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ModifiedPremera BluecrossPolicy N/A

Prescription Digital Therapeutics (PDTs) Coverage Criteria

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Defines medical necessity and investigational coverage criteria for FDA-regulated prescription digital therapeutics prescribed by licensed healthcare practitioners and used to evaluate, diagnose, manage, or treat illnesses or symptoms.

Policy Summary

PayerPremera Bluecross

PolicyPrescription Digital Therapeutics (PDTs) Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review with coding and device list updates

Effective DateApr 1, 2026

Last ReviewMar 10, 2026

Next Review Date

Key ActionWhen requesting coverage, submit FDA authorization details and supporting clinical trial evidence and device usage/adherence data as part of prior authorization.

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.

A and B requiredMedical necessity logic

A9294New HCPCS

~25 productsExample PDTs listed

YesPediatric indications included

Coverage Criteria and Evidence

Medical Necessity

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

A. Device-level criteria: The prescription digital therapeutic has been approved by the US Food and Drug Administration (FDA); AND there is credible scientific evidence which permits reasonable conclusions regarding the impact of the prescription digital therapeutic on health outcomes; AND the prescription digital therapeutic has been proven to improve the net health outcome or is considered as beneficial as another established alternative.

Credible scientific evidence defined in policy.

B. Patient- and ordering-level criteria: The prescription digital therapeutic requires a prescription by a licensed healthcare practitioner; AND there is documentation supporting that the PDT was ordered for a covered purpose (preventing, evaluating, diagnosing, or treating an illness, injury or disease or its symptoms) and in accordance with generally accepted standards of medical practice; AND the requested prescription digital therapeutic is not primarily for the convenience of the individual, physician, or health care provider.

Investigational

Policy Summary

PayerPremera Bluecross

PolicyPrescription Digital Therapeutics (PDTs) Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review with coding and device list updates

Effective DateApr 1, 2026

Last ReviewMar 10, 2026

Next Review Date

Key ActionWhen requesting coverage, submit FDA authorization details and supporting clinical trial evidence and device usage/adherence data as part of prior authorization.

SourceLink

On This Page

Investigational / Not medically necessary

Investigational PDTs: Prescription digital therapeutics are considered investigational when ALL of the above medical necessity criteria are not met.

FDA-approved prescription digital therapeutics that do not meet the policy's evidence or appropriateness criteria are considered investigational (examples listed in policy).

Product-specific indications and evidence summaries

Evidence summaries and indications for selected prescription digital therapeutics (examples only):

Halo AF Detection System: Monitors PPG via compatible Samsung smartwatch to detect atrial fibrillation; flags rhythms for physician review via cloud portal; available by prescription.

No published peer-reviewed evidence identified in this section.

Insulia Diabetes Management Companion: Mobile app/web portal recommending basal insulin doses for adults with type 2 diabetes based on provider-created plan; includes dose explanations and clinician monitoring; available by prescription.

No published studies on Insulia; evidence summarized from predecessor Diabeo (RCTs) presented elsewhere in policy.

leva Pelvic Digital Health System: Intravaginal motion-sensor wand with app coaching for pelvic floor muscle training for stress, mixed, and mild-moderate urgency urinary incontinence in women; prescribed use twice daily up to 12 weeks; prescription-only.

Device intended for single-user repeated use and clinician monitoring via app.

Luminopia One: Software-only therapy used with VR headset to improve visual acuity in amblyopia (ages 4-7) as adjunct to full-time refractive correction; 1 hour/day, 6 days/week for 12 weeks; prescription-only.

Patient portal for caregiver monitoring available.

MamaLift Plus: Mobile CBT-based modules (8 modules over 8-9 weeks) for mild-moderate postpartum depression in adults ≥22 years as adjunct to clinician-managed care; not for serious mental illness; prescription-only.

Includes clinician dashboard for monitoring.

My Dose Coach / Insulin titration apps: Apps designed to support basal insulin titration per provider plan; available by prescription; predecessor systems (Diabeo) have RCT evidence showing HbA1c improvements in some trial arms.

Diabeo RCTs summarized (TeleDiab-1, TeleDiab-2, TELESAGE) showing mixed results and limitations.

