CurrentPremera BluecrossPolicy 3.03.02

Prescription Digital Therapeutics

Defines medical necessity, investigational status, coding, and related requirements for FDA-regulated prescription digital therapeutics (PDTs) prescribed by licensed practitioners and used to evaluate, diagnose, manage, or treat illnesses; applies to Premera Bluecross coverage determinations.

Policy Summary

PayerPremera Bluecross

PolicyPrescription Digital Therapeutics

Policy CodePolicy 3.03.02

Change TypeInterim review — no material changes

Effective Date

Next Review Date

Key ActionObtain and document prior authorization details including device name, patient age eligibility, and prescribed regimen/duration when requesting coverage for a prescription digital therapeutic.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~20FDA-cleared devices listed

MultipleDevices with RCT evidence

SeveralDevices lacking peer-reviewed evidence

SeveralItems judged insufficient

Coverage Criteria for Prescription Digital Therapeutics

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.

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 means well-designed peer-reviewed investigations; see policy for definitions

B. Patient-level appropriateness: The prescription digital therapeutic requires a prescription by a licensed healthcare practitioner; and There is documentation supporting that the prescription digital therapeutic 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.

Documentation and prescriber licensing required

Investigational

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

Investigational determination: Any prescription digital therapeutic that does not meet all device-level criteria (FDA approval, credible evidence of benefit or equivalence) AND all patient-level appropriateness criteria is considered investigational.

Policy lists examples of FDA-cleared/approved PDTs that remain investigational when other criteria are not met

Insufficient Evidence / Not Proven

Items judged insufficient or lacking peer-reviewed evidence

Insufficient evidence group: Products explicitly identified in the document as having no published peer‑reviewed evidence (examples include EpiMonitor, Halo AF Detection System, Mahana for IBS [mobile version], MindMotionGO) are considered to have insufficient evidence to determine improvement in net health outcome.

Absence of peer‑reviewed evidence cited as basis for insufficient evidence

Insulia/Diabeo (digital insulin titration) — mixed RCT evidence

Insulia/Diabeo (insulin management companion) evidence summary

Diabeo/Insulia evidence: Multiple randomized trials (TeleDiab‑1, TeleDiab‑2, TELESAGE) reported HbA1c reductions versus control with some statistically significant findings, but limitations include sample size, attrition, reliance on post‑hoc analyses, and limited generalizability; the document judges the evidence insufficient to determine improvement in net health outcome.HbA1c reductions reported (examples: -1.44% to -1.48% at 4 months in TeleDiab‑2; TELESAGE post‑hoc reductions -0.41% to -0.66% in users)

Larger samples and longer follow‑up needed; policy conclusion: evidence insufficient to determine net health benefit

My Dose Coach (insulin titration app)

My Dose Coach evidence summary

My Dose Coach evidence: Evidence includes a single‑arm pilot and a 12‑week randomized trial showing HbA1c reductions favoring My Dose Coach versus written titration with a modest between‑group difference (adjusted between‑group difference -0.31% at 12 weeks); limitations include short follow‑up, lack of blinding, specialized study settings, and potential sponsor bias; overall judged insufficient to determine net health outcome improvement.12‑week HbA1c between‑group difference -0.31% (p=0.0388)

Durability and generalizability uncertain; policy concludes evidence insufficient

Luminopia One (pediatric amblyopia)

Luminopia One evidence summary

Luminopia One RCT: A randomized trial in children aged 4–7 with amblyopia showed a statistically significant improvement in amblyopic‑eye visual acuity at 12 weeks (mean improvement 1.8 lines vs 0.8 lines); the trial was stopped early for efficacy. Limitations include prior treatments in many participants, missing data, and lack of a standard patching comparator or longer‑term follow‑up.improvement 1.10 lines (P=0.0011) between groups at interim analysis

Promising RCT evidence but requires replication and longer follow‑up to establish durability and comparative effectiveness

MamaLift Plus (postpartum depression)

