America’s Blood Centers (ABC), the Association for the Advancement of Blood & Biotherapies (AABB), and the American Red Cross (ARC) have submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the agency’s Healthcare Common Procedure Coding System (HCPCS) Level II Code Public Meeting held on May 30th. In the comments regarding the new HCPCS code request by the blood community, the organizations urge that CMS’ Division of Coding and Diagnosis Related Groups (DCDRG) “revisit and approve” the submitted application for establishment of a new HCPCS Level II that, “identifies Red Blood Cells, Leukocytes Reduced, Oxygen/Carbon Dioxide Reduced (RBCs, LR, O2/CO2 Reduced) (request #4, HCP231002Y5WRL).”
The comments regarding the new HCPCS code request by the blood community also explained that, “RBCs, LR, O2/CO2 Reduced is a novel blood product where leukocyte reduced red blood cells are processed by the Hemanext ONE system to store and reduce the oxygen and carbon dioxide levels. Research shows that for certain populations, RBCs, LR, O2/CO2 Reduced can improve post-transfusion recovery, improve oxygen delivery for transfusion dependent patients, and potentially reduce healthcare costs by decreasing the number of transfusions a patient may need.” ABC, AABB, and the ARC also noted in the comments that, “in patients requiring chronic RBC transfusions (e.g., transfusion-dependent sickle cell disease and beta thalassemia), these functional advantages offer the potential to reduce transfusion requirements, reduce iron overload associated with frequent transfusion, and attenuate a multitude of pulmonary, cardiovascular, renal and other serious clinical complications associated with RBC hemolysis.”
The organizations added that U.S. Food and Drug Administration (FDA) has approved the Hemanext ONE system, “[t]herefore, 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 code for this product, which is clearly distinct from other blood components. CMS has established specific HCPCS Level II codes for other FDA device-based systems.” The blood community listed examples of, “HCPCS code descriptor terms identifying specific blood component processing methods, associated existing HCPCS codes including pathogen reduction and irradiation, and how these processing methods clinically differentiate each product,” explaining that, “[i]n a number of instances, individual HCPCS-coded blood products incorporate multiple processing methods that differentiate their functionality in multiple ways for use in specific clinical situations.”
The comments concluded by recommending that, “CMS’ policies should uniformly support patients’ access to novel products, which are often differentiated based on the processing method. We request that CMS reconsider the request for establishment of a HCPCS Level II code specifically identifying RBCs, LR, O2/CO2 Reduced.”