In 2024, a policy decision was made by leadership and staff at the Centers for Medicare and Medicaid Services (CMS) and it was implemented on January 1, 2025 to move all oral-only therapies, including Phosphate Lowering Therapies (PLTs) into Part B of the End-Stage Renal Disease (ESRD) Medicare Prospective Payment System—commonly known as the “Bundled Payment System."

Nearly 600,000 Americans are on dialysis, and approximately 440,000 of them are dependent upon PLTs to manage their phosphate levels and health effectively. Patients with kidney failure often experience high levels of phosphate in their bloodstream which, if untreated, have been independently associated with an increased susceptibility to heart attacks or strokes. These conditions negatively impact patients, burden the health system, and pose tremendous costs to taxpayers through the Medicare system.

This CMS decision was made despite fierce opposition from kidney patients, kidney professionals, kidney advocacy organizations, and the recommendations of the Government Accountability Office (GAO). AAKP predicted care disruptions for vulnerable kidney patients and an undermining of the kidney health goals outlined in the 2019 Executive Order on Advancing American Kidney Health. In November 2023, GAO also warned CMS against integrating PLTs into the CMS bundle payment because they believed the decision could reduce or delay patient care choice by perpetuating burdens for providers and increasing the risk that medical professionals will resort to using older and less effective medications. 

An independent survey conducted by the AAKP Center for Patient Research and Education released results of more than 500 kidney patients and professionals that demonstrated the extent of disruption caused by CMS’ 2024 decision. Responses indicated that 38% of patients and 72% of kidney professionals have experienced PLT access disruption since January 1st.

Further, AAKP recently learned of a variance in CMS’ original policy expectations and current reality patients encounter. In the fall of 2024, when CMS published the 2025 End Stage Renal Disease Prospective Payment System final Rule, CMS stated:  “We anticipate that the incorporation of oral-only drugs into the ESRD PPS will increase access to these drugs for beneficiaries. We estimate that there will be an increase in Medicare spending as a result of this increase in access. Specifically, CMS has been monitoring and analyzing data regarding beneficiary access to Medicare Part D drugs; increases in expenditures for renal dialysis drugs paid under Medicare Part D; health equity implications of varying access to Medicare Part D drugs among patients with ESRD; and ESRD facility behavior regarding drug utilization.  Lastly, as part of the preparation for the inclusion of phosphate binders into the ESRD PPS, CMS has monitored Part D utilization of, and spending for, phosphate binders. We have developed budgetary estimates of the changes in Medicare Part B and Part D spending, which are discussed in section VII.C.1 of this final rule.”

However, in the proposed rule published July 2025 CMS stated that for PLTs, it projects Medicare spending will be “more than 50% lower than projected” ($380 million in 2025 as opposed to the projected $870 million). CMS does not explain why the spending is lower. 

AAKP believes this variance in costs is an indication that CMS seriously misjudged the consequences of their decision on patient care choice and access to PLTs – and CMS officials should be held fully accountable for disrupting kidney patient care.

Please personalize the letter to your right and ask your Members of Congress to urge CMS to respond to the immediate crisis created by their 2024 decision to add phosphate lowering therapies (PLTs) in the ESRD bundle.