Genzyme accepts CMS decision for delaying Renvela administration to dialysis patients

Genzyme Corp. (NASDAQ: GENZ) today said it welcomed the Centers for Medicare and Medicaid Services' (CMS) decision not to include oral medications without IV equivalents in Medicare's End Stage Renal Disease (ESRD) patient benefit. According to the final rule, these medications, including Genzyme's Renvela^® (sevelamer carbonate), will not be included in the bundle until January 1, 2014.

“We look forward to working with CMS and the nephrology community to establish quality measures for treating CKD and related mineral and bone disorders (MBD) to protect the quality of care each patient receives.”

"Genzyme is encouraged by CMS' final decision, as we believe it will put the needs of the patients first by providing the time needed to collect data to document the current standard of care, enabling assessment in the future of any unintended negative consequences that the new bundled payment system may have on the management and outcomes of dialysis patients," said Dan Regan, senior vice president and general manager of Genzyme's renal business. "We look forward to working with CMS and the nephrology community to establish quality measures for treating CKD and related mineral and bone disorders (MBD) to protect the quality of care each patient receives."

In the United States, 100,000 CKD patients start dialysis treatment every year and protections for quality of care and adequate treatment reimbursement are critical for this vulnerable patient population. CMS' decision to delay the inclusion of ESRD-specific oral drugs, including phosphate binders and calcimimetics, helps reduce the potential for conflict between best clinical practices and economic incentives. CMS is expected to finalize quality measures for dialysis and CKD-MBD in the coming months.