Funding Innovative Dialysis Technology in the United States: Home Dialysis and the ESRD Transitional Add-on Payment for New and Innovative Equipment and Supplies (TPNIES).

Innovative, patient-centered, and pragmatic dialysis technologies are urgently needed to accommodate the growing national interest in home dialysis use. To help achieve this goal, the US Centers for Medicare & Medicaid Services (CMS) are expanding reimbursement for eligible home dialysis machines through an existing payment mechanism, the transitional add-on payment for new and innovative equipment and supplies (TPNIES). This mechanism incentivizes the early adoption of innovative equipment into practice by reimbursing dialysis providers up to 26% of the total cost of approved home dialysis machines. Machines are evaluated for TPNIES eligibility using prespecified substantial clinical improvement (SCI) criteria that are derived from the Inpatient Prospective Payment System (for non-nephrology technologies). Although the SCI criteria may be suitable for some non-nephrology technologies, they have not been adapted to consider the unique and complex care inherent in home dialysis. Thus, many of the SCI criteria appear unsuitable for home dialysis machines. To better incentivize innovation, CMS should develop nephrology-specific transparent and pragmatic criteria for TPNIES. In this perspective, we provide an overview of the TPNIES payment mechanism, highlight areas of concern within the policy, and offer solutions for improving TPNIES that could better promote the adoption of new home dialysis machines.