Following the establishment of new CMS reimbursement codes for digital mental health treatments, the funding will support the commercial expansion of two prescription products.
Key takeaways:
- Big Health raised $23.7 million in a round co-led by .406 Ventures and AlleyCorp to accelerate access to its prescription digital therapeutics.
- The funding follows the introduction of G-codes in the 2025 Physician Fee Schedule, allowing Medicare reimbursement for FDA-cleared Digital Mental Health Treatments.
- SleepioRx for insomnia and DaylightRx for generalized anxiety disorder are among nine FDA-cleared treatments in this new category.
- The capital will be used to expand provider partnerships and integrate the therapeutics into clinical workflows.
Big Health has completed a strategic funding round of $23.7 million to accelerate the adoption of its US Food and Drug Administration (FDA)-cleared digital therapeutics: SleepioRx for insomnia disorder and DaylightRx for generalized anxiety disorder.
The funding comes as the Centers for Medicare & Medicaid Services (CMS) implements a new payment policy for digital mental health treatments. The 2025 Physician Fee Schedule created specific G-codes that enable national Medicare coverage for FDA-cleared digital mental health treatments. SleepioRx and DaylightRx are among nine treatments currently recognized in this category, which distinguishes FDA-cleared medical devices from non-regulated wellness apps.
CMS adopted three codes, G0552-G0554, for digital mental health treatment devices furnished under a behavioral health treatment plan of care. It also adopted six HCPCS codes that parallel the existing CPT codes for interprofessional consultations for use by certain nonphysician mental health professionals who CMS says cannot report the CPT codes with the goal of better integrating behavioral health treatment into primary care and other settings.
“For the first time, providers can offer proven, safe, and effective digital treatments that deliver measurable, reproducible outcomes, and receive reimbursement just as they would for traditional treatments,” says Yael Berman, CEO of Big Health, in a release. “We’re already seeing the most innovative health systems seize this opportunity, and this funding will help us scale access to these treatments faster.”
The financing was co-led by .406 Ventures and AlleyCorp, with participation from CVS Health Ventures, Blue Venture Fund, Sandbox Clinical Ventures, Gilde Healthcare, and Supermoon Capital. The funds are earmarked to support commercialization efforts, including expanding strategic provider partnerships and integrating the digital therapeutics into clinical workflows.
SleepioRx and DaylightRx are prescription digital therapeutics designed for use alongside usual care. To date, Big Health reports supporting more than 750,000 individuals. Clinical studies cited by the company show that up to 76% of SleepioRx patients achieve improvement in insomnia, while 71% of DaylightRx patients experience improvement in anxiety disorder
Investors noted the significance of the new reimbursement landscape for digital health.
“We are thrilled to be investing in the Big Health team as they unlock the potential created by CMS’s wise decision to reimburse for FDA-cleared digital treatments targeting conditions where such an intervention is proven to be appropriate, superior to current pharmaceutical-only approaches, and ultimately better value for the system,” says Liam Donohue, managing partner at .406 Ventures, in a release.
Current adoption partners include health systems such as Henry Ford and Northwell.
“There’s a significant gap between people who need mental health care and those who can access it,” says Alyssa Reisner, executive director and partner at CVS Health Ventures, in a release. “SleepioRx and DaylightRx can help fill that gap—offering first-line, evidence-based treatment for insomnia and anxiety at scale, where and when patients need it most.”
