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CurrentAetnaPolicy 0462

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.

Policy Summary

PayerAetna

PolicyHeadaches: Nonsurgical Management

Policy CodePolicy 0462

Change TypeNo material change

Effective DateOct 12, 2000

Last ReviewJul 23, 2026

Next Review DateMay 13, 2027

Key ActionObtain prior authorization when required for listed drug administration HCPCS codes (for example, J1110, J3475, J0706, J3032, J1885).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

0462Policy 0462

6Medically necessary interventions

10+Experimental interventions

MultipleCPT/HCPCS/ICD codes listed

19%REN 2‑hr pain freedom benefit

Coverage Criteria — Medically Necessary and Experimental Interventions

Medically necessary nonsurgical interventions

Aetna considers the following nonsurgical interventions medically necessary when criteria are met:

IV DHE indications: Intravenous dihydroergotamine (DHE) for any ONE of: (1) status migrainosus (a debilitating migraine lasting >72 hours) in the emergency room, urgent care or hospital setting; OR (2) other intractable severe migraine attacks unresponsive to analgesics and triptans in the emergency room, urgent care or hospital setting; OR (3) cluster headache attacks that do not respond to oxygen or triptans in the emergency room, urgent care or hospital setting; OR (4) medication overuse headache when treated in the inpatient setting.> 72 hours for status migrainosus when applicable

See policy Scope of Policy and Background for dosing and setting specifics

IM ketorolac: Intramuscular ketorolac tromethamine (Toradol) for short-term management of acute migraine when total combined IM and oral ketorolac use is ≤ 5 days.<=5 days

Per policy Scope and ketorolac product labeling

Policy Summary

PayerAetna

PolicyHeadaches: Nonsurgical Management

Policy CodePolicy 0462

Change TypeNo material change

Effective DateOct 12, 2000

Last ReviewJul 23, 2026

Next Review DateMay 13, 2027

Key ActionObtain prior authorization when required for listed drug administration HCPCS codes (for example, J1110, J3475, J0706, J3032, J1885).

SourceLink

On This Page

Experimental, investigational, or unproven interventions

The following non-surgical interventions are considered experimental, investigational, or unproven because effectiveness has not been established:

Various therapies listed as experimental/investigational: Cranio‑sacral therapy; intra‑oral splints for tension‑type headache; IV DHE for headache types not listed in the medically necessary section or for admissions without an active prolonged debilitating headache; measurement of serum/CSF TNF‑alpha for intractable migraine/cluster headache; Cefaly (supraorbital TENS); P2G chemodenervation; intramuscular bupivacaine; intramuscular or intranasal ketamine; intramuscular magnesium; intramuscular nalbuphine or other opioid agonist‑antagonists; intranasal lidocaine; intrathecal opioids; IV aspirin (lysine acetylsalicylate); IV lidocaine; IV nalbuphine or other opioid agonist‑antagonists; IV propofol; IV valproic acid (Depacon); kinetic oscillation stimulation (KOS); supraorbital transcutaneous stimulation for indications outside established evidence; transcranial magnetic stimulation (SpringTMS and similar); Tx360 nasal applicator; Nerivio (remote electrical neuromodulation) except where RCT evidence supports use; occipital nerve stimulation; orally inhaled DHE; oral magnesium; sphenopalatine ganglion stimulation; photo‑biomodulation; Reed procedure (combined occipital and supraorbital neurostimulation); combination benztropine/diphenhydramine/promethazine with IV haloperidol or droperidol for status migrainosus; epidural steroid injection and radiofrequency ablation for cervicogenic headache—these approaches lack established effectiveness for routine coverage.

