Which digital therapeutics companies have achieved reimbursement codes from payers?

The answer depends on what you mean by “achieved reimbursement codes.” In digital therapeutics (DTx), there are three different milestones:

1. Obtained a dedicated HCPCS/CPT code (coding recognition)
2. Had payers create coverage/payment pathways (payer policy recognition)
3. Generated meaningful reimbursed claims volume (commercial reimbursement at scale)

Only a small number of DTx companies have reached the first two milestones, and even fewer have demonstrated broad reimbursement.

Companies with dedicated DTx reimbursement codes or coding pathways

Companies with reimbursement success but not necessarily a dedicated “DTx code”

These companies generally rely on existing medical billing codes, employer contracts, health-plan arrangements, value-based care contracts, or digital-care benefits rather than a single DTx HCPCS code:

• Omada Health — diabetes prevention and chronic disease programs; primarily payer/employer contracting.
• Virta Health — value-based contracts for type 2 diabetes care.
• Hinge Health — employer and payer contracts for MSK care.
• Sword Health — payer/employer reimbursement arrangements.
• Kaia Health — payer and employer coverage models.

These companies have achieved reimbursement traction, but not necessarily through a dedicated prescription DTx HCPCS code.

Key takeaway

The companies that have crossed the “true reimbursement code” threshold are a short list:

1. Pear Therapeutics — first major DTx HCPCS code precedent (A9291)
2. Luminopia — product-specific visual therapy code (A9292)
3. AppliedVR — DME-style HCPCS pathway (E1905)
4. Newer FDA-cleared mental health DTx products (Big Health, Otsuka/Click, PursueCare, Curio) — increasingly using Medicare digital mental health treatment codes

The broader lesson from the market is that FDA clearance + a billing code does not automatically equal payer reimbursement. Coverage policies, provider workflows, prior authorization, and willingness of clinicians to “prescribe software” remain the bottlenecks.

I can also provide a venture/investor-style table ranking DTx companies by reimbursement maturity (code → payer coverage → revenue scale) if useful.

Securing dedicated reimbursement codes has been one of the biggest hurdles for the digital therapeutics (DTx) industry . While many early pioneers struggled or folded due to a lack of structured payer coverage, the landscape shifted significantly when the Centers for Medicare & Medicaid Services (CMS) established specific HCPCS billing codes (such as G0552) for FDA-cleared Digital Mental Health Treatment (DMHT) devices.

Companies and platforms that benefit from or have products aligned with formal public and commercial reimbursement pathways include:

• Otsuka Precision Health & Click Therapeutics – Their product Rejoyn™ (the first FDA-cleared prescription digital therapeutic for major depressive disorder as an adjunct to antidepressants) qualifies under the CMS digital mental health treatment HCPCS billing framework.
• Omada Health – A prominent leader in chronic disease prevention and management that utilizes a blend of employer-sponsored models alongside targeted medical billing structures (such as specific AMA CPT Category III and customized coding paths) to secure claims reimbursement.
• Companies with FDA-cleared/De Novo Digital Mental Health Devices – Following the creation of Medicare's permanent payment codes for software-based mental health interventions (covering conditions like substance use disorder and major depressive symptoms), developers whose tools meet FDA 510(k) or De Novo standards are positioned to utilize these codes when furnished under a professional care plan.

Would you like to explore the specific HCPCS code breakdowns (like G0552) or look into commercial insurer policies for a particular therapeutic area?

The reimbursement landscape for digital therapeutics (DTx) has historically relied on bespoke, individual contracts between manufacturers and commercial health plans or employers . However, a major structural breakthrough occurred when the Centers for Medicare & Medicaid Services (CMS) established dedicated HCPCS Level II codes (G0552, G0553, and G0554) for Digital Mental Health Treatment (DMHT).

Rather than paying directly for software as a consumer app, these codes allow clinicians and healthcare organizations to bill Medicare (and subsequent adopting commercial payers) for prescribing, onboarding, and managing FDA-cleared digital therapeutics.

