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M102 Remark Code: Equipment Not FDA-Approved for Use

M102 means the payer denied the service because it was not performed on equipment the FDA approved for that purpose. Coverage depends on the device being cleared or approved for the specific use billed.

Quick facts

Code
M102 (RARC M102)
Status
Active In use since January 1, 1997.
Code set
Remittance Advice Remark Codes (RARC)
Group codes
  • CO (Contractual Obligation): The service is denied under coverage rules and is a provider write-off unless the patient agreed in advance to pay.
  • PR (Patient Responsibility): The patient is responsible, typically only with a valid advance notice.
Official description
Service not performed on equipment approved by the FDA for this purpose.
X12 Remittance Advice Remark Codes, retrieved September 25, 2026
Last verified
against the official X12 list.

What M102 means

Many coverage policies require that a service be performed with a device the U.S. Food and Drug Administration has approved or cleared for that particular use. M102 tells you that the payer believes your equipment did not meet this requirement for the service billed. The service itself might be covered if performed on qualifying equipment.

The phrase for this purpose is important. A device may be cleared for one indication and still fail this rule when used for another.

Common causes

  • Using a device for an indication outside its FDA-cleared uses.
  • Equipment that is investigational or awaiting clearance.
  • A payer requirement to report device information that was not included, so the payer assumed non-qualifying equipment.
  • Billing a code that implies a specific technology when a different device was used.

How to fix it

  1. Identify the device used: manufacturer, model, and version.
  2. Check its FDA clearance or approval and the intended uses listed.
  3. If it qualifies, send a reconsideration or appeal with the documentation and any device identifiers the payer requires.
  4. If it does not qualify, write off the service or bill the patient only when a proper advance notice was signed.
  5. Review coding to make sure the code billed matches the technology used.

How to prevent it

  • Keep FDA clearance documentation for key equipment on file.
  • Review coverage policies before introducing new devices or new uses.
  • Obtain advance notices for services that may not meet equipment requirements.

Codes that may appear with M102

  • CO-114 (Procedure/product not approved by the Food and Drug Administration.): The procedure or product is not approved by the FDA.
  • CO-96 (Non-covered charge(s).): Non-covered charge, with M102 explaining that the equipment did not qualify.
  • CO-50 (These are non-covered services because this is not deemed a 'medical necessity' by the payer.): The payer considers the service not reasonable and necessary as performed.
  • N386 (This decision was based on a National Coverage Determination (NCD).): The decision was based on a National Coverage Determination that may set equipment requirements.
  • N115 (This decision was based on a Local Coverage Determination (LCD).): The decision was based on a Local Coverage Determination.

M102 FAQ

Does M102 mean my equipment is illegal to use?

No. It means the payer's coverage requires equipment approved or cleared for the specific purpose billed. The legal status of the device is a separate question.

How can I show the equipment qualifies?

Provide the device manufacturer, model, and its FDA clearance or approval information for the intended use. Manufacturers often supply this documentation.

Can the patient be billed?

Only if they were informed in advance and agreed to pay, following the payer's notice rules.