ModifiedPremera BluecrossPolicy N/A

Prescription Digital Therapeutics

Defines medical necessity and investigational coverage criteria for prescription digital therapeutics prescribed by licensed practitioners and used to evaluate, diagnose, manage, or treat illnesses or symptoms; applies to Premera benefit determinations.

Policy Summary

PayerPremera Bluecross

PolicyPrescription Digital Therapeutics

Policy CodePolicy N/A

Change TypeAnnual reviewcoding and investigational-list updates

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, baseline severity, and a licensed provider prescription when requesting coverage for a prescription digital therapeutic.

SourceLink

POLICY UPDATE CHANGES

Added SleepioRX to list of investigational digital therapeutic devices that are considered investigational.

Removed d-Nav Insulin management, Mahana for IBS, and Regulora for IBS as they are no longer marketed in the US.

Added new HCPCS code A9294, effective April 1, 2026.

A9294new HCPCS code

SleepioRXdevice added to investigational list

~30named PDTs mentioned

FDA required

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

core coverage requirement

Coverage Criteria for Prescription Digital Therapeutics

Medical Necessity — Prescription digital therapeutics are considered medically necessary when ALL of the following criteria in A and B have been met:

inv-01: Medical Necessity — Prescription digital therapeutics are considered medically necessary when ALL of the following criteria in A and B have been met:

ALL of the following

ALL of the following
- The prescription digital therapeutic has been approved by the US Food and Drug Administration (FDA);
- There is credible scientific evidence which permits reasonable conclusions regarding the impact of the prescription digital therapeutic on health outcomes;
- The prescription digital therapeutic has been proven to improve the net health outcome or is considered as beneficial as another established alternative. (See Related Policies)
ALL of the following
- The prescription digital therapeutic requires a prescription by a licensed healthcare practitioner;
- There is documentation supporting that the prescription digital therapeutic was ordered for a covered purpose such as preventing, evaluating, diagnosing, or treating an illness, injury or disease or its symptoms and in accordance with generally accepted standards of medical practice;
- The requested prescription digital therapeutic is not primarily for the convenience of the individual, physician, or health care provider

Investigational — Prescription digital therapeutics are considered investigational when ALL of the above criteria are not met.

inv-02: Investigational — Prescription digital therapeutics are considered investigational when ALL of the above criteria are not met.

ALL of the following

Prescription digital therapeutics are considered investigational when one or more medical necessity criteria are not met (e.g., no FDA approval/clearance for the intended use, insufficient credible scientific evidence demonstrating net health benefit, or not appropriate for the individual);
FDA-approved or cleared devices may still be considered investigational if evidence for the specific indicated use, population, or clinical outcome is insufficient or if limitations in study design/generalizability exist;
Examples of products considered investigational (not exhaustive): BlueStarRx System; Canvas Dx autism diagnosis aid; CT-132; CureSight CS 100 System; DaylightRx; EndeavorRx; EpiMonitor; HaloAF Detection System; Insulia Diabetes Management Companion; leva Pelvic Digital Health System; Luminopia One; MamaLift Plus; MindMotion GO; My Dose Coach; NightWare; Rejoyn; RelieVRx; ReSet; ReSet-O; RevitalVision; SleepioRX.

General sufficiency conclusions — Conclusions from the evidence summaries in this section

inv-04: General sufficiency conclusions — Conclusions from the evidence summaries in this section

ALL of the following

Evidence for many prescription digital therapeutics is limited by small sample sizes, short follow-up, high attrition, lack of blinding, or single-center designs;
Randomized controlled trials exist for some products with positive signals for specific outcomes (e.g., Luminopia One, Luminopia RCT; RelieVRx RCT), but generalizability and durability often remain uncertain;
Where randomized evidence is absent, conflicting, or of low quality, the evidence is insufficient to determine improvement in net health outcome;
FDA clearance/approval status should be considered alongside the strength and applicability of peer-reviewed evidence when evaluating coverage decisions.