NightWare: Apple Watch app to detect nightmares and deliver vibration alerts during sleep; available by prescription.

Single pivotal trial failed to meet primary efficacy endpoint; evidence insufficient.

RelieVRx: In-home VR system delivering an 8-week CBT-based curriculum for chronic low back pain adults ≥18; daily sessions average 7 minutes; prescription-only and device returned after completion.

Described as adjunctive pain relief via behavioral skills; RCT evidence summarized elsewhere.

RevitalVision / CureSight / other amblyopia therapies: Several home-based digital binocular/perceptual training programs for amblyopia in children/adolescents with RCT evidence for CureSight showing noninferiority to patching over 16 weeks and improved adherence.

Evidence details for CureSight and RevitalVision summarized in policy.

DaylightRx: Digital CBT program for generalized anxiety disorder in adults ≥22 with RCTs showing symptom reduction versus waitlist controls; limitations include self-reported diagnoses and limited generalizability.

Two RCTs summarized with improvements in GAD-7 and secondary outcomes but limitations noted.

EndeavorRx: Video game therapeutic for children 8-12 with ADHD; one double-blind RCT (n=348) showed improvement on an objective attention measure but no between-group differences on parent or clinician ratings; evidence insufficient to replace established treatments.

Evidence insufficient for net health outcome improvement.

Products lacking peer-reviewed evidence: EpiMonitor, Halo AF Detection System, and others are noted as having no published peer-reviewed evidence in this section.

Absence of published evidence noted explicitly for several products.

Insulia/Diabeo evidence considerations

Evidence from RCTs shows potential HbA1c reductions in select telemonitoring/insulin titration interventions but limitations affect net health outcome certainty.

Insulia/Diabeo RCT evidence: TeleDiab-1, TeleDiab-2, and TELESAGE trials reported HbA1c reductions with smartphone/telemonitoring interventions in adults with diabetes; some comparisons reached statistical significance in certain arms or user subgroups.

TELESAGE post-hoc analyses showed benefit primarily among actual users; high nonuse rates and missing ITT significance weaken conclusions.

leva Pelvic Digital Health System

Evidence insufficient to determine net health outcome.

leva evidence: Small pilot and a multicenter RCT with mixed results; pilot showed physiologic and questionnaire improvements but was uncontrolled; an RCT showed no difference on primary outcomes though some secondary measures improved.

Trial was prematurely terminated for technical reasons; larger powered trial underway.

Luminopia One (amblyopia)

RCT showed clinically meaningful improvement in amblyopic eye visual acuity versus refractive correction alone at 12 weeks.

Luminopia One efficacy: In children 4-7 years, RCT (n=105) found amblyopic eye visual acuity improved by 1.8 lines vs 0.8 lines in control at 12 weeks; study stopped early for benefit.

Longer follow-up and comparison to standard patching/atropine needed for durability and comparative effectiveness.

MamaLift Plus (postpartum depression)

Pivotal double-blind RCT demonstrated substantial improvement versus sham app at 8 weeks.

MamaLift Plus efficacy: In postpartum individuals with EPDS 13-19, 86.3% in intervention improved ≥4 EPDS points vs 23.9% in sham (P<0.0001) at 8 weeks.

Longer follow-up and additional clinician-rated scales would strengthen evidence; masking efficacy uncertain.

My Dose Coach (basal insulin titration)

Evidence includes a single-arm pilot and an RCT showing modest HbA1c benefit versus written titration chart.

My Dose Coach evidence: Pilot single-arm study showed mean HbA1c reduction ~1.97% but lacked comparator; a 12-week RCT (n=251) found adjusted between-group difference -0.31% favoring the app (p=0.0388).

Limitations include short follow-up, generalizability concerns related to study setting, and industry sponsorship.

NightWare (nightmare disorder/PTSD-associated nightmares)

Pivotal trial did not meet primary efficacy endpoint; evidence insufficient.

NightWare evidence: Single pivotal trial did not meet its primary efficacy endpoint and was likely underpowered; benefit is uncertain.

A well-designed blinded RCT is needed to determine efficacy.

