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Aetna Preventive Care & Digital Therapeutics Coding: A Comprehensive Guide

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses prescription digital therapeutics and Aetna’s coverage stance, particularly in the context of preventive care coding.

  1. Medical Necessity for Aetna Preventive Care Coding

    Aetna recognizes the importance of preventive care and, in alignment with federal mandates, considers certain FDA-approved or cleared mobile applications for contraception based on fertility awareness as medically necessary. When prescribed by a healthcare provider, these digital therapeutics fall under preventive care benefits.

    Specifically, Natural Cycles, currently the only FDA-cleared fertility awareness app, is considered medically necessary for contraception. Aetna’s preventive care coding policy covers one annual subscription to Natural Cycles per benefit period. It’s important to note that no additional supplies or services related to Natural Cycles are covered under this preventive care coding.

  2. Experimental, Investigational, or Unproven Prescription Digital Therapeutics

    While Aetna acknowledges the evolving landscape of digital therapeutics, many prescription digital therapeutics (PDTs) are currently considered experimental, investigational, or unproven. This designation is based on a thorough review of published, peer-reviewed literature, which currently lacks sufficient evidence to definitively establish the effectiveness of these PDTs.

    The following PDTs fall into this category and are not covered under Aetna’s preventive care coding or standard medical necessity guidelines due to insufficient evidence:

    1. BlueStar Rx
    2. Canvas Dx
    3. DaylightRx
    4. d-Nav Insulin Management Program
    5. Drowzle Pro
    6. Endeavor Rx
    7. Freespira
    8. Halo AF Detection System
    9. Insulia
    10. Leva Pelvic Health System
    11. Luminopia One (Digital Binocular Therapy)
    12. MindMotion GO
    13. My Dose Coach
    14. myVisionTrack (Home Vision Monitor [HVM])
    15. Nerivio
    16. NightWare
    17. Parallel
    18. Regulora
    19. RelieVRx
    20. reSET
    21. reSET-O
    22. SleepioRx
    23. Somryst.

  3. Related Policies

    (Table reference from original document, if applicable within Aetna’s internal documentation)

CPT Codes / HCPCS Codes / ICD-10 Codes Relevant to Aetna Preventive Care Coding for Digital Therapeutics

This section outlines the relevant HCPCS and CPT codes concerning Aetna’s coverage of digital therapeutics, particularly in relation to preventive care coding and those PDTs currently not covered.

Code Code Description
### HCPCS codes covered under Aetna Preventive Care Coding if selection criteria are met:
*FDA approved or cleared mobile apps for contraception based on fertility awareness***-no specific codes for Aetna preventive care coding**
A9293 Fertility cycle (contraception & conception) tracking software application, fda cleared, per month, includes accessories (e.g., thermometer)
### HCPCS codes not covered by Aetna for PDTs listed as experimental:
Drowzle Pro, MindMotion GO, My Dose Coach, myVisionTrack (Home Vision Monitor [HVM]), Parallel, Regulora, RelieVRx, DaylightRx and SleepioRx – no specific codes for non-covered PDTs
A9291 Prescription digital behavioral therapy, fda cleared, per course of treatment
A9292 Prescription digital visual therapy, software-only, fda cleared, per course of treatment
E1905 Virtual reality cognitive behavioral therapy device (cbt), including pre-programmed therapy software
S9002 Intra-vaginal motion sensor system, provides biofeedback for pelvic floor muscle rehabilitation device
### Other HCPCS codes related to Aetna’s Digital Therapeutics Policy:
T1505 Electronic medication compliance management device, includes all components and accessories, not otherwise classified

Background: Navigating Aetna Preventive Care Coding and the Landscape of Digital Therapeutics

The healthcare industry is experiencing a technological revolution, with software solutions rapidly emerging to enhance healthcare delivery. The Food and Drug Administration (FDA) categorizes these innovations as “device software functions,” encompassing mobile medical applications (MMAs). These applications, accessible on smartphones, computers, and integrated into medical devices, empower individuals to manage their health, assist healthcare providers in improving patient care, aid in diagnosis, and trigger necessary patient actions. Examples like the Radiation Emergency Medical Management (REMM) app and the National Institute of Health’s LactMed highlight the diverse functionalities of MMAs.

