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www.fdanews.com/articles/132358-innovative-devicemakers-struggle-to-get-their-devices-reimbursed

Innovative Devicemakers Struggle to Get Their Devices Reimbursed

December 3, 2010
Small startup device companies are finding that getting FDA clearance or approval is only half the challenge. A growing hurdle is getting a new device reimbursed, Michael Beebe, reimbursement practice leader at Hillco Health, said, as more products are receiving Category III billing codes from the American Medical Association’s Current Procedural Terminology (CPT) editorial panel. A Category III means the device probably won’t be reimbursed by insurers or the Centers for Medicare & Medicaid Services, according to Beebe, a former director of the CPT panel.
Devices & Diagnostics Letter