code assignment (L-2005). But those hopes have not been realized, and it is clear that SCOs still face an uphill battle that some experts fear may never be won.

SCO Technology Update

Current SCO technology includes a number of mechanical stance control approaches that are triggered by weight bearing and ankle and hip motion, as well as electronic alternatives that range from basic to complex. However, few new stance control developments have emerged since the 2008 list was published.

"State-of-the-art technology in mechanical stance control has not made many large strides in the last four or five years; it virtually stopped," observes Eric Weber, CPO/L, FAAOP, national orthotics specialist, Hanger Clinic, headquartered in Austin, Texas. "What we have seen is the next leap into the [Ottobock] OMS [orthotronic mobility system] C-Brace system, which does not lock at all."

An internal survey that Weber conducted on behalf of Hanger in August/September 2014 included 121 practitioners from across the United States who were asked which manufacturers' stance control products the respondents most frequently recommended. The findings reveal an even distribution among three major manufacturers: Fillauer was named by 37 percent of the respondents, followed by Becker Orthopedic with 32 percent, and Ottobock with 30 percent.

Underprescribed, Underutilized, Misunderstood

Despite the value that SCOs deliver, few are being fit on the thousands of patients who might be identified as appropriate candidates, records show. As cited in the aforementioned article in The O&P EDGE, according to data extracted from Medicare usage figures at that time, an estimated 1,200-1,600 stance control devices were fit annually; today, Liz Hillen, MEd, CPO/L, clinical specialist-orthotics, Ottobock, Austin, notes those numbers have barely grown. "About 25,000 new KAFO wearers are identified annually; about 40 percent of those patients (10,000) we would also consider stance control candidates. However, only about 1,800 new patients are identified annually for stance control."

Gary Horton, CO/L, who developed and introduced his own stance control design in 2000, the stance control orthotic knee joint (SCOKJ), notes that he has seen a decrease in the number of candidates coming in to be fit for the device. "Initially there was a lot of interest generated and a lot of people coming in who really weren't candidates for it. The practitioners and physicians who are now putting patients in stance control are a little more realistic regarding the potential and what it can do; I think that's the reason for the decrease.

The SCO Advantage

There is much to recommend more extensive fitting of SCOs, and there is likewise a significant number of potential users who could benefit from the devices.

  • Studies reveal that stance control devices offer users a range of motion during swing phase that is much closer to normal and significantly improves gait biomechanics compared to locked-knee KAFOs. Most patients have a strong preference for walking in stance control mode, noting that it takes less effort, or that they feel it takes less energy to walk.
  • Motion in the rest of the body is also much closer to normal, demonstrating a positive effect on the opposite leg, the trunk, head, arms, and locomotor apparatus.
  • In the long term, such improvements might spare users secondary complications as elderly adults.
  • Additional studies also demonstrate improvements in patients' gaits and consequential improvements in their energy consumption for better outcomes overall.

"To be honest, when I started doing this myself, I thought there was more utilization than there is. But reality set in over the years; I have to agree that in most of the country it is still underutilized."

Horton recently suspended manufacture of the SCOKJ and is currently in talks with manufacturers interested in taking over the brand. "We're still seeing patients that have stance control orthoses, but it just wasn't feasible for us to continue producing them," he explains.

W. Clint Snell, CPO, president, Snell's Orthotics & Prosthetics, Shreveport, Louisiana, is an SCO user who describes himself as "sold on the technology," and agrees that it is underutilized. "With the stance control, you have huge benefits of energy savings and stability. I know in my own case it totally changes my gait. I'm much more erect, standing up straight, and have a much more stable and secure gait pattern and improved ambulation.

"But with the current climate of documentation and justification for any type of orthotic or prosthetic care, I'm not sure we've done a good job on documenting those SCO outcomes and being able to prove it to insurance companies and other healthcare payers."

Gary Bedard, CO, FAAOP, Becker Orthopedic, Troy, Michigan, points out that "from an efficiency standpoint, a stance control orthosis is probably in excess of 25 percent more efficient than a drop-lock KAFO in terms of energy expenditure."

