Headaches: Nonsurgical Management
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Defines Aetna's coverage stance for nonsurgical interventions for migraine, cluster, tension-type, and other headache disorders for members receiving medical care; specifies medically necessary therapies and interventions considered experimental or unproven.
No material clinical or coverage changes in this revision.
Coverage Criteria — Medically Necessary and Experimental Interventions
Medically necessary nonsurgical interventions
Aetna considers the following nonsurgical interventions medically necessary when criteria are met:
See policy Scope of Policy and Background for dosing and setting specifics
Per policy Scope and ketorolac product labeling
Cross-reference: CPB 0970 for specific selection criteria
Use per treating clinician and documented indication
Indication limited to PDPH and inability to take oral caffeine
Use consistent with ED/hospital practice and patient renal function/contraindications
Experimental, investigational, or unproven interventions
The following non-surgical interventions are considered experimental, investigational, or unproven because effectiveness has not been established:
Extensive list from policy Scope of Policy indicating experimental/investigational status
Evidence summaries (no explicit coverage rules in this excerpt)
Specific interventions for cluster headache considered experimental/investigational include:
The policy lists specific procedure, drug administration and diagnosis codes referenced elsewhere in the coverage criteria. Covered administration codes include 96365 (IV infusion, initial up to 1 hour) and 96372 (therapeutic/diagnostic IM/SC injection), and the HCPCS code J1110 for dihydroergotamine per 1 mg when selection criteria are met. HCPCS drug codes that may be covered if selection criteria are met include J1885 (ketorolac per 15 mg), J3032 (eptinezumab 1 mg), J3475 (magnesium sulfate per 500 mg), and J0706 (caffeine citrate 5 mg).
The policy also enumerates codes that are not covered for the CPB indications, including CPT codes 64405 (greater occipital nerve injection), 83520 (quantitative immunoassay — eg, TNF-alpha), and 97140 (manual therapy techniques), and HCPCS/ADA codes for intra-oral splints (e.g., D4322/D4323) and device/supply codes associated with some neuromodulation or experimental devices. In addition, ICD-10 diagnosis codes are referenced for covered indications (for example G43.00-G43.919 families for migraine with/without status migrainosus and G44.001-G44.029 for cluster headache) and specific not-covered ICD-10 codes are listed (for example G44.86 Cervicogenic headache and M54.2 Cervicalgia).
Per the FDA-approved product labeling cited in the policy, DHE-45 (dihydroergotamine) is contraindicated in: nursing mothers; pregnant women; persons with conditions predisposing to vasospastic reactions (for example known peripheral arterial disease, coronary artery disease including Prinzmetal's angina, sepsis, recent vascular surgery, uncontrolled hypertension, or severely impaired hepatic or renal function); persons receiving vasoconstrictors; persons with hemiplegic or basilar migraine; and persons with known hypersensitivity to ergot alkaloids. These labeling contraindications and the potential for serious vasospastic events should be documented and considered when selecting IV DHE therapy.
A technology assessment (CTAF) review found the available evidence inadequate to demonstrate that certain neuromodulation devices (for example some TMS and TENS devices) are as effective as currently available care options. The CTAF panel therefore judged evidence insufficient for those devices, a determination that may inform payer coverage decisions for devices lacking robust comparative-effectiveness data.
Systematic reviews and guideline panels identified insufficient or low-quality evidence to support several interventions for acute headache management. Examples include limited or poor-quality data for intranasal lidocaine and mixed or weak evidence supporting agents such as IV propofol; guideline authors and reviews concluded that evidence is inadequate to recommend routine use of these therapies, and recommended further high-quality randomized trials.
Deep brain stimulation (DBS) has controlled-trial evidence for refractory chronic cluster headache but is recommended to be reserved for extremely difficult-to-treat patients given risks and heterogeneity of outcomes. Occipital nerve stimulation (ONS) has mixed randomized-trial evidence with high complication rates in some series; overall, neuromodulation approaches require careful patient selection and are generally considered later-line options for chronic cluster headache and refractory conditions.
Available trials of intravenous valproic acid for acute migraine are small, mostly open-label or non–placebo-controlled, and use variable dosing and outcome measures. Systematic review authors concluded IV valproic acid has not been proven effective for acute migraine and was inferior to prochlorperazine in at least one trial; larger, placebo-controlled trials with standardized dosing and outcomes are needed.
