Which digital therapeutics companies have achieved reimbursement codes from payers?

The Centers for Medicare & Medicaid Services (CMS) established formal HCPCS Level II billing codes (specifically G0552, G0553 , and G0554 ) for Digital Mental Health Treatment (DMHT) devices. These codes allow licensed healthcare providers to bill Medicare for supplying, onboarding, and managing monthly treatment programs using specific FDA-cleared, prescription-grade software.

Several digital therapeutics (DTx) companies have products that officially qualify for reimbursement under these framework and coding policies:

• Big Health — Maker of SleepioRx (for chronic insomnia) and DaylightRx (for generalized anxiety disorder). Both are FDA-cleared and qualify for reimbursement under the federal DMHT codes.
• Otsuka Precision Health & Click Therapeutics — Jointly commercialize Rejoyn , a prescription digital therapeutic for major depressive disorder that meets the criteria for CMS's digital mental health codes.
• PursueCare — Offers reSET (for substance use disorder) and reSET-O (for opioid use disorder), originally pioneered by Pear Therapeutics and integrated into qualifying federal and commercial coverage pathways.
• Nox Health — Maker of Somryst , an FDA-cleared prescription digital therapeutic for chronic insomnia that qualifies for the established G-codes.
• Curio Digital Therapeutics — Developer of MamaLift Plus , an FDA-cleared digital mental health tool aimed at maternal mental health and postpartum depression management, qualifying for the DMHT billing structure.

Would you like to explore specific payment rates for these HCPCS codes (G0552-G0554) or look into commercial insurance coverage policies for these platforms?

It depends on what you mean by "achieved reimbursement codes." In digital therapeutics (DTx), there are three distinct milestones:

1. A dedicated billing code (HCPCS or CPT) that enables claims submission.
2. Payer coverage (commercial insurers, Medicaid, or Medicare agree to reimburse).
3. Routine reimbursement at scale across many payers.

Only a small number of DTx companies have achieved the first milestone with dedicated national billing codes. Many others have secured reimbursement by using existing CPT codes (e.g., Remote Therapeutic Monitoring) or through direct payer and employer contracts rather than obtaining product-specific codes.

Companies with payer reimbursement but no dedicated national billing code

These companies have achieved meaningful reimbursement through commercial insurers, employers, or existing billing infrastructure:

• Akili Interactive (EndeavorRx): selective commercial payer coverage and medical-benefit reimbursement, but no unique national HCPCS code.
• Mahana Therapeutics (Mahana IBS): commercial payer agreements for IBS treatment; reimbursement varies by insurer.
• Click Therapeutics: pursuing reimbursement through existing digital therapeutic billing frameworks and payer contracts.
• Big Health (Sleepio, Daylight): commercial payer and employer reimbursement, primarily through negotiated contracts rather than dedicated billing codes.

Companies reimbursed primarily through existing CPT or value-based models

Several of the largest digital care companies generate substantial revenue without product-specific HCPCS codes:

• Omada Health — uses existing CPT pathways (including chronic care management and remote monitoring) plus commercial payer contracts.
• Hinge Health — employer contracts, health-plan agreements, and value-based reimbursement.
• Sword Health — employer and payer contracts combined with existing reimbursement mechanisms.
• Kaia Health — payer agreements and Remote Therapeutic Monitoring (RTM) CPT codes.
• Virta Health — reimbursed largely through employer and health-plan contracts rather than dedicated DTx codes.

Industry perspective

The reimbursement landscape has shifted over the past several years:

• Dedicated HCPCS codes remain rare. Pear Therapeutics' A9291 code was a landmark, but few companies have obtained comparable product-class-specific codes.
• Existing reimbursement mechanisms are now more common. Companies increasingly use RTM, RPM, chronic care management CPT codes, or negotiated payer contracts instead of waiting for new HCPCS codes.
• Coverage is distinct from coding. A billing code enables claims submission, but individual commercial payers and Medicare Advantage plans still determine whether and under what conditions they will reimburse a product.

For investors, one analysis of U.S. digital health IPOs found that companies with established reimbursement billing codes at the time of their IPO substantially outperformed those without such codes, highlighting the commercial importance of reimbursement strategy.

There are two distinct reimbursement milestones in digital therapeutics (DTx), and it's helpful to separate them:

1. Obtaining a dedicated billing code (HCPCS or CPT) that payers can use.
2. Achieving actual payer coverage/reimbursement (commercial insurers, Medicaid, Medicare Advantage, employers, etc.).

