By Marique Newell

Revolutionary. Innovative. One of the greatest advancements in modern-day orthotics. Those in the O&P field don’t hesitate to use these terms when talking about the stance control knee orthosis.

    “Everyone always wanted a brace that would lock and unlock without user manipulation and would allow a patient to walk normally,” Joe McTernan, AOPA’s assistant director of reimbursement services, said based on his discussions with AOPA members. “The stance control orthosis basically [took] 50 years of what everyone knew about long-leg bracing and turned it upside down.”
    “The stance control orthosis was revolutionary when it came out,” agreed Mitchell Dobson, CPO, of Hanger Orthopedic Group Inc., based in Bethesda, Md. “It allowed for devices to be stable or under control during stance phase, but then release and swing during swing phase.”
    In 2002, major O&P manufacturers across the country began introducing various stance control devices, one by one. Since then, the O&P field has eagerly embraced the novel technology, fought for its L code and treated hundreds of patients with various stance control devices.
    And, as happens with a new product, theory or way of practice, challenges—in both design and reimbursement—still remain for those practitioners and patients.

History 101
    This great technological achievement was first introduced in Sweden around 1960. Then, in March 1995, Nils Van Leerdam, of Ambroise, Holland, released the first reliable stance control brace, the UTX.
    The UTX made its way into the U.S. market through Orthocraft in New York in the late 1990s and through Becker Orthopedic Appliance Co., in Troy, Michigan, in 2002.
    Then Horton’s Technology, in Little Rock, Ark., drew major industry attention when the company debuted its first stance control device, the Horton, at the Academy’s 2002 Annual Meeting & Scientific Symposium.
    “Everybody was ecstatic about it,” recalled Gary Horton, CO, FAAOP, president of Horton’s Technology. “At that first educational course in Orlando in 2002, they had to take all the tables out and bring extra chairs in to get everyone into the room. They finally had to stop letting people in. It was an exciting time.”
    Soon after, Becker began promoting the UTX and launched the E-Knee, the first microprocessor-controlled KAFO.
Fillauer Inc., in Chattanooga, Tenn., and Otto Bock HealthCare, in Minneapolis, quickly followed suit and released their own stance control orthoses, each similar but with slight differences. Fillauer released the Swing Phase Lock knee, with three modes of control, and Otto Bock released the Free Walk Stance Control Knee/Ankle System.
    Now, not only did practitioners and patients finally have stance control technology available to them, but they also had a variety of quality devices.

Reimbursement woes
    From the moment stance control orthoses were introduced, no one questioned that the devices vastly improved the quality of life for most patients. Horton and Dobson said patients commented on their ability to be more active and walk more normally.
    However, manufacturers and practitioners immediately saw that stance control orthoses were costlier to manufacture than traditional KAFOs, requiring more time, effort and resources. The devices were also more difficult for practitioners to fit.
    And so, the quest for a device-specific L code began almost as soon as they hit the market in 2002.

L code applications
    “We, meaning the four manufacturers, each submitted our own L code applications,” explained Horton. “We did talk at one time of doing a joint L code, but there are enough differences between our products that we decided we’d each do our own.”
    The companies—Horton’s, Becker, Fillauer and Otto Bock—submitted the applications in early 2003. When the new codes were released in 2004, the O&P field discovered that the Centers for Medicare and Medicaid (CMS) had simply changed the L 2405 code for the drop lock knee to include the stance control orthosis.
    “This was a huge error,” Dobson noted. “All the manufacturers, as well as AOPA, were up in arms.”
    “The denial stems from the initial lack of documented clinical evidence showing the wonderful benefits these braces gave to patients,” explained Jonathan Naft, CPO, of Geauga Rehabilitation Engineering Inc., Chardon, Ohio. “CMS has a rationale that in order to grant a code, substantial units of the device must have been sold to justify CMS’s need to issue a new code.”
    McTernan pointed out that this rationale is a catch-22. “In order to get an L code, you need to sell numerous devices. But people won’t buy because they can’t get reimbursed.”
And so, with the help of AOPA staff, Becker, Horton’s, Fillauer and Otto Bock decided to pool their resources and work together to mend CMS’s mistake.
    “In early January 2004, we all jointly went to CMS and each took a sample of our orthosis to convince them to look at the concept, because at first they were saying it was no different than a drop lock,” Horton recalled. “We went to make the point of what these new knee joints were doing.”
    “AOPA was able to work with manufacturers, clinicians and CMS staff to review the need for a stance control device,” Naft added.
    The extra efforts worked. In January 2005, when the new codes were released, the stance control orthosis had its own L code: L 2005.  
    “I felt like it was a very cooperative effort between the four manufacturers and AOPA to get a unified stance control orthosis code,” said Dobson.

