In your post from 2019 on moving the needle of progress, you mention health (or better, wellness) as one of four key levers toward progress, and you highlight patient empowerment and using data from wearable devices as potentially big opportunity.
Do you have any thoughts on what is stopping this from happening? It seems that using data to empower people to live healthier is a win all around: better quality of life/more energy/less pain for the individual, lower medical cost for the insurance and employer, and higher worker productivity. Why aren’t we, for example, seeing health insurance plans that incentivize healthy behavior that can be tracked via wearables and provide meaningful financial incentives (similar to safe driver programs)?
I think the biggest obstacle is FDA clearance for these devices.
The FDA seems to be concerned about people using consumer-grade products to make medical decisions. Let’s say Apple or Google release a smart watch with non-invasive blood glucose capability. Maybe it’s not perfectly accurate, but still useful information for non-diabetics to see how their blood glucose spikes after eating and to monitor the speed at which the body clears out the glucose.
If a diabetic customer starts giving themselves insulin shots based on the watch instead of a measurement from a medical device, that could be bad. Therefore, FDA is very restrictive about devices that report medically-relevant facts, even if there are disclaimers that they should not be used for medical purposes.
So it’s a slog to get the new non-invasive tech to be as accurate as medical-grade tech, to prove that they are equally accurate, and/or to get FDA to sign off on disclaimers that say the data shouldn’t be used to administer medication, etc.
I still think we’ll get there. There’s some info online about the Apple/Rockley Photonics partnership. You can expect a future Apple Watch to have not only its current sensor suite but also measurements for blood pressure, blood alcohol, lactate, and glucose. Blood pressure in the next 2 years, the rest maybe a couple of years later.
Why aren’t insurance companies paying for it yet? I think the current device sensor suite isn’t high enough on cost-benefit for them yet. As prices come down and the new capabilities are added, it seems like a no-brainer. Like in 2035 a device with all the capabilities I described above might be $100. Probably worth it then.
Thanks for the quick response, Eli. My follow-up is similar to Jasons: I’m wondering not so much why insurance companies don’t pay for these devices right now, but more why there isn’t a push to use them to financially reward or incentivize healthy behavior or outcomes.
For example, if it costs an insurance company $10K more to care for someone with diabetes than someone without, what if the insurer offered the patient a deal: if via non-medication means you reverse your diabetes (as measured by insulin and hemoglobin A1C or HbA1c test), we’ll pay you $5,000 (or, if they pay privately for their insurance, we’ll give you a year-end cost refund of $$).
Or, different approach: if you do specific behaviors that we know will lead to your diabetes improving, we’ll pay you a certain amount per month each month you meet the targets consistently (e.g., wear a fitness tracker and exercise 5x per week for 30 min at vigorous intensity and wear a continuous glucose monitor and stick to a 10-hour feeding window by practicing intermittent fasting for at least 20 days/month).
Of course, the details would need to be worked out and there are lots of questions (e.g., how does this work for people who are already metabolically healthy vs. those who aren’t). But there are companies playing this space at a small scale, using biofeedback and clear lifestyle incentives to improve health outcomes (albeit without insurance pay-back), such as VirtaHealth, Levels, and HealthyWage, and commercial supportive counseling programs like Noom.
Given how immense the cost of metabolic disease is for individuals and society I’m surprised that there isn’t a larger effort to use these trackers to fundamentally change how the incentives work. Wouldn’t it be better if insurance companies actually helped people get healthy, rather than pay for ongoing medication for multiple chronic diseases?
I’m really curious if anyone has done any digging on the regulatory barriers that would make it hard to make this happen. (Or maybe this is an untapped business opportunity for someone, if there aren’t any major regulatory hurdles!)
Thanks for that link, Eli. This is exactly the type of context I was looking for. It woulds like there is a regulatory hurdle here with significant potential liability if the program were to get challenged as not meeting those requirements both on the actual program design and on the documentation.
I meant more on the question of financial incentives for metrics. Basically, charging healthy people less / charging more for risk factors. Are you allowed to do this? I think some amount of this is allowed in some jurisdictions, but are there crucial limitations on it?
The ability to charge people more and less based on observed (but not demographic) characteristics got pretty limited by the Affordable Care Act. I’m not sure of the details, however.
In your post from 2019 on moving the needle of progress, you mention health (or better, wellness) as one of four key levers toward progress, and you highlight patient empowerment and using data from wearable devices as potentially big opportunity.
