Reps. want oral drugs in ESRD bundles

Rep. Peter Welch (D-Vt.) and three other representatives introduced a bill that would eliminate a two-year delay for adding oral drugs to CMS's bundled payment rate for end-stage renal disease (ESRD). The delay was included as a provision in the American Taxpayer Relief Act of 2012, which was enacted earlier this month to prevent the expiration of income tax cuts and to defer for two months the implementation of budget sequestration (see BioCentury Extra, Jan. 2).

Welch said in a statement the delay for oral drugs, which includes dialysis drug Sensipar cinacalcet from Amgen Inc. (NASDAQ:AMGN), would cost CMS almost $500 million over the two-year period. Amgen said in a statement that a 2011 Government Accountability Office report "recognized that it would not be in the best interest of patients to include oral-only medications into the Medicare bundle for dialysis patients because of unreliable data systems and a lack of quality metrics." The biotech said the delay "provides CMS with the time needed to develop quality metrics and further develop their data systems." ...