Genzyme 'Encouraged' by Oral-Drug Delay in Bundle


CAMBRIDGE, Mass.—In a July 27 news release, Genzyme Corp. said it was “encouraged” by the Centers for Medicare & Medicaid Services’ (CMS) decision not to immediately include oral medications without IV equivalents in the newly released dialysis bundled payment system.

According to the final rule, these medications, including Genzyme’s phosphate binder Renvela and Amgen’s calcimimetic Sensipar, will not be included in the bundle until Jan. 1, 2014.

“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.”

CMS originally proposed that ESRD-related oral drugs be included in the new bundle. However, the idea met resistance from the renal community because these drugs are not usually given in dialysis clinics and are often paid for through Medicare Part D and not the end-stage renal disease program.

As a result, CMS said will still include the drugs in the new bundle, but it is delaying paying for those drugs under the ESRD payment system until Jan. 1, 2014. 

CMS said it is pushing back the implementation date in order to address data/pricing issues, and to “evaluate and correct any potential concerns that may emerge as a result of the inclusion of the oral drugs and biologicals with other forms of administration in the payment bundle effective January 1, 2011.”

“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,” Genzyme said in the news release.

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