Only a small number of digital therapeutics companies have achieved the first milestone.

Companies with payer reimbursement but without dedicated product billing codes

Several leading digital therapeutics companies have achieved substantial reimbursement through existing reimbursement pathways instead of unique HCPCS codes.

Companies pursuing dedicated reimbursement pathways

Several FDA-cleared prescription DTx companies have pursued dedicated reimbursement codes or are positioned to use emerging reimbursement pathways:

• Akili Interactive (EndeavorRx) requested a product-specific HCPCS code from CMS after FDA clearance.
• Click Therapeutics is positioned to use newer digital mental health reimbursement pathways as products reach commercialization.

Broader reimbursement infrastructure

Rather than obtaining product-specific billing codes, many digital therapeutics leverage existing CPT reimbursement, including:

• Remote Physiologic Monitoring (RPM): CPT 99453, 99454, 99457, 99458
• Remote Therapeutic Monitoring (RTM): CPT 98975–98981
• Online digital evaluation/management (eVisits)

These codes, developed through the AMA's digital medicine initiatives, are reimbursed by CMS and many commercial insurers and have become the primary reimbursement mechanism for many digital health companies.

Bottom line

If you define "achieved reimbursement codes" as dedicated national HCPCS codes specific to prescription digital therapeutics, the list remains very short:

1. Pear Therapeutics — HCPCS A9291
2. Better Therapeutics — HCPCS A9292

If you broaden the definition to include companies that have achieved routine payer reimbursement through existing CPT codes or direct payer contracts, the list expands to include companies such as Omada Health, Hinge Health, Sword Health, Big Health, and Virta Health, among others. The industry trend has been toward fitting DTx into established reimbursement frameworks rather than creating new product-specific billing codes.

The commercial and federal reimbursement landscape for digital therapeutics (DTx) shifted significantly with the implementation of the Centers for Medicare & Medicaid Services (CMS) Medicare Physician Fee Schedule, which established specific HCPCS Level II supply and management codes (G0552, G0553, and G0554 ) for FDA-cleared Digital Mental Health Treatment (DMHT) devices.

Only a select group of FDA-cleared/authorized prescription software products align directly with these defined federal and commercial payer coding structures. Companies whose digital therapeutics qualify for or have achieved integration into these and prior reimbursement frameworks include:

• Big Health — Known for SleepioRx (for insomnia) and DaylightRx (for generalized anxiety disorder), which qualify for the CMS DMHT HCPCS reimbursement pathway.
• Click Therapeutics / Otsuka Precision Health — Co-developer of Rejoyn , a prescription digital therapeutic for major depressive disorder that qualifies under the federal mental health coding system.
• Nox Health — Developer of Somryst , a prescription digital therapeutic for chronic insomnia that meets the criteria for CMS digital mental health coding.
• Curio Digital Therapeutics — Developer of MamaLift Plus , focused on maternal mental health, which is recognized under the updated Medicare framework.
• PursueCare — Provides access to FDA-cleared substance use and opioid use disorder applications like reSET and reSET-O (originally pioneered through early commercial/Medicaid and evolving federal pathways).
• JOGO Health — Utilizes a neuromuscular platform that has secured broader coverage paths via standard medical benefit structures and localized Medicare/commercial contractor policies for pain and neuro-re-education.

(Note: While companies like Pear Therapeutics and Better Therapeutics previously achieved groundbreaking FDA clearances and early regional or ad-hoc payer pilots, the absence of standardized national codes during their operational windows contributed to severe commercial scaling hurdles. The current G-codes represent the first formalized federal volume baseline for qualifying neurological and behavioral software.)

Would you like to explore specific billing workflows for the G0552–G0554 codes or look into international reimbursement models (like Germany's DiGA fast-track process) for digital therapeutics?

Several digital therapeutics (DTx) companies have achieved reimbursement codes from payers, particularly with the introduction of new CMS codes in 2025 and increasing adoption of existing HCPCS and CPT codes . These companies primarily focus on behavioral health, chronic disease management, and digital mental health.

