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Competing for the Sports Brace Market

By Deborah Conn

Back in the "old days," fitting off-the-shelf soft goods--splints, back braces, and the like--was the sole purview of orthotists.  "I've been in this profession for 37 years," says David Wegner, CPO, FAAOP, "and when I started, all those devices would go through an O&P facility."

Wegner, whose facility, Achilles Prosthetics and Orthotics, is located in Bakersfield, Calif., realizes that times have changed.  These days, you'll find orthopedic technicians, physical therapists, manufacturers' representatives, and others fitting patients with off-the-shelf orthoses, particuarly sports braces.

Is this a bad thing?  Does it compromise quality of care or simply make some kinds of care more accessible to patients?  Should orthotists fear enroachment
or simly focus on their core business of custom devices?

The answer to these questions, of course, depend on whom you ask.

A growing market
Off-the-shelf sports braces are available for just about every body part. “Anything you can hurt, we can brace,” says Brian Moore, director of athletics and PT business, with DJO, Inc., a medical device company based in Vista, Calif. DJO leads the market in non-operative orthopedic products.

Anecdotally, at least, the market for off-the-shelf bracing (as well as custom bracing) appears to be growing. “We see more and more prescriptions for off-the-shelf knee braces,” says Wegner.

In fact, the most common type of sports bracing by far is for the knee. Wegner estimates that knee braces account for as much as 80 to 85 percent of the off-the-shelf market. According to Daniel Minert, CO, of Kensington Valley Orthotic and Sports Services in Brighton, Mich., such knee orthoses are designed to prevent hyperextension, assist in giving proprioceptive feedback, and provide some control over rotation.

Other off-the-shelf products include ankle braces, which are designed to provide medial lateral stability where there may be muscle weakness or ligament instability.

Upper-limb elbow braces help control hyperextension and rotation.

Wrist orthoses, says Minert, are frequently used for protection in sports and are often found in sports specialty stores. “A bowling shop would carry wrist supports; skateboard shops would have special wrist protection for those who skate,” he says.

Who’s fitting the braces?
No one is debating the fact that certified orthotists are getting a lot of competition.

In fact, many manufacturing companies have sales representatives who fit their products on patients.

DJO’s Brian Moore says, “Our knee braces, both off-the-shelf and custom, are prescribed products. If the doctor chooses to dispense them in the office, our representative will go to the office and handle the service piece. All our representatives are certified as brace fitters as part of their training, and many are licensed athletic trainers.”

Both the American Board for Certification in Orthotics and Prosthetics (ABC) and the Board for Certification in Orthotics and Prosthetics (BOC) offer certification as orthotic fitters.

“When it comes to routine patients, those with proportional leg sizing and no other clinical complications other than a post-surgical ACL repair, fitting an off-the-shelf knee brace is a pretty straightforward process,” says Rick Riley, CEO of Townsend Design in Bakersfield, Calif.

“While we prefer orthotists to fit our braces, most manufacturers today feel their off-the-shelf knee braces can be adequately fit by trained representatives and orthotic fitters. For custom braces and complicated patients—[those with] post-polio [syndrome], no quadriceps muscle [or] gait challenges—it is evident that a rigorously trained orthotist is better positioned to assess the patient’s mobility challenges than someone who has just taken a fitter’s course.”
 
Some say, “Orthotists only!”
Consultant Peggy Kime has been in the industry for more than 30 years, serving as national sales manager for several medical products companies and now as a consultant and exhibits manager at AliMed, in Dedham, Mass. “I think it depends on the brace,” she says. “Anyone can fit something as simple as a stirrup brace for an ankle. But a more complicated functional knee brace cannot be fit properly by anyone other than an orthotist.

“I’ve been in some offices where doctors say, ‘Brace it,’ and give it to the orthopedic technician to choose the correct brace. Certainly that’s wrong. An orthotist should be doing that.”

Patrick Spenlau of Truform OTC Orthotics and Prosthetics, a division of Cincinnati’s Surgical Appliance Industries, says, “We sell to a network of dealers—O&P facilities, pharmacies, home medical companies, a whole gamut of medical supply companies. Our representatives don’t do any fitting; we sell to others who do the fitting.

