Drugs, Biologicals and Injections Documentation Requirements

It is expected that patient's medical records reflect the need for care/services provided. The listing of records is not all inclusive. Providers must ensure all necessary records are submitted to support services rendered. They may include:

Check
Brief Description
Correct Beneficiary and Date of Service
Relevant and/or current records from physician's office, e.g., procedure note, office notes, history and physical, labs, etc. as supporting documentation of medical necessity for service provided
Valid electronic physician and/or clinician signatures (If an Electronic Health Record [EHR] is used, the Electronic Order Signature Process should be submitted to verify provider's Electronic Ordering System is secure)
Physician or Non-Physician Practitioner (NPP) order for date(s) of service medication(s) was administered, including name of medication, dose, route of administration and frequency
Medication Administration Record (MAR) from date(s) of service that include name of medication(s), dose, route of administration and infusion start and stop times, if applicable
Physician or Non-Physician Practitioner (NPP) Order and/or Intent (*Note intent [i.e. progress notes] should be properly authenticated by ordering provider)
Diagnostic test results/reports, including imaging and/or laboratory reports, including those prior to claim date(s) of service if related, to support medical necessity and reason for medication administration, if applicable
Procedure/operative/anesthesia report, if applicable
Documentation to support indications and/or criteria as specified in a Local Coverage Determinations (LCDs), National Coverage Determinations (NCDs), or coverage article for service(s) billed, if applicable
Advance Beneficiary Notice of Noncoverage (ABN), if applicable
Completed Noridian Part B Signature Attestation Statement or Signature Log for illegible signature, if applicable

Multiple CMS contractors are charged with completing reviews of medical records. See Identifying Which Entity Completed a Part B Claim Review for detailed information about each of these contractors.

Documentation Submission

Once a provider/supplier compiles all the necessary documentation, it is important to submit them to the appropriate contractor according to the request received. Select the request below to view the appropriate submission instructions.

View the Drugs, Biologicals and Injections webpage for additional information and resources.

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Documentation Requirements Disclaimer

The documentation requirements contents/references provided within this section were prepared as educational tools and are not intended to grant rights or impose obligations. Use of these documents are not intended to take the place of either written law or regulations.

The listing of records is not all inclusive. Providers must ensure all necessary records are submitted to support services rendered.

Important that physician intent, physician decision and physician recommendation to provide services derived clearly from the medical record and properly authenticated.

The submission of these records shall not guarantee payment as all applicable coverage requirements must be met.