Wearables for health are popular. The industry is expanding rapidly thanks to rising consumer demand for health monitoring. This includes devices such as smartwatches, fitness trackers and smart rings. But thus far health insurers have often been reluctant to reimburse given the lack of clinical validation. This could soon change as Medicare embarks upon an initiative to facilitate access to wearables while gathering data to evaluate health outcomes.

Wearables for health are non-invasive electronic tools worn on the body, such as smartwatches and biosensors. These digital health trackers collect, track and transmit physiological and biometric data. Advanced wearables integrate the use of smartphones and artificial intelligence.

Insurers sometimes cover wearables for preventive care purposes. And as part of chronic disease management regimens, government and commercial payers may reimburse certain wearables for patients with conditions like diabetes or hypertension to monitor vital signs. But insurance coverage is spotty which means that in many instances consumers must pay for wearables out-of-pocket.

The Centers for Medicare and Medicaid Services and Food and Drug Administration have introduced several major initiatives to integrate wearables, digital health technology and coaching apps into patient healthcare in Medicare, the public program for seniors and certain disabled individuals.

Last December, for example, the agency unveiled a demonstration project called ACCESS. It’s intended to encourage technology-supported care to improve chronic disease management. The 10-year pilot program starts next month.

CMS will reimburse device companies for wearables and app use with upfront payments for Medicare beneficiaries with, among others, chronic musculoskeletal pain, depression, diabetes and high blood pressure. But full payment is contingent on improvement in health outcomes. This implies the need for comprehensive generation of evidence generation and data reporting.

The CMS pilots are an indication of how serious the Trump administration is about wearables and evidence generation associated with their use. Health and Human Services Secretary Robert F. Kennedy Jr. is actively promoting wearable health devices as a cornerstone of its Make America Healthy Again strategy. He said he wants all Americans to be wearing a health tracker within four years.

Special Case of Continuous Glucose Monitors

Continuous glucose monitors are one such device. These are wearable devices that measure patients’ glucose levels found in interstitial fluid (fluid between cells) rather than directly from a person’s blood. This can be done at discrete intervals or continuously. According to the Independent , Kennedy asserts that CGMs could be a tool for Americans to “take control over their own health,” adding that they can “take responsibility” and “begin to make good judgments about their diet, about their physical activity, about the way they live their lives.”

Since 2017, CMS has covered CGMs for certain Medicare patients with diabetes. CMS justified reimbursement in part by pointing to supportive data that suggested better outcomes, at least for particular subsets of patients. Historically, however, the eligibility criteria for coverage have been extensive , for instance, initially requiring patients to check their blood glucose multiple times each day.

Under the Biden administration, Medicare expanded access in 2023 to include anyone on insulin, scrapping the blood glucose check requirements.

Companies and patient advocates are now pushing Medicare to also cover CGMs for type 2 diabetes patients who don’t use insulin. Currently, patients who don’t take insulin can only get CGM reimbursement if they have a history of problematic or documented severe hypoglycemia. Proponents suggest there is now positive evidence for this subgroup of non-insulin dependent diabetics, too.

It’s possible that fairly recent advances in diabetes medications, including GLP-1s like Ozempic and Mounjaro, have caused a concurrent improvement in the use value of CGMs.

The device industry is of course enthusiastic about wearables , viewing them as possible game changers in healthcare. But whether wearables across the board are cost-effective remains to be seen. There’s a need for more clinical validation as well as health economic data.

In a study examining the clinical and cost-effectiveness of wearables, researchers looked at a wide range of wearable technologies applied in different healthcare settings and for time horizons from less than one year to a lifetime. These included respiratory rate monitors, pedometers, fall-prediction devices, hospital-acquired pressure injury prevention monitors, seizure detection devices, heart rate monitors, insulin therapy sensors and wearable cardioverter defibrillators.

The authors suggest that the wearable technologies can be cost-effective and potentially cost saving, but there is considerable variation depending on the type of device and health condition being addressed. They state that “more research is needed to fully understand the long-term benefits and to strengthen the evidence base for health care providers, policymakers, and patients.”

From an insurer perspective the financial burden of purchasing devices is immediate while the return on investment is often delayed, uncertain and even nonexistent in some instances when administrative costs and a possible lack of actionable data are taken into account. In fact, some of the data overload and noise, including false alarms, may in certain cases lead to an increase in costs with no offset in terms of better outcomes.

Similar to what happened over time with CGMs, it seems vital that the evidence base for all wearables increase. And if there’s gold standard data, such as from a randomized clinical trial showing wearables reduce aggregate expenditures or, say, hospital admissions within a certain timeframe, all the better.