A recent shift in Medicare coverage for key medications used in dialysis treatment has created significant challenges for nursing home residents and the facilities that care for them. This change, impacting access to oral phosphate binders, has disrupted established supply chains and raised concerns about patient well-being and regulatory compliance.
Starting January 1st, Medicare bundled payments for seven oral phosphate binders into its End Stage Renal Disease Prospective Payment System (ESRD PPS). These medications are crucial for dialysis patients, helping to manage excess phosphate levels that can lead to serious health complications like vascular damage and bone loss. Previously, long-term care pharmacies supplied these medications under Medicare Part D. Now, dialysis providers are responsible for their delivery.
This shift has inadvertently favored large dialysis providers, often operating freestanding centers, over the established long-term care pharmacy network. “People forget about our nursing home patients,” says Jim Lewis, senior director of policy and advocacy at the American Society of Consultant Pharmacists. “Unfortunately, 90% of the time, CMS is thinking about Joe who lives down the street and goes to his dialysis center. For him, getting it mail ordered is not a problem. But for our patients, it absolutely is a challenge.” This highlights the disparity in care delivery models and the unintended consequences of policy changes.
The result has been a bottleneck in medication delivery for nursing home patients, with reports of delays up to two weeks. Furthermore, the medications are sometimes arriving in non-compliant packaging, requiring nursing home staff to repackage and label them, increasing the risk of medication errors. This situation also creates compliance risks for the nursing homes themselves. “That’s going to ensure that they get the product in a timely manner and we’ve got all of our rules about how it’s going to be incorporated in the patient’s packaging and it’s part of their standard med pass now,” adds Lewis. “Regardless of who pays for it and who gets paid for it, there is nothing that prohibits the dialysis provider from having a relationship with our pharmacies to dispense that product to the patient.”
Paul Conway, chair of policy and global affairs for the American Association of Kidney Patients (AAKP), notes that this issue is indicative of broader problems with the ESRD PPS. “I think there will be more conversation across the kidney community across a variety of therapeutics for patients being up against the bundle and not being able to move as rapidly as possible to get innovative therapeutics to patients and doctors,” Conway stated. AAKP advocates for dismantling the entire bundle, arguing that it hinders innovation and patient access to newer treatments. They are taking these concerns, including the phosphate binder shortage, to the new CMS administrator. Conway, a transplant recipient and former dialysis patient, understands the critical role these medications play in improving quality of life. He encourages patients and nursing homes to actively advocate for their needs by contacting physicians, nurse practitioners, nephrologists, state regulatory bodies, and elected officials.
The current situation underscores the need for a more nuanced approach to healthcare policy, one that considers the unique challenges faced by nursing home residents and the complexities of medication management within this setting. The long-term impact of this payment change remains to be seen, but the immediate consequences are clear: vulnerable patients are facing disruptions in their care, and nursing homes are navigating a complex landscape of compliance risks and logistical hurdles. According to the National Kidney Foundation, approximately 37 million American adults have Chronic Kidney Disease (CKD), and about 90% of those who have CKD are not even aware they have it. This statistic highlights the prevalence of kidney disease and the importance of ensuring access to necessary treatments for this population, especially within the nursing home setting.