"The dosing recommendations for anemic patients with chronic renal failure have been revised to recommend maintaining hemoglobin levels within 10-12g/dL."
CMS stands alone -- along with insurers who jumped on board to save money -- as the only government agency to limit access based on safety.
Why does CMS think that ESAs are less safe at anything more than 10g/dL when everyone else thinks otherwise? Why does CMS think it can limit doctor discretion?
Here is the FDA label update.