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Bone healing stimulator gets expanded Medicare coverage
Smith & Nephew's Exogen system now reimbursed for all fracture nonunion cases.
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The U.S. Centers for Medicare and Medicaid Services has expanded Medicare coverage for the Exogen bone healing system, according to a press release from Smith & Nephew, makers of the device.
Since 2000, Medicare has reimbursed the use of the Exogen system only for nonunion cases following surgical repair. Under the new expanded coverage, Medicare will now reimburse for use of the device in all nonunion cases, regardless of whether the patient had undergone prior surgical repair, the company said.
“This decision opens up more options for patients and surgeons, providing a noninvasive alternative to surgical treatment,” Joe Woody, vice president and general manager of the clinical therapies division of Smith & Nephew, said in the release.
“We have worked closely with CMS, providing data from clinical studies and other scientific data that consistently demonstrated similar healing rates in patients with and without previous surgery, as well as economic analyses that highlighted the cost-effectiveness of Exogen,” he said.
The Exogen bone healing system delivers low-intensity pulsed ultrasound to a fracture site. It is the only FDA-approved ultrasound device for treating nonunion fractures and the only FDA-approved osteogenic bone stimulator indicated for accelerating the healing of fresh fractures, the company said.
Three clinical studies evaluating the system showed that the device, used daily for 20 minutes with no other change in treatment, significantly aided fracture healing irrespective of the fracture location or the type of orthopedic fracture management, according to the release.
Additional data published recently indicates that Exogen affects a range of cells important to the fracture healing process and that the system is more cost-effective than other bone stimulators, the company said.
For more information:
- The complete coverage decision by the U.S. Centers for Medicare and Medicaid Services can be accessed at: http://www.cms.hhs.gov/coverage/DM042605.pdf.