Hemanext Inc. Announces New HCPCS Code for “Red Blood Cells, Leukocytes Reduced, Oxygen/Carbon Dioxide Reduced, Each Unit”
The Centers for Medicare & Medicaid Services (CMS) has officially issued a new Healthcare Common Procedure Coding System (HCPCS) code for “Red blood cells, leukocytes reduced, oxygen/carbon dioxide reduced, each unit,” an innovative blood transfusion product produced by the Hemanext ONE Red Blood Cell Processing and Storage System.
Lexington, MA, September 09, 2024 --(PR.com)-- Hemanext Inc., a leading innovator in blood processing, storage, and transfusion technology, marks a significant milestone for the company’s innovative blood processing and storage system, Hemanext ONE©. The Centers for Medicare & Medicaid Services (CMS) has officially issued a new Healthcare Common Procedure Coding System (HCPCS) code for “Red blood cells, leukocytes reduced, oxygen/carbon dioxide reduced, each unit,” an innovative blood transfusion product produced by the Hemanext ONE Red Blood Cell Processing and Storage System.
HCPCS Code Details:
Code: P9027
Description: “Red blood cells, leukocytes reduced, oxygen/carbon dioxide reduced, each unit” - Manufactured with Hemanext ONE by Hemanext, Inc.
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, (1-6) and designed to bring new levels of innovation, clinical value and consistency to transfusion medicine. This novel product leverages cutting-edge technology to protect the quality, functionality, and viability of RBCs by processing and storing them in a low-oxygen (hypoxic) state. (2,11-13)
HRBCs have the potential to benefit all patients, particularly those requiring transfusion for chronic conditions, such as thalassemia (7), sickle cell disease (SCD) (8), and myelodysplastic syndromes (MDS), (9) as well as those in need of urgent peri-operative transfusions. (10) "We are pleased to see CMS recognize the significance of HRBCs with the issuance of a new HCPCS code," said Andrew Dunham, CEO at Hemanext Inc. "This milestone represents a major step forward in our mission to improve patient outcomes through innovative blood management solutions. We are committed to supporting healthcare providers in delivering the highest standard of care with HRBCs."
The Association for the Advancement of Blood & Biotherapies (AABB), America’s Blood Centers and the American Red Cross jointly stated, "AABB, ABC, and Red Cross commend CMS for supporting patients’ access to novel products.”
CMS maintains Level II HCPCS codes to represent supplies, products, and services not maintained by the American Medical Association (AMA) Current Procedure Terminology (CPT) codes. The U.S. healthcare system uses HCPCS codes to represent medical procedures to Medicaid, Medicare, and other third-party payers.
The Hemanext ONE RBC Processing and Storage System is used solely by non-hospital blood establishments to manufacture the HRBCs. This product is then supplied to hospitals for transfusion into patients. Hospitals receive only the final HRBC product, which, as with all existing HCPCS Level II-coded blood component products, is billed separately from its associated outpatient transfusion procedure.
The new 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.
About Hemanext
Hemanext is a privately held medical technology company based in Lexington, MA that is dedicated to improving the quality, safety, efficacy, and cost of transfusion therapy. The company’s research and development efforts center on the study of hypoxically stored RBCs. The company’s aim is to significantly improve the quality of stored RBCs worldwide.
Visit hemanext.com to learn more about the Company.
About Hemanext ONE
Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration. It is intended to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared within the standard 8-hour hold time. Processing of Red Blood Cells processed with the HEMANEXT ONE system must be initiated within 8 hours of collection and completed within 12 hours of collection. The Red Blood Cells must be processed at room temperature (20-26° C). The HEMANEXT ONE system limits O2 and CO2 levels in the storage environment. Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced may be stored for up to 42 days at 1-6°C. HEMANEXT ONE is used for volumes no greater than 350 mL of LR RBC.
In Europe, Hemanext ONE is CE marked which allows the medical device to be placed in the market in the European Economic Area (EEA).