MamaLift Plus evidence summary

MamaLift Plus pivotal RCT: A double‑blind randomized trial in postpartum depression (N=95) reported large differences in clinically meaningful EPDS improvement at 8 weeks (86.3% vs 23.9%; P<0.0001) versus a sham control; limitations include short follow‑up and limited secondary outcome reporting.EPDS improvement >=24 points used as primary endpoint

Strong positive signal in pivotal RCT within trial limitations; further data on durability desirable

NightWare (nightmare disorder / PTSD-associated nightmares)

NightWare evidence summary

NightWare trial: The single pivotal trial for NightWare did not meet its primary efficacy endpoint and was likely underpowered; because of recruitment and design limitations, the evidence is insufficient to determine benefit for nightmare disorder or PTSD‑associated nightmares.trial failed primary endpoint

Further well‑designed RCTs are needed

Ieva/Leva pelvic digital therapeutic (urinary incontinence)

Ieva/Leva pelvic digital health system evidence summary

Ieva/Leva evidence: Evidence includes a small pilot prospective study showing physiologic and questionnaire improvements and an RCT (Weinstein 2022) that found no difference in primary outcomes but reported some secondary outcome improvements; overall the evidence is insufficient to determine improvement in net health outcome.small sample sizes and mixed RCT secondary findings

A larger powered RCT is ongoing

Regulora (digital gut-directed hypnotherapy for IBS)

Regulora for IBS evidence summary

Regulora RCT: A randomized parallel‑group study (N=362) comparing Regulora to digital muscle relaxation found no significant difference on the primary endpoint (30.4% vs 27.1% achieving >=30% abdominal pain reduction; p nonsignificant), indicating insufficient evidence of improved net health outcome.primary endpoint not met

Further investigation required before concluding net health benefit

Rejoyn / CT-152 (major depressive disorder)

Rejoyn (CT-152) for major depressive disorder evidence summary

CT-152 RCT: A randomized trial (N=386) in adults with MDD and inadequate response to antidepressant monotherapy showed modest between‑group MADRS improvements favoring CT‑152 (primary endpoint difference -1.78, P=0.0568; 6‑week change difference -2.12, P=0.0211). Limitations include a demographically homogenous sample, industry sponsorship, and limited follow‑up; conclusions are cautious and call for additional studies.MADRS change difference near statistical significance for primary endpoint

Promising but limited evidence; longer and more diverse trials needed

Regulora (IBS) — Insufficient evidence

Evidence appraisal summaries (per product) indicating coverage stance:

Regulora - IBS: Randomized trial showed no significant difference versus active digital muscle relaxation (30.4% vs 27.1% meeting primary endpoint); evidence was judged insufficient to determine improved net health outcome.

Policy conclusion: insufficient evidence for improved net health outcome

Rejoyn/CT-152 (MDD) — Promising but limited

Rejoyn/CT-152 - MDD: RCT in adults on antidepressant monotherapy showed modest between‑group MADRS improvements favoring CT‑152 (6‑week change differences up to -2.12 with some p‑values near significance); limitations include demographic homogeneity, industry sponsorship, and limited follow‑up—additional studies needed to confirm durability and generalizability.

Promising but limited evidence

RelieVRx/EaseVRx (Chronic low back pain) — Evidence supports benefit with limitations

RelieVRx/EaseVRx - Chronic low back pain: Double‑blind randomized trials demonstrated EaseVRx superiority versus sham VR for reductions in pain intensity and pain‑related interference with moderate effect sizes and durability to 6 and 24 months in follow‑up analyses; limitations include reliance on self‑reported outcomes, failed blinding at later follow‑up, sample demographic homogeneity, and industry sponsorship.

Evidence more robust than for many other PDTs but generalizability and objective confirmation remain limitations

RevitalVision (Amblyopia) — Potential benefit; limited data

RevitalVision - Amblyopia: Prospective studies and an RCT reported improvements in visual acuity and contrast sensitivity versus controls or patching in some populations; limitations include small sample sizes, short follow‑up, and limited generalizability—evidence suggests potential benefit but remains limited.

