ModifiedCignaPolicy 0528

Laser Interstitial Thermal Therapy

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Coverage of brain laser interstitial thermal therapy for epilepsy, malignant brain neoplasms, and radiation necrosis, subject to applicable benefit plan terms, laws, and individual clinical facts.

Policy Summary

PayerCigna

PolicyLaser Interstitial Thermal Therapy

Policy CodePolicy 0528

Change TypeModified

Effective DateNov 15, 20261d

Next Review DateAug 15, 2027

Key ActionDocument multidisciplinary physician agreement, including a neurosurgeon trained in LITT, and confirm that LITT is the best treatment option after considering all relevant alternatives.

SourceLink

POLICY UPDATE CHANGES

Policy statements for LITT in epilepsy, malignant brain neoplasms, and radiation necrosis were revised.

3Clinical indication groups with medical-necessity criteria

≤3 cmMaximum lesion diameter

2+Antiepileptic regimens required for refractory epilepsy

2Medically necessary CPT codes

Not covered

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ModifiedCignaPolicy 0528

Laser Interstitial Thermal Therapy

Customize your policy alerts

Sign up for Cigna Policy 0528 alerts

Get alerted when Policy 0528 changes without checking for updates manually.

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Coverage of brain laser interstitial thermal therapy for epilepsy, malignant brain neoplasms, and radiation necrosis, subject to applicable benefit plan terms, laws, and individual clinical facts.

Policy Summary

PayerCigna

PolicyLaser Interstitial Thermal Therapy

Policy CodePolicy 0528

Change TypeModified

Effective DateNov 15, 20261d

Next Review DateAug 15, 2027

Key ActionDocument multidisciplinary physician agreement, including a neurosurgeon trained in LITT, and confirm that LITT is the best treatment option after considering all relevant alternatives.

SourceLink

POLICY UPDATE CHANGES

Policy statements for LITT in epilepsy, malignant brain neoplasms, and radiation necrosis were revised.

3Clinical indication groups with medical-necessity criteria

≤3 cmMaximum lesion diameter

2+Antiepileptic regimens required for refractory epilepsy

2Medically necessary CPT codes

Not covered

3Revised clinical areas

Medical Necessity and Coverage Criteria

Epilepsy

Covered when ALL of the following are met:

Refractory epilepsy

Disabling seizures despite medication: There is documentation of disabling seizures despite use of two or more antiepileptic drug regimens.two or more antiepileptic drug regimens
This establishes medically refractory epilepsy.
Accessible epileptogenic focus: There is a well-defined epileptogenic focus in the temporal lobe or hypothalamus accessible by LITT.
Multidisciplinary agreement and best-option determination: A multidisciplinary team of physicians, including a neurosurgeon trained in LITT, has agreed on the treatment plan and, after considering all relevant possible treatment approaches, determined that LITT is the best treatment option.

Malignant Brain Neoplasms

Covered when ALL of the following are met:

Malignant brain neoplasms

Tumor size: The neoplasm measures no more than 3 centimeters (cm) in diameter.up to 3 cm
Poor surgical candidacy: The individual is considered a poor surgical candidate for resection via craniotomy.
Multidisciplinary agreement and best-option determination: A multidisciplinary team of physicians, including a neurosurgeon trained in LITT, has agreed on the treatment plan and, after considering all relevant possible treatment approaches, determined that LITT is the best treatment option.

Radiation Necrosis

Covered when ALL of the following are met:

Radiation necrosis

Necrosis size: The radiation necrosis measures no more than 3 centimeters (cm) in diameter.up to 3 cm
Poor surgical candidacy: The individual is considered a poor surgical candidate for resection via craniotomy.
Multidisciplinary agreement and best-option determination: A multidisciplinary team of physicians, including a neurosurgeon trained in LITT, has agreed on the treatment plan and, after considering all relevant possible treatment approaches, determined that LITT is the best treatment option.

Other Indications

Not medically necessary:

Other indications: LITT is considered not medically necessary for all other indications.

