Resources

Instructions for Use

Instructional Video

Reimbursement Code

Bibliography

Instructions for Use

Hemanext ONE IFU (USA)

Instructions for Use, English, 4pp.

Hemanext ONE IFU (EEA)

Instructions for Use, Multilanguage, 60pp. For the European Economic Area.

Instructional video
Reimbursement code

The Centers for Medicare & Medicaid Services (CMS) have established a distinct reimbursement code for oxygen-controlled red blood cell (RBC) units, supporting adoption of scientifically validated transfusion innovation.

RBC processed with Hemanext ONE® are recognized by CMS under the unique Healthcare Common Procedure Coding System (HCPCS) Level II code P9027 as “Red blood cells, leukocytes reduced, oxygen/carbon dioxide reduced, each unit”. This designation reflects the advancement represented by oxygen-controlled RBC storage and provides hospitals and blood establishments with a clear reimbursement pathway within existing billing systems.

HCPCS Coding Overview

CMS HCPCS Code P9027
Description “Red blood cells, leukocytes reduced, oxygen/carbon dioxide reduced, each unit”.
Category Outpatient reimbursement.
Coverage CMS Outpatient Prospective Payment System (OPPS).

The P9027 code distinguishes oxygen-controlled RBC units from conventionally stored RBC units. This enables hospitals and transfusion centers to bill appropriately for the additional quality and innovation associated with oxygen-controlled storage. The code applies to RBC units processed using the FDA-authorized oxygen-controlled RBC storage system Hemanext ONE.

Reimbursement Framework

Under CMS’s Outpatient Prospective Payment System, the reimbursement rate for oxygen-controlled red blood cell units (P9027) is set at a level nearly three times that of conventional RBC. This rate recognizes the scientific and clinical value associated with maintaining higher RBC quality and aligns with CMS’s broader commitment to support innovation in transfusion medicine. The reimbursement framework allows hospitals and blood establishments to provide a premium-quality, evidence-based product without altering existing billing or operational workflows.

Note: CMS rates are determined by the agency and may be subject to annual review and adjustment. The information presented here is for educational purposes only and does not guarantee payment or coverage. Institutions should verify current rates through CMS or local carriers.

Additional Information

Hemanext Inc. Announces New HCPCS Code for Red Blood Cells (code P9027) — read the press release.

For institution-specific reimbursement guidance, consult your local Medicare Administrative Contractor (MAC) or payer representative.

CMS Coding Decision

HCPCS Level II Code, effective 1 Oct 2024.

Bibliography

Title / Author search:

A clinical investigation of hypoxic red blood cell administration in patients with transfusion-dependent hematological malignancies and burns
Reikvam H, Lunde THF, Kristoffersen EK, Omert L, Bagdasarian J, Almeland SK.

J Blood Med. 2026;17:573232.

DOI: 10.2147/JBM.S573232

Storage under hypoxia improves the ability of red cells to release oxygen in ex vivo–perfused human kidneys
Rabcuka J, Fallon J, Meli A, et al.

Blood Red Cells & Iron. 2026;2(1).

DOI: 10.1016/j.brci.2025.100038

Evaluating the effects of hypoxic storage on platelet function and health using a novel storage system
Weaver AJ, McIntosh CS, Kelly SG, et al.

Transfusion. 2024;64(4):693-704.

DOI: 10.1111/trf.17784

Hypoxically stored RBC resuscitation in a rat model of traumatic brain injury and severe hemorrhagic shock
Muller C, Courelli V, Govender K, et al.

Life Sciences. 2024:340:122423.

DOI: 10.1016/j.lfs.2024.122423

Global burden of transfusion in sickle cell disease
Inusa Baba, Atoyebi W, Andermariam B, Hourani J, Omert L.

Transfusion and Apheresis Science. 2023;62(5):103764.

DOI: 10.1016/j.transci.2023.103764

Safety of hypoxic red blood cell administration in patients with transfusion-dependent hematological malignancies: an interim analysis
Reikvam H, Hetland G, Ezligini F, et al.

Transfusion and Apheresis Science. 2023;62(5):103755.

DOI: 10.1016/j.transci.2023.103755

Global burden and unmet needs in treatment of transfusion dependent β-thalassemia
Forni GL, Grazzini G, Boudreaux J, Agostini V, Omert L.

Frontiers in Hematology. 2023.

DOI: 10.3389/frhem.2023.1187681

Modeling hemoglobin levels of patients chronically transfused with red blood cells
Carter P, Dunham A.

Transfusion. 2023;63(5):952-959.

DOI: 10.1111/trf.17305

Hypoxic storage of donor red cells preserves deformability after exposure to plasma from adults with sickle cell disease
Karafin MS, Field J, Ilich A, et al.

Transfusion. 2023;63(1):193-202.

DOI: 10.1111/trf.17163

Tools and metrics for the assessment of post-storage performance of red blood cells: no one is left over [Editorial]
Antonelou M.

Transfusion. 2023;63(1):1-6.

