Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Intensity-Modulated Radiation Therapy (IMRT) (Independence Administrators)

Policy #:09.00.17o

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Intensity-modulated radiation therapy (IMRT) is considered medically necessary and, therefore, covered if at least one of the following criteria is met for the indications listed, and when IMRT is not used as a replacement for conventional or three-dimensional conformal radiation therapy, and sparing surrounding normal tissue is of added benefit:
  • The target volume is in close proximity to critical structures that must be protected.
    • The volume of interest must be covered with narrow margins to adequately protect immediately adjacent structures.
  • An immediately adjacent area has been previously irradiated and abutting portals have been established with high precision.
  • The target volume is concave or convex, and critical normal tissues are within or around that convexity or concavity.
  • Dose escalation is planned to deliver radiation doses in excess of those commonly utilized for similar tumors with conventional treatment.
  • The use of IMRT techniques would decrease the probability of Grade 2 or Grade 3 radiation toxicity, compared with conventional radiation in greater than 15 percent of similar cases.

ABDOMEN AND PELVIS
  • Cancer of the anus/anal canal
  • Cancer of the abdomen and pelvis, including but not limited to, the following list 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:
    • Stomach (gastric)
    • Hepatobiliary tract
    • Pancreas
    • Rectal locations
    • Gynecological tumors (e.g., cervical, endometrial, and vulvar)
    • Abdominal malignancies when dose constraints to the small bowel or other normal abdominal tissue are exceeded and present administration of a therapeutic dose

BREAST AND LUNG
  • Left-sided breast cancer when used for whole-breast irradiation following breast conserving surgery when all the following criteria are met:
    • Significant cardiac radiation exposure cannot be avoided using alternative radiation techniques.
    • IMRT dosimetry demonstrates significantly reduced cardiac target volume radiation exposure.
  • Breast cancer in individuals with large breasts when treatment with 3-D conformal radiation results in hot spots (i.e., focal regions with dose variation greater than 10% of target) and the hot spots can be avoided with IMRT
  • Lung cancer when all the following criteria are met:
    • Radiation therapy is being given with curative intent.
    • 3-D conformal radiation will expose greater than 35% of normal lung tissue to more than 20 Gy dose-volume (V20).
    • IMRT dosimetry demonstrates reduction in the V20 to at least 10% below the V20 that is achieved with the 3-D plan.

CENTRAL NERVOUS SYSTEM
  • Tumors of the central nervous system (primary, metastatic, or benign) when the tumor is in close proximity to organs at risk (e.g., brain stem, spinal cord, cochlea, eye structures including optic nerve and chiasm, lens and retina) and 3-D conformal radiation planning is not able to meet dose volume constraints for normal tissue tolerance.
  • Primary or metastatic tumors of the spine where the spinal cord tolerance may be exceeded with conventional treatment or where the spinal cord has previously been irradiated.

HEAD AND NECK
  • Primary, metastatic, benign, or recurrent lesions to the head and neck area including any of the following:
    • Orbits
    • Sinuses
    • Skull base
    • Aero-digestive tract
    • Salivary glands
  • Thyroid cancers in close proximity to organs at risk (e.g., esophagus, salivary glands, and spinal cord) and 3-D conformal radiation planning is not able to meet dose volume constraints for normal tissue tolerance.

PROSTATE
  • Localized prostate cancer
  • As adjuvant therapy after radical prostatectomy when there are adverse pathological findings at prostatectomy or with a persistently detectable prostate-specific antigen (PSA) level post-prostatectomy
    • Adverse pathological findings at prostatectomy include positive surgical margins, seminal vesicle invasion, extraprostatic extension, and Gleason scores of 8 to 10
  • As salvage therapy after radical prostatectomy when there is evidence of biochemical or local recurrence when there is no evidence of distant metastatic disease
    • Biochemical recurrence is a detectable or rising PSA value after surgery that is 0.2 ng/ml or greater with a second confirmatory level of 0.2 ng/ml or greater

OTHER INDICATIONS
  • Thoracic malignancies
  • Pediatric tumors (benign or malignant)
  • Re-irradiation that meets the requirements for medical necessity listed above

EXPERIMENTAL/INVESTIGATIONAL

IMRT is considered experimental/investigational and, therefore, not covered for the following indications:
  • Partial-breast irradiation following breast-conserving surgery
  • Postmastectomy irradiation of the chest wall

NOT MEDICALLY NECESSARY

IMRT is considered not medically necessary and, therefore, not covered for the following indications:
  • As a palliative treatment option for lung cancer
  • All uses for IMRT that do not meet the above criteria are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the diagnosis or treatment of illness or injury.