Key Companies with Reimbursement Success

• AppliedVR: Achieved a significant milestone by having their RelieVRx® program recognized by CMS as Durable Medical Equipment (DME), enabling reimbursement for chronic lower back pain.
• Akili Interactive: Known for EndeavorRx®, a video game-based treatment for pediatric ADHD. While navigating a shift to a direct-to-consumer model, they previously operated within the emerging prescription digital therapeutics space.
• Big Health: Provides Sleepio (for insomnia) and Daylight (for anxiety), which have secured coverage with some commercial payers and pharmacy benefit managers (PBMs).
• Click Therapeutics: Develops FDA-cleared software for mental health, migraines, and schizophrenia, and has acquired assets to strengthen its commercialization pathway.
• Omada Health: A leader in digital care for diabetes and cardiometabolic conditions, utilizing alternative reimbursement routes outside traditional Medicare.

Reimbursement Pathways and Codes

• 2025 CMS Codes (GMBT1-GMBT3): Effective January 1, 2025, CMS introduced codes allowing clinicians to bill Medicare for digital mental health treatments (DMHT) that are FDA-cleared and part of a behavioral therapy plan.
• HCPCS Code A9291: Established in 2022 specifically for "prescription digital behavioral therapy, FDA cleared, per course of treatment," facilitating coverage for Medicaid and commercial payers.
• Remote Therapeutic Monitoring (RTM) Codes: Some companies utilize these existing codes (e.g., CPT 98975, 98976, 98977, 98980, 98981) to receive payment for monitoring patient data through digital tools.

Industry Context

• The Digital Therapeutics Alliance (DTA): Actively works to define and increase adoption of reimbursement codes to ensure Medicare and commercial coverage.
• Market Challenges: Despite progress, many companies still face a challenging landscape, with some, such as Pear Therapeutics, facing bankruptcy due to a lack of broad reimbursement coverage, highlighting that FDA clearance does not guarantee reimbursement.

If you are interested in a specific therapeutic area (e.g., mental health, chronic pain), I can list the specific codes they use.

If you'd like to understand the differences in how payers (Medicare vs. Commercial vs. Medicaid) are adopting these, I can provide that as well.

The answer depends on what you mean by "reimbursement codes." In digital therapeutics (DTx), there are three distinct reimbursement milestones:

1. A dedicated billing code (e.g., HCPCS or CPT).
2. Payer coverage (commercial insurers, Medicaid, or Medicare Advantage agreeing to reimburse).
3. Routine reimbursement at scale across multiple payers.

Only a small number of companies have obtained dedicated HCPCS codes specifically for prescription digital therapeutics (PDTs). Many more have achieved reimbursement through existing CPT codes (such as Remote Therapeutic Monitoring) or negotiated payer contracts.

Companies with meaningful payer reimbursement but no dedicated product code

These companies generate substantial revenue through negotiated contracts, existing CPT codes, or value-based reimbursement rather than a product-specific HCPCS code.

An important shift in reimbursement

The market has evolved away from seeking a unique billing code for every DTx product. Increasingly, companies are using:

• Existing Remote Therapeutic Monitoring (RTM) CPT codes
• Chronic care management and behavioral health CPT codes
• CMS digital mental health treatment payment pathways
• Employer self-insured contracts
• Value-based agreements with health plans and provider organizations

As a result, obtaining a dedicated HCPCS code is no longer viewed as the only—or even the primary—commercialization strategy for many digital therapeutics companies.

In summary, if your criterion is dedicated reimbursement codes, the list is very short, led by Pear Therapeutics and Better Therapeutics, with AppliedVR establishing a distinct Medicare payment pathway. If your criterion is successful payer reimbursement, a much broader group—including Omada, Hinge, Sword, Virta, Kaia, Akili, Mahana, and Click—has achieved reimbursement through existing coding frameworks and negotiated payer contracts rather than product-specific HCPCS codes.

The answer depends on what you mean by "achieved reimbursement codes," because there are three different milestones:

1. Obtaining a dedicated billing code (HCPCS or CPT) that enables claims submission.
2. Obtaining payer coverage (commercial, Medicaid, Medicare Advantage, etc.).
3. Achieving broad routine reimbursement across multiple payers.

Only a handful of digital therapeutics (DTx) companies have been associated with dedicated reimbursement codes. Many more have achieved reimbursement through existing CPT codes, Remote Therapeutic Monitoring (RTM), or negotiated payer contracts.