May be considered adjunctive to refractive correction; further larger trials needed

Documented FDA indications (informational)

Devices and indications cleared by FDA as documented; coverage decisions are not provided in this excerpt. Listed indications (examples) follow the device labeling:

CT-132 (Click Therapeutics): Indicated for preventive treatment of episodic migraine in individuals 18 years and older as adjunctive use alongside acute and/or other preventive treatments.age >=18

De Novo clearance DEN240064; FDA product code: SEE

DaylightRx (Big Health): Prescription digital therapeutic to treat generalized anxiety disorder in individuals 22 years and older as an adjunct to usual care delivering CBT.age >=22

510(k) K233872; Product Code: SCP

MamaLift Plus (Curio Digital Therapeutics): Intended to treat mild to moderate postpartum depression in individuals 22 years and older as adjunct to clinician‑managed outpatient care.age >=22

510(k) K223515; Product Code: SAP

Rejoyn / CT-152 (Otsuka): Prescription digital therapeutic for treatment of Major Depressive Disorder symptoms as adjunct to clinician‑managed outpatient care for adults 22 years and older who are on antidepressant medication.age >=22

510(k) K231209; Product Code: SAP

EpiMonitor (Empatica): Adjunct to seizure monitoring in adults and children aged 6 and older in home or healthcare facility; wearable senses EDA and motion to detect patterns associated with generalized tonic‑clonic seizures and alerts caregivers.age >=6

510(k) K232915; Product Code: POS

Luminopia One: Indicated for improvement in visual acuity in amblyopia patients age 4 to <9 (often stated 4–7) associated with anisometropia and/or mild strabismus as adjunct to full‑time refractive correction.age 4-7 (or <9 depending on labeling)

De Novo DEN21OO05; Product Code: QQU

Mahana and Regulora: Prescription digital therapeutics providing CBT or gut‑directed hypnotherapy for adults 22 years and older diagnosed with IBS as a three‑month adjunctive treatment to reduce IBS symptoms.age >=22

510(k) K211372 (Mahana), K211463 (Regulora); Product Code: QMY

RelieVRx: Home‑use immersive VR system providing adjunctive CBT‑based pain relief for chronic low back pain in individuals 18 and older with >3 months duration.age >=18 and chronicity >3 months

FDA product code QRA

EndeavorRx: Software intended to provide therapy for ADHD to improve attention function in children ages 8–12 with primarily inattentive or combined‑type ADHD.age 8-12

De Novo DEN200026; later 510(k) K231337; Product Code: QFT

NightWare: Provides vibrotactile feedback based on heart rate and motion during sleep for temporary reduction of sleep disturbance related nightmares in adults 22 years or older.age >=22

De Novo DEN200033; Product Code: QMZ

Diabetes insulin dosing/management software (BlueStarRx, My Dose Coach, Insulia): Software systems that capture glucose data and provide coaching or insulin dose suggestions/titration for individuals with type 1 or type 2 diabetes per device labeling; healthcare provider configuration/activation often required.varies by device

Multiple 510(k)s and product codes documented

Digital therapeutics that are available over the counter or without a prescription and professional services related to managing these devices are generally excluded from most plans unless an employer/group elects separate coverage. If a member or provider requests coverage under the health plan for an OTC or nonprescription digital therapeutic, the plan’s specific contract language determines benefit applicability and the criteria in this policy will be applied when benefits under the health plan are being used.

The policy identifies specific devices and software for which no published peer‑reviewed evidence exists. Examples explicitly noted in the document include EpiMonitor, the Halo AF Detection System, and CT‑132. Claims or requests for devices or software with no published peer‑reviewed evidence are at elevated risk for denial because the evidence base is insufficient to determine an improvement in net health outcome.

Products called out in the report as having no published peer‑reviewed evidence include: EpiMonitor, Halo AF Detection System, Mahana for IBS (mobile version distinctions noted), and MindMotionGO. The document states these items lack peer‑reviewed study data and therefore have insufficient evidence to determine net health benefit.

