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June 2, 2022

Targeted Probe and Education Program to Focus on Drugs and Biological Claims

The CGS Targeted Probe and Education program will begin review of claims associated with drugs and biologicals. Guidance for may be found in the CMS Internet Only Manual 100-04 Medicare Claims Processing Manual Chapter 17External PDF.

All drugs and biologicals claims must meet all requirements regarding medical reasonableness and necessity as outlined in the applicable statute, regulations, and manual provisions.

We expect the documentation submitted to include a copy of the following legible and signed documentation from each patient's medical record:

  • Beneficiary's name
  • Date of service
  • Patients weight for doses requiring calculation
  • Documentation of frequency, as noted above, must support accepted prescribing guidelines
  • Signed Progress Notes which establish:
    • Medical necessity and relevant history
    • Signed order for the drug administration
    • Purchase order for the drug.
    • Information regarding single use vs. multi use vials
    • Generic name (if applicable)
    • Patient consent
  • Drug Administration Record, which supports:
    • The deliverance of the order
    • Name of drug
    • Amount of drug administered
    • Route
    • Location
    • Amount of drug wasted and by whom and billed with JW modifier
  • A copy of any mandatory ABNs
  • Appropriate signatures
    • Signature and credentials of person performing the service must meet CMS requirements
    • Amendments/corrections/delayed entries are properly identified

For additional documentation requirements, please reference:

CPT codes under review will include:

  • J0129 – Orencia (abatacept)
  • J0178 – Eylea (aflibercept)
  • J0717 – Cimzia (certolizumab)
  • J2778 – Lucentis (ranibizumab)
  • J0897 – Prolia (denosumab)
  • J0585 – Botox (Botulism Toxin Type A)
  • J1602 – Simponi Aria (golimumab)
  • J7326 – Gel-One (hyaluronan)

For more information on Targeted Probe and Education, please see the following links:

Consider using the myCGS Portal for claim review status and submission of documentation. For more information, please access myCGS.

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