Systematic reviews of ketamine for migraine report few randomized trials (total n small), substantial heterogeneity in delivery routes and comparators, and high or unclear risk of bias across studies. The evidence base is limited and inconsistent — some small trials report benefit for specific outcomes while others show no advantage or inferiority versus standard agents — and reviewers call for further double-blind controlled studies with longer follow-up before routine use can be recommended.
Product labeling for ketorolac tromethamine restricts the combined duration of IM/IV plus oral ketorolac to a maximum total of ≤ 5 days. Use beyond this combined duration is outside the product labeling and associated with increased risk of adverse effects; the policy highlights this duration limit.
The body of evidence for many interventions is limited by small sample sizes, heterogeneous study designs and delivery methods, variable outcome measures, and varying risk of bias. These limitations reduce confidence in effect estimates and complicate generalizability; reviewers emphasize that heterogeneity and low-quality evidence should be considered when interpreting trial results and when making coverage determinations.
Remote electrical neuromodulation (REN, Nerivio) is FDA-cleared for acute treatment of migraine in adults who do not have chronic migraine. The device applies upper-arm stimulation to invoke conditioned pain modulation and is described in the policy as an FDA-cleared indication for acute migraine in eligible adults.
REN evidence includes retrospective surveys and real-world observational studies that are subject to limitations such as self-reported diagnoses, selection bias toward users who continued therapy, and lack of randomized comparative-effectiveness against active medications. The policy notes these limitations (recall bias, selective sampling of responders, and lack of physician-confirmed diagnoses) when summarizing REN studies.
Historically many neuromodulation devices have been considered experimental or investigational and not covered by conventional insurance plans. The document emphasizes that, with few recent exceptions, most neuromodulation technologies remain under investigation, and payers have commonly excluded or limited coverage pending stronger multicenter randomized evidence and cost-effectiveness data.
Because devices and procedures lacking robust, replicated evidence are commonly categorized as investigational, they are frequently not covered by many plans. The policy lists multiple device- and procedure-level interventions (for example Cefaly, Tx360, KOS, ONS, SPG stimulation, and others) as experimental/investigational, reflecting that many payers exclude such technologies in the absence of convincing effectiveness data.
Long-term REN datasets cited in the policy derive from voluntary, app-based and manufacturer‑supported cohorts and include only a small subset of initial users (for example, 224 of ~18,000 initiators in a three‑year cohort). The policy highlights selection bias, underreporting of adverse events in voluntary reporting systems, and limited generalizability of these long-term app-based datasets as important constraints on interpreting sustained effectiveness and safety.
Several interventions (for example photo-biomodulation, cranio‑sacral therapy, intra‑oral splints) are supported only by trials with very‑low certainty evidence or small, heterogeneous RCTs showing clinically unimportant effects. The policy reiterates that therapies with very‑low certainty evidence and marginal clinical effect sizes are not supported for routine use.
Systematic reviews and guideline updates cited in the policy found either negative or insufficient evidence for some agents. For example, an RCT of prolonged‑release melatonin (2 mg) did not show benefit over placebo, and recent guideline updates (American Headache Society 2025; IHS 2024) do not mention vitamin B for acute migraine management, indicating lack of guideline support for vitamin B in the acute setting.
The policy explicitly lists numerous interventions as experimental, investigational, or not medically necessary for migraine and cluster headache (see experimental lists), reiterating that these therapies lack established effectiveness and are not supported for routine clinical care.
A systematic review of melatonin RCTs (4 trials, 351 subjects) concluded the overall quality of evidence was very low and found insufficient data to support routine clinical use of melatonin for primary headaches; one cited randomized trial (extended‑release 2 mg) did not demonstrate benefit over placebo.
Multiple modalities discussed in the policy lack supportive, high‑quality evidence or have guideline statements noting insufficient evidence. Examples include intranasal lidocaine (insufficient or poor‑quality trials), IV propofol (guideline reviewers found insufficient evidence or recommended against), and photo‑biomodulation (low‑certainty data); these modalities are not supported by robust RCT evidence.