Do you have any thoughts on what is stopping this from happening? It seems that using data to empower people to live healthier is a win all around: better quality of life/more energy/less pain for the individual, lower medical cost for the insurance and employer, and higher worker productivity. Why aren’t we, for example, seeing health insurance plans that incentivize healthy behavior that can be tracked via wearables and provide meaningful financial incentives (similar to safe driver programs)?
I think the biggest obstacle is FDA clearance for these devices.
The FDA seems to be concerned about people using consumer-grade products to make medical decisions. Let’s say Apple or Google release a smart watch with non-invasive blood glucose capability. Maybe it’s not perfectly accurate, but still useful information for non-diabetics to see how their blood glucose spikes after eating and to monitor the speed at which the body clears out the glucose.
If a diabetic customer starts giving themselves insulin shots based on the watch instead of a measurement from a medical device, that could be bad. Therefore, FDA is very restrictive about devices that report medically-relevant facts, even if there are disclaimers that they should not be used for medical purposes.
So it’s a slog to get the new non-invasive tech to be as accurate as medical-grade tech, to prove that they are equally accurate, and/or to get FDA to sign off on disclaimers that say the data shouldn’t be used to administer medication, etc.
I still think we’ll get there. There’s some info online about the Apple/Rockley Photonics partnership. You can expect a future Apple Watch to have not only its current sensor suite but also measurements for blood pressure, blood alcohol, lactate, and glucose. Blood pressure in the next 2 years, the rest maybe a couple of years later.
Why aren’t insurance companies paying for it yet? I think the current device sensor suite isn’t high enough on cost-benefit for them yet. As prices come down and the new capabilities are added, it seems like a no-brainer. Like in 2035 a device with all the capabilities I described above might be $100. Probably worth it then.
Thanks for the quick response, Eli. My follow-up is similar to Jasons: I’m wondering not so much why insurance companies don’t pay for these devices right now, but more why there isn’t a push to use them to financially reward or incentivize healthy behavior or outcomes.
For example, if it costs an insurance company $10K more to care for someone with diabetes than someone without, what if the insurer offered the patient a deal: if via non-medication means you reverse your diabetes (as measured by insulin and hemoglobin A1C or HbA1c test), we’ll pay you $5,000 (or, if they pay privately for their insurance, we’ll give you a year-end cost refund of $$).
Or, different approach: if you do specific behaviors that we know will lead to your diabetes improving, we’ll pay you a certain amount per month each month you meet the targets consistently (e.g., wear a fitness tracker and exercise 5x per week for 30 min at vigorous intensity and wear a continuous glucose monitor and stick to a 10-hour feeding window by practicing intermittent fasting for at least 20 days/month).
Of course, the details would need to be worked out and there are lots of questions (e.g., how does this work for people who are already metabolically healthy vs. those who aren’t). But there are companies playing this space at a small scale, using biofeedback and clear lifestyle incentives to improve health outcomes (albeit without insurance pay-back), such as VirtaHealth, Levels, and HealthyWage, and commercial supportive counseling programs like Noom.
Given how immense the cost of metabolic disease is for individuals and society I’m surprised that there isn’t a larger effort to use these trackers to fundamentally change how the incentives work. Wouldn’t it be better if insurance companies actually helped people get healthy, rather than pay for ongoing medication for multiple chronic diseases?
I’m really curious if anyone has done any digging on the regulatory barriers that would make it hard to make this happen. (Or maybe this is an untapped business opportunity for someone, if there aren’t any major regulatory hurdles!)
It looks like certain wellness programs that are allowed, but there are limits on what you can do if you make it outcome-contingent. https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/publications/caghipaaandaca.pdf
Thanks for that link, Eli. This is exactly the type of context I was looking for. It woulds like there is a regulatory hurdle here with significant potential liability if the program were to get challenged as not meeting those requirements both on the actual program design and on the documentation.
Are there any restrictions on what insurance companies are allowed to do with this kind of info? Health insurance is highly regulated too.
I’m not sure what the privacy implications are, but they can definitely give you the devices for free if it’s cost-effective for them to do that.
I meant more on the question of financial incentives for metrics. Basically, charging healthy people less / charging more for risk factors. Are you allowed to do this? I think some amount of this is allowed in some jurisdictions, but are there crucial limitations on it?
The ability to charge people more and less based on observed (but not demographic) characteristics got pretty limited by the Affordable Care Act. I’m not sure of the details, however.