IMAGE-GUIDED RADIATION THERAPY (IGRT)

When required, image-guided radiation therapy (IGRT) is considered medically necessary and, therefore, covered and eligible for separate reimbursement when used and documented with medically necessary IMRT treatment delivery.

BILLING REQUIREMENTS -- IMRT

The following Current Procedural Terminology (CPT) codes are part of the development of the IMRT treatment planning (CPT code 77301) and, therefore, considered integral and are not eligible for separate reimbursement when billed on the same date of service as the IMRT treatment plan code 77301:

CPT Code CPT Code Description
77014Computerized axial tomography guidance for placement of radiation therapy fields
77280Therapeutic radiology simulation-aided field setting, simple
77285Therapeutic radiology simulation-aided field setting, intermediate
77290Therapeutic radiology simulation-aided field setting, complex
77293Respiratory motion management simulation (List separately in addition to code for primary procedure)
77295 3-dimensional radiotherapy plan, including dose-volume histograms
77331 Special dosimetry (e.g., TLD, microdosimetry) (specify), only when prescribed by the treating physician

IMRT TREATMENT PLANNING
IMRT planning (77301) should typically reported only once per course of IMRT.

IMRT DOSIMETRY
Basic radiation dosimetry calculations (77300) arrive at the relationship between monitor units (or time) and doses, and encompass the physician's verification, review, and approval. The documentation should contain the independent check of each field, separate from the computer-generated IMRT plan. This code can be typically billed once for each IMRT beam or arc, up to a limit of ten.

IMRT TREATMENT DEVICES
Multi-leaf collimator devices for IMRT (77338), should be reported once per IMRT plan.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the following:

1. The medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

2. A prescription that defines the dose to the target and the dose constraints to the nearby critical structures.

3. A signed IMRT inverse plan that meets prescribed dose constraints for the planning target volume (PTV) and surrounding normal tissue.

4. Target verification methodology, which must include the following:
    a. Documentation of the clinical treatment volume (CTV) and the PTV
    b. Documentation of immobilization and patient positioning

6. Independent basic dose calculations of monitor units for each beam before the individual's first treatment.

7. Documentation of fluence distributions (recomputed and measured in a phantom or dosimetry measuring device).

8. Identification of structures that traverse high- and low-dose regions created by respiration (voluntary breath-holding alone is not a satisfactory solution for accounting for organ motion).

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

Intensity-modulated radiation therapy (IMRT) is excluded from the capitated radiology program and is, therefore, eligible for separate reimbursement consideration.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, IMRT is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Description

The goal of radiation therapy is to attain the highest possible tumor control or cure with the least amount of morbidity and toxicity to adjacent tissues. The achievement of optimal patient care outcomes (e.g., homogeneous radiation delivery to reduce secondary malignancies and tissue toxicity among others) requires the delivery of the desired dose distribution of ionizing radiation to target tissue while limiting the radiation dose to the surrounding tissue to an acceptable level. By taking into account axial anatomy and complex tissue contours, intensity-modulated radiation therapy (IMRT) allots for refined dose calculations and dose delivery. IMRT differs from conventional, and other conformal external beam radiation techniques, in that through the application of a multileaf collimator (MLC), the number and intensity of fields projected into the target volume are modulated. Beam modulation results in increased conformality and may permit escalated tumor doses without increasing normal tissue toxicity and thus may improve local tumor control, with decreased exposure to surrounding normal tissues.

IMRT TREATMENT PLANNING

IMRT treatment plans are geometrically more accurate and tailored to target volumes than conventional or three-dimensional radiation plans. The IMRT planning computer algorithm describes the necessary field sizes, gantry angles, and other beam characteristics needed to achieve the desired dose distribution. The essential feature of an IMRT plan is that it describes the means to deliver treatment utilizing non-uniform beam intensities.