DOI: 10.1111/trf.17228

A deep 96-well plate RBC storage platform for high-throughput screening of novel storage solutions
Nikulina M, Nemkov T, D'Alessandro A, et al.

Front. Physiol. 2022;13:1004936.

DOI: 10.3389/fphys.2022.1004936

Metabolic reprograming under hypoxic storage preserves faster oxygen unloading from stored red blood cells
Rabcuka J, Blonski S, Meli A, et al.

Blood Adv. 2022;6(18):5415-5428.

DOI: 10.1182/bloodadvances.2022007774

Preclinical evaluation of the preservation of red blood cell concentrates by hypoxic storage technology for transfusion in sickle cell disease [Letter to the Editor]
Bencheikh L, Nguyen K-A, Chadebech P, et al.

Haematologica. 2022;107(8):1944–1949.

DOI: 10.3324/haematol.2021.279721

Intervening on the storage time of RBC units and its effects on adverse recipient outcomes using real-world data
Bruun-Rasmussen P, et al.

Blood. 2022;139(25):3647–3654.

DOI: 10.1182/blood.2022015892

High-throughput metabolomics platform for the rapid data-driven development of novel additive solutions for blood storage
Nemkov T, Yoshida T, Nikulina M, D'Alessandro A.

Front. Physiol. 2022;13:833242.

DOI: 10.3389/fphys.2022.833242

Effect of hypoxic blood infusion on pulmonary physiology
Pittman R, Yoshida T, Omert L.

Front. Physiol. 2022;13:842510.

DOI: 10.3389/fphys.2022.842510

Modelling haemoglobin incremental loss on chronic red blood cell transfusions
Carter P, Dunham A.

Vox Sang. 2022;117(6):831-838.

DOI: 10.1111/vox.13261

Age of red cells for transfusion and outcomes in patients with ARDS
Graw J, Bünger V, Materne L, et al.

J. Clin. Med. 2022;11(1):245.

DOI: 10.3390/jcm11010245

The oxygen saturation of red blood cell concentrates: the basis for a novel index of red cell oxidative stress
Yoshida T, McMahon E, Croxon H, et al.

Transfusion. 2022;62(1):183-193.

DOI: 10.1111/trf.16715

Effects of hypoxic storage on the efficacy of gamma irradiation in abrogating lymphocyte proliferation and on the quality of gamma-irradiated red blood cells in additive solution 3
Sowemimo-Coker S, Fast L.

Transfusion. 2021;61(12):3443-3454.

DOI: 10.1111/trf.16683

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Preserving What's Vital to Life — Recognized by CMS

By producing higher quality RBCs, the Hemanext ONE system has the potential to enable fewer and more effective transfusions for patients. I am truly excited by the possibility of bringing this improved red blood cell replacement therapy to populations in the U.S. that have been waiting for a transformative technology like this one.

Dr. Philip C. Spinella
Professor, Department of Surgery and Department of Critical Care Medicine at University of Pittsburgh

We value our partnership with Hemanext to enhance blood product quality and availability. Hemanext ONE has the potential to strengthen the resiliency of the blood supply, and this FDA authorization is a significant milestone to that end.

Ralph Vassallo, MD, FACP
Executive Vice President, Chief Medical and Scientific Officer of Vitalant

The Hemanext ONE system offers promise to improve the treatment landscape for patients burdened by transfusions and could be an essential step towards performing fewer and better transfusions. Having long championed Hemanext’s transformative initiatives, I eagerly anticipate witnessing the positive influence, right here in the United States, on the advancement of transfusion therapy quality.

Paul M. Ness, MD
Former Director, Division of Transfusion Medicine at Johns Hopkins University and board member of Hemanext

By deoxygenating red cells and maintaining them in their hypoxic state throughout storage, the resulting red cells experience less oxidative stress and oxidative damage, have improved metabolism, and are also more deformable leading to improved micro vascular profusion and less hemolysis.

Dr. Steven Spitalnik, MD
Co-Director of the Laboratory of Transfusion Biology, Colombia University

The preclinical data by Williams et al. show anaerobically stored RBCs achieve multiple clinically important functional resuscitation goals, with a smaller volume of fluid and the FDA benchmark of 24-hour RBC recovery. I look forward to the clinical trials in bleeding patients.

John Holcomb, MD, FACS
University of Alabama at Birmingham

I have had several patients who have received Hemanext hypoxic blood, and several of the patients have personally said thanks for having been given the opportunity and also that they have felt better after transfusion with hypoxic blood compared to conventional transfusion. One must of course be careful not to attach too much importance to such observations, but I would still like to mention that there has been a remarkable tendency towards this.

Håkon Reikvam, MD, PhD
Professor, Department of Clinical Science, University of Bergen, Norway

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This website may contain information on products or uses of those products that are not authorized in all countries or regions. Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration. In Europe Hemanext ONE is CE marked which allows the medical device to be placed in the market in the EEA. Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Hemanext, Hemanext ONE, and the logos are registered trademarks of Hemanext, Inc. © 2026 Hemanext, Inc. All rights reserved.

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