TPNIES: A Step in the Right Direction for ESRD

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On November 8, CMS published a final rule that, among other provisions, establishes a transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) under the end-stage renal disease Prospective Payment System. The decision is encouraging for industry as it holds the promise of spurring the development and adoption of innovative new dialysis and other device technologies; however, it leaves out one critical element: capital-related assets/equipment.

An important final rule (CMS 1713-F) was handed down by the Centers for Medicare & Medicaid Services (CMS) at the end of last month, that will have a direct impact on the dialysis device industry. As part of the first-of-its-kind ruling’s extensive provisions, a transitional add-on payment has been established to support ESRD facilities in the uptake of innovative new renal dialysis equipment and supplies under the ESRD Prospective Payment System (PPS). Referred to as Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES), the ruling has received broad support from industry and organizations such as the National Kidney Foundation (NKF), KidneyX (a partnership between the US Department of Health and Human Services and the American Society of Nephrology), and others, as an important step in advancing the overall patient- and innovation-focused goals of the July 2019 Advancing American Kidney Health Initiative Executive Order.

However, many ESRD industry stakeholders have expressed concern over the areas in which they feel TPNIES is lacking, including the exclusion of certain “capital-related assets,” such as dialysis machines that are both leased and owned. In the words of Leslie Trigg, CEO of dialysis innovator Outset Medical Inc., in a recent interview with Market Pathways, the ruling isn’t taking into consideration “swing-for-the-fences innovation.”

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