Three-dimensional image acquisition by simulation (e.g., computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET], or similar image fusion technology) is a prerequisite to IMRT treatment planning. The physician then outlines (contours) the visible abnormality seen on each slice of the image set. The three-dimensional summation of these contours defines the gross tumor volume (GTV). The physician draws a margin around the GTV to generate a clinical target volume (CTV), which encompasses the volume of tissue at risk for microscopic disease (not visible on imaging studies). To account for potential individual set-up variation or organ and individual motion, a final margin is then added to create the planning target volume (PTV). The physician also contours nearby normal structures that potentially could be damaged by radiation (“organs at risk”).

The physician assigns specific dose requirements for the PTV (i.e., minimum dose and dose homogeneity) and dose constraints for the organs at risk (i.e., maximum allowable doses). A treatment plan that satisfies these requirements and constraints should maximize the potential for disease control and minimize the risk of radiation injury to normal tissue.

The radiation physicist or a supervised dosimetrist calculates a complex multi-beam treatment plan to deliver the dose to the PTV and satisfy the normal tissue dose constraints. The radiation beam is, in effect, a collection of “beamlets,” each with a different level of radiation intensity. The summation of these “beamlets” distributes the characteristic, highly conformal IMRT dose. The PTV, therefore, receives a high dose of radiation while nearby organs receive significantly lower doses.

Prior to treatment delivery, the physicist performs basic dose calculations on each of the modulated beams. These specific monitor unit computations verify through a second dose calculation method (independent of treatment planning) that the computer has correctly performed the treatment planning calculations. The calculated beams are then delivered to either a phantom or a dosimetry measuring device to confirm that the point dose and dose distribution are physically verifiable and that the intensity-modulated beams are technically feasible.

IMRT TREATMENT DELIVERY

IMRT treatment delivery can be accomplished through a variety of technologies. The most common approach utilizes a multi-leaf collimator (MLC) to modulate the intensity of the beam. The basic requirement for all forms of IMRT treatment delivery is that the technology must accurately produce the calculated dose distribution described by the IMRT plan. IMRT techniques utilize either fixed gantry or moving gantry technology, and include the following:
  • Static MLC (step and shoot), where the leaves do not move when the beam is on
  • Dynamic MLC (sliding window), where the leaves move during treatment
  • Fan-beam therapy, which uses a binary collimator to deliver slice-by-slice treatment
  • Intensity-modulated arc therapy, in which the gantry rotates while moving MLCs create a non-uniform dose to the PTV during individual arc segments

A different technical solution for IMRT is to use a solid compensator with varying thickness filters to modulate the beam.

The highly conformal dose distribution produced by IMRT results in much sharper spatial dose gradients than conventional or three-dimensional conformal radiation therapy. Consequently, small changes in individual or target position within the body can cause large changes in the dose delivered to the PTV and to the organs at risk. Thus, individual immobilization is required for precision IMRT. Changes in the location of the target within the body during a single fraction can arise from respiratory motion or other physiologic variances. To accommodate such changes, the PTV may be drawn based upon published studies of organ motion or on dynamic imaging studies; treatment delivery may also be actively modulated by direct measures of motion during treatment.

Following the treatment planning, simulation directs the treatment beams to the specific volume of interest. Simulation may be carried out using a conventional simulator, CT scanner, radiation therapy treatment unit (e.g., linear accelerator), or diagnostic imaging equipment (e.g., fluoroscopy, CT, MR). The typical course of radiation therapy requires between one and three simulations performed on various days. Simulations are described as: simple, intermediate, complex, and three-dimensional.

Basic radiation dosimetry is a separate service from IMRT planning. The radiation dose delivered by each IMRT beam must be calculated and verified before the course of radiation treatment begins.

Treatment devices are used in conjunction with the delivery of IMRT radiotherapy. The devices ensure that the beam is accurately on target.

Medical radiation physics consultation includes assessment of the treatment parameters, quality assurance of dose delivery, and review of the treatment documentation in support of the radiation oncologist.

