Ortho Biotech to Submit Official Request for Reconsideration to CMS Regarding ESA Cover...( - Request Provides CMS wit...),Health

- Request Provides CMS with New Scientific Evidence -

BRIDGEWATER, N.J., Nov. 8 /PRNewswire/ -- Ortho Biotech Products, L.P., the company that markets PROCRIT(R) (Epoetin alfa), today will formally request that the Centers for Medicare and Medicaid Services (CMS) reconsider its final National Coverage Determination (NCD) for erythropoiesis-stimulating agents (ESAs). The company's request will be available online at http://www.orthobiotech.com and http://www.VoiceForCancerPatients.com.

The company will provide new scientific evidence and highlight specific areas in which it believes that CMS materially misinterpreted existing data in reaching its current NCD. These two conditions are specified by CMS as necessary for reconsideration of an NCD.

"The goal of our reconsideration request is to re-open an evidence-based dialogue with CMS to ensure that Medicare reimbursement for ESAs supports safe and effective treatment of anemia for patients receiving chemotherapy," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/Nephrology, Ortho Biotech Products L.P. "The policy of most concern is the imposition of a coverage limit on ESA treatment once hemoglobin levels reach 10 grams per deciliter of blood (g/dL). We will present CMS with additional scientific data demonstrating the importance of individualizing ESA therapy -- particularly when to initiate and stop therapy -- based on the medical needs of Medicare patients."

In its request, Ortho Biotech will present new evidence, including:

-- Data addressing the hemoglobin concentrations at which Medicare

patients receive transfusions;

-- Data addressing transfusion risks associated with various hemoglobin

concentrations at which ESA therapy is initiated;

-- Data correlating maximum hemoglobin limits to achieved hemog
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