Medicare Now Covers Abbott’s FreeStyle Libre CGM
By Brian Levine, Adam Brown, and Kelly Close
Available to people with type 1 or type 2 diabetes on intensive insulin therapy. Another continuous glucose sensor option for people over 65 is now covered, in addition to Dexcom G5!
This just in: Medicare will now cover Abbott’s FreeStyle Libre real-time continuous glucose monitoring (CGM) system. The news came in much faster than we had expected, only three months after the FDA approved the no-calibration FreeStyle Libre as a replacement for fingersticks and safe for dosing insulin. This also came quite fast after FreeStyle Libre launched last month in retail pharmacies in the US.
Starting today, those on Medicare with type 1 or type 2 diabetes using intensive insulin therapy (multiple daily injections or a pump) now have access to two CGM systems: Abbott’s FreeStyle Libre (real-time) and Dexcom’s G5. The criteria for FreeStyle Libre coverage is identical to that for Dexcom’s G5. That is, someone covered by Medicare is eligible for reimbursement for either device if he or she:
Has type 1 or type 2 diabetes;
Currently uses a home blood glucose monitor (BGM) and performs at least four fingersticks per day;
Takes insulin, either with multiple daily injections (MDI) or an insulin pump;
And has an insulin plan that requires frequent changes based on CGM readings.
As diaTribe understands it, Medicare will cover the following FreeStyle Libre components for those eligible (see this article for Dexcom specifics):
One FreeStyle Libre handheld reader device (which should last three years);
Three CGM sensors per month (each is 10-day wear);
Test strips to be used with the blood glucose meter embedded in the FreeStyle Libre reader. Abbott has not clarified how many strips, but these would be used during FreeStyle Libre’s 12-hour warmup period and at other times. Dexcom’s Medicare G5 bundle comes with 60 strips per month, but Libre may come with fewer since it doesn’t require fingerstick calibrations.
Unfortunately, the Libre system is unavailable in major retail pharmacies for those covered by Medicare. Instead, Libre will be available by prescription in the United States through Edgepark Medical Supplies, Byram Healthcare, Solara Medical Supplies, Edwards Health Care Services, Better Living Now, Mini Pharmacy, and Advanced Diabetes Supply.
Those covered by Medicare for Dexcom typically pay approximately 20% of the costs of CGM themselves, or roughly $50 per month. (This additional amount may be covered by secondary insurance.) Medicare will typically cover the remaining 80%. We’d guess this out-of-pocket pricing is also true for FreeStyle Libre as Medicare has set them at the same pricing.
Like Dexcom’s G5 bundle, FreeStyle Libre will require a prescription and will ship through mail order for those on Medicare. As mentioned last month, for those with private insurance or paying cash, FreeStyle Libre is only available in pharmacies.
That the US Centers for Medicare and Medicaid Services (CMS) decided to cover FreeStyle Libre on such short notice is a positive sign. Dexcom paved the way for Libre with a two-year push to finally receive the first fingerstick replacement designation from FDA for G5 in December 2016, followed by CMS’s decision to reimburse in March 2017.
Dexcom, in its early efforts to ship its G5 system to Medicare patients, experienced some reimbursement hurdles. However, as of the last update in November, over 4,000 individuals had received a G5 bundle through the mail, and Dexcom hoped to ship about 20,000 by the end of 2017. We’ll have to see if Abbott encounters similar challenges.
Abbott’s FreeStyle Libre is different from Dexcom’s G5 in several key respects, including no alarms, no fingerstick calibrations, a longer 12-hour warmup, a 10-day sensor wear period that cannot be extended, a fully disposable on-body component, and a simpler insertion process. If you are eligible for coverage, we include some notes on key differences below.
Even if you’re not on Medicare, Abbott’s website has an encouraging statistic: Most people with private insurance in the US pay no more than $75 per month out-of-pocket to get FreeStyle Libre. That translates to $2.50 or less per day, which is favorable compared to other options. Abbott says FreeStyle Libre is already as widely covered under private insurance as other CGMs, and its goal is further accessibility through the pharmacy. Conversations with insurers are underway.
Could Medicare CGM even help those with private insurance? It’s possible, since many insurers look to Medicare for guidance. Now that Medicare has approved coverage for two CGM systems for type 1 AND type 2 intensive insulin users, it could nudge all private insurers to more widely cover CGM.