Companies that feature FDA-cleared or authorized products matching these specific reimbursement codes and formal payer frameworks include:

• Big Health – Known for SleepioRx (for insomnia disorder) and DaylightRx (for generalized anxiety disorder), which are positioned directly to leverage the CMS DMHT G-codes (G0552–G0554) following institutional funding rounds meant to scale their clinical adoption.
• Akili – Creator of EndeavorRx (historically known for pediatric ADHD cognitive treatment) and developer of pipeline cognitive digital therapeutics, which helped pioneer the regulatory and reimbursement path for Software-as-a-Medical-Device (SaMD).
• Orexo / Click Therapeutics / Reset-developer lineage – Companies with FDA-cleared software targeting substance use disorders (SUD) and opioid use disorder (OUD) fit squarely into the therapeutic categories designated by federal and private insurance coverage rules for digital behavioral health.

Note: While many companies like Omada Health and Noom have achieved widespread financial scale and reimbursement, they traditionally operate under hybrid employer-sponsored, chronic-care management, or remote monitoring frameworks rather than strictly relying on standalone prescription digital therapeutic (PDT) device codes.

Would you like to explore how the G0552–G0554 billing workflow functions for a clinical practice, or look into specific commercial insurers (like Cigna or regional Blues) that have started accepting these codes?

There are two different meanings of “achieved reimbursement codes” in digital therapeutics (DTx):

1. Obtained a dedicated HCPCS/CPT code that creates a billing pathway.
2. Achieved actual payer reimbursement through contracts, benefit policies, employer plans, pharmacy benefits, DME benefits, or existing CPT codes.

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

Companies with dedicated or near-dedicated reimbursement coding pathways

Companies with payer reimbursement but not a unique DTx code

These companies have generated reimbursement through payer contracts, employer health plans, pharmacy benefits, value-based arrangements, or existing medical billing pathways.

Important distinction: code ≠ coverage

A reimbursement code only gives payers a mechanism to process claims. It does not guarantee that a payer will cover the product. Commercial insurers can still classify a DTx as investigational, require prior authorization, restrict eligibility, or exclude it from benefits.

Short list of strongest reimbursement precedents

If you are benchmarking DTx companies by reimbursement maturity:

1. Pear Therapeutics — strongest historical example of creating a dedicated DTx HCPCS pathway (A9291).
2. Luminopia — strong example of a product-specific code plus payer recognition (A9292).
3. AppliedVR — important example of reimbursement through an established medical benefit pathway.
4. Big Health — important example of newer CMS digital mental health reimbursement infrastructure.

The broader trend is that most successful DTx businesses have moved away from waiting for a unique “digital therapeutic” code and instead combine payer contracts, employer distribution, remote monitoring codes, pharmacy benefit approaches, and value-based reimbursement.

Companies with payer reimbursement but not a unique DTx code

These companies have generated reimbursement through payer contracts, employer health plans, pharmacy benefits, value-based arrangements, or existing medical billing pathways.

Important distinction: code ≠ coverage

A reimbursement code only gives payers a mechanism to process claims. It does not guarantee that a payer will cover the product. Commercial insurers can still classify a DTx as investigational, require prior authorization, restrict eligibility, or exclude it from benefits.

Short list of strongest reimbursement precedents

If you are benchmarking DTx companies by reimbursement maturity:

Yes. I searched the current U.S. reimbursement/coding landscape, and the important distinction is between (1) getting a dedicated HCPCS/CPT code and (2) actually getting payers to cover/pay claims using that code. Those are not the same milestone. The AMA notes that commercial payer adoption of digital-medicine codes remains inconsistent.

The clearest companies to have achieved a dedicated reimbursement code

A9294 is particularly noteworthy: CMS initially considered a product-specific code but instead created a broader category for biofeedback-based DTx, with Freespira as the product that prompted the determination.