While the FDA champions the development of MMAs to improve healthcare access and provide valuable information to both consumers and practitioners, it also recognizes its responsibility to ensure the safety and efficacy of these device software functions. The International Medical Device Regulators Forum (IMDRF), guided by the FDA, has established a framework for evaluating the clinical evidence, safety, and efficacy of device software functions and MMAs. This framework classifies medical purpose software into:

  1. Software embedded within a medical device.
  2. Software as a Medical Device (SaMD).

The FDA’s Center for Devices and Radiological Health adopts a risk-based approach, prioritizing regulatory oversight for software functions that meet the regulatory definition of a “device” and pose a potentially higher risk. This ensures that these higher-risk software functions undergo thorough FDA review. Software functions requiring regulatory oversight include:

  • Software that acts as an extension of existing medical devices by connecting to and controlling them or analyzing their data.
  • Software, often mobile apps, that transform a mobile platform into a regulated medical device through attachments, screens, sensors, or functionalities mirroring existing regulated medical devices. Compliance with device classification is mandatory for these transformed platforms.
  • Software that becomes a regulated medical device by performing patient-specific analysis, leading to patient-specific diagnoses or treatment recommendations, similar to previously cleared or approved software devices.

Conversely, the FDA exercises regulatory discretion for software functions deemed to pose minimal risk. This category includes software that:

  • Helps patients self-manage their conditions or diseases without providing specific treatment suggestions.
  • Automates simple tasks for healthcare providers.

The Emergence of Prescription Digital Therapeutics (PDTs) and Aetna’s Perspective on Preventive Care Coding

A novel class of therapeutics, known as prescription digital therapeutics (PDTs), has emerged within the digital healthcare space. PDTs distinguish themselves from general health and wellness apps through several key characteristics, which are crucial in understanding Aetna’s preventive care coding and coverage decisions:

  • Evidence-Based and High-Quality Interventions: PDTs deliver software-driven therapeutic interventions grounded in clinical evidence, designed to diagnose, prevent, manage, or treat medical disorders or diseases. They can be used independently or in conjunction with medications, devices, or other treatments to optimize patient care and health outcomes.
  • FDA Authorization: PDTs receive authorization from the FDA (clearance or approval) and have approved directions for use, ensuring a level of regulatory scrutiny and validation.
  • Rigorous Clinical Evaluation: PDTs undergo rigorous evaluation for safety and effectiveness through clinical trials, with results published in peer-reviewed journals, demonstrating a commitment to scientific validation.
  • Prescription and Healthcare Professional Initiation: PDTs are prescribed and initiated by qualified and licensed healthcare practitioners, integrating them into the established healthcare ecosystem.

To streamline the regulatory process for software-based medical devices, the FDA launched the Pre-Cert Pilot Program in 2019. This program proposes that software products from pre-certified companies continue to meet the same safety and effectiveness standards expected of products following traditional market pathways. The program aims to shift focus towards the software developer or digital health technology developer, emphasizing a holistic approach rather than solely focusing on individual products.

The FDA’s Total Product Lifecycle (TPLC) approach enables the evaluation and monitoring of software products throughout their lifecycle, from premarket development to post-market performance, ensuring ongoing demonstration of organizational excellence. Key components of the FDA’s TPLC methodology include:

  • Excellence Appraisal: Defining objective criteria and methodologies for pre-certifying companies and maintaining their pre-certification status.
  • Review Determination: Developing a risk-based framework for pre-certified companies to determine the appropriate premarket review pathway for their products. Lower-risk devices from pre-certified companies may potentially bypass premarket review or undergo streamlined review processes.
  • Streamlined Review: Identifying the necessary information for pre-certified companies to include in premarket submissions for FDA review of software product safety and effectiveness before patient access.
  • Real-world Performance: Establishing mechanisms for pre-certified companies to access and utilize real-world performance data of their software products to support regulatory status and inform the evolution of product functions.

