Outset Medical’s Tablo® Hemodialysis System Receives Landmark TPNIES Approval From CMS
01 Novembre 2021 - 1:03PM
Business Wire
TPNIES approval to provide additional
reimbursement for Tablo home dialysis treatments
Outset 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.
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the full release here:
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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)
TPNIES 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.
“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.”
More 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 dialysis can create a significant burden on
patients, impacting their quality of life, ability to maintain
employment and adherence to their dialysis treatment regimen.
“Doing in-center dialysis treatments during the first year of
the COVID-19 pandemic was terrifying,” said Tablo patient Ron
Kapke. “When my healthcare team suggested home hemodialysis with
Tablo in early 2021, I jumped at the opportunity and never turned
back. Recovery time after Tablo is so much shorter, allowing me to
get back to the job I love — farming — within thirty minutes post
treatment. My life has become so much more enjoyable, my energy has
returned, and I dare say that there is a sense of normalcy
returning.”
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.
“Outset’s Tablo Hemodialysis 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 Dr. Varshi
Broumand, System Dialysis Medical Director at CHRISTUS Health.
“Since most adults in the United States 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 hospitalizations.
There’s no question that when it comes to patient comfort and
delivering superior outcomes, home dialysis via Tablo is the
undisputed winner.”
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.
A selection of excerpts from the public TPNIES comments is provided
below.
About Outset Medical, Inc.
Outset is a medical technology company pioneering a
first-of-its-kind technology to reduce the cost and complexity of
dialysis. The Tablo Hemodialysis System, FDA cleared for use from
the hospital to the home, represents a significant technological
advancement that transforms the dialysis experience for patients
and operationally simplifies it for providers. Tablo serves as a
single enterprise solution that can be utilized across the
continuum of care, allowing dialysis to be delivered anytime,
anywhere and by anyone. The integration of water purification and
on-demand dialysate production enables Tablo to serve as a dialysis
clinic on wheels, with 2-way wireless data transmission and a
proprietary data analytics platform powering a new holistic
approach to dialysis care. Tablo is a registered trademark of
Outset Medical, Inc.
Forward-Looking Statements
This press release may contain forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements include statements regarding Outset’s
expectations with respect to the anticipated benefits of the TPNIES
approval. Forward-looking statements are inherently subject to
risks and uncertainties, some of which cannot be predicted or
quantified, which could cause actual results and other events to
differ materially from those expressed or implied in such
statements. These risks and uncertainties include risks described
in the Risk Factors section of Outset’s most recent annual report
on Form 10-K and quarterly report on Form 10-Q filed with the U.S.
Securities and Exchange Commission. These forward-looking
statements speak only as of the date hereof and should not be
unduly relied upon. Outset disclaims any obligation to update these
forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20211101005342/en/
Nicole Shannon Director, Marketing Communications for Outset
Medical nshannon@outsetmedical.com
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