A serial entrepreneur launching a weight-bearing CT scanning device to better diagnose foot and ankle problems that received 510(k) clearance from the U.S. Food and Drug Administration earlier this year is finding that it can be tough to balance innovation with the challenge of reimbursement.
Arun Singh is the CEO of Curve Beam, whose lead product pedCAT got 510(k) clearance in April, three years after he launched the bootstrapped company in Warrington, Pennsylvania, where the device is manufactured.
The pedCAT uses cone beam computed tomography to generate three dimensional images of the foot and ankle. It is based on the technology used for i-CAT Cone Beam, a 3-D dental imaging system. He developed that technology at Imaging Sciences International in Hatfield, Pennsylvania, which was acquired by Danaher Corp. in 2007.
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One of the strengths of the device, claims Singh, is it shows bones and the ankle in alignment because patients are standing when their feet are scanned. It also takes less time — 20 seconds compared with 30 minutes with a standing MRI, which is better suited to taking images of soft tissue and ligaments, Singh said in a phone interview with MedCity News.
The goal is to show the true physiological conditions of the foot to allow for a more accurate diagnosis and to aid presurgical planning and to avoid repeating surgeries because of an improperly placed screw in the ankle, said Singh. He added the company sees an opening for the device with foot problems associated with complications from diabetes and for arthritic conditions. A version of the device for hands and elbows is also in the works.
Radiation concerns
Cone beam CT scans have come under some criticism, particularly regarding their use by dentists and orthodontists performing these scans on children since they give a bigger dose of radiation than a traditional X-ray. But Singh said the radiation dose is significantly lower than a scan of the same region taken by a medical CT scan, and is only slightly higher than a plain X-ray. He points out that the company advocates that physicians order a pedCAT scan only if merited, like if the 2D X-ray comes back inconclusive. He added that the company also has supported proposed guidance by the FDA that would require stricter labeling for pediatric use.
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Reimbursement challenges
As with many new technologies, reimbursement is a vexing problem and it’s CurveBeam’s biggest challenge for getting pedCAT into the offices of orthopedic surgeons and podiatrists. It has hired a CT reimbursement expert to assemble tip sheets for medical professionals to help guide them on the best ways to submit a claim. But Medicare reimbursement poses an even bigger challenge. As of the start of the year, Medicare requires a device is “accredited before it will reimburse scans. United Healthcare has also adopted this guideline.
As part of the accreditation guidelines, physicians are required to interpret the scans and a radiology technician is required to act as the operator of the device. CurveBeam’s target market includes podiatrists.
A study by David W. Lee of GE Healthcare, and Frank Levy of the Massachusetts Institute of Technology in Boston found that a prior authorization requirement has slowed down the number of CT imaging scans being requested. The physician’s order of a non-emergency study has to comply with the radiology benefit manager’s guidelines before an imaging study can be considered reimbursable. If it doesn’t, the physician has to justify why the guidelines should not apply or risk losing insurance reimbursement.
“We are working with accreditation bodies and national medical organizations to create an accreditation pathway tailored for cone beam CT devices,” Singh said.
