Billing and Coding: MolDX: Category B IDE Studies

This policy provides billing and coding requirements for MolDX Category B IDE studies: routine care and IDE device-related services must be billed with the appropriate CPT and ICD-10-CM codes, and one unit of service (1 UOS) per CPT. Claims must include the clinical trial number (and IDE number for device-related services) in EDI Loop 2300 and the appropriate DEX Z-code adjacent to the CPT code in the specified Part A/Part B electronic or paper claim fields.

"Routine care services related to an Investigational Device Exemption (IDE) clinical trial may be billed when the appropriate CPT code is submitted with 1 unit of service, the clinical trial number ..."

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