Which digital therapeutics companies have achieved…

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.
Luminopia	Luminopia One	HCPCS A9292 — prescription digital visual therapy	Commercial payer policies recognize A9292/Luminopia; Premera's 2026 policy explicitly maps A9292 to Luminopia.
AppliedVR	RelieVRx	HCPCS E1905 — VR cognitive behavioral therapy device	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 98979, 98984 and 98985.

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.

Sources cited in this answer10

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:

Tier 1 — demonstrated payer reimbursement/coverage

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.”

Sources cited in this answer10

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.

Sources cited in this answer12

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.

Which digital therapeutics companies have achieved reimbursement codes from payers?

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