Digital Therapeutics Companies Have… AI recommendations | Parse
Which digital therapeutics companies have achieved reimbursement codes from payers?
Data as of Sep 26, 2026 · Based on 295 AI responses from ChatGPT Search and Google AI Mode · See how Parse measures this
Several companies have secured reimbursement, including AppliedVR for chronic back pain via a DME benefit category, and Big Health for insomnia and anxiety through CMS or payer coverage. Other notable companies with reimbursement status include Otsuka Precision Health/ (depression), (substance use), and (insomnia). Note that some pioneers, like Pear Therapeutics, achieved significant coding milestones before filing for bankruptcy.
Big Health is a notable choice for insomnia and anxiety, having obtained reimbursement pathways for products like SleepioRx and Daylight, with these products qualified for CMS codes and payer coverage.
AppliedVR is a primary fit for chronic pain management, having achieved a Medicare benefit category that allows its RelieVRx product to be billed under durable medical equipment (DME) coverage pathways.
Now that digital therapeutics have Medicare coverage, the real test beginshttps://www.healthcare-brew.com/stories/2025/04/04/digital-therapeutics-medicare-coverage-test-begins
8%
New reimbursement pathways have opened doors for using ...https://www.apaservices.org/practice/business/technology/tech-talk/reimbursement-pathways-digital-therapeutics
5%
Case Study: Innovative Reimbursement Strategy for Digital Therapeutics - Medical Device Innovation Consortiumhttps://mdic.org/resources/case-study-innovative-reimbursement-strategy-for-digital-therapeutics/
4%
How CMS codes could change the digital therapeutics industryhttps://www.healthcare-brew.com/stories/2024/07/22/cms-proposed-reimbursement-codes-digital-therapeutics-industry
3%
Digital Therapeutics Sector Sees Billing Codes as Key to ...https://medcitynews.com/2024/08/digital-therapeutics-reimbursement-cms-medicare-insurance-payers-clinical-trials/
3%
How to get paid for digital therapies, including codes for billing, remote patient monitoring, telehealth, AI, and 2026 Digital Therapeutics Billing: CPT, HCPCS, RPM/RTM, AI – Odelle Technologyhttps://odelletechnology.com/unlocking-reimbursement-for-digital-therapeutics-the-comprehensive-guide-to-us-billing-codes-origins-and-current-challenges/
2%
Informing the future of digital therapeutics: lessons learnt - PMChttps://pmc.ncbi.nlm.nih.gov/articles/PMC12314708/
2%
Clarity on Digital Therapeutics Reimbursement Could Lead to More Behavioral Health Adoption - Behavioral Health Businesshttps://bhbusiness.com/2022/10/26/clarity-on-digital-therapeutics-reimbursement-could-lead-to-more-behavioral-health-adoption/
2%
Data shows growing use of new Medicare codes for digital ...https://www.healthcare-brew.com/stories/2025/07/29/growing-use-new-medicare-codes-digital-therapeutics
2%
Pear's Reimbursement Efforts Bear Fruit for Digital Therapeuticshttps://www.mddionline.com/regulatory-quality/pear-s-reimbursement-efforts-bear-fruit
2%
Question: Which digital therapeutics companies have achieved reimbursement codes from payers?
Pear Therapeutics — reSET/reSET-O/Somryst: HCPCS A9291; CMS established the code in 2022. Pear also had commercial/Medicaid reimbursement arrangements, though it ceased operations in 2023.
Luminopia — Luminopia One: A9292, with commercial-payer coverage policies recognizing the product.
Reimbursement for digital therapeutics (DTx) has historically relied on individual, custom value-based contracts or pilot programs with commercial payers . However, the landscape shifted when the Centers for Medicare & Medicaid Services (CMS) introduced dedicated HCPCS Level II codes for Digital Mental Health Treatment (DMHT) devices.
Rather than assigning codes to specific corporate brand names, CMS and commercial payers issue codes for categories of qualifying, FDA-cleared software-as-a-medical-device (SaMD) interventions. Companies whose FDA-cleared prescription or digital mental health treatments align with these coverage pathways benefit directly.
