Preauthorization may be required for implantable neurostimulators

Some implantable neurostimulator procedures and devices (cranial nerve/peripheral neurostimulator implantation, generator and lead HCPCS) are listed in the policy and typically require preauthorization per payer policy practices.

• Examples of listed codes include 64568, 64569, 64570, 64575 and device HCPCS C1767, C1778, C1816, C1883.

Prior authorization for neurostimulator implantation and device codes

Implantation and revision neurostimulator procedures, and many implantable device HCPCS/L-codes cited in the policy coding lists, typically require verification of selection criteria and preauthorization prior to coverage.

• Procedure and device codes referenced include CPTs for implantation/revision (e.g., 64555, 64575) and HCPCS/L-codes such as L8679, L8680–L8689 and C1767–C1897.

Use trial and guideline evidence to inform prior authorization

Clinical trial and guideline evidence (randomized trials, meta-analyses, and society guidance) are referenced in the policy and may be used to inform utilization management and prior authorization decisions.

• GONB randomized trials and a meta-analysis are cited as supportive evidence; AHS guidance (Level A 'must offer' in ED) is referenced for GONB.
• ONS studies and small randomized/crossover data are discussed as contextual evidence for selection of candidates.

Document multidisciplinary evaluation and refractory status

Selection for invasive neuromodulation should document multidisciplinary specialist evaluation and prior medical management, including evidence of refractory disease and prior diagnostic/therapeutic occipital nerve block responses when applicable.

• Studies required pre-implant psychological evaluation and multidisciplinary care (headache, psychology, neuromodulation).
• Documentation of prior conservative therapies and refractoriness is expected to justify invasive neuromodulation.

Staged ONS implantation — require documented trial >50% relief

Reported ONS protocols describe a staged approach: perform a temporary trial (e.g., 10-day trial or external stimulation) and proceed to permanent implantation only if the trial yields greater than 50% pain relief.

• Example protocol: 10-day trial with external stimulator; permanent pulse generator implanted only if >50% pain relief achieved.

Document medically refractory headache before neuromodulation

Requests for implantable neuromodulation (e.g., ONS) should include documentation that the headache is medically refractory and that conservative treatments were tried and optimized before consideration of implantation.

• Policy emphasizes documentation of medically refractory headache and multidisciplinary evaluation prior to implantation.
• Regulatory status (no FDA-approved ONS device currently) may influence coverage assessment.

Prior authorization should document repetitive SPG block regimen

Repetitive SPG block protocols used in trials (eg, Tx360: 0.3 cc of 0.5% bupivacaine twice weekly for 6 weeks — 12 treatments) are described; prior authorization requests should document the planned regimen if seeking coverage.

• Tx360 trial regimen: 0.3 cc 0.5% bupivacaine administered twice weekly × 6 weeks (12 treatments).
• Document treatment schedule and intended monitoring/outcomes when requesting authorization.

Vet trigger‑site surgery requests via prior authorization

Migraine trigger‑site (peripheral nerve) surgery is considered investigational by guideline panels (AHS) and should be vetted (for example, via prior authorization) when proposed outside a clinical trial.

• American Headache Society recommends that migraine trigger-site surgery not be performed outside clinical trials.
• Policy notes variability and methodological limitations in surgical studies that raise denial risk for non‑trial use.

Expect prior authorization for invasive migraine procedures

Because invasive migraine procedures require careful patient selection and standardized outcome reporting, prior authorization is implied to ensure failure of conservative therapies and an appropriate rationale for surgery.

• Providers should document failure of conservative measures and provide objective pre‑/post‑operative outcome measures to support requests.
• Policy cites need for transparent patient selection and follow‑up reporting in surgical series.

Require objective diagnostic documentation for RCPH surgery requests

Prior authorization may be appropriate for endoscopic nasal/sinus surgery for rhinogenic contact point headache to ensure objective diagnostic confirmation (CT/endoscopy) and failed adequate medical therapy are documented.

