Nearly 550,000 Americans are undergoing dialysis, and an estimated 440,000 patients rely on phosphate-lowering therapies (PLTs) to effectively manage their health. Since foods cannot be consumed during dialysis sessions or present at dialysis centers, patients must take these drugs at home with a meal or snack. Patients currently have broad access to PLTs under Medicare Part D, but unless Congress acts quickly, the Centers for Medicare and Medicaid Services (CMS) will move forward with plans to restrict patient care choice and access.
How does CMS plan to do this? They have stated they will shift oral-only therapies, like PLTs, into the Part B End-Stage Renal Disease (ESRD) Medicare Prospective Payment System (PPS or “bundle”) starting January 1, 2025. This may sound like a lot of Washington. D.C. jargon, and it is, but the practical implications for kidney patients and taxpayers are very negative.
The “bundled payment system,” was created by CMS to limit kidney care costs nearly 15 years ago. It is a complex system of protocols overseen by non-kidney administrators with little sensitivity to patients' lived experience and patient-reported outcomes. The bundled payment system has simply failed to keep pace with patient-centered medicine and the new care innovations, that advocates like you and AAKP have fought hard to advance through the FDA regulatory process.
In fact, many of the decisions CMS makes are completely at odds and counter-intuitive to the expert medical advice of AAKP’s allied nephrologists and the highly individualized plans these healthcare professionals develop with their patients to keep them healthy.
Make no mistake about it, if CMS is allowed to take this action, it represents a negative Government Determinant of Health (GDoH). Patients will be denied choice and access to certain medications, including promising new therapies! As you know, patients may respond better to one specific drug, or a combination of drugs, to achieve their clinical serum phosphorus level targets. AAKP believes doctors and patients should have the ability and freedom to align the right treatment, to the right patient, at the right time. CMS seems determined to ignore this reasoning and, instead, plans to plow ahead with a policy that will force patients into a “one size fits all” approach.
CMS is even ignoring a November 2023 Government Accountability Office (GAO) report that warned them against integrating these drugs into the CMS bundle payment. In that report, GAO cited potential reduced or delayed patient choice, additional practical burdens for kidney providers, and the risk that medical professionals, who patients trust, will be forced to use older and less effective medications.
You can and must help stop this effort by CMS to drive PLTs into the “bundled” payment system.
- Please personalize the letter template found to your right and ask your U.S. Senators to include date-change provisions to postpone the integration of oral-only PLTs into the ESRD payment bundle by one year, and
- ask them to consider supporting The Kidney PATIENT Act (H.R. 5074 / S. 4510) which was successfully voted out of both the Ways & Means and Energy & Commerce Committees. This bipartisan legislation would instruct CMS to delay adding PLTs to the ESRD bundle until 2033 or until the Food and Drug Administration (FDA) approves an intravenous treatment for lowering phosphate.