Guideline reviewers and systematic reviews have recommended against or found insufficient evidence for several agents and modalities. The policy cites moderate‑ to low‑quality evidence reviews that advised against routine use of agents such as propofol and raised concerns about low‑quality evidence for intranasal lidocaine and other therapies, supporting the recommendation to avoid these agents absent stronger evidence.
Randomized controlled trial evidence for occipital nerve stimulation (ONS) is limited and inconclusive, and systematic reviews report high complication rates in some series. The policy notes that RCTs and feasibility studies for ONS do not provide definitive support for broad use and that patient selection and procedural standardization remain challenges.
Available studies of IV valproic acid are small and often non‑placebo‑controlled; systematic reviewers concluded IV valproic acid has not been proven effective for acute migraine and recommended larger, standardized placebo‑controlled trials before routine adoption.
Systematic reviews of ketamine for migraine indicate few randomized trials with small sample sizes, heterogeneous delivery routes, and high or unclear risk of bias. The policy states routine use of intranasal or IV ketamine for migraine is not supported by high‑quality evidence and should be reserved for individualized, refractory cases pending better data.
Authors of systematic reviews concluded that current evidence is insufficient to recommend melatonin for routine clinical practice in primary headaches; the quality of available RCTs was rated very low.
The REN (Nerivio) device descriptions and trial excerpts in the policy present positive efficacy and safety findings, but the policy excerpts do not include an explicit statement declaring REN universally "not medically necessary"; instead, REN is described with its FDA clearance for acute migraine and with summaries of trial and real‑world evidence.
Some background excerpts note the absence of explicit not‑medically‑necessary (NMN) adjudication language for many neuromodulation technologies in those particular text segments, but the overall document repeatedly describes most neuromodulation devices as historically considered investigational and often excluded by payers pending stronger evidence.
Although explicit denial or exclusion language is not always present in every background excerpt, the policy highlights evidence limitations (for example inadequate CTAF findings, low‑quality trials, selection bias in device registries) that payers may use to justify limited coverage or denials when robust supporting evidence is lacking.
The policy reiterates that several interventions produce only very‑low certainty evidence and small or clinically unimportant RCT effects (for example cranio‑sacral therapy, photo‑biomodulation, intra‑oral splints). Such interventions are summarized as lacking sufficient evidence to support routine clinical use.
Covered administration and drug HCPCS codes that may require prior authorization when selection criteria are met include J1110 (dihydroergotamine), J3475 (magnesium sulfate), J0706 (caffeine citrate), J3032 (eptinezumab), and J1885 (ketorolac). The policy coding section identifies these HCPCS codes as linked to covered infusions/injections when clinical criteria are satisfied.
The policy lists CPT codes that are not covered for the CPB indications, including 64405 (greater occipital nerve injection), 83520 (quantitative immunoassay), and 97140 (manual therapy techniques). These not‑covered CPT entries are explicitly identified in the coding/exclusions sections.
An example HCPCS code explicitly listed as not covered for specific CPB indications is J0585 (onabotulinumtoxinA unit), with additional HCPCS and supply codes associated with experimental procedures and devices enumerated in the coding tables as not covered for the CPB indications.
ICD‑10 diagnosis code families referenced for covered indications include migraine‑related codes (for example the G43.x series such as G43.001 and related G43.xx codes for migraine with status migrainosus/intractable presentations) and cluster headache codes (for example G44.001‑G44.029). These ICD‑10 code ranges are cited in the coding section as associated with covered services when clinical criteria are met.
The policy mentions procedure and diagnosis codes associated with certain interventional services, including CPT codes 64483 and 64484 (transforaminal epidural with imaging guidance, lumbar/sacral single and additional levels), and flags ICD‑10 codes such as G44.86 (cervicogenic headache) and M54.2 (cervicalgia) in the coding/exclusion listings.
