A runner looks at her smartphone and smart watch heart rate monitor.
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The popularity of health wearables is on the rise, driven by growing consumer interest in health monitoring. This surge includes the use of smartwatches, fitness trackers, and smart rings. Despite their popularity, health insurers have largely refrained from providing reimbursements due to insufficient clinical validation. However, this may change as Medicare launches an initiative aimed at improving access to wearables and collecting data to assess health outcomes.
Health wearables are non-invasive electronic devices worn on the body, such as smartwatches and biosensors, that collect and transmit physiological and biometric data. More advanced models incorporate smartphones and artificial intelligence.
While insurers occasionally cover wearables for preventive care, coverage for chronic disease management is inconsistent. Government and commercial payers may reimburse certain wearables for patients with conditions like diabetes or hypertension, but many consumers still face out-of-pocket expenses due to spotty insurance coverage.
The Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration are introducing significant initiatives to integrate wearables, digital health technologies, and coaching apps into Medicare, which serves seniors and certain disabled individuals.
In December, CMS introduced a demonstration project named ACCESS, aimed at promoting technology-supported chronic disease management. This 10-year pilot program is set to commence next month.
Under this program, CMS will reimburse device companies for wearables and app usage with upfront payments for Medicare beneficiaries with chronic musculoskeletal pain, depression, diabetes, and high blood pressure. Full reimbursement will depend on demonstrated improvements in health outcomes, underscoring the need for comprehensive data collection and evidence generation.
These CMS pilots illustrate the Trump administration’s commitment to wearables and the evidence generation process associated with their use. Health and Human Services Secretary Robert F. Kennedy Jr. is advocating for health trackers as a central element of the Make America Healthy Again strategy, aiming for widespread adoption within four years.
Special Case of Continuous Glucose Monitors
Continuous glucose monitors (CGMs) are a type of wearable device that measures glucose levels in interstitial fluid rather than directly from blood. They can provide readings at intervals or continuously. According to the Independent, Kennedy asserts that CGMs can empower Americans to take control of their health, encouraging responsible lifestyle choices regarding diet and physical activity.
Since 2017, CMS has reimbursed CGMs for specific Medicare patients with diabetes, citing data that suggests improved outcomes for certain groups. Initially, coverage eligibility criteria were extensive, requiring multiple daily blood glucose checks.
In 2023, the Biden administration expanded Medicare access to CGMs for all insulin users, removing the blood glucose check requirement.
Efforts are now underway by companies and advocates to extend Medicare coverage of CGMs to type 2 diabetes patients not using insulin. Currently, only those with a history of severe hypoglycemia are eligible. Proponents argue that there is now positive evidence supporting coverage for this group.
Recent advances in diabetes medications, including GLP-1s like Ozempic and Mounjaro, may have bolstered the usefulness of CGMs.
The device industry is optimistic about wearables as potential game-changers in healthcare. Nonetheless, the cost-effectiveness of wearables remains uncertain, highlighting the need for further clinical validation and health economic data.
A study evaluating the clinical and cost-effectiveness of wearables examined various technologies across healthcare settings, ranging from respiratory rate monitors to wearable cardioverter defibrillators. The findings suggest that while wearables can be cost-effective and potentially cost-saving, their efficacy varies by device type and health condition. The authors emphasize the need for more research to understand long-term benefits and strengthen the evidence base for providers, policymakers, and patients.
From an insurer’s perspective, the immediate cost of devices contrasts with delayed and sometimes uncertain returns on investment, especially when administrative costs and insufficient actionable data are considered. Excessive data and false alarms may also lead to higher costs without better outcomes.
As with the evolution of CGM coverage, expanding the evidence base for all wearables is crucial. Gold-standard data, such as from randomized clinical trials showing wearables reduce costs or hospital admissions within a specific timeframe, would be particularly valuable.