Drug-resistant Epilepsy

The ASSFN lists MRgLITT as a treatment option for drug-resistant epilepsy when both criteria are met:

MRgLITT drug-resistant epilepsy criteria

Medication resistance: Failure to respond to, or intolerance of, at least 2 appropriately chosen medications at appropriate doses for disabling, localization-related epilepsy.>= 2 medications
Accessible epileptogenic target: A well-defined epileptogenic focus or critical pathway of seizure propagation is accessible by MRgLITT.

MRgLITT is contraindicated when the epileptogenic focus or critical pathways within the epileptogenic network cannot be identified.

MRgLITT is contraindicated when the patient cannot undergo magnetic resonance imaging (MRI) for medical reasons.

Medical contraindications to surgery are contraindications to MRgLITT, including unstable cardiac or respiratory conditions, anticoagulants that cannot be stopped, and bleeding diatheses.

LITT is considered not medically necessary for all indications other than the covered categories of refractory epilepsy, qualifying malignant brain neoplasms, and qualifying brain radiation necrosis.

Coding and Clinical Thresholds

Considered Medically Necessary CPT CodesCPTCovered

61736	Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance imaging guidance, when performed; single trajectory for 1 simple lesion.
61737	Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance imaging guidance, when performed; multiple trajectories for multiple or complex lesion(s)

Antiepileptic drug regimens

Required regimensTwo or more antiepileptic drug regimens

Clinical significanceDisabling seizures despite these regimens establish medically refractory epilepsy

Covered applicationRefractory epilepsy with a well-defined epileptogenic focus accessible by LITT

Lesion diameter

Maximum diameterUp to 3 centimeters (cm)

Malignant brain neoplasmsThe neoplasm must measure up to 3 cm in diameter

Radiation necrosis

Documentation and Denial Risk

Documentation Required

Refractory Epilepsy Documentation

Document disabling seizures despite treatment with two or more antiepileptic drug regimens and identify a well-defined epileptogenic focus accessible by LITT.

Temporal lobe or hypothalamic focus
Medically refractory epilepsy with disabling seizures despite two or more antiepileptic drug regimens

Documentation Required

Neoplasm or Radiation Necrosis Documentation

For malignant brain neoplasm or radiation necrosis cases, document the diagnosis, lesion size, poor candidacy for craniotomy resection, and applicable medical-necessity findings.

Covered neoplasm categories: newly diagnosed primary glioblastoma or other glioma, recurrent primary brain neoplasm, or metastatic malignant brain neoplasm
Radiation necrosis of the brain
Lesion measures no more than 3 cm in diameter
Individual is a poor surgical candidate for resection via craniotomy

Therapy Overview

Laser interstitial thermal therapy (LITT) is a minimally invasive neurosurgical procedure in which a laser fiber is introduced through a small cranial burr hole to thermally ablate targeted brain tissue. MRI thermometry monitors temperature changes in real time and helps model the extent of tissue injury.

Terms and Technology

LITT

AbbreviationLITT

Full termLaser Interstitial Thermal Therapy

Procedure typeA minimally invasive procedure that uses thermal energy to treat targeted brain tissue

MRgLITT

AbbreviationMRgLITT

Full termMagnetic Resonance-Guided Laser Interstitial Thermal Therapy

Guidance methodTreatment is monitored in real time by MR thermometry

Policy Summary

PayerCigna

PolicyLaser Interstitial Thermal Therapy

Policy CodePolicy 0528

Change TypeModified

Effective DateNov 15, 20261d

Next Review DateAug 15, 2027

Key ActionDocument multidisciplinary physician agreement, including a neurosurgeon trained in LITT, and confirm that LITT is the best treatment option after considering all relevant alternatives.

