When I walk into a dialysis unit today, it looks much the same as it did when I entered nephrology practice in 1995. Yet if I were to walk into a cardiac care unit or a cancer treatment suite, it would look dramatically different. The medications have changed so much that those who taught me about heart disease or cancer in the 1980s and 1990s would not be able to teach the students and residents of today.
Why is there such a disparity in innovation between nephrology and other medical fields? The ability to make money drives entrepreneurs and “sharks” to invest their creativity, drive, and money to a field. When the United States Government amended the Social Security Act in 1973 to permit Medicare payment for patients requiring dialysis, they paid $138 per treatment; an equivalent payment based on inflation would be $1,033 in 2025. The base rate paid today is $273.82.
Recognizing the lack of drivers of innovation, the kidney community banded together and asked Congress and the Centers for Medicare and Medicaid Services (CMS) to consider additional payment for new, innovative medications and equipment which could improve the quality of life and outcomes of patients requiring dialysis. In 2016, CMS introduced two payment pathways: the Transitional Drug Add-on Payment Adjustment (TDAPA) and the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES).
These programs provide payment of 65 percent of the average sales price of new products. The first products to qualify for TDAPA payment were calcimimetics, medications which mimic the action of calcium on the parathyroid gland, reducing the incidence of bone complications of chronic kidney disease. When initially introduced, the IV form (etelcalcetide or Parsabiv) was thought to represent a significant advance compared with the oral form (cinacalcet or Sensipar) and widespread use was anticipated. However, over the two-year TDAPA period, providers and physicians found little difference between the two forms of the medication, so when a generic form of cinacalcet was introduced in 2018, its use dramatically surpassed that of etelcalcetide. At the end of the two-year TDAPA period, payment for etelcalcetide was reduced further and its use was even more limited.
Another product, Korsuva (difelikefalin) was introduced in 2021 for treatment of itching associated with kidney disease. Because of the side effects of other medications used to treat itching like Benadryl (diphenhydramine), Korsuva was thought to be a tremendous advance. However, physicians used very little Korsuva because there was no pathway to permanent payment and they knew patients would not be able to pay for it after the TDAPA period ended. When TDAPA ended, CMS determined, based on use and pricing, to add nine cents for its ongoing use. Since the payment was sufficiently inadequate, Korsuva was withdrawn from the market in 2024.
A new drug called XPHOZAH (tenapanor) has been approved by the FDA to help lower phosphorus levels in people undergoing dialysis. The developers are seeking to ensure its continued availability for patients through legislative changes or adjustments to the payment system. If these changes do not occur, access to this medication may also be at risk.
So far, TDAPA and TPNIES have not spurred innovation for patients requiring dialysis. The best way for patients to change the programs to gain more innovation is to talk about what they need, and talk to anyone who will listen: friends, other patients, doctors, dialysis unit staff, representatives at the local, state, or federal level, and officials in the department of health at the local, state, and federal level.
Often patients feel ill-equipped to talk to their representatives, but it is precisely patient stories and experiences which are needed. Since these programs were created to serve patients, those who oversee them need to understand where the programs work and where they fall short of reaching their goals.
Talking to officials may seem intimidating at first, but after a couple of meetings it will feel much more routine. Talking with your representatives alongside others in the kidney community—whether patients, physicians, or representatives of dialysis providers—may make these meetings feel easier.
New medications and equipment have the potential to improve the lives of people who have kidney disease. However, people who are impacted by these innovations need to make their voices heard. You can find support and help from organizations like the Renal Support Network. It is our voices which will force changes in a system that has changed little over the past 50 years!
As a physician, I will continue to speak up about the flawed payment system that does not spur innovation in treatment, and I hope you will join me!
Jeffrey Silberzweig, MD is the Chief Medical Officer of The Rogosin Institute, leads the dialysis programs at New York-Presbyterian Hospital as Chair of the Dialysis Executive Council and is the medical director of the dialysis units at the Weill Cornell and Lower Manhattan Hospital Campuses. He has been a nephrologist and leader in the community for over 25 years and has received many prestigious awards.
Web ID: 44098