Rejoyn / CT-152 (major depressive disorder adjunctive therapy)

RCT showed small between-group improvement on MADRS favoring CT-152, but clinical significance and durability uncertain.

Rejoyn evidence: In adults with MDD resistant to antidepressant monotherapy, CT-152 produced greater MADRS improvement versus sham at week 6 (between-group differences approximately -1.78 to -2.12 points), though primary comparisons were marginal and clinical durability is uncertain.

Industry sponsorship and participant demographics limit generalizability; longer follow-up needed.

RelieVRx (EaseVRx) for chronic low back pain

Double-blind RCT demonstrated superiority over sham VR on primary outcomes with maintained effects.

RelieVRx efficacy: In a double-blind RCT (n=179), EaseVRx reduced average pain intensity and pain-related interference versus sham VR at 56 days with moderate effect sizes; benefits were maintained on several outcomes in follow-up to 3-6 months and signals to 24 months.

Limitations include self-reported data, generalizability concerns, potential unblinding, and industry sponsorship.

Evidence summaries relevant to coverage assessment

Evidence summaries and limitations relevant to assessing coverage:

RelieVRx evidence summary: RCT evidence (Garcia et al., 2021) N=179 showed EaseVRx superior to sham for primary pain outcomes at 56 days with moderate effect sizes and durability to 6 months; longer-term and more generalizable studies desirable.

Limitations: self-report outcomes, limited diversity, blinding failures, industry sponsorship.

RevitalVision/perceptual learning: Small studies and limited RCT data report improvements in visual acuity for amblyopia and related indications, but sample sizes and follow-up are limited.

Limitations include small samples, short follow-up, and nonrandomized designs in some reports.

SleepioRx/dCBT-I evidence: Multiple RCTs and meta-analyses show large effect sizes for digital CBT-I (including Sleepio) on insomnia outcomes, but generalizability is limited by high attrition, unblinded self-reported outcomes, and exclusion of comorbid psychiatric or sleep disorders in many trials.

NICE and other HTA findings cited; further research comparing to face-to-face CBT-I recommended.

Regulatory Indications (informational)

Regulatory and indication summaries: Entries list FDA clearance pathway and indicated use for each product; many are indicated as adjunctive to clinician-managed care or usual care and are prescription-only.

Regulatory status is informational and not itself a coverage determination.

General coverage statement (document excerpt)

Policy scope and history excerpt: Coverage and investigational status depend on FDA authorization/clearance and whether products meet the policy's evidence and appropriateness criteria; policy history documents revisions and coding updates.

This excerpt contains administrative statements and revision history; specific clinical criteria appear elsewhere in the policy.

Digital therapeutics that are available over-the-counter or without a prescription are generally excluded from coverage under most plans; coverage depends on individual contract language and benefit limits. Professional services related to managing or supporting a device (for example, training, monitoring, or device-management services) are considered investigational and may be excluded when the device itself does not meet the policy's medical necessity criteria.

MamaLift Plus is indicated as a prescription digital therapeutic for mild-to-moderate postpartum depression and is intended to be used as an adjunct to clinician-managed outpatient care. It is not intended as a stand-alone therapy and is contraindicated for use in patients with serious mental illness, psychosis, or active suicidal/homicidal ideation. The product is listed among FDA-cleared PDTs that remain investigational under this policy when the broader medical necessity criteria are not met.

Rejoyn (CT-152) is described as a prescription-only PDT that does not provide a physician portal and does not send monitoring alerts to the prescribing provider. Because it lacks direct clinician monitoring or automated alerting to the prescriber, the device may have limited applicability where ongoing provider oversight is required and this limitation is noted in the evidence summary.

Products with study limitations such as high attrition, early trial termination, or pivotal trials that failed to meet primary endpoints are treated in the policy as having insufficient evidence to determine improved net health outcomes. Examples include systems with large nonuse rates or trials stopped early for technical reasons and NightWare, whose single pivotal trial did not meet its primary efficacy endpoint; such evidence gaps support an investigational determination unless stronger data are provided.

Clinical trials for many digital therapeutics routinely exclude individuals with certain comorbid conditions. Common exclusions noted include bipolar disorder, psychosis, severe depression, untreated obstructive sleep apnea, narcolepsy, seizure disorder, or concurrent use of sleep medications. These exclusions limit generalizability of trial results and should be considered when assessing appropriateness for individual patients.