The CMS Billing Codes (The Reimbursement Backbone)
Under the Medicare Physician Fee Schedule, CMS established three specific codes that allow clinicians to bill for prescribing, onboarding, and managing digital mental health treatments:
G0552: Supply of a digital mental health treatment device and initial education and onboarding, per course of treatment.
G0553: First 20 minutes of monthly treatment management services directly related to the patient's therapeutic use of the DMHT device (including clinical review and interactive communication).
G0554: Subsequent additional time blocks for monthly treatment management.
Key Companies and Products Poised or Approved for Code-Aligned Reimbursement
The following prominent digital therapeutics companies feature FDA-cleared or authorized software products that fit into these federal and commercial reimbursement frameworks:
Otsuka America Pharmaceutical / Click Therapeutics
Products:Rejoyn (for major depressive disorder) and RESET / RESET-O (for substance use and opioid use disorders). Click Therapeutics focuses heavily on prescription-based cognitive behavioral software that aligns with emerging behavioral health integration codes.
Pear Therapeutics (Assets acquired/revived under new stewardship) & Big Health
Products: & (for chronic insomnia), and (for generalized anxiety). These sleep and anxiety platforms have led the charge in securing early commercial medical policy inclusions (such as coverage expansions by major entities like Healthcare).
If you're looking into a specific product or therapeutic area (like insomnia, substance use, or musculoskeletal pain), let me know and I can detail its exact coverage status with commercial insurers like Cigna or UnitedHealthcare.
Yes. If by “achieved reimbursement codes from payers” you mean DTx companies whose products have obtained a recognized billing code and/or a payer coverage/reimbursement pathway, the U.S. landscape is still fairly small.
A key distinction: a billing code does not itself mean an insurer will pay a claim. CMS can establish a HCPCS code, while commercial payers separately decide coverage, medical necessity, benefit category, and payment.
Companies with the clearest U.S. reimbursement precedent
Company
DTx/product
Code / reimbursement pathway
Payer/reimbursement evidence
Pear Therapeutics
reSET, reSET-O, Somryst
HCPCS A9291 — FDA-cleared prescription digital behavioral therapy, per course
CMS established A9291 effective April 2022. Pear also had commercial-payer and Medicaid reimbursement arrangements, although Pear ceased operations after its 2023 bankruptcy.
CMS established E1905 in 2023 and subsequently assigned it a DME payment/rental pathway. This is one of the strongest examples of a DTx being incorporated into an existing Medicare benefit category.
Freespira
Freespira
HCPCS A9294, effective April 1, 2026
A9294 is specifically for FDA-cleared prescription cognitive/behavioral therapy using biofeedback. Premera's 2026 policy incorporates the code.
Akili
EndeavorRx
Commercial payer reimbursement/coverage pathway; broader Medicare digital mental-health-treatment (DMHT) framework is relevant
EndeavorRx has been reimbursed/covered by some payers, although its current public-facing access model still includes self-pay. FDA confirms EndeavorRx as an authorized digital therapeutic for pediatric ADHD.
Big Health
SleepioRx / DaylightRx
Medicare G0552–G0554 DMHT pathway, subject to applicable requirements
These CMS codes created a broader Medicare billing mechanism for qualifying FDA-cleared/authorized digital mental-health-treatment devices rather than a product-specific HCPCS code.
The important evolution in 2025–26
There are really three levels of reimbursement maturity:
A unique product/category HCPCS code
Examples: Pear's A9291, Luminopia's A9292, AppliedVR's E1905, and the newer A9294 category.
A commercial payer actually recognizes the product/code
For example, Premera's current policy specifically maps A9291 → reSET/reSET-O, A9292 → Luminopia, and A9294 → biofeedback DTx.
A defined Medicare payment pathway
This is newer. CMS's 2026 RTM framework explicitly includes “digital therapeutic intervention,” with new codes .
The broader commercial market remains limited. An IQVIA analysis of pharmacy-dispensed PDTs found that only 58 of 211 payers (27%) receiving new PDT prescriptions had approved at least one PDT claim through May 2024; reSET-O, EndeavorRx, reSET, Luminopia, Somryst and Mahana IBS were among the products analyzed.
