Big Health

🎉 SleepioRx has received FDA clearance! 🎉 We are thrilled to share that the US Food and Drug Administration has granted clearance for SleepioRx, our flagship digital treatment for insomnia. This milestone comes after a decade of research, evidence generation, and partnerships with leading voices across healthcare.   SleepioRx’s clearance comes on the heels of new proposed reimbursement codes from the Centers for Medicare & Medicaid Services (which proposed to pay healthcare providers for FDA-cleared digital mental health treatments). Together, this paves the way for broader access to critical mental health treatment for those in need nationwide.    We are humbled and excited to have the opportunity to better serve patients across the country in need of effective mental health care. Read more about what clearance means in this article from Fierce Healthcare (big thank you to Anastassia Gliadkovskaya for covering this story): https://lnkd.in/gQZRm9Bt

Thank you to our partner, Xealth, for inviting Big Health's Chief Medical Officer Jenna Carl, PhD, to join their latest customer forum alongside leaders from Digital Therapeutics Alliance and Consumer Technology Association. They discussed everything you need to know about CMS reimbursement for digital mental health treatments and how to take advantage of the changes coming in 2025. Read their summary of the conversation for all the details ⬇️

Exciting developments are shaping the future of mental health care — don’t miss this podcast episode for a glimpse into what’s ahead 🎙 Our Chief Medical Officer, Jenna Carl, PhD, joined the Expanding Access podcast live at #BHT2024 to share her insights on the evolving digital health landscape. In this episode, Dr. Carl discusses the potential of FDA-cleared digital mental health treatments, CMS approval of new reimbursement codes, and her vision for the future of digital health. Catch the recording here: https://lnkd.in/eurvQe49 #mentalhealthinnovation #digitaltreatments #insomnia #anxiety

Are you a clinician interested in learning more about CBT for insomnia? Big Health co-founder Colin A. Espie had the pleasure of joining Rachel Handley with the British Association for Behavioural & Cognitive Psychotherapies (BABCP) on the Let’s Talk About CBT - Practice Matters podcast last month. In this episode, Dr. Espie debunks common myths about sleep, discusses the importance of sleep as a foundation of overall health, and explains how CBT techniques target sleep disorders like insomnia. 🎧 Listen here: https://lnkd.in/gadrw6D2

Thank you to everyone who stopped by our Big Health booth at the 2024 Behavioral Health Tech (BHT2024) Conference in Phoenix last week! 🐾 We hope you enjoyed taking a break to snuggle with the adorable pups from Paws4Life—a local nonprofit dedicated to giving rescue dogs a fresh start. Each badge scan at our booth helped us make a donation directly to Paws4Life, supporting their mission to provide loving foster homes and new beginnings for these wonderful dogs. Big Health is passionate about mental health and community wellness, and we’re grateful to all who joined us to support these furry friends. Swipe through for a dose of puppy cuteness, and let’s keep spreading the love for digital health and wagging tails! 🐶💙 #BigHealth #BehavioralHealth #Paws4Life #MentalHealth #FosterDogs #BehavioralHealthTech #CommunityWellness

Big Health recently partnered with Professor Jasper Smits at The University of Texas at Austin on a large study of the cost-effectiveness and cost-benefit of digital mental health treatment DaylightRx for generalized anxiety disorder, which found: ✔ DaylightRx delivers effective therapy for GAD, at a lower price than therapist-delivered cognitive behavioral therapy (CBT) ✔ DaylightRx generated more value than medications due to strong clinical benefits and reduced need for ongoing anxiety management visits The study, which was recently published by PLOS Mental Health, modeled anxiety treatment for 100,000 patients in the US. The interdisciplinary research team concluded that DaylightRx was cost-beneficial for both private payers and society at large when measured against other treatment options (including medication and therapist-delivered CBT). Read more about the study findings: https://lnkd.in/gnEkqMBY

We're at the start of a pivotal chapter for digital therapeutics and for Big Health. Starting January 1, 2025, CMS will introduce rules allowing Medicare reimbursement for digital mental health treatments — a major step forward for accessible care. As reported today by Mario Aguilar in STAT, this change opens doors for FDA-cleared treatments like SleepioRx and DaylightRx, designed for insomnia disorder and generalized anxiety disorder, to reach Medicare patients in need. This shift marks a meaningful moment for Big Health, the broader healthcare industry, and most importantly, for patients nationwide. We’re ready to make a difference. https://lnkd.in/dS3M3K-9

🌟 A Historic Step Forward in Mental Health Care 🌟 The Centers for Medicare & Medicaid Services (CMS) has released the Calendar Year 2025 Medicare Physician Fee Schedule, finalizing new Digital Mental Health Treatment (DMHT) codes: a DMHT supply code (G0552) and two treatment management codes (G0553, G0554). This historic milestone marks the first Medicare coverage for prescription digital mental health treatments, significantly enhancing access to safe, effective first-line treatments like our FDA-cleared SleepioRx and DaylightRx. We anticipate that these codes will also be adopted by commercial insurance plans, paving the way for broader coverage for Americans. Designed to cover only FDA-cleared digital health mental treatments (DHMTs) that meet rigorous evidence and quality standards, the codes currently apply to a limited number of products cleared under FDA regulation 21 CFR 882.5801, “Computerized Behavioral Therapy Device for Psychiatric Disorders.” We look forward to collaborating with health systems and providers to make our treatments accessible to their patients under these new codes. Drawing on our extensive experience distributing digital treatments through numerous channels in the UK and the US, we are well-prepared for this opportunity. We believe Medicare is a perfect starting point. The prevalence of behavioral health conditions within the Medicare population is significant, and years of data—including our own studies—show that access to safe and effective treatments has been severely limited, often relying on medications with serious side effects. There is no better population to start with, and both we and our clinical partners are eager for solutions. Together with our clinical partners, we can greatly improve access to mental health solutions for those in need.

🐾 Calling all animal lovers at the 2024 Behavioral Health Tech (BHT2024) Conference! 🐾 Stop by the Big Health booth (#515) for some puppy snuggles and support a great cause! We’re hosting Puppy Snuggling Sessions featuring adoptable pups from Paws 4 Life AZ , a local rescue group: 📅 Tuesday, Nov. 5th | 1:00 - 3:00 PM 📅 Wednesday, Nov. 6th | 10:00 AM - 12:00 PM For every badge scanned during the sessions, Big Health will donate $1 to Paws 4 Life, helping them continue their amazing work rescuing and rehoming dogs and cats. 🐕❤️ Come by, meet these adorable pups, and maybe even find your new best friend! Don't miss your chance to relax, de-stress, and give back. #BehavioralHealth #PuppyLove #BigHealth #MentalHealthMatters #GoingDigitalBHT #Paws4Life

Advice for prioritizing mental health at work, tips for navigating election season stress, and the latest in wellness — all in this month’s edition of the Big Health Break. Don’t miss it ⬇️