There is no national Medicare coverage determination (NCD) for the prescription digital therapeutics discussed in this policy.

This medical policy does not apply to Medicare Advantage. Member benefits and coverage determinations for Medicare Advantage plans should be verified through the applicable plan documents or customer service.

An FDA clearance or approval alone does not guarantee coverage under this policy. FDA-approved or -cleared PDTs that do not meet the policy's evidence or appropriateness criteria (device-level and patient-level requirements) are considered investigational and thus not medically necessary for coverage purposes until the criteria are satisfied.

The policy explicitly cites examples where evidence is judged insufficient to demonstrate net health benefit despite regulatory clearance. Noted products with inadequate evidence include BlueStarRx (no published peer-reviewed evidence for its insulin dose calculator) and EndeavorRx (RCT showed improvement on an objective attention measure but no corresponding parent or clinician-rated symptom improvements), supporting investigational determinations absent additional data.

Several devices in the policy have no published peer‑reviewed evidence or only limited, small, uncontrolled studies supporting use; MindMotionGO and BlueStarRx are specifically noted as lacking peer-reviewed publications. Where peer-reviewed evidence is absent or very limited, the policy treats the device as investigational pending higher-quality data.

In the document segments provided there are no explicit “not medically necessary” determinations stated for individual products; instead, products failing to meet the policy's medical necessity criteria are categorized as investigational.

The reviewed policy excerpts do not contain standalone explicit “not medically necessary” rulings within these chunks; investigational status is the classification applied when criteria are unmet and specific not‑medically‑necessary language appears elsewhere in related policy sections.

Historically, products that do not meet the policy's device- and patient-level criteria have been considered investigational. The policy notes that specific “not medically necessary” determinations and detailed product-level coverage decisions are provided in other sections or related policies when applicable.

Coding and Billing

Covered CPT CodesCPT

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.

Covered HCPCS / DME / Other CodesHCPCS

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).
A9294	Prescription digital cognitive and/or behavioral therapy, biofeedback, FDA cleared, per course of treatment (new code effective 04/01/26).
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 identifiers mentionedmixed

DEN240064	De Novo pathway identifier referenced for CT-132 (Click Therapeutics) - preventive treatment of episodic migraine (per company)
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, Inc.)

FDA clearances and identifiersmixed

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

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HCPCS and CPT codes referenced in policy historymixed

A9291	HCPCS code referenced historically in policy updates
A9292	HCPCS code added 10/01/23 per history
A9294	New HCPCS code added effective April 1, 2026
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
0704T	CPT code added 01/01/23
0705T	CPT code added 01/01/23

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Age indications and treatment durations (examples)

CureSight (CureSight CS100)Pediatric amblyopia: ages 4 to ≤9; regimen example: 90 minutes/day, 5 days/week for 16 weeks (home-based eye-tracking therapy).

Luminopia OnePediatric amblyopia: ages 4–7; prescribed use 1 hour/day, 6 days/week for 12 weeks as an adjunct to full-time refractive correction.

RevitalVisionAmblyopia/perceptual learning: generally completed within ~3 months with sessions ≈30 minutes each, training 3×/week (total 20–40 sessions).

RelieVRx (EaseVRx)Chronic low back pain (adults ≥18): delivered over a 56-day (8-week) course with brief daily sessions (average ~7 minutes per session in trials).

Literature review cutoff

Literature review cutoff dateLiterature review for this policy updated through September 22, 2025.

Most recent policy approvalAnnual Review approved March 10, 2026 (policy updated with literature review through 9/22/2025).

Coding update effective date noted in historyNew HCPCS code A9294 added effective April 1, 2026 (history entry referencing literature review period).

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and coding note

Prior authorization may be required for coverage of prescription digital therapeutics (PDTs) and related professional services; coverage of professional services may be considered investigational when the device does not meet medical necessity criteria. Providers should follow payer-specific prior authorization rules when submitting requests for PDTs and associated services.

Prior authorization requirements are governed by the member's plan and payer rules.
Professional services tied to a PDT that does not meet medical necessity criteria may be considered investigational.