IMAGE-GUIDED RADIATION THERAPY (IGRT)

IGRT utilizes imaging technology (e.g., ultrasound, kilovoltage or megavoltage cone beam CT scan, stereoscopic X-ray) to modify treatment delivery to account for changes in the position of the intended target and to guide the delivery of radiation to the PTV. IGRT is used in conjunction with IMRT in individuals whose tumors are located near or within critical structures and/or in tissue with inherent setup variation.
References


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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

77014, 77280, 77285, 77290, 77293, 77295, 77300, 77301, 77321, 77331, 77332, 77333, 77334, 77336, 77338, 77370, 77385, 77386, 77387


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medical necessity as listed in the policy.


HCPCS Level II Code Number(s)



G6001 Ultrasonic guidance for placement of radiation therapy fields

G6002 Stereoscopic x-ray guidance for localization of target volume for the delivery of radiation therapy

G6015 Intensity modulated treatment delivery, single or multiple fields/arcs,via narrow spatially and temporally modulated beams, binary, dynamic mlc, per treatment session

G6016 Compensator-based beam modulation treatment delivery of inverse planned treatment using 3 or more high resolution (milled or cast) compensator, convergent beam modulated fields, per treatment session


Revenue Code Number(s)

0333 Radiology-Therapeutic and/or Chemotherapy Administration-Radiation Therapy

Coding and Billing Requirements



Policy History

Revisions from 09.00.17o:
01/01/2019This policy has been identified for the CPT code update, effective 01/01/2019.

The following CPT narrative has been revised in this policy:

77387:

FROM: Guidance for localization of target volume for delivery of radiation treatment delivery, includes intrafraction tracking, when performed

TO: Guidance for localization of target volume for delivery of radiation treatment, includes intrafraction tracking, when performed

Revisions from 09.00.17n:
11/21/2018This policy has been reissued in accordance with the Company's annual review process.
11/17/2017The following changes were made to the Policy Section:

ABDOMEN AND PELVIS

The following indication was added as Medically Necessary under cancer of the abdomen and pelvis:
  • Abdominal malignancies when dose constraints to the small bowel or other normal abdominal tissue are exceeded and present administration of a therapeutic dose

CENTRAL NERVOUS SYSTEM

The following coverage statement was revised:
    FROM:
    Tumors of the central nervous system (primary or metastatic) when the tumor is in close proximity to organs at risk (e.g., brain stem, spinal cord, cochlea, eye structures).
    TO:
    Tumors of the central nervous system (primary, metastatic, or benign) when the tumor is in close proximity to organs at risk (e.g., brain stem, spinal cord, cochlea, eye structures including optic nerve and chiasm, lens and retina) and 3-D conformal radiation planning is not able to meet dose volume constraints for normal tissue tolerance.

The following indication was added as Medically Necessary:
    Primary or metastatic tumors of the spine where the spinal cord tolerance may be exceeded with conventional treatment or where the spinal cord has previously been irradiated.

HEAD AND NECK

The following coverage statements were revised:
    FROM:
    • Primary, metastatic, or benign lesions to the head and neck area including any of the following:
        • Orbits
        • Sinuses
        • Skull base
        • Aero-digestive tract
        • Salivary glands
    • Thyroid cancers in close proximity to organs at risk (e.g., esophagus, salivary glands, and spinal cord)
    TO:
    • Primary, metastatic, benign or recurrent lesions to the head and neck area including any of the following:
        • Orbits
        • Sinuses
        • Skull base
        • Aero-digestive tract
        • Salivary glands
    • Thyroid cancers in close proximity to organs at risk (e.g., esophagus, salivary glands, and spinal cord) and 3-D conformal radiation planning is not able to meet dose volume constraints for normal tissue tolerance.

PROSTATE

The following coverage statement was revised:
    FROM:
    • As salvage therapy when there is evidence of biochemical or local recurrence when there is no evidence of distant metastatic disease
    TO:
    • As salvage therapy after radical prostatectomy when there is evidence of biochemical or local recurrence when there is no evidence of distant metastatic disease

OTHER INDICATIONS

The following indication was added as Medically Necessary under Other Indications:
  • Thoracic malignancies

The following CPT Codes were removed from the table located under Billing Requirements: 76376, 76377, 77306, 77307

CODING

The following CPT Codes were removed from the Coding Table: 76376, 76377, 77306, 77307


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 01/03/2019
Version Reissued Date: N/A

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