For Regulora (a digital gut‑directed hypnotherapy app for IBS), the randomized trial reported no significant difference versus a digital muscle relaxation comparator on the prespecified primary endpoint (30.4% vs 27.1% achieving ≥30% abdominal pain reduction; p nonsignificant). Because the primary endpoint was not met, the evidence was judged insufficient to determine improvement in net health outcome, and the product may be excluded from coverage on that basis until additional supportive data are available.

The regulatory summaries in the document record FDA 510(k) clearances and De Novo authorizations for multiple products and list device indications and age ranges, but these excerpts do not state explicit payer coverage exclusions. Regulatory clearance is documented for informational purposes; coverage determinations remain subject to the policy’s medical necessity criteria and contract benefits.

This medical policy does not apply to Medicare Advantage plans.

FDA‑cleared or FDA‑approved prescription digital therapeutics that do not meet the policy’s device‑level criteria (FDA authorization plus credible evidence of benefit or equivalence) or the patient‑level appropriateness requirements are considered investigational. Investigational PDTs are not covered under the medical necessity standard in this policy.

The report concludes that evidence is insufficient to determine improved net health outcomes for several products. Examples cited include BlueStarRx (pilot evidence limited) and EndeavorRx (single RCT with limitations); these products are described as lacking sufficient evidence to be considered medically necessary based on the current literature summarized.

Regulora was specifically judged insufficient when compared with an active control in the reported randomized trial; because it did not demonstrate superiority on the primary endpoint, Regulora is described as not demonstrated to be medically necessary based on the current evidence and would remain noncovered until further robust evidence becomes available.

Within the provided excerpts there are no explicit ‘not medically necessary’ determinations listed as standalone policy statements; rather, the document applies investigational or insufficient‑evidence characterizations and indicates coverage decisions depend on meeting the medical necessity criteria and applicable member benefits.

Relevant Billing Codes and Identifiers

Covered CPT Codes (listed as relevant to PDTs in policy)CPT

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 (use to report: CureSight CS 100) days
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 education (use to report: d-Nav Insulin Management Program)
0741T	Remote autonomous algorithm-based recommendation system for insulin dose calculation and titration; provision of software; data collection, transmission; and storage_each 30 (use to report: d-Nav Insulin Management Program) days
99199	Unlisted special service, procedure or report

Relevant 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)
A9999
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 (new code effective 01/01/25)
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 (new code effective 01/01/25)
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 (new code effective 01/01/25)
S9002	Intravaginal motion sensor system, provides biofeedback for pelvic floor muscle rehabilitation device (used to report Leva Pelvic Health System)

CT-132 / Click Therapeutics identifiersmixed

DEN240064	De Novo pathway identifier for CT-132 (Click Therapeutics, Inc)
FDA Product Code: SEE	Product code stated for CT-132

DaylightRx identifiersmixed

K233872	510(k) clearance for DaylightRx (Big Health Inc)
FDA Product Code: SCP	Product code for DaylightRx

MamaLift Plus identifiersmixed

K223515	510(k) clearance for MamaLift Plus (Curio Digital Therapeutics, Inc)
FDA Product Code: SAP	Product code for MamaLift Plus

Rejoyn / CT-152 identifiersmixed

K231209	510(k) clearance for Rejoyn (Otsuka America Pharmaceutical Inc), also known as CT-152
FDA Product Code: SAP	Product code for Rejoyn/CT-152

EpiMonitor identifiersmixed

K232915	510(k) clearance for EpiMonitor (Empatica Inc)
FDA Product Code: POS	Product code for EpiMonitor

Luminopia One identifiersmixed

DEN21OO05	De Novo pathway identifier for Luminopia One
FDA Product Code: QQU	Product code for Luminopia One

Regulora identifiersmixed

K211463	510(k) clearance for Regulora (metaMe Health, Inc)
FDA Product Code: QMY	Product code for Regulora

Mahana IBS identifiersmixed

K211372	510(k) clearance for Mahana Parallel Digital CBT Mobile Application for IBS (Mahana Therapeutics, Inc)
FDA Product Code: QMY	Product code for Mahana IBS

