Medicare ESA Coverage Will Not Experiment With Clinical Trial Approach
Executive Summary
CMS has abandoned the idea of limiting some uses of erythropoiesis-stimulating agents to a research trial setting, despite receiving public comments that the "coverage with evidence development" approach may be acceptable in some circumstances
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Medicare Proposes Changes To Target Hemoglobin Levels In ESRD Treatment
CMS aims at “retiring” the floor hemoglobin level of 10 g/dL and lowering the target upper level to 11 g/dL in its proposed rule for the Medicare Part B prospective payment system for treatment of end-stage renal disease, a move that could apply more pressure to Amgen’s erythropoiesis-stimulating agents franchise.
Medicare Proposes Changes To Target Hemoglobin Levels In ESRD Treatment
CMS aims at “retiring” the floor hemoglobin level of 10 g/dL and lowering the target upper level to 11 g/dL in its proposed rule for the Medicare Part B prospective payment system for treatment of end-stage renal disease, a move that could apply more pressure to Amgen’s erythropoiesis-stimulating agents franchise.
FDA Advisory Committee Will Review ESAs In The Renal Setting Oct. 18
Meeting also could be next step in the process of determining whether safety issues are enough to drive changes to erythropoiesis-stimulating agent reimbursement at CMS.