Insurance Deductibles Don't Work Well for Patients with Chronic Illnesses. Some strategies for PWD's With HDHP's to Consider.

As of 2022, the U.S. Internal Revenue Service (IRS) defined a High-Deductible Health Plan (HDHP) as a health plan with an annual deductible that is not less than $1,500 for self-only coverage or $3,000 for family coverage, and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts) must be satisfied before coverage kicks in. About half of all Americans with employer-sponsored healthcare insurance plans have deductibles to satisfy before the insurance covers much, although some employers provide Health Reimbursement Accounts (HRAs) to help offset the deductible. That said, the IRS has also ruled that a HDHP can actually cover certain types of "preventive" care without a deductible, or with a deductible that is much less than the annual deductible applicable to all other healthcare services, which is why the 2019 IRS decision to add care for a number of chronic medical conditions including diabetes to the list of "preventive" care benefits that may be provided by HDHP's was a big deal (catch my coverage of that at https://blog.sstrumello.com/2019/09/in-2020-people-with-diabetes-may-wish.html). While HDHP's can now cover insulin and test strips and a growing number actually do, many health plans still exclude CGMs since those were not explicitly named by IRS.

Consider the cost of CGM sensors. 

One reliable source to determine the actual cost of a CGM sensor is the Costco Member Prescription Program https://www.costco.com/cmpp which provides cash prices for some CGM sensors and other prescriptions Costco Pharmacy carries. Costco reports the cash prices for CGM sensors ranges from $57.33/sensor to $61.28/sensor. But the cost calculation is NOT complete yet. The reason is because the wear-time for CGM sensors also varies. For example, Dexcom G6/G7 sensors enable users to wear the CGM sensors for 10 calendar days, while Abbott Freestyle Libre 3 sensors can be worn for 14 calendar days. More frequent CGM sensor replacement generally costs patients more money out-of-pocket unless your insurance covers a portion of the cost. Hence a true cost comparison for CGM sensors must also calculate the cost of wearing the CGM sensor on a daily basis. Using the per sensor CGM costs computed from Costco CMPP, then the cash cost per day of wearing CGM sensors is as follows:

• Dexcom G6 Sensors cost $6.13 per day of usage
• Dexcom G7 Sensors cost $5.73 per day of usage
• Abbott Freestyle Libre 3 Sensors cost $4.23 per day of usage

The cost of using the lowest-price Dexcom CGM device (G7) therefore still costs 35.5% MORE than using an Abbott Freestyle Libre 3 CGM device costs unless a patient's insurance pharmacy benefit assumes some portion of the cost which is increasingly the case. 

CVS Health which owns/operates my own insurance carrier Aetna has chosen to cover just enough (about 37%) of the cost of using a CGM device to make it more attractive for me as a covered patient to use my own employer-sponsored insurance pharmacy benefit rather than me completely bypassing my insurance. If I were paying the costs completely out-of-pocket, my cost would have been $6.13 per day for a Dexcom G6 CGM sensor if I bought it at Costco Pharmacy. But it's actually cheaper for me to use my insurance (I pay about $3.88 per day of usage). That way, CVS Caremark still gets a cash rebate kickback from Dexcom which they would not collect if I bypassed insurance and bought an Abbott Freestyle Libre 3 instead. 

Of course, patients might still consider using Dexcom anyway in spite of it having a higher cost. For example, Dexcom has the most partnerships signed on Automated Insulin Delivery ("AID") systems (see https://t1dexchange.org/status-update-automated-insulin-delivery-devices/), and peer-reviewed medical research studies have shown that patients using AID systems have generally superior glycemic control, and those systems also make life vastly easier for patients, so the higher price might still be worth it for some (not necessarily all) patients.