RelieVRx, EndeavorRx, Halo AF identifiersmixed

QRA	FDA Product Code for RelieVRx
DEN2O0026	De Novo identifier for EndeavorRx (Akili Interactive Labs, Inc)
QFT	Product code for EndeavorRx
K201208	510(k) clearance for Halo AF Detection System (LIVMOR, Inc)
FDA Product Code: DXH	Product code for Halo AF Detection System

NightWare and leva identifiersmixed

DEN200033	De Novo pathway identifier for NightWare
FDA Product Code: QMZ	Product code for NightWare
K180637	510(k) clearance for leva Pelvic Floor Trainer (Renovia, Inc)
K192270	510(k) expansion for leva Pelvic Digital Health System indications
FDA Product Code: HIR	Product code associated with leva devices

MindMotionGO and BlueStar Rx identifiersmixed

K173931	510(k) clearance for MindMotionGO (MindMaze)
FDA Product Code: LXJ	Product code for MindMotionGO
K162532	510(k) clearance for BlueStar Rx (WellDoc, Inc)
FDA Product Code: LNX, NDC, MRZ	Product codes associated with BlueStar Rx iterations

Diabetes management software identifiersmixed

K193654	510(k) clearance expanding BlueStarRx for basal insulin users
K203434	510(k) clearance adding bolus titration feature to BlueStarRx
K163099	510(k) clearance for My Dose Coach (Sanofi, Inc)
K161433	510(k) clearance for Insulia Diabetes Management Companion (Voluntis)
FDA Product Code: NDC	Product code recurring for insulin-management software

RevitalVision identifiersmixed

K012530	510(k) clearance for RevitalVision (Talshir Medical Technologies LTD)
FDA Product Code: HJT	Product code for RevitalVision

Policy-related CPT/HCPCS codes (added/removed/updated in history)mixed

A9291	HCPCS code referenced in policy history
A9292	HCPCS code referenced in policy history
A9281	HCPCS code removed (historical note)
E1905	HCPCS code added (coding update)
S9002	HCPCS code added (policy history)
T1505	HCPCS code removed (policy history note)
0704T	CPT code added to policy
0705T	CPT code added to policy
0706T	CPT code added to policy
0740T	CPT code added (effective 1/1/2023)

1–10 of 13

1/2

Minimum age for use (examples)

Luminopia OneIndicated for amblyopia in children age 4 to 7 (also described as <9 in one statement); listed age range: 4–7 years (or <9 depending on statement)

EpiMonitor (EmbracePlus)Available by prescription for adults and children aged 6 years and older

RelieVRx (EaseVRx)Intended for adults 18 years and older with chronic low back pain (>3 months)

CT-132 (Click Therapeutics) — example De Novo deviceIndicated for episodic migraine prevention in individuals 18 years and older

DaylightRx / MamaLift Plus / Rejoyn (examples)Several prescription DTx (DaylightRx, MamaLift Plus, Rejoyn/CT-152) specify adult use age 22 years and older in their FDA labeling

Provider Billing, Authorization, and Documentation Actions

Prior Authorization

Prior Authorization Required

Prior authorization may be required by the payer for prescription digital therapeutics (PDTs) and related services. Providers should verify member-specific benefit requirements and obtain any necessary prior authorization before prescribing or billing PDTs to avoid claim denials.

Check member benefit booklet or contact member services for plan-specific prior authorization rules
Requests that do not meet all medical necessity criteria (sections A and B) are at risk for denial

Prior Authorization

Prior Authorization Suggested for Select Products

For select products with promising randomized controlled trial (RCT) signals, the policy suggests prior authorization may be appropriate to ensure medical necessity and appropriate use (examples in the policy include Luminopia One, RelieVRx, MamaLift Plus, and others with positive RCT data).

Prior authorization suggested for products with positive RCT evidence (e.g., Luminopia One, RelieVRx, MamaLift Plus)
Use clinical trial data and indication-specific elements to justify medical necessity

Prior Authorization

Prior Authorization for Prescription Digital Therapeutics

Prescription digital therapeutics that are FDA-cleared or De Novo may still be subject to prior authorization by payers. When a PDT is FDA-authorized, include the device/product name, FDA clearance type, indicated age range, and intended adjunctive or standalone use in the authorization request.