Bottom line: If you're looking for companies that have demonstrated that a DTx can get beyond FDA clearance into an actual payer-recognized reimbursement mechanism, the most instructive precedents are Pear, AppliedVR, Luminopia, Freespira, and Akili, with Big Health representing the newer Medicare DMHT route.
If you're evaluating this from an investment/market-map perspective, I can also give you a more comprehensive table of ~15–20 DTx companies, their FDA status, CPT/HCPCS codes, named payer contracts, covered lives, and whether reimbursement is currently active vs. merely historical.
Instead of specific companies being individually assigned unique, proprietary reimbursement codes, the digital therapeutics (DTx) industry relies on general category billing codes established by regulatory bodies like the Centers for Medicare & Medicaid Services (CMS) and the American Medical Association (AMA).
To qualify for reimbursement under these codes, a company's product must be an FDA-cleared or FDA-authorized Software as a Medical Device (SaMD) targeting specific conditions (such as depression, anxiety, insomnia, substance use disorders, or ADHD) rather than general wellness apps.
The Standardized Reimbursement Codes
CMS finalized a dedicated framework of Level II HCPCS codes for Digital Mental Health Treatment (DMHT):
HCPCS G0552: Covering the supply of the digital mental health treatment device, initial setup, and patient onboarding (billed once per treatment course).
HCPCS G0553: Covering the first 20 minutes of clinical staff time per calendar month for reviewing data, consulting, and managing treatment protocols.
HCPCS G0554: Covering each additional 20 minutes of monthly clinical management time.
In addition, remote therapeutic monitoring (RTM) CPT codes (such as codes 98975, 98977, and 98980–98981) are used by various musculoskeletal and respiratory digital therapeutic providers to bill for patient data tracking and management.
Eligible Companies & Platforms
Any company with an FDA-cleared prescription digital therapeutic (PDT) meeting the device classification criteria can utilize these payer codes when prescribed by a clinician. Prominent examples include:
Akili: Developer of EndeavorRx , the first FDA-authorized prescription video game treatment for attention-deficit/hyperactivity disorder (ADHD) in pediatric patients. Its coverage maps directly onto expanded CMS mental/behavioral health device provisions.
Pear Therapeutics (Assets acquired/redistributed post-restructuring): Known for pioneering products like reSET and reSET-O for substance and opioid use disorders, which helped pave the policy and coding road for prescription software reimbursement.
Big Health: Creator of Daylight (for anxiety) and Sleepio (for insomnia), which are clinically validated, FDA-evaluated/cleared or reviewed approaches eligible for behavioral health and remote management codes.
: Developer of the therapeutic system, an FDA-cleared digital therapeutic intended to temporarily reduce sleep disturbance related to nightmares in patients with PTSD.
Note: Commercial insurance coverage varies significantly by payer, though major entities like Cigna Healthcare have increasingly established formal coverage review criteria for qualifying prescription digital therapeutics alongside Medicare's baseline framework.
Would you like to explore how to verify coverage criteria for a specific commercial insurer or look into Remote Therapeutic Monitoring (RTM) coding requirements for a particular medical specialty?
Securing dedicated reimbursement codes (such as specific CPT or HCPCS codes) has historically been one of the biggest hurdles for the digital therapeutics (DTx) industry. While early pioneers struggled with lack of coverage—contributing to high-profile restructurings or bankruptcies like Pear Therapeutics—the reimbursement landscape shifted notably when the Centers for Medicare & Medicaid Services (CMS) introduced dedicated HCPCS Level II codes (G0552, G0553, and G0554) under the Medicare Physician Fee Schedule for Digital Mental Health Treatment (DMHT) devices.
Companies whose FDA-cleared or FDA-authorized prescription software products align with these federal reimbursement pathways, or which leverage remote therapeutic monitoring (RTM) codes, include the following:
Big Health – Maker of SleepioRx (for chronic insomnia) and DaylightRx (for generalized anxiety disorder), which map to the FDA-cleared categories eligible under the updated DMHT framework.
Click Therapeutics – Developer of prescription digital therapeutics like Rejoyn (cleared for major depressive disorder), which qualifies for use under the 2025/2026 CMS digital mental health billing codes.
