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What are the medical record documentation requirements for participants in clinical trials?

Consistent with Medicare Claims Processing Manual, Chapter 32, §69.3, if a patient is involved in a clinical trial, Medicare requires the following information be recorded in the beneficiary’s medical record:

  • Trial Name
  • Sponsor’s Name
  • Sponsor Assigned Protocol Number

Currently Medicare does not require this information to be submitted with the claim, but must be provided if requested during a medical review.  This detailed information need only be documented once in the patient’s medical record, however each visit associated with this clinical trial must be clearly identified as such.

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