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

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

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

Prescription‑only devices may require prior authorization

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

• Examples of prescription‑only devices in this policy: SleepioRX, MamaLift Plus, Rejoyn, RelieVRx, Luminopia One, CureSight CS100, Insulia, My Dose Coach, NightWare, Halo AF, leva Pelvic Health System
• OTC or non‑prescription digital therapeutics are generally excluded from most Plans

Prior authorization requirements — documentation expectations

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

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

Prescription and FDA‑clearance implication

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Failed primary endpoint — pivotal trial failures increase denial risk

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

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

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

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

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

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

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

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

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

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

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

Need for objective diagnosis and medication documentation

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

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

Benefit verification — member contracts differ; confirm benefits

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

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

Step therapy — No explicit step therapy rules specified

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

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

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

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

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

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

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

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

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

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

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