Companies with payer reimbursement but without dedicated national HCPCS codes

These companies have secured reimbursement through commercial insurers, employers, Medicare Advantage, or existing CPT pathways:

• AppliedVR (RelieVRx)

  • Medicare established a reimbursement pathway through an existing benefit category rather than creating a unique DTx HCPCS code.
  • Commercial payer coverage has followed selectively.

• Akili Interactive (EndeavorRx)

  • Coverage through selected commercial health plans and employer benefits.
  • No dedicated HCPCS code specific to the product.

• Mahana Therapeutics (Mahana IBS)

  • Commercial payer agreements.
  • Uses existing reimbursement infrastructure rather than a proprietary billing code.

• Click Therapeutics

  • Pursuing reimbursement through existing prescription DTx frameworks and payer contracts rather than proprietary HCPCS/CPT codes.

• Big Health (Sleepio, Daylight)

  • Commercial payer and employer reimbursement.
  • Benefits from newer digital mental health reimbursement pathways but does not have its own national billing code.

Digital health companies using existing CPT reimbursement

Several high-growth companies have built large businesses without dedicated DTx billing codes:

• Omada Health
• Hinge Health
• Sword Health
• Kaia Health
• Virta Health

These organizations generally rely on combinations of:

• Remote Therapeutic Monitoring (RTM) CPT codes
• Remote Patient Monitoring (RPM)
• Chronic Care Management (CCM)
• Value-based reimbursement
• Direct commercial payer contracts
• Employer-sponsored benefits

rather than product-specific HCPCS codes.

Current U.S. landscape

The market has shifted away from creating a unique HCPCS code for every digital therapeutic. Instead, successful reimbursement strategies increasingly involve:

• Existing CPT reimbursement (especially RTM)
• Digital Mental Health Treatment (DMHT) payment pathways for eligible FDA-authorized devices
• Commercial payer contracts
• Medicare Advantage coverage
• Employer and value-based arrangements

As a result, very few companies have obtained dedicated HCPCS codes, while many successful digital therapeutics companies have achieved meaningful reimbursement without them.

Several digital therapeutics (DTx) companies have achieved reimbursement codes from payers, notably with the introduction of new CMS codes for Digital Mental Health Treatment (DMHT) devices in 2025 . While reimbursement has historically been challenging, firms focusing on FDA-cleared products for chronic conditions have seen success in securing billing pathways.

Here are the companies and products that have achieved reimbursement, coverage, or created specialized billing codes:

Companies with Specific Reimbursement Codes

• AppliedVR: Achieved a significant milestone by working with CMS to include RelieVRx in the durable medical equipment (DME) benefit category, making it the first immersive VR therapeutic to use this strategy for reimbursement.
• Akili Interactive Labs: Known for creating video game-based treatments (e.g., EndeavorRx) and has been active in navigating reimbursement landscapes.
• Click Therapeutics: Develops software for mental health, migraines, and schizophrenia, and has emphasized the importance of securing billing codes for commercialization.
• Big Health: Known for its products Sleepio (insomnia) and Daylight (anxiety).
• Voluntis S.A.: Develops digital therapeutics that act as treatments supported by software.

Products with Specific Coverage

According to a report as of November 2025, several FDA-cleared mental health therapeutics have qualified for reimbursement under new, specific codes:

• SleepioRx (Chronic Insomnia)
• Somryst (Chronic Insomnia)
• ReSET and ReSET-O (Substance Use/Opioid Use Disorder)
• Rejoyn (Depression)
• DaylightRx (Generalized Anxiety Disorder)
• MamaLift Plus (Postpartum Depression)

Key Reimbursement Pathways & Codes

• CMS 2025 Medicare Physician Fee Schedule (PFS): Introduced three codes (GMBT1, GMBT2, GMBT3 ) designed to allow clinicians to bill for providing apps and digital treatments as part of behavioral health care.
• HCPCS Code A9291: A Level II code for "prescription digital behavioral therapy, FDA cleared, per course of treatment," added in 2022 to facilitate coverage.
• Digital Mental Health Treatment (DMHT) Devices: A category recognized in the 2025 update for reimbursement.
• Remote Patient Monitoring/Virtual Therapeutic Monitoring Codes: Used by companies as a pathway for direct reimbursement.

While some firms, such as Pear Therapeutics , previously managed to gain coverage for products treating opioid use disorder, they faced challenges in achieving sustainable, widespread reimbursement.