Coding — Covered and Not-Covered Codes, Dosing Thresholds, Definitions
| J0585 | Injection, onabotulinumtoxinA, 1 unit. |
| G43.001 | Migraine with status migrainosus and/or intractable. |
| G44.001 | Cluster headaches. |
| R51.0 | Headache. |
| 64483 | transforaminal epidural, with imaging guidance (fluoroscopy or CT), lumbar or sacral, single level. |
| 64484 | transforaminal epidural, with imaging guidance (fluoroscopy or CT), lumbar or sacral, each additional level (List separately in addition to code for primary procedure). |
| G44.86 | Cervicogenic headache |
| M54.2 | Cervicalgia |
| 60 mg | Dose of intramuscular ketorolac commonly studied for acute migraine |
Provider Actions — Prior Authorization, Documentation, Denial Risks, Step Therapy
Obtain authorization for listed HCPCS drug administration codes
Certain HCPCS drug administration codes listed in the policy (for example, J1110 dihydroergotamine, J3475 magnesium sulfate, J0706 caffeine citrate, J3032 eptinezumab, and J1885 ketorolac) are identified as covered if selection criteria are met and should be authorized per payer rules when applicable.
Document prescription/authorization and age for Cefaly
Cefaly (supraorbital transcutaneous stimulator) is FDA-authorized for migraine prevention in adults and should be prescribed and documented as a preventive device (daily use, 20 minutes) with patient age ≥18 noted in authorization materials.
- Device indicated for patients 18 years and older
- Use once daily for 20 minutes
- FDA cleared via de-novo pathway based on a 67-subject trial
Expect prior authorization for occipital nerve stimulation (ONS)
Occipital nerve stimulation (ONS) is an implantable therapy for medically intractable chronic migraine and prior authorization is expected; requests should document medically intractable status (e.g., ≥15 headache days/month), trials of medical therapy, and objective diary data supporting refractoriness as used in trials.
- ONS studied in randomized/feasibility trials with responder definitions (≥50% reduction or ≥3‑point pain decrease)
- Document chronicity (≥15 days/month) and prior treatment failures
Consider coverage and document trial period for gammaCore
Payers are encouraged to consider coverage of non-invasive vagal nerve stimulation (gammaCore) for episodic cluster headache as an acute option, with expectations for follow-up and stopping treatment if symptoms do not improve within the recommended trial period (e.g., 3 months per NICE guidance).
- Panel recommended gammaCore as a first-line acute option for eCH
- NICE recommends stopping gammaCore if symptoms do not reduce in first 3 months
Support anti‑CGRP mAb requests with baseline frequency and prior therapy history
Prior authorization requests for anti-CGRP monoclonal antibodies (for example erenumab dosing studied at 70 mg and 140 mg) should include baseline monthly migraine days and prior preventive therapy history, since randomized trials demonstrated reductions in monthly migraine days and increased responder rates versus placebo.
- Document baseline monthly migraine days
- Document prior preventive therapy trials and prior responses
Authorize multi‑day inpatient ketamine/lidocaine infusions with justification
Prior authorization may be required for inpatient multi-day continuous ketamine or lidocaine infusions for refractory chronic migraine; documentation should justify refractory status and prior treatment failures given limited and low-quality evidence.
- Justify inpatient admission and refractory chronic migraine diagnosis
- Provide details of infusion regimen, concurrent meds, monitoring, and outcomes
Do not assume no prior authorization when background is silent — verify with payer
Background sections do not state explicit prior-authorization codes or mandates for some procedures; absence of explicit PA language in policy excerpts means providers should verify payer-specific requirements rather than assume authorization is not needed.
- Policy notes lack of standardized SPG protocols and variability in use
- Verify payer rules for SPG blocks and related procedures
Include REN regulatory indication and patient age in authorization requests
The REN (Nerivio) device is FDA-cleared for acute treatment of migraine and preventive use in persons 12 years and older; while the document summarizes regulatory clearance, it does not specify payer prior‑authorization rules — include the device's FDA indication and patient age in requests.
- FDA-cleared for acute treatment and preventive use in patients ≥12 years
- Include FDA indication and patient age when seeking coverage
Expect prior authorization (or exclusion) for investigational neuromodulation devices
Many neuromodulation devices continue to be considered experimental or investigational; prior authorization is likely required or coverage may be excluded — provide detailed documentation of diagnosis, prior therapies, and rationale when seeking approval.
