ABBOTT PARK, Ill., Sept. 1, 2020
/PRNewswire/ -- Abbott (NYSE: ABT), the worldwide leader in
continuous glucose monitoring (CGM),4 announced today
its next-generation FreeStyle® Libre 2 integrated
continuous glucose monitoring (iCGM) system is now available to
Medicare patients. Having met the codes for therapeutic CGM systems
used for coverage by the U.S. Centers for Medicare & Medicaid
Services (CMS), the FreeStyle Libre 2 system is now accessible
to all Medicare patients with diabetes who meet the
eligibility criteria.
"Abbott designed the FreeStyle Libre portfolio for performance,
access and affordability to make it broadly available to people
with diabetes who need it," said Jared
Watkin, senior vice president, Diabetes Care, Abbott. "By
securing reimbursement, Abbott is making sure our latest
life-changing technology can get to everyone who needs it, whether
they're children, adults or seniors eligible for Medicare."
The FreeStyle Libre 2 system includes a sensor that is the
easiest to apply5,6 and is worn on the back of the upper
arm for up to 14 days, measuring glucose every minute. With a
one-second scan using a handheld reader over the sensor, the system
provides users with a real-time glucose reading, trend arrow and
eight-hour history to help them and their healthcare providers make
more informed treatment decisions.
The FreeStyle Libre 2 system includes optional real-time alarms
and measures glucose levels every minute, meeting the highest level
of accuracy standards7 over 14 days, including superior
day one6 accuracy compared to the other iCGM and excellent accuracy
and alarm performance at low end glucose levels.8 With a
14-day wear time, the FreeStyle Libre 2 system is the
longest-lasting, self-applied iCGM sensor currently available,
eliminating the need for fingersticks2 –
and priced at a third of the cost of other CGM
systems.3
The pandemic is changing the way healthcare is delivered with
greater acceptance of telehealth and medical technologies with
remote monitoring capabilities such as CGMs. For instance, during
the public health emergency, CMS is giving healthcare professionals
more flexibility to prescribe CGMs9 to those who
qualify. Additionally, the U.S. Food and Drug Administration (FDA)
is allowing the FreeStyle Libre system to be used in hospital
settings10 during the pandemic, making Abbott's diabetes
technology more easily accessible.
As the #1 sensor-based glucose monitoring system used in the
U.S. and worldwide,4 Abbott's FreeStyle Libre portfolio
has changed the lives of more than 2 million people across more
than 50 countries6 by providing breakthrough technology that is
accessible and affordable.3 Abbott has secured partial
or full reimbursement for the FreeStyle Libre portfolio in 37
countries, including Canada,
France, Germany, Japan, the United
Kingdom and the U.S. For more information, visit
www.freestylelibre.us.
Indications and Important Safety Information
The
FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous
glucose monitoring (CGM) device with real time alarms capability
indicated for the management of diabetes in persons age 4 and
older.*
WARNINGS/LIMITATIONS:
The System must not be used with automated insulin dosing (AID)
systems, including closed loop and insulin suspend systems. Remove
the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do
not take high doses of vitamin C (more than 500 mg per day), as
this may falsely raise your Sensor readings. Failure to use the
System according to the instructions for use may result in missing
a severe low blood glucose or high blood glucose event and/or
making a treatment decision that may result in injury. If glucose
alarms and readings from the System do not match symptoms or
expectations, use a fingerstick blood glucose value to make
diabetes treatment decisions. Seek medical attention when
appropriate and contact Abbott Toll
Free (855-632-8658) or visit
* www.freestylelibre.us for detailed indications for use
and safety information.
*Please refer to www.freestylelibre.us for the indications
and important safety information.
About Abbott
Abbott is a global healthcare leader that
helps people live more fully at all stages of life. Our portfolio
of life-changing technologies spans the spectrum of healthcare,
with leading businesses and products in diagnostics, medical
devices, nutritionals and branded generic medicines. Our 107,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at
www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
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1
Patients must meet Medicare eligibility
coverage criteria. Local Coverage Determination: Glucose Monitors
(L33822), January 2020.
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2
Fingersticks are required if your glucose
alarms and readings do not match symptoms or when you see Check
Blood Glucose symbol during the first 12 hours.
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3
Based on a comparison of list prices of
the FreeStyle Libre 14 day system versus competitors' CGM systems.
FreeStyle Libre 2 system list price is the same rate as FreeStyle
Libre 14 day system. The actual cost to patients may or may not be
lower than other CGM systems, depending on the amount covered by
insurance, if any.
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4
Data on file, Abbott Diabetes Care. Data
based on the number of users worldwide for the FreeStyle Libre
portfolio compared to the number of users for other leading
personal-use, sensor-based glucose monitoring systems.
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5
Based on comparison to Dexcom
G6.
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6
Data on file, Abbott Diabetes
Care.
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7
Based on FDA iCGM special
controls.
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8
Based on comparison between FreeStyle
Libre 2 and Dexcom G6 User Manuals and low glucose alarms set at 70
mg/dL.
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9
CMS Interim Final Rule, CMS-5531-IFC, RIN
0938-AU32. Published in the Federal Register on May 8, 2020 and is
available at
https://www.govinfo.gov/content/pkg/FR-2020-05-08/pdf/2020-09608.pdf.
CMS Issues Interim Final Rules with Comment (CMS-1744-IFC &
CMS-5531-IFC) – COVID-19 Public Health Emergency – Revised May 21,
2020
https://www.cgsmedicare.com/jc/pubs/news/2020/05/cope17333.html.
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10
Patients must be able to scan their
FreeStyle Libre 14 day sensor by themselves.
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SOURCE Abbott