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Outset Medical’s Tablo® Hemodialysis System Receives Landmark TPNIES Approval From CMS

TPNIES approval to provide additional reimbursement for Tablo home dialysis treatments SAN JOSE, Calif.--(BUSINESS WIRE)-- Outset Medical, Inc. (Nasdaq: OM)

articleOutset Medical, Inc.November 1, 20213/company/outset-medical-inc/news/outset-medicals-tablor-hemodialysis-system-receives-landmark-tpnies-approval-from-cms
Outset Medical’s Tablo® Hemodialysis System Receives Landmark TPNIES Approval From CMS

About this update from Outset Medical, Inc.

[{"type":"text","content":"\nTPNIES approval to provide additional reimbursement for Tablo home dialysis treatments\n\n SAN JOSE, Calif.--(BUSINESS WIRE)--\nOutset Medical, Inc. (Nasdaq: OM) (“Outset”) today announced that its Tablo® Hemodialysis System has received the first-ever approval from the Centers for Medicare & Medicaid Services (CMS) for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). This pioneering decision will help encourage healthcare providers to embrace new technology enabling more patients to dialyze at home and reclaim their independence.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211101005342/en/The Tablo® Hemodialysis System combines consumer product simplicity, wireless connectivity, and real-time integrated water purification in one, compact 35-inch unit. Named a substantial clinical improvement by CMS, Tablo is the first product approved for the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). (Photo: Business Wire)\nTPNIES is a recently enacted program by CMS to increase access to new and innovative medical technologies for end-stage renal disease (ESRD) patients. Introduced in 2020, the add-on payment addresses barriers in the ESRD bundled payment system that discourage providers from adopting new technologies when they come to market. As part of the TPNIES approval, healthcare providers will have access to supplemental reimbursement over the next two years to support their patients’ use of Tablo at home.\n\n“For too long ESRD patients have faced a lack of innovation and options for their kidney treatment, restricting how, when and where they dialyze,” said Leslie Trigg, Outset Medical’s Chief Executive Officer. “At Outset, we have always believed that dialyzing at home is vital to restoring identity, autonomy and a sense of self-worth for those managing kidney disease. Today’s news is a victory for innovation and patient choice.”\n\nMore than half a million Americans depend on dialysis treatments three or more times per week. And while there are few physical limitations on who can receive home hemodialysis treatment, only two percent of people currently do, despite data indicating more favorable outcomes with home compared to in-center hemodialysis. Receiving in-center...

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