Positive signals with limitations — Devices with RCTs showing benefit in at least one outcome but with limitations

inv-05: Positive signals with limitations — Devices with RCTs showing benefit in at least one outcome but with limitations

ANY of the following

RelieVRx (EaseVRx): RCTs show reductions in pain intensity and interference versus sham VR with moderate effect sizes and durability to 6 months, but studies had limited generalizability and potential bias;
Luminopia One: RCT demonstrated improvement in amblyopic eye visual acuity versus refractive correction alone in children 4–7 years, but study stopped early and had some missing data;
CureSight CS 100: RCT evidence exists for amblyopia treatment versus patching with specified dosing regimens, though direct comparisons and long-term outcomes vary;
EndeavorRx: RCT showed improvement on a validated attention test but no consistent improvements on parent/clinician symptom ratings; authors noted insufficiency to replace established ADHD treatments.

Coverage considerations by product — Evidence-based coverage considerations depend on device, indication, and quality/duration of evidence. Examples from the document:

inv-06: Coverage considerations by product — Evidence-based coverage considerations depend on device, indication, and quality/duration of evidence. Examples from the document:

ALL of the following

Products with robust randomized, placebo- or active-controlled trials demonstrating clinically meaningful and durable benefit for specified outcomes are more likely to meet medical necessity when prescribed within the studied indication and population;
Products supported only by single-arm studies, small RCTs with methodological limitations, or nonpeer-reviewed data are less likely to meet medical necessity until higher-quality evidence is available;
Common exclusions in study populations (e.g., bipolar disorder, psychosis, seizure disorder, concurrent psychotherapy or medication changes) should be considered when applying trial results to individual patients;
Use outside FDA-cleared indications (e.g., age ranges, standalone use when studied as adjunctive therapy) requires careful justification and typically is investigational.

Coverage when meeting FDA-cleared indication — Devices listed have FDA-cleared indications; coverage should be considered when the device is prescribed for the FDA-cleared intended use...

inv-07: Coverage when meeting FDA-cleared indication — Devices listed have FDA-cleared indications; coverage should be considered when the device is prescribed for the FDA-cleared intended use and the medical necessity criteria are satisfied.

ALL of the following

When a prescription digital therapeutic is prescribed consistent with its FDA-cleared/approved indication and the individual meets the medical necessity criteria, coverage may be considered;
Examples of devices with FDA clearance/approval and specified indications include (but are not limited to): Luminopia One (amblyopia, ages 4–7), RelieVRx (chronic low back pain, adults 18+), EndeavorRx (ADHD attention function, children 8–12), NightWare (temporary reduction of sleep disturbance related nightmares, adults 22+), Halo AF Detection System (pulse rhythm monitoring for atrial fibrillation), leva Pelvic Health System (pelvic floor strengthening for urinary incontinence), BlueStarRx and Insulia/My Dose Coach (diabetes management aids), CureSight CS100 (amblyopia, ages 4–<9).

Investigational / Medical Necessity status (document history) — Policy-level determinations and historical actions

inv-08: Investigational / Medical Necessity status (document history) — Policy-level determinations and historical actions

ALL of the following

Policy history documents additions and removals of products considered investigational vs medically necessary over time; updates include device additions, coding updates (HCPCS/CPT), and periodic literature reviews through specified dates;
As of the 04/01/26 annual review, SleepioRX was added to the list of investigational devices and HCPCS code A9294 was added effective April 1, 2026;
This policy is not applicable to Medicare Advantage and member contract language may alter benefit determinations; always verify individual plan benefits.

