The American Kidney Fund will administer Genzyme's interim patient assistance program providing Renagel to dialysis patients enrolled in Medicare Part D.

Announced July 31, Genzyme's program is aimed at patients who have reached the Part D coverage gap, or "donut hole," and must pay all expenses out-of-pocket until reaching Medicare's catastrophic spending ceiling.

The American Kidney Fund will "make the final determination about who qualifies" for the PAP and will handle distribution of the product to the patient's health care provider, Genzyme said. The approach extends Genzyme's ongoing relationship with the Kidney Fund to administer its Renagel assistance program.

The Cambridge, Mass.-based biotechnology company plans to offer the Part D assistance program through the end of 2006. The initiative is "designed to meet the immediate needs [of patients who use Renagel] but also allows us to evaluate where we are at the end of the year and determine what the best long term plan is," Genzyme said.

Genzyme joins about a half dozen pharma companies who recently have stepped forward with PAPs for Part D enrollees, many taking their cue from an April HHS Office of Inspector General advisory opinion permitting Schering-Plough's PAP for Part D. Companies had been reluctant to assist Medicare patients after the OIG issued a bulletin in 2005 warning that manufacturer-sponsored PAPs could run afoul of fraud and abuse rules.

Renagel is used to control serum phosphorus in patients with chronic kidney disease on hemodialysis. Individuals who require kidney dialysis qualify for Medicare regardless of age.

To be eligible for Genzyme's PAP, an individual must have reached the Part D coverage gap, have no alternative insurance, have an income between 135% and 300% of federal poverty levels and have spent at least 3% of income on prescription drugs. Patients with incomes below 135% of federal poverty level are eligible for either Medicaid or Part D's subsidy for low-income individuals.

Consistent with the OIG advisory opinion to Schering, Genzyme is stipulating that PAP recipients cannot count Renagel donations towards their true out-of-pocket costs tally, which determines when they reach the catastrophic ceiling.

Genzyme's Part D assistance efforts would likely to limited to Renagel because most of its products are not covered by Part D.

-- Gregory Twachtman

[Editor's note: This article appears courtesy of Medicare Drug Focus, a new publication from F-D-C Reports offering in-depth analysis of Part D. Register for your 30-day, risk-free trial at ¹ www.MedicareDrugFocus.com or call 800-332-2181.]

Genzyme Renagel PAP For Part D Enrollees Relies on American Kidney Fund For Administration

More from Archive

More from Pink Sheet