CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Remote electrical neuromodulation for acute migraine

Policy governs coverage determination for remote electrical neuromodulation (REN) devices (e.g., Nerivio) for acute treatment of migraine for Commercial Products under Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyRemote electrical neuromodulation for acute migraine

Policy CodePolicy N/A

Change TypeClarified (no material change)

Effective DateDec 1, 2022

Next Review Date

Key ActionClaims for remote electrical neuromodulation (e.g., HCPCS A4540 or K1023 for prior dates) for acute migraine will be considered not medically necessary and not covered for Commercial Products; submitters should refer to the member's Benefit Booklet/Evidence of Coverage for applicable benefits.

SourceLink

POLICY UPDATE CHANGES

Policy states REN for acute migraine is not covered / considered not medically necessary for Commercial Products.

1Coverage stance (Not Medically Necessary)

A4540/K1023Codes referenced as not covered

FDA clearedRegulatory status noted

Coverage Summary

Overview: This policy addresses Remote electrical neuromodulation (REN) for acute migraine (policy subject). Effective date: 12/01/2022; Policy last updated / last review: 08/17/2022. Headline coverage stance: not covered / not medically necessary for Commercial Products (REN, e.g., the Nerivio device, is considered not medically necessary and not covered for Commercial Products).

Key facts

Effective date12/01/2022

Last review08/17/2022

Coverage stanceNot Medically Necessary / Not Covered for Commercial Products

Regulatory noteNerivio received FDA de novo in 2019 and 510(k) clearance (K201824) in 2020; cleared for ages 12+ in 2021

Codes referencedHCPCS A4540 (effective 1/1/2024); use K1023 for dates of service to 1/1/2024; related ICD-10 codes G43.001, G43.719, G43.801, G43.919

Medical Necessity / Policy Statement

Policy Statement

Coverage determination:

ALL of the following

Remote electrical neuromodulation for acute migraine is not covered as the evidence is insufficient to determine the effects of the technology on health outcomes
For Commercial Products: Remote electrical neuromodulation for acute migraine is considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes

Coding

Not covered HCPCSHCPCSNot Covered

A4540	Distal transcutaneous electrical nerve stimulator; stimulates peripheral nerves of the upper arm (New Code Effective 1/1/2024. For Dates of Service to 1/1/2024, HCPCS code K1023 must be used)
K1023	Prior HCPCS code to be used for dates of service to 1/1/2024 (referenced in policy)

Related ICD-10-CM diagnosis codes referencedICD-10

G43.001
G43.719
G43.801
G43.919

Provider Actions / Billing Impact

Denial Risk

Services considered not medically necessary

Claims for remote electrical neuromodulation (REN) for acute migraine filed with HCPCS A4540 (or K1023 for prior dates of service) will be considered not medically necessary and will not be covered for Commercial Products. Providers and billers should refer to the member's Benefit Booklet/Evidence of Coverage for applicable benefits and coverage determinations.

A4540
K1023 (use for dates of service prior to 1/1/2024)

Background & Evidence Summary

Background summary: REN (e.g., Nerivio) is a nonpharmacologic, wearable upper-arm device intended for the acute treatment of migraine. The device stimulates peripheral nerves on the upper arm via controlled electrical stimulation (patient-controlled intensity up to ~40 mA for up to 45 minutes, initiated at migraine or aura onset and controlled through a smartphone app) to induce conditioned pain modulation, which is believed to reduce perceived migraine intensity. Evidence for REN includes two small randomized controlled trials (N=212) showing some greater symptom improvement at 2 hours versus sham and additional nonrandomized/uncontrolled studies; BCBSRI concluded the evidence is insufficient to demonstrate an improvement in net health outcome and therefore insufficient to determine the effects of the technology on health outcomes.

Evidence

Regulatory

Definition: Remote electrical neuromodulation (REN) — A device-based therapy that applies peripheral nerve stimulation (for example, the upper-arm device Nerivio) to induce conditioned pain modulation for the acute treatment of migraine.

Revision History

2022-10Provider Update

Provider Update October 2022: Policy states REN for acute migraine is not covered / considered not medically necessary for Commercial Products. No clinical policy statement changes indicated in header; published Provider Update October 2022.

2022-12-01Policy Effective DateLatest

Policy effective date: Remote electrical neuromodulation for acute migraine is not covered as the evidence is insufficient to determine the effects of the technology on health outcomes; for Commercial Products REN is considered not medically necessary.