Companies with payer reimbursement/coverage, but not necessarily their own product-specific code

There is a considerably larger group here:

• AppliedVR — RelieVRx: established a Medicare reimbursement pathway through the DME benefit category, rather than a dedicated DTx HCPCS code.
• Akili Interactive — EndeavorRx: has obtained selected commercial/employer coverage, but there isn't a broadly adopted product-specific national HCPCS code.
• Big Health — SleepioRx / DaylightRx: increasingly fits into the CMS digital mental-health-treatment reimbursement infrastructure rather than having a unique product code.
• Click Therapeutics / Otsuka — Rejoyn: has a payer/reimbursement pathway under the newer digital mental-health framework.
• Mahana Therapeutics — Parallel/Mahana IBS: has had commercial payer contracting, but not a unique national DTx HCPCS code.
• Omada, Hinge Health, Sword, Kaia and Virta: substantial payer/employer reimbursement, but primarily through contracts, existing CPT/RTM codes, bundled/value-based arrangements rather than a DTx-specific HCPCS code.

The distinction matters because payer coverage can exist without a unique code, and conversely a code can exist while an individual payer excludes it. For example, BCBS Rhode Island's 2026 policy lists A9291 and A9294 but excludes them for its Medicare Advantage and commercial products.

A major new development: CMS's G-codes

For 2025 onward, CMS created a separate billing pathway for Digital Mental Health Treatment (DMHT) devices:

• G0552 — supply of DMHT device + initial education/onboarding
• G0553 — first 20 minutes/month of treatment management
• G0554 — each additional 20 minutes/month

CMS describes these specifically as services involving a patient's therapeutic use of a digital mental-health-treatment device.

This means newer DTx companies don't necessarily need to win a bespoke HCPCS code like Pear did. They can potentially fit into the G0552–G0554 reimbursement architecture, assuming the product and clinical workflow meet the requirements.

My take: who has actually crossed the reimbursement "moat"?

I'd divide the landscape into three tiers:

Tier 1 — Dedicated DTx code obtained

1. Pear Therapeutics → A9291
2. Better Therapeutics → A9292
3. Freespira → A9294

Tier 2 — Established payer reimbursement pathway without a unique product code 4. AppliedVR 5. Akili 6. Big Health 7. Click/Otsuka 8. Mahana

Tier 3 — Strong payer economics but primarily contracting/value-based reimbursement 9. Omada 10. Hinge Health 11. Sword Health 12. Kaia Health 13. Virta Health

One important caveat: having a CMS/HCPCS code does not mean Medicare pays it. CMS itself made clear that A9291 was created to facilitate coverage by non-Medicare payers; coverage decisions remain payer-specific.

Also, Pear is a historical precedent rather than a currently operating DTx company: it ceased operations after its 2023 bankruptcy, even though its coding achievement remains highly relevant to the industry. Current payer policies explicitly note that its products are no longer being dispensed.

If you're looking at this from an investment/competitive-intelligence perspective, I can also build you a company-by-company table of ~20 DTx companies showing FDA clearance → HCPCS/CPT code → specific payer(s) → reimbursement status → estimated commercial scale, which is probably the more useful way to assess who has truly cracked reimbursement.

The reimbursement landscape for digital therapeutics (DTx) has shifted from generic billing workarounds to dedicated operational frameworks. Rather than assigning individual product-specific codes, the Centers for Medicare & Medicaid Services (CMS) and the American Medical Association (AMA) established overarching HCPCS Level II codes (G0552–G0554) and category pathways for Digital Mental Health Treatment (DMHT) devices.

FDA-cleared prescription software that aligns with these behavioral health treatment classifications qualifies for provider billing and reimbursement. Companies with regulated products qualifying under these and related pathways include:

