Back to library
CARC Code Reference

CARC 188: This product/procedure is only covered when used according to FDA recommendations.

This product/procedure is only covered when used according to FDA recommendations.

Group code CO, PI or PR
Category Medical Necessity
Risk level High
Appealable Yes

Common RARC pairings

RARCs (Remittance Advice Remark Codes) provide the specific reason detail alongside CARC 188 on the 835 electronic remittance. These are the RARCs seen most often with this CARC.

RARCMeaning
M61 We cannot pay for this as the approval period for the FDA clinical trial has expired.
M102 Service not performed on equipment approved by the FDA for this purpose.
N386 This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. Visit CMS.gov and search for Medicare Coverage Database to find a copy of the policy.
N415 This service is allowed 1 time in an 18-month period.

See the full resolution workflow for CARC 188

Members of the EDI-Code Intelligence Lab get the step-by-step rework path, appeal language, root-cause drivers, and prevention checklist for every CARC and RARC pairing, plus payer-specific quirks.

Open in EDI Lab