In September 2017, the FDA selected nine companies, including Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, and Samsung, from over 100 candidates to participate in the Software Pre-Cert Pilot Program, signifying a collaborative approach to digital health regulation.

Professional organizations like the American Medical Association, American Psychiatric Association, and the Academy of Managed Care Pharmacy are also actively developing frameworks and guidelines to assist healthcare practitioners in integrating mobile health technologies, apps, and digital therapeutics into patient care delivery, further solidifying the role of digital solutions in modern healthcare and influencing considerations for Aetna preventive care coding and coverage.

In-Depth Review of Experimental, Investigational, or Unproven PDTs in Relation to Aetna Preventive Care Coding

The following sections provide a detailed overview of each PDT listed as experimental, investigational, or unproven by Aetna. This analysis summarizes the available clinical evidence and rationale for their current non-covered status under Aetna preventive care coding and standard medical necessity guidelines.

BlueStar Rx

Alt text: BlueStar Rx mobile app interface showcasing blood glucose tracking and personalized coaching messages for diabetes management.

BlueStar Rx, developed by WellDoc, is an FDA-cleared software app designed to aid adults (18+) with type 1 or type 2 diabetes in self-management. It functions as a complement to existing diabetes therapies, offering an “always-on” automated software coach that sends reports to healthcare providers. While it includes features like blood glucose logging, medication adherence support, and an insulin dose calculator, Aetna considers BlueStar Rx experimental due to the mixed evidence regarding its effectiveness in real-world clinical settings.

A key study by Quinn et al. (2011) demonstrated a significant reduction in glycosylated hemoglobin levels in patients using a mobile diabetes intervention system, which included components similar to BlueStar Rx. However, a later pragmatic randomized controlled trial by Agarwal et al. (2019) evaluating BlueStar specifically did not show a significant impact on HbA1c levels in a diverse participant group. The study highlighted significant variation in app usage, suggesting that patient engagement might be a critical factor in the effectiveness of BlueStar Rx. These conflicting findings contribute to the current experimental designation by Aetna and its exclusion from preventive care coding coverage.

Canvas Dx

Alt text: Canvas Dx diagnostic output screen displaying autism spectrum disorder risk assessment results based on AI analysis of questionnaires and video.

Canvas Dx, developed by Cognoa, is an FDA-cleared software medical device intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD) in children aged 18 to 72 months. It utilizes AI to analyze parent/caregiver questionnaires, video analysis, and healthcare provider questionnaires to generate a diagnostic output. Despite FDA clearance, Aetna classifies Canvas Dx as experimental, citing the need for more robust evidence to support its effectiveness as a standalone diagnostic tool in routine clinical practice.

While studies by Abbas et al. (2017, 2020) and Megerian et al. (2022) have shown promising results regarding the accuracy of AI-based autism screening tools like Canvas Dx, including improved specificity and sensitivity compared to traditional screening methods, these studies also acknowledge limitations. These limitations include the pre-selected high-risk study populations and the need for validation in primary care settings. Furthermore, Wall et al. (2023) highlight the ongoing development and refinement of AI-based medical devices like Canvas Dx through pre-determined change control plans, emphasizing the evolving nature of this technology and the need for continued evidence accumulation before widespread adoption and coverage under Aetna preventive care coding.

DaylightRx

Alt text: DaylightRx mobile interface displaying interactive lessons and guided exercises for cognitive behavioral therapy to treat generalized anxiety disorder.