• Prospective studies diagnosed RCPH with CT scans, endoscopy, and lidocaine testing prior to surgery.
• Document imaging/endoscopy findings and results of local anesthetic (lidocaine) test when available.

Confirm indication and prior therapies in authorization requests

Prior authorization requests for device-based therapies (e.g., nVNS) should confirm the indication aligns with FDA clearance or trial evidence and include documentation of prior therapies attempted.

• gammaCore is FDA-cleared for acute treatment of pain associated with episodic cluster headache (eCH) in adults; requests for other indications require supporting evidence.
• Document prior abortive and preventive therapies tried and rationale for nVNS use.

No explicit prior‑auth rules in these excerpts — consult full policy

These excerpts do not list explicit payer procedural prior authorization requirements or a definitive list of codes that must be preauthorized; consult the full Aetna clinical policy bulletin for specific prior authorization procedures and code-level rules.

• Policy text in this window states no explicit prior authorization requirements are presented.
• Refer to the full Aetna policy bulletin and plan program provisions for detailed authorization procedures.

Consult full Aetna policy bulletin for prior‑auth code lists and procedures

This document section does not enumerate specific prior authorization codes or step-by-step preauthorization processes; providers should consult the full Aetna policy bulletin and payer resources for exact authorization workflows.

• Policy history and Additional Information links are provided for locating authorization procedures and plan disclosures.
• Clinical Policy Bulletins assist in administering benefits but do not constitute guarantees of coverage.

Use linked plan resources to locate prior authorization procedures

Additional policy resources (Plan Disclosures, Program Provisions, glossary) are linked in the bulletin and may contain plan‑specific prior authorization procedures — use those resources to find local authorization requirements.

• Links provided include Plan Disclosures and Program Provisions pages where authorization procedures may be defined.
• Contact the payer or review the full CPB for plan‑specific submission instructions.

Occipital nerve block is preferred initial invasive intervention

Occipital nerve block (including greater occipital nerve block) is identified in the policy as the preferred initial invasive intervention for occipital neuralgia and some headaches; other surgical or device‑based interventions are generally considered experimental/investigational.

• Policy states occipital nerve block is medically necessary for occipital neuralgia and other headaches.
• Numerous other invasive procedures are listed as experimental, investigational, or unproven.

GON injections (CPT 64405) — coverage limited by indication

Greater occipital nerve injections (CPT 64405) are covered only when selection criteria are met and are explicitly noted as not covered for cluster headache and other chronic headaches including chronic migraine in the policy.

• Policy: 64405 allowable for occipital neuralgia but 'not covered for cluster headache & other chronic headaches including chronic migraines.'

Try conservative/less invasive therapies before invasive procedures

Conservative measures and less invasive options (nerve blocks, medications, oxygen for cluster attacks, triptans, verapamil and other preventives) are described as first-line and should be tried before invasive procedures; however, no formal step‑therapy rules are specified in these excerpts.

• Documents repeatedly recommend exhausting conservative medical therapies and non‑invasive options before invasive neuromodulation or surgery.
• No explicit payer step‑therapy algorithm is provided in the cited sections.

Document trials of recommended medical therapies before invasive options

First‑line medical therapies (for example, high‑flow oxygen and triptans for acute cluster attacks; verapamil, corticosteroids and other prophylactics for prevention) are expected prior to considering invasive procedures for cluster and chronic headaches.

• Policy cites oxygen and triptans as effective acute cluster treatments and verapamil/corticosteroids for prophylaxis.
• Document prior trials of these recommended medications when seeking authorization for invasive options.

Require exhaustion of non‑invasive treatments before invasive neuromodulation

Guidelines and reviews cited in the policy recommend exhausting non‑invasive treatments and conventional pharmacologic preventives prior to considering invasive neuromodulation; invasive approaches are considered mainly for patients refractory to other preventives.

