The Centers for Medicare & Medicaid Services (CMS) has approved a new Healthcare Common Procedure Coding System (HCPCS) code P9027 for “red blood cells (RBCs), leukocytes reduced, oxygen/ carbon dioxide reduced, each unit,” according to a news release from Hemanext. The new code is P9027 for RBCs, leukocytes reduced, oxygen/carbon dioxide reduced, each unit” manufactured with Hemanext ONE by Hemanext, Inc. This new HCPCS code for RBCs marks an important milestone.
America’s Blood Centers and the blood community previously submitted comments in July 2024 to CMS, in response to the agency’s HCPCS Level II Code Public Meeting from May 2024, that urged the agency to, “revisit and approve” the submitted application for establishment of a new HCPCS Level II that, “identifies RBCs, Leukocytes Reduced, Oxygen/Carbon Dioxide Reduced.” The organizations explained that, ” the U.S. Food and Drug Administration (FDA) process for approving new blood and blood
components is unique. FDA formally approves the manufacturing systems used by U.S. blood
establishments to collect and manufacture blood and blood components. Following the approval of the
manufacturing system, individual blood collection establishments may submit to the FDA for licensure of
the blood and blood components collected and processed using the system. In September 2023, FDA
approved the Hemanext One container system, which permits blood establishments “to process and store
Red Blood Cells, Leukocytes Reduced, O2/CO2 Reduced” and allows an appropriately licensed blood
establishment to introduce the component into interstate commerce. Therefore, our organizations strongly support the application for a new HCPCS Level II code for FDA-approved RBCs, LR, O2/CO2 Reduced. [There is a clear need for a new HCPCS code specifically identifying RBCs that meet these criteria, including the new HCPCS Code for these RBCs.] CMS has established specific HCPCS Level II codes for other FDA device-based systems. For example, CMS recently relied on FDA’s approval of a processing container device — the INTERCEPT Blood System for Plasma — when the Agency assigned new HCPCS codes for novel blood component products, including Pathogen Reduced Cryoprecipitated Fibrinogen Complex (P9026) and Pathogen Reduced Plasma, Cryoprecipitate Reduced (P9025).”
The organizations commended CMS in the Hemanext news release regarding the new P9027 code, “for supporting patients access to novel products [by approving the new [HCPCS code].”
According to Hemanext, “red blood cells, leukocytes reduced, oxygen/carbon dioxide reduced are also known as hypoxic red blood cells (HRBCs). The Hemanext ONE RBC Processing and Storage System (Hemanext, Inc.) that produces HRBCs, was developed to limit the detrimental effects of oxidative damage on RBCs during storage, and designed to bring new levels of innovation, clinical value and consistency to transfusion medicine…The new P9027 HCPCS code facilitates streamlined billing and coding processes, ensuring that healthcare providers can efficiently incorporate HRBCs into their patient care protocols. This update is expected to support better integration of HRBCs into routine clinical practice and enhance accessibility of this novel innovation for patients and healthcare providers.”