DaylightRx, developed by Big Health, is an FDA-cleared digital therapeutic designed to deliver cognitive behavioral therapy (CBT) for adults (22+) with generalized anxiety disorder (GAD). As an adjunct to usual care, DaylightRx offers interactive lessons and guided exercises to address the cognitive and behavioral patterns underlying chronic worry and anxiety. Despite its recent FDA clearance, Aetna currently considers DaylightRx experimental due to the limited peer-reviewed evidence published specifically on DaylightRx’s clinical effectiveness and its impact on patient outcomes in diverse populations. While CBT is an established therapy for anxiety, the digital delivery of DaylightRx requires further independent validation to warrant coverage under Aetna preventive care coding or standard medical necessity guidelines beyond the initial FDA clearance.

d-Nav Insulin Management Program

Alt text: d-Nav Insulin Management Program handheld device interface showing personalized insulin dose recommendations based on glucose readings.

The d-Nav Insulin Management Program, offered by Hygieia, is a digital therapeutic for adults with type 2 diabetes who use insulin injections. It combines an FDA-cleared AI-powered mobile app with virtual clinical support to provide autonomous insulin dose adjustments based on patient glucose levels. While d-Nav has shown promise in improving glycemic control in several studies, Aetna currently classifies it as experimental due to concerns about the generalizability of study findings and the need for more robust, real-world evidence.

Studies by Bergenstal et al. (2012, 2019), Bashan and Hodish (2012), and Donnelly et al. (2015) have demonstrated the potential of d-Nav in improving glycemic control and reducing HbA1c levels. However, concerns have been raised by Garg (2019) regarding the study design of Bergenstal et al. (2019), particularly the limited clinical care provided to the control group. Furthermore, Harper et al. (2023) highlight the complexity of insulin management and the need for individualized approaches, suggesting that while d-Nav can automate dose titration, its effectiveness in diverse patient populations and long-term clinical practice needs further validation before it can be considered for broader coverage under Aetna preventive care coding.

Drowzle Pro

Alt text: Drowzle Pro mobile app displaying sleep analysis results and sleep apnea risk assessment based on smartphone-recorded breathing patterns.

Drowzle Pro, developed by Resonea, is an FDA-cleared mobile app functioning as a digital home sleep test for obstructive sleep apnea (OSA) screening in adults. It utilizes a smartphone to collect symptom data and record sleep breathing patterns, which are then analyzed to assess sleep-related health risks. Despite FDA clearance, Aetna considers Drowzle Pro experimental due to the limited peer-reviewed evidence demonstrating its effectiveness as a standalone diagnostic tool and its clinical utility in improving patient outcomes compared to standard diagnostic methods like polysomnography. While Drowzle Pro offers convenience and accessibility for home sleep testing, its accuracy and impact on clinical decision-making require further independent validation before it can be considered for coverage under Aetna preventive care coding.

EndeavorRx

Alt text: EndeavorRx video game interface showcasing engaging gameplay designed to improve attention function in children with ADHD.

EndeavorRx, developed by Akili Interactive Labs, is an FDA-authorized digital therapeutic video game designed to improve attention function in children (8-12 years) with ADHD. It is intended to be used as part of a broader therapeutic program and requires a prescription. Aetna classifies EndeavorRx as experimental, citing the need for more evidence to confirm its clinical efficacy and long-term benefits in improving ADHD symptoms and functional outcomes in real-world settings.

The STARS-ADHD study by Kollins et al. (2020) demonstrated that EndeavorRx (AKL-T01) improved attentional performance in pediatric ADHD patients compared to a digital control intervention. However, further research is needed to assess its effectiveness in diverse clinical populations, its comparative efficacy against standard ADHD treatments, and its long-term impact on broader ADHD-related outcomes beyond computer-based attention tests before Aetna can consider it for coverage under preventive care coding or standard medical necessity guidelines.

Freespira

Alt text: Freespira device with nasal cannula and tablet display showing real-time respiratory biofeedback for panic disorder and PTSD treatment.