Pear Therapeutics (Assets/Ip acquired post-restructuring) – Originally creator of RESET and RESET-O (for substance use and opioid use disorders) and Somryst (for chronic insomnia). Though the original corporate entity faced market access challenges, their pioneering FDA-authorized products set the clinical precedent and now fall under these emerging behavioral health device billing rules.
MindPeace / Women's digital health innovators – Products like MamaLift Plus (for postpartum depression) are positioned within the ecosystem of FDA-cleared computerized behavioral therapies targeted by the new G-codes.
Remote Therapeutic Monitoring (RTM) / General Platforms – Various musculoskeletal and respiratory digital care providers (such as Omada Health or specialized virtual care platforms) have similarly utilized general RTM CPT codes (98975, 98977, etc.) for provider-driven patient data tracking, even as dedicated software-specific codes expand.
Would you like to explore how to bill these specific G0552–G0554 codes under Medicare, or look into commercial insurance policies (like Cigna's recent coverage expansions) for digital therapeutics?
If by “achieved reimbursement codes from payers” you mean digital-therapeutics companies whose products obtained a recognized U.S. billing/reimbursement pathway and, ideally, actual payer coverage, the list is still fairly short.
A key distinction: having a CPT/HCPCS code does not automatically mean a payer will reimburse it. CMS can establish a code while commercial plans separately decide whether to cover it. IQVIA notes that early DTx codes such as A9291 and A9292 were used only minimally because they lacked national pricing and associated provider-service codes.
The clearest examples
Company
Product
Reimbursement code/pathway
Evidence of payer reimbursement/coverage
Pear Therapeutics
reSET, reSET-O, Somryst
HCPCS A9291 — prescription digital cognitive/behavioral therapy
Yes — strongest historical example. CMS created A9291 effective Apr. 1, 2022. Pear also had agreements with Oklahoma Medicaid and Point32Health.
Luminopia
Luminopia One
HCPCS A9292 — prescription digital visual therapy
Yes — increasingly clear commercial coverage. Highmark approved coverage in 2024 and Anthem Blue Cross/Blue Shield approved coverage in 2025.
AppliedVR
RelieVRx
HCPCS E1905 / DME pathway
Yes, but via DME rather than a pure software DTx code. This is an important example of a hardware/software DTx obtaining a more conventional Medicare reimbursement pathway.
WellDoc
BlueStar
CPT 99453/99454/99457 and related remote-monitoring pathway
Yes. BlueStar has historically been reimbursed through remote patient monitoring and health-plan/employer arrangements rather than a dedicated DTx HCPCS code.
A newer development: Medicare DMHT codes
The landscape changed materially in 2025. CMS introduced three Medicare HCPCS codes specifically for digital mental health treatment (DMHT):
G0552 — supply of the FDA-approved digital mental-health treatment device and onboarding
G0553 — first 20 minutes/month of treatment management
G0554 — additional 20 minutes/month
These are actual Medicare payment codes, although the requirements are important: the practitioner must furnish/pay for the device as part of an ongoing behavioral-health treatment plan, and G0552 is contractor-priced rather than having a single national payment rate.
This creates a new reimbursement route for products such as FDA-authorized digital treatments for behavioral health/ADHD, rather than relying exclusively on the older A9291 framework.
Companies/products worth watching
There are several additional companies with codes or payer-policy recognition, but I would be more cautious about calling them “successfully reimbursed”:
Big Health — DaylightRx and SleepioRx. These are FDA-authorized PDTs and can potentially fit into the newer Medicare DMHT framework, but broad payer reimbursement is still developing.
Akili — EndeavorRx. It has FDA clearance and is now relevant to the Medicare DMHT coding framework, but commercial reimbursement has historically been much less established than coding alone would suggest.
Otsuka / Click Therapeutics — Rejoyn. FDA-cleared for major depressive disorder; the product could potentially use the emerging DMHT reimbursement infrastructure, but that shouldn't be conflated with established broad payer coverage.
Curio Digital Therapeutics — .
The important point is that FDA clearance ≠ reimbursement code ≠ payer coverage ≠ paid claims. The industry has historically struggled at each successive step. A recent review notes that even Pear had only about half of prescriptions covered by insurance, despite having the landmark A9291 code.
