Blood Community Asks CMS to Establish HCPCS Code for Novel Blood Product

AABB, America’s Blood Centers, and the American Red Cross urged the Centers for Medicare and Medicaid Services (CMS) to establish a new HCPCS Level II code for a novel blood product: red blood cells, leukocytes reduced, oxygen/carbon dioxide reduced (RBCs, LR, O²/CO² reduced). This product involves leukocyte-reduced RBCs processed by the Hemanext ONE system to store and reduce oxygen and carbon dioxide levels.

In a July 8 letter to CMS’s Jason Bennett, director, Technology, Coding and Pricing Group, the blood community highlighted research demonstrating that for certain populations, RBCs, LR, O²/CO² reduced, may improve post-transfusion recovery and improve oxygen delivery for transfusion-dependent patients. This could potentially reduce health care costs by decreasing the number of transfusions a patient may need.

The letter also noted the Food and Drug Administration’s unique process for approving new blood and blood components. Following the FDA's approval of the Hemanext ONE system, blood establishments are now permitted to process and store RBCs, LR, O²/CO² reduced, and introduce the component into interstate commerce.

Given the agency’s precedent for establishing specific HCPCS Level II codes for other FDA-approved device-based systems, the blood community urged CMS to support the application for a new HCPCS Level II code for FDA-approved RBCs, LR, O²/CO² reduced.