US · guidance
CMS Pub. 100-04, ch. 32, § 100.1.2
Special Billing Requirements for A/B MACs (A) for Inpatient Billing
• The second or subsequent diagnosis code must be ICD-10-CM Z00.6 (Encounter for exam for normal
comparison and control in clinical research program). These diagnoses alert the claims processing
system that this is a clinical trial.
• For patients in an FDA-approved category B IDE clinical trial the -Q0 modifier must be reported with
the cochlear implantation device and all other related costs or; (see note below)
• For patients in an approved clinical trial under the clinical trial policy the -Q1 modifier must be billed
for routine costs and not for the device itself
NOTE: The -Q0/-Q1 modifiers do not need to be applied to these services (92601-92604, 92507 & 92521-
92524).
History
(Rev. 11875; Issued:02-23-23; Effective: 09-26-22; Implementation: 03-24-23)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
a0d5ce167312c0d9e7b1f57a4aaa664d9be33d36016f689ddc23845ad30ecd04
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