• Otsuka America Pharmaceutical / Pear Therapeutics portfolio (RESET and RESET-O) : Pioneered early coding frameworks for substance use and opioid use disorders, which continue under updated operational structures.
• Nox Health (Somryst) : FDA-cleared prescription digital therapeutic for chronic insomnia that qualifies under established behavioral and mental health frameworks.
• Pear / ResMed portfolio (SleepioRx) : Validated digital intervention for chronic insomnia management.
• Otsuka / Click Therapeutics (Rejoyn) : FDA-cleared prescription software application adjunctive to clinician-managed care for major depressive disorder.
• Pear / Big Health (DaylightRx) : Prescription digital therapeutic targeting generalized anxiety disorder.
• Curio (MamaLift Plus) : Focused on maternal mental health and postpartum depression support, aligning with targeted federal coverage rules.
• Akili Interactive / Lumos Labs : Video game-based and cognitive systems targeting ADHD, which have been incorporated into expanding CMS payment rule considerations.
• Freespira : Specialized digital breathing treatment systems for panic attacks and PTSD that navigate specific medical device and remote treatment pathways.

Would you like to explore specific billing criteria for Medicare's G-codes , or are you looking for details on commercial insurance coverage policies for a particular condition?

Yes—but there’s an important distinction between having a billing/reimbursement code and having actual payer coverage at scale. In U.S. digital therapeutics (DTx), only a relatively small group has achieved a dedicated HCPCS/CPT pathway, while more companies have secured contracts or coverage through existing codes, pharmacy benefits, DME benefits, or value-based arrangements.

The clearest examples

A newer development: A9294

There is also a new DTx-specific HCPCS code, A9294, effective April 1, 2026:

A9294 — Prescription digital cognitive and/or behavioral therapy, biofeedback, FDA cleared, per course of treatment.

This is particularly relevant to the next generation of DTx companies because it creates a distinct coding category for biofeedback-based digital therapeutics. Aetna's current policy lists A9294, and Premera incorporated it into its 2026 coding policy.

However, a new HCPCS code does not automatically mean Medicare or commercial coverage. CMS explicitly created A9291 to facilitate non-Medicare payer access, and coverage decisions remain with individual payers.

There's another important reimbursement pathway: CPT/RTM

Some DTx companies don't need a product-specific HCPCS code because their intervention can be billed through Remote Therapeutic Monitoring (RTM) codes.

For 2026, CMS added:

• 98979 — RTM treatment-management service
• 98984 — respiratory-system RTM
• 98985 — musculoskeletal-system RTM

CMS describes these codes as including digital therapeutic interventions.

The AMA has also revised RTM coding to explicitly incorporate digital therapeutic interventions.

That means a company can have a viable reimbursement model without owning a unique code for its product.

My ranking of the strongest reimbursement precedents

If you're looking at this from an investment, market-entry, or competitive-intelligence perspective, I'd divide the companies into three tiers:

Tier 1 — Proven DTx-specific reimbursement precedent

1. Pear Therapeutics — strongest historical precedent; drove creation of A9291.
2. Luminopia — dedicated A9292 visual-therapy code + payer incorporation.
3. AppliedVR / RelieVRx — E1905/DME pathway.
4. Freespira — particularly notable for actual payer contracting and outcomes-based value proposition.

Tier 2 — Commercial payer coverage, but less standardized coding 5. Akili / EndeavorRx 6. Mahana Therapeutics 7. Other prescription DTx companies covered selectively through medical, pharmacy, DME, or employer benefits.

Tier 3 — Reimbursement through broader digital-health codes A much larger set of companies can potentially monetize through RTM, RPM, CPT, DME, or provider-service codes rather than obtaining a unique DTx HCPCS code.

One caution: “payer reimbursement” is not synonymous with “payer coverage.” A code merely gives the payer a mechanism to process a claim; the payer can still designate the product investigational, require prior authorization, or decline payment. For example, current payer policies show substantial variation in which DTx products are covered and under what conditions.

If you're evaluating the U.S. DTx market specifically, I can also give you a company-by-company table of ~20 leading DTx companies showing FDA clearance, HCPCS/CPT code, commercial payer contracts, Medicaid coverage, Medicare status, and current 2026 reimbursement status.

Rather than individual proprietary codes assigned to single corporate products, the United States reimbursement framework relies on standardized HCPCS Level II and CPT codes established by the Centers for Medicare & Medicaid Services (CMS) and the American Medical Association (AMA).

