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news.Genzyme has accepted 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.
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Genzyme said as per the final rule, these medications, including its Renvela (sevelamer carbonate), will not be included in the bundle until January 1, 2014.
Renvela is indicated in the US for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Renvela is contraindicated in patients with bowel obstruction.
CMS is expected to finalise quality measures for dialysis and CKD-MBD in the coming months.
Dan Regan, senior vice president and general manager of renal business at Genzyme, said: “Genzyme is encouraged by CMS’ final decision, as we believe it is expected to 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.
“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).”