In the proposed CY 2025 Physician Fee Schedule (PFS) published in the Federal Register on July 31, the Centers for Medicare & Medicaid Services (CMS) is soliciting comments on a proposal to revise the Medicare Claims Processing Manual (Manual) to better reflect the complexities of furnishing and billing non-chemotherapeutic drug administration infusion services and provide complex clinical characteristics for the Medicare Administrative Contractors (MACs) to consider as criteria when determining payment of claims for certain infusion administrations.

Background

In December 2023, CMS directed A/B MACs not to 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 directed that CPT Codes involving the administration of monoclonal, complex biological, and rheumatological therapies be paid as complex administration as long as all of the elements of these codes that are required for appropriate billing are met.

To satisfy billing requirements for codes CPT 96401-96549, the TDL directs providers to the billing guidelines in Chapter 12, Section 30.5 of the Manual, which 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. However, the Manual does not currently provide guidance on when a drug, an infusion or an injection encounter rises to the level of a complex therapy. The proposed revisions would remedy this issue.

Historically, some MACs had issued local coverage determinations (LCDs) or articles indicating that the administration of specific drugs – such as Tysabri, Prolia and Cimzia – could only be billed using non-complex administration codes. These LCDs generally classified complex administration as those administrations involving serious patient risk requiring frequent consultation with staff with advanced practice training and competencies, such as a physician or other qualified healthcare professional. Such staff are needed to monitor patients during infusions due to the incidence of severe adverse reactions. The LCDs further note that there may also be special considerations for the preparation, dosage, or disposal of infusion drugs. After the publication of the TDL, however, these LCDs were generally retired or removed from MAC’s websites, but the TDL did not fully resolve the issue, as it did not give specific guidance on when an infusion or injection encounter rises to the level of a complex therapy, and MACs still have discretion on the issue.

Proposal to Update Manual

In the Proposed CY 2025 PFS, CMS states that it is soliciting comments on an update to Section 30.5 of the Manual to include language stating that infusion administration for certain kinds of drugs and biologics can be considered complex and may be appropriately reported using the chemotherapy administration CPT codes 96401-96549.

The update aims to provide complex clinical criteria for MACs to consider when determining payment of claims for such services, as the current Manual language does not include unique characteristics of the administration of these drugs, which could provide additional context for MACs when determining payment. CMS notes that updating the Manual with increased detail on these codes will ensure the Manual is consistent with already published guidance. CMS solicits comments on its proposal to revise the Manual to better reflect the complexities of furnishing and billing non-chemotherapeutic drug administration infusion services. Comments should be submitted by September 9, 2024.