Prescription Digital Therapeutics - (0565) — MM 0565 | CIGNA Coverage Update

TL;DR: Cigna Healthcare modified MM 0565, its prescription digital therapeutics coverage policy, effective December 16, 2025. All three HCPCS codes currently addressed by this policy — E0738, E0739, and E1905 — carry an Experimental, Investigational, and Unproven designation. Here's what that means for your billing team right now.

Cigna Healthcare updated MM 0565, the Cigna prescription digital therapeutics coverage policy, with an effective date of December 16, 2025. The policy governs FDA-required prescription digital therapeutics (PDTs) — software-based interventions delivered via mobile apps, wearable devices, and digital platforms for adult and pediatric patients. The three HCPCS codes in scope, E0738, E0739, and E1905, are all classified as Experimental, Investigational, and Unproven (EIU). If your team bills any of these codes to Cigna, the denial risk is high and immediate.

Quick-Reference Table

Cigna Prescription Digital Therapeutics Coverage Criteria and Medical Necessity Requirements 2025

Under MM 0565, Cigna defines a prescription digital therapeutic as a software-based intervention that meets three specific criteria. It must require a prescription from a licensed healthcare provider. It must hold FDA approval or clearance. And its safety and effectiveness must be supported by published, peer-reviewed clinical evidence for treating, managing, or preventing a specific disease or disorder.

That last requirement carries real weight. Cigna isn't just asking whether the FDA cleared a device — it wants published peer-reviewed evidence of clinical benefit. General wellness apps, fitness platforms, and tools used solely to inform, monitor, or diagnose a condition don't qualify as PDTs under this coverage policy. They aren't treating a disease, so they're out of scope.

Components covered under a PDT may include devices, accessories, software, smartphone apps, and other elements needed to deliver the therapy. The policy applies to both adult and pediatric populations, which is broader than many payers allow in the PDT space.

Here's the problem: despite setting up that criteria framework, Cigna classifies all three HCPCS codes currently assigned to PDT services — E0738, E0739, and E1905 — as Experimental, Investigational, and Unproven. That means even if a product meets every definition in the policy, Cigna is not covering it under these codes right now. Medical necessity criteria exist on paper, but reimbursement under MM 0565 isn't happening through these three codes at this time.

If you're billing for prescription digital therapeutics and relying on Cigna reimbursement, this policy is a hard stop. Before the effective date of December 16, 2025, talk to your compliance officer about how this affects your revenue cycle for any PDT services in your patient mix.

Cigna Prescription Digital Therapeutics Exclusions and Non-Covered Indications

MM 0565 draws a clear line between PDTs and general digital health tools. Cigna explicitly excludes several categories from coverage consideration under this policy.

Software programs used for general health promotion, wellness, or fitness don't qualify as PDTs. Neither do tools used solely to inform, monitor, or diagnose — even if they're software-based and clinician-ordered. The policy is explicit: if the tool doesn't treat a disease, it's not a PDT.

Digital therapeutics that don't require a prescription are also outside the scope of MM 0565. Those products may go through separate benefit determination, but this policy doesn't govern them. Don't assume a non-prescription DTx product is covered just because a related PDT might be.

The three HCPCS codes in this policy carry the EIU designation, which is Cigna's way of saying the evidence base doesn't yet meet its clinical coverage standards — regardless of FDA status. FDA clearance alone does not trigger Cigna coverage. That distinction matters when patients ask whether their PDT device is "approved." FDA-approved and Cigna-covered are two different things.

Prior authorization is unlikely to unlock reimbursement when the underlying code is designated EIU. Sending a prior auth request for E0738, E0739, or E1905 under Cigna will almost certainly result in a denial. Don't waste your team's time on prior authorization submissions for these codes until Cigna changes the coverage position.

Coverage Indications at a Glance

Cigna Prescription Digital Therapeutics Billing Guidelines and Action Items 2025

The practical impact of this policy update is straightforward, but the operational steps take time to execute. Act before December 16, 2025.

One additional note on prescription digital therapeutics billing broadly: this space is evolving fast. CMS hasn't established a clear national coverage determination for PDTs, and Cigna's EIU position reflects where most commercial payers currently sit. Don't build your revenue model around PDT reimbursement from Cigna — or most major commercial payers — until coverage positions change.

CPT, HCPCS, and ICD-10 Codes for Prescription Digital Therapeutics Under MM 0565

Not Covered / Experimental Codes

All three HCPCS codes under MM 0565 carry the Experimental, Investigational, and Unproven designation. None are covered under Cigna's current prescription digital therapeutics coverage policy.

Key ICD-10-CM Diagnosis Codes

The policy data does not list specific ICD-10-CM codes. MM 0565 does not tie coverage criteria to specific diagnosis codes — the EIU designation applies across all indications for these HCPCS codes.