Prior Authorization

Prescription-only requirement

Many products described in the policy are available only by prescription; a licensed healthcare practitioner order is required for access to these prescription-use devices/apps.

Examples labeled as prescription-only include Halo AF Detection System, Insulia Diabetes Management Companion, leva Pelvic Digital Health System, My Dose Coach, NightWare, Luminopia One, RelieVRx, and others.
Prescription status implies a clinician must order the PDT for the patient.

Prior Authorization

Prior authorization: request trial evidence and adherence data

When submitting a prior authorization request for a PDT, include clinical trial evidence summaries and device usage/adherence data demonstrating real-world effectiveness and safety for the specific indication.

Provide RCT details (study design, sample size, key outcomes) and published evidence supporting net health outcome.
Include device usage/adherence data or real-world use rates to support effectiveness claims (post-hoc analyses showing effect among actual users were cited).

Prior Authorization

Prescription device requirement (clinician order required)

Some digital therapeutics cleared by the FDA are designated prescription-use devices (for example, SleepioRx and other 510(k)/De Novo cleared PDTs); clinician order is required per the device's regulatory clearance.

SleepioRx FDA 510(k) clearance statement: 'Sleepio is a prescription device... can be made available on the order of a licensed healthcare provider.'
Luminopia One and RelieVRx are labeled for prescription use per their FDA clearances.

Note

Prescription status noted for individual products

The policy documents prescription status for multiple individual products; several products are explicitly described as prescription digital therapeutics or prescription-use devices.

Examples with noted prescription status include DaylightRx, SleepioRx, MamaLift Plus, Luminopia One, RelieVRx, CureSight-CS100, and others.
Prescription status is provided per regulatory summaries and product descriptions in the policy.

Billing Rule

Coding update (A9294) and potential PA

A new HCPCS code (A9294) for prescription digital cognitive/behavioral therapy with biofeedback is effective April 1, 2026; coverage and any prior authorization requirements for services reported with this or other PDT codes remain subject to the policy and the member contract.

HCPCS A9294 listed as 'new code effective 04/01/26' in coding section.
Coverage determinations for coded services are subject to the policy and member benefit limits.

Note

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Step Therapy

Step therapy not specified; document prior standard therapy when applicable

The policy text does not specify mandatory step therapy or sequencing requirements for prescription digital therapeutics; however, when established alternative therapies exist, documentation that standard therapies were tried or are contraindicated is recommended.

No step therapy rules are stated in the cited policy chunks.
If alternatives exist (e.g., patching/atropine for amblyopia; standard insulin titration practices), require documentation that standard therapies were tried or are contraindicated before approving a novel PDT.

Step Therapy

Step therapy considerations: document prior standard treatments

When conventional treatments are available, prior authorization should require documentation that standard therapies were attempted and were ineffective, not tolerated, or contraindicated before approving the PDT.

Amblyopia: document prior patching or atropine attempts or rationale for alternative therapy.
Insulin titration apps: document standard titration practices and why the digital titration aid is needed.

Step Therapy

Consideration of step to face-to-face CBT-I before digital CBT-I

Policy guidance notes that face-to-face CBT-I may be superior to digital CBT-I; consider reserving digital CBT-I for patients who are not eligible for, have no access to, or have contraindications to in-person CBT-I and document this in the request.

NICE guidance recommends further research comparing Sleepio to face-to-face CBT-I and indicates face-to-face CBT-I may be superior.
Document inability to access in-person CBT-I or reason why digital CBT-I is being selected.

Note

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Note

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Documentation Required

Required documentation to support medical necessity

Documentation submitted for medical necessity must show the PDT was ordered for a covered purpose (preventing, evaluating, diagnosing, or treating an illness, injury, disease, or its symptoms), was prescribed by a licensed healthcare practitioner, and meets the device- and patient-level criteria in the policy.

Evidence that the PDT has FDA authorization/clearance and credible scientific evidence supporting improved health outcomes (device-level criteria).
Patient-level documentation: prescription order, indication, and statement that use is consistent with generally accepted standards of medical practice.