My shortlist of “proven” reimbursement precedents
If you're evaluating companies from an investment, market-access, or competitive-intelligence perspective, I'd divide them this way:
Pear Therapeutics — A9291; Medicaid/commercial agreements, though the company subsequently failed.
Luminopia — A9292 plus documented Highmark and Anthem coverage.
WellDoc — established reimbursement through RPM/medical-benefit mechanisms.
AppliedVR — DME reimbursement pathway for RelieVRx.
Tier 2 — coding achieved, but reimbursement/coverage is less mature
Big Health
Akili
Otsuka/Click Therapeutics
Curio Digital Therapeutics
MetaMe Health
The most interesting development for 2026 is probably not another company-specific code, but CMS's G0552–G0554 DMHT framework. It potentially turns Medicare into a much more standardized reimbursement channel for FDA-authorized digital mental-health treatments.
If you want, I can also build you a comprehensive table of ~20 DTx companies showing FDA product, CPT/HCPCS code, payer(s), coverage status, reimbursement amount, and whether they have actual paid claims—which is a more useful way to distinguish “has a code” from “actually gets reimbursed.”
Achieving specific reimbursement codes (such as HCPCS or CPT codes) is a major milestone for digital therapeutics (DTx) companies, though securing actual payer coverage and payment still varies widely by commercial and state Medicaid plans.
Key digital therapeutics and software-based medical device companies that have successfully driven the creation or assignment of dedicated billing and reimbursement codes include:
Pear Therapeutics – Pioneered early coding milestones when the Centers for Medicare & Medicaid Services (CMS) established Level II HCPCS code A9291 (Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment). This code was built to describe behavioral software solutions like Pear's reSET and reSET-O (for substance/opioid use disorder) and Somryst (for chronic insomnia). (Note: Pear underwent Chapter 11 liquidation, but its legacy coding framework paved the baseline for behavioral DTx).
Hygieia – Secured specific American Medical Association (AMA) Category III CPT codes (0740T and 0741T ) for its automated, algorithm-based insulin dose calculation, titration, and remote data storage platform.
NovaSight – Achieved alignment with CPT Category III codes (0704T–0706T ) and HCPCS code A9292 (Prescription digital visual therapy, software-only, FDA cleared, per course of treatment) for its CureSight remote amblyopia (lazy eye) eye-tracking treatment system.
Luminopia – Utilizes software-based digital visual therapy for amblyopia, mapping directly to optical/visual digital therapy codes like A9292 recognized in major commercial payer medical policies.
MindMaze / Neuraly / RTM-aligned providers – Many companies focusing on neurological rehab or virtual physical therapy (such as Kaia Health ) lean on Remote Therapeutic Monitoring (RTM) codes (98975–98981 ) which payers have gradually adopted for adherence and therapeutic tracking, even when product-specific codes are still rolling out.
If you're working on a reimbursement strategy or market access analysis, would you like to explore:
The difference between HCPCS Level II codes vs. Category III CPT codes for software?
Current coverage hurdles from major commercial payers (like Aetna or Anthem) regarding these codes?
If by “achieved reimbursement codes from payers” you mean DTx companies whose products have both (1) a recognized billing code and (2) evidence that a commercial payer/PBM actually incorporated the product into a covered/reimbursable pathway, the list is still fairly short.
Strongest U.S. examples
Company
DTx/product
Reimbursement code/pathway
Payer evidence
Status
Pear Therapeutics
reSET / reSET-O
HCPCS A9291 — prescription digital behavioral therapy, FDA-cleared, per course
Multiple commercial payers/PBMs; Pear reported 30 payers covering >31.7M lives before its bankruptcy
Strongest historical precedent
Luminopia
Luminopia One
HCPCS A9292 — prescription digital visual therapy
Anthem now covers Luminopia as a medical benefit; other payer policies recognize A9292
Active
AppliedVR
RelieVRx
E1905 — VR cognitive behavioral therapy device
Commercial-payer coverage/reimbursement pathways; Premera specifically identifies E1905 for RelieVRx
Active/established
Freespira
Freespira
Payer-specific contracting/benefit pathways; newer A9294 is relevant to biofeedback DTx
Highmark and other payer relationships; coverage is generally plan-specific
Active
d-Nav / Insulia-type diabetes DTx
Diabetes-management software
CPT 0740T/0741T and related pathways
Payer policies have incorporated these codes/products
Active, but different coding model
CMS created A9291 specifically for prescription digital behavioral therapy and made it effective April 1, 2022. Importantly, CMS said the purpose included facilitating access for non-Medicare payers; creation of the code itself did not establish Medicare payment.
