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Radiotherapy may be an integral component in the treatment of cancers of the abdomen and pelvis. Intensity-modulated radiotherapy (IMRT) has been proposed as a method of radiotherapy that allows adequate radiotherapy to the tumor while minimizing the radiation dose to surrounding normal tissues and critical structures.
Conventional External-Beam Radiotherapy
Three-Dimensional Conformal Radiation
Increased conformality may permit escalated tumor doses without increasing normal tissue toxicity, and may thus improve local tumor control. 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.
Because 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
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.
Note: Evidence for the following abdominal and pelvic cancers has not yet been reviewed and is beyond the scope of this current policy: bladder, kidney, ureter, and esophageal cancer, and sarcoma.
Related medical policies are Intensity-Modulated Radiation Therapy (IMRT) of the Prostate, Intensity Modulated Radiation Therapy (IMRT) of the Breast and Lung, and Intensity-Modulated Radiation Therapy (IMRT): Head and Neck Cancers.
POLICYIntensity-modulated radiotherapy may be considered medically necessary as an approach to delivering radiotherapy for patients with cancer of the anus/anal canal.
When dosimetric planning with standard 3-D conformal radiation predicts that the radiation dose to an adjacent organ would result in unacceptable normal tissue toxicity (see Policy Guidelines), intensity-modulated radiotherapy (IMRT) may be considered medically necessary for the treatment of cancer of the abdomen and pelvis, including but not limited to:
Intensity-modulated radiotherapy (IMRT) would be considered investigational for all other uses in the abdomen and pelvis.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
Radiation Tolerance Doses for Normal Tissues
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
In order for IMRT to provide outcomes that are superior to 3DCRT, there must be a clinically meaningful decrease in the radiation exposure to normal structures with IMRT compared to 3DCRT. There is not a standardized definition for a clinically meaningful decrease in radiation dose. In principle, a clinically meaningful decrease would signify a significant reduction in anticipated complications of radiation exposure. In order to document a clinically meaningful reduction in dose, dosimetry planning studies should demonstrate a significant decrease in the maximum dose of radiation delivered per unit of tissue, and/or a significant decrease in the volume of normal tissue exposed to potentially toxic radiation doses. While radiation tolerance dose levels for normal tissues are well-established, the decrease in the volume of tissue exposed that is needed to provide a clinically meaningful benefit has not been standardized. Therefore, precise parameters for a clinically meaningful decrease cannot be provided.
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.
POLICY HISTORY5/20/2009: Policy added
7/16/2009: Approved by Medical Policy Advisory Committee (MPAC)
08/12/2010: Policy description updated to add links to related medical policies. Policy statement revised to state that IMRT may be considered medically necessary as an approach to delivering radiation therapy for patients with squamous cell cancer of the anus/anal canal, effective 05/13/2010. IMRT remains investigational for other locations in the abdomen and pelvis. The definition of investigative service added to the policy guidelines. Coding information removed from the policy guidelines; this information is provided in the Code Reference section. FEP verbiage added to the Policy Exceptions section. All codes moved from non-covered to covered. Added CPT code 77338 and ICD-9 codes 154.2 and 154.3.
04/10/2013: Policy statement revised to state that IMRT may be considered medically necessary for the treatment of cancer of the abdomen and pelvis when dosimetric planning with standard 3-D conformal radiation predicts that the radiation dose to an adjacent organ would result in unacceptable normal tissue toxicity. IMRT remains investigational for all other uses in the abdomen and pelvis. Policy guidelines updated regarding radiation tolerance doses for normal tissues of the abdomen and pelvis.
03/13/2014: Policy reviewed; no changes.
12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 77385 and 77386. Added the following HCPCS codes to the Code Reference section: G6015, G6016.
01/27/2015: Policy description updated regarding radiation techniques. Policy statements updated to change "radiation therapy" to "radiotherapy." Removed "squamous cell" from the first medically necessary policy statement. It previously stated: Intensity modulated radiation therapy may be considered medically necessary as an approach to delivering radiation therapy for patients with squamous cell cancer of the anus/anal canal.
08/28/2015: Medical policy revised to add ICD-10 codes.
05/26/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions. Removed deleted CPT codes 77418 and 0073T from the Code Reference section.
SOURCESBlue Cross & Blue Shield Association Policy # 8.01.49
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.