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M61 Remark Code: FDA Clinical Trial Approval Expired

M61 means the payer denied the service because the approval period for the FDA clinical trial it belongs to had expired on the date of service. Coverage tied to that trial is no longer available.

Quick facts

Code
M61 (RARC M61)
Status
Active In use since January 1, 1997.
Code set
Remittance Advice Remark Codes (RARC)
Group codes
  • CO (Contractual Obligation): The provider absorbs the amount unless the patient was properly informed in advance and agreed to pay.
  • PR (Patient Responsibility): The patient may be responsible where a valid advance notice or trial consent covering payment was signed.
Official description
We cannot pay for this as the approval period for the FDA clinical trial has expired.
X12 Remittance Advice Remark Codes, retrieved September 25, 2026
Last verified
against the official X12 list.

What M61 means

Some investigational devices and services are covered only while the associated FDA-approved clinical trial is within its approval period. M61 says the payer checked the trial dates and found the approval had ended before the date of service. The service is therefore not payable under that trial.

It is a Medicare-rooted remark, typically seen by hospitals and physicians participating in device studies.

Common causes

  • The trial approval expired and the research team did not update billing.
  • The payer’s records do not reflect an extension or amendment.
  • The claim listed an outdated trial or device exemption number.
  • The service was performed after the patient’s participation period ended.

What to do

  1. Contact the research office or sponsor for the current approval status and dates.
  2. If an extension exists, provide the documentation and ask the payer to reprocess or file an appeal.
  3. If the approval expired, determine whether any other coverage applies to the service, and review the patient’s consent terms.
  4. Correct the trial or exemption number if the wrong one was reported, and submit a corrected claim with resubmission code 7.

How to prevent it

Keep a research billing calendar that lists each trial’s approval dates, and route research encounters through a review before billing. For more on eligibility-driven denials, see eligibility and COB denials.

Codes that may appear with M61

  • CO-96 (Non-covered charge(s).): The service is non-covered because the trial approval lapsed.
  • CO-B7 (This provider was not certified/eligible to be paid for this procedure/service on this date of service.): The provider or study was not eligible to be paid for the service on this date.
  • MA50 (Missing/incomplete/invalid Investigational Device Exemption number or Clinical Trial number.): The investigational device exemption or clinical trial number is missing or invalid.
  • MA97 (Missing/incomplete/invalid Medicare Managed Care Demonstration contract number or clinical trial registry number.): The clinical trial registry number or demonstration contract number is missing or invalid.
  • CO-96 (Non-covered charge(s).): The non-covered reason code usually paired with M61.

M61 FAQ

How do I confirm the trial's approval dates?

Ask the study sponsor or research office for the FDA approval and any payer approval dates, and compare them with the date of service.

Can routine costs in the trial still be covered?

Routine care costs may have separate coverage rules. M61 specifically says the trial approval period no longer supports payment for this service.

What if the approval was extended?

Send documentation of the extension to the payer and request reprocessing.