The benefits offered by Ottobock's C-Brace, or OMS device, are even more dramatic: "What we're seeing in the field is remarkable," Hillen says. "We're already seeing major functional gains beyond what we had imagined. We are literally getting patients out of their wheelchairs. Patients who would normally otherwise be confined to a locked KAFO and the wheelchair can now walk with minimal use of assistive devices, and that makes a big difference. It means they can use their hands to hold their children, they can carry groceries, dance with their partners, so many different things."

Kelly Clark, CO, Kelly Clark Consulting, Minneapolis, points out that mechanical SCOs have limitations not shared by OMS devices. "In today's world, unless you're at a mall, there's not a lot of level ground. Your stance control device may not function well on inclines, declines, stairs, uneven terrain, and even grass."

He describes a stance control wearer who participated in a C-Brace trial. "Within ten minutes he was outdoors, doing stairs and climbing a grassy hillside all the way to the top. Back at the bottom he said, 'I haven't done that for eight-and-a-half years!'"

Hillen cites findings that a C-Brace patient descending a ramp is able to demonstrate less time spent on the sound limb. "That equates to reduction of overuse injury."

The Reimbursement Barrier

Why, then, in the face of all the demonstrated advantages, aren't more patients wearing SCOs or their updated electronic and microprocessor versions?

obstacles sign

John Michael, MEd, CPO, FISPO, FAAOP, an orthotic and prosthetic consultant, and director of education for the Northwestern University Prosthetics-Orthotics Center (NUPOC) Master's in Prosthetics and Orthotics program, believes that while there is a reasonable range of SCO choices available, "the number of choices has been shifting and diminishing, largely in response to the barely adequate reimbursement that Medicare established some years ago. I think Medicare continues to effectively limit access to this technology for people who would truly benefit from it. You really have to make a commitment to provide a stance control KAFO on a pure dollars and cents basis; it probably doesn't make a lot of sense to do that. You have to be really committed to the patient and the process-and you have to do it despite the barriers."

Notwithstanding the historic collaboration of major manufacturers during efforts to achieve a reasonable code and reimbursement that would make SCO technology available and affordable to patients-as recalled by Clark and Horton-reimbursement levels remain uninspiring.

"My hope has always been that stance control technology would improve-and it has improved some. But not at the pace I envisioned ten to 11 years ago," reflects Horton. "Unfortunately, everything is reimbursement driven. The C-Brace is an excellent device-but I'm afraid they're going to run into the same problems. Who's going to pay for it?"

Weber notes that under the descriptor of code L-2005, the Centers for Medicare & Medicaid Services (CMS) reimburses at the same amount for an electronic hip- or weight-activated system as for a mechanical SCO, despite the cost difference: "So unfortunately you end up with...a choice between a $7,000-10,000 electronic version and a $3,000-4,000 mechanical version, both reimbursed at the same amount. It has become a significant barrier to delivering treatment, without question."

He explains that anything new that is not described in the coding system needs to be redescribed on its own, and that process can take quite a while. "In the interim, it's a Catch-22: I can't gather objective data using outcome measures if [CMS doesn't] pay for enough patients to participate in trials."

Michael believes, however, that existing research has validated SCO principles. "I think we have more than enough research to support the value of stance control technology. In my view, the holdup is a deliberate effort by Medicare to limit access to new technology-not just stance control, but that's one of the primary examples-and unfortunately, we know what will happen if inappropriate reimbursement is applied on a continuing basis. In my view, some of the best solutions technologically are some of the ones that have disappeared. They're disappearing, in part, not-as we would hope would be the case-because they weren't a really good solution for the people who need it, but because of artificially created fiscal pressures."

Horton concurs, fearing the situation is likely to continue. "I haven't seen any movement on the reimbursement side. Everything is pretty much driven by Medicare reimbursement, and there has never been any real interest in Medicare to reanalyze this, even though there were studies done at [NUPOC] years ago, of the effectiveness of stance control. Until people can get reimbursed fairly, stance control is never going to grow."

