Prescription PDT and FDA authorization required

RelieVRx and other prescription VR therapeutics must be FDA‑authorized prescription digital therapeutics (PDTs) and be prescribed by a healthcare provider; the product is intended for home use under provider direction.

• Scope requires: PDT, FDA marketing authorization, and prescription by a healthcare provider (Scope of Review).
• RelieVRx is an FDA De Novo–authorized prescription immersive VR system intended for adjunctive treatment of chronic lower back pain in adults and is used at home under provider direction (8‑week program).

Prior authorization — confirm prescription‑use indication and program

Prior authorization should confirm that the request is for RelieVRx as a prescription‑use adjunctive treatment in adults and that the patient will use the 8‑week, 56‑session home program under provider direction.

• Confirm indication: adjunctive treatment of chronic lower back pain in patients ≥18 years.
• Confirm program details: 8‑week, self‑administered behavioral skills program delivered via VR headset (56 sessions, daily sessions ~2–16 minutes).

Prior authorization and coding — include HCPCS/CPT/ICD codes

When requesting prior authorization or claims review, include applicable procedure and diagnosis codes; Medicare coverage determinations via the DME pathway are made on a claim‑by‑claim basis and CMS has established HCPCS E1905 for RelieVRx.

• CMS HCPCS Level II: E1905 established for RelieVRx (DME pathway).
• Procedure CPT listed for VR technology: 0770T; include relevant ICD‑10 codes for low back pain (e.g., M54.50, M54.51, M54.59, M54.15–M54.17, M54.40–M54.42).

Document nonpharmacologic therapies and RelieVRx’s role

Clinical practice guidelines recommend nonpharmacologic treatments (e.g., CBT, exercise, mindfulness) as initial therapy for chronic low back pain; RelieVRx delivers CBT and related behavioral methods consistent with those therapies.

• ACP recommends initial selection of nonpharmacologic treatments including CBT, exercise, mindfulness, and progressive relaxation.
• RelieVRx content includes CBT, mindfulness, relaxation training, and interoceptive awareness techniques delivered via immersive VR.

Step therapy / role in care pathway

RelieVRx may be used as an alternative entry‑level behavioral treatment or, depending on plan expectations, as a replacement for in‑person CBT; the appropriate comparator should be specified because evidentiary expectations differ if used as a replacement versus an alternative.

• If intended to replace in‑person CBT, noninferiority to in‑person CBT is the relevant standard.
• If intended as an entry‑level alternative, comparisons to sham VR or usual care are appropriate.

No step therapy sequence specified for VR therapeutics

The policy does not specify a VR‑specific step therapy sequence; nonpharmacologic treatments are recommended by ACP but VR sequencing is not addressed in this document.

• No explicit stepwise sequencing for VR therapeutics is provided in this policy excerpt.
• ACP guideline recommendations for nonpharmacologic initial therapy are noted but do not address VR‑specific sequencing.

Documentation must confirm FDA‑authorized PDT and medical necessity

Document that the device is an FDA‑authorized prescription digital therapeutic (PDT) prescribed by a healthcare provider and include evidence of medical necessity tied to the member’s clinical status.

• Support that the product is an FDA‑authorized PDT used under provider direction (scope and regulatory statements).
• Include clinical rationale demonstrating medical necessity (age, chronicity, baseline pain/interference thresholds where applicable).

Prescription and program documentation required

Include documentation that RelieVRx is prescribed as the 8‑week, self‑administered adjunctive behavioral skills VR program for chronic lower back pain in an adult patient and note that therapy will be used at home under provider direction.

• Specify program duration (8 weeks) and session structure (56 sessions, daily sessions ~2–16 minutes).
• Record patient age (≥18 years) and that treatment is adjunctive and home‑based under provider direction.

Coding and documentation references to include on claims

Claims and prior authorization requests should reference relevant procedure and diagnosis codes (e.g., CPT 0770T; ICD‑10 M54.* series) and note CMS’s HCPCS E1905 for RelieVRx when applicable.

• CPT: 0770T — Virtual reality technology to assist therapy.
• HCPCS: E1905 — Virtual reality cognitive behavioral therapy device (cbt), including pre‑programmed therapy software.
• ICD‑10 examples: M54.50, M54.51, M54.59, M54.15–M54.17, M54.40–M54.42.

Coverage subject to member‑specific benefit plan terms

Coverage is subject to member‑specific benefit plan terms; when plan language conflicts with this policy, the member‑specific benefit plan supersedes the medical policy.

• Identify member eligibility and the member‑specific benefit plan prior to applying this policy.
• Member‑specific contract terms take precedence over this medical policy.

Clinical exclusion conditions from trials — evaluate appropriateness

Patients meeting trial exclusion criteria (for example, seizure disorder, epilepsy, dementia, significant visual or hearing impairment, hypersensitivity to flashing light or motion, migraines, or medical conditions predisposing to nausea/dizziness) were excluded from trials and may be inappropriate for VR use or at higher risk for noncoverage.

• Pivotal trial exclusions included PHQ‑2 ≥2 (depressive symptoms), epilepsy/seizure disorder, dementia, migraines or neurological disease preventing VR use, significant visual/hearing impairment, and hypersensitivity to flashing light/motion.
• Patients with these conditions should be evaluated for clinical appropriateness and potential noncoverage risk.

Evidence uncertainty may trigger denial if benefit is not established

The evidence is considered insufficient to determine net health benefit for VR therapeutics overall; divergence across trials and population concerns create uncertainty and may lead to denial when clinical benefit is not established for a given patient.

• Some trials showed statistical superiority but with modest between‑group differences; an independent federally funded trial found no superiority, raising uncertainty about the specific benefit of CBT content versus immersion/distraction.
• When clinical benefit is not clearly established for the member, coverage may be denied on that basis.