There's one option also worth acknowledging here, which is if you're insurance doesn't cover CGM sensors at all until your deductible is satisfied: Dexcom has a manufacturer coupon program which covers up to $200 per month. Using Costco's CMPP to check prices, its cost for 1 Box of Dexcom G6 Sensors (each box contains 3 sensors) is $183.84 (or $61.28 per sensor) while 1 Box of Dexcom G7 Sensors (each box contains 3 sensors) is $171.99 (or $57.33 per sensor), so the newer product is marginally cheaper. GoodRx distributes Dexcom manufacturer coupons, or you can easily download the coupon from Dexcom's website at https://www.dexcom.com/en-us/savings-center-cgm-without-insurance/. Disregard whether it asks if you have insurance; if you have a deductible to satisfy before your insurance covers it, then you're effectively uninsured and should therefore use the Dexcom manufacturer coupon (just don't try to use a manufacturer coupon WITH insurance; you must use one or the other but usually not both; choose the one which costs you the least. Also, if you use Medicare, beware that coupons do not generally work WITH Medicare, but might work if you pay cash for a prescription, in which case, you might want to calculate which option costs you the least. Beware that some find it easier to fill scripts using coupons at a completely different pharmacy.

Another possibility is to consider using a longer-term CGM at the end of the calendar year which will last you for six months. In theory, insurance will likely pay for it by December. You can then use the Eversense E3 CGM for six months, which will carry you until June 2024. Perhaps by next June, your deductible will already be satisfied. 

 

Interestingly, on June 2, 2023, Senseonics https://www.senseonics.com/ and its collaborating partner Ascensia https://www.ascensiadiabetes.com/eversense/ announced it had landed Eversense E3 CGM coverage from the nation's largest commercial healthcare insurance company: United Healthcare (see https://www.businesswire.com/news/home/20230602005099/en/Senseonics-Announces-UnitedHealthcare-Coverage-of-Eversense%C2%AE-E3-CGM-for-Adults-with-Diabetes for the press release) which was kind of a big deal for the CGM startup.

Eversense had gained coverage from United Healthcare even though CGM rival Dexcom pays rebates to its OptumRx PBM unit which are paid by Dexcom contingent upon "formulary exclusion" for all rival CGM systems. But the reason for that seeming oxymoronic coverage decision was because Eversense CGMs must be inserted in (and removed from) patients' arms by a medical doctor. Hence, Eversense CGM's are typically reimbursed under the patient's medical (not pharmacy) benefit. That said, Abbott's Libre CGM system is definitely excluded from United Healthcare's OptumRx formulary. Ditto for CVS Health/Aetna/Caremark, which like United Healthcare, announced in 2018 that it would cover Eversense CGMs (see https://www.businesswire.com/news/home/20181022005926/en/Senseonics-Announces-Aetna%E2%80%99s-Positive-Coverage-Decision-for-Eversense for more). Curiously, Cigna's Express Scripts does not currently have a formulary exclusion for Abbott Freestyle Libre CGMs, although I'm not certain if Eversense currently has coverage from Cigna (it might). 

I suspect the Federal Trade Commission's 6(b) study now underway on PBM business practices might play a role because Express Scripts had the longest history of data which was subpoenaed by FTC for the study, and the company likely did not want to add anymore potential wrongdoing to its already-long list of matters which the FTC could cite and sue them over. The FTC is the only government agency which has the legal authority with subpoena power that does not necessarily have a law-enforcement intent, although it could if FTC uncovers any proof of wrongdoing.

Recall that on June 16, 2022, FTC issued a revised policy statement (see https://www.ftc.gov/news-events/news/press-releases/2022/06/ftc-ramp-up-enforcement-against-illegal-rebate-schemes) that it intends to ramp up enforcement against any illegal bribes and rebate schemes that block patients' access to competing lower-cost prescriptions. However, as a practical reality, enforcement hasn't really happened until the FTC 6(b) study on the business practices of the six largest pharmacy benefit managers concludes. That 6(b) study was expanded earlier this year to also include PBM-owned Group Purchasing Organizations (GPOs), including Express Scripts Ascent Health Services GPO which is based in Switzerland, and OptumRx's Emisar Pharma Services GPO which is based in Ireland. 