Coding and Billing

Covered CPT/HCPCS Codes (examples listed)mixedCovered

0687T	Treatment of amblyopia using an online digital program; device supply, educational set-up, and initial session (use to report: RevitalVision)
0688T	Treatment of amblyopia using an online digital program; assessment of patient performance and program data by physician or other qualified health care professional, with report, per calendar month (use to report: RevitalVision)
0704T	Remote treatment of amblyopia using an eye tracking device; device supply with initial set-up and patient education on use of equipment (use to report: CureSight CS 100)
0705T	Remote treatment of amblyopia using an eye tracking device; surveillance center technical support including data transmission with analysis, with a minimum of 18 training hours, each 30 days (use to report: CureSight CS 100)
0706T	Remote treatment of amblyopia using an eye tracking device; interpretation and report by physician or other qualified health care professional, per calendar month (use to report: CureSight CS 100)
0740T	Remote autonomous algorithm-based recommendation system for insulin dose calculation and titration; initial set-up and patient
0741T	Remote autonomous algorithm-based recommendation system for insulin dose calculation and titration; provision of software, data collection, transmission, and storage, each 30 days
99199	Unlisted special service, procedure or report
A9291	Prescription digital cognitive and/or behavioral therapy, FDA-cleared, per course of treatment (use to report: ReSet and ReSet-O)
A9292	Prescription digital visual therapy, software-only, FDA cleared, per course of treatment (use to report: Luminopia)

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Additional HCPCS and DME codesmixedCovered

A9999	Miscellaneous DME supply or accessory, not otherwise specified
E1399	Durable medical equipment, miscellaneous
E1905	Virtual reality cognitive behavioral therapy device (CBT), including pre-programmed therapy software (use to report: RelieVRx)
G0552	Supply of digital mental health treatment device and initial education and onboarding, per course of treatment that augments a behavioral therapy plan
G0553	First 20 minutes of monthly treatment management services directly related to the patient's therapeutic use of the digital mental health treatment (dmht) device that augments a behavioral therapy plan
G0554	Each additional 20 minutes of monthly treatment management services directly related to the patient's therapeutic use of the digital mental health treatment (dmht) device that augments a behavioral therapy plan
S9002	Intravaginal motion sensor system, provides biofeedback for pelvic floor muscle rehabilitation device (used to report Leva Pelvic Health System)

Regulatory Submission / Clearance IDsmixed

DEN240064	De Novo submission identifier for CT-132 (Click Therapeutics)
K233872	510(k) clearance for DaylightRx (Big Health Inc.)
K233577	510(k) clearance for SleepioRx (Big Health Inc.)
K223515	510(k) clearance for MamaLift Plus (Curio Digital Therapeutics)

FDA clearances and De Novo identifiersmixed

DEN240064	De Novo authorization identifier for CT-132 (Click Therapeutics)
K233872	FDA 510(k) clearance for DaylightRx (Big Health Inc.)
K233577	FDA 510(k) clearance for SleepioRx (Big Health Inc.)
K223515	FDA 510(k) clearance for MamaLift Plus (Curio Digital Therapeutics)
K231209	FDA 510(k) clearance for Rejoyn (CT-152) (Otsuka)
K232915	FDA 510(k) clearance for EpiMonitor (Empatica)
K221375	FDA 510(k) clearance for CureSight-CS100 (NovaSight)
DEN210005	De Novo authorization for Luminopia One
DEN210014	De Novo authorization for RelieVRx (AppliedVR)
DEN200026	De Novo authorization for EndeavorRx (Akili Interactive Labs)

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HCPCS / policy coding historyHCPCS

A9294	HCPCS code added effective 04/01/2026
A9291	HCPCS code present in history entries
A9292	HCPCS code present in history entries
A9281	HCPCS code removed earlier (history notes correction)
E1905	HCPCS code added 04/01/23
S9002	HCPCS code added 06/01/24
G0552	HCPCS code added 01/01/25
G0553	HCPCS code added 01/01/25
G0554	HCPCS code added 01/01/25

CPT codesCPT

0704T	CPT code added 01/01/23
0705T	CPT code added 01/01/23
0706T	CPT code added 01/01/23
0740T	CPT code added 01/01/23
0741T	CPT code added 01/01/23
0687T	CPT code added 06/01/24
0688T	CPT code added 06/01/24

Treatment duration examples — product-specific dosing/duration

EndeavorRx (Akili Interactive Labs)Typical regimen: 30 minutes per day, 5 days per week for 4 weeks (game-based therapeutic for pediatric ADHD) .

