Amgen's Statement on the Dialysis Facility Bundle

On July 26, 2010 the Centers for Medicare and Medicaid Services (CMS) issued the Final Rule for the dialysis facility “bundle” (also known as the End Stage Renal Disease Prospective Payment System (ESRD PPS), which will be implemented beginning January 1, 2011.

Amgen is supportive of policies that improve the quality and efficiency of health care delivery as well as preserve patient access to important medicines for patients on dialysis. The ESRD PPS demonstrates CMS’s strong commitment to these principles.

By aligning the anemia management quality indicators in the bundle with the FDA approved prescribing information, we expect that healthcare providers will be encouraged to provide appropriate care for their patients with anemia in the bundled payment system.

In addition, CMS acknowledged the concerns expressed by the dialysis community and delayed including oral drugs without IV equivalents (“oral-only drugs”) in the dialysis bundle until January 1, 2014. Amgen joins the dialysis community in its belief that this will help maintain access to important therapies for dialysis patients.

We are continuing to review the Final Rule to better understand the potential impact on patient access and quality of care.