Cerus Corporation Announces CMS Has Granted New Technology Add-On Payment for INTERCEPT Fibrinogen Complex

Rhea-AI Summary

Cerus Corporation (Nasdaq: CERS) announced that CMS has granted a new technology add-on payment (NTAP) for INTERCEPT Fibrinogen Complex under the Medicare Hospital Inpatient Prospective Payment System (IPPS). The NTAP, applicable for patients with massive bleeding due to fibrinogen deficiency, allows additional payment of up to $2,535 per patient when costs exceed the MS-DRG payment. This decision supports improved access to this innovative blood product, enhancing care in urgent situations. The INTERCEPT Blood System for Cryoprecipitation received FDA Breakthrough Device designation and was approved in November 2020.

Positive

• CMS granted NTAP for INTERCEPT Fibrinogen Complex, enhancing hospital reimbursement.
• Up to $2,535 extra payment per patient improves access for patients with fibrinogen deficiency.
• Supports Cerus' innovative blood product aimed at urgent, life-threatening bleeding events.

Negative

• None.

Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for INTERCEPT Fibrinogen Complex within the Medicare Hospital Inpatient Prospective Payment System (IPPS). The NTAP was granted under CMS’ alternative NTAP pathway, which recognizes the transformative nature of products granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).

The NTAP for patients receiving IFC for control of massive bleeding associated with fibrinogen deficiency is in addition to existing Medicare payment corresponding to the Medicare severity diagnosis-related group (MS-DRG) assigned for each inpatient stay. In the IPPS Final Rule, CMS has indicated the value of the NTAP will be up to a maximum of $2,535 per patient receiving IFC and will apply when the patient’s cost-of-care exceeds the MS-DRG payment.

“CMS’ issuance of an NTAP for IFC will support Medicare beneficiary and provider access to this innovative new blood product designed to address urgent, life-threatening bleeding events in the inpatient setting,” said Jessica Hanover, Ph.D., Cerus’ vice president, corporate affairs. “We applaud CMS for their decision to provide this incremental payment for IFC. The need for effective tools to help clinicians manage bleeding events is critical. When minutes matter in the life-saving care of a bleeding patient, having the convenience of IFC with its 5-day post-thaw shelf will enable many hospitals to have improved access.”

The U.S. FDA granted approval of the INTERCEPT Blood System for Cryoprecipitation, which is used to produce INTERCEPT Fibrinogen Complex for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency, in November 2020. 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.

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FAQ

What is the significance of the NTAP granted to Cerus Corporation's CERS?

The NTAP enhances hospital reimbursement for INTERCEPT Fibrinogen Complex, promoting access for patients with massive bleeding associated with fibrinogen deficiency.

How much additional payment will hospitals receive under the NTAP for CERS?

Hospitals will receive up to $2,535 per patient when care costs exceed the standard MS-DRG payment.

When was the INTERCEPT Blood System for Cryoprecipitation approved by the FDA?

The INTERCEPT Blood System was approved by the FDA in November 2020.

What condition does the INTERCEPT Fibrinogen Complex address?

It addresses massive bleeding associated with fibrinogen deficiency.