Miller, Colleagues Ask CMS For More Information on Oral-Only Drugs Coming into ESRD Bundle

Washington, D.C. - Congresswoman Carol Miller (R-WV) led a letter to Centers for Medicare and Medicaid Services (CMS) asking for further guidance on how they plan to incorporate oral-only drugs into the End Stage Renal Disease (ESRD) Prospective Payment System (PPS) Bundle. Joining Congresswoman Miller in sending the letter are Representatives Terri Sewell (D-AL), Buddy Carter (R-GA), Ann McLane Kuster (D-NH), Larry Buschon (R-IN), and Suzan DelBene (D-WA).

On How Oral-Only Drugs Help ESRD Patients:

"Many ESRD patients on dialysis rely on oral-only phosphate binders to remove excess phosphorus from the body to properly manage serum phosphorus levels, which is crucial to maintaining health and reducing morbidity and mortality among this population. ESRD patients now have broad access to phosphate binders under Medicare Part D, but unless action is taken to delay implementation, oral-only therapies like phosphate binders will move into the bundle, impacting patient access to care starting on January 1, 2025."

On Concerns About How These Guidelines Could Harm Current ESRD Patients:

"CMS has stated both in recent guidance and preambles to prior rules, and most recently in the Calendar Year 2025 (CY25) ESRD PPS Proposed Rule that the agency plans to replicate the process used for incorporating the calcimimetics when implementing the phosphate binder class in the ESRD PPS. We have concerns about the translatability of the calcimimetics process and the impact that policy will have on quality patient care. Calcimimetics are a smaller class of products used in about 32 percent of patients living with ESRD, and there were only two products available at the time of the bundling of this class of drugs, one of which was administered intravenously. Unlike calcimimetics, phosphate binders must be taken with food, meaning they should not be taken during a dialysis session where consuming food and drink are generally not allowed.

"Every patient's treatment plan and response to certain phosphate binders is different, and many patients only respond to one drug or a combination of drugs to achieve their goal serum phosphorus level. The Government Accountability Office's (GAO) November 2023 report warns that moving these drugs into the bundle would potentially result in a reduced or delayed availability of phosphate binders for patients as the number of oral drug prescriptions dispensed by dialysis facilities is expected to "quadruple." The report also highlights that staff, including pharmacists, will need to be hired if oral-only phosphate binders move into the bundle, further exacerbating workforce pressure.

"We are also concerned about the impact of this policy change for the near 50 percent of Medicare ESRD patients now enrolled in Medicare Advantage (MA). By the end of 2022, almost half of the roughly 450,000 Medicare beneficiaries with ESRD enrolled in an MA plan. Unlike Traditional Medicare, MA plan contracts do not account for newly bundled products until they are updated, which can take up to 18 months. In the case of oral-only drugs, where patients are already on these prescribed therapies, the change in coverage from Part D to Part C could cause sudden disruption for patients enrolled in MA plans. With the rapid shift of beneficiaries to MA, we believe it is imperative for policymakers to better understand the impact bundling has on this sizeable segment of the ESRD population."

Click here to read the full letter.

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