ARTICLE SUMMARY:
In its proposed End Stage Renal Disease 2023 payment rule, CMS advances payment proposals for dialysis. Excerpted from Pathways Picks June 22: Medicare News, EU IVDR Rules, FDA Actions.
Total Medicare payments to dialysis facilities would increase by 3.1% next year under CMS’ proposed End Stage Renal Disease 2023 payment rule, issued June 21. This covers reimbursements for facility-based and home-based dialysis, including adjustments based on an array of quality and performance metrics. As part of the annual payment-setting process, three dialysis devices are pursuing bonus payments next year from CMS to help support market access, but they all have long odds based on the agency’s track record and comments in the proposed rule. The Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) for dialysis devices was launched in 2020, but so far only one device has qualified for the 65% bonus—Outset Medical’s Tablo home hemodialysis system. CMS won’t make any official rulings until the final rule this fall, but the agency underscored concerns with each of the three applicants for 2023 TPNIES add-ons:
- The CloudCath Peritoneal Dialysis Drain Set Monitoring System (CloudCath), FDA cleared in February, is a remote monitoring system intended to catch a serious side effect of peritoneal dialysis more quickly. But in the ESRD proposed rule, CMS questions whether the data affirmed that the quicker diagnosis actually impacts patient treatment and outcomes.
- The SunWrap System (Sun Scientific Inc.) is a compression sleeve intended to manage the puncture and support hemostasis following removal of a dialysis needle, but CMS questions whether the firm’s data meets the “substantial clinical improvement” threshold for TPNIES. In addition, the TPNIES is supposed to be for FDA-authorized devices, but SunWrap is a Class I exempt device, meaning it doesn’t have an FDA authorization. “Our intent...was to exclude devices that lack FDA marketing authorization,” CMS writes. “However, we welcome public comment on these issues.”
- The Theranova Dialyzer (Baxter Healthcare Corp.) is making its second go at a TPNIES payment after falling short for 2021. Baxter has submitted additional data in support of the device, which is a single-use dialyzer designed to more comprehensively remove certain harmful proteins compared to current systems, while maintaining essential proteins during hemodialysis. But CMS doesn’t appear convinced yet, noting that most of the submitted studies for the device are open-label and observational, “which may potentially bias results.”
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