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COVID-19 UPDATES

USE OF FREESTYLE LIBRE 14 DAY SYSTEM IN THE HOSPITAL SETTING

Abbott’s FreeStyle® Libre 14 day system is now available for use in U.S hospitalized patients with diabetes during COVID-19 pandemic. This will permit healthcare professionals to remotely monitor patients with diabetes receiving inpatient care by assessing real-time glucose levels and glucose trends and eight hours of glucose history in real-time.

As a result, Abbott can provide the FreeStyle Libre 14 day system to hospitals who want to implement the technology for remote monitoring of glucose in patients who are able to scan the sensor themselves.

The following information should be reviewed carefully before using FreeStyle Libre 14 day systems in hospital settings.

 

Important information for hospitals using FreeStyle Libre 14 day system with hospitalized patients during the COVID-19 Pandemic

  • Hospitals should consider whether they have the resources and expertise necessary to adequately implement FreeStyle Libre 14 day system use in their facility and provide appropriate training to healthcare providers.
  • The FreeStyle Libre 14 day system should only be used in patients who are able to perform glucose scans themselves.
  • FreeStyle Libre 14 day system glucose results are less accurate than blood glucose results obtained using traditional testing methods (e.g., lab glucose, blood glucose meters) in hospital settings. Users should consider all FreeStyle Libre 14 day system glucose information (e.g. history, trends) along with individual glucose values and interpret results in the context of the full clinical picture.
  • The FreeStyle Libre 14 day sensor is subject to interferences that may generate falsely high and falsely low glucose readings. Levels of interference depend on drug concentration; substances that may not significantly interfere in non-hospitalized patients may interfere when used in the hospital setting because of higher dose levels. Most drugs used in hospital or critical care settings have not been evaluated and their interference with the FreeStyle Libre 14 day system is unknown. Known interferences include a significant positive bias due to high doses of ascorbic acid (Vitamin C) and a slight negative bias when taking salicylic acid (used in some pain relievers such as aspirin). Other reducing drugs/ compounds may also interfere.
  • Poor peripheral blood perfusion may cause inaccurate sensor readings. FreeStyle Libre 14 day system results should be interpreted considering accompanying patient conditions and medications. Other clinical conditions may also cause inaccurate readings.

 

For more information about using FreeStyle Libre 14 day system in the hospital, please contact:

Abbott Diabetes Care Hospital Sales                                                                   1-800-401-1183

 

OTHER IMPORTANT UPDATES & WHAT YOU SHOULD KNOW

MEDICARE HAS EXPANDED COVERAGE OF CGM- THE FREESTYLE LIBRE 14 DAY SYSTEM, DURING COVID-19.

On May 8th, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a number of new actions to provide more options for treating Medicare beneficiaries during the COVID-19 public health emergency.1,2,**. On an interim basis, CMS will not enforce the clinical indications for therapeutic CGMs in LCDs.

  • This includes temporary non-enforcement of the 4x/day testing requirement.
  • CMS stated that the use of therapeutic CGM may allow Medicare beneficiaries to proactively treat their diabetes and prevent the need for hospital-based diabetic care.
  • CMS noted that practitioners will also have greater flexibility to allow more of their Medicare beneficiaries with diabetes to better monitor their glucose and adjust insulin doses from home by using a therapeutic CGM.
  • This enforcement discretion applies to all Medicare beneficiaries, regardless of their COVID-19 status.
  • This enforcement discretion will only apply during the Public Health Emergency.
  • The statutory standard for “reasonable and necessary” items and services still apply.

This will now provide healthcare professionals (HCPs) greater flexibility for prescribing CGMs to appropriate patients. People with underlying medical conditions, including patients with diabetes, are at a higher risk of more serious complications from COVID-19.3 As CMS notes in its rulemaking, “use of therapeutic continuous glucose monitors may allow patients to proactively treat their diabetes and prevent the need for hospital-based diabetic care.” It is now, more important than ever to ensure that Medicare patients can benefit from the FreeStyle Libre 14 day system to monitor diabetes remotely.

Click here to download our Medicare order form   Click here to be contacted by your representative

YOU CAN DO IT REMOTELY

If you are unable to see your patients with diabetes in your office, you are able to access your patients’ FreeStyle Libre 14 day glucose reports remotely including a complete picture of their glucose patterns via LibreView*. This allows for your patients to remain safe at home while giving you the data you need to make more informed treatment decisions.

Our FreeStyle Libre digital ecosystem provides your patients with the FreeStyle LibreLink  mobile app and LibreView* a secure cloud- based reporting software that allow both you and your patients to connect remotely at no cost.
Here’s how to get started

 

*The LibreView data management software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluations of historical glucose meter data to support effective diabetes management. The LibreView software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

†The FreeStyle LibreLink app is only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the app. Use of the FreeStyle LibreLink app requires registration with LibreView. 

** As a courtesy to its customers, Abbott provides the most accurate and up-to-date information available, but it is subject to change and interpretation. The customer is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients. Abbott does not guarantee third party coverage of payment for our products or reimburse customers for claims that are denied by third-party payors.

References: 1. 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.pdf2. 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 3. See https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-at-higher-risk.html.

                                                                                                                                                                                                                    ADC-21076 V3.0 09/21

Important Safety Information

FreeStyle Libre 14 day system: Failure to use FreeStyle Libre 14 day system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.

FreeStyle Libre 2 and FreeStyle Libre 3 systems: Failure to use FreeStyle Libre 2 or FreeStyle Libre 3 systems as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.

FreeStyle Libre Pro: The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns and glucose level excursions above or below the desired range, facilitating therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for use by health care professionals and requires a prescription.

IMPORTANT: The device may inaccurately indicate hypoglycemia. The results of the clinical study conducted for this device showed that 40% of the time when the device indicated that user sensor glucose values were at or below 60 mg/dL, user glucose values were actually in the range of 81-160 mg/dL. Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should only be based on the trends and patterns analyzed through time using the reports available per the intended use.

CONTRAINDICATIONS: Remove the Sensor before MRI, CT scan, X-ray, or diathermy treatment.

WARNINGS/LIMITATIONS: The FreeStyle Libre Pro System does not provide real-time results and patients should adhere to their blood glucose monitoring routine while using the system. If a sensor breaks, contact physician and call Customer Service. Patients with high levels of ascorbic acid (Vitamin C) or salicylic acid (used in Aspirin) or severe dehydration or excessive water loss may experience inaccurate results with this system. The FreeStyle Libre Pro System is not approved for pregnant women, persons on dialysis, or recommended for critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. Review all product information before use or contact Abbott Toll Free (855-632-5297) (or visit provider.myfreestyle.com) for detailed indications for use and safety information.

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ADC-45115 v5.0 05/22