ModifiedCignaPolicy 0528

Laser Interstitial Thermal Therapy

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This policy governs coverage of brain laser interstitial thermal therapy (LITT), also called magnetic resonance-guided LITT, for epilepsy, malignant brain neoplasms, and brain radiation necrosis. It applies to health benefit plans administered by Cigna, subject to the applicable benefit plan, laws, and individual clinical circumstances.

Policy Summary

PayerCigna

PolicyLaser Interstitial Thermal Therapy

Policy CodePolicy 0528

Change TypeModified

Effective DateNov 15, 20268d

Next Review DateAug 15, 2027

Key ActionDocument disabling seizures despite two or more antiepileptic drug regimens, an accessible epileptogenic focus, and multidisciplinary agreement that LITT is the best treatment option.

SourceLink

POLICY UPDATE CHANGES

New Level III recommendations address LITT as an individualized alternative to craniotomy for tumor progression after stereotactic radiosurgery and as an alternative to medical management for radiation necrosis after stereotactic radiosurgery.

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

3Covered clinical indication groups

2Covered CPT codes

3 cm

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ModifiedCignaPolicy 0528

Laser Interstitial Thermal Therapy

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Policy Summary

PayerCigna

PolicyLaser Interstitial Thermal Therapy

Policy CodePolicy 0528

Change TypeModified

Effective DateNov 15, 20268d

Next Review DateAug 15, 2027

Key ActionDocument disabling seizures despite two or more antiepileptic drug regimens, an accessible epileptogenic focus, and multidisciplinary agreement that LITT is the best treatment option.

SourceLink

POLICY UPDATE CHANGES

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

3Covered clinical indication groups

2Covered CPT codes

3 cm

Maximum lesion diameter

2+Required antiepileptic drug regimens

Not medically necessaryOther indications

Medical Necessity Criteria

Epilepsy

LITT is considered medically necessary in the treatment of refractory epilepsy when ALL of the following criteria are met:

ALL of the following

There is documentation of disabling seizures despite use of two or more antiepileptic drug regimens (i.e., medically refractory epilepsy).
There is a well-defined epileptogenic focus in the temporal lobe or hypothalamus accessible by LITT.
The treatment plan to use LITT has been agreed upon by a multidisciplinary team of physicians to include a neurosurgeon trained in LITT and, after considering all relevant possible treatment approaches, LITT is determined to be the best treatment option.

Malignant Brain Neoplasms

LITT is considered medically necessary in the treatment of newly diagnosed (i.e., primary) glioblastoma or other glioma, any recurrent primary brain neoplasm, or metastatic malignant brain neoplasms when ALL of the following criteria are met:

ALL of the following

The neoplasm measures up to 3 centimeters (cm) in diameter.≤ 3 cm
The individual is considered a poor surgical candidate for resection via craniotomy.
The treatment plan to use LITT has been agreed upon by a multidisciplinary team of physicians to include a neurosurgeon trained in LITT and, after considering all relevant possible treatment approaches, LITT is determined to be the best treatment option.

Radiation Necrosis

LITT is considered medically necessary in the treatment of radiation necrosis in the brain when ALL of the following criteria are met:

ALL of the following

The radiation necrosis measures up to 3 cm in diameter.≤ 3 cm
The individual is considered a poor surgical candidate for resection via craniotomy.
The treatment plan to use LITT has been agreed upon by a multidisciplinary team of physicians to include a neurosurgeon trained in LITT and, after considering all relevant possible treatment approaches, LITT is determined to be the best treatment option.

MRgLITT Selection Considerations for Drug-Resistant Epilepsy

The ASSFN Position Statement lists the following indications and selection considerations for MRgLITT as a treatment option for patients with drug-resistant epilepsy (DRE):

ALL of the following

Failure to respond to, or intolerance of, at least 2 appropriately chosen medications at appropriate doses for disabling, localization-related epilepsy.
Well-defined epileptogenic foci or critical pathways of seizure propagation accessible by MRgLITT.

Post-SRS Tumor Progression

For adults who have undergone stereotactic radiosurgery (SRS) for brain metastases with subsequent imaging progression due to tumor progression:

Individualized management considerations

The patient is an adult who has undergone SRS for brain metastases.
Subsequent imaging progression is due to tumor progression.
LITT may be considered equivalent to craniotomy in terms of progression-free survival (PFS) and overall survival (OS).
Level III recommendation.
The choice of management should be individualized based on the unique characteristics of the tumor location and the patient's clinical status.

