Cerus Corporation Announces CMS Granted New Technology Top-Up Payment for INTERCEPT Fibrinogen Complex

CONCORD, Calif .– (COMMERCIAL THREAD) – Cerus Corporation (Nasdaq: CERS) today announced that the United States Centers for Medicare & Medicaid Services (CMS) has granted a new Technology Top-Up Payment (NTAP) for INTERCEPT Fibrinogen Complex under Medicare Hospital Inpatient Prospective Payment System (IPPS)). The NTAP was granted as part of CMS’s NTAP Alternative Pathway, which recognizes the transformative nature of products that have received Breakthrough Device designation by the United States Food and Drug Administration (FDA).

The NTAP for patients receiving IFC for the control of massive bleeding associated with fibrinogen deficiency is in addition to the existing Medicare payment corresponding to the Medicare Severity Diagnosis Group (MS-DRG) assigned for each inpatient stay. In the final IPPS rule, CMS indicated that the value of NTAP will be up to a maximum of $ 2,535 per patient receiving IFC and will apply when the cost of patient care exceeds the MS-DRG payment. .

“CMS issuance of an NTAP for IFC will support Medicare beneficiaries and providers’ access to this innovative new blood product designed to treat urgent and life-threatening bleeding events in a hospital setting, ”said Jessica Hanover, Ph.D. ., Vice President of Cerus. , corporate affairs. “We applaud CMS for its decision to provide this additional payment for IFC. The need for effective tools to help clinicians manage bleeding events is critical. When minutes count in the life-saving care of a bleeding patient, the convenience of IFC with its 5-day post-thaw tablet will give many hospitals better access.

In November 2020, the US FDA approved the INTERCEPT Blood System for cryoprecipitation, which is used to produce the INTERCEPT fibrinogen complex for the treatment and control of bleeding, including massive bleeding, associated with deficiency in fibrinogen. IFC has already obtained the revolutionary device designation from the FDA. based on its potential to improve the treatment of massive bleeding, a potentially life-threatening medical condition.

ABOUT CERUS

Cerus Corporation is solely dedicated to safeguarding the blood supply in the world and aims to become the world’s leading blood products company. Headquartered in Concord, Calif., The company develops and supplies life-saving technologies and pathogen-protected blood components to blood centers, hospitals and ultimately to patients who depend on safe blood. The INTERCEPT Blood System for Platelets and Plasma is available worldwide 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 advanced clinical development in the United States. Also in the United States, 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 bleeding, associated with fibrinogen deficiency. For more information on Cerus, visit www.cerus.com and follow us on LinkedIn.

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

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