HEMANEXT ONE creates HRBCs, RBCs that have been processed to reduce oxygen and carbon dioxide content of RBCs and to maintain this level throughout storage up to 42 days. (5,6) HRBCs have demonstrated positive impacts on multiple in vitro metrics of RBC quality in preclinical studies. (14,15) Clinical studies are underway to determine the impact of HRBCs on patient outcomes and estimate potential cost savings from expected improvements in care and reductions in transfusion volumes. (16)
About AABB
AABB (Association for the Advancement of Blood & Biotherapies) is an international, not-for-profit organization representing individuals and institutions involved in the fields of transfusion medicine and biotherapies. The Association works collaboratively to advance the field by developing and delivering standards, accreditation, and education programs. AABB is dedicated to its mission of improving lives by making transfusion medicine and biotherapies safe, available, and effective worldwide. For more information, visit www.aabb.org.
About America’s Blood Centers
Founded in 1962, America’s Blood Centers is the national organization bringing together community-based, independent blood centers. Its member organizations operate more than 600 blood collection sites providing close to 60 percent of the U.S., and a quarter of the Canadian, blood supply. These blood centers serve more than 150 million people and provide blood products and services to more than 3,500 hospitals and healthcare facilities across North America. All ABC U.S. members are licensed and regulated by the U.S. Food and Drug Administration.
About the American Red Cross
The Red Cross shelters, feeds and provides comfort to victims of disasters; supplies about 40% of the nation’s blood; teaches skills that save lives; distributes international humanitarian aid; and supports veterans, military members and their families. The Red Cross is a nonprofit organization that depends on volunteers and the generosity of the American public to deliver its mission.
References
1. Karafin MS, Field J, Ilich A, et al. Hypoxic storage of donor red cells preserves deformability after exposure to plasma from adults with sickle cell disease. Transfusion. 2022;1-10. Doi: 10.1111/trf.17163.
2. DʼAlessandro A, Yoshida T, Nestheide S, et al. Hypoxic storage of red blood cells improves metabolism and post-transfusion recovery. Transfusion. 2020;60(4):786-798.
3. Yoshida T, Prudent M, D'Alessandro A. Red blood cell storage lesion: causes and potential clinical consequences. Blood Transfus. 2019;17(1):27-52.
4. Yoshida T, Shevkoplyas SS. Anaerobic storage of red blood cells. Blood Transfus. 2010;8(4):220-36.
5. HEMANEXT ONE® (Blood container set used to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced) [US Instructions for Use]. Lexington, MA: Hemanext Inc.
6. HEMANEXT ONE® (Blood container set used to process and store CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced) [OUS Instructions for Use]. Lexington, MA: Hemanext Inc.
7. Farmakis D, Porter J, Taher A, et al. 2021 Thalassemia International Federation Guidelines for the management of transfusion-dependent thalassemia. 2022;6:8.
8. Chou S, Alsawas M, Fasano R, et al. American Society of Hematology 2020 guidelines for sickle cell disease: transfusion support. Blood Adv. 2020;4:2.
9. Germing U, Oliva E, Hiwase D, and Almeida A. Treatment of anemia in transfusion-dependent and non-transfusion-dependent lower-risk MDS: current and emerging strategies. 2019;3(6). doi: 10.1097/HS9.0000000000000314.
10. American College of Surgeons. ACS TQIP massive transfusion in trauma guidelines. ACS TQIP. 2014.
11. Williams AT, Jani VP, Nemkov T, et al. Transfusion of anaerobically or conventionally stored blood after hemorrhagic shock. Shock. 2020;53(3):352-362.
12. DOF. Report Document. Test Report CLIN-0001.2019.
13. DOF. Report Document. Test Report CLIN-0002.2019.
14. Yoshida T, Blair A, D’Alessandro A, et al. Enhancing uniformity and overall quality of red cell concentrate with anaerobic storage. Blood Transfus. 2017;15(2):172-81.
15. Yoshida T, McMahon E, Croxon H, et al. The oxygen saturation of red blood cell concentrates: The basis for a novel index of red cell oxidative stress. Transfusion. 2022;62(1):183-193. doi: 10.1111/trf.16715.
