Navigating New Waters: The Challenges of Integrating Oral-Only Medications Into Dialysis Programs

Running a dialysis program is inherently challenging, requiring a balance between clinical efficacy, regulatory compliance, and operational efficiency. Dialysis program administrators are facing a potential new challenge: the inclusion of payment for oral-only medications such as phosphate binders in the End-Stage Renal Disease Prospective Payment System (ESRD PPS). Currently, the American Taxpayer Relief Act states that the ESRD PPS will include oral-only ESRD medications effective January 2025. This change presents logistical, patient insurance coverage, and cost-related challenges that administrators must navigate to ensure the continued delivery of high-quality care. 

Logistical Challenges 

One primary logistical challenge posed by the inclusion of oral-only medications in the ESRD PPS is integrating these medications into the existing management and distribution systems. Unlike injectable medications provided during dialysis treatment or during the monthly clinic visit, oral phosphate binders must be taken several times daily. The dialysis program would need to contract with a retail pharmacy to ensure patients receive medications for home use, adding to the complexity of medication management and necessitating a more integrated tracking system. It is crucial for dialysis programs to update their internal systems to ensure seamless coordination between prescription, procurement, delivery, and billing processes. 

Patient Insurance Coverage Challenges 

In addition to logistical challenges, dialysis programs should closely monitor each patient’s insurance coverage, which will likely determine which patients will continue to receive phosphate binders from their local pharmacy and which patients will receive the medication through their dialysis program. During the first years of the Transitional Drug Add-On Payment Adjustment, dialysis programs struggled to obtain reimbursement for calcimimetics from payers other than traditional Medicare. This reduced the availability of calcimimetics to patients without traditional Medicare. Many Medicare Advantage plans took over a year to update their claims processing systems to accurately reimburse for calcimimetics, and some never did due to contract issues. There is a concern in the renal community that insurance coverage and reimbursement issues may cause unnecessary barriers to reimbursement that could make it challenging for patients to obtain necessary medications. 

Cost Challenges 

The inclusion of oral-only medications in the ESRD PPS also brings substantial financial implications. It is not breaking news that dialysis programs operate under tight budget constraints. The ESRD PPS aims to cover all necessary services, but there are many challenges that prevent dialysis programs from recouping the costs associated with every patient’s treatment. The addition of oral medications to this bundle without a commensurate increase in reimbursement rates from all payer sources, not just Medicare, strains the financial viability of many facilities.  

Studies have examined the potential impact of the costs of oral phosphate binders on dialysis programs. Many of these studies indicate that it is unlikely the reimbursement afforded in the ESRD PPS will be sufficient to cover the costs associated with phosphate binders and could jeopardize dialysis programs’ ability to continue to provide care.  

Over the last decade, the renal community has successfully demonstrated to the US Congress that the inclusion of oral-only medications, such as phosphate binders, in the ESRD PPS should be postponed. Clear processes that ensure adequate reimbursement and help dialysis programs navigate the many challenges associated with providing phosphate binders to dialysis patients should be in place before oral-only ESRD drugs are included in the ESRD PPS.  

At the time of this writing, HR 5074, a bill to delay the inclusion of oral-only ESRD drugs in the ESRD PPS until January 1, 2033, or until an approved intravenous drug is available, is making its way to be passed by the US House of Representatives. Dialysis programs will be ahead of the game if they plan for oral-only drugs to be included in the ESRD PPS in January 2025, even though many in the renal community are hopeful HR 5074 is signed into law and the inclusion of oral-only drugs is delayed.