If you're looking for information on a specific therapeutic area, such as behavioral health, chronic pain, or diabetes , I can provide a more tailored list of companies.

Several digital therapeutics (DTx) companies have achieved reimbursement milestones in the U.S. through FDA clearance, specific billing codes (HCPCS/CPT), or inclusion in payer digital formularies, particularly with the introduction of new Medicare codes in 2025.

Key companies and their products that have secured or are utilizing reimbursement pathways include:

• Click Therapeutics: Focused on mental health, migraine, and schizophrenia, Click utilizes clinician-supervised pathways. They also acquired assets from Better Therapeutics in 2024 to strengthen their portfolio.
• AppliedVR: Achieved a major milestone by working with CMS to classify their RelieVRx® immersive virtual reality system as durable medical equipment (DME), allowing it to fit into existing payment structures for chronic lower back pain.
• Better Therapeutics (Assets acquired by Click): Developed prescription digital therapeutics for cardiometabolic diseases.
• Akili Interactive: Known for its ADHD treatment EndeavorRx, the company transitioned from a prescription model to a direct-to-consumer (DTC) model due to challenges with insurer reimbursement.
• Pear Therapeutics (Defunct): Though bankrupt, Pear set early precedents for reimbursement for its substance use disorder apps, reSET and reSET-O.
• Propeller Health: Utilized a pharma partnership model for its digital solutions for asthma and COPD, often aligning with remote patient monitoring (RPM) strategies.

Key Reimbursement Pathways & Codes

• Medicare Codes (2025): The Centers for Medicare & Medicaid Services (CMS) introduced new codes (GMBT1, GMBT2, GMBT3) in the 2025 Physician Fee Schedule (PFS) for "Digital Mental Health Treatments" (DMHT).
• Remote Monitoring Codes: The American Medical Association (AMA) has established codes for remote patient monitoring (RPM) and virtual therapeutic monitoring that are used to pay for digital therapies.
• Digital Formularies: Pharmacy benefit managers (PBMs) and payers like Express Scripts and Optum have developed digital formularies, covering applications for insomnia, smoking cessation, and diabetes.

Companies like Omada Health are notable for securing coverage for diabetes and cardiometabolic care through employers and commercial health plans, rather than relying on CMS coding.

Would you like information on the specific 2025 billing codes mentioned or information on European reimbursement pathways (e.g., DiGA in Germany)?

It depends on what you mean by "achieved reimbursement codes." In digital therapeutics (DTx), there are three different reimbursement milestones:

1. A dedicated billing code (typically HCPCS) that enables claims processing.
2. Payer coverage (commercial insurers, Medicaid, Medicare Advantage, etc.) using either dedicated or existing codes.
3. Routine reimbursement at scale, which is still uncommon in the U.S.

Only a handful of prescription digital therapeutics have been associated with dedicated reimbursement codes. Most successful digital health companies instead rely on existing CPT codes (such as Remote Therapeutic Monitoring), value-based payment models, or direct contracts with health plans.

Companies with meaningful reimbursement but no dedicated DTx billing code

Several leading digital therapeutics and digital care companies generate substantial revenue through existing reimbursement infrastructure rather than product-specific HCPCS codes:

• Omada Health — commercial payer contracts, Medicare Advantage, and existing CPT pathways (e.g. chronic care management and remote monitoring).
• Hinge Health — employer and health plan contracts, largely value-based reimbursement.
• Sword Health — employer and payer agreements rather than dedicated DTx codes.
• Kaia Health — payer contracts combined with Remote Therapeutic Monitoring (RTM) workflows.
• Virta Health — reimbursed primarily through employer and payer contracts rather than fee-for-service billing.

Key takeaway

Dedicated reimbursement codes remain the exception rather than the rule:

• Dedicated HCPCS codes: Pear Therapeutics (A9291) and Better Therapeutics (A9292) are the clearest U.S. examples.
• Coverage without dedicated codes: Companies like Akili, Mahana, AppliedVR, and Click Therapeutics have secured reimbursement through payer agreements or other CMS pathways.
• Most successful digital health companies: Omada, Hinge, Sword, Kaia, and Virta have built large businesses through negotiated payer contracts, employer benefits, existing CPT codes, Remote Therapeutic Monitoring (RTM), or value-based care arrangements rather than obtaining product-specific billing codes.