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Phosphate binder rule is disease-specific discrimination

December 9, 2024

In April, CMS issued guidance for the inclusion of oral-only drugs in the end-stage renal disease bundled payment. The directive included Xphozah as a renal dialysis service.

Xphozah, (tenapanor, Ardelyx) is a first-in-class phosphate absorption inhibitor approved to lower serum phosphorus levels for adults on dialysis. CMS intends to include the agent in the ESRD prospective payment system effective Jan. 1, 2025, but unlike calcimimetics and phosphate binders, tenapanor will have its own transitional drug add-on payment adjustment (TDAPA) and be excluded in the calculation for a permanent add-on payment.

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