In this week’s roundup: CMS has finalized many of its 2022 annual payment rules, with important policies impacting dialysis devices, AI, and the broader sweep of the healthcare system. Also: MCIT repeal getting close, IVD regulatory updates in Europe and China, and more from FDA and HHS.
Here are a few highlights from the 2022 payment rules, and more from CMS:
First dialysis-tech bonus pay. Two years into its new-technology bonus payment program for renal dialysis tools, CMS will make its first award to Outset Medical’s Tablo home hemodialysis system. The agency announced the bonus payment, to kick in on January 1, 2022, in its End-Stage Renal Disease final 2022 payment rule, released October 29. CMS launched the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) in January 2020, modeling the established new-technology add-on payment (NTAP) for hospital inpatient procedures as a way to provide extra reimbursement for new technologies, allowing more time for CMS to collect economic data for the devices.
Outset and a couple of other companies have previously tried to qualify for a TPNIES payment, but have fallen short. Additional data from Outset, and a policy tweak last year by CMS to put more focus on home dialysis devices, helped seal the deal this time around. Outset argued, and the agency agreed, that Tablo, FDA-cleared in 2020, improved medication and dialysis adherence compared to existing home hemodialysis offerings—in particular, Fresenius Medical Care’s NxStage system. CMS and the company didn’t disclose the bonus-payment amount awarded, but the agency did state in the final rule that, “overall TPNIES payment amounts in CY 2022 would be approximately $2.5 million, of which, approximately $490,000 would be attributed to beneficiary coinsurance amounts.”
Another 2022 TPNIES applicant, CloudCath, had to withdraw its application because it didn’t gain FDA marketing authorization in time for its peritoneal dialysis drain set monitoring system.