Oral-only drugs used for the treatment of end-stage renal disease (ESRD) are covered under the Medicare Part D prescription drug benefit. However, the Centers for Medicare and Medicaid Services (CMS) has indicated that it will start including oral-only ESRD drugs in the ESRD Prospective Payment System (PPS), also known as the "bundle," starting Jan. 1, 2025. CMS had planned to implement this change earlier, but Congress previously stepped in and passed legislation delaying when CMS could make this change to how oral-only ESRD drugs are covered in Medicare.
Phosphate-lowering drugs are oral-only medications taken by most people on dialysis, and there are many types of phosphate-lowering drugs that work for different patients. Moving coverage of oral-only phosphate-lowering drugs to the ESRD payment bundle would create access issues for patients taking these critical drugs. There would also be logistical challenges for ESRD facilities that would now be responsible for acquiring, storing and distributing these drugs, of which there are many types and many patients prescribed them. Additionally, patients take phosphate-lowering drugs multiple times a day with meals and snacks, so the quantity of pills also contributes to the logistical challenges.
With the new beneficiary out-of-pocket cap in the Medicare Part D program and the expanded eligibility for the low-income subsidy, the affordability of Part D drugs is further enhanced. Keeping coverage of oral-only ESRD drugs in the Part D program makes sense in terms of patient affordability and maintaining patient access to treatments.
The Kidney PATIENT Act (H.R. 5074) is bipartisan legislation that would delay the move of oral-only ESRD drugs into the ESRD bundle until 2033 or until new intravenous therapies come to the market. The bill would ensure patients have access to the medications they and their doctors have determined work best for them. In addition, the bill would save money for taxpayers because it would delay an increase in the ESRD base rate that determines the bundled payment that would occur when adding oral-only drugs to the bundle.
Please ask your member of Congress to support the Kidney PATIENT Act.