Meaningful engagement: A quality framework for digital therapeutics platforms

Digital health and healthcare apps are exploding. There are currently more than 1,000 weight management and healthy living apps, in addition to the hundreds of apps offering resilience and behavioral health guidance to address sleep, mindfulness, anxiety and depression.

The ability to offer evidence-based programs through these apps is beneficial to physicians, and can serve a valuable role in scaling these programs to reach the many people who need them. Payers recognize this, and they are increasingly including digital apps as an alternative -- or adjunct -- to in-person programs and services.

However, with the continuing influx of new apps into the digital health market, there is wide variety in the evidence-based practices incorporated into program delivery, and no standardized definition for engagement tied to behavior change and outcomes. Outcomes data from digital app vendors are often skewed to present findings in the most positive light, for obvious reasons.

The digital healthcare industry needs a standard set of outcomes-based quality metrics and program integrity oversight to ensure that these apps are meeting the needs of individual patients and have documented engagement and outcomes metrics. Food and Drug Administration oversight of digital apps for non-medical use or lifestyle behavior change is still limited, and more oversight is needed. While these apps offer an opportunity for scale and personalization, physicians need assurance that the apps they are referring patients to are effective.

There are several digital therapeutics platforms adapting evidence-based prevention programs traditionally delivered via in-person, such as the National Diabetes Prevention Program, into virtual experiences. Eight-six million U.S. adults are currently at high risk for developing type 2 diabetes and could benefit from participation in the DPP. The DPP is a standardized curriculum with oversight by the Centers for Disease Control and Prevention. It is typically delivered as a 60-minute weekly in-person class that has been demonstrated to reduce the risk of developing type 2 diabetes. The evidence for the effectiveness of the DPP is strong -- both randomized clinical trials and real-world implementation studies have proven that the program can help prevent or delay type 2 diabetes by 60% in people with prediabetes.

The DPP is paid as a covered preventive benefit through medical claims. It was originally designed to be delivered via in-person group sessions, but in 2015, the CDC allowed digital therapeutics platforms to deliver the DPP. In 2016, the American Medical Association established a specific Current Procedural Terminology code for the DPP, which specifies that the service is a 60-minute class or equivalent. The challenge for payers is to determine which digital or hybrid apps meet the equivalent of in-person classes, especially since there are more than 50 DPP digital or hybrid apps listed on the CDC website. The challenge for digital DPP providers is to document that app users are completing a sufficient amount of activity equivalent to a 60-minute in-person class in order to be eligible for health plan reimbursement through medical claims.

A DPP integrator can help meet this challenge by handling the program integrity, data validation, quality oversight and other functions needed to comply with the regulatory requirements. DPP integrators can establish a common set of performance metrics and minimum requirements for digital apps to be the equivalent of in-person sessions of evidence-based program. Some have already begun doing this, establishing “Meaningful Engagement” criteria to quantify the minimum amount of activity a patient must complete each week to be the equivalent of a 60-minute class. These activities should correlate with sustained engagement and 5% weight loss, which are the target outcome goals of the program. Activities include coach interaction, group interaction, whether the patient completed the curriculum via a quiz or video, the number and type of meals logged, the number of weights taken, physical activity and app-based communications, including text messaging.

The “Meaningful Engagement” criteria for each digital platform delivering the DPP are different depending on how the program is delivered, which is specific to the app. The DPP integrators import and track the data and patient activity information to document patient activity. This level of program integrity oversight allows the integrators to submit medical claims to payers who cover the DPP as a preventive benefit for their members. By benchmarking meaningful engagement, sustained program engagement, weight loss outcomes and satisfaction, these integrators provide oversight and program integrity on behalf of the digital therapeutics platform (and other non-clinical DPP providers) to give physicians and payers confidence that their members and patients are participating in quality programs that work.

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