CureSight CS 100 (NovaSight)Typical regimen: 90 minutes per day, 5 days per week for 16 weeks (binocular eye‑tracking therapy for pediatric amblyopia).

Luminopia One (Luminopia, Inc.)Typical regimen: 1 hour per day, 6 days per week for 12 weeks (video-modified therapy using a VR headset as adjunct to full‑time refractive correction).

Provider Requirements, Authorization, and Documentation

Prior Authorization

Coding‑linked authorization — Prior authorization required and must use listed codes

Prior authorization/coverage determination is required for prescription digital therapeutics when billing for covered services. Billing must use the CPT/HCPCS codes listed in the policy and authorization will be linked to those codes; use of alternative or unlisted codes may result in denial or delay.

Effective codes include CPT 0687T, 0688T, 0704T-0706T, 0740T-0741T, 99199
HCPCS A9291, A9292, A9294 (new effective 04/01/2026); A9999, E1399, E1905, G0552-G0554, S9002

Prior Authorization

Prescription‑only devices may require prior authorization

Many prescription digital therapeutics are regulated as prescription‑only devices; a valid prescription/order from a licensed practitioner is required for coverage. Lack of a required prescription or ordering inconsistent with FDA labeling may trigger non‑coverage.

Examples of prescription‑only devices in this policy: SleepioRX, MamaLift Plus, Rejoyn, RelieVRx, Luminopia One, CureSight CS100, Insulia, My Dose Coach, NightWare, Halo AF, leva Pelvic Health System

Background and Evidence Summary

Prescription digital therapeutics (PDTs) are software‑based, prescribed interventions intended to evaluate, diagnose, manage, or treat diseases or symptoms. PDTs differ from general wellness or over‑the‑counter apps by being evidence‑based and subject to FDA regulatory pathways such as De Novo or 510(k); examples in the policy include device‑level FDA clearances and De Novo authorizations for multiple prescription‑use digital therapeutics.

Definitions

Digital therapeutics (DTx) — definition

DefinitionDeliver therapeutic, evidenced-based interventions driven by software to treat, manage, and prevent a broad spectrum of behavioral, mental, and physical diseases and disorders.

ModalitySoftware-driven interventions (apps, web platforms) intended to produce clinical benefit, distinct from general wellness apps.

RegulationMay be subject to FDA regulatory pathways (510(k), De Novo, etc.) when intended for prescription use.

Direct to consumer — definition

DefinitionProducts sold directly to customers, commonly online or via other marketing venues; these products typically do not require a prescription.

AccessOften available via app stores, websites, or retail channels without a clinician order.

Policy Revision History

2026-04-01Annual review / substantive updateLatest

Annual review approved March 10, 2026; literature review through September 22, 2025; SleepioRX added to the list of investigational prescription digital therapeutics; d-Nav Insulin management, Mahana for IBS, and Regulora for IBS removed as no longer marketed in the US; HCPCS A9294 added effective April 1, 2026.

2025-09-01Annual review

Annual review approved August 12, 2025; CT-132 added to the list of investigational prescription digital therapeutics.

2024-10-01Annual review / coding update

Policy Summary

PayerPremera Bluecross

PolicyPrescription Digital Therapeutics

Policy CodePolicy N/A

Change TypeAnnual reviewcoding and investigational-list updates

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, baseline severity, and a licensed provider prescription when requesting coverage for a prescription digital therapeutic.

SourceLink

On This Page

OTC or non‑prescription digital therapeutics are generally excluded from most Plans

Documentation Required

Prior authorization requirements — documentation expectations

Prior authorization requires supporting documentation demonstrating medical necessity: diagnosis, baseline severity measures, validated outcome scores where applicable, and objective clinical data (e.g., HbA1c for diabetes tools). Ensure documentation demonstrates the device is ordered for a covered purpose and consistent with generally accepted standards of practice.