- Devices often labeled investigational and not covered by conventional plans
- Provide detailed clinical rationale and prior-treatment documentation
Provide comprehensive evidence and prior‑therapy documentation for neuromodulation PA requests
Because payers have historically considered many neuromodulation devices investigational, prior authorization is likely required and coverage decisions are variable; include objective diary data and prior-treatment failures in submissions.
- Document prior therapies tried and objective outcome measures
- Cite randomized trial evidence for REN where available (e.g., 2‑hour pain freedom)
Cite REN RCT evidence and preventive trial data in coverage requests
Coverage decisions for REN may consider randomized controlled trial evidence demonstrating acute 2‑hour pain freedom benefit and preventive trial results; when requesting coverage, include RCT outcomes and note limitations of real‑world long‑term datasets.
- Pivotal REN trial: 2‑hour pain-free 37.4% active vs 18.4% sham
- Preventive trial (Tepper 2023) showed mean reduction in migraine days (therapeutic gain 2.7 days)
Seek PA for neuromodulation or RFA with documentation of refractory status and prior therapies
When proposing high‑cost neuromodulation (ONS, DBS) or radiofrequency ablation (cervical medial branch RFA), prior authorization is appropriate and should document refractory status, prior therapies attempted, and objective outcome measures to justify intervention.
- ONS and DBS discussed as options for refractory conditions with pooled response rates cited
- Document prior failures of established acute and preventive therapies
Expect PA for novel neuromodulation devices (e.g., KOS) given limited evidence
Novel neuromodulation devices with limited evidence (for example Kinetic Oscillation Stimulation) may require prior authorization due to small single‑center trials; include study citations and rationale when requesting coverage.
- KOS pilot RCT (Juto & Hallin 2015) was small (n=36) and authors call for multicenter studies
- Provide objective measures and prior therapy history for consideration
No formal step‑therapy sequences stated — verify payer rules and document prior therapies
No explicit step therapy sequences are defined in the policy excerpts; do not assume formal required medication sequencing — document prior therapies tried when relevant, but confirm plan‑specific step‑therapy rules separately.
- Policy states no explicit step therapy sequences are defined
- Verify payer-specific step therapy or prior‑authorization requirements
Document prior outpatient trials and rationale when escalating to inpatient therapies
Clinical discussions describe escalation of care (for example, from outpatient care to multi‑day inpatient IV DHE or infusions) for refractory cases, but these are not formal step‑therapy mandates — document prior outpatient trials and reasons for escalation when requesting inpatient care.
- IV DHE multi‑day administration described for refractory or status migrainosus (>72 hours)
- Hospitalization may be necessary after outpatient maximal treatment fails
Document failure of standard therapies before proposing invasive modalities
For refractory chronic headache, guidance suggests considering more invasive modalities (such as neurostimulation) only after trials of specific drugs have failed; include documentation of failed standard therapies before escalation.
- Authors recommend addressing comorbidities and escalating to more invasive modalities as third‑line therapies
- Document trials of specific acute and preventive drugs
Prioritize guideline‑recommended agents and document trials before non‑supported options
Guideline reviews prioritize certain acute agents (e.g., prochlorperazine, specific triptans, NSAIDs) and discourage agents with low‑quality evidence, implying trial of guideline‑recommended pharmacologic therapies before less‑supported options; document such trials when relevant.
- Prochlorperazine and certain triptans have higher evidence grades
- Agents like propofol, IV lidocaine have limited/insufficient evidence per reviews
Try less‑invasive neuromodulation before invasive procedures and document trials
Non‑invasive neuromodulation techniques are generally recommended to be considered before more invasive neuromodulation modalities; when proposing invasive devices, document trials of less invasive options and safety/tolerability considerations.
- Non‑invasive options (nVNS, REN, tSNS, TMS) preferred before invasive techniques
- ONS and DBS reserved for refractory, difficult‑to‑treat patients
Document attempts or contraindications to less‑invasive neuromodulation before invasive options
Less invasive neuromodulation techniques (e.g., nVNS, transcranial stimulation, REN) are generally preferred to more invasive techniques (e.g., DBS); include documentation of attempts or contraindications to less invasive options when requesting invasive therapy.