Freespira, developed by Freespira, Inc., is an FDA-cleared digital therapeutic for panic disorder (PD) and post-traumatic stress disorder (PTSD) symptoms. It utilizes a sensor, physiological feedback, and coaching to guide patients in normalizing respiratory irregularities associated with anxiety attacks and PTSD. While Freespira has FDA clearance, Aetna considers it experimental due to the need for more robust and independent evidence demonstrating its clinical effectiveness and cost-effectiveness compared to established treatments for PD and PTSD.

A single-arm trial by Tolin et al. (2017) showed promising results for Freespira in treating panic disorder, with significant response and remission rates. However, Kaplan et al. (2020) highlighted the need for further research to fully evaluate Freespira’s impact on healthcare costs and patient outcomes in diverse clinical settings. More controlled trials comparing Freespira to standard treatments are needed to establish its clinical value and justify coverage under Aetna preventive care coding.

Halo AF Detection System

Alt text: Halo AF Detection System displayed on a Samsung smartwatch, illustrating continuous pulse rhythm monitoring for atrial fibrillation detection.

The Halo AF Detection System, developed by LIVMOR, is an FDA-cleared digital technology delivered via a Samsung smartwatch for continuous monitoring of pulse rhythms to detect atrial fibrillation (AF). Despite FDA clearance, Aetna classifies the Halo AF Detection System as experimental primarily because of the current lack of publicly available peer-reviewed evidence demonstrating its clinical effectiveness, accuracy, and impact on patient outcomes in real-world scenarios. While continuous AF monitoring holds promise, independent clinical validation and comparative studies against established AF detection methods are needed before Aetna can consider coverage under preventive care coding or standard medical necessity guidelines.

Insulia

Alt text: Insulia mobile app interface showing features for basal insulin titration, data capture, and healthcare provider communication for type 2 diabetes management.

Insulia, developed by Voluntis, is an FDA-cleared mobile app designed to assist healthcare professionals and adults with type 2 diabetes in basal insulin titration. It provides personalized insulin dose recommendations based on patient data and healthcare provider instructions. Aetna considers Insulia experimental due to the need for more evidence to demonstrate its superior clinical effectiveness and cost-effectiveness compared to standard insulin titration methods in diverse patient populations and real-world clinical practice.

The TeleDiab-2 study by Franc et al. (2019) demonstrated that the Diabeo-BI app software, similar to Insulia, improved HbA1c reduction compared to standard care. However, more research is needed to confirm these findings specifically for Insulia, to assess its long-term impact on glycemic control and patient outcomes, and to justify broader coverage under Aetna preventive care coding.

Leva Pelvic Health System

Alt text: Leva Pelvic Health System components including an intravaginal wand with motion sensors and a smartphone app for pelvic floor muscle training to treat urinary incontinence.

The Leva Pelvic Health System, developed by Renovia Inc., is an FDA-cleared medical device consisting of an intravaginal wand and app-based software for pelvic floor muscle training (PFMT) in women with urinary incontinence (UI). While Leva has FDA clearance, Aetna classifies it as experimental due to the mixed and evolving evidence regarding its clinical effectiveness compared to standard PFMT and other UI treatments.

Studies by Rosenblatt et al. (2019), Weinstein et al. (2022a, 2022b, 2023), and Keyser et al. (2023) have investigated the effectiveness of Leva in treating UI, with some showing statistically significant improvements in UI symptoms and quality of life compared to home PFMT or PFMT alone. However, Weinstein et al. (2022a) found no statistical difference in primary outcomes compared to PFMT alone in one study. These mixed findings and the need for further research to assess long-term effectiveness, patient adherence, and cost-effectiveness contribute to Aetna’s current experimental designation and exclusion from preventive care coding coverage.

Luminopia One (Digital Binocular Therapy)

Alt text: Luminopia One digital binocular therapy using a VR headset to deliver dichoptic treatment for amblyopia in children.

