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:
| 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 |
| Medication administration records (MAR) from date of service that include a dose and route given |
| Records of patient's condition before, during and after this billing period to support medical necessity and reason service was provided |
|Documentation to support coverage requirements as indicated in Erythropoiesis Stimulating Agents Local Coverage Determination [PDF] (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 |
|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.
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.
- Noridian Medical Review - Additional Documentation Request (ADR)
- Comprehensive Error Rate Testing (CERT) - CID Request
- Level One Appeal - Redetermination Request
View the Drugs, Biologicals and Injections webpage for additional information and resources.
Last Updated Feb 08, 2019
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.