Amgen Statement on Proposed Changes to the Quality Incentive Program in Dialysis

Amgen joins nephrology patient and clinician groups in expressing concern about the Centers for Medicare & Medicaid Services’ (CMS) proposal to retire the less than 10 g/dL anemia measure in the Quality Incentive Program (QIP) for dialysis, and urges the agency to retain the measure. The QIP serves a critical function under the recently implemented prospective payment system for dialysis by safeguarding patients against the under-utilization of services and helping to ensure that treatment plans are not undermined by the desire to reduce costs. As established by Congress in 2008, the QIP is intended to reduce a dialysis facility’s payment by up to two percent based on how well the facility meets certain quality standards.

ESAs are an important therapy for most patients with chronic kidney disease on dialysis as they help reduce the need for blood transfusions and minimize the serious risks associated with transfusions. There are also important safety considerations when ESAs are used to target hemoglobin levels greater than 11 g/dL, including greater risks for death, serious adverse cardiovascular reactions, and stroke. However, a less than 10 g/dL anemia measure in the dialysis population is consistent with the goal of ESA therapy to reduce the need for transfusions as reflected in the label. Amgen recommends CMS work with the community to determine the appropriate percentage of patients allowed to have hemoglobin levels less than 10 g/dL and incorporate it into the QIP anemia measure to account for the recent modification to the ESA labels.