New code still needed
    Although the manufacturers were victorious in obtaining a code specifically for stance control devices, Horton believes the code still restricts the ability of the practitioner to customize the brace.
    “It’s a very generic type L code, which is bad news for our profession,” he said. “The code they came out with is a stance control KAFO brace, using any material, any component, meaning no matter what you put on that device, you’re going to get reimbursed at one price.”
    He noted that having just one code doesn’t reflect the extra time, money and resources needed to produce and fit a stance control orthosis properly.
    “Some patients need a free ankle and some need an ankle assist,” Horton said. “Regardless, you have more time in fabrication and more time in fitting, and based on all of that extra time, the reimbursement is still not high enough.”
    Naft agreed new codes are still needed, primarily because he believes many patients require the computer-controlled E-Knee instead of a mechanical system.

Dollars and treatment
decisions
    Although the reimbursement may not be high enough yet, as soon as the stance control devices received an L code last year, the companies producing the devices noticed an immediate spike in sales. Since somewhat adequate reimbursement rates were in place, practitioners were able to recommend the devices more readily, without the worry of exorbitant out-of-pocket expenses.
    “In a perfect world, reimbursement would never drive treatment decisions,” said McTernan. “But, in a world of business where it’s a matter of getting reimbursed for a device containing less technology or not getting reimbursed for a device with more technology—and both devices will provide the patient with good ambulation—then, yes, reimbursement does drive treatment.”
    “Reimbursement does drive O&P treatment, specifically, in the context of new technology,” Dobson, who is also a clinical presenter at AOPA’s Coding and Billing seminar and has been a member of the coding committee for the past three years, added. “I base this assessment on questions posed during AOPA’s Coding and Billing seminars. Practitioners are leery to provide new technology services under an unlisted code. But this hesitancy can be seen as a protection for Medicare, which doesn’t want to pay for something until the services and efficacy of that product are proven. And, in a capitalistic society, people provide services for money. That’s the nature of [free-market] health care.”
    Naft agreed. “Health care is costly, and it is unfortunate that we are often unable to fit a patient with a clinically indicated device because proper funding is not available.”
    Horton noted the effect of changing reimbursement rates over the years. He said that in the past, practitioners could be more flexible with payments because reimbursements were higher.
    “I want to give the best to the patient that I can, but I have to do it within what reimbursement I’m being paid,” he said.

Different devices
    Naft explained how the various products differ.
    All stance control devices on the market today, he said, can be categorized into weight-activated or gait-activated. Weight-activated devices use floor reaction with the patient’s weighting of the limb to lock the otherwise unstable knee. Gait-activated devices require the patient to specifically position his or her leg relative to the gait cycle to achieve knee stability.  
    “Currently, the Horton and Becker E-Knee are weight-activated devices,” Naft said. “The UTX, Free Walk and SPL are gait-activated.”
    Steve Hughes, Fillauer’s director of custom fabrication, pointed out that Fillauer’s SPL is the only device on the market that works off a pendulum system, whereas the other stance control devices work off of a cable or weight-bearing system.
    “The SPL doesn’t require a foot section, so it can be fabricated as just a knee orthosis,” Hughes explained. “It also includes three different modes of functioning.”
    “When a practitioner is making a determination on a SCO, they should review the advantages and disadvantages and the patient’s criteria to determine which SCO they should be using,” explained Dobson. “There’s no one SCO that’s good for all patients.
    “Everyone has their favorite, but practitioners also know the limitations of that favorite and know it won’t work on all patients,” he continued. “That’s the beauty of the stance control options out there—you have so many more patients that you can treat than if we just had one style.”

The patient perspective
    The praise for stance control orthoses rings loud and clear from the practitioners in the O&P field. But what do patients have to say?
    Hughes, Horton, Naft and Dobson all agreed that the majority of the feedback they receive from patients is extremely positive and encouraging.
    “By and large, the amount of success patients who are fit with the right device feel is amazing,” Dobson remarked. “It’s phenomenal. For most patients, it’s a quality-of-life benefit they haven’t had since the onset of their condition or need for a device.”
    Dobson noted that the stance control devices help with back and hip pain and help create the appearance of a natural, fluid gait, which is extremely important to patients.
    “It’s incredible how many patients tell me they like to look ‘normal,’” Horton said. “Our patients tell us that the device has changed their lives.”

Back to the drawing board
    Of course, after praise comes criticism. The most frequent complaint manufacturers and practitioners hear is that the devices are bulky and heavy.
    “The biggest issue we hear about is weight,” said Hughes. “The SPL is the slimmest joint on the market, but it’s made out of stainless steel. So, of course, it’s kind of heavy, even though it’s just under a pound.”
Horton also hears the size complaint from patients.
    “I’d like to do exactly what people tell me and downsize it, make it the size of a quarter,” he said. “Maybe with the newer composite materials that are coming out, we might be able to change the size.”
    Despite areas needing improvement, practitioners and patients have responded enthusiastically and gratefully to this technology. No one questions that stance control orthoses have virtually changed orthotic care.
    “The engineering of stance control devices is a true innovation in orthotic management,” McTernan said. “It’s one of those things that comes along and literally changes everything.”  

Marique Newell is the associate editor for the O&P Almanac.