Orals in the payment bundle: What will the future hold?
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Effective Jan. 1, 2025, CMS will begin including phosphate-binders in the end-stage renal disease prospective payment system bundle.
Initially, these medications will be billable by dialysis centers through a Transitional Drug Add-on Payment adjuster, later to be included in the dialysis base rate.
Notably, the United States Renal Data System estimates that 20% of patients with ESRD currently lack access to part D coverage. CMS holds that allowing these oral products to be paid for in the ESRD prospective payment system (PPS) under Medicare Part B will increase access.
Education is key for patients with ESRD who are accustomed to getting some non-IV drugs from their dialysis providers. This includes oral medications, like cinacalcet, vitamin D, diuretics and lidocaine/prilocaine cream. This fall, dialysis providers will start educating both patients and their nephrologists about the upcoming change.
Prescriptions for these drugs will need to be transferred from their current retail pharmacies to a centralized pharmacy contracted by the provider. In some cases, that may be a mail-order pharmacy responsible for mailing these oral drugs to patients’ homes. In other cases, that may be a pharmacy that ships these drugs to the dialysis unit or alternative sites preferred by the patient.
There has been speculation about how providers will incorporate these phosphate binders into their formularies. Some have wrongly speculated that only the least expensive agents, in this case calcium-based binders, would be used or that the clinical targets for phosphorus control will change. While there is a lot of complexity to implement a change of this magnitude, we have been working on this for more than a year. Given the rapidly approaching deadline, other providers are working on what they need to implement this as well.
Patient access to their most clinically appropriate medications is the leading driver in our organization’s approach. Therefore, our intent is to include one or more agents from each binder class in our formulary to ensure that patients and physicians have access to their binder of choice. We anticipate that the transition of phosphate binder payment from Medicare Part D to Part B (and inclusion in the ESRD PPS bundle) will increase access to certain binder classes for our patients, specifically the iron-based binders.
Further, DaVita’s phosphate targets, which are grounded in evidence-based and expert-consensus guidelines, will not change. Freed from the formulary and copays of Medicare Part D, physicians will be able to make the optimal choice for their patients with greater assurance their patient can access the medication.
Operationally, much work is needed to ensure that our patients and physicians have a seamless transition when these drugs go into the bundle. Our teams have been working on this transition for the last year and are confident that we can meet the CMS mandate.
Being on dialysis is difficult, caring for patients on dialysis should not be. More patients having access to binders is clinically beneficial for patients and provides increased choice to physicians and better oversight of prescription data for dieticians. This change has the potential to improve patient care and potentially reduce pill burden.
From our perspective, we are ready for this change and look forward to working with our patients and prescribers to improve bone and mineral outcomes as a result.
- Reference:
- United States Renal Data System. 2023 Annual Data Report. Available at https://usrds-adr.niddk.nih.gov/2023. Accessed Oct. 8, 2024.
- For more information:
- Jeffrey Giullian, MD, MBA, FASN, is chief medical officer of DaVita Inc. and a Healio | Nephrology News & Issues Editorial Advisory Board Member. He can be reached at jeffrey.giullian@davita.com.
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