Include FDA clearance pathway (510k, De Novo) and product code where available (see Regulatory Status section)
Provide indication, age eligibility, and whether the PDT is adjunctive to standard therapy

Note

Prior Authorization Not Specified in This Excerpt

The excerpt does not specify a universal payer-wide prior authorization policy for all PDTs; authorization requirements vary by product and member benefit. Providers must confirm plan-specific rules.

Regulatory clearance alone does not guarantee coverage — verify member benefits
No single prior authorization rule is listed for all devices in this excerpt

Billing Rule

Coding Updates Affect Authorization

Coding updates in the policy history have added and removed CPT/HCPCS/other codes; these changes can affect authorization workflows and billing. Providers should use current codes when requesting authorization and billing claims.

Recent additions: CPT 0687T, 0688T, 0704T–0706T, 0740T–0741T; HCPCS A9291, A9292, S9002; new G-codes effective 01/01/25 (G0552, G0553?, G0554)
Policy history documents coding changes and effective dates that may impact prior authorization

Denial Risk

Evidence‑Based Denial Risk

Requests lacking credible peer‑reviewed evidence or adequate clinical justification are at higher risk for denial. Payors may classify technologies as investigational when evidence is insufficient to conclude a net health benefit.

Technologies listed as investigational in the policy (e.g., BlueStarRx, EpiMonitor initially) may be denied when peer‑reviewed evidence is missing
Denial risk increases when product effectiveness for relevant populations or outcomes is unproven

Denial Risk

Insufficient Evidence — Denial Risk

Products without published, peer‑reviewed evidence demonstrating improved net health outcomes are at particular risk of being denied as investigational. Include published RCTs and peer‑reviewed studies when available.

Examples with insufficient published evidence noted in the policy: BlueStarRx, EpiMonitor (until clearance and peer-reviewed data are available)
If peer‑reviewed evidence is lacking, document rationale and any surrogate or real-world data supporting use

Note

Medicare Coverage Gap

There is no Medicare national coverage determination for prescription digital therapeutics in this policy. Medicare coverage gaps may affect coverage decisions for Medicare members; providers should consult Medicare guidance and the member's specific plan.

Policy explicitly states: 'There is no national coverage determination'
Medicare Advantage applicability: this medical policy does not apply to Medicare Advantage — verify MA plan rules separately

Documentation Required

Documentation Recommended to Support Medical Necessity

Documentation supporting medical necessity should include the prescription or order, the specific PDT/device name, FDA clearance status, indication, age eligibility, prescribed regimen (frequency/duration), and clinical rationale linking the patient's condition to the PDT's intended purpose.

Order must support covered purpose: prevention, evaluation, diagnosis, or treatment per generally accepted standards of medical practice
Specify regimen details (e.g., session length, frequency, total duration) and whether therapy is adjunctive

Documentation Required

Supporting Clinical Documentation

Supporting clinical documentation should include diagnosis confirmation, prior treatment attempts, relevant outcome measures, and citations of RCTs or peer‑reviewed literature where available to demonstrate applicability of trial populations to the member.

Provide prior therapy history (e.g., psychotherapy attempts, pharmacologic treatments) and reasons for intolerance or inadequate response when applicable
Include relevant validated outcome measures used in trials (e.g., VA lines for amblyopia, HbA1c for diabetes, EPDS for PPD, pain scales for chronic low back pain)

Documentation Required

Regulatory Documentation to Reference

When available, include regulatory documentation in requests: FDA clearance/De Novo letters, stated indications, age ranges, and FDA product codes. This helps payers align authorization decisions with the device's authorized use.

Cite FDA pathway (510(k), De Novo) and specific device indication (e.g., Luminopia One: amblyopia ages 4–7; NightWare: adults 22+ for nightmare disorder/PTSD-related nightmares)
Reference FDA product codes included in the policy's Regulatory Status section

Step Therapy

Adjunctive / Step Therapy Expectations

Many PDTs are intended to be used as adjuncts to standard care (behavioral therapy, medications, refractive correction, etc.). Authorization requests should document adjunctive use and prior/concurrent standard therapies when applicable.

