Category III Codes

Category III CPT codes are temporary tracking codes and their presence does not establish that a procedure is safe, effective, or covered by Medicare. Coverage requires that the service be reasonable and necessary as determined by A/B MACs, devices be approved for FDA marketing (including 510(k) clearance) or be provided within qualifying clinical trials per NCD 310.1 or under an FDA IDE trial; services that are experimental, not medically necessary, or not meeting accepted standards are noncovered.

"Procedures using devices that have been approved for marketing by the FDA (including 510(k) cleared devices) may be considered for Medicare coverage when the service is reasonable and necessary to ..."

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