THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Amgen (NASDAQ:AMGN), today submitted testimony for the record of the Committee on Ways & Means hearing on “Patient Safety and Quality Issues in End Stage Renal Disease Treatment.” In its testimony, Amgen reinforces the patient benefits of EPOGEN® (Epoetin alfa) and underscores the quality of care and safety of EPOGEN when used in accordance with the Food and Drug Administration (FDA) approved product labeling. Amgen also documents that the majority of physicians use EPOGEN appropriately and notes that current Center for Medicare & Medicaid Services (CMS) policies are consistent with the FDA label, and that CMS policy ensures appropriate EPOGEN utilization for Medicare beneficiaries. Amgen calls for completion of the already-mandated CMS bundling demonstration project before implementing a new payment policy that bundles dialysis services with separately billable dialysis drugs. Unless sophisticated and complex case-mix adjustment and quality safeguards are studied in the CMS demonstration project and appropriately analyzed, premature, incomplete changes in payment policy could put patients at serious risk and providers subject to financial impairment.