This has been many years in the making, thanks to amazing advocates, the CGM companies, and Medicare. This is very positive access news to start the year for people with diabetes who are on insulin and who do not already have CGM.
More Details and FAQ:
Fingerstick calibration: FreeStyle Libre does not require fingerstick calibration, whereas Dexcom requires two per day.
Warmup: FreeStyle Libre has a 12-hour warmup where no real-time data is displayed. Dexcom only has a two-hour warmup period. Due to the 12-hour warmup period for Libre, people will have to use fingersticks instead (for 12 hours, every 10 days). Since the warm-up time is significantly shorter in the international version of Libre (one hour), many hope Abbott can reduce it over time in the US. For those willing to purchase a separate FreeStyle Libre reader and overlap sensor wear times, it is possible to avoid the 12-hour warmup; read more here. Medicare users will need to pay cash to obtain a second reader.
Communication/Alarms: FreeStyle Libre does not have alarms and does not communicate continuously with a display device – the sensor must be manually scanned with the reader to obtain a real-time value. Dexcom sends data continuously to the receiver and has alarms. The presence of alarms makes Dexcom a good choice for people with impaired awareness of hypoglycemia and/or frequent hypoglycemia. In studies, FreeStyle Libre has driven strong reductions in hypoglycemia, but the added “safety blanket” of an audible alarm with Dexcom can be a big difference-maker.
Wear time/Restart: FreeStyle Libre is labeled for 10-day wear, while Dexcom is labeled for 7-day wear. FreeStyle Libre cannot be “restarted” with the Abbott reader device – it has a “hard stop,” meaning that once 10 days are up, a brand-new sensor must be inserted. On the other hand, Dexcom sensors can be restarted – once an already-inserted sensor expires, it can go through a new two-hour warmup and continue giving data.
Transmitter: FreeStyle Libre does not have a separate transmitter – the sensor patch is fully disposable and is discarded after 10 days. Dexcom’s G5 has a reusable transmitter that lasts three months, attaches to each disposable body-worn sensor, and relays data to the receiver.
These product differences will change over time – some potentially this year. For instance, Dexcom’s next-gen G6 is currently under FDA review, with plans to launch before the end of 2018. It is currently under review for one fingerstick calibration per day and 10-day wear, but FDA discussions are also underway for a no-calibration version. Meanwhile, Dexcom’s next-next-gen sensor with Verily requires no calibration, will be fully disposable, and last 10 or 14 days. Abbott is currently developing a next-gen FreeStyle Libre as part of its Bigfoot partnership, which will add continuous communication to the FreeStyle Libre sensor. We’d guess it could add alarms too, but this is speculation on our part.
At this time, app communication and remote monitoring are not allowed for therapeutic CGMs. Dexcom has had to turn off this function in its G5 Medicare system, a tremendous frustration for users due to the current Medicare reimbursement codes. We know that Dexcom is working to fix this, along with a number of patient and organizational advocates. Unfortunately, there is no timing to report, but we hope to see this policy overturned as soon as possible – remote monitoring of CGM data can save lives!
Abbott’s FreeStyle Libre does not have an approved smartphone reader app in the US right now. Its LibreLink and LibreLinkUp apps are available outside the US, though we’re not sure when they’ll come to the US.
It’s hard to know at this point. Senseonics’ 90-day implantable Eversense CGM is currently under FDA review, but not for fingerstick replacement. This means that the first approval, which might come this year, wouldn’t make it eligible for Medicare coverage. A secondary submission for fingerstick replacement could follow at some point, and if approved, Eversense could qualify for coverage.
Medtronic’s Guardian Connect mobile CGM is also currently under FDA review, with US launch expected by April. We’d guess that it will not be designated therapeutic CGM upon approval because (i) the product label for the Guardian-sensor-integrated 670G hybrid closed loop states that fingersticks are always to be used when taking a bolus; and (ii) three to four fingersticks per day are recommended.
At this time, Medicare coverage is only available to those that meet the criteria above. We feel very strongly that others at risk of hypoglycemia, especially those on sulfonylureas (e.g., glipizide, glyburide, glimepiride), should also have access to CGM. We will be working on advocacy on this front – let us know if you’d like to help.
If you have other questions on Abbott’s FreeStyle Libre, Dexcom’s G5, and Medicare coverage, please send them here.