Laboratory 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
  Legible handwritten physician and/or clinician signatures
  Valid electronic physician and/or clinician signatures
  Physician or Non-Physician Practitioner (NPP) order for date(s) of laboratory service
  • If order for clinical diagnostic test be unsigned, there must be medical documentation (e.g. a progress note) by treating physician that he/she intended clinical diagnostic test to be performed
  • Documentation showing intent that test be performed must be authenticated by author via a handwritten or electronic signature
  Lab report/results for the date(s) of service billed
  Records of patient's condition before, during and after this billing period to support medical necessity and reason lab was completed
  • Most recent physician clinic/progress notes pertaining to diagnosis/reason lab was completed
  • Nurse notes, if applicable
  Copy of CLIA certificate
  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 indications and/or criteria as specified in 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

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 Laboratory Services 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.