- nVNS and SPG stimulation have at least one positive sham‑controlled trial for chronic cluster headache
- REN has randomized evidence for acute and preventive use
Document prior standard therapy failures before inpatient ketamine/lidocaine infusions
Ketamine or lidocaine infusions are often used after failure of other therapies (a stepwise escalation); when seeking authorization, document prior standard therapy attempts and rationale for infusion therapy per local payer expectations.
- Modified multi‑day inpatient infusion approaches are used for refractory chronic migraine after other treatments fail
- Standardized rCM diagnostic criteria are needed and documentation should reflect refractory status
Consider SPG/GON blocks after pharmacotherapy failure and document technique and prior trials
SPG and greater occipital nerve blocks are typically considered after failure of pharmacotherapies in refractory patients; although not formal step therapy rules, include prior pharmacotherapy trials and details of block technique and agents used in documentation.
- Tx360 studies used defined schedules (twice weekly for 6 weeks) and required baseline/follow‑up NRS measurements
- GONB meta‑analysis showed pooled pain‑free proportion at 1 month; document prior meds and response
Document REN use context (monotherapy vs adjunct) and prior medication history
When integrating REN into practice there is no mandated ordering relative to medications; consider patient characteristics and preferences and document whether REN is used as monotherapy or adjunctive therapy and prior medication history.
- Guidance suggests REN can be used as monotherapy or in combination for acute and preventive treatment
- Document device prescription, age, diagnosis (episodic vs chronic), and prior treatments
Policy does not define formal step‑therapy — verify payer‑specific rules
No specific step therapy or required medication trials are specified in the policy excerpts; providers should not infer mandated sequences from these background sections and must verify any payer-specific step therapy programs.
- Policy excerpts explicitly state no formal step therapy sequences
- Confirm insurer formularies and step‑therapy programs separately
Document pediatric REN rationale (age, school barriers) when requesting coverage
For pediatric REN use, authors suggest REN could be considered first‑line in school‑aged students due to barriers to medication administration at school; document age, school‑related barriers, and prior medication attempts when requesting coverage for pediatric patients.
- Studies and consensus suggest REN is a pragmatic option in school settings
- Document patient age and rationale for preferring non‑pharmacologic treatment
Document patient preference or intolerance when proposing REN over medications
REN may be offered as an alternative to pharmacotherapy for patients preferring nonpharmacologic approaches or with inadequate response/intolerance to medications; include patient preference and prior medication intolerance/nonresponse in documentation.
- American Headache Society consensus supports REN as option for patients preferring non‑pharmacologic approaches
- Include prior medication intolerance or inadequate response in records
Document trials or contraindications to standard ED agents before IV magnesium authorization
Insurers may require trials of standard ED agents (e.g., metoclopramide, prochlorperazine) or documentation of contraindication/intolerance before authorizing IV magnesium in ED/hospital settings; include prior ED treatments and contraindications in authorization requests.
- Practice advisory recommends IV magnesium 1–2 g over 15 minutes in appropriate patients without contraindications
- Document prior ED agent trials or contraindications to them
Document conservative therapy attempts prior to neuromodulation requests
Systematic reviews and guideline panels imply conservative and less‑invasive treatments are typically considered before neuromodulation; when requesting coverage for neuromodulation, include documentation of less‑invasive treatment attempts and rationale for escalation.
- Conservative therapies are typically tried before neuromodulation or RFA
- Include documentation of prior conservative therapy attempts and durations
Document trials of established therapies before seeking coverage for emerging interventions
Established acute and preventive therapies should be considered before emerging interventions (such as KOS or high‑dose vitamin regimens); include documentation of prior established therapies and objective symptom scores when seeking coverage for emerging treatments.
- KOS pilot data are small and authors call for larger trials
- Provide objective measures (e.g., MIDAS, pain scores) and prior therapy history
Document diagnosis and treatment setting consistent with covered indications
Ensure clinical indication documentation matches covered indications (for example, status migrainosus >72 hours, intractable severe migraine, cluster headache not responsive to oxygen/triptans) to support coverage of IV DHE, IV magnesium, caffeine infusion, eptinezumab, and related interventions.
- Status migrainosus defined as migraine lasting >72 hours
- Match ICD‑10 codes to covered indications per coding tables
Document procedure details and matching diagnosis codes for CPT 64483/64484
When billing or requesting authorization for procedures (e.g., transforaminal epidural codes 64483 and 64484), document the associated diagnosis codes and clinical justification consistent with the policy coding section to avoid coding‑based denials.