16. Reikvam H, Hetland G, Ezligini F, et al. Safety of hypoxic red blood cell administration in patients with transfusion-dependent hematological malignancies: An interim analysis. Transfus Apher Sci. 2023; doi: 10.1016/j.transci.2023.103755.
HCPCS Code Details:
Code: P9027
Description: “Red blood cells, leukocytes reduced, oxygen/carbon dioxide reduced, each unit” - Manufactured with Hemanext ONE by Hemanext, Inc.
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, (1-6) and designed to bring new levels of innovation, clinical value and consistency to transfusion medicine. This novel product leverages cutting-edge technology to protect the quality, functionality, and viability of RBCs by processing and storing them in a low-oxygen (hypoxic) state. (2,11-13)
HRBCs have the potential to benefit all patients, particularly those requiring transfusion for chronic conditions, such as thalassemia (7), sickle cell disease (SCD) (8), and myelodysplastic syndromes (MDS), (9) as well as those in need of urgent peri-operative transfusions. (10) "We are pleased to see CMS recognize the significance of HRBCs with the issuance of a new HCPCS code," said Andrew Dunham, CEO at Hemanext Inc. "This milestone represents a major step forward in our mission to improve patient outcomes through innovative blood management solutions. We are committed to supporting healthcare providers in delivering the highest standard of care with HRBCs."
The Association for the Advancement of Blood & Biotherapies (AABB), America’s Blood Centers and the American Red Cross jointly stated, "AABB, ABC, and Red Cross commend CMS for supporting patients’ access to novel products.”
CMS maintains Level II HCPCS codes to represent supplies, products, and services not maintained by the American Medical Association (AMA) Current Procedure Terminology (CPT) codes. The U.S. healthcare system uses HCPCS codes to represent medical procedures to Medicaid, Medicare, and other third-party payers.
The Hemanext ONE RBC Processing and Storage System is used solely by non-hospital blood establishments to manufacture the HRBCs. This product is then supplied to hospitals for transfusion into patients. Hospitals receive only the final HRBC product, which, as with all existing HCPCS Level II-coded blood component products, is billed separately from its associated outpatient transfusion procedure.
The new 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.
About Hemanext
Hemanext is a privately held medical technology company based in Lexington, MA that is dedicated to improving the quality, safety, efficacy, and cost of transfusion therapy. The company’s research and development efforts center on the study of hypoxically stored RBCs. The company’s aim is to significantly improve the quality of stored RBCs worldwide.
Visit hemanext.com to learn more about the Company.
About Hemanext ONE
Hemanext ONE has been granted marketing authorization for commercial distribution via the De Novo process by the U.S. Food & Drug Administration. It is intended to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC) that have been prepared within the standard 8-hour hold time. Processing of Red Blood Cells processed with the HEMANEXT ONE system must be initiated within 8 hours of collection and completed within 12 hours of collection. The Red Blood Cells must be processed at room temperature (20-26° C). The HEMANEXT ONE system limits O2 and CO2 levels in the storage environment. Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced may be stored for up to 42 days at 1-6°C. HEMANEXT ONE is used for volumes no greater than 350 mL of LR RBC.
In Europe, Hemanext ONE is CE marked which allows the medical device to be placed in the market in the European Economic Area (EEA).
HEMANEXT ONE creates HRBCs, RBCs that have been processed to reduce oxygen and carbon dioxide content of RBCs and to maintain this level throughout storage up to 42 days. (5,6) HRBCs have demonstrated positive impacts on multiple in vitro metrics of RBC quality in preclinical studies. (14,15) Clinical studies are underway to determine the impact of HRBCs on patient outcomes and estimate potential cost savings from expected improvements in care and reductions in transfusion volumes. (16)
About AABB
AABB (Association for the Advancement of Blood & Biotherapies) is an international, not-for-profit organization representing individuals and institutions involved in the fields of transfusion medicine and biotherapies. The Association works collaboratively to advance the field by developing and delivering standards, accreditation, and education programs. AABB is dedicated to its mission of improving lives by making transfusion medicine and biotherapies safe, available, and effective worldwide. For more information, visit www.aabb.org.
About America’s Blood Centers
Founded in 1962, America’s Blood Centers is the national organization bringing together community-based, independent blood centers. Its member organizations operate more than 600 blood collection sites providing close to 60 percent of the U.S., and a quarter of the Canadian, blood supply. These blood centers serve more than 150 million people and provide blood products and services to more than 3,500 hospitals and healthcare facilities across North America. All ABC U.S. members are licensed and regulated by the U.S. Food and Drug Administration.
About the American Red Cross
The Red Cross shelters, feeds and provides comfort to victims of disasters; supplies about 40% of the nation’s blood; teaches skills that save lives; distributes international humanitarian aid; and supports veterans, military members and their families. The Red Cross is a nonprofit organization that depends on volunteers and the generosity of the American public to deliver its mission.
References
1. Karafin MS, Field J, Ilich A, et al. Hypoxic storage of donor red cells preserves deformability after exposure to plasma from adults with sickle cell disease. Transfusion. 2022;1-10. Doi: 10.1111/trf.17163.
2. DʼAlessandro A, Yoshida T, Nestheide S, et al. Hypoxic storage of red blood cells improves metabolism and post-transfusion recovery. Transfusion. 2020;60(4):786-798.
3. Yoshida T, Prudent M, D'Alessandro A. Red blood cell storage lesion: causes and potential clinical consequences. Blood Transfus. 2019;17(1):27-52.
4. Yoshida T, Shevkoplyas SS. Anaerobic storage of red blood cells. Blood Transfus. 2010;8(4):220-36.
5. HEMANEXT ONE® (Blood container set used to process and store CP2D/AS-3 Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced) [US Instructions for Use]. Lexington, MA: Hemanext Inc.
6. HEMANEXT ONE® (Blood container set used to process and store CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced) [OUS Instructions for Use]. Lexington, MA: Hemanext Inc.
7. Farmakis D, Porter J, Taher A, et al. 2021 Thalassemia International Federation Guidelines for the management of transfusion-dependent thalassemia. 2022;6:8.
8. Chou S, Alsawas M, Fasano R, et al. American Society of Hematology 2020 guidelines for sickle cell disease: transfusion support. Blood Adv. 2020;4:2.
9. Germing U, Oliva E, Hiwase D, and Almeida A. Treatment of anemia in transfusion-dependent and non-transfusion-dependent lower-risk MDS: current and emerging strategies. 2019;3(6). doi: 10.1097/HS9.0000000000000314.
10. American College of Surgeons. ACS TQIP massive transfusion in trauma guidelines. ACS TQIP. 2014.
11. Williams AT, Jani VP, Nemkov T, et al. Transfusion of anaerobically or conventionally stored blood after hemorrhagic shock. Shock. 2020;53(3):352-362.
12. DOF. Report Document. Test Report CLIN-0001.2019.
13. DOF. Report Document. Test Report CLIN-0002.2019.
14. Yoshida T, Blair A, D’Alessandro A, et al. Enhancing uniformity and overall quality of red cell concentrate with anaerobic storage. Blood Transfus. 2017;15(2):172-81.
15. Yoshida T, McMahon E, Croxon H, et al. The oxygen saturation of red blood cell concentrates: The basis for a novel index of red cell oxidative stress. Transfusion. 2022;62(1):183-193. doi: 10.1111/trf.16715.
16. Reikvam H, Hetland G, Ezligini F, et al. Safety of hypoxic red blood cell administration in patients with transfusion-dependent hematological malignancies: An interim analysis. Transfus Apher Sci. 2023; doi: 10.1016/j.transci.2023.103755.
Contact
Hemanext
Robert Haime, Vice President, Commercial
781-301-7474
https://hemanext.com
Robert Haime, Vice President, Commercial
781-301-7474
https://hemanext.com
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