Luminopia followed with A9292, effective October 1, 2023. CMS explicitly established the code for Luminopia but assigned no Medicare payment at the time. Commercial reimbursement is a different question: Anthem now states that Luminopia is covered as a medical benefit for eligible members.
An important distinction
There are really three levels of “reimbursement success” in DTx:
A unique HCPCS/CPT code exists.
A commercial payer has a coverage policy that recognizes the code/product.
The payer actually pays claims at an established rate.
Those are not equivalent. For example, Aetna's current policy lists numerous DTx products—including EndeavorRx, Freespira, Luminopia One, NightWare, RelieVRx, reSET/reSET-O and others—but being listed in a payer policy does not necessarily mean every listed product is covered; the policy distinguishes covered products, noncovered products and products requiring specific criteria.
The newer 2026 development
There is now another dedicated DTx code:
A9294 — “Prescription digital cognitive and/or behavioral therapy, biofeedback, FDA cleared, per course of treatment,” effective April 1, 2026.
Premera's 2026 policy incorporates A9294, while its policy also specifically maps A9291 to reSET/reSET-O and A9292 to Luminopia.
Separately, CMS expanded Remote Therapeutic Monitoring (RTM) in 2026 with codes 98979, 98984 and 98985, explicitly including “digital therapeutic intervention” in the code descriptors. This creates a reimbursement route that doesn't require a DTx-specific HCPCS code.
Bottom line
If you're looking for companies that have demonstrated actual payer reimbursement rather than merely FDA clearance, I'd put them roughly into these buckets:
Pear Therapeutics — strongest historical proof point, with A9291 and substantial commercial/PBM adoption, although Pear itself is no longer operating as it did historically.
Luminopia — strongest current example of a dedicated DTx code + active major-payer coverage.
AppliedVR — strong example of reimbursement through a DME/medical-device code (E1905), rather than a pure DTx-specific HCPCS code.
Freespira — notable for actual payer contracting and outcomes-based reimbursement work, although its coding situation is less clean than Pear/Luminopia.
One particularly interesting point is that “getting a code” is no longer necessarily the key milestone. The 2026 RTM expansion means a DTx company can potentially obtain reimbursement through an existing clinical-service pathway, while dedicated HCPCS codes such as A9291/A9292/A9294 provide a more explicit product-level mechanism.
If you're evaluating this for investment or competitive intelligence, I can build a 2026 table of ~20 DTx companies with FDA status, HCPCS/CPT code, named payer, covered lives, Medicare/Medicaid status, and whether there is evidence of actual paid claims. That would give a much clearer picture of who has truly cracked reimbursement versus who merely has a billing code.
Separately, CMS expanded Remote Therapeutic Monitoring (RTM) in 2026 with codes 98979, 98984 and 98985, explicitly including “digital therapeutic intervention” in the code descriptors. This creates a reimbursement route that doesn't require a DTx-specific HCPCS code.
Bottom line
If you're looking for companies that have demonstrated actual payer reimbursement rather than merely FDA clearance, I'd put them roughly into these buckets:
Yes. But there’s an important distinction: a reimbursement code is not the same thing as payer coverage. CMS/AMA establish billing codes; commercial insurers and Medicaid plans decide whether to cover and pay them.