Luminopia One, developed by Luminopia, Inc., is an FDA-approved digital therapeutic using a software-only approach delivered through commercially available VR headsets for treating amblyopia (“lazy eye”) in children aged 4-7. Despite FDA approval, Aetna considers Luminopia One experimental due to the need for further independent validation of its clinical effectiveness, comparative efficacy against established amblyopia treatments like patching, and its long-term impact on visual outcomes and quality of life.

Studies by Xiao et al. (2021, 2022) and Elhusseiny et al. (2021) have shown promising results for Luminopia One in improving visual acuity in children with amblyopia. However, a Cochrane review by Tailor et al. (2022) suggests that binocular treatments like Luminopia One may have comparable efficacy to traditional patching, but more robust, long-term data is needed. Furthermore, Wygnanski-Jaffe et al. (2023) and Zhu et al. (2023) have also explored other binocular eye-tracking-based treatments for amblyopia, highlighting the ongoing research and evolving landscape of digital amblyopia therapies. The AAO’s Preferred Practice Pattern (2024) acknowledges the ongoing research in binocular digital therapy, indicating that further evidence is needed to delineate its optimal use in amblyopia treatment before widespread coverage consideration under Aetna preventive care coding.

MindMotion GO

Alt text: MindMotion GO software interface displaying game-based rehabilitation exercises for upper extremity, trunk, and lower extremity recovery.

MindMotion GO, developed by MindMaze, is an FDA-cleared medical device software used with Microsoft Kinect and Leap Motion controllers to support physical rehabilitation in adults. It offers game-based therapies for upper and lower extremities and trunk rehabilitation. Aetna classifies MindMotion GO as experimental due to the limited peer-reviewed evidence demonstrating its superior clinical effectiveness and cost-effectiveness compared to traditional rehabilitation methods in various clinical settings. While MindMotion GO offers innovative digital rehabilitation tools, more robust, independent clinical trials are needed to validate its clinical value and justify coverage under Aetna preventive care coding or standard medical necessity guidelines.

My Dose Coach

Alt text: My Dose Coach mobile app interface providing basal insulin dose suggestions based on fasting blood glucose and healthcare provider instructions for type 2 diabetes management.

My Dose Coach, developed by Sanofi, is an FDA-cleared basal insulin titration app for adults with type 2 diabetes. It provides dose suggestions based on healthcare provider instructions and patient-reported fasting blood glucose levels. Aetna considers My Dose Coach experimental, similar to Insulia, due to the need for more evidence demonstrating its superior clinical effectiveness and cost-effectiveness compared to standard basal insulin titration methods and other digital titration tools. While My Dose Coach offers a convenient digital aid for insulin titration, further independent clinical validation and comparative studies are needed to justify coverage under Aetna preventive care coding.

myVisionTrack (Home Vision Monitor [HVM])

Alt text: myVisionTrack mobile app interface showing a vision function test for detecting metamorphopsia in individuals with maculopathy.

myVisionTrack, developed by Visual Art and Science, LLC, is an FDA-cleared mobile app designed as a vision function test for detecting and characterizing metamorphopsia (visual distortion) in individuals with maculopathy, such as age-related macular degeneration and diabetic retinopathy. Aetna classifies myVisionTrack as experimental because of the limited peer-reviewed evidence demonstrating its clinical utility in improving patient outcomes and its impact on clinical decision-making compared to standard vision monitoring methods. While myVisionTrack offers a convenient home-based vision test, more robust clinical studies are needed to validate its clinical value and justify coverage under Aetna preventive care coding.

Nerivio

Alt text: Nerivio wearable neuromodulation device worn on the upper arm, controlled by a smartphone app, for acute migraine treatment.

Nerivio, developed by Theranica Bio-Electronics Ltd., is an FDA-cleared wearable neuromodulation device for the acute treatment of migraine in patients 12 years and older. It is applied to the upper arm and operated via a smartphone app. Aetna considers Nerivio experimental due to the need for more evidence to confirm its clinical effectiveness, comparative efficacy against standard migraine treatments, and long-term impact on migraine frequency and severity in real-world settings.