Documentation Required

Clinician monitoring and documentation

For PDTs that include clinician dashboards or portals (e.g., Insulia, My Dose Coach, MamaLift Plus), providers should document monitoring plans and oversight in the member's medical record to support clinical use.

Document frequency of review, parameters monitored, and any treatment adjustments made based on device data.
Include clinician dashboard access notes or summaries of data reviewed when relevant to clinical decision-making.

Documentation Required

Submit supporting clinical trial data with PA requests

When requesting coverage, submit supporting clinical trial data including randomized trial summaries, sample sizes, and primary outcomes (for example: Luminopia One VA change, MamaLift Plus EPDS improvement, My Dose Coach HbA1c change, RelieVRx pain outcomes).

Include citations to the pivotal RCT(s), key outcomes, and any limitations relevant to generalizability or ITT analyses.
If trial benefits were seen primarily in adherent users or in post-hoc analyses, include adherence/use data to contextualize effectiveness.

Documentation Required

Documentation considerations: provide objective diagnostic and usage data

Trial reports often rely on self-reported outcomes and may lack objective diagnostic confirmation; include objective clinical documentation (diagnoses, relevant test results, medication records) when possible to strengthen the request.

Provide objective confirmation of diagnosis where feasible (e.g., validated scales, clinician assessment, diagnostic testing).
Note limitations of published trials (high attrition, self-reported outcomes) and supply supporting objective data from the member's care when available.

Documentation Required

Prescription / clinician approval required (document the order)

Some devices are explicitly prescription-use only and require clinician approval or instructions prior to use; ensure the prescription/order is documented in the medical record (examples: Luminopia One, RelieVRx, RevitalVision, MindMotionGO).

Document the prescribing clinician's name, licensure, the order date, indication, and any device-specific instructions.
Record any patient education or onboarding provided as part of device use.

Note

Verify member benefits and plan limitations

Verify member benefits and consult the member benefit booklet or contact customer service to determine whether specific benefit limits, exclusions, or plan conditions apply to coverage of PDTs.

Coverage is subject to member contract limits and plan-specific exclusions.
Some plans may exclude over-the-counter or non-prescription digital therapeutics even if ordered by a clinician.

Denial Risk

Denial triggers: unmet device- or patient-level criteria

Requests for PDTs that do not meet the policy's device-level criteria (FDA clearance/approval and credible evidence of improved health outcomes) or patient-level criteria (prescription requirement, documentation for covered purpose, and not primarily for convenience) may be deemed investigational and denied.

Device-level denials: lack of FDA authorization/clearance or insufficient credible evidence of net health benefit.
Patient-level denials: missing prescription/order, inadequate documentation of clinical need, or request primarily for convenience.

Prior Authorization

Prescription requirement: document clinician order

Products described as prescription-only imply a prescription requirement; absence of a documented clinician order may result in denial or claim rejection.

Ensure a licensed healthcare practitioner has authored and documented the prescription order for the PDT.
Requests lacking the required prescription/order should not be approved per policy device- and patient-level criteria.

Denial Risk

Evidence limitations that may affect coverage

High attrition in trials and lack of device use in intention-to-treat populations were noted for some PDT studies; payers may determine evidence insufficient when ITT outcomes are not robust or when real-world adherence is poor.

TELESAGE/Diabeo: large proportions of randomized participants never used the device; positive effects were seen mainly in post-hoc analyses of actual users.
Digital CBT-I trials and other RCTs had high dropout/noncomplete rates and reliance on self-reported outcomes.

Denial Risk

Insufficient efficacy in pivotal trial (NightWare) — risk of noncoverage

A single pivotal trial that failed to meet its primary efficacy endpoint (NightWare) poses a risk of noncoverage due to insufficient evidence of benefit.

NightWare pivotal trial did not meet the primary endpoint and was likely underpowered; further well-designed blinded RCTs are needed.
Coverage may be denied where the pivotal evidence is negative or inconclusive.

Note

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Note

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Denial Risk

Benefit limitations may cause denial; confirm plan coverage

Coverage of PDTs is subject to member benefit plan limits and conditions; lack of an applicable benefit or plan exclusions may cause denial—confirm plan coverage before submitting an authorization request.