Examples: Luminopia One and other amblyopia therapies are adjuncts to full‑time refractive correction; CT‑132 is indicated as adjunctive preventive migraine therapy
Document that adjunctive standard treatments (e.g., glasses, pharmacotherapy, psychotherapy) are being used as appropriate

Step Therapy

Step Therapy Consideration for Insulin‑Titration Apps

For insulin‑titration apps and autonomous dosing systems (e.g., d‑Nav, Insulia, My Dose Coach), payers may request documentation of prior standard titration attempts or clinician oversight steps. Demonstrate how the app's algorithm integrates with the clinician's treatment plan.

Document prior insulin‑titration approaches and outcomes, baseline HbA1c, and how the PDT will be used in conjunction with clinician oversight
Include safety monitoring plans and any physician-entered titration parameters required by the product

Note

No Step Therapy Requirements Described

The policy does not define universal step therapy requirements for all PDTs in this excerpt. Some guideline-informed expectations (e.g., psychotherapy before specialized DTx for IBS) are noted, but specific step therapy pathways are determined by plan benefits.

No explicit, uniform step therapy pathways described in this excerpt — check member benefit details
Guideline suggestions (ACG, NICE) may inform payer expectations but are not prescriptive authorization rules here

Definitions and Background

Digital therapeutics are evidence‑based software interventions designed to evaluate, diagnose, prevent, or treat medical and behavioral conditions. They differ from general wellness apps because they are intended to deliver therapeutic interventions and—when higher‑risk—are regulated by the FDA as software as a medical device.

Definition — Digital therapeutics (DTx)

TermDigital therapeutics (DTx)

DefinitionEvidence-based, software-driven interventions delivered by software to treat, manage, or prevent behavioral, mental, and physical diseases and disorders.

ContextTypically regulated as software-driven medical devices distinct from general wellness apps; may require prescription and clinician oversight depending on FDA labeling.

Definition — Mobile application (app)

TermMobile application (app)

DefinitionA software application designed to run on a mobile device (commercial off-the-shelf handheld computing platforms such as smartphones or tablets) or an internet-based platform.

NotesMay be distributed as prescription-only or over-the-counter depending on device labeling and FDA regulation.

Definition — Prescription Digital Therapeutic

TermPrescription Digital Therapeutic

DefinitionA software-based medical device cleared or approved by the FDA and available by prescription to treat or adjunctively manage specific conditions under clinician supervision.

ExampleEndeavorRx, EpiMonitor (EmbracePlus), Insulia — available by prescription per device labeling.

Definition — EpiMonitor / EmbracePlus (wearable seizure monitoring)

TermEpiMonitor / EmbracePlus

DefinitionA prescription wearable seizure monitoring system (EmbracePlus wrist device paired with the EpiMonitor mobile app) that senses electrodermal activity and motion, analyzes patterns to detect generalized tonic-clonic seizures, and sends caregiver alerts via cloud connectivity.

Age indicationIndicated for adults and children aged 6 years and older (prescription-only).

Definition — Insulin-titration app

TermInsulin-titration app

DefinitionSmartphone or web-based applications that use clinician-configured algorithms and patient-entered glucose and hypoglycemia data to recommend basal (and in some devices bolus) insulin dose adjustments and provide coaching and data transmission to clinicians.

ExamplesInsulia (Diabetes Management Companion), My Dose Coach, BlueStarRx — device labeling and RCT evidence summarized in policy.

Definition — Digital therapeutic for amblyopia (e.g., Luminopia One)

TermDigital therapeutic for amblyopia (e.g., Luminopia One)

DefinitionHead-mounted display or software delivering dichoptic visual stimuli (contrast-modified video content) intended to improve amblyopic eye visual acuity as an adjunct to full-time refractive correction.

Example/LabelingLuminopia One indicated for amblyopia in children age 4–7 (also described as <9 in another statement); used per prescribed frequency and duration (e.g., 1 hour/day, 6 days/week for 12 weeks in trial).