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:

ref":"b0_2","title":"Interventions considered experimental for cluster headache"},{

citations":["19","20","21","22","24","27","36"],"intro":"Clinical coverage considerations and supporting evidence excerpts","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"DHE use for severe or intractable migraine\",\"text\":\"Parenteral DHE (subcutaneous, IM, IV) can be administered in office, clinic, emergency room or inpatient settings; IV administration provides rapid peak levels and is most effective when rapid effect is desired or for intractable severe headache including status migrainosus.\",\"threshold\":\"clinical judgement\",\"note\":\"Background and Scope describe settings and indications\",\"children\":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"IV DHE multi‑day protocols\",\"text\":\"Repetitive IV DHE may be given using multi‑day protocols (eg, test dose 0.33 mg then 0.5 mg every 6 hours with antiemetic) and may require hospitalization for 24–72 hour administration when outpatient maximal treatment fails.\",\"threshold\":\"protocolized dosing as described\",\"note\":\"Raskin‑type and variations described in policy background\",\"children\":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"DHE contraindications\",\"text\":\"DHE‑45 is contraindicated in nursing mothers; persons with conditions predisposing to vasospasm (eg, peripheral arterial disease, coronary artery disease, uncontrolled hypertension, severe hepatic/renal impairment); persons on vasoconstrictors; hemiplegic or basilar migraine; known hypersensitivity to ergot alkaloids; and pregnancy.\",\"threshold\":\"presence of listed condition\",\"note\":\"Contraindications per FDA‑approved product labeling\",\"children\":[]}","{\"operator\":\"any\",\"n\":0,\"label\":\"Alternative/adjunct acute treatments\",\"text\":\"Other acute options discussed include IV prochlorperazine (often used immediately prior to IV DHE), intranasal or inhaled DHE formulations with some supportive trials, IV aspirin in limited settings, and chlorpromazine which in one ED RCT was superior to IV DHE and lidocaine; selection should be individualized.\",\"threshold\":\"clinical selection\",\"note\":\"Evidence excerpts note mixed results across agents\",\"children\":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"Nonpharmacologic/device options\",\"text\":\"Supraorbital transcutaneous stimulation (Cefaly) demonstrated reduced monthly migraine days and an improved 50% responder rate versus sham in a randomized trial (PREMICE); compliance and blinding limitations were noted.\",\"threshold\":\"device use per trial protocol\",\"note\":\"See PREMICE trial summary\",\"children\":[]}"]

ref':'b0_3',

title":"Clinical coverage considerations and evidence"},{

citations":["36","41","45","51","52"],"intro":"Summaries of evidence and regulatory status relevant to coverage determinations:","nodes":["{\"operator\":\"all\",\"n\":0,\"label\":\"Cefaly evidence summary\",\"text\":\"PREMICE randomized sham‑controlled trial (n=67) showed verum supraorbital transcutaneous stimulation reduced monthly migraine days and increased 50% responder rate (38.1% verum vs 12.1% sham); FDA de‑novo authorization (March 11, 2014) cleared Cefaly for preventive daily use in adults ≥18 (20 minutes daily).\",\"threshold\":\"\",\"note\":\"Limitations include possible partial unblinding and compliance issues\",\"children\":[]}","{\"operator\":\"all\",\"n\":0,\"label\":\"Tx360 / SPG blockade evidence\",\"text\":\"Pilot and randomized placebo‑controlled studies of Tx360 delivering bupivacaine to the SPG demonstrated rapid reductions in NRS at 15 and 30 minutes and sustained at 24 hours in a small randomized chronic migraine study (final n=38), suggesting promise but requiring further trials.\",\"threshold\":\"\",\"note\":\"See Cady et al. Tx360 randomized pilot study\",\"children\":[]}","{\"operator\":\"any\",\"n\":0,\"label\":\"Other neuromodulation and pharmacologic agents\",\"text\":\"rTMS and other neuromodulation modalities have inconsistent results; implantable peripheral nerve stimulation trials have mixed primary endpoint results; memantine and CGRP receptor antagonists have varying levels of evidence from RCTs and meta‑analyses.\",\"threshold\":\"\",\"note\":\"CTAF and systematic reviews cited\",\"children\":[]}"]','ref':'b0_4','title':'Evidence summaries relevant to coverage'},{'citations':['54','56','58','64','71'],'intro':'','nodes':['{"operator":"all","n":0,"label":"Evidence summaries present","text":"CGRP antagonists/monoclonal antibodies demonstrate efficacy in RCTs and meta‑analyses for migraine prevention; intramuscular para‑spinous bupivacaine shows favorable case‑series signals; intranasal lidocaine evidence is mixed; IV propofol evidence limited and guideline reviews recommend against or weakly against some agents; occipital nerve stimulation has feasibility and randomized trials with mixed primary endpoint results.","threshold":"","note":"Use these evidence summaries when forming coverage determinations.","children":[]}'],'ref':'b0_5','title':'Evidence summaries (no explicit coverage rules in this excerpt)'}]}]},

