Southern West Virginia News

Congresswoman Carol Miller (R-WV) has led a letter to the Centers for Medicare and Medicaid Services (CMS), seeking further guidance on the incorporation of oral-only drugs into the End Stage Renal Disease (ESRD) Prospective Payment System (PPS) Bundle. Representatives Terri Sewell (D-AL), Buddy Carter (R-GA), Ann McLane Kuster (D-NH), Larry Buschon (R-IN), and Suzan DelBene (D-WA) joined her in this request.

Addressing the role of oral-only drugs in ESRD treatment, the letter states: “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.”

The representatives also expressed concerns about potential negative impacts of these guidelines on current ESRD patients. They noted: “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 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."

They highlighted differences between calcimimetics and phosphate binders: "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 bundling 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."

The letter also addressed variability in patient responses: “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."

Referring to a Government Accountability Office’s November 2023 report, they warned: "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."

Concerns were also raised regarding Medicare Advantage (MA) enrollees: “We are also concerned about the impact of this policy change for nearly 50 percent of Medicare ESRD patients now enrolled in Medicare Advantage (MA). By the end of 2022, almost half of 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 case of oral-only drugs where patients are already on these prescribed therapies, change in coverage from Part D to Part C could cause sudden disruption for patients enrolled in MA plans. With rapid shift of beneficiaries to MA, we believe it is imperative for policymakers to better understand impact bundling has on this sizeable segment of ESRD population.”

To read more details from their letter click here.