NIHB Coverage for the Freestyle Libre
As a Canadian Certified Diabetes Educator (CDE) I have had the opportunity to assist many individuals to access and use the Freestyle Libre flash glucose monitor to assist with their diabetes management. A colleague recently asked me about non-insured health benefits coverage for the Freestyle Libre Flash Glucose Monitoring device so that prompted me to share some of what I know to help others learn as well.
The Freestyle Libre is a blood glucose monitoring device that has become a popular piece of diabetes technology in recent years. It helps those living with Type 1 and Type 2 diabetes to skip the fingerpokes and instead scan their arm to check their blood sugar/blood glucose and to see patterns in their daily blood sugar trends. People with diabetes need to know their blood sugar levels at any given time for many reasons including to help them decide how much insulin to give themself, to show their body’s responses to food and activity, and also to tell the patient if they are at a safe blood sugar level for exercise or to drive.
The Freestyle Libre gives information beyond the single blood sugar test and does this without the pain of a fingerpoke. The Freestyle Libre, which is both a sensor device that is worn on the arm and a reader (Libre scanner or smartphone), gives patients their current blood sugar levels, their blood sugar pattern over the last day or days, and also gives an indication of where their blood sugars are going over the next 15 minutes.
The Freestyle Libre Device
The Freestyle Libre sensor is a small wearable device, about the size of a Canadian “Toonie” ($2 coin) that is worn on the arm. The sensor records sugar/glucose levels every 15 minutes and also whenever the sensor is scanned. This impressive device captures over a thousand (1000) blood sugar test results each day for up to 14 days.
The Libre differs from a continuous glucose monitor (CGM) in that the information is not ‘pushed’ to a separate device like it is with a CGM but instead the user must scan the sensor with the reader to see and transfer the information to the reader device. The libre sensor holds 8 hours of blood sugar information and the user must scan the sensor with the reader every 8 hours to transfer that data over to the reader.
It is important to note the libre does not read a true “blood sugar” in that the sensor is not sitting in the blood. The device estimates the person’s blood sugar based on the glucose levels of the interstitial fluid, which is fluid just under the skin.
In Canada, the Freestyle Libre has been available since August 2017. People living with Type 1 and Type 2 diabetes are excited for the ability to know their blood sugars in real time without fingerpoke testing. Self monitoring of blood glucose (SMBG) is painful, expensive, and only offers a single piece of information to the person living with diabetes. Often people with diabetes need to test at least 2 times (referred to in practice as “testing in pairs”) to have enough information to make treatment decisions. This gets expensive and is cumbersome for the patient.
Currently the Freestyle Libre is widely available in pharmacies across Canada. A prescription is not required for the over-the-counter purchase of the Libre but is required if you want to be reimbursed for the cost by your health plan. Many 3rd party insurers, such as those who provide workplace coverage, also cover the Freestyle Libre for people with diabetes but each plan differs in their coverage. It is best to call your plan administrator directly if you have workplace coverage for the Freestyle Libre as they will have the most current coverage amounts for you.
Non Insured Health Benefit (NIHB) Coverage
If you work with Indigenous peoples in Canada who have health benefits under the Non Insured Health Benefits (NIHB) program, you may have wondered about coverage for the Freestyle Libre using this health benefits plan. The NIHB benefits plan does offer coverage for the Freestyle Libre but the patient will need to also meet the criteria required for the Exceptional Approval category of the benefits plan. As many have discovered after searching the internet, this Exceptional Approval criteria is not published. In order to respect NIHB’s processes, I will discuss criteria believed to be required for the NIHB approval for the Freestyle Libre.
Coverage under the NIHB Benefits Program
Once a prescriber has prescribed the Freestyle Libre to their patient, the prescription is sent to the patient’s pharmacy. The pharmacist sends the prescription to NIHB for approval whereby NIHB sends a criteria sheet back to the prescriber to assess the individual’s qualifications for coverage. This can take several days or even weeks. Talk about barriers to timely access! Then NIHB will fax a request to the prescriber or the CDE to fill out verification paperwork. Once that is complete, fax the paperwork back in to NIHB for processing.
It is believed that coverage under NIHB is initially for only a 12-month period. This places a time frame to the commitment by NIHB and also holds a level of responsibility on both the patient and the prescriber to confirm that the patient needs this device on an ongoing basis beyond the 12 month approval window.
Freestyle Libre Coverage Criteria
NIHB coverage is not publicized but we can assume a few of the aspects of criteria needed for benefit coverage.
Adults
The approval for use by Health Canada is for adults 18 and over only. Does this mean those under 18 cannot use the Libre. NO! What it means is either the company did not apply for use and benefit coverage in those under 18 years of age, or there was not enough clinical evidence provided to support the accuracy and efficacy for use in children and teens at the time of the approval by Health Canada.
Are children and teens using the Libre? YES but it is considered off-label use which is described as using a product in a different way than its intended use. Families are using this device in their sons and daughters, allowing greater autonomy for their children to participate in daily activities with increased diabetes management confidence in their health and safety because of the information and trends offered by the Libre. It is not known if NIHB allows coverage for off-label use.
Hypoglycemia
Hypoglycemia, or low blood sugar, is a significant health concern to the individual living with diabetes and a constant source of stress and worry for the loved ones of people living with diabetes. Hypoglycemia reduces quality of life and daily productivity for people with diabetes and can reduce their ability to function for minutes to hours as they recover from the life-threatening experience of their blood sugars dropping below 4mmol/L. Hypoglycemia can be mild, moderate or severe and is always a risk in anyone who injects insulin. We can assume that NIHB feels that this significant outcome of uncontrolled diabetes is within their approval criteria.
Other Coverage Criteria
There are further eligibility criteria for the Freestyle Libre required by NIHB. In order to respect the NIHB processes, I will not provide further details in this post. Please visit my private Facebook group Diabetes Training 101 Inc. Community of Learning. In addition to outlining the full criteria there, I will share what I have learned from my practice as a Certified Diabetes Educator working with NIHB benefits and with patients who access the Non Insured Health Benefits program.
Want to learn more about blood sugar testing, the Freestyle Libre and testing in pairs?
Click the link below to access free videos and previews for our Diabetes Manager University (DMU) online training program for Canadian Healthcare Professionals. In the DMU we have a full session dedicated to the use and interpretation of blood sugar testing tools. The DMU training program can help you Learn to Make a Difference in Diabetes. https://diabetes-training-101-inc.thinkific.com/
What has your experience been with the Freestyle Libre? What are your patients saying about using it to manage their diabetes? Drop a comment or a question here or join us on Facebook in the Diabetes Training 101 Inc. Community of Learning.
Michelle Archer, RD, CDE
Registered Dietitian & Certified Diabetes Educator
Diabetes Training 101 Inc.
References
- Libre Availability August 2017: https://www.cadth.ca/dv/ieht/flash-glucose-monitoring-system-diabetes
- Health Canada Approval https://hpr-rps.hres.ca/reg-content/summary-basis-decision-medical-device-detailThree.php?linkID=SBD00477&wbdisable=false