Jul 22,2024 TOP STORY

What CMS’s proposed reimbursement codes could mean for the digital therapeutics industry

The Centers for Medicare and Medicaid Services (CMS) has proposed new CPT payment codes for digital therapeutics, marking a significant step towards widespread reimbursement for the DTx products. Previously, CMS introduced Level II HCPCs codes for behavioral health digital therapeutics, which mainly applied to Medicare and Medicaid. The new CPT codes, applicable to all payers, could significantly expand coverage. These codes were included in the 2025 Medicare Physician Fee Schedule proposed rule and are specific to digital therapeutics for mental health conditions. The proposed codes (GMBT1, GMBT2, and GMBT3) allow physicians to bill for digital therapeutics similarly to how they bill for vaccines, covering initial provision, patient education, and ongoing management services. This proposal is expected to lead to broader payer coverage and increase demand from employers, potentially boosting the industry’s sustainability and attracting more investment.

#reimbursement

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Jun 19,2024 TOP STORY

Mika Health, AstraZeneca, and Daiichi Sankyo Partner on UNITE Program

Mika Health has partnered with AstraZeneca and Daiichi Sankyo on the "UNITE" program to enhance support for breast cancer patients in Switzerland. Mika Health, known for its digital therapeutic platform aiding over 100,000 cancer patients, will provide mental health coaching, AI-powered recommendations, and symptom monitoring through its app. The UNITE program, starting in German-speaking regions and expanding to French and Italian-speaking areas, integrates these digital solutions with prescribed medications. The Mika Health app, combining therapeutic methods and AI, offers educational content and support for depressive symptoms and fatigue.

COLLABORATION PARTNERSHIP

#institution

#coaching

#mobile app

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Jun 05,2024

Feel unveils a cutting-edge Wearable Device paired with AI for Emotional & Mental Health

Feel Therapeutics has unveiled the Feel Monitor, a state-of-the-art wearable device paired with AI designed for 24/7 monitoring of mental health. The device, compliant with FDA standards, aims to address the rising prevalence of mental health disorders like anxiety and depression by providing objective measurements through continuous monitoring. The Feel Monitor uses five advanced sensors, including Electrodermal Activity and Photoplethysmography sensors, to track mood, stress, sleep, and other mental health indicators.

PRODUCT

#connected device

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May 29,2024 TOP STORY

Virtual Therapeutics, Akili Interactive Enter Into Definitive Merger Agreement

Virtual Therapeutics and Akili Interactive have signed a definitive merger agreement to create a leading digital health company. Under the agreement, Akili shareholders will receive $0.4340 per share in cash, representing a 4% premium to Akili’s closing stock price on May 28, 2024, and an 85% premium to its price on April 29, 2024. Post-merger, the combined entity will operate as Virtual Therapeutics, with Akili as a wholly owned subsidiary. The merger aims to leverage Virtual Therapeutics' VR-based mental health solutions and Akili's mobile digital therapeutics expertise to address global mental health challenges. The transaction, approved by both companies' boards, is expected to close in the third quarter of 2024, subject to certain conditions. After completion, Akili's stock will be delisted from public exchanges.

COLLABORATION MERGERS & ACQUISITION

#product & service

#virtual reality

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May 29,2024

Otsuka defies digital health downturn with new company

Otsuka America has launched Otsuka Precision Health, a new company focused on digital health, with Sanket Shah as its president. Despite a challenging environment for digital health firms, marked by decreased funding and high-profile bankruptcies, Shah is optimistic about the sector's long-term potential. Otsuka Precision Health plans to develop and partner on digital solutions, starting with Rejoyn, a prescription digital therapeutic for major depressive disorder, set to launch this summer. The company will also continue to focus on mental health and explore other health solutions, like support for Alzheimer's caregivers. Shah emphasizes a patient-centric approach, leveraging data and technology to improve healthcare experiences.

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May 22,2024

Study Finds Spark Direct Effective in Improving Mood Among Adults With Depression

Big Health announced the successful results of a randomized controlled trial showing that their digital CBT program for depression, Spark Direct, significantly improves mood and quality of life in adults. The study, involving 61 adults with moderate to moderately-severe depression, highlighted Spark's ease of use (95% satisfaction) and its effectiveness in enhancing motivation and providing actionable coping strategies. Participants using Spark experienced mood improvements 2.5 times greater than those in the control group, with benefits sustained for an additional five weeks post-program. Quality of life improvements for Spark users were nearly double that of the control group. Spark Direct, which utilizes cognitive-behavioral techniques, covers mental health education, behavioral activation, mindfulness, and long-term skill maintenance.

CLINICAL STUDY

#cbt

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May 09,2024

Woebot Health Wins MedTech Breakthrough's Mental Health Innovation Award

Woebot Health has received the "Mental Health Innovation Award" in the 8th annual MedTech Breakthrough Awards. This recognition highlights their Woebot Health Platform, which utilizes clinically proven techniques and artificial intelligence to provide accessible chat-based mental health support. The platform includes Woebot, a digital companion offering personalized support through chat-based conversations based on evidence-based approaches like Cognitive Behavioral Therapy, Interpersonal Psychotherapy, and Dialectical Behavioral Therapy. The CEO of Woebot Health, Michael Evers, expressed excitement about the award and emphasized the importance of innovative digital solutions in improving mental health care.

PRODUCT

#cbt

#chatbot

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May 06,2024 TOP STORY

Otsuka America, Inc’s. Data and Technology Company will Support Rejoyn™ Commercialization & Personalized Patient Engagement

Otsuka America, Inc. (OAI) has announced the launch of Otsuka Precision Health, Inc. (OPH), aimed at delivering tailored interventions along patients’ health journeys. OPH will prioritize enhancing the patient experience, focusing on nephrology, mental health, and beyond. The recent FDA clearance of Rejoyn™, the first prescription digital therapeutic for adjunctive treatment of major depressive disorder (MDD) symptoms, is a proof-point for the possibilities of what OPH can bring to the market to enable a better patient experience, claims the Company. OPH will serve to commercialize Rejoyn™. Rejoyn™ will also be showcased at the 2024 American Psychiatric Association (APA) Annual Meeting in New York City from May 4 to May 8, reflecting OPH's dedication to mental health advancements.

PRODUCT

#pdt

#cbt

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Apr 23,2024

Curio Digital Therapeutics Inc. Announces the FDA Clearance of MamaLift Plus

Curio Digital Therapeutics announces the FDA clearance of MamaLift Plus, marking the first prescription digital therapeutic for postpartum depression (PPD). MamaLift Plus is an eight-week prescription digital therapeutic intended for patients 22 years and older, to be used under healthcare provider supervision. It offers neurobehavioral interventions including Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT). Clearance is based on the SuMMER study, a national, sham-controlled, pivotal randomized controlled trial (RCT), where MamaLift Plus demonstrated efficacy in improving symptoms of depression. The study achieved its primary endpoint with 86.3% of participants experiencing a clinically meaningful improvement.

REGULATORY FDA

#pdt

#cbt

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Apr 30,2024

Feel Therapeutics Granted 2nd Patent for Emotion AI Technology

Feel Therapeutics has achieved a significant milestone with the granting of its second US patent, No. 11,967,339, by the United States Patent and Trademark Office. This patent extends the scope of the company's Emotion AI technology, allowing for the detection and recognition of a user's emotional state. Feel Therapeutics utilizes AI technology to passively and continuously monitor physiological signals through various sensors, including those in wearable devices and mobile phones. These advancements enhance the accuracy and reliability of emotion detection, minimizing the impact of external factors on collected data.

PRODUCT

#connected device

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