2025 Medicare PFS Proposed Rule Addresses Prehospital Transfusion, Therapeutic Apheresis

July 17, 2024

The Centers for Medicare and Medicaid Services (CMS) released the calendar year (CY) 2025 Medicare Physician Fee Schedule (PFS) proposed rule, which is scheduled for publication in the Federal Register on July 31. The agency also released an accompanying fact sheet. The proposed rule contains several provisions of interest to the blood and biotherapies community.

Prehospital Blood Transfusion

In the proposed rule, CMS proposes to modify the definition of “advanced life support, level 2 (ALS2)” by adding the administration of low titer O-positive whole blood transfusion therapy (WBT) to the list of ALS2 procedures. Under this proposal, a ground ambulance transport that provides WBT would independently qualify an ALS2-level transport.

In explaining its rationale, CMS cited that the administration of WBT and handling of low titer O+ whole blood “requires a complex level of care beyond ALS1 for which EMS providers and suppliers at the EMT-Intermediate or paramedic level require additional training.” Furthermore, WBT requires specialized equipment such as a blood warmer and rapid infuser, the agency noted.

While CMS did not include alternative blood product treatments in its proposal, it is seeking comments on whether CMS should add alternative blood products like packed red blood cells and plasma to the list of ALS2 procedures. “We invite comments on this proposal to add the administration of low titer O+ whole blood transfusion as an ALS2 procedure and comments on whether we should add alternative blood product treatments such as the administration of PRBCs or plasma,” the proposed rule read.

Therapeutic Apheresis

CMS also finalized the following CPT codes for therapeutic apheresis and photopheresis:

  • 36514 (Therapeutic apheresis; for plasma pheresis).
  • 36516 (Therapeutic apheresis; with extracorporeal immunoadsorption, selective adsorption or selective filtration and plasma reinfusion).
  • 36522 (Photopheresis, extracorporeal).

In the 2024 final rule, CMS finalized these codes as “potentially misvalued,” as the agency believed there may have been a possible disparity with the clinical labor type. Upon review by two CMS committees, members agreed that clinical staff code L042A (RN/LPN) did not appropriately represent the work of an apheresis nurse specialist.

While there is not a clinical staff code for an apheresis nurse specialist, the committee agreed with the specialty societies’ recommendation that the training and experience of an oncology nurse (L056A, RN/OCN) would more accurately reflect the work of an apheresis nurse for these CPT codes. The committee submitted new PE recommendations for these three codes based on the use of the L056A clinical labor type.

Submitting Comments on the Proposed Rule

CMS is accepting feedback on the proposed rule until 5 p.m. ET on Sept. 9. Instructions are available in the unpublished Federal Register notice.