Drug Administration 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:

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Brief Description
Beneficiary identification, date of service, and provider of the service should be clearly identified on each page of the submitted documentation
Practitioner, nurse, and ancillary progress notes
Physician order for the medication(s) administered with valid physician signature, including date, dose, route and frequency
Medication Administration Record (MAR) and/or Infusion Flowsheet documenting the quantity administered include a dose, route, and frequency given and/or Medication invoice or evidence of free drug program if applicable
Documentation to support drug wastage billed
If the dosage for the drug under review is outside the allowed amount per the drug compendium, submit documentation to support the medical necessity of this dose variance (i.e. Clinical trial, article, studies, etc.)
Documentation supporting the diagnosis for the medication administered which may include authenticated physician notes, diagnostic testing or previous laboratory testing
Operative / procedure report
Listing of most current beneficiary medications
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
Documentation supporting the diagnosis code(s) required for the item(s) billed
Documentation to support the code(s) and modifier(s) billed
List of all non-standard abbreviations or acronyms used, including definitions
Any other supporting/pertinent documentation
Documentation to support National Coverage Determination (NCD), Local Coverage Determination (LCD) and/or Policy Article
Signatures are required for medical review for the following purposes: 1) To satisfy specific signature requirements in statute, regulation, National Coverage Determination (NCD) or Local Coverage Determination (LCD); and 2) To resolve authenticity concerns related to legitimacy of falsity of the documentation
If an electronic health record is utilized, include your facility's process of how the electronic signature is created. Include an example of how the electronic signature displays once signed by the physician
Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC)

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.