Imagine being diagnosed with a life-threatening illness—only to learn that your doctor is limited to using treatments and tools from the 2000s instead of more advanced therapies.
That’s exactly what’s happening to patients with kidney disease today. While treatments in other advanced disease states, such as cancer and heart disease, are improving at an exponential pace, generating hundreds of billions of dollars in new investment, kidney care innovations remain stuck in the past.
Nephrologists provide care for patients with chronic kidney disease (CKD), which, without intervention, can progress to End-Stage Kidney Disease (ESKD) or kidney failure. Unfortunately, for kidney patients and their doctors, many of the available treatments aren’t much different from those offered decades ago because outdated Medicare policies are holding them back.
It’s time for Congress and the Centers for Medicare & Medicaid Services (CMS) to support incentives for innovation in kidney care, as is done in other advanced chronic disease treatment fields such as cancer, cardiology, AIDS and ALS. And it is the millions of Americans living with kidney disease who feel the cascade of these policy decisions that have left many without innovative options.
Medicare’s capitated “bundled payment system” for dialysis care is grossly outdated and underfunded, discouraging investment in the development of innovative treatment options for ESKD patients since it was implemented in 2011. For the past 14 years, Medicare has been reimbursing kidney care providers with a single, fixed fee for dialysis services and all medications related to the treatment. While the intent of this payment system was to control costs, its real-world impact has been to decrease access for patients to innovative therapies and penalize care providers who try to offer new and potentially life-changing treatments.
Recognizing the limitations of this reimbursement system, CMS implemented two policies—the Transitional Drug Add-on Payment Adjustment (TDAPA) and the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPINIES)—to reimburse new drugs and technologies for up to two years. While this initially provided hope for increased access to innovative treatment options for patients, most drugs and devices that came to market still failed to reach patients.
A recent prime example of these limitations is difelikefalin (Korsuva), the first and only FDA-approved drug to treat CKD-associated pruritus (CKD-aP)—a distressing condition characterized by persistent, intense skin itching and irritation. This is not a minor inconvenience or annoyance; CKD-associated pruritus can lead to bleeding, skin infections, sleep disorders, depression and anxiety, which result in serious complications requiring hospitalization.
Recognizing the need for more effective treatment options for this condition, the FDA expedited its review process for Korsuva. However, Medicare dismissed the drug as merely a substitute for an antihistamine, Benadryl, even though antihistamines are used to treat allergies and insect bites, not a condition like CKD-aP. CMS placed Korsuva in the same functional category—a distinct grouping of drugs or biologicals—as Benadryl based on this fundamentally inaccurate medical analogy.
In doing so, the agency failed to acknowledge that Korsuva—a first-in-class, breakthrough designated product that received FDA expedited review—would require more resources than a generic antihistamine that can have significant side effects, came to the market 80 years ago, and is not effective in treating CKD-aP. As a result, CMS refused to permanently adjust Medicare’s payments to dialysis providers to provide adequate resources to allow patients to access Korsuva. In turn, without adequate reimbursement for the drug, this decision essentially prevented doctors from prescribing it to some patients who would benefit from it, and left patients to suffer without it. This led to its manufacturer withdrawing from the market.
There’s no reason that kidney care patients should be forced to suffer without the benefits of medical innovations because of outdated policies. Medicare policy should be a bridge to innovation, not a barrier.
Thankfully, Senators Marsha Blackburn (R-TN) and Cory Booker (D-NJ) recently introduced the bipartisan Kidney Care Access Protection Act (S. 2730), which, if passed, would help a payment system that supports the long-term adoption of new kidney care treatments and therapies—not one that forces them off the market before they have a chance to make a difference in the lives of patients.
We urge lawmakers to advance this legislation and work together to build a better Medicare payment system—as they have done for other diseases—that ensures CKD and ESKD patients can benefit from medical innovation. It’s time for kidney care to join other medical specialties in the 21st century.
Suzanne Watnick, M.D., is the health policy scholar in residence at the American Society of Nephrology. Jeffrey Silberzweig, M.D., is chief medical officer of the Rogosin Institute.