As of 2026, the U.S. digital-therapeutics companies with the strongest evidence of having achieved a payer-recognized reimbursement pathway include:
Company
Product
Code / pathway
Payer status
Pear Therapeutics
reSET, reSET-O, Somryst
A9291
Strong historical precedent; commercial and Medicaid coverage existed, but Pear ceased operations in 2023
Luminopia
Luminopia One
A9292
Dedicated HCPCS code and payer policies recognizing the product
AppliedVR
RelieVRx
E1905
DME/VR reimbursement pathway; recognized by commercial payer policies
Freespira
Freespira
A9294
New dedicated HCPCS code effective Apr. 1, 2026; payer policies are beginning to incorporate it
Big Health
SleepioRx, DaylightRx
G0552–G0554
Medicare DMHT pathway beginning 2025
Akili / EndeavorRx
EndeavorRx
G0552–G0554
Medicare DMHT pathway expanded in 2026 to include ADHD devices
Otsuka / Click Therapeutics
Rejoyn
G0552–G0554
Potentially within the Medicare DMHT pathway, subject to the device/service and coverage requirements
The strongest examples
1. Pear Therapeutics — the original benchmark
Pear's reSET/reSET-O products were the catalyst for HCPCS A9291, created in 2022 for FDA-cleared prescription digital cognitive/behavioral therapy. CMS explicitly discussed the lack of coding infrastructure as an access problem.
There was actual payer adoption: for example, SelectHealth added reSET-O as a covered benefit for certain commercial members, and payer surveys identified reSET and reSET-O among the most frequently covered PDTs.
The caveat is that Pear went bankrupt in 2023, so I would classify this as a successful reimbursement precedent, not a current commercial success.
2. Luminopia — one of the clearest surviving code + payer examples
Luminopia One has its own HCPCS code, A9292, for prescription digital visual therapy. Premera's current policy specifically identifies A9292 for Luminopia, while other Blue Cross policies have incorporated Luminopia into their covered/authorized DTx frameworks.
3. AppliedVR — successful device/DME route
RelieVRx is interesting because it demonstrates an alternative to the pure-software DTx model. Payers such as Premera recognize E1905, the VR cognitive-behavioral-therapy device code, for RelieVRx.
4. Freespira — the newest product-specific code
A significant 2026 development is A9294, created for FDA-cleared prescription digital cognitive/behavioral therapy using biofeedback. The code became effective April 1, 2026. Current payer policies identify Freespira under A9294.
The bigger development: Medicare's G-codes
The most important change for the industry is arguably G0552, G0553 and G0554, introduced January 1, 2025:
G0552 — supply of a digital mental-health-treatment device and initial education/onboarding
G0553 — monthly treatment management
G0554 — additional monthly treatment-management time
CMS created these specifically for FDA-cleared/authorized digital mental-health-treatment devices used alongside ongoing behavioral-health treatment.
And in 2026, CMS expanded the policy to cover qualifying digital devices for ADHD, which is particularly relevant to EndeavorRx/Akili.
What I would not count
I would not put companies such as Omada, Hinge Health, Sword Health, Virta, etc. in the same category if your question is specifically about a DTx obtaining a dedicated reimbursement code. They have substantial payer/employer reimbursement, but largely through conventional medical services, value-based contracts, employer benefits, RTM, or other existing mechanisms rather than a dedicated prescription-DTx HCPCS code.
That's an important distinction if you're doing a competitive landscape or evaluating "who has actually solved reimbursement?"
Also, having a code doesn't mean broad payment: IQVIA notes that the early A9291/A9292 codes had no national pricing and were used relatively minimally, while current payer policies can still make coverage plan-specific.
Bottom line: if you're looking for the strongest U.S. reimbursement precedents, I'd rank Pear (historical), Luminopia, AppliedVR, and Freespira as the clearest examples of product-specific coding + payer recognition, while Big Health and Akili are especially important examples of the newer Medicare G-code pathway.
If you'd like, I can also build a company-by-company table of 15–25 DTx companies showing FDA clearance, CPT/HCPCS code, specific payer coverage (United, Cigna, Aetna, BCBS, Medicaid, Medicare), reimbursement amount, and whether reimbursement is currently active in 2026.
RelieVRx is interesting because it demonstrates an alternative to the pure-software DTx model. Payers such as Premera recognize E1905, the VR cognitive-behavioral-therapy device code, for RelieVRx.
4. Freespira — the newest product-specific code
A significant 2026 development is A9294, created for FDA-cleared prescription digital cognitive/behavioral therapy using biofeedback. The code became effective April 1, 2026. Current payer policies identify Freespira under A9294.
