Erythropoietin Stimulating Agent (ESA) 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
Legible handwritten physician and/or clinician signatures
Valid electronic physician and/or clinician signatures
Physician or Non-Physician Practitioner (NPP) authenticated order for date(s) of service for medication(s) to be administered including dose, route of administration and frequency
  • If order for medication(s) be unsigned, there must be medical documentation (e.g. a progress note) by treating physician that he/she intended medication(s) to be administered including dose, route of administration and frequency
  • Documentation showing intent for medication administration must be authenticated by author via a handwritten or electronic signature
Medication administration records (MAR) from date of service that include a dose and route given
  • Include clinician name and credentials
  • Nurse notes related to the administration of medication
Records of patient's condition before, during and after this billing period to support medical necessity and reason service was provided
  • Most recent physician clinic/progress notes pertaining to diagnosis/reason medication is being given
  • Documentation to support continued administration or dose reductions
Documentation to support coverage requirements as indicated in Erythropoiesis Stimulating Agents Local Coverage Determination (LCD) and National Coverage Determination (NCD) 110.21
Diagnostic test results/reports including those prior to claim date(s) of service if related, to support medical necessity and reason drug was administered
  • Hemoglobin and hematocrit including pretreatment levels
  • Erythropoietin level
  • Bone marrow biopsy results with blast count
  • Iron, Folate and B12
  • Serum creatinine, creatinine clearance or glomerular filtration rate
If dosage for drug under review is outside allowed amount per drug compendium, submit documentation to support medical necessity of this dose variance (i.e. clinical trial, article, studies, etc.)
Itemization of services
Office visit and/or evaluation and management (E&M) documentation if billed on same date(s) of service under medical review
Documentation to support coverage requirements, and/or criteria as specified in LCDs, National Coverage Determinations (NCDs), or coverage article for service(s) billed, if applicable
Advance Beneficiary Notice of Noncoverage (ABN), if applicable

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 Jun 18 , 2024

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.