Member contracts differ; consult the member benefit booklet or customer service to determine coverage applicability.
Some plans exclude over-the-counter or non-prescription digital therapeutics even if ordered by a licensed practitioner.

Background and Scope

Prescription digital therapeutics (PDTs) are software-driven, evidence-based interventions that are prescribed by a licensed clinician to evaluate, diagnose, manage, or treat medical and behavioral conditions. FDA regulatory oversight for PDTs is risk‑based (De Novo, 510(k), or PMA pathways) and the policy focuses on FDA‑regulated prescription-use PDTs intended to be used as adjuncts to clinician-managed care or as specified in their cleared indications.

Definitions and Key Terms

Digital therapeutics (DTx)

DefinitionDigital therapeutics (DTx): deliver therapeutic, evidence-based interventions driven by software to treat, manage, and prevent behavioral, mental, and physical diseases and disorders.

Regulatory contextDTx addressed in this policy are FDA-regulated products (De Novo, 510(k), or PMA) intended to be prescribed by a licensed healthcare practitioner.

Clinical roleDTx are intended to evaluate, diagnose, or treat illnesses or their symptoms rather than only collecting health data.

Mobile application (app)

DefinitionMobile application (app): a software application designed to run on a mobile device or an internet-based software application tailored to a mobile platform.

Platform examplesMobile platforms include commercial off-the-shelf handheld devices such as smartphones, watches, and tablets.

Distribution noteSome prescription apps are not available via public app stores and require clinician prescription and direct download per manufacturer instructions.

PPG — Photoplethysmography

PPG (photoplethysmography)Optical signals recorded by smartwatches that capture pulse-volume changes used to detect irregular pulse rhythms suggestive of atrial fibrillation (analyzed by device algorithms).

Use casePPG data are processed by software algorithms (example: Halo AF Detection System) to flag rhythms for clinician review via a cloud portal.

LimitationPPG-based detection is device- and algorithm-dependent and requires clinician confirmation and review of flagged rhythms.

CBT-I — Cognitive Behavioral Therapy for Insomnia

DefinitionCBT-I (Cognitive Behavioral Therapy for Insomnia): structured behavioral and cognitive interventions delivered digitally to treat chronic insomnia as an adjunct to usual care.

DeliveryDelivered through prescription digital therapeutics (example: SleepioRx) via sleep diaries, instructional content, and behavioral modules on a mobile app.

Evidence considerationsMeta-analyses and multiple RCTs show substantial short-term effects for dCBT-I but limitations include high attrition, self-reported outcomes, and limited long-term data.

Diabeo/Insulia system

DefinitionDiabeo/Insulia system: smartphone-based insulin dosing recommendation software used to support basal (and in some systems bolus) insulin titration based on provider-created treatment plans.

Evidence baseDiabeo (predecessor) has randomized controlled trial evidence (e.g., TeleDiab, TELESAGE) showing HbA1c reductions in some arms; Insulia’s regulatory clearance describes functionality for adult type 2 diabetes patients on long-acting insulin.

Clinical featuresSystems incorporate blood glucose inputs, hypoglycemia reporting, dose explanation, and clinician monitoring portals to adjust plans as needed.

RelieVRx (EaseVRx)

Product descriptionRelieVRx (EaseVRx): an in-home virtual reality program delivering an 8-week CBT-based curriculum for adults with chronic low back pain; tested in randomized controlled trials versus sham VR.

Treatment courseDelivered over 56 days with brief daily sessions (trial average session length ~7 minutes); prescribed use and device return processes noted in product descriptions.

Intended roleIntended as adjunct to usual care to teach behavioral pain-coping skills rather than a replacement for medical treatment.

RelieVRx / EaseVRx — VR-based DTx evaluated in RCTs

Clinical evaluationRelieVRx / EaseVRx is a VR-based digital therapeutic evaluated in randomized controlled trials demonstrating superiority to sham VR on primary pain intensity and interference outcomes at 56 days (double-blind RCT, N=179).

DurabilityTrial follow-up showed maintained benefits at 3 months with additional longer-term follow-up reported in related analyses.

LimitationsLimitations include trial sample demographics, self-reported outcomes, and potential blinding challenges in follow-up analyses.