Provide baseline and follow‑up NRS scores for Tx360/SPG blockade authorization
Clinical trials of SPG blockade (Tx360) required baseline headache measures and follow‑up numeric rating scale (NRS) scores at specified timepoints (pre‑treatment, 15 minutes, 30 minutes, 24 hours); include similar outcome documentation when justifying SPG procedures.
- Tx360 randomized trial measured NRS at baseline, 15, 30 minutes and 24 hours
- Include Headache Impact Test‑6 where available
Include headache diaries and responder definitions when supporting neuromodulation requests
For neuromodulation requests, include patient headache diaries and predefined responder definitions (for example, ≥50% reduction in headache days or ≥3‑point pain intensity reduction) as used in ONS trials to document benefit and refractoriness.
- ONS trials used headache diaries and responder definitions (≥50% reduction or ≥3‑point pain drop)
- Provide objective diary data covering baseline and follow‑up periods
Provide comprehensive documentation of selection, regimen, outcomes, and consent for neuromodulation
Document patient selection, treatment regimen, outcome measures (attack frequency, severity, medication use, quality of life), and informed consent acknowledging uncertainty of efficacy when seeking authorization for neuromodulation or novel devices.
- Document selection criteria, regimen, outcomes, device durability, and informed consent
- Track functional outcomes and adverse events
Document baseline migraine days and prior preventive therapy when requesting anti‑CGRP mAbs
Prior‑authorization requests for anti‑CGRP monoclonal antibodies should include prior treatment history and objective baseline migraine frequency (monthly migraine days) and prior responses since RCTs report changes in monthly migraine days and responder rates.
- Document baseline monthly migraine days and prior preventive therapy responses
- Cite randomized trial outcomes for erenumab as relevant
Supply comprehensive inpatient infusion documentation for ketamine/lidocaine
For inpatient lidocaine or ketamine infusions, provide documentation supporting the refractory diagnosis, prior treatment failures, indication for admission, infusion regimen details, monitoring plans, and observed outcomes (pain scores, length of stay).
- Retrospective cohorts reported effectiveness but high adverse‑event rates; include monitoring and risk mitigation plans
- Detail prior trials and rationale for inpatient infusion
Document specific technique, agents, and prior responses for nerve blocks and TPIs
Practice surveys show variability in nerve block and trigger‑point techniques; when requesting coverage, document indication, specific sites injected, agents used (eg, local anesthetic, corticosteroid), schedule/protocol, and prior response to other therapies to reduce documentation‑based denials.
- Surveys highlight variability in injection sites, agents, dosing, and schedules
- Provide precise procedural details and prior outcomes
Include trial outcome metrics and AE data when supporting device effectiveness claims
Document clinical trial outcomes and device tolerability data (for example, 2‑hour pain relief/pain‑free rates and adverse event rates) when claiming effectiveness for REN or other neuromodulation devices to support medical necessity.
- REN pivotal trial: 2‑hour pain relief 66.7% active vs 38.8% sham; pain‑free 37.4% vs 18.4%
- Report device‑related AE rates from trials and real‑world datasets
Include device/app symptom diaries (eg, Nerivio) and MIDAS in documentation
Capture patient symptom reporting collected via device apps (for REN, the Nerivio app records pre‑treatment and 2‑hour post‑treatment diaries); include such app‑derived diaries or MIDAS scores in authorization documentation when available.
- Nerivio app captures pre‑treatment and 2‑hour post‑treatment symptom reports
- Real‑world programs collected MIDAS scores and device utilization metrics
Provide MIDAS, prospective pain/disability reports, and device utilization as supporting documentation
Suggested supporting documentation to establish medical necessity includes MIDAS scores, prospective pain and disability reports, device utilization patterns, and objective pre/post treatment outcomes; include these where possible to strengthen authorization requests.
- MIDAS score changes and prospective 2‑hour outcomes support effectiveness
- Device utilization metrics (treatments per month) and adverse events help contextualize benefit and safety
Document pediatric/ED REN use details and app‑reported outcomes
When prescribing REN for pediatric patients or in ED settings, document device prescription, patient age, diagnosis (episodic vs chronic migraine), prior treatments tried, and whether REN is used alone or with medications, and record treatment sessions and patient‑reported outcomes via the device app.