With nearly 100 patients now wearing C-Braces, Hillen refers to three times that number of trial-fit patients who have received the devices and are still awaiting insurance authorizations. "Research studies that are being conducted will hopefully expedite resolution of reimbursement delays," she notes.

Bedard identifies not only the questionable reimbursement levels to clinically support fitting SCOs, but also the ongoing costs of patient follow up, assessment, gait training, warranty work, and maintenance on the devices as significant obstacles. "When you take it as a totality, it can be a daunting task for a practice to offer this technology when they probably can see patients and apply other ideologies or other product needs and have a higher level of clinical reimbursement support."

STANCE CONTROL PREDICTIONS

What's in the future? With orthotronic mobility systems (OMS) entering the picture, are embattled SCOs likely to become obsolete?

John Michaelk

John Michael, MEd, CPO, FISPO, FAAOP: With enough collective experience, the really effective solutions will gradually become more and more dominant, which has always happened in the history of prosthetic and orthotic care. The problem is if the application is being artificially restricted, then we're not going to get that experience as quickly, and we're not going to be able to help as many people in the process of sorting this out, as we otherwise would have. I think that's probably the tragedy.

I think this marginal reimbursement is going to continue to limit access for people who need the care, and I think it has had a chilling effect on people who were formerly considering developing innovative orthoses. I know of several instances where companies abandoned their plans mid-stream for unrelated orthotic developments when they saw the way Medicare treated the developers of stance control orthoses.

The good news is that despite all the negative artificial forces, there continues to be innovation in this area, of which the C-Brace is one example.

Kelly Clark

Kelly Clark, CO: That's difficult to say. Of necessity, because of the reimbursement environment, I think we're always going to have SCOs. The best outcome for patients is by and large the OMS; if the financial means aren't there and I want to give them an augmented outcome, I can still use an SCO.

Gary Bedard

Gary Bedard, CO, FAAOP: You have to have an economic engine that drives research and development. We were thinking that it was going to be a V-8 market, and it's more like a four-cylinder market. Because of all the barriers and such a burden of implementation, the economic engine that drives research and development is diminished.

Since you have a range of products that are current now and that people are familiar with, that's going to satisfy the need of the current market until you have this incremental growth where it might drive further development down the road.

I love this technology. I've seen the efficacy and the improvement in the daily lives of these patients, but the burden of advocacy, the burden of acceptance by the field-it's a very high bar to reach.

Gary Horton

Gary Horton, CO: I think stance control devices are here to stay. They offer an essential benefit; I just think that until reimbursement changes, we're not going to see a whole lot of innovation.

The bundled L-Code restricts the flexibility of practitioners to receive clinical reimbursement support adequate to manage SCO patients, Bedard adds. "There are practitioners that feel that the reimbursement rate at this point is still so low that it doesn't cover their real expenses in terms of using that technology for their patients."

A drop-lock patient might need clinical care once every 18 months or so, because he or she unlocks the knee joint an average of only 70 times per day to do a sit-to-stand or stand-to-sit maneuver; however, he speculates that stance control patients may take 10,000 steps daily in the course of normal ambulation, requiring considerably more follow-up preventive care due to the significantly greater use and wear on the knee joint.

Although stance control has much to offer, it lacks a strong advocacy group to work actively for better reimbursement, such as the advocacy that prosthetics has by the Amputee Coalition. Bedard points out that the patients who are candidates for stance control devices have diagnoses as diverse as polio, spinal cord injuries, traumatic brain injuries, multiple sclerosis, and more- too diffuse to approach CMS with one strong voice to appeal for reasonable reimbursement for the stance control devices they need. "The noise level is much lower," he notes, "There has not been the consumer drive to push CMS to validate that there is a need."