Studies by Grosberg et al. (2021), Hershey et al. (2021), and Yarnitsky et al. (2019) have shown promising results for Nerivio in acute migraine treatment, including pain relief and pain freedom. Monteith et al. (2023) suggest potential preventive effects with frequent use. Werner et al. (2024) found it safe and effective in children. However, further research, including comparative trials against standard migraine medications and long-term outcome studies, is needed to solidify its clinical value and justify coverage under Aetna preventive care coding.

NightWare

Alt text: NightWare app interface on an Apple Watch, illustrating sleep disturbance monitoring and vibration-based nightmare interruption.

NightWare, developed by NightWare, Inc., is an FDA-cleared smartwatch-based medical device utilizing AI to reduce sleep disturbance associated with nightmares in adults (22+) with nightmare disorder or PTSD-related nightmares. Despite FDA clearance and Breakthrough Device designation, Aetna classifies NightWare as experimental due to the lack of publicly available peer-reviewed evidence demonstrating its clinical effectiveness, comparative efficacy against standard nightmare treatments, and long-term impact on sleep quality and PTSD symptoms. While NightWare offers a novel digital approach to nightmare management, independent clinical validation and comparative studies are needed before Aetna can consider coverage under preventive care coding.

Parallel

Alt text: Parallel mobile app interface designed to deliver cognitive behavioral therapy for irritable bowel syndrome symptom management.

Parallel (formerly ReguI8), developed by Mahana Therapeutics, is an FDA-cleared digital therapeutic mobile app delivering cognitive behavioral therapy (CBT) for adults (22+) with irritable bowel syndrome (IBS). Aetna considers Parallel experimental due to the limited peer-reviewed evidence demonstrating its clinical effectiveness, comparative efficacy against standard IBS treatments, and long-term impact on IBS symptom severity and quality of life in diverse patient populations. While Parallel offers a digital CBT approach for IBS management, more robust, independent clinical trials are needed to validate its clinical value and justify coverage under Aetna preventive care coding.

Regulora

Alt text: Regulora mobile app interface providing gut-directed hypnotherapy for abdominal pain management in irritable bowel syndrome.

Regulora, developed by metaMe Health Inc., is an FDA-cleared prescription-only digital therapeutic software for treating abdominal pain associated with IBS. It delivers gut-directed hypnotherapy via a mobile device. Aetna classifies Regulora as experimental, similar to Parallel, due to the need for more evidence demonstrating its clinical effectiveness, comparative efficacy against standard IBS pain management strategies, and long-term impact on pain reduction and quality of life in diverse IBS patient populations. While Regulora offers a digital hypnotherapy approach for IBS pain, further independent clinical validation is needed to justify coverage under Aetna preventive care coding.

RelieVRx

Alt text: RelieVRx virtual reality system including a VR headset and software program delivering cognitive behavioral therapy for chronic lower back pain.

RelieVRx (formerly EaseVRx), developed by AppliedVR, Inc., is an FDA-authorized prescription-use immersive virtual reality system for adjunctive treatment of chronic lower back pain in adults (18+). It delivers cognitive behavioral therapy and pain education through VR. Aetna considers RelieVRx experimental due to the need for more evidence demonstrating its clinical effectiveness, comparative efficacy against standard chronic lower back pain treatments, and long-term impact on pain reduction and functional improvement in real-world settings. While RelieVRx offers an innovative VR-based approach to pain management, more robust, independent clinical trials are needed to validate its clinical value and justify coverage under Aetna preventive care coding.

reSET

Alt text: reSET mobile app interface delivering cognitive behavioral therapy based on the community reinforcement approach for substance abuse disorder treatment.

reSET, developed by Pear Therapeutics, Inc., is an FDA-cleared software application providing cognitive behavioral therapy for substance abuse disorder (SUD) as an adjunct to outpatient treatment and contingency management for adults (18+). Aetna classifies reSET as experimental due to the need for more evidence demonstrating its clinical effectiveness, comparative efficacy against standard SUD treatments, and long-term impact on abstinence rates and treatment retention in diverse patient populations and real-world clinical settings.