- Orr et al pilot trial in pediatric ED used REN vs standard IV therapy; document feasibility and outcomes
- Record whether REN used as monotherapy or adjunct and track 2‑hour outcomes
Document timing and outcome measures when using REN adjunctively during procedures
Document REN use during procedures (for example, applied 10 minutes before BoNT‑A injections and continued during procedure) with recorded procedural pain scores and postprocedural headache incidence to support claims of procedural benefit.
- Mayo Clinic randomized crossover trial applied REN 10 minutes before and during BoNT‑A injections with significant pain reduction
- Record pre‑, intra‑, and post‑procedure VAS scores
Detail diagnosis, RFA technique, and follow‑up outcomes to reduce documentation‑based denials
Provide clear diagnostic criteria, prior conservative therapies attempted, the specific RFA technique (continuous vs pulsed, temperature, duration), and follow‑up outcomes when requesting coverage for RFA or related procedures to mitigate documentation risk due to heterogeneity in studies.
- Systematic reviews note variability in RFA technique and patient selection
- Include procedural parameters and follow‑up pain outcomes
Provide detailed prior therapies, dosing, and objective scores for KOS / vitamin requests
Include details of prior therapies, indication (acute vs prophylactic), specific device or supplement regimen, dosing (eg, thiamine 990 mg/day in cited trial), and objective symptom scores/timepoints when requesting coverage for KOS or vitamin regimens, given limited trial evidence.
- KOS pilot RCT small (n=36) and calls for multicenter studies
- Thiamine trial used 990 mg daily; document dosing and trial outcomes
Avoid billing not‑covered CPT/HCPCS/ICD‑10 codes to prevent denials
Use of CPT/HCPCS/ICD‑10 codes listed as 'not covered' (for example, cranio‑sacral therapy or intra‑oral splint codes) for CPB indications may trigger claim denials — do not bill those codes for covered claims.
- CPT/HCPCS codes for cranio‑sacral therapy and intra‑oral splints are listed as not covered
- Verify billing codes against the policy's not‑covered list before claim submission
Ensure diagnosis codes align with policy to avoid coding‑based denials
ICD‑10 diagnosis codes that are noted as not covered for CPB indications (for example G44.86 Cervicogenic headache and M54.2 Cervicalgia) may lead to coding‑based denials; ensure diagnosis coding aligns with covered indications in the policy.
- ICD‑10 codes listed as not covered include G44.86 and M54.2
- Map the procedure to an appropriate covered ICD‑10 when billing
Be aware CTAF evidence judgments can lead to non‑coverage — include robust evidence
Technology assessments that judged evidence inadequate for certain devices (for example CTAF findings for Cefaly and SpringTMS) may result in non‑coverage or denial if submissions rely on devices deemed inadequately supported; include higher‑quality evidence when available.
- CTAF voted evidence inadequate to show equivalence to standard care for some devices
- Provide controlled‑trial data and economic rationale where possible
Expect denial risk for therapies with limited evidence; provide strong justification and prior‑therapy documentation
Interventions with insufficient or low‑quality evidence (for example propofol, IV valproic acid, ketamine) face higher risk of denial; include compelling, case‑specific justification and comprehensive prior‑therapy documentation when requesting coverage for these therapies.
- Guideline reviews recommended against or found insufficient evidence for propofol and intranasal lidocaine
- IV valproic acid not proven effective and was inferior to prochlorperazine in one trial
- Ketamine trials are few, small, and at high risk of bias
Background — Condition Overviews, Device Descriptions, and Mechanisms
Migraine and cluster headache are primary headache disorders associated with substantial morbidity and disability. Pharmacologic symptomatic treatments aim to abort or reduce attacks and restore function; parenteral agents and device‑based neuromodulation are discussed as options for intractable or severe attacks, with IV DHE, IV/IM agents, and neuromodulation modalities described in the background evidence summaries.
Definitions and Key Terms
Revision History
Policy last reviewed on 2026-07-23.
Policy originally became effective on 2000-10-12.
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