Prescription Digital Therapeutics (PDTs) Coverage Criteria
Customize your policy alerts
Sign up for all Premera Bluecross policy alerts
Know when Premera Bluecross releases new policies or updates existing guidance.
Monitor payer policy activity
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.
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.
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:
Credible scientific evidence defined in policy.
Investigational
Investigational / Not medically necessary
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):
No published peer-reviewed evidence identified in this section.
No published studies on Insulia; evidence summarized from predecessor Diabeo (RCTs) presented elsewhere in policy.
Device intended for single-user repeated use and clinician monitoring via app.
Patient portal for caregiver monitoring available.
Includes clinician dashboard for monitoring.
Diabeo RCTs summarized (TeleDiab-1, TeleDiab-2, TELESAGE) showing mixed results and limitations.
Single pivotal trial failed to meet primary efficacy endpoint; evidence insufficient.
Described as adjunctive pain relief via behavioral skills; RCT evidence summarized elsewhere.
Evidence details for CureSight and RevitalVision summarized in policy.
Two RCTs summarized with improvements in GAD-7 and secondary outcomes but limitations noted.
Evidence insufficient for net health outcome improvement.
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.
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.
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.
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.
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.
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.
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.
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.
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:
Limitations: self-report outcomes, limited diversity, blinding failures, industry sponsorship.
Limitations include small samples, short follow-up, and nonrandomized designs in some reports.
NICE and other HTA findings cited; further research comparing to face-to-face CBT-I recommended.
Regulatory Indications (informational)
Regulatory status is informational and not itself a coverage determination.
General coverage statement (document excerpt)
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
| 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). |
| 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). |
| 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.) |
| 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) |
| 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 |
Provider Requirements, Prior Authorization, and Documentation
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.
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: 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).
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.
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.
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.
—
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 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.
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.
—
—
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.
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.
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 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.
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.
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 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.
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.
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.
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.
—
—
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
Policy Revision History
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.
Annual Review approved August 12, 2025; added CT-132 to the list of FDA‑approved prescription digital therapeutics considered investigational.
Added new HCPCS codes G0552, G0553, and G0554 (coding update effective January 1, 2025).
Annual Review approved September 10, 2024; added RevitalVision to the list of FDA‑approved prescription digital therapeutics considered investigational and removed HCPCS code T1505.
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.
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).
Coding update added new HCPCS code A9292 (effective October 1, 2023).
Annual Review approved June 13, 2023; added Regulora and Luminopia One to the list of FDA‑approved prescription digital therapeutics considered investigational.
Coding update added HCPCS code E1905 (April 1, 2023).
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.
Interim Review approved September 12, 2022; updated A9291 description, removed Canvas DX content (moved to another policy), and standardized wording.
Coding update added new HCPCS code A9291 (April 1, 2022).
New policy approved July 13, 2021 establishing medical necessity and investigational criteria for prescription digital therapeutics.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.