• NICE, Taiwan Headache Society, and reviews emphasize reserving invasive procedures for refractory cases after standard therapies fail.
• Non‑invasive neuromodulation options are described as promising and preferable prior to invasive techniques.

Require documented optimization of conservative therapies prior to invasive procedures

Providers should attempt and document optimized conservative and medical therapies first; peripheral and invasive procedures are discussed as options for refractory subgroups and require justification of medical refractoriness.

• Policy emphasizes multidisciplinary assessment and documented optimization of medical therapy prior to ONS.
• Retrospective and small‑series evidence highlights the importance of careful patient selection and documented prior treatment failures.

Consider minimally invasive procedures only after conservative treatment failure

Minimally invasive procedures (e.g., greater occipital nerve block, subcutaneous peripheral nerve field stimulation) are typically considered after failure of conservative therapies; documentation of prior conservative treatment attempts should accompany requests.

• sPNFS and GON blocks are discussed as options for patients unresponsive to conservative therapy.
• Policy and studies recommend documenting prior conservative therapies and outcomes.

Require failed conservative therapy before migraine surgery

Migraine surgery is described as indicated when disease is not controlled by conservative measures (medication and behavioral therapy), implying a prerequisite of failed conservative therapy before surgical intervention.

• StatPearls and surgical reviews state surgery is considered when conservative measures have failed.
• Providers should document prior medication and behavioral therapy trials and outcomes.

Attempt conservative medical therapy before RCPH surgery

For suspected rhinogenic contact point headache, conservative medical therapy should be attempted prior to surgical intervention; surgery is considered in select patients refractory to medical treatment.

• Prospective studies used CT, endoscopy and lidocaine testing to diagnose RCPH; surgery showed benefit over medical therapy in select cohorts.
• Policy emphasizes careful diagnostic confirmation and failed medical therapy prior to surgery.

Expect standard‑of‑care therapies tried/intolerant before nVNS approval

Economic models and some studies present nVNS as an adjunct to standard of care; payers may expect failure or intolerance of appropriate standard of care abortive and preventive therapies before approving nVNS as adjunctive therapy.

• Economic analyses modeled nVNS as adjunct to SoC and suggested cost‑effectiveness when added to SoC.
• gammaCore is FDA‑cleared for acute eCH; adjunctive use in cCH is supported by open‑label PREVA data but requires contextual documentation.

No explicit step‑therapy rules listed here — clinical principles only

No formal step therapy protocol or mandatory stepwise code‑based rules are specified in these excerpts; the policy describes clinical stepwise care principles but does not list payer step therapy enforcement details.

• Cited sections state no step therapy requirements are detailed in the provided excerpts.
• Consult the full policy or plan provisions for any formal step therapy rules.

Additional info section does not specify step therapy rules

No step therapy rules are specified in the Additional Information sections of this excerpt; providers should verify plan‑level step therapy requirements separately.

• Additional Information links and Plan Disclosures may contain plan‑specific step therapy rules not present in this excerpt.

Document and submit appropriate CPT/HCPCS codes on claims

Providers must document appropriate CPT/HCPCS codes when submitting claims for invasive headache procedures; the policy includes numerous CPT and HCPCS codes relevant to invasive interventions that should be used to support claims.

• Examples of codes listed include 64405 (GON block), 64555/64575 (neurostimulator implantation), and L8680–L8689 (implantable neurostimulator supplies).
• Use the policy's CPT/HCPCS lists to determine which codes are covered or not covered for specific indications.

Use listed CPT/HCPCS code lists to support billing and coverage determinations

Use the policy's listed CPT and HCPCS codes to support claims and to determine whether a code is designated covered or not covered for the requested indication.

• Policy lists multiple CPT, HCPCS and L‑codes and flags certain HCPCS/L codes as not covered for the CPB indications (e.g., C1778, C1816, E0745, L8680–L8689).