Specifically, CMS's implementation of Digital Mental Health Treatment (DMHT) supply and management codes (G0552, G0553 , and G0554 ) opened a standardized operational pathway for billing provider-ordered, FDA-cleared software treatments.

FDA-cleared prescription digital therapeutics (DTx) that officially qualify for reimbursement under these federal and expanding commercial codes include:

• Big Health (Products: SleepioRx for chronic insomnia and Daylight for generalized anxiety)
• Click Therapeutics / Otsuka Precision Health (Product: Rejoyn for major depressive disorder)
• Curio Digital Therapeutics (Product: MamaLift Plus for maternal mental health)
• Nox Health (Product: Somryst for chronic insomnia)
• PursueCare (Products: reSET for substance use disorder and reSET-O for opioid use disorder—originally developed by the pioneering, now-defunct Pear Therapeutics)

Would you like to explore how specific commercial payers (like Cigna or regional Medicaid programs) are implementing these G-codes, or look into the regulatory filing requirements to qualify a device?

Yes—but there’s an important distinction between getting a reimbursement/billing code and getting a payer to actually cover the product. Payers generally don't create the codes; CMS/AMA establish codes, and insurers decide whether/how to reimburse them.

As of August 2026, the clearest U.S. examples are:

1. Pear Therapeutics — the historical benchmark

Pear was the company that most clearly established the dedicated DTx HCPCS-code model in the U.S.

CMS created A9291, effective April 1, 2022, with the description "Prescription digital behavioral therapy, FDA cleared, per course of treatment." CMS explicitly said the code could facilitate access through commercial insurers and Medicaid, even though it did not establish Medicare payment for Pear's products.

Importantly, this wasn't merely theoretical: Highmark subsequently incorporated A9291 into its digital-therapeutics policy, with covered diagnoses including substance-use disorders and PTSD. Highmark's Medicaid policy also specifically references reSET/reSET-O.

Pear subsequently went bankrupt, so I would treat it as a coding/reimbursement-pathway success but not a current commercial-company success story.

2. Luminopia — perhaps the cleanest visual-DTx example

Luminopia One, a prescription digital therapy for amblyopia, maps to A9292, the dedicated HCPCS code for prescription digital visual therapy.

This is more than a code sitting in the CMS database: payer policies have incorporated the code. For example, Premera's current policy identifies A9292 specifically for Luminopia, and Blue Cross plans have used A9292 in their prior-authorization infrastructure.

Highmark's commercial DTx policy also lists Luminopia One among its recognized digital therapeutics.

3. AppliedVR — a particularly important payer-contract precedent

AppliedVR's RelieVRx is another significant example because its reimbursement isn't dependent solely on a generic "app" code. Highmark has explicitly recognized RelieVRx for chronic low-back pain in its digital-therapeutics policy, using E1905, the VR cognitive behavioral therapy device code.

That makes AppliedVR useful as a precedent for companies developing device + software DTx, rather than pure software.

4. Big Health — the major new Medicare pathway

Big Health is arguably the most important current example.

CMS created three new codes effective January 1, 2025:

• G0552 — supply/onboarding of the DMHT
• G0553 — first 20 minutes/month of treatment management
• G0554 — each additional 20 minutes/month

These are specifically for FDA-cleared/authorized digital mental-health-treatment devices used as part of ongoing behavioral-health treatment. CMS continues to recognize the codes in its current Medicare materials.

Big Health's SleepioRx and DaylightRx are FDA-cleared under the relevant DMHT classification and are explicitly positioned for reimbursement under these codes. Big Health says the pathway creates a reimbursement opportunity for Medicare patients, while appropriately noting that a code doesn't guarantee payment under every commercial or Medicare Advantage plan.

This is an important evolution from the Pear model: instead of creating a code for one company's particular product/category, CMS created a broader treatment-management reimbursement framework.

5. Natural Cycles — code + insurance reimbursement, but a borderline DTx

CMS established A9293 in April 2024 for FDA-cleared fertility-cycle tracking software. Natural Cycles announced that the code was intended to facilitate insurance claims and reimbursement.