SourceLink

On This Page

Brain radiation necrosis must measure up to 3 cm in diameter

Preferred brain tumor or radiation necrosis lesion diameter

Preferred diameterLess than 3 cm

Preferred lesion characteristicsThe lesion is ideally circumscribed

Treatment rationaleSmaller lesions are more likely to achieve better ablation with a single laser

FDA-described laser wavelength

Wavelength1064 nm

FDA-described useThe laser is used to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy

Neurosurgical applicationThe described use is under magnetic resonance imaging guidance in neurosurgery

ClearPoint Prism MRI compatibility

MRI field strength3.0T MRI

Compatible systemsSiemens MRI Magnetom and GE MRI Signa systems

Thermal monitoringCompatible MRI sequences support monitoring of relative tissue-temperature changes during therapy

Documentation Required

Multidisciplinary Treatment-Plan Documentation

Document that a multidisciplinary physician team agreed to the LITT treatment plan, including a neurosurgeon trained in LITT, and determined that LITT is the best option after considering all relevant treatment approaches.

Record physician agreement with the treatment plan
Identify the participating LITT-trained neurosurgeon
Document consideration of all relevant possible treatment approaches and the determination that LITT is best

Documentation Required

Drug-Resistant Epilepsy Candidate Documentation

For drug-resistant epilepsy, document failure to respond to or intolerance of at least two appropriately chosen medications at appropriate doses and the clinical factors supporting MRgLITT candidacy.

Disabling, localization-related epilepsy
Failure to respond to or intolerance of at least two appropriately chosen medications at appropriate doses
Well-defined epileptogenic foci or critical pathways of seizure propagation accessible by MRgLITT

Denial Risk

Indication Outside Covered Categories

LITT is not medically necessary for indications other than the covered epilepsy, malignant brain neoplasm, and brain radiation-necrosis categories and their applicable criteria.

Claims for other indications are subject to denial as not medically necessary

Denial Risk

Missing Covered Codes

Claims may be denied as not covered when they are not submitted with the covered diagnosis and/or procedure code(s) applicable under the policy.

Use the most appropriate codes in effect on the submission date
Verify that covered diagnosis and procedure codes accompany each request

Denial Risk

Failure to Meet Medical-Necessity Criteria

Ensure that every medical-necessity criterion applicable to the specific indication is documented and satisfied before submitting a LITT request.

Epilepsy: disabling seizures despite two or more antiepileptic drug regimens, an accessible well-defined epileptogenic focus, and multidisciplinary treatment-plan agreement
Malignant brain neoplasm or radiation necrosis: lesion no more than 3 cm, poor candidacy for craniotomy resection, and multidisciplinary treatment-plan agreement

Denial Risk

Contraindications to MRgLITT

Do not pursue MRgLITT for drug-resistant epilepsy when the epileptogenic focus or critical pathways cannot be identified, MRI cannot be performed for medical reasons, or surgery is medically contraindicated.

Inability to identify the epileptogenic focus or foci or critical pathways within epileptogenic networks
Inability to undergo MRI because of medical reasons
Medical contraindications to surgery, including unstable cardiac or respiratory conditions, anticoagulants that cannot be stopped, or bleeding diatheses

Laser interstitial thermal therapy

Energy sourceThermal energy induces cell death by damaging DNA and causing protein denaturation

Fiber placementA thin laser fiber is introduced through a small cranial burr hole into the brain until its tip reaches the target

Temperature monitoringLaser-induced temperature change is monitored in real time by MR thermometry and correlated with predicted cell death by computer models

ClearPoint Prism Neuro Laser Therapy System

SystemClearPoint Prism Neuro Laser Therapy System

Laser specificationUses a 1064-nm laser under MRI guidance

Therapeutic functionNecrotizes or coagulates soft tissue through interstitial irradiation or thermal therapy

MRgLITT

DefinitionMagnetic resonance-guided laser interstitial thermal therapy

MRI compatibilityThe ClearPoint Prism system is described for use with 3.0T MRI systems

Image-based monitoringCompatible MRI sequences can provide information about relative tissue-temperature changes during therapy

Level III recommendation

Recommendation levelLevel III, also designated Level C

Evidence basisCase series, comparative studies with historical controls, case reports, and expert opinion

Additional evidence typeSignificantly flawed randomized controlled trials

Laser interstitial thermal therapy (LITT)

TechniqueA neurosurgical thermal or interstitial irradiation technique

Tissue effectUsed to ablate, necrotize, or coagulate intracranial soft tissue

Examples of treated tissueIncludes brain tumors and radiation necrosis