Diabetes tools: baseline and follow‑up HbA1c, hypoglycemia frequency, insulin regimen and medication history, usage/adherence data
Mental health tools: validated scales such as EPDS, HAMD-17, MADRS or other disorder‑specific validated instruments
Sleep/insomnia tools: Insomnia Severity Index (ISI) or clinician diagnosis of insomnia; consider evidence of prior face‑to‑face CBT‑I when applicable

Note

Prescription and FDA‑clearance implication

FDA regulatory status can affect coverage and whether a device is prescription‑only; De Novo or 510(k) clearance may clarify intended use and prescription requirements. Coverage is contingent on meeting medical necessity criteria and supporting evidence, regardless of clearance.

Devices cleared via De Novo or 510(k) (examples: Luminopia One, RelieVRx, EndeavorRx, SleepioRX, DaylightRx, CT‑132) may still be subject to prescription requirements and prior authorization
FDA clearance for adjunctive use (e.g., adjunct to clinician‑managed care) often implies prescription and monitoring expectations

Prior Authorization

Prior authorization and prescription — devices are often adjunctive and clinician‑managed

Many covered devices are prescription‑use software intended as adjuncts to clinician‑managed care; prior authorization should reflect that ongoing clinician oversight and monitoring channels (e.g., clinician dashboards) may be required.

Products often include clinician portals or dashboards (e.g., Insulia, My Dose Coach, MamaLift Plus) and prior authorization may require documentation of the prescribing clinician's role and follow‑up plan
Adjunctive‑use devices are not intended as first‑line standalone replacements for established therapies

Billing Rule

Coding / prior authorization note — coding updates and new HCPCS A9294 (04/01/2026)

Coding and prior authorization rules are updated periodically; note the addition of new HCPCS code A9294 effective 04/01/2026. Use current code lists when submitting authorization and claims to avoid denial.

New HCPCS: A9294 effective 04/01/2026 (Prescription digital cognitive/behavioral therapy, biofeedback)
Verify CPT/HCPCS changes at time of submission and reference policy history for recent updates

Denial Risk

Triggers for denial — services not meeting medical necessity or documentation requirements

Services that do not meet ALL applicable medical necessity criteria, lack required prescription or supporting documentation, fail to use authorized billing codes, or rely on devices with insufficient evidence (failed primary endpoints, high attrition, limited generalizability) are at risk for denial.

Failed pivotal trial primary endpoint (e.g., NightWare) is a denial trigger
High nonuse/attrition rates or insufficient real‑world adherence data may lead to investigational determination and denial
Absence of FDA clearance/prescription‑only labeling when required may prompt non‑coverage

Denial Risk

Nonuse / attrition risk — high attrition may limit evidence of effectiveness

High attrition, limited long‑term data, or failure to demonstrate net health outcome improvements in pivotal trials may render a device investigational and not covered. Document actual device use/adherence when available to support effectiveness claims.

dCBT‑I (e.g., Sleepio) trials show high dropout/nonuse rates (average noncompletion ~35–41%); this may limit coverage unless adherence and outcomes are documented
Diabetes titration tools: benefits in analyses often driven by users who regularly engaged with the tool; low usage in intent‑to‑treat populations weakens evidence

Denial Risk

Failed primary endpoint — pivotal trial failures increase denial risk

A pivotal trial that fails its primary efficacy endpoint (e.g., NightWare) is a significant evidence limitation and may lead to an investigational determination and denial of coverage.

NightWare pivotal trial did not meet the primary efficacy endpoint; coverage is uncertain and investigational per policy

Documentation Required

Required documentation — order, objective diagnosis, baseline measures, and benefit verification

Required documentation for prior authorization includes an order from a licensed practitioner, diagnosis tied to a covered purpose, objective baseline measures, prior therapy history, and plan for clinician monitoring. Member benefit verification is required to confirm applicable benefits and any exclusions.

Order/prescription from licensed practitioner documenting covered purpose and indication
Objective diagnosis and baseline severity (e.g., HbA1c, ISI, EPDS, pain scores) and prior therapy history including medications and trials of standard care when applicable
Plan for clinician follow‑up and monitoring (dashboard access, scheduled visits, treatment management services codes when billed)
Verify member contract/benefit booklet or contact customer service for plan‑specific coverage

Documentation Required

Diabetes outcomes and adherence — HbA1c, hypoglycemia, and usage data required

For diabetes digital therapeutics and insulin titration tools, prior authorization should include baseline and follow‑up HbA1c, record of hypoglycemic events, medication and regimen details, and documented adherence to allow assessment of clinical benefit.