Unlike traditional pharmaceuticals or hardware medical devices, digital therapeutics (DTx) have historically faced a unique reimbursement bottleneck. Rather than receiving product-specific billing codes, DTx products have relied heavily on general service-based codes (such as Remote Therapeutic Monitoring [RTM] CPT codes 98975–98981 ) or specific macro-level HCPCS codes created by the Centers for Medicare & Medicaid Services (CMS).
The regulatory and payment landscape centers around structural code categories rather than individual corporate branding, though several pioneering companies have successfully aligned their FDA-cleared software with these active reimbursement pathways:
General & Category-Adapting Pathways (RTM & DMHT Codes)
Instead of dedicated permanent product codes for every brand, CMS established overarching framework codes that clinicians use to bill for patient onboarding, data review, and monthly management of software-driven therapies:
Remote Therapeutic Monitoring (RTM) Codes (98975, 98977, 98980): Cover musculoskeletal and respiratory data tracking. Companies offering digital physical therapy, joint rehabilitation, or remote chronic disease management (such as Hinge Health or K ماهی/Kare -adjacent musculoskeletal apps) have aligned their platforms with these codes so providers can bill for clinician-led oversight.
Digital Mental Health Treatment (DMHT) HCPCS Codes (G0552, G0553, G0554): Implemented via the Medicare Physician Fee Schedule to reimburse mental/behavioral health digital devices and treatment plans. This opened avenues for prescription and clinical mental health apps.
Pioneering Companies & Specific Milestones
Pear Therapeutics (Pioneered initial coding efforts): Pear achieved a major milestone when CMS established HCPCS code A9291 (Prescription digital behavioral therapy, FDA cleared, per course of treatment ) for products like reSET® and reSET-O® . Although Pear subsequently underwent Chapter 11 restructuring, their market groundwork defined how prescription digital therapeutics (PDTs) map onto payer systems.
Akili Interactive: Maker of EndeavorRx (FDA-cleared for ADHD). Akili shifted commercial strategies toward direct employer/payer contracting and broader institutional pathways rather than relying on standard procedural outpatient codes, highlighting the friction of traditional medical billing for standalone pediatric video-game therapeutics.
, , and : These companies have secured various levels of commercial health plan coverage (such as targeted PBM [Pharmacy Benefit Manager] or medical policy inclusions) by proving cost-offsets to insurers, though they largely navigate a patchwork of custom medical policy exceptions rather than universal dedicated national coding.
The Current Reality
As highlighted by the Digital Therapeutics Alliance (DTA), rather than individual companies holding exclusive "reimbursement codes," the industry operates via shared general CPT/HCPCS frameworks . Clinicians utilize established RTM or DMHT administrative codes to get paid for monitoring patient data and engagement inside an FDA-cleared software platform.
If you're evaluating a specific product, let me know:
The specific company or product name you are looking into
Whether you are interested in Medicare/Medicaid or commercial payer coverage policies
I can dig deeper into their current market access strategy or clinical reimbursement status.
Products: Digital musculoskeletal (MSK) therapy applications. While distinct from pure mental health DMHT codes, Kaia has successfully secured targeted commercial health plan reimbursement codes and remote therapeutic monitoring (RTM) pathways for back and joint pain.
Akili Interactive
Products:EndeavorRx (the first FDA-cleared video-game treatment for ADHD). Akili transitioned part of its strategy toward direct access and targeted clinical pathways, navigating the nuanced device classification rules required for federal and private reimbursement.
Welldoc
Products: Multi-condition chronic management platform (diabetes, heart failure, hypertension). Welldoc has historically utilized a combination of Remote Patient Monitoring (RPM) CPT codes and direct enterprise/employer payer contracts rather than waiting solely on standalone DTx category codes.
98979, 98984 and 98985
NightWare
NightWare
MamaLift Plus
MetaMe Health — Regulora.
Voluntis — Insulia.
Mahana Therapeutics — Mahana IBS.
A broader second tier—Akili/EndeavorRx, Mahana, NightWare, d-Nav, etc.—has payer coverage or billing pathways, but the evidence for broad, standardized reimbursement is less compelling.