Include diagnostic block and preoperative documentation for surgical candidacy

Use CT‑fluoroscopy‑guided percutaneous cervical nerve block or diagnostic occipital nerve blocks to confirm diagnosis of occipital neuralgia and to demonstrate sensory effect prior to ablative or surgical procedures; include these diagnostic block results in documentation.

• CT‑fluoroscopy guided C2–C3 nerve root blocks were used to confirm occipital neuralgia before intradural cervical dorsal rhizotomy.
• Positive diagnostic block response was required in some ONS and CDR study protocols prior to definitive procedures.

Document prior diagnostic block responses and device‑related history

Include prior occipital nerve block response, device history (lead migration, infection, battery changes), and prior trial stimulation outcomes in clinical documentation when applicable to support patient selection and follow‑up.

• Studies documented prior occipital nerve block responses and device‑related complication histories as relevant selection and follow‑up information.
• High rates of lead migration and infections were reported in some ONS studies — document prior device complications.

Include psychological evaluation and documented positive diagnostic block in ONS workup

Studies of ONS included pre‑implant psychological evaluation and documentation of a positive diagnostic occipital nerve block response; consider including these elements in pre‑implant documentation to support requests.

• Prospective ONS evaluations required psychological assessment and positive response to an occipital nerve block before implantation.
• Outcome measures (VAS, headache frequency, medication use) and long‑term follow‑up were prospectively measured in studies.

Document multidisciplinary specialist evaluations and therapy optimization

Specialist multidisciplinary evaluation (headache specialist, psychology, neuromodulation) and documentation of optimization of medical therapy are described as part of patient selection prior to considering ONS and other invasive procedures.

• Policy emphasizes multi‑disciplinary care and optimization of medical therapy prior to invasive neuromodulation.
• Document consultations and evidence of treatment optimization in authorization or medical necessity submissions.

Provide objective pre‑ and post‑operative outcome measures in surgical documentation

Surgical case reports and series commonly report pre‑ and post‑operative migraine indices, symptom inventories, and follow‑up measures; include objective baseline and follow‑up outcome measures (e.g., VAS, MIDAS, attack frequency) in surgical documentation.

• Single‑surgeon series report outcomes at ≥12 months using headache indices and symptom inventories — include comparable measures in documentation.
• Objective measures such as headache days/month, VAS and MIDAS are used to evaluate surgical efficacy.

Include comprehensive required documentation elements for invasive procedures

Documentation should include clear patient selection criteria, detailed prior medical and pharmacologic therapy trials, surgical procedure details, adverse events, and objective outcome measures with follow‑up to support medical necessity for invasive procedures.

• Policy states documentation should cover selection criteria, prior therapy details, surgical procedure descriptions, adverse events and outcomes.
• Transparent reporting and standardized selection improve support for coverage decisions.

Document objective nasal imaging/endoscopy and lidocaine test results for contact‑point surgery

For superior turbinate/contact‑point surgery, document objective confirmation of mucosal contact (CT and endoscopy), failed adequate medical therapy, and lidocaine/local anesthetic test results when used, plus baseline and follow‑up headache measures.

• Prospective studies used CT, endoscopy and lidocaine testing to diagnose RCPH prior to surgery.
• Include VAS and MIDAS before and after surgery to demonstrate benefit in authorization/supporting records.

Document diagnosis, prior therapies, treatment protocol and outcomes for nVNS requests

For nVNS, document the specific diagnosis (episodic vs chronic cluster headache or migraine), prior therapy trials and refractoriness, the planned treatment protocol (acute vs prophylactic dosing), and objective outcome measures (headache days/month, VAS, MIDAS) and adverse events.

• nVNS studies and pilot trials required clear diagnosis and documented prior therapies; ACT1/ACT2 RCTs used predefined acute treatment protocols.
• Document treatment regimen, response during evaluation period, and any adverse device effects.

