The Visibility of Emerging Digital Health Technologies — From a Contraceptive App to the Apple Watch

How emerging digital health technologies gain visibility in healthcare through FDA approvals and dedicated codes. 

The integration of digital health technologies into healthcare has been gaining momentum. Insurers and HSA/HRA accounts are beginning to cover certain mobile apps and digital wearables for biometric tracking as they gain FDA approval. While most of these tools are not captured in typical healthcare data or grouped with other devices, some are now getting their own identifiers. For example, the Natural Cycles fertility app, used in conjunction with a thermometer to track fertility at home, received FDA approval as a contraceptive method in 2018 and a dedicated HCPCS code in April 2024. Common mobile devices have received approvals for specific use cases: the Apple Watch ECG app was FDA approved in 2018 for the detection of atrial fibrillation (AFib), and Samsung’s Health Monitor app, used on the Galaxy watch, was FDA approved in 2020 for blood pressure monitoring. However, these tools are currently categorized with other types of monitoring devices.

With the establishment of new HCPCS codes to track usage of these tools, stakeholders gain visibility into patient behaviors that were once absent from traditional claims and medical records. Little longitudinal data exists on the prescribing, utilization, and reimbursement of these tools or the patient demographics for claims. To elucidate what is currently visible in healthcare data, we used our Healthcare Map™ and our MapLab™ Cohort Events and Patient Counts Over Time template. 

We looked at the utilization of the HCPCS code for Natural Cycles, the only app of its kind approved for use as birth control in the US. We also examined the two CPT codes that would include the Apple Watch for AFib monitoring and the Samsung watch for blood pressure monitoring. The latter two codes group together all ambulatory or wearable devices, so we were interested to see if there was an increase in utilization at the time of the FDA approvals for each of the watches. Here’s what we found:

In the first two months after the establishment of the dedicated Natural Cycles code, the code was used by just 38 patients.
While this initial uptake is small, it is likely that others may be receiving reimbursement through the traditional ICD code for “Encounter for other contraceptive management,” highlighting the benefit of dedicated, tool-specific codes for visibility and research. Some patients are likely paying out of pocket despite being eligible for reimbursement, and others may have plans, such as Medicaid, that do not cover the contraceptive tool. While not all insurance plans require a prescription for reimbursement, most do.

Claims for external electrocardiographic monitors have increased steadily in patients diagnosed with AFib, growing 107% between 2016 and 2023. 
Looking at the code for external patient and wearable electrocardiographic rhythm, CPT 93268, steady increases in claims were seen over the past eight years. No significant differences in growth were seen in any one year, which may reflect an overall increase in wearable AFib monitoring and not specifically the Apple Watch. 

Claims by patients for wearable electrocardiogram monitors (CPT 93784) have also increased steadily, growing 32% between 2016 and 2023.

Claims for wearable blood pressure monitors (CPT 93784) have also increased steadily, growing 28% between 2016 and 2023. 

The FDA approval of certain digital health tools and the establishment of tool-specific codes represent a significant step toward the integration of new technologies into standard medical practice. However, more such codes are needed, along with provider and patient education, to help patients obtain insurance coverage and capture utilization effectively. This coverage has the potential to enhance patient engagement by reducing out-of-pocket costs and promoting adherence to prescribed health regimens. Integration into payer data systems can broaden patient profiles and stakeholder visibility into patient behaviors, bolstering the capacity for meaningful engagement and strategic decision-making. At the patient level, it furthers the ecosystem of personalized care and precision medicine to improve health outcomes. Analysis of this data can then inform relevant provider education, clinical guidelines, and health policies. 

By offering robust insights into the utilization and reimbursement patterns of emerging health technologies, Komodo empowers stakeholders to make informed decisions that drive better patient outcomes. This approach underscores Komodo's commitment to harnessing data to bridge gaps in care, support health equity, and enhance the overall healthcare ecosystem.

For another example of how Komodo is using new ICD codes to unlock patient insights, check out our research into long COVID and ME/CFS.

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