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.

Coding — Covered and Not-Covered Codes, Dosing Thresholds, Definitions

Covered/related administration codesmixedCovered

96365	Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour.
96372	Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular.
J1110	Injection, dihydroergotamine mesylate, per 1 mg.

HCPCS drug codes covered if selection criteria are metHCPCSCovered

J1885	Injection, ketorolac tromethamine, per 15 mg.
J3032	Injection, eptinezumab-jjmr, 1 mg.
J3475	Injection, magnesium sulfate, per 500 mg.
J0706	Injection, caffeine citrate, 5 mg.

CPT codes listed as not covered for CPB indicationsCPTNot Covered

64405	Injection(s), anesthetic agent(s) and/or steroid; greater occipital nerve.
83520	Immunoassay for analyte other than infectious agent antibody or infectious agent antigen, quantitative; not otherwise specified.
97140	Manual therapy techniques, 1 or more regions, each 15 minutes.

HCPCS codes listed as not covered for specific indicationsHCPCSNot Covered

J0585

Injection, onabotulinumtoxinA, 1 unit.

ICD-10 codes referenced for covered indicationsICD-10

G43.001	Migraine with status migrainosus and/or intractable.
G44.001	Cluster headaches.
R51.0	Headache.

Procedure and ICD-10 codes mentionedmixed

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

Ketorolac dosing detail (not a billing code)mixed

60 mg

Dose of intramuscular ketorolac commonly studied for acute migraine

Duration threshold for status migrainosus — key value

Status migrainosus duration threshold> 72 hours

Clinical contextDefined as a debilitating migraine lasting more than 72 hours; IV DHE indicated in ER/urgent care/hospital for this condition

Policy referenceAetna lists status migrainosus as an indication for IV DHE when headache persists beyond 72 hours

Ketorolac maximum combined duration — key value

Maximum combined ketorolac duration≤ 5 days (combined injectable + oral) per product labeling

Initiation routeTherapy should be initiated with IV or IM dosing; oral only for continuation if necessary

Safety noteTotal duration limit due to increased frequency/severity of adverse reactions with longer use

Medication overuse frequency thresholds — key value

Medication overuse — triptans/ergotamines/opioids/combination analgesicsRegular intake ≥10 days/month for >3 months

Medication overuse — simple analgesics (eg, acetaminophen, aspirin, NSAIDs)Regular intake ≥15 days/month for >3 months

ICHD-3 requirementHeadache on ≥15 days/month plus regular overuse >3 months of specified drugs; not better accounted for by another diagnosis

Provider Actions — Prior Authorization, Documentation, Denial Risks, Step Therapy

Prior Authorization

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.

Examples of HCPCS codes: J1110, J3475, J0706, J3032, J1885

Prior Authorization

Confirm prior authorization for CPT 64483 / 64484

Verify payer prior-authorization requirements for interventional procedure CPT codes listed in the policy (notably 64483 and 64484) before scheduling or billing.