“We offer in-depth, intensive training programs to our retail partners on both the scientific and practical aspects of fitting all sorts of off-the-shelf orthoses and health supports. In fact, our program is a recognized prerequisite for certified orthotic fitter credentialing from both ABC and BOC.”

Training or not, many certified orthotists are concerned. “From the practitioner’s standpoint, we’ve invested a lot of time and energy getting credentials and knowing what is appropriate,” says George Boutross, CPO, vice president of American Prosthetics Inc., in Braintree, Mass. “That expertise is being diluted by individuals who want to make a quick buck.”

Jeffrey Roy has been involved in sports bracing for at least 10 years. His experience with non-orthotists fitting patients is that “it gives bracing a bad name. I’ve heard doctors say, ‘Those braces don’t work. I’ve tried them; people didn’t get any better.’ But,” says Roy, “it’s really a fit issue.”

“Representatives are specialists in their own brace,” says Fox, of Multi Sport Orthotics. “It’s not a question of whether they are competent. But even if you go through the company training, and you know how a particular brace works, do you know which brace a patient needs? I don’t believe there is one brace that will work with everyone.”

Fox, who is certified as an athletic trainer as well as an orthotist, combines his specialties to evaluate the patient’s needs. “I consider the patient’s occupation, lifestyle, sports, hobbies—all the demands—and decide along with the surgeon what we are trying to achieve. Then I can pick the best product for the patient.”

David Wegner says, “When you have representatives going into doctors’ offices and saying they can fit their products to patients, they are undermining O&P facilities with trained people who have years of education and experience under their belts.

“Furthermore, if a patient needs repair or adjustment, sometimes the representative is no longer to be found and the patient is sent to a facility like ours. Then we end up being asked to work on a device we didn’t even supply, and that’s a liability issue.”

Follow-up is a key issue for Roy, as well. “I challenge you to find a representative who covers three states to get back for a kid’s Friday night game when a strap comes off on Wednesday,” he says. “Or who has the resources to make a comfort adjustment, or more important, the biomechanical training on how to improve the function of a brace beyond what the engineers designed it for.”

DJO’s Moore disagrees. “We have great follow-up. No one wants bad information going back to the doctor. We want to handle that patient from beginning to end. We always follow up with a phone call, and we make sure the patient has our local representative’s business card if there are any questions.”
 
Others say, “Let it go.”
Not all certified practitioners agree that orthotists should be fitting all off-the-shelf devices. Kenneth Cornell, CO, FAAOP, of Cornell Orthotics and Prosthetics Inc. in Peabody, Mass., is one.

“The focus of orthotics has to be on core procedures—custom-made devices,” he says. “None of us went to school to put on a sling or a knee immobilizer. We’ve lost the off-the-shelf business anyway. We’re doing such a small percentage now, it’s not worth the fight. It’s not that we can’t provide those items, but we shouldn’t be restricting others from doing that work.”

Joe Sansone is CEO of TMC Orthopedic, LP, in Houston. His facility has employed orthotists and prosthetists certified by ABC and BOC, athletic trainers, registered nurses, and certified fitters and cast technicians. He says, “My opinion is that the majority of soft goods, such as arm slings and immobilizers, neoprene supports, ankles braces, etc., are being fitted in emergency rooms and physicians’ offices.

“The average patient goes to the emergency room and needs the product then and there. How can we accommodate the needs of the emergency room when a patient needs a brace right away? Their needs are not limited from nine to five.

“What about a patient who gets an arm cast in a doctor’s office? Should she go without an arm sling while she makes her way to an O&P facility? Or a patient with an ankle fracture who needs a fracture walker. Should he hobble over to our office to be fit? The physician needs to be concerned about liability.”

Sansone continues, “Patients typically spend over an hour in a doctor’s office waiting and being examined. Should they then spend another 30 minutes to an hour being treated in a CO’s office?

“Furthermore, as a business owner, I may not want one of my highly compensated, trained, licensed and certified practitioners fitting wrist splints all day. There may be a less expensive alternative such as a certified fitter or an athletic trainer who can apply items that are commonly available at your local pharmacy.”

