New Medicare rules offer a lifeline for digital therapeutics firms

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The Centers for Medicare and Medicaid Services proposed new codes in the 2025 Physician Fee Schedule that would allow clinicians to bill for digital mental health treatments like apps delivering cognitive behavioral therapy. These codes are limited to FDA-cleared medical devices and cover the cost incurred by clinicians. While over 20 software-based medical treatments have been cleared by the FDA, only a few would fall under the new regulation. This development could be a significant boost for health tech startups looking to offer digital mental health treatments and receive payment through Medicare.

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