The Centers for Medicare and Medicaid Services (CMS) issued an
unpublished final rule on Nov. 1 to finalize changes for Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies for calendar year (CY) 2025.
The final rule is scheduled for publication in the Federal Register on Dec. 9 and contains several sections relevant to the blood and biotherapies community. AABB has summarized these sections below.
Prehospital Transfusion
CMS will modify the definition of “advanced life support, level 2 (ALS2)” (as defined in
CFR Section 414.605) by adding the administration of prehospital blood transfusion (PHBT) and including low-titer O-positive and O-negative whole blood transfusion therapy.
In response to
advocacy efforts from AABB, America’s Blood Centers and the American Red Cross, the agency will also include packed red blood cells (PRBCs), plasma or a combination of PRBCs and plasma. A ground ambulance transport that provides one of these PHBTs would constitute an ALS2 level transport.
Notably, there is no new payment associated with this change. CMS reiterated that the agency does not have the authority to provide an additional payment for the administration of whole blood transfusions under the ambulance fee schedule. However, the agency indicated that it may consider suggestions for future rulemaking.
CAR T-Cell Therapy Services
CMS will finalize its
AABB-supported proposal to pay separately for CAR-T CPT code 38228 (chimeric antigen receptor [CAR] T-cell therapy; CAR T-cell administration autologous). Additionally, CMS will bundle the remaining CAR-T CPT codes for collection and processing (CPT codes 38225, 38226 and 38228), making them non-payable.
CMS’s rationale is that they “believe that bundled status is appropriate for these codes in order to remain in alignment with OPPS to not pay separately for each step used to manufacture a drug or biological.”
Therapeutic Apheresis and Photopheresis
CMS 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).
The agency also finalized its proposal to base these codes on the use of the L056A RN/oncology nurse clinical labor type, which
AABB supported.