What About a “Stock and Bill” Set-up?
A particularly contentious topic is the so-called “stock and bill” arrangement, also known as a consignment closet. This arrangement between a physician and a supplier, either a manufacturer or an O&P facility, can take several forms. One of the most common is for the physician to store off-the-shelf devices in the office. When a patient needs a brace, it will be fitted in the office by the physician, an orthotic fitter, an orthopedic tech, or a manufacturer’s representative. The physician notifies the supplier or O&P facility, which bills for the device.

According to Kathy Dodson, AOPA’s senior director of government affairs, these arrangements are fraught with problems (see “Consignment Closets: Are They Legal?” O&P Almanac, January 2006). “Medicare has not come out and said this is illegal, but the OIG [Office of the Inspector General] has listed it as a risk area,” she says.

One of the problems is that a stock-and-bill setup creates a climate ripe for abuse. Suppliers may “rent” space from the physician to store their devices. If so, Dodson said, it has to be fair market value for the space used. “They can’t pay $10,000 for two feet of shelving.”

And according to Sansone, some suppliers have been known to give physicians free products, calling it “shrinkage.” He bluntly calls it inducement.

But even when there is no financial reward, says Dodson, “there’s always the appearance that the O&P facility or manufacturer’s representative is doing a favor for the doctor. Maybe that doctor is giving all referrals back to that supplier. This may or may not be going on, but it is a gray area.”

Dodson has a personal concern as well. “When the facility or representative bills Medicare, they are representing that they have provided treatment and follow-up on that patient, when they’ve never even seen the patient. This is too close to false billing for my comfort level, even if Medicare hasn’t prohibited it.”

Joe Sansone of TMC Orthopedic has more than 90 stock-and-bill programs in the Houston area. He believes that consignment closets can be established within the confines of federal regulations as long as you take precautions, and he advises working with a knowledgeable healthcare attorney when setting up such arrangements.

He said, “I just don’t pay rent. I never give anything away for free. I never give advice or free consultation. And I avoid the increasingly popular programs wherein stock-and-bill arrangements are bundled with other ‘creative’ programs, such as teaching the doctor how to bill, billing directly for the physician and/or collecting a percentage.

“Many dissenters feel that patient care is sacrificed with stock-and-bill programs, but we have delivered over 50,000 products throughout the years, and we have yet to hear from one doctor or one patient about a bad outcome.”
 
Adjusting to fit the market
If many orthotists are worried about encroachment by manufacturers’ representatives and others, what can they do?

“I think it’s wrong to take the approach of trying to legislate,” says Jeffrey Roy. “Even on a small scale, that tends to backfire because people get territorial. My approach has been to consistently show PTs, for example, that they don’t want to spend their time doing this, and I can do a better job.

“I don’t know any PTs who want to be tinkering with this stuff. Not only do their patients come out ahead of the game, I develop a better working relationship with the therapists.”

Nurturing professional relationships is working for Daniel Minert as well, although his are with the manufacturers as well as physicians. “My approach is not to be negative about anyone’s orthosis. I have a good reputation among the representatives in this area. So these people feel I am a source of business, and they send their patients to me.”

To Sansone, the issue is being able to meet the needs of patients. “The obvious evidence of our inability to do so is the proliferation of stock-and-bill programs. If, as practitioners, we were doing our job and making it easy, quick, and convenient for physicians to use us, they would be doing so,” he says.

Sansone believes that to eliminate confusion, the profession must identify which devices need to be fit by a certified practitioner. “Some are obvious,” he says.

“Functional knee braces, post-operative knee braces, and off-the-shelf rigid LSOs should be fit by certified orthotists. Items you can buy at the local pharmacy, like neoprene supports, wrist braces, etc. do not.

“After classifications have been developed for the different products then practitioners as well as other providers will have a set of rules to live by. In such a manner it would then be easier for practitioners and business owners to make decisions about the level of care they would like to offer.”
 
Deborah Conn is a freelance writer based in Falls Chuch, Va.


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