Definition — Regulora

TermRegulora

DefinitionA prescription mobile app that delivers gut-directed hypnotherapy as a behavioral therapy for adults diagnosed with irritable bowel syndrome (IBS); labeled as a three-month adjunctive treatment for adults 22 years and older.

Regulatory statusFDA 510(k) K211463; FDA Product Code: QMY

Definition — Rejoyn (CT-152)

TermRejoyn (CT-152)

DefinitionA prescription digital therapeutic (also known as CT-152) delivering cognitive-emotional and behavioral interventions via a smartphone app as an adjunct to antidepressant medication for adults with major depressive disorder.

Regulatory statusFDA 510(k) K231209; labeled for adults 22 years and older; Product Code: SAP

Definition — RelieVRx (EaseVRx)

TermRelieVRx (EaseVRx)

DefinitionAn immersive home-use virtual reality system delivering a multi-week CBT-based program intended as adjunctive treatment for chronic low back pain in adults; clinical trials report reductions in pain intensity and interference versus sham VR.

Regulatory statusFDA clearance as RelieVRx; indicated for adults 18 years and older with chronic low back pain (Product Code: QRA).

Definition — RevitalVision

TermRevitalVision

DefinitionA perceptual learning digital therapy for amblyopia that uses interactive computerized programs to improve visual acuity and contrast sensitivity; evidence includes prospective studies and an RCT across age ranges.

Regulatory statusFDA 510(k) K012530; indicated for treatment of amblyopia in patients 9 years and older (per FDA clearance).

Definition — Prescription digital therapeutic (general)

TermPrescription digital therapeutic (general)

DefinitionSoftware-based medical device cleared by the FDA for treatment or adjunctive treatment of specific conditions, intended for use by or under the supervision of a licensed healthcare provider and often available by prescription only.

Key featuresMay include mobile apps, VR systems, or paired wearable sensors; FDA labeling specifies indication, age ranges, and prescribed regimen/duration for use.

Step	Recommended prior interventions (per guidelines)	Rationale / applicable conditions	Coverage note
1	Standard pharmacologic therapy appropriate to condition (e.g., IBS: antispasmodics, laxatives, low‑FODMAP guidance; depression: antidepressant medication as clinically indicated); and/or guideline-recommended psychotherapy (CBT, gut-directed hypnotherapy, or other psychological interventions)	Guidelines (ACG, NICE) recommend psychological interventions or standard pharmacologic treatments be considered before specialized digital therapeutics for conditions such as IBS or refractory symptoms	Step often expected prior to authorizing certain prescription digital therapeutics (payer may require documentation of trial/failure of standard therapies)
2	Clinician-supervised medication titration or conventional management strategies (e.g., clinician-directed insulin titration for diabetes) where applicable	For insulin‑titration apps and other adjunctive DTx, documentation of prior attempts at standard titration/management may be appropriate before authorizing app-based support	Prior authorization requests should include documentation of prior standard care attempts when applicable; lack of such documentation may increase risk of denial
3	Referral to or documentation of engagement with qualified behavioral health professionals for CBT or similar therapies when indicated	Guideline-informed expectation that gut-directed psychotherapies or CBT be tried for IBS patients who do not respond to initial therapies; similar expectations apply for behavioral health indications	Coverage may be contingent on evidence that guideline-recommended non-digital therapies were attempted or considered prior to specialized DTx

Intended Site of Use

Note

DTx and monitoring devices are typically for outpatient/home adjunctive use

Most digital therapeutics and monitoring devices are intended for outpatient/home use as adjuncts to clinician‑managed care; follow device labeling and note product‑level site‑of‑care instructions when documenting intended use.

Indicate home or outpatient use in the authorization if the product labeling specifies it.
Ensure prescriber oversight is documented for prescription‑only DTx.

Policy Summary

PayerPremera Bluecross

PolicyPrescription Digital Therapeutics

Policy CodePolicy 3.03.02

Change TypeInterim review — no material changes

Effective Date

Next Review Date

SourceLink

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