Outset Medical gains landmark CMS approval for Tablo home haemodialysis system

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Tablo system

Outset Medical has announced that its Tablo haemodialysis 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 dialyse at home and reclaim their independence, according to an Outset press release.

TPNIES is a recently enacted programme 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, the release adds.

“Outset’s Tablo haemodialysis system not only addresses a 15-year gap in dialysis innovation, but it also delivers a device that is far easier and safer for users to navigate,” said Varshi Broumand, system dialysis medical director at CHRISTUS Health. “Since most adults in the USA now have smartphones with similar touchscreen interfaces, patients have felt at home with Tablo’s touchscreen, on-screen animations and step-by-step instructions. This comfort has made the dialysis experience easier on patients, resulting in fewer complications and hospitalisations. There is no question that, when it comes to patient comfort and delivering superior outcomes, home dialysis via Tablo is the undisputed winner.”

Tablo offers a new level of simplicity aimed at solving the problems that have limited home dialysis adoption to date, including burdensome training requirements, complex machine operation and time-consuming preparation before treatments. Designed to reduce the costs and complexity of dialysis, while simplifying the patient and provider experience, Tablo is an all-in-one solution with integrated water purification and the ability to deliver multiple dialysis treatment types in a compact, 35-inch unit. A connected and intelligent device, Tablo has two-way communication with the cloud, which allows treatment data to be sent electronically and enables physicians to remotely monitor patients at home.

“For too long, ESRD patients have faced a lack of innovation and options for their kidney treatment, restricting how, when and where they dialyse,” said Outset CEO Leslie Trigg. “At Outset, we have always believed that dialysing 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.”

The TPNIES approval was made after a comprehensive review of Tablo’s technology, as well as an open public comment period. Nearly 200 comments supportive of Tablo as a significant innovative improvement over the existing technology were submitted by healthcare providers, clinicians and patients during this process, the Outset release concludes.

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