Effective December 21, 2023, the Centers for Medicare & Medicaid Services (CMS) has directed A/B MACs to not make downward adjustments to claims for CPT Codes for complex therapy administration (96401-96549) based solely on the specific drug being administered. In CMS Technical Direction Letter –  Transmittal 12397 (TDL), CMS directs that CPT Codes involving the administration of monoclonal, complex biological, and rheumatological therapies shall be paid as complex administration as long as all of the elements of these codes that are required for appropriate billing are met.

In order to meet the billing requirements for codes CPT 96401-96549, the TDL directs providers to the billing guidelines in Chapter 12, Section 30.5 of the Medicare Claims Processing Manual. Section 30.5 provides general guidance for codes that are not separately billable when provided in conjunction with complex therapy infusion or injection administration and how to bill multiple infusions or injections. Notably, the CMS Claims Processing manual does not provide guidance on when a drug, an infusion or an injection encounter rises to the level of a complex therapy.

The TDL is important because historically, some MACs had issued local coverage determinations (LCD) or articles indicating that administration of specific drugs – such as Tysabri, Prolia and Cimzia – could only be billed using non-complex administration codes. As a consequence of the TDL, these LCDs have been retired or removed from the MACs’ websites.  In fact, most, if not all, MAC websites now link to the TDL. In a January coding billing and coding article by the National Government Services, the A/B MAC Jurisdictions 6 and K removed 96372, the CPT code for therapeutic, prophylactic, and diagnostic substance by subcutaneous or intramuscular injections and infusions, from the CPT/ HCPCS Codes section for Prolia and Xgeva.

CMS also stated that it intends to provide further clarification on the policy in future rulemaking.