In this week’s roundup: CMS’ recently established new-tech bonus payment for innovative dialysis devices remains a steep climb for companies, and more Medicare news. In Europe, the first centralized expert panel issued an opinion on a high-risk device’s clinical assessment, and it didn’t pull any punches. Also, UDI updates from the US and Brazil, the latest from the MDUFA V talks, China standards, and more.
US reimbursement updates:
Climbing Mt. TPNIES. CMS’ recently established add-on payment for innovative renal dialysis devices—called the “transitional add-on payment adjustment for new and innovative equipment and supplies” (TPNIES)—will continue to be a steep climb for interested device makers, based on discussions in the agency’s 2022 End Stage Renal Disease (ESRD) proposed payment rule posted July 7. Two companies applied for bonus TPNIES payments to support adoption of new technologies last year and both were rejected. Two are now applying for 2022 payments, and CMS appears to have big questions for the submissions. Outset Medical Inc. is making its second go at winning extra payment for its 2020 FDA-authorized Tablo System for patient-driven home hemodialysis, but CMS is questioning the company’s clinical claims compared to Fresenius Medical Care’s NxStage home hemodialysis system, among other issues. In addition, CloudCath is seeking a TPNIES add-on for its CloudCath remote monitoring-based peritoneal dialysis system, but CMS doesn’t appear convinced.
“It is not clear to us whether the studies submitted demonstrate or examine the impacts of using the technology on patients with ESRD such that we can determine whether it represents an advance that substantially improves the treatment of Medicare beneficiaries compared to renal dialysis services previously available,” the agency notedin the proposed rule. In addition, CloudCath has yet to announce 510(k) clearance for the technology, so it may not have met the July 6 deadline for the program. But CMS makes clear that it will not make a final determination until the final ESRD rule is out in the fall.