About this policy
The information in this article contains billing, coding or other guidelines that complement the conditions specified in the IDE regulations (42 CFR 405 Subpart B) and in the Medicare Coverage Related to Investigational Device Exemption (IDE) Studies Medicare Coverage Related to Investigational Device Exemption (IDE) Studies | CMS . To report a service, please submit the following claim information: For routine care for IDE related to the clinical trial Select CPT ® code Enter 1 unit of service (UOS) Enter clinical trial number in EDI Loop 2300 Enter the appropriate DEX Z-Code ® identifier adjacent to the CPT ® code in the comment/narrative field for the following Part B claim field/types: Loop 2400 or SV101-7 for the 5010A1 837P Box 19 for paper claim Enter the appropriate DEX Z-Code ® identifier adjacent to the CPT ® code in the comment/narrative field for the following Part A claim field/types: Line SV202-7 for 837I electronic claim Block 80 for the UB04 claim form Select the appropriate ICD-10-CM code For IDE device related to the clinical trial Select CPT ® code Enter 1 unit of service (UOS) Enter clinical trial and IDE number in EDI 837P, Loop 2300 Enter the appropriate DEX Z-Code ® identifier adjacent to the CPT ® code in the comment/narrative field for the following Part B claim field/types: Loop 2400 or SV101-7 for the 5010A1 837P Box 19 for paper claim Enter the appropriate DEX Z-Code ® identifier adjacent to the CPT ® code in the comment/narrative field for the following Part A claim field/types: Line SV202-7 for 837I electronic claim Block 80 for the UB04 claim form Select the appropriate ICD-10-CM code
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.