Drugs, Biologicals and Injections Documentation Requirements

Chemotherapy Administration

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
Physician/Non Physician (NPP) order
Beneficiary name and date of service on all documentation
Diagnostic tests, radiological reports, lab results, pathology reports, and other pertinent test results and interpretations
  • Support diagnosis, if applicable
Beneficiary medical records to support drug is reasonable and necessary
  • Support LCD and NCD requirements, if applicable
Medication administration record (MAR) and/or infusion flowsheet
  • Start and stop times
  • Dose, route, frequency
  • Medication administered
Documentation to support drug wastage billed
  • Support JW modifier, if applicable
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.)
Office visit/E&M documentation if billed on same date of service under review
Itemization of services
Advance Beneficiary Notice
Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services)
Facility process of how electronic signature is created if using electronic health record

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

Documentation Submission

Once a provider 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.

Drug Administration

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
Physician/Non Physician (NPP) order
Beneficiary name and date of service on all documentation
Diagnostic tests, radiological reports, lab results, pathology reports, and other pertinent test results and interpretations
  • Support diagnosis, if applicable
Beneficiary medical records to support drug is reasonable and necessary
  • Support LCD and NCD requirements, if applicable
Medication administration record (MAR) and/or infusion flowsheet
  • Start and stop times
  • Dose, route, frequency
  • Medication administered
Documentation to support drug wastage billed
  • Support JW modifier, if applicable
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.)
Office visit/E&M documentation if billed on same date of service under review
Itemization of services
Advance Beneficiary Notice
Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services)
Facility process of how electronic signature is created if using electronic health record

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

Documentation Submission

Once a provider 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.

Last Updated $dateUtil.getDate( $modifieddate , "MMM dd , yyyy" , $locale , $tzone )

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.