This document addresses the use of practitioner-prescribed software applications for health management purposes when used on a mobile device (e.g., mobile phone, laptop, smartwatch, or tablet) with the intent to evaluate, diagnose or treat an illness, injury, disease or its symptoms. This document does not address mobile-based software applications (MSAs) that are used in the function or control of another FDA-cleared or approved stand-alone hardware medical device. This document also does not address MSAs accessible to the general public for download (including direct-to-consumer [DTC] or “over the counter” applications), applications that promote general wellness, or applications operated by a healthcare practitioner in a clinical setting for remote health monitoring.

Note: Some benefit plans may exclude coverage of consumer wearable or personal mobile devices (such as a smart phone, smart watch, or other personal tracking devices), including any software or applications. DTC applications are generally excluded from benefit plan coverage.

Clinical Indications

Medically Necessary:

Mobile-based health management applications are considered medically necessary when all of the following criteria in I and II have been met:

1. Criteria to evaluate the mobile software application (MSA):
   1. The MSA has been approved or cleared by the Food and Drug Administration (FDA); and
   2. There is credible scientific evidence which permits reasonable conclusions regarding the impact of the MSA on health outcomes; and
   3. The MSA has been proven materially to improve the net health outcome or be as beneficial as any established alternative;
      AND
2. Criteria to evaluate the appropriateness of the MSA for the individual:
   1. The MSA has been prescribed by a healthcare practitioner; and
   2. There is documentation supporting that the MSA was ordered for a covered purpose such as preventing, evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and in accordance with generally accepted standards of medical practice;* and
   3. The requested MSA is not primarily for the convenience of the individual, prescribing clinician, caregiver, or other healthcare provider.

*Generally accepted standards of medical practice means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician specialty society recommendations and the views of physicians practicing in relevant clinical areas, and any other relevant factors.

Not Medically Necessary:

Mobile-based health management applications are considered not medically necessary when the criteria above have not been met.