Codes specifically listed: 64483 (transforaminal epidural, single level) and 64484 (each additional level)

Prior Authorization

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

Prior Authorization

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

Prior Authorization

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

Prior Authorization

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

Prior Authorization

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

Note

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

Note

Documentation Required

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

Prior Authorization

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

Prior Authorization

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)

Prior Authorization

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)

Prior Authorization

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

Prior Authorization

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

Note

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

Documentation Required

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

Step Therapy

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

Step Therapy

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

Step Therapy

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

Step Therapy

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

Step Therapy

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

Step Therapy

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

Documentation Required

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

Note

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

Documentation Required

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

Documentation Required

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

Step Therapy

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

Step Therapy

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

Step Therapy

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

Documentation Required

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

Billing Rule

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.

CPT 64483 and 64484 listed in policy coding section
Ensure ICD‑10 diagnosis supports the procedure per policy

Documentation Required

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

Documentation Required

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

Documentation Required

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

Documentation Required

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

Documentation Required

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

Documentation Required

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

Documentation Required

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

Documentation Required

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

Documentation Required

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

Documentation Required

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

Documentation Required

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

Documentation Required

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

Documentation Required

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

Denial Risk

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

Denial Risk

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

Denial Risk

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

Denial Risk

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

Note

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.

Status migrainosus definition — key value (> 72 hours)

Definition (duration)A debilitating migraine lasting more than 72 hours

Clinical significanceOne of the most appropriate indications for IV DHE; often requires ER/urgent care/hospital-level care

Related usesIV administration provides rapid peak plasma levels and is most effective when a rapid effect is desired

Cluster headache definition — key value

Core clinical featuresSevere, sudden unilateral pain around the eye, often with onset within 2–3 hours of falling asleep

Disorder typeCluster headache (a trigeminal autonomic cephalalgia) characterized by severe unilateral periorbital pain

Treatment contextAcute pharmacologic treatments aim to abort attacks; some neuromodulation approaches studied for cluster headache

Status migrainosus clinical note — key value about intractable severe migraine and IV therapy

Clinical noteStatus migrainosus described as an intractable severe migraine attack that may require intravenous therapy (eg, DHE) and sometimes hospitalization for multi-day administration

Indication for IV therapyIV DHE is most effective for rapid effect or intractable severe headache including status migrainosus

Care settingsAdministration may occur in office, clinic, ER, or inpatient settings depending on severity and response

Cefaly (supraorbital transcutaneous stimulator) — device definition

Device categorySupraorbital transcutaneous stimulator (Cefaly) — a prescription TENS device applied across the forehead to stimulate trigeminal branches

Regulatory statusFDA allowed marketing (de-novo) as a preventive treatment for migraine on March 11, 2014

Usage parametersIndicated for patients ≥18 years and intended for once-daily 20-minute sessions

Cefaly device—description and prescription note

DescriptionA portable, battery-powered, prescription supraorbital TENS headband positioned above the eyes using a self-adhesive electrode to stimulate trigeminal nerve branches

Indication and useFDA-authorized for migraine prevention in adults; applied once daily for 20 minutes

Evidence summaryRandomized sham-controlled trial (PREMICE) showed reductions in monthly migraine days and a greater 50% responder rate for verum vs sham

Tx360 nasal applicator — device definition

Device descriptionTx360 nasal applicator — an FDA-cleared trans-nasal, needleless applicator to deliver topical anesthetic to mucosa over the sphenopalatine ganglion (SPG)

Intended useDesigned for SPG blockade to provide topical local anesthetic delivery for acute or repetitive SPG block procedures

Clinical evidencePilot and randomized pilot studies used Tx360 to deliver bupivacaine for SPG block with reported rapid pain relief in some trials

CGRP antagonists / monoclonal antibodies — definition

DefinitionCGRP antagonists/monoclonal antibodies: pharmacologic agents that block calcitonin gene–related peptide signaling for acute or preventive migraine therapies

Examples and rolesIncludes small-molecule CGRP receptor antagonists (acute) and monoclonal antibodies (preventive agents such as TEV-48125/eptinezumab) with RCT evidence of efficacy

Evidence noteMeta-analyses and randomized trials report 2-hour pain freedom and reductions in monthly migraine days for CGRP-targeted agents