Michael agrees. "The problem with the group who can benefit from stance control orthoses is that they have multiple diagnoses, and it's only a small number of people within each diagnostic cohort who require this care, so there's not a natural affinity group that would speak with one voice-and that's probably the piece that's missing. The field has done a very good job of asserting their views, but without the support from an independent consumer group, it's really hard to have your voice heard. It's assumed to be self-serving-even though it's not."

The Education Barrier

Bedard identifies stance control technology as somewhat of an outlier technology. "NCOPE [National Commission on Orthotic and Prosthetic Education] does not require stance control content within the schools as part of their accreditation. Nor does NCOPE require any stance control task to be completed to satisfy your orthotic residency. The ABC [American Board for Certification in Orthotics, Prosthetics and Pedorthics] does not have questions that deal with stance control on the orthotics boards to become a certified practitioner."

If stance control is thus slighted within the orthotics profession, how much less likely are other members of the rehabilitation team-physical medicine and rehabilitation residents and physical therapy students-to have had exposure to stance control technology, he wonders.

Bedard describes the shock experienced by a residency student pursuing a study on SCOs who encountered unexpected push-back from practitioners who resisted using the technology, even when clinically appropriate. "We trained a lot of people on stance control, but I still think that a lot of good practitioners don't truly understand it well enough to offer it and-sad to say- you can put patients in a more conventional KAFO and have a lot less fitting issues, and a lot less hassles with third-party payers trying to get paid for it."

Weber's study illuminates the information deficit that inhibits practitioners. "It was telling to me that 68 percent of the respondents, [when] asked why they chose stance control technology, answered 'because it was the clinician's preference', and 13 percent cited price, reimbursement, or insurance coverage as reasons why they stopped using SCOs. Only 2 percent cited that it was a patient issue-that the patient decided to stop using it.

"From an industry standpoint, it appears to be the clinician's task to make sure they do due diligence in identifying successful candidates before, and staying with them afterward," Weber says.

Clark points out the human tendency to gravitate toward the familiar. "And if we don't repeat a task often, the tendency can be to readopt earlier habits. Many people go back to locking the knee as they did before stance control. And the doctors that are referring them may not always be aware that the technology is out there. It's still a struggle."

Although reimbursement improved somewhat with the awarding of the L-Code, our profession has a long memory, Clark notes, and practitioners remember the previous poor reimbursement rate, he believes. Snell agrees that longtime habits can be hard to break, and stresses the importance of educating physicians who lack specific training in SCO, and encouraging practitioners to pursue new and potentially better solutions for their patients.

Identifying SCO Candidates

"We need to readjust our thinking for orthoses," Weber recommends, "and find better ways to identify and prequalify patients for specific devices in order to achieve successful outcomes. As technology improves and advances, we need to take far more time in developing a treatment protocol."

Patients should be evaluated based on function and individual presentation rather than on diagnosis, he notes, and likewise treated for function rather than only for safety or stability.

"We [Hanger Clinic's National Orthotics Program] are collecting data and developing a qualification and training program now, using validated measures and techniques, as well as working with a number of universities around the country; [and] piggybacking on some of their data, using all of the composite materials and thermoplastic properties so that we can match patients based on their muscle strength, range of motion, and previous experience with an orthosis containing appropriate functional capabilities," Weber says.

arms with thumbs up

Hillen describes polio patients who were diagnosed at age four and have worn locked KAFOs for more than 50 years who are now learning to walk using stance control devices or even C-Braces. "Patients must have some coordination, however, and must be mentally ready to take on the challenge of physical therapy, too.

"We're not fixed on diagnosis; we're focused on how the patient is presenting, and for the patient who presents with significant leg weakness or flaccidity but is able to reciprocate- meaning they are able to swing the leg on their own through their hips or trunk muscles-we're identifying those patients as good candidates. And there's a ton of those patients out there."

Judith Philipps Otto is a freelance writer who has assisted with marketing and public relations for various clients in the O&P profession. She has been a newspaper writer and editor and has won national and international awards as a broadcast writer-producer.