For patients with diabetes who have substantial annual deductibles to satisfy, Eversense might be a compelling option if the patient coordinates having the first Eversense CGM sensor inserted in December. That would translate into no more costs for CGM sensors until the following June since replacement is done every 6-months, and presumably, many will have already satisfied their annual deductible by that time. 

The most notable downside is that Eversense E3 displays and updates real-time glucose readings every 5 minutes, just as Dexcom G6 and G7. By comparison, Abbott Freestyle Libre 3 displays and updates real-time glucose readings every minute. Eversense also enables (and indeed, requires for the first 21 days) calibrations. Because Eversense requires a small outpatient surgical procedure in a physician's office to insert and remove the sensor — that can potentially result in scar tissue. Also, you have to wear the black plastic transmitter on your upper arm over the inserted sensor, which really is not particularly discrete. The transmitter adhesive backing must also be replaced every 24 hours, plus you have to charge the transmitter for about 10 minutes every day (the charge lasts a max of roughly 42 hours); if the battery runs out, your readings will be interrupted until you charge it. By comparison, Libre 3 does not enable calibrations, but that is offset by the fact that Abbott Freestyle Libre 3 gives users 1440 new blood glucose readings per day compared to only 288 readings per day with Dexcom or Eversense. Whether more updates makes much practical difference remains open to debate, but its a factor to consider if you have a choice.

Like Dexcom, Eversense also has a patient assistance program called Eversense PASS which covers part of the cost of the system. Visit https://www.prnewswire.com/news-releases/ascensia-diabetes-care-expands-payment-assistance-and-simple-savings-program-for-eversense-e3-cgm-system-301818639.html for more on that program.

For patients who rely mainly on automated insulin delivery (AID) systems, Eversense E3 is not currently integrated with any of those systems except the DIY systems which have gained international credibility since being published in peer-reviewed medical journals; there Dexcom is the hands-down winner (although Abbott Freestyle Libre already has an AID system with Ypsomed called the mylife YpsoPump system https://www.mylife-diabetescare.com/en/ which is CGM platform-neutral, meaning it's compatible with both Abbott Freestyle Libre as well as Dexcom). Technically, CGM platform-neutrality will also potentially be true for Tandem and it was true for Insulet until February 2023 when that company acquired intellectual property rights for a closed-loop system from Bigfoot Biomedical, although even Tandem has yet to announce U.S. plans for their AID systems to work with Abbott CGMs in the U.S. Lilly abandoned its joint project with Ypsomed to enter the U.S. insulin pump market in December 2022, but Ypsomed has nevertheless told investors it still plans to submit its YpsoPump system to the U.S. FDA for approval in the second half of 2023 according to plan. It will then shop around for a new U.S. partner to help commercialize the AID system once it attains FDA approval. YpsoPump is currently used in Germany, Austria, Switzerland, the UK and other European markets, so the system is already very well-tested.

Meanwhile, the Eversense E3 medical vs. pharmacy benefit coverage is likely to be the way for Senseonics/Ascensia to get around formulary exclusions which have limited Abbott Freestyle Libre system from more rapid U.S. growth, although Senseonics/Ascensia still have a major challenge getting doctors trained to insert the Eversense sensors themselves because so few doctors are trained to insert and remove the Eversense sensors.

Eversense E3 is still relatively small in the U.S. But the team at Taking Control Of Your Diabetes (TCOYD) has a video of Dr. Steven V. Edelman getting an Eversense E3 CGM sensor inserted in his arm real-time, while his collaboration partner Dr. Jeremy H. Pettus was an observer. They also include the website link for Eversense at https://www.ascensiadiabetes.com/eversense/get-started-today/ if you're interested in learning more. In their dialogue, they mention that some patients find the Eversense E3 to be more accurate than other CGM's. A key feature is that Eversense has vibration alerts which enable patients to know if blood glucose levels are low or high and they have those without access to their phones or receivers. 

Catch the video at https://youtu.be/v6pqBiFZtow?si=t9A_QISQXTc-Gm7Z or below.