Occipital nerve stimulation (ONS) — device definition

DefinitionOccipital nerve stimulation (ONS) — an implantable peripheral nerve stimulation technique targeting occipital nerves for medically intractable chronic headache disorders

Clinical contextStudied in randomized and open-label trials for refractory chronic migraine and cluster headache; mixed trial results with some benefit in secondary endpoints

Safety/limitationsComplications include implant-site pain; blinding remains challenging in trials due to paresthesias and additional controlled data are needed

Occipital Nerve Stimulation (ONS) — additional definition entry

Technique summaryONS delivers electrical stimulation to occipital nerves via implanted leads to modulate central pain processing

Trial findingsLarge multicenter randomized trial did not meet its primary endpoint but showed significant improvements in several secondary outcomes (eg, headache days, disability)

Research needFurther controlled studies with standardized endpoints are warranted to define patient selection and stimulation parameters

Non-invasive Vagal Nerve Stimulation (nVNS / gammaCore) — definition

DefinitionNon-invasive vagal nerve stimulation (nVNS / gammaCore) — portable transcutaneous stimulator targeting the cervical branch of the vagus nerve

Clinical useHas some evidence for cluster headache; NICE recommends use with special arrangements and trial periods to assess benefit

GovernanceNICE recommends informed consent, clinical governance, and audit when used due to limited quantity/quality of efficacy evidence

Sphenopalatine Ganglion Stimulation (SPGS) — definition

DefinitionSphenopalatine ganglion stimulation (SPGS) — neuromodulation methods targeting the SPG for acute and preventive treatment of cluster and craniofacial pain

ModalitiesIncludes blocks, radiofrequency ablation, and implantable stimulation; SPG block has the strongest evidence among SPG procedures for CH

Evidence noteSystematic reviews report variable efficacy (eg, SPG block 76.5% in CCH in some series) but standardized protocols and controlled trials are needed

Chronic migraine (CM) trial definition — key value

Chronic migraine (trial definition)Defined in cited trials as 15 or more headache days per month, of which 8 or more were migraine days

Use in trialsThis trial definition was used for enrollment in erenumab and other CM preventive studies

Clinical implicationChronic migraine patients may be candidates for certain preventive therapies and for consideration of advanced interventions when refractory

Chronic cluster headache (cCH) — definition

DefinitionChronic cluster headache (cCH) — a cluster headache subtype discussed in neuromodulation literature with some controlled-trial evidence for neurostimulation modalities

Treatment contextNeuromodulation (eg, nVNS, SPG stimulation, ONS, DBS) has been studied for cCH; DBS reserved for extremely difficult-to-treat patients

Evidence notenVNS and SPG stimulation have at least one positive sham-controlled trial for cCH

Refractory chronic migraine (rCM) — definition

DefinitionRefractory chronic migraine (rCM) — chronic migraine patients who have failed multiple standard treatments and may be considered for inpatient multi-day infusion therapies

Clinical practiceAggressive inpatient infusion approaches (eg, continuous ketamine or lidocaine with adjuncts) are used for rCM when other treatments fail

Evidence gapA standardized diagnostic set for rCM is needed to guide trials and treatment selection

Transcutaneous supraorbital neurostimulation (tSNS/Cefaly) — definition

DefinitionTranscutaneous supraorbital neurostimulation (tSNS/Cefaly) — noninvasive device delivering supraorbital electrical stimulation for migraine prevention

Clinical useShown superior to sham in episodic migraine prevention trials; may reduce monthly migraine days and acute medication use

Adverse effectsGenerally well tolerated; high-frequency stimulation may decrease vigilance in some users

Trigger point injections (TPIs) — definition

DefinitionTrigger point injections (TPIs) — injection of local anesthetic, sometimes with steroid, into identified myofascial trigger points in head/neck to reduce referred pain and headache frequency/intensity

Evidence summarySmall uncontrolled and randomized studies show variable responder rates; overall quality of evidence is limited

