MedCity Influencers

Protect Personalized, Independent Kidney Care

A pending CMS policy could cause havoc for independent kidney care facilities and patients who need life-sustaining treatments.

For 50 years, the community-based dialysis center where I work has helped close healthcare gaps in our community by ensuring that patients can access high-quality kidney care in a convenient setting. But next January, a pending policy would make it much harder for our patients to maintain control over their care. Here’s why. 

Not only do your kidneys help filter toxins and control blood pressure, but they also work to remove excess electrolytes and minerals like phosphate. When patients have severe chronic kidney disease, however, their kidney function declines, and they often lose the ability to filter phosphates from their blood properly, leading to a condition known as hyperphosphatemia. Without treatment, hyperphosphatemia can lead to bone fractures, heart disease, and even death. 

Thankfully, oral-only phosphate-lowering drugs help patients with severe CKD keep their phosphate levels within normal limits. In fact, the majority of patients on dialysis are prescribed some type of this medication. When patients go to pick up their phosphate binder drug from the pharmacy, pharmacists will ensure that patients have the necessary guidance to administer the drug safely and correctly. These instructions are important to boost medication adherence, particularly in the case of oral-only phosphate-lowering drugs that have to be taken with every meal. 

However, a pending policy from the Centers for Medicare & Medicaid Services (CMS) threatens to upend the status quo by including these medications in the ESRD Prospective Payment System (PPS) in 2025. If this policy proceeds as planned, dialysis providers – rather than pharmacies – will be responsible for dispensing these drugs to patients. 

From my experience as a community-based dialysis provider, I cannot understate the havoc this will cause for independent kidney care facilities and our patients in need of these life-sustaining treatments. 

While dialysis centers remain committed to working closely with patients, there is no denying that pharmacists are best suited to provide them with detailed drug information. If oral-only phosphate-lowering drugs are included in the broader dialysis payment bundle, the responsibility to ensure correct medication management and review for drug interactions will shift from the pharmacy to dialysis providers. This is problematic given that some states have laws that limit who can provide this medication management guidance. In my home state of Ohio, for example, providers who prescribe medications cannot advise on how it is meant to be taken. This reality will leave many patients confused and without an expert to consult on how to boost medication adherence and, consequently, ensure positive outcomes. 

Dialysis centers also aren’t well-situated to provide these medications. While in-center dialysis typically happens three times per week, these phosphate-lowering drugs must be taken multiple times per day, every day, with meals or snacks, in order to be effective. 

Further, not all facilities have the infrastructure to support the additional storage and administrative requirements that this policy will create. For example, independent centers treat 15,000 patients, more than 90% of whom are on at least one phosphate binder. With this policy in place, centers would need to securely store over 13,000 bottles of medication, a formidable challenge for any small to midsize provider. 

Additionally, there are multiple types of phosphate-lowering drugs from which physicians and patients must select to get the right outcomes for each individual patient. While centers ideally prescribe to meet each patient’s specific needs, some may be forced to limit supply to only a select few oral-only phosphate-lowering drugs due to storage constraints. This will create a one-size-fits-all model for phosphate-lowering drugs – a devastating setback for personalized kidney care. 

Thankfully, Congress has a chance to support the kidney care community and protect uninterrupted access to these drugs through the Kidney PATIENT Act (H.R. 5074), which would delay the inclusion of oral-only drugs in the ESRD PPS payment bundle. While this legislation is not a cure-all, this delay will enable the kidney community to find a solution that works for patients and providers alike. It’s critical that lawmakers step up and advance this legislation to ensure that patients can access the medication they need in the most appropriate setting. 

Photo:, Getty Images

David Oppenlander is a former Chief Financial Officer for an independent dialysis provider in Northeast Ohio.

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