* Minimum hemoglobin target could be removed
* Final Medicare rule due November 1 (Adds Amgen comment)
By Deena Beasley
LOS ANGELES, July 1 (Reuters) - The U.S. Medicare federal health insurance program has proposed removing its requirement that kidney dialysis providers keep patient hemoglobin levels above a set minimum, which could lead to lower use of Epogen, the anemia drug sold by Amgen (AMGN.O).
The U.S. government health plan said last month that it had no plans to change its reimbursement terms for anemia drugs used to treat kidney patients.
But in a statement on its website on Friday, the agency proposed retiring a requirement that patients’ hemoglobin, or red blood cell, levels be kept above 10 milligrams per deciliter.
It said such an action would be “consistent with revised U.S. Food and Drug Administration guidelines.”
Last week, the FDA changed the labels for Amgen’s Epogen and Johnson and Johnson’s (JNJ.N) Procrit to call for lower dosing of the anemia drugs, which have been linked in recent years to safety concerns such as increased risk of heart problems.
“Clinicians should use the lowest dose of ESA (erythropoiesis stimulating agent) sufficient to reduce the need for red blood cell transfusions,” Patrick Conway, chief medical officer at the Centers for Medicare and Medicaid (CMS) said in the statement.
Amgen said it recognizes that the labeling for ESAs has changed, but is concerned that the proposal would remove an important safeguard designed to protect dialysis patients from being undertreated.
The Medicare guidelines “should have a measure that protects patients from hemoglobin levels that fall too low,” the biotechnology company said in an emailed statement.
Sales of the anemia drugs have declined steeply in recent years, but Amgen’s Epogen, along with its second-generation drug Aranesp, and J&J’s Procrit are still expected to generate around $6 billion in 2011 sales, according to data from Thomson Reuters Pharma.
The proposed change would apply under Medicare’s quality performance standards for “bundled” payments to dialysis providers and would affect payment years 2013 and 2014, the agency said.
CMS projected that its payment rates for dialysis treatments would increase by 1.8 percent in 2012, representing projected inflation of 3 percent less a projected productivity adjustment of 1.2 percent. It also estimated that federal payments to dialysis facilities in 2012 would total $8.3 billion.
While Medicare traditionally covers just elderly and disabled Americans, kidney disease patients are an exception. The program covers all those with end stage renal disease under a decades-old law.
Medicare said it would accept comments on the proposed rule until the end of August and will respond to them in a final rule to be issued by November 1. (Reporting by Deena Beasley)