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CON Frowns On Dental CT Scanners
WHITE CLOUD — John Schondelmayer is one of a handful of dentists in Newaygo County’s White Cloud, which has 1,420 residents, more than 20 percent subsisting in poverty, according to Census 2000.
This quiet West Michigan town might be an unlikely incubator for the latest gizmo in dentistry, but Schondelmayer became one of the first in Michigan to acquire a miniature CT scanner and soon found himself running afoul of state authorities because of it.
“I stepped on toes and I didn’t know I was doing it,” rued Schondelmayer.
With the development of small-scale computerized axial tomography scanners, the Certificate of Need Commission — the state’s overseer of growth for medical facilities — has decided to regulate a piece of dental equipment for the first time. New standards for the scanners went into effect in December, said Larry Horvath, manager for the Certificate of Need review section.
Horvath said the public health code states that CT scanners are covered by the Certificate of Need process, no matter who is operating the equipment. But standards in Michigan, one of 36 states using a CON process, addressed only the full-body scanners used in hospitals. For example, standards required a minimum annual volume of 7,500 scans, a threshold a dental practice would find difficult to meet.
“The question arose to the commission … that just the sheer volume that a dentist would do compared to radiologists — there’s probably a distinct difference,” Horvath said. But a variety of voices at a 2006 public hearing united on one point, he said. “They said we really need to address these standards.”
As of December, the CON Commission had approved just one dental scanner, for the University of Michigan Dental School, according to the CON Web site. Eight additional applications are pending, including one from Chad Seabold, DDS, in Kalamazoo and practitioners in Traverse City, Gaylord, Jackson, three in the Detroit area, and a second request from U-M.
Schondelmayer is running his scanner under provisional CON permission, but his request starts with the Grand Rapids-based Alliance for Health, which reviews CON requests in West Michigan before they move on to Lansing.
Many people are familiar with hospital-based CT scanners, which require the prone patient to enter a tunnel-like device that creates three-dimensional images of the internal structures of the body. The cost of these full-size scanners can run hospitals as much as $2 million.
Now several manufacturers are offering miniature versions based on a slightly different technology called cone-beam radiation. These units cost about $200,000 or less, fit into smaller rooms, emit less radiation, and provide a more accurate view, particularly for procedures such as implants that depend on millimeters. Several models were developed by U-M researchers who spun off a company called Xoran Technologies in Ann Arbor.
These small-scale units are being marketed to medical specialists such as ear, nose and throat doctors, emergency rooms and orthopedists, as well as to dentists. For some of the models, patients simply sit in a chair surrounded by the machine. The model used in White Cloud still requires the patient to lie down, but the scanner is shaped more like a doughnut than a tunnel.
Schondelmayer said many of his patients are reluctant to see dental specialists for two reasons: They don’t like negotiating city traffic and they can’t bear the costs. So, he said, he is asked to perform a wider variety of procedures, including implants, than an urban dentist might.
Dental CT scans are particularly expensive, he said, and often patients bear them as out-of-pocket charges. He said one patient paid $2,000 for a dental CT scan, the services of the radiologist and other charges associated with having the imaging done at a hospital for a two-tooth implant.
Trained in implants in 2004 and 2005, Schondelmayer was impressed with the ability to precisely place them with help from the scanner’s image. Plus, the cost is less and patients are exposed to one-eighth to one-tenth of the exposure as a full-body CT scan.
“The imaging is fantastic. What you can do with it is unbelievable,” Schondelmayer said. “When I saw that, I knew that was the way to go.”
His charges for dental scans top out at $375, he said. He set up a separate company called Smart Beam to handle the business he thought he’d get from referrals, attended the manufacturer’s training program on how to use the scanner, and hoped that other local dentists and nearby doctors could use the $179,000 scanner he acquired in April 2006.
That’s when he ran into trouble.
“I didn’t know I had to comply with CON,” he said. “In the history of dentistry, there’s never been a case.”
The state halted Schondelmayer’s scans for four months before allowing him to do procedures, strictly for dental use, on a temporary basis. He said he expects to easily meet the CON threshold of performing a minimum of 200 dental scans per year, estimating 332 on his CON application to Alliance for Health. He said there’s little insurance coverage for the procedures. He said he paid a $1,500 filing fee, plus fees for a professional to fill out the paperwork. “It’s just the cost of doing business,” he said.
“It’s not as much the cost of the scan itself that we’re expecting to pay for the machine,” Schondelmayer said. “It’s the fact that we’ll make possible doing other surgeries.”
Schondelmayer said he’s hopeful that someday he’ll get the OK for medical use of his scanner, with those images then forwarded to a radiologist. But Michigan’s new CT scanner regulations currently prevent that use.
Alliance for Health President Lody Zwarensteyn cautioned against inventing uses for small-scale CT scanners, driving up health costs. “It’s one thing to say ‘I will use it.’ It’s another to say ‘I need to use it in comparison to the other tools I have available.’”
Zwarensteyn also noted that entities operating full-size CT scanners, such as hospitals, shouldn’t become too reliant on the machines for income flow, which could be interrupted as other health professionals jump onto the small scanner bandwagon.
Horvath said the CON Commission this year will review standards for all CT scanners and has invited input from the public. The commission intends to empanel a New Technology Review Committee this year, which will look at the impact in Michigan of new medical devices winding through the federal Food and Drug Administration process, Horvath said.
Richard Panek, DDS, an oral and maxillofacial specialist in Rockford, said he’s considering whether a small CT scanner would benefit his practice. While he doesn’t expect that general practice dentists will add CT scanners any time soon, specialists will be interested in its high-quality images, he said.
“Within 10 years it will become common in surgical specialist offices that are busy. The only thing limiting it, other than CON, is cost,” Panek said. “Dentists in West Michigan are very conservative to embrace new technology.”