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Wednesday, 03/13/2024 12:07:48 AM

Wednesday, March 13, 2024 12:07:48 AM

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Legislation pushes for a delay in placing phosphate binders in the ESRD payment bundle

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Key takeaways:
The Kidney Patient Act would delay placement of oral phosphate binders into the dialysis payment bundle.
Binders would be placed in the bundle if an injectable version receives FDA approval.
Congress is reviewing legislation that would delay inclusion of oral phosphate binders into the End-Stage Renal Disease Prospective Payment System bundled payment system.

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CMS currently has plans to include oral binders in the bundle by Jan. 1, 2025, but the Kidney Patient Act (H.R. 5074), sponsored by U.S. Rep. Earl L. “Buddy” Carter, R-Ga., would amend the American Taxpayer Relief Act of 2012 to delay inclusion of the binders until 2033.

“Ensuing that the pending inclusion of oral-only drugs in the [End-Stage Renal Disease] Prospective Payment System (PPS) bundle meets the needs of the ESRD community is a priority for Kidney Care Partners, so we’re encouraged by the recent activity in the House of Representatives on this policy,” Mahesh Krishnan, MD, MPH, MBA, FASN, chair of Kidney Care Partners (KCP), told Healio.

“Without congressional action, this harmful policy would exacerbate the challenges the kidney community already faces, including diminished access to innovative therapies, insufficient reimbursement and limited or nonexistent choice of insurance coverage for patients,” KCP, a kidney community advocacy group, said in a press release.

According to language in the bill, placement of oral drugs indicated for the “reduction, management or control of the serum phosphate of an individual” would be delayed until 2033 unless “an intravenous drug indicated for the reduction, management or control of the serum phosphate of an individual has been approved by the [FDA].”

The General Accounting Office (GAO) released a report last November reviewing plans by CMS to include oral phosphate binders in the PPS by 2025. The report notes that dialysis organizations interviewed by the GAO “expressed concerns that the modified bundled payment may not fully account for the costs of acquiring, shipping and dispensing phosphate binders.”
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