Clinical considerationsTechniques, agents, dosing and schedules vary widely among practitioners

Greater occipital nerve block (GONB) — definition

DefinitionGreater occipital nerve block (GONB) — perineural injection of local anesthetic with or without steroid targeting the greater occipital nerve to reduce pain in cervicogenic and cluster headaches

Evidence summarySystematic reviews report pooled 50% pain-free at 1 month and positive effects on attack intensity/frequency, though heterogeneity exists

SafetyGenerally mild and transient adverse events reported

Sphenopalatine ganglion (SPG) block/stimulation — definition

DefinitionSphenopalatine ganglion (SPG) block/stimulation — procedures targeting the SPG (blocks, RFA, stimulation) intended to treat cluster and migraine headaches by modulating cranial autonomic pathways

ModalitiesIncludes topical/needleless applicators (eg, Tx360), injections, radiofrequency, and implantable stimulation

Evidence noteSPG block has supportive evidence for CH; standardized protocols are lacking and further controlled trials are needed

External trigeminal nerve stimulation (eTNS) / REN — definition

DefinitionExternal trigeminal nerve stimulation (eTNS) / Remote electrical neuromodulation (REN) — noninvasive devices applied transcutaneously to modulate trigeminal or peripheral afferents to prevent or acutely treat migraine

ExamplesCefaly (eTNS) and Nerivio (REN) are representative devices with RCT evidence for prevention and acute treatment respectively

MechanismMay modulate central pain pathways and engage conditioned pain modulation mechanisms

Remote Electrical Neuromodulation (REN) — definition and device summary

Definition and deviceRemote Electrical Neuromodulation (REN; Nerivio) — a non-invasive device that applies non-painful electrical stimulation to upper-arm peripheral nerves to induce conditioned pain modulation for acute migraine treatment

Device formWireless, wearable, battery-operated device affixed to the arm and controlled by a smartphone app for ~45-minute sessions

Indications and evidenceFDA-cleared for acute treatment in eligible age groups (≥12 years) and RCTs show benefit for 2-hour pain freedom and preventive reduction in migraine days

Conditioned Pain Modulation (CPM) — definition

DefinitionConditioned Pain Modulation (CPM) — an endogenous descending pain inhibitory mechanism where a conditioning stimulus inhibits pain in remote body regions ('pain inhibits pain')

REN relationREN is proposed to activate A-delta and C fibers to engage CPM and inhibit trigeminal nociceptive transmission

Physiologic substratesMediated via brainstem structures including periaqueductal gray and rostral ventromedial medulla

REN (Nerivio) device summary — wireless wearable description

Device summaryNerivio (REN) — wireless, wearable, non-invasive, battery-operated device controlled by a smartphone app for acute and preventive migraine treatment

Session/dosingAcute treatments applied within attack onset (eg, within 1 hour) with sessions of ~20–45 minutes; preventive use studied every-other-day regimens

Regulatory and guideline notesFDA-cleared for acute treatment in people 12 years and older; AHS consensus lists REN as a tier 2 treatment

Therapeutic gain definition — key value

Therapeutic gain (REN prevention)Therapeutic gain = between-groups difference (REN minus placebo) in change from baseline; REN preventive trial showed mean reduction of 2.7 migraine days greater than sham

InterpretationTherapeutic gain quantifies the absolute benefit attributable to REN versus placebo in preventive trials

Evidence certaintyGRADE certainty for REN preventive and acute endpoints was rated moderate in systematic review

REN device description and indications — key value

Device descriptionREN (Nerivio) is a prescribed, wearable, FDA-cleared neuromodulation device controlled by a smartphone app for acute and preventive migraine treatment

IndicationsCleared for acute treatment of migraine; preventive benefit shown in RCT when used every-other-day

Operational noteEffectiveness depends on timing of application (earlier use within attack associated with superior outcomes)