Baseline HbA1c and periodic HbA1c follow‑up values
Documentation of insulin regimen, dosing plan entered by clinician, and any clinician configuration of dosing algorithms
Adherence or utilization data (frequency of app use, entries, engagement) and reports of hypoglycemia

Documentation Required

Mental health outcome measures — use validated scales and document clinician oversight

Behavioral and mental health digital therapeutics require validated outcome measures (e.g., EPDS for postpartum depression, HAMD‑17, MADRS) and confirmation that the device is intended as adjunctive to clinician‑managed care rather than a standalone treatment for serious mental illness.

Provide baseline and follow‑up scores on validated scales used in pivotal studies (e.g., EPDS ≥4 point change considered clinically meaningful in MamaLift Plus)
Document concomitant clinician management, ongoing medication use, and safety monitoring plans

Documentation Required

Need for objective diagnosis and medication documentation

Objective confirmation of diagnosis and documentation of relevant medication history are needed for several devices (e.g., antidepressant use with Rejoyn, insulin medications with titration apps). Absence of objective diagnosis or medication documentation may lead to denial.

Confirm the diagnosed condition in the medical record and include pertinent medication lists and prior treatment attempts
For combination adjunctive indications, document that the patient remains on prescribed medications when required by device indication

Note

Benefit verification — member contracts differ; confirm benefits

Verify member benefits before initiating authorization — member contracts vary and some plans exclude digital therapeutics or OTC products; coverage under an employer or carve‑out may follow different rules.

Consult the member benefit booklet or contact customer service to confirm whether the specific device and associated services are a covered benefit
Coverage granted by an employer group outside of standard plan benefits may not be governed by this policy

Step Therapy

Step therapy — No explicit step therapy rules specified

Step therapy is not specified in this portion of the policy. There are no explicit step therapy rules documented here; follow plan‑specific utilization management rules if applicable.

If step therapy requirements exist for a plan, those are implemented operationally outside the scope of this policy

Documentation Required

Adjunctive use / not first‑line — document rationale for adjunctive therapy

Many digital therapeutics are intended as adjunctive treatments and not replacements for established first‑line therapies. Prior authorization should document that the device is being used as adjunctive therapy when indicated and not as a substitute for standard care.

Examples: Sleepio, MamaLift Plus, Rejoyn, RelieVRx, Luminopia One — labeled or studied as adjunctive to clinician‑managed care
Document prior standard therapy tried when device is not intended as first‑line

Documentation Required

Consideration of face‑to‑face CBT‑I before digital CBT‑I

For digital CBT‑I (dCBT‑I) devices, consider whether face‑to‑face CBT‑I has been offered or is appropriate; evidence suggests face‑to‑face CBT‑I may be superior for some patients. Prior authorization may request documentation that face‑to‑face CBT‑I was not available or contraindicated when relevant.

If face‑to‑face CBT‑I is clinically indicated and available, document rationale for choosing a digital CBT‑I adjunct (access barriers, patient preference, or clinician recommendation)
NICE guidance notes Sleepio may be cost‑saving but more research is needed comparing to face‑to‑face CBT‑I

Documentation Required

Adjunctive use documentation — show clinician oversight and evidence for adjunctive indication

When a device is used adjunctively, include documentation that clarifies the adjunctive indication, clinician monitoring responsibilities, and evidence that adjunctive use is supported by credible studies or FDA labeling.

Provide evidence that adjunctive use aligns with FDA‑cleared indication and that clinician management (monitoring, medication adjustments) is planned
Adjunctive use without documentation of clinician oversight or needed safety monitoring may be denied

Coverage implicationProducts that are over‑the‑counter or direct‑to‑consumer are generally excluded from prescription‑only PDT coverage criteria.