Provide baseline attack frequency and trial outcomes to support coverage

Document baseline attack frequency, prior preventive and abortive therapy trials, and clinical response during any evaluation period (e.g., diaries, PRO measures) to support continued use or device coverage requests.

• Policy recommends recording baseline attack frequency and response to prior therapies and evaluation periods as evidence of benefit.
• Use headache diaries, PROs and objective measures to substantiate coverage requests.

Include CT, endoscopy and lidocaine test results for RCPH diagnostic documentation

CT scans, nasal endoscopy, and lidocaine testing were used in reported prospective RCPH studies to establish diagnosis; include these diagnostic tests and results in the record to support surgical requests.

• Lavalle et al (2025) diagnosed RCPH using CT, endoscopy and lidocaine testing before endoscopic surgery and reported improved outcomes vs medical therapy.
• Include imaging and testing to document objective mucosal contact points.

Consult policy history and additional info links for documentation and authorization details

Policy history, definitions, review history, and links to Clinical Policy Bulletin notes and plan disclosures are provided; providers should consult these resources for full documentation and authorization requirements.

• Use the Policy History and Additional Information links to locate detailed documentation or prior authorization requirements not listed in this excerpt.
• Clinical Policy Bulletins assist in administering benefits but do not guarantee coverage.

Denial risk for experimental, investigational or unproven procedures

Claims for procedures listed as experimental, investigational, or unproven (such as many listed surgical interventions, ONS, trigger‑site surgery, vagus nerve stimulation for certain indications) may be denied as not medically necessary.

• Policy explicitly lists numerous interventions considered experimental/investigational/unproven and subject to denial.
• Examples include C2 ganglion nerve block, cryo‑denervation, decompression/micro‑decompression of occipital nerves, ONS, and trigger‑site surgery.

Non‑covered HCPCS and L‑codes may lead to claim denial

Certain HCPCS and L‑codes (for example, C1778, C1816, E0745, L8680–L8683, L8685–L8689) are listed in the policy as not covered for the indications included in this clinical policy bulletin and may lead to claim denial if billed for those indications.

• HCPCS/C codes flagged as not covered include C1778, C1816, E0745; L‑codes not covered include L8680–L8689 in listed CPB contexts.

Do not bill listed non‑covered device HCPCS/C codes for CPB indications

Certain HCPCS/C device codes (C1778, C1816, E0745, L8680, L8681, L8682, L8683, L8685–L8689) are listed as not covered for the CPB indications; using these codes for listed indications risks denial.

• Policy's 'HCPCS codes not covered for indications listed in the CPB' section enumerates these device codes.
• Verify coverage status before billing these device codes for CPB indications.

Regulatory (FDA) status may affect coverage decisions

The policy notes that use of devices or procedures not approved by the FDA (for example, there is currently no FDA‑approved device for ONS) may affect coverage considerations and can increase the risk of denial.

• Policy states FDA has not approved any device for ONS and guideline panels do not recommend surgery due to unclear long‑term effectiveness.
• Document rationale and supporting evidence when requesting coverage for non‑FDA‑cleared uses.

Trial stimulation and diagnostic block response (>50%) required in some protocols

In cited ONS protocols, permanent implantation was performed only after a positive response (>50% pain relief) to a preliminary occipital nerve block and a successful trial stimulation; failure to document trial response may risk denial.

• Example: preliminary occipital nerve block followed by a trial stimulation; permanent implant only if >50% pain relief achieved.
• Document trial dates, measured pain relief percentage, and assessment results in records submitted for authorization/coverage.

Evidence insufficiency increases risk of noncoverage

Retrospective studies, small series and inadequate outcome measures are cited as limitations; procedures lacking rigorous randomized trial evidence, standardized selection, or transparent reporting have an increased risk of being unsupported and denied.

• Policy repeatedly notes the low quality of evidence for many surgical and neuromodulation procedures and the need for well‑designed RCTs.
• Provide high‑quality outcome measures and transparent selection criteria to mitigate denial risk.