Medicare Claims Processing Manual (Pub. 100-04), Ch. 32 § 69.3
Medical Records Documentation Requirements
69.3 - Medical Records Documentation Requirements
(Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A)
The billing provider must include in the beneficiary's medical record the following information: trial name, sponsor,
and sponsor-assigned protocol number. This information does not need to be submitted with the claim but must be
provided if requested for medical review.