Studies by Campbell et al. (2014), Luderer et al. (2022), and Maricich et al. (2022) have shown promising results for reSET in improving abstinence rates and treatment retention in SUD patients. However, the VA/DoD Clinical Practice Guideline (2021) notes that the literature supporting FDA clearance did not meet inclusion criteria for their systematic evidence review. More independent, real-world studies are needed to fully validate reSET’s clinical value and justify coverage under Aetna preventive care coding.

reSET-O

Alt text: reSET-O mobile app interface delivering cognitive behavioral therapy based on the community reinforcement approach for opioid use disorder treatment.

reSET-O, also developed by Pear Therapeutics, Inc., is an FDA-cleared software application providing cognitive behavioral therapy for opioid use disorder (OUD) as an adjunct to outpatient treatment with buprenorphine and contingency management for adults (18+). Similar to reSET, Aetna considers reSET-O experimental due to the need for more evidence demonstrating its clinical effectiveness, comparative efficacy against standard OUD treatments, and long-term impact on abstinence rates and treatment retention in diverse patient populations and real-world clinical settings.

Studies by Christensen et al. (2014), Maracich et al. (2021a, 2021b), and Velez et al. (2021) have shown promising results for reSET-O in improving abstinence rates and treatment retention in OUD patients, and potentially reducing healthcare resource utilization. Luderer et al. (2023) are exploring its use in unsupervised buprenorphine initiation. However, like reSET, the VA/DoD guideline (2021) notes limitations in the supporting literature. More independent, real-world studies are needed to solidify reSET-O’s clinical value and justify coverage under Aetna preventive care coding.

SleepioRx

Alt text: SleepioRx mobile app interface delivering cognitive behavioral therapy for insomnia, featuring personalized sleep tracking and therapeutic content.

SleepioRx, developed by Big Health, is an FDA-cleared digital therapeutic for chronic insomnia/insomnia disorder in adults (18+). It delivers cognitive behavioral therapy for insomnia (CBT-I) through a mobile app. Despite its recent FDA clearance, Aetna currently considers SleepioRx experimental due to the need for more peer-reviewed evidence specifically on SleepioRx’s clinical effectiveness and its impact on patient outcomes in diverse populations, beyond the general evidence for digital CBT-I.

Studies on digital CBT-I, such as Espie et al. (2012), Felder et al. (2020), and Fleming et al. (2024), demonstrate the effectiveness of web-based CBT-I for improving insomnia symptoms in various populations, including pregnant women and stroke survivors. However, specific validation for SleepioRx and comparative studies against face-to-face CBT-I and other insomnia treatments are needed before Aetna can consider it for broader coverage under preventive care coding or standard medical necessity guidelines.

Somryst

Alt text: Somryst mobile app interface providing digital cognitive behavioral therapy for insomnia, with sleep diaries and personalized sleep restriction recommendations.

Somryst, developed by Pear Therapeutics, Inc., is an FDA-cleared software app providing digital CBT-I for chronic insomnia in adults (22+). Aetna classifies Somryst as experimental due to the need for more evidence demonstrating its superior clinical effectiveness and cost-effectiveness compared to face-to-face CBT-I and other insomnia treatments in diverse patient populations and real-world clinical settings.

Studies by Ritterband et al. (2022, 2017) and Christensen et al. (2016) have demonstrated the effectiveness of SHUTi, the precursor to Somryst, in improving insomnia symptoms and reducing depression symptoms. Forma et al.’s network meta-analysis (2022) suggests Somryst may have the highest probability of being most effective compared to face-to-face CBT-I and prescription medications for insomnia. However, further independent real-world evidence and comparative studies are needed to solidify Somryst’s clinical value and justify broader coverage under Aetna preventive care coding.

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