Early vs Late REN treatment — timing classification

Early treatment'Early' REN treatment denotes initiation within one hour of migraine onset and is associated with substantially better acute outcomes

Late treatment'Late' denotes initiation >1 hour after onset and shows lower rates of pain relief and freedom compared with early treatment

EvidenceLarge app-based study (55,261 patients; 586,981 treatments) found early treatment produced higher pain relief and pain freedom rates (all p<0.001)

Conditioned pain modulation (CPM) mechanism — key value

CPM mechanismConditioned pain modulation involves descending brainstem pathways (eg, periaqueductal gray, RVM) that inhibit nociceptive transmission — 'pain inhibits pain'

REN mechanism linkREN is hypothesized to trigger CPM via activation of A-delta and C fibers from upper-arm stimulation, promoting serotonin and norepinephrine release

Clinical implicationEngaging CPM may explain REN's acute analgesic effects when applied early during migraine attacks

Tachyphylaxis (REN context) — definition

Tachyphylaxis (REN context)Defined as absence of clinically meaningful increase in treatment intensity >2.5 units on a 100-point stimulation scale between consecutive years

Long-term findingThree‑year real-world cohort found no evidence of tachyphylaxis with average intensity increases below the prespecified threshold

Monitoring implicationTachyphylaxis assessment uses changes in device stimulation intensity over time as an objective metric

IHS-recommended endpoints — key value (2-hour pain freedom)

IHS endpointIHS-recommended acute migraine endpoint: 2-hour pain freedom (used in pivotal REN sham-controlled trials)

Trial adherenceSeveral REN acute trials adhered to IHS endpoints (2-hour pain freedom) increasing methodological rigor

Regulatory/evidence notePivotal REN trial reported 2-hour pain-free rates of 37.4% (active) vs 18.4% (sham), absolute benefit 19%

Refractory chronic cluster headache (rCCH) — definition from European consensus

rCCH definition (European consensus)Refractory chronic cluster headache (rCCH) defined per European Headache Federation consensus as used in systematic reviews of preventive treatments

ContextrCCH denotes cluster headache cases resistant to multiple preventive therapies and often considered for neuromodulation

Therapeutic implicationsONS and DBS studied as preventive neuromodulation options in rCCH with pooled response rates reported

Kinetic oscillation stimulation (KOS) — device definition

Device descriptionKinetic oscillation stimulation (KOS) — a minimally invasive intranasal device with an inflatable oscillating tip intended to stimulate nasal mucosa and trigeminal afferents

ProcedureAdministered via nasal catheter with oscillating balloon catheter delivering targeted stimulation to nasal mucosa

EvidenceSmall randomized pilot trial (n=36) reported rapid pain reduction versus placebo; further multicenter studies needed

KOS additional definition entry — definition

Additional definition noteKOS uses an inflatable oscillating-tip nasal catheter to activate trigeminal sensory afferents with rapid onset pain reduction observed in a small RCT

SafetyLimited AEs reported (one vasovagal event in placebo arm); larger studies required to confirm safety profile

Research needAuthors recommend multicenter, longer-term follow-up studies to validate efficacy and generalizability

Medication overuse headache (ICHD-3) — definition and frequency thresholds

Medication overuse headache (ICHD-3) definitionHeadache on ≥15 days/month in a patient with pre-existing headache disorder plus regular overuse for >3 months of specified acute medications

Frequency thresholds≥10 days/month for >3 months for triptans/ergotamines/opioids/combination analgesics; or ≥15 days/month for >3 months for simple analgesics

Diagnostic notePatients meeting both medication overuse headache and chronic migraine receive both diagnoses

Headaches: Nonsurgical Management

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Coverage Criteria — Medically Necessary and Experimental Interventions

Coding — Covered and Not-Covered Codes, Dosing Thresholds, Definitions

Provider Actions — Prior Authorization, Documentation, Denial Risks, Step Therapy

Background — Condition Overviews, Device Descriptions, and Mechanisms

Definitions and Key Terms

Revision History