Mobile application (app) — definition

DefinitionA software application designed to run on a mobile device (smartphone, tablet, smartwatch) or an internet‑based application tailored to a mobile platform.

ExamplesMobile apps used as digital therapeutics (e.g., CT-132, DaylightRx, SleepioRx) are delivered via iOS/Android apps or web portals.

Platform featuresMay include data capture, clinician dashboards, cloud storage, and real‑time monitoring functions.

Halo AF Detection System (Heart Beam) — product definition/example

ProductHalo AF Detection System (Heart Beam) — a smartwatch‑based photoplethysmography (PPG) rhythm monitoring system that analyzes pulse rhythms, flags signals suggestive of atrial fibrillation to a cloud‑based portal for physician review; available by prescription only and FDA 510(k) cleared (K201208).

Use caseIntermittent nighttime or on‑demand daytime monitoring via compatible Samsung smartwatch; intended to alert physicians to irregular rhythms.

ComponentsSmartwatch PPG sensor, Halo + Home Monitoring System tablet for analysis, and cloud physician portal for review.

Luminopia One / RevitalVision / RelieVRx — product definitions/examples

Luminopia OneSoftware-only digital therapeutic used with a compatible VR headset to improve visual acuity in amblyopia (ages 4–7); typical regimen: 1 hour/day, 6 days/week for 12 weeks; prescribed by a trained eye‑care professional and used adjunctively with full‑time refractive correction (DEN210005).

RevitalVisionPerceptual‑learning vision training software for amblyopia (patients ≥9 years); program consists of 20–40 interactive sessions (~30 minutes each) generally completed within 3 months; available by prescription only and FDA 510(k) cleared (K012530).

RelieVRx (EaseVRx)Virtual reality–delivered therapeutic for chronic low back pain delivered via headset over a 56‑day program; evaluated in randomized trials showing reductions in pain intensity and interference versus sham VR (DEN210014).

Insulia / Diabeo system — product definition/example

Insulia Diabetes Management CompanionMobile app/web portal that recommends basal insulin doses for adults with type 2 diabetes based on a provider‑created treatment plan, blood glucose inputs, and hypoglycemia reports; available by prescription only and FDA 510(k) cleared (K161433).

FunctionProvides dose recommendations with explanations, educational coaching messages, and clinician remote monitoring capabilities.

CompatibilityCompatible with multiple long‑acting insulin analogs per FDA summaries and includes secure data capture and reporting features.

Diabeo / Insulia — predecessor system definition

Diabeo system (predecessor)Smartphone‑based insulin dose recommendation software developed for use with provider‑defined treatment plans; studied in RCTs (TeleDiab) showing HbA1c reductions in certain arms for adults with type 1 and type 2 diabetes.

Evidence roleDiabeo trials serve as the evidence basis referenced for Insulia in absence of direct published studies on Insulia.

Regulatory statusDiabeo was a CE‑marked Class IIb device in Europe and does not have FDA approval; Diabeo evidence is used as historical comparator in the policy review.

EaseVRx / RelieVRx — VR therapeutic definition

EaseVRx / RelieVRx — VR therapeuticA virtual reality‑based therapeutic program for adults with chronic low back pain delivered via headset over a 56‑day program; in an RCT EaseVRx demonstrated superiority to sham VR for pain intensity and pain‑related interference with moderate clinically meaningful effect sizes.

DeliveryHeadset‑based immersive program with scheduled sessions over the treatment period; intended as adjunct to usual care.

Evidence durabilityBenefits were observed at end of treatment and reported to maintain at follow‑up (durability reported to 6 months in evidence summaries).

RelieVRx / EaseVRx — VR‑delivered therapeutic summary

RelieVRx / EaseVRx — summaryRelieVRx is a VR‑delivered digital therapeutic for chronic low back pain evaluated in randomized trials showing reductions in pain intensity and interference versus sham VR; intended for adjunctive use and supported by FDA De Novo clearance (DEN210014).

Population and limitationsRCT population was predominantly female, White, and urban; generalizability and blinding limitations were noted in the evidence.

