Kidney health organizations, medical providers and dialysis patients are pushing Congress to move forward quickly on the Kidney PATIENT Act of 2023. The bipartisan legislation would maintain patient access to oral-only medications by retaining coverage through the Medicare Part D prescription drug benefit.
“More than 500,000 patients undergoing dialysis require numerous medications to manage their health, and, for many patients this includes certain oral-only medications, such as phosphate binders,” according to the American Society of Nephrology. “These vital oral-only medications are best dispensed by pharmacies, who have dedicated infrastructure suited to promoting at-home medication adherence and are more accessible to patients.”
The Centers for Medicare & Medicaid Services will move payments for oral-only drugs from Medicare Part D into the End Stage Renal Disease Prospective Payment System starting on January 1, 2025. Oral-only drugs for patients would be bundled with other services provided through dialysis clinics. Kidney health advocates are concerned that dialysis clinics are not prepared to distribute these medications to patients.
“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,” the American Kidney Fund explains. “There would also be logistical challenges for ESRD facilities [dialysis clinics] 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.”
The Kidney PATIENT Act would delay the change. The full title of the proposed legislation is the Kidney Patient Access to Technologically Innovative and Essential Nephrology Treatments Act, and it is HR 5074 and S. 4510.
“Kidney patients should be able to access as many therapies as possible, as cost-effectively as possible,” Congresswoman Carol Miller (R-WV), said in introducing the bill. “Access to oral-only drugs is critical to many patients. The Kidney PATIENT Act will not only save taxpayers money but provide affordable treatment for kidney patients across the country.”
“Patients with complex medical conditions like End Stage Renal Disease (ESRD) must have access to the medications that they need,” said Congresswoman Ann McLane Kuster (D-NH), a co-sponsor of the bill. “Changes in Medicare’s ESRD Prospective Payment System could create barriers to essential medications and should be delayed until it's clear that patients’ access will not be impacted."
“The kidney bundled payment is a relic of the decades-old, pre-innovation mindset that prioritized drug access restrictions and short-term cost controls over long-term patient outcomes and taxpayer savings,” according to Edward V. Hickey III, president of the American Association of Kidney Patients. “We encourage all kidney patients and professionals to immediately call their elected leaders and demand that CMS abandon their proposed rule, recommit themselves to improved kidney patient health, and stop interfering with phosphorus management therapies.”
The American Kidney Fund has a form for contacting lawmakers at about the Kidney PATIENT Act and other kidney care legislation at https://www.kidneyfund.org/action/ask-congress-help-us-enact-kidney-legislation-end-2024
The American Association of Kidney Patients has a form at https://www.votervoice.net/iframes/AAKP/Campaigns/117321/Respond
Nephrology nurses can submit a letter through ANNA at https://www.votervoice.net/iframes/ANNANURSE/Campaigns/116109/Respond
Additional supporters of the Kidney PATIENT Act include: National Minority Quality Forum Action Network, Dialysis Patient Citizens, Lupus and Allied Diseases Association, National Kidney Foundation, Renal Healthcare Association, Renal Physicians Association and Renal Support Network.