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DESCRIPTIONRadiotherapy (RT) is an integral component in the treatment of many brain tumors, both benign and malignant. Intensity-modulated radiotherapy (IMRT) has been proposed as a method of RT that allows adequate RT to the tumor while minimizing the radiation dose to surrounding normal tissues and critical structures.
RT and Brain Tumors
The standard approach to the treatment of brain tumors depends on the type and location of tumor. For glioblastoma multiforme (GBM), a malignant high-grade tumor, treatment is multimodal, with surgical resection followed by adjuvant RT and chemotherapy.
For benign and low-grade brain tumors, gross total resection remains the primary goal. However, RT may be used in selected cases. Some examples are when total resection is not possible, when a more conservative surgical approach may be necessary to achieve long-term treatment goals, and with atypical tumors that may need radiotherapy even after gross total resection to reduce the risk of local recurrence. Therefore, RT, either definitive or in the postoperative adjuvant setting, remains an integral component in the management of residual, recurrent, and/or progressive benign and low-grade brain tumors for maximizing local control.
Brain metastases occur in up to 40% of adults with cancer and can shorten survival and detract from quality of life. Many patients who develop brain metastases will eventually die of progressive intracranial disease. Among patients with good performance status, controlled extracranial disease, favorable prognostic features, and a solitary brain metastasis, randomized studies have shown that surgical excision followed by whole brain radiotherapy (WBRT) prolongs survival. Stereotactic radiosurgery (SRS) may be able to replace surgery in certain circumstances, delivering obliteratively high single doses to discrete metastases. For bulky cerebral metastases, level one evidence has also shown that delivering a higher radiation dose with an SRS boost is beneficial in addition to standard WBRT. The use of a concomitant boost with IMRT during WBRT has been attempted to improve overall local tumor control without the use of SRS to avoid additional planned radiation after WBRT (“Phase II” or SRS) and its additional labor and expense.
Conventional external beam radiotherapy. Over the past several decades, methods to plan and deliver RT have evolved in ways that permit more precise targeting of tumors with complex geometries. Most early trials used 2-dimensional treatment planning based on flat images and radiation beams with cross-sections of uniform intensity that were sequentially aimed at the tumor along 2 or 3 intersecting axes. Collectively, these methods are termed “conventional external beam RT.”
3-dimensional conformal radiotherapy. Treatment planning evolved by using 3-dimensional images, usually from computed tomography (CT) scans, to delineate the boundaries of the tumor and discriminate tumor tissue from adjacent normal tissue and nearby organs at risk for radiation damage. Computer algorithms were developed to estimate cumulative radiation dose delivered to each volume of interest by summing the contribution from each shaped beam. Methods also were developed to position the patient and the radiation portal reproducibly for each fraction and immobilize the patient, thus maintaining consistent beam axes across treatment sessions. Collectively, these methods are termed 3-dimensional conformal radiotherapy (3D-CRT).
Intensity-modulated radiotherapy (IMRT). IMRT, which uses computer software and CT and magnetic resonance imaging (MRI) images, offers better conformality than 3D-CRT, as it is able to modulate the intensity of the overlapping radiation beams projected on the target and to use multiple shaped treatment fields. It uses a device (a multileaf collimator, MLC) which, coupled to a computer algorithm, allows for “inverse” treatment planning. The radiation oncologist delineates the target on each slice of a CT scan and specifies the target’s prescribed radiation dose, acceptable limits of dose heterogeneity within the target volume, adjacent normal tissue volumes to avoid, and acceptable dose limits within the normal tissues. Based on these parameters and a digitally reconstructed radiographic image of the tumor and surrounding tissues and organs at risk, computer software optimizes the location, shape and intensities of the beams ports, to achieve the treatment plan’s goals.
Increased conformality may permit escalated tumor doses without increasing normal tissue toxicity and thus may improve local tumor control, with decreased exposure to surrounding, normal tissues, potentially reducing acute and late radiation toxicities. Better dose homogeneity within the target may also improve local tumor control by avoiding underdosing within the tumor and may decrease toxicity by avoiding overdosing.
Since most tumors move as patients breathe, dosimetry with stationary targets may not accurately reflect doses delivered within target volumes and adjacent tissues in patients. Furthermore, treatment planning and delivery are more complex, time-consuming, and labor-intensive for IMRT than for 3D-CRT. Thus, clinical studies must test whether IMRT improves tumor control or reduces acute and late toxicities when compared with 3D-CRT.
Methodological Issues with IMRT Studies
Multiple-dose planning studies have generated 3D-CRT and IMRT treatment plans from the same scans, then compared predicted dose distributions within the target and in adjacent organs at risk. Results of such planning studies show that IMRT improves on 3D-CRT with respect to conformality to, and dose homogeneity within, the target. Dosimetry using stationary targets generally confirms these predictions. Thus, radiation oncologists hypothesized that IMRT may improve treatment outcomes compared with those of 3D-CRT. However, these types of studies offer indirect evidence on treatment benefit from IMRT, and it is difficult to relate results of dosing studies to actual effects on health outcomes.
Comparative studies of radiation-induced side effects from IMRT versus alternative radiation delivery are probably the most important type of evidence in establishing the benefit of IMRT. Such studies would answer the question of whether the theoretical benefit of IMRT in sparing normal tissue translates into real health outcomes. Single-arm series of IMRT can give some insights into the potential for benefit, particularly if an adverse effect that is expected to occur at high rates is shown to decrease by a large amount. Studies of treatment benefit are also important to establish that IMRT is at least as good as other types of delivery, but in the absence of such comparative trials, it is likely that benefit from IMRT is at least as good as with other types of delivery.
The U.S. Food and Drug Administration (FDA) has approved a number of devices for use in IMRT, including several linear accelerators and multileaf collimators. Examples of approved devices and systems are the NOMOS Slit Collimator (BEAK™) (NOMOS Corp.), the Peacock™ System (NOMOS Corp.), the Varian Multileaf Collimator with dynamic arc therapy feature (Varian Oncology Systems), the Saturne Multileaf Collimator (GE Medical Systems), the Mitsubishi 120 Leaf Multileaf Collimator (Mitsubishi Electronics America Inc.), the Stryker Leibinger Motorized Micro Multileaf Collimator (Stryker Leibinger), the Mini Multileaf Collimator, model KMI (MRC Systems GMBH), and the Preference® IMRT Treatment Planning Module (Northwest Medical Physics Equipment Inc.).
Related policies are –
Intensity-modulated radiotherapy (IMRT) may be considered medically necessary for the treatment of tumors of the central nervous system when the tumor is in close proximity to organs at risk (brain stem, spinal cord, cochlea and eye structures including optic nerve and chiasm, lens and retina) and 3-D CRT planning is not able to meet dose volume constraints for normal tissue tolerance. (see Policy Guidelines)
Intensity-modulated radiotherapy (IMRT) is considered not medically necessary for the treatment of tumors of the CNS for all indications not meeting the criteria above.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESOrgans at risk are defined as normal tissues whose radiation sensitivity may significantly influence treatment planning and/or prescribed radiation dose. These organs at risk may be particularly vulnerable to clinically important complications from radiation toxicity. The following table outlines radiation doses that are generally considered tolerance thresholds for these normal structures in the CNS:
Radiation tolerance doses for the cochlea have been reported to be 50 Gy
aTD 5/5, the average dose that results in a 5% complication risk within 5 years
bTD 50/5, the average dose that results in a 50% complication risk within 5 years
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/19/2012: Approved by Medical Policy Advisory Committee.
08/09/2013: Policy reviewed; no changes.
07/21/2014: Policy title changed from "Intensity Modulated Radiation Therapy (IMRT) Central Nervous System Tumors" to "Intensity-Modulated Radiotherapy: Central Nervous System Tumors." Policy description and statement updated to change "radiation therapy" to "radiotherapy." Added policy statement: Intensity-modulated radiotherapy (IMRT) is considered not medically necessary for the treatment of tumors of the CNS for all indications not meeting the criteria above.
12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 77385 and 77386. Added the following new 2015 HCPCS codes to the Code Reference section: G6015 and G6016.
08/28/2015: Medical policy revised to add ICD-10 codes.
09/16/2015: Policy reviewed; no change in policy statements. Policy Guidelines section updated to add medically necessary and investigative definitions.
SOURCE(S)Blue Cross Blue Shield Association policy #8.01.59
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.