Intended useDelivered via VR headset over a defined program (56 days) with clinician oversight and patient monitoring tools.

SleepioRx — prescribed CBT‑I digital therapeutic definition

SleepioRx — definitionPrescription digital therapeutic delivering Cognitive Behavioral Therapy for Insomnia (CBT‑I) via an app for adults aged 18 and older as an adjunct to usual care; available by prescription only and FDA 510(k) cleared (K233577).

Delivery and featuresProvides sleep diaries, video/audio CBT‑I content, and clinician‑directed access; app is obtained by prescription and downloaded from the company's website (not an app store).

EvidenceMultiple RCTs, systematic reviews, and meta‑analyses inform efficacy but note high attrition and limited long‑term data compared with face‑to‑face CBT‑I.

RevitalVision — perceptual‑learning digital therapy definition

RevitalVision — definitionA perceptual‑learning–based digital therapy for amblyopia (patients ≥9 years) delivering interactive visual training sessions (20–40 sessions, ~30 minutes each) to improve visual acuity and contrast sensitivity; FDA 510(k) cleared (K012530).

Program lengthTypically completed within about 3 months with individualized training algorithms that adapt session difficulty based on performance.

Evidence limitationsStudies include small cohorts and some nonrandomized designs; generalizability and clinical significance vary by age and prior treatment history.

Prescription digital therapeutic — general definition (FDA‑cleared/authorized software intended for prescription use)

Prescription digital therapeutic — general definitionSoftware or digital device cleared or authorized by the FDA for prescription use to treat or manage specific medical conditions and intended to be used as adjunctive therapy to clinician‑managed or usual care.

Access requirementRequires an order or prescription from a licensed healthcare provider per FDA clearance statements for many devices (e.g., SleepioRx, DaylightRx, CT-132).

Regulatory pathwaysMay be authorized via FDA 510(k), De Novo, or other premarket pathways depending on device novelty and risk profile.

De Novo authorization — FDA pathway definition

De Novo authorization — definitionAn FDA pathway for novel low‑to‑moderate‑risk devices without a predicate that grants marketing authorization with specific indications (examples in the policy: CT-132, EndeavorRx, RelieVRx, Luminopia One).

ImplicationDevices cleared via De Novo have specific intended uses and may require prescription and adherence to indicated age ranges or adjunctive‑use conditions.

Reference examplesPolicy cites De Novo identifiers such as DEN240064 (CT‑132), DEN200026 (EndeavorRx), and DEN210014 (RelieVRx) as examples.

Regulatory status — FDA 510(k) and De Novo summaries cited

510(k) summaryFDA 510(k) clearance indicates the device is substantially equivalent to a marketed predicate; multiple digital therapeutics in the policy have 510(k) clearances (e.g., Halo AF K201208, SleepioRx K233577, DaylightRx K233872, MamaLift Plus K223515).

De Novo summaryDe Novo grants marketing authorization for novel devices without predicates and is used for several PDTs (e.g., EndeavorRx DEN200026, RelieVRx DEN210014, CT‑132 DEN240064).

CitationsPolicy references specific FDA documents and identifiers in the Regulatory Status and References sections (see cited 510(k) and De Novo IDs).

Annual review approved September 10, 2024; RevitalVision added to the list of investigational prescription digital therapeutics and HCPCS code T1505 removed.

2024-06-01Interim review / additions

Interim review approved May 14, 2024; EpiMonitor, Rejoyn, and MamaLift Plus added to the list of investigational prescription digital therapeutics; CPT codes 0687T and 0688T and HCPCS S9002 added.

2023-11-01Interim review / content removal

Interim review approved October 10, 2023; Pear Therapeutics products ReSet, ReSet-O, and Somryst removed as no longer in business and HCPCS code A9281 removed (history later corrected).

As a historical policy note, prescription digital therapeutics that do not meet the policy's medical necessity criteria have been classified as investigational (not medically necessary) in prior history entries; the policy history documents the dates and rationale for additions and removals to that list.