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 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 ⬇️

Today is #WorldMentalHealthDay, a reminder to pause and recognize how vital mental health is—not just for surviving the daily grind, but for truly living well. This year’s theme — prioritizing mental health at work — shines a light on the hidden costs of neglecting mental health in the workplace. While many companies have updated their policies to support employee well-being in recent years, there’s often a big gap between what’s written on paper and what’s actually helping employees. This World Mental Health Day, it's time to bridge that gap and make meaningful change. Check out our latest blog for real, actionable tips to create a workplace where mental health truly comes first. Get the tips 👉 https://lnkd.in/gDtT7v4C

🎉 Get ready for an unforgettable evening! Big Health, along with apree health, Pelago, and Maven Clinic, is throwing a Backyard Bash during the International Foundation of Employee Benefit Plans (IFEBP) Conference — and YOU are invited! 🎉 Meet us at Happy Does, San Diego’s coolest retro spot in the Gaslamp Quarter, on Monday, November 11th, from 7:30 PM to 10:00 PM. 🕺💃 We’ve got a DJ, backyard games like cornhole and darts, plus tons of good vibes waiting for you. 🌟 Open to IFEBP attendees and their families — but don’t wait! Space is limited, so secure your spot now. 🔗 REGISTER HERE ➡️ https://lnkd.in/gZWKz5Ug Come hang out with our crew — we can’t wait to see you there! ✌️

👉 “If we can’t get everybody to a therapist, the next best thing is getting them into a self-paced, evidence-based program that models that therapeutic relationship as best we can." Congratulations to our Chairman Arun Gupta who was recently honored at the Business Journal’s Innovator of the Year Awards at the Irvine Marriott on Sept. 12. In the article below, Orange County Business Journal covers this recognition as well as our recent strategic wins, including two FDA clearances: SleepioRx for insomnia, and DaylightRx for anxiety. Learn more about our journey: https://lnkd.in/g4pHkyQc SleepioRx for insomnia: https://lnkd.in/gyB3Hagr DaylightRx for anxiety: https://lnkd.in/g3ZGtA6k #digitaltreatments #mentalhealth #digitalhealth