I would include it in a broad "digital therapeutics/reimbursable digital health" landscape, but not in a strict prescription-DTx peer set because contraception is a somewhat different reimbursement category.

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What about Cigna, Aetna, Premera, etc.?

The payer landscape has actually become more significant in 2025–26.

Cigna, for example, now maintains a dedicated Prescription Digital Therapeutics coverage policy. Its current policy includes specific coding for products including RelieVRx and recognizes A9291/A9294 and other relevant codes, although coverage varies by product and benefit plan.

Premera likewise has a dedicated PDT policy and explicitly maps codes to products such as reSET/reSET-O, Luminopia and RelieVRx.

Highmark is another particularly useful payer to study because it has maintained explicit commercial and Medicaid PDT policies and has added specific guidance for Somryst in 2026.

Interestingly, Aetna is much less favorable: its June 2026 policy still classifies a long list of PDTs—including DaylightRx, EndeavorRx, SleepioRx, Somryst, reSET and reSET-O—as experimental/investigational, despite listing the relevant HCPCS codes.

That illustrates the key point: a code ≠ coverage ≠ payment.

Bottom line

If you're looking for companies that have demonstrated the fullest reimbursement progression, I'd rank the U.S. precedents roughly:

Tier 1 — dedicated code + documented payer pathway

• Pear Therapeutics — A9291 / reSET family
• Luminopia — A9292 / Luminopia One
• AppliedVR — E1905 / RelieVRx
• Big Health — G0552–G0554 / SleepioRx, DaylightRx

Tier 2 — payer reimbursement/coverage, but less cleanly tied to a dedicated DTx code

• Mahana Therapeutics
• Akili
• Freespira
• Click Therapeutics
• WellDoc
• Omada Health
• Hinge Health / Sword Health (broader digital care rather than classic FDA prescription DTx)

The latter group often gets described as "reimbursed DTx," but their economics typically rely on employer/health-plan contracts, existing CPT/RTM/CCM codes, or value-based arrangements, rather than a dedicated national DTx HCPCS code.

If you're evaluating this for an investment, market map, or a new DTx reimbursement strategy, the most useful next step would be a matrix of ~20 DTx companies × product × FDA status × HCPCS/CPT code × payer (Cigna/Aetna/UHC/BCBS/Highmark/etc.) × covered vs. investigational × Medicare/Medicaid/commercial, because that exposes which companies have actual paid claims versus merely having a code.

With the implementation of Medicare's Digital Mental Health Treatment (DMHT) HCPCS Level II codes (G0552, G0553 , and G0554 ) and prior HCPCS codes like A9291 , a select group of FDA-cleared and authorized prescription digital therapeutics (PDTs) qualify for public payer reimbursement pathways in the U.S.

According to the Digital Therapeutics Alliance (DTA), the following companies and their flagship FDA-cleared software products qualify for these reimbursement codes:

• Big Health – Developer of SleepioRx (for chronic insomnia) and DaylightRx (for generalized anxiety disorder).
• Click Therapeutics & Otsuka Precision Health – Co-developer of Rejoyn (for major depressive disorder symptoms).
• Curio Digital Therapeutics – Developer of MamaLift Plus (for maternal and postpartum mental health).
• Nox Health – Developer of Somryst (for chronic insomnia).
• PursueCare (inheriting assets from Pear Therapeutics' portfolio) – Provider of reSET (for substance use disorder) and reSET-O (for opioid use disorder).
• Akili Interactive – Developer of video-game treatment systems targeting ADHD (integrated into expanded CMS fee schedules).
• Lumos Labs – Developer of their 510(k)-cleared cognitive system for ADHD management.

If you'd like to dive deeper, let me know if you are interested in:

• The specific billing requirements and documentation needed for the G0552–G0554 codes
• International reimbursement models (such as Germany’s DiGA fast-track framework)
• Details on commercial payer coverage policies beyond Medicare