Post-SRS Radiation Necrosis

For adults who have undergone stereotactic radiosurgery (SRS) for brain metastases with subsequent imaging progression due to radiation necrosis:

Individualized management considerations

The patient is an adult who has undergone SRS for brain metastases.
Subsequent imaging progression is due to radiation necrosis.
LITT may be considered equivalent to medical management for radiation necrosis.
Level III recommendation.
The choice of management should be individualized based on the unique characteristics of the tumor location and the patient's clinical status.

LITT is not medically necessary outside the qualifying covered indications described in this policy.

This policy addresses brain laser interstitial thermal therapy, also known as magnetic resonance-guided laser interstitial thermal therapy. For interstitial laser coagulation of the prostate, see CP 0159, Benign Prostatic Hyperplasia (BPH) Treatments.

MRgLITT is contraindicated when the epileptogenic focus (or foci) or critical pathways within epileptogenic networks cannot be identified.

MRgLITT is contraindicated when the individual is unable to undergo magnetic resonance imaging (MRI) because of medical reasons.

MRgLITT is contraindicated when there are medical contraindications to surgery, including unstable cardiac or respiratory conditions, anticoagulants that cannot be stopped, or bleeding diatheses.

LITT is considered not medically necessary for all other indications.

Coding and Technical Parameters

CPT Codes Considered Medically Necessary When Policy Criteria Are MetCPTCovered

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 treatment historyTwo or more antiepileptic drug regimens

Clinical contextDisabling seizures despite treatment

Policy applicationUsed to establish medically refractory epilepsy

Lesion diameter

Malignant brain neoplasmsUp to 3 centimeters (cm) in diameter

Brain radiation necrosisUp to 3 centimeters (cm) in diameter

Maximum diameter

Documentation and Denial Prevention

Documentation Required

Document Refractory Epilepsy Criteria

Before requesting LITT for refractory epilepsy, document disabling seizures despite two or more antiepileptic drug regimens, a well-defined accessible epileptogenic focus, and multidisciplinary agreement that LITT is the best treatment option.

Disabling seizures despite use of two or more antiepileptic drug regimens.
Well-defined epileptogenic focus in the temporal lobe or hypothalamus accessible by LITT.
Treatment plan agreed upon by a multidisciplinary physician team, including a neurosurgeon trained in LITT, after consideration of all relevant treatment approaches.

Documentation Required

Document Malignant Neoplasm Criteria

For malignant brain neoplasms, submit documentation establishing the qualifying diagnosis, lesion size, poor candidacy for craniotomy-based resection, and multidisciplinary determination that LITT is the best treatment option.

Newly diagnosed primary glioblastoma or other glioma, recurrent primary brain neoplasm, or metastatic malignant brain neoplasm.

Clinical Background

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 deliver thermal energy and ablate targeted brain tissue. MRI thermometry provides real-time monitoring of temperature changes and helps define the treatment zone.

Terms and Technology

LITT

AbbreviationLITT

Full termLaser Interstitial Thermal Therapy

ProcedureA minimally invasive procedure that introduces a thin laser fiber through a small cranial burr hole to thermally ablate targeted brain tissue

MRgLITT

AbbreviationMRgLITT

Full termMagnetic Resonance-Guided Laser Interstitial Thermal Therapy

Guidance methodLaser interstitial thermal therapy performed with MRI guidance and MR thermometry

Policy Summary

PayerCigna

PolicyLaser Interstitial Thermal Therapy

Policy CodePolicy 0528

Change TypeModified

Effective DateNov 15, 20268d

Next Review DateAug 15, 2027

Key ActionDocument disabling seizures despite two or more antiepileptic drug regimens, an accessible epileptogenic focus, and multidisciplinary agreement that LITT is the best treatment option.

SourceLink

On This Page

Preferred lesion diameter for brain tumor or radiation necrosis treatment

Preferred lesion sizeLess than 3 cm

Preferred lesion characteristicsCircumscribed lesion

RationaleSmaller lesions are more likely to achieve better ablation

Visualase wavelength range described

Visualase wavelength range800 nm through 1064 nm

Therapy contextWavelengths described for laser therapy across multiple medical specialties

MRI monitoringThe Visualase system can process compatible MRI data to determine relative tissue-temperature changes during therapy

ClearPoint Prism wavelength

Specified wavelength1064 nm

SystemClearPoint Prism Neuro Laser Therapy System

GuidanceThermal therapy under 3.0T magnetic resonance imaging (MRI) guidance

Neoplasm measures up to 3 cm in diameter.

Individual is a poor surgical candidate for resection via craniotomy.

Multidisciplinary physician team, including a neurosurgeon trained in LITT, agrees that LITT is the best treatment option after considering relevant alternatives.

Documentation Required

Document Radiation Necrosis Criteria

For radiation necrosis, document the diagnosis, lesion size, poor candidacy for craniotomy-based resection, and multidisciplinary determination that LITT is the best treatment option.

Radiation necrosis in the brain measures up to 3 cm in diameter.
Individual is a poor surgical candidate for resection via craniotomy.
Multidisciplinary physician team, including a neurosurgeon trained in LITT, agrees that LITT is the best treatment option after considering relevant alternatives.

Unsupported block type: documentation

Denial Risk

Epilepsy Criteria Not Met

LITT for refractory epilepsy may be denied when the required documentation of drug-resistant disabling seizures, an accessible epileptogenic focus, or multidisciplinary treatment selection is absent.

No disabling seizures despite use of two or more antiepileptic drug regimens.
No well-defined epileptogenic focus in the temporal lobe or hypothalamus accessible by LITT.
No multidisciplinary agreement that LITT is the best treatment option.

Denial Risk

Malignant Neoplasm Criteria Not Met

LITT for malignant brain neoplasms may be denied when the diagnosis is not a qualifying malignant brain neoplasm, the lesion exceeds 3 cm, the individual is not a poor craniotomy candidate, or the required multidisciplinary determination is missing.

Indication is not newly diagnosed primary glioblastoma or other glioma, recurrent primary brain neoplasm, or metastatic malignant brain neoplasm.
Neoplasm measures more than 3 cm in diameter.
Individual is not considered a poor surgical candidate for resection via craniotomy.
Required multidisciplinary agreement that LITT is the best treatment option is absent.

Denial Risk

Radiation Necrosis Criteria Not Met

LITT for brain radiation necrosis may be denied when the lesion exceeds 3 cm, the individual is not a poor craniotomy candidate, or the required multidisciplinary determination is missing.

Radiation necrosis measures more than 3 cm in diameter.
Individual is not considered a poor surgical candidate for resection via craniotomy.
Required multidisciplinary agreement that LITT is the best treatment option is absent.

Denial Risk

Indication Outside Covered Categories

LITT is not medically necessary for indications outside the qualifying refractory epilepsy, malignant brain neoplasm, and brain radiation necrosis categories.

Documented indication must fall within a covered category.
All other indications are considered not medically necessary.

Billing Rule

Use Supported Billing Codes

Claims may be denied as not covered when they are not submitted with the applicable covered procedure and diagnosis codes or when services are billed for conditions not covered by the policy.

Use the most appropriate codes in effect on the submission date.
Include applicable covered procedure and diagnosis code(s).
Claims without covered code(s) under the policy may be denied as not covered.

Denial Risk

Screen for Contraindications to MRgLITT

Screen for MRgLITT contraindications before proceeding and document that the patient can safely undergo MRI and surgery and that the epileptogenic target or critical seizure-propagation pathways can be identified.

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.

Brain laser interstitial thermal therapy

ProcedureA thin laser fiber is introduced through a cranial burr hole into a targeted brain location

Thermal deliveryThe fiber delivers thermal energy to induce cell death by damaging DNA and causing protein denaturation

Treatment monitoringMR thermometry monitors laser-induced temperature change and computer models correlate it with predicted cell death

MRgLITT

GuidanceMRI-guided laser therapy

Image processingUses compatible MRI sequences and temperature-sensitive image processing

Monitoring functionMonitors relative tissue-temperature changes during thermal ablation

ClearPoint Prism Neuro Laser Therapy System

SystemClearPoint Prism Neuro Laser Therapy System

Intended tissue effectNecrotizes or coagulates soft tissue through interstitial irradiation or thermal therapy

MRI and temperature processingUnder MRI guidance, compatible image data can be processed to relate changes in complex phase angle to relative tissue temperature

Visualase system

System typeMRI-compatible laser therapy system

Image processingProcesses MRI image data to determine relative changes in tissue temperature during therapy when compatible MRI sequences are available

Monitoring displaySelected data points may be monitored and displayed over time

Drug-resistant epilepsy

DefinitionEpilepsy that has not responded to, or is not tolerated because of, appropriately selected antiseizure medications

ASSFN medication criterionFailure or intolerance of at least 2 appropriately chosen medications at appropriate doses

Relevant epilepsy typeDisabling, localization-related epilepsy

Level III (or C) recommendation

Recommendation levelLevel III (or C)

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

Evidence limitationSignificantly flawed randomized controlled trials may also support this level

Laser interstitial thermal therapy (LITT)

DefinitionA neurosurgical tool FDA indicated for ablation, necrosis, or coagulation of intracranial soft tissue

ApplicationsIncludes brain tumors, radiation necrosis, and epileptogenic foci

Delivery methodThrough interstitial irradiation or thermal therapy using laser technology in neurosurgery