RevitalVision / perceptual learning

Product descriptionRevitalVision: a perceptual learning vision therapy platform for amblyopia (prescription-only) delivering interactive computerized training sessions to improve visual acuity and contrast sensitivity.

Typical regimenTraining involves 20–40 sessions over approximately 3 months (sessions ~30 minutes each), with individualized algorithms adjusting task difficulty.

EvidenceEvidence includes small observational studies, cohort studies, and RCTs reporting improvements in VA and contrast sensitivity but limited by small sample sizes and short follow-up.

SleepioRx

Product descriptionSleepioRx: a prescription digital therapeutic delivering CBT-I via a smartphone app for adults aged ≥18 as an adjunct to usual care.

Access and distributionSleepioRx is prescription-only per FDA 510(k) clearance and is not available via public app stores; it must be made available on the order of a licensed healthcare provider.

Evidence summaryMultiple RCTs and meta-analyses of dCBT-I (including Sleepio in some trials) show substantial short-term effects but limitations include high attrition and limited long-term data and generalizability.

Prescription digital therapeutic / prescription-use device

DefinitionPrescription digital therapeutic / prescription-use device: a software-based medical product cleared by FDA for use under the order of a licensed healthcare provider, intended to be used as an adjunct to clinician-managed care or usual care for specific indications.

Regulatory implicationPrescription status implies clinician order is required for access and may affect payer prior authorization and coverage determinations.

ExamplesProducts cited as prescription-use include RelieVRx, SleepioRx, Luminopia One, and others with FDA 510(k)/De Novo clearances specifying prescription-only availability.

De Novo vs 510(k)

De Novo pathwayDe Novo provides regulatory clearance for novel low-to-moderate risk devices without a predicate and is cited for products such as CT-132, Luminopia One, RelieVRx, and EndeavorRx.

510(k) pathway510(k) clearance indicates substantial equivalence to a predicate device and is cited for products including DaylightRx, SleepioRx, MamaLift Plus, Insulia, and others.

RelevancePolicy references these pathways to characterize regulatory status of specific digital therapeutics when assessing device-level criteria for coverage.

FDA regulatory summaries

FDA summaries referencedDe Novo and 510(k) decision summaries and Premarket Notification summaries are cited (examples: DEN240064 for CT-132; DEN210005 for Luminopia One; K233577 for SleepioRx).

Purpose of citationsThese FDA regulatory summaries are used to document clearance/authorization pathway and indicated use for specific prescription digital therapeutics referenced in the policy.

Reference detailsPolicy reference list includes URLs and FDA document identifiers for device summaries and De Novo/510(k) decision summaries used in evidence and regulatory status sections.

Policy Revision History

2026-04-01Annual review / coding updateLatest

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

2025-09-01Annual review

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

2025-01-01Coding update

Added new HCPCS codes G0552, G0553, and G0554 (coding update effective January 1, 2025).

2024-10-01Annual review

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

2024-06-01Interim review

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

2023-11-01Interim review / administrative

Interim Review approved October 10, 2023; removed certain Pear Therapeutics products (ReSet, ReSet‑O, Somryst) from the policy and removed HCPCS code A9281 (correction later noted).

2023-10-01Coding update

Coding update added new HCPCS code A9292 (effective October 1, 2023).

2023-07-01Annual review

Annual Review approved June 13, 2023; added Regulora and Luminopia One to the list of FDA‑approved prescription digital therapeutics considered investigational.

2023-04-01Coding update

Coding update added HCPCS code E1905 (April 1, 2023).

2023-01-01Annual review / coding update

Annual Review approved December 13, 2022; added CureSight and CPT codes 0704T, 0705T, 0706T, and added CPT codes 0740T and 0741T effective 01/01/2023.

2022-10-01Interim review

Interim Review approved September 12, 2022; updated A9291 description, removed Canvas DX content (moved to another policy), and standardized wording.

2022-04-01Coding update

Coding update added new HCPCS code A9291 (April 1, 2022).

2021-08-01New policy

New policy approved July 13, 2021 establishing medical necessity and investigational criteria for prescription digital therapeutics.

Note