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Cerus Corporation Announces CMS Issuance of P-Codes for Hospital Outpatient Billing of INTERCEPT-Based Therapeutic Products

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Cerus Corporation (Nasdaq: CERS) has received permanent HCPCS Level II codes from CMS for its INTERCEPT Fibrinogen Complex (IFC) and Pathogen Reduced Plasma, effective October 1, 2021. These codes will aid hospitals in billing for these innovative products, enhancing access to transfusion medicine. Earlier, Cerus announced a new technology add-on payment for IFC within the Medicare Hospital Inpatient Prospective Payment System. The INTERCEPT Blood System, which also includes IFC, is designed for treating massive hemorrhage and has FDA Breakthrough Device designation.

Positive
  • Permanent HCPCS Level II codes granted for IFC and Pathogen Reduced Plasma enhance hospital billing.
  • Facilitates hospital utilization of new pathogen-reduced blood products.
  • Previously received a new technology add-on payment for IFC under Medicare IPPS.
  • INTERCEPT Blood System obtained FDA approval and Breakthrough Device designation.
Negative
  • None.

Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted permanent Healthcare Common Procedure Coding System (HCPCS) Level II codes for Pathogen Reduced Cryoprecipitated Fibrinogen Complex, or INTERCEPT Fibrinogen Complex (IFC), and Pathogen Reduced Plasma, Cryoprecipitate Reduced. These new P-codes, P9026 and P9025, respectively, are effective October 1, 2021.

“By providing a means for hospitals to bill for Cerus’ recently-approved products in the hospital outpatient setting, CMS’ decision to establish these new codes enables provider and patient access to continued innovation in transfusion medicine,” said Jessica Hanover, Ph.D., Cerus’ vice president, corporate affairs. “We are pleased that these codes will facilitate hospital utilization of our new pathogen reduced blood products, which address critical unmet needs for so many patients.”

The establishment of HCPCS Level II P-codes follows the announcement earlier this month that CMS has granted a new technology add-on payment (NTAP) for IFC within the Medicare Hospital Inpatient Prospective Payment System (IPPS). In November 2020, the U.S. Food and Drug Administration (FDA) granted approval of the INTERCEPT Blood System for Cryoprecipitation, which is used to produce IFC as well as Pathogen Reduced Plasma, Cryoprecipitate Reduced. IFC was previously granted FDA Breakthrough Device designation based on its potential to improve treatment of massive hemorrhage, a life-threatening medical condition.

ABOUT CERUS

Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

FAQ

What are the new HCPCS codes granted to Cerus Corporation?

Cerus Corporation has received HCPCS Level II codes P9026 for INTERCEPT Fibrinogen Complex and P9025 for Pathogen Reduced Plasma.

When do the new HCPCS codes for Cerus products take effect?

The new codes are effective from October 1, 2021.

What is the significance of the new HCPCS codes for Cerus Corporation?

These codes enable hospitals to bill for Cerus' innovative products, improving access to advanced transfusion medicine.

What recent approval did Cerus receive for its INTERCEPT Blood System?

Cerus received a new technology add-on payment for INTERCEPT Fibrinogen Complex under the Medicare Hospital Inpatient Prospective Payment System.

What is the purpose of the INTERCEPT Blood System?

The INTERCEPT Blood System is designed to produce pathogen-reduced blood components, aiming to improve treatment for conditions like massive hemorrhage.

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