CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Occipital Nerve Stimulation (ONS) — Coverage Criteria

Defines Blue Cross & Blue Shield of Rhode Island coverage stance for insertion, implantation, revision, or replacement of occipital nerve stimulation devices for treatment of migraine and other headaches; applies to BCBSRI Commercial and BlueCHiP for Medicare products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyOccipital Nerve Stimulation (ONS) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date06|01|2015

Next Review DateN/A

Key ActionReport ONS procedures using unlisted CPT 64999 and verify member benefits prior to billing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not medically necessaryCommercial stance

Not coveredBlueCHiP for Medicare

No FDA-cleared ONS (Sep 2014)Regulatory status

64999Coding

Coverage Determinations

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Overall coverage determination: Occipital nerve stimulation (ONS) insertion/implantation is considered not medically necessary or not covered for treatment of migraine and other headaches because the evidence is insufficient to determine effects on health outcomes.

Applies to initial implantation and to revision or replacement procedures.

Revision or replacement of an occipital nerve stimulator is not covered/not medically necessary because the policy treats these procedures the same as the initial implantation. The document states that for BlueCHiP for Medicare and for Commercial products, revision or replacement is not covered or is not medically necessary "as the initial implantation procedure is also not covered/not medically necessary."

For Commercial products, occipital nerve stimulation (ONS) is considered not medically necessary. The policy explains this determination is based on insufficient evidence to establish that ONS improves health outcomes for individuals with migraine or other head pain, and it explicitly applies this stance to both initial implantation and revision or replacement procedures.

Provider Actions and Billing Guidance

Prior Authorization

Prior authorization — Not applicable. Follow the payer's web-based preauthorization tool guidance where instructed for related procedures.

Applies to BlueCHiP for Medicare and Commercial Products

Step Therapy

Step therapy note

Step therapy — No specific step-therapy requirement is stated in this policy. Verify any plan-specific step therapy or medication trial requirements in the member's benefit booklet or evidence of coverage before proceeding.

Documentation Required

Coding and benefits documentation

Report occipital nerve stimulation with the unlisted procedure code and verify member benefits prior to scheduling. There is no specific CPT/HCPCS for ONS; use unlisted procedure code 64999. Confirm coverage and medical necessity with the member's plan and document rationale in the medical record to support claims.

Use CPT 64999 (unlisted procedure, nervous system) when submitting claims for occipital nerve stimulation
Verify member-specific benefits and whether ONS is considered covered or not medically necessary under the member's contract before performing the procedure

Denial Risk

Denial risk — Medicare and Commercial

Denial risk — For BlueCHiP for Medicare, ONS and revision/replacement procedures are not covered. For Commercial products, ONS and revision/replacement procedures are considered not medically necessary. Anticipate claim denials when policy-level coverage is absent and include this in pre-service benefit verification.

Do not assume coverage; obtain prior verification of benefits and document member notification of potential noncoverage
Consider advanced beneficiary notification or obtain authorization when appropriate to inform members of potential financial liability

Background

Occipital nerve stimulation (ONS) involves a subcutaneously implanted pulse generator (commonly placed in the chest wall or abdomen) connected by tunneled extension leads to electrodes positioned across one or both occipital nerves at the base of the skull. Continuous or intermittent electrical stimulation is delivered to attempt relief of refractory migraine and certain other headache disorders. As noted in the policy, no ONS device had received FDA clearance for treatment of headache as of September 2014, and available evidence was deemed insufficient to demonstrate clinical benefit; therefore the service is considered not medically necessary.

Definitions

Occipital nerve stimulation (ONS) — device/components definition

Device componentsSubcutaneously implanted pulse generator (chest wall or abdomen) plus tunneled extension leads with electrodes placed across one or both occipital nerves at the base of the skull.

Stimulation modeContinuous or intermittent electrical stimulation may be used.

Anatomic targetElectrodes positioned across one or both occipital nerves at the base of the skull.

Regulatory statusNo FDA-cleared occipital nerve stimulation device for treatment of headache as of September 2014.

Intended useAttempted treatment of refractory migraine and other headaches (eg, hemicrania continua, cluster headaches).

Not medically necessary — definition / rationale (insufficient evidence)

Coverage determinationOccipital nerve stimulation (ONS) insertion/implantation is considered not medically necessary or not covered because the evidence is insufficient to determine effects on health outcomes.

ScopeApplies to initial implantation and to revision or replacement procedures; revision/replacement is also not covered or not medically necessary.

Evidence rationaleFor individuals with migraine or non-migraine headaches who receive ONS, the evidence is insufficient to determine effects on health outcomes.

Practical implicationServices for ONS may be denied or considered not covered by the payer due to insufficient evidence.