Coverage Policy Manual
Policy #: 2003015
Category: Radiology
Initiated: June 2003
Last Review: November 2018
  Intensity Modulated Radiation Therapy (IMRT)

Description:
Intensity modulated radiation therapy (IMRT) refers to a technique of conformal radiation planning and delivery that is designed to better target the lesion, thus sparing surrounding normal tissue and ultimately limiting side effects. The reduced morbidity may also permit higher dosing to the target lesions, thus reducing the risk of local recurrence. One distinguishing feature if IMRT is that the radiation fluence varies across the beam, in contrast to conventional radiation therapy in which a homogeneous radiation dose is delivered to the tumor target, minimally modulated by the use of traditional wedges, blocks and compensators. Specifically in IMRT, non-uniform intensities are assigned to tiny subdivisions of beams, called “beamlets,” enabling custom design of optimum dose distributions.
 
The decision process for using IMRT requires an understanding of accepted practices that take into account the risks and benefits for such therapy compared to conventional treatment techniques. While IMRT technology may empirically offer advantages over conventional or 3-Dimensional conformal radiation, a comprehensive understanding of all consequences is required before applying this technology.
 
There is considerable documentation required in the medical record to support the use of IMRT.
 
Related policies:
2009036_Intensity Modulated Radiation Therapy (IMRT)_Breast
2009034_Intensity Modulated Radiation Therapy (IMRT)_Prostate
2011071_Intensity Modulated Radiation Therapy (IMRT)_Anus, Anal Canal
2009035_Intensity Modulated Radiation Therapy (IMRT)_Lung

Policy/
Coverage:
Effective November 2018
 
IMRT meets primary coverage criteria for effectiveness and is covered for:
 
    • Treatment of radiosensitive tumors of the brain, head, neck, thyroid, spine and paraspinal regions; or
    • Treatment of pleural mesothelioma if done as a component of a curative treatment regimen.
    • Treatment of inguinal and axillary area for locally advanced malignant melanoma and Merkel cell carcinoma.
 
IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
Effective Prior to November 2018
 
IMRT meets primary coverage criteria for effectiveness and is covered for:
 
    • Treatment of radiosensitive tumors of the brain, head, neck, thyroid, spine and paraspinal regions; or
    • Treatment of pleural mesothelioma if done as a component of a curative treatment regimen.
    • Treatment of inguinal and axillary area for locally advanced malignant melanoma.
 
IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
Effective Prior to February 2017
 
IMRT meets primary coverage criteria for effectiveness and is covered for:
 
    • Treatment of radiosensitive tumors of the brain, head, neck, thyroid, spine and paraspinal regions; or
    • Treatment of pleural mesothelioma if done as a component of a curative treatment regimen.
 
IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Codes for IMRT planning and therapy delivery are not to be used for services associated with stereotactic radiosurgery.
 
Effective prior to July 2012
 
IMRT  meets primary coverage criteria for effectiveness and is covered for:
 
    • Treatment of radiosensitive tumors of the brain, head, neck, spine and paraspinal regions; or
    • Treatment of pleural mesothelioma if done as a component of a curative treatment regimen.
 
IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, IMRT for patients with lