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DESCRIPTIONRadiotherapy (RT) is an integral component in the treatment of breast and lung cancers. 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.
For certain stages of many cancers, including breast and lung, randomized clinical trials have shown that postoperative RT improves outcomes for operable patients. Adding radiation to chemotherapy also improves outcomes for those with inoperable lung tumors that have not metastasized beyond regional lymph nodes.
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 radiation therapy (2D-RT) 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 radiation therapy” (EBRT).
3-dimensional conformal radiation (3D-CRT). 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 radiation therapy (3D-CRT).
Intensity-modulated radiotherapy (IMRT). IMRT, which uses computer software, CT images, and magnetic resonance imaging (MRI), 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.
Methodologic 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.
In general, IMRT systems include intensity modulators, which control, block, or filter the intensity of radiation; and, RT planning systems, which plan the radiation dose to be delivered.
A number of intensity modulators have received marketing clearance through the U.S. Food and Drug Administration (FDA) 510(k) process. Intensity modulators include the Innocure Intensity Modulating Radiation Therapy Compensators (Innocure) decimal tissue compensator (Southeastern Radiation Products) FDA product code: IXI. Intensity modulators may be added to standard linear accelerators to deliver IMRT when used with proper treatment planning systems.
RT treatment planning systems have also received FDA 510(k) marketing clearance. These include the Prowess Panther (Prowess), TiGRT (LinaTech), Ray Dose (Ray Search Laboratories), and the eIMRT Calculator (Standard Imaging). FDA product code: MUJ.
Fully integrated IMRT systems also are available. These devices are customizable, and support all stages of IMRT delivery, including planning, treatment delivery, and health record management. One such device to receive FDA 510(k) clearance is the Varian IMRT system (Varian Medical Systems). FDA product code: IYE.
POLICYIntensity-modulated radiotherapy (IMRT) may be considered medically necessary as a technique to deliver whole breast irradiation in patients receiving treatment for left-sided breast cancer after breast-conserving surgery when all the following conditions have been met:
Intensity-modulated radiotherapy (IMRT) may be considered medically necessary in individuals with large breasts when treatment planning with 3D conformal results in hot spots (focal regions with dose variation greater than 10% of target) and the hot spots are able to be avoided with IMRT. (See Policy Guidelines.)
Intensity modulated radiotherapy (IMRT) of the breast is considered investigational as a technique of partial breast irradiation after breast-conserving surgery.
Intensity modulated radiotherapy (IMRT) of the chest wall is considered investigational as a technique of postmastectomy irradiation.
Intensity-modulated radiotherapy (IMRT) may be considered medically necessary as a technique to deliver radiation therapy in patients with lung cancer when all of the following conditions are met:
Intensity-modulated radiotherapy (IMRT) is considered not medically necessary as a technique to deliver radiation therapy in patients receiving palliative treatment for lung cancer.
IMRT is not medically necessary for the treatment of breast or lung cancer 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 GUIDELINESThe following are an example of clinical guidelines that may be used with IMRT in left-sided breast lesions:
The following are examples of criteria to define large breast size when using IMRT to avoid hot spots, as derived from randomized studies:
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 HISTORY7/23/2007: Policy added
11/15/2007: Policy approved by MPAC
5/11/2009: Policy reviewed, no changes
08/17/2010: Policy description unchanged. Policy statement regarding IMRT as a technique to deliver whole breast irradiation in patients receiving treatment for breast cancer after breast-conserving surgery was changed from investigational to not medically necessary. IMRT as a technique of partial breast irradiation after breast-conserving surgery remains investigational. Policy statement regarding use of IMRT in lung cancer was changed from investigational to not medically necessary. FEP verbiage added to the Policy Exceptions sections. Added new CPT code 77338 to the Code Reference section.
12/30/2010: Policy reviewed; no changes.
04/26/2012: Policy description updated regarding treatment techniques. Added policy statement to indicate that chest wall IMRT postmastectomy is investigational. Added policy statement to indicate that whole breast IMRT may be medically necessary in large-sized breasts. Changed policy statements regarding whole breast and lung IMRT from not medically necessary to medically necessary if certain conditions are met. Policy statement on partial breast IMRT remains investigational. Added statement to indicate that IMRT of the chest wall is considered investigational as a technique of postmastectomy irradiation. Policy guidelines updated regarding patient selection criteria. The Code Reference section was changed from non-covered to covered; added ICD-9 codes 162.3 - 162.9, 174.0 - 174.9, 175.0 - 175.9 as covered diagnoses.
08/09/2013: Policy reviewed; no changes.
07/18/2014: Policy title changed from "Intensity Modulated Radiation Therapy (IMRT) of the Breast and Lung" to "Intensity-Modulated Radiotherapy of the Breast and Lung." Policy description and statement updated to change "radiation therapy" to "radiotherapy" throughout policy. Added policy statement: IMRT is not medically necessary for the treatment of breast or lung cancer 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 description updated regarding IMRT systems. Policy statements unchanged. Policy Guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Blue Cross Blue Shield Association Policy # 8.01.46
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.