Health Affairs August 10, 2022
Nearly five years have passed since the US Food and Drug Administration (FDA) cleared the first prescription digital therapeutic (PDT), and nearly another dozen have followed. PDTs are defined as FDA-cleared or -approved software-based medical devices, prescribed by a clinician, that are intended to prevent, manage, or treat a medical condition. Cleared PDTs to date span a range of clinical indications, from substance use disorder to ADHD to insomnia. Yet, to date, there is neither a Medicare benefit category nor a physician fee schedule for these products.
Currently, the only public coverage for PDTs is via one-off contracts with state Medicaid plans. Commercial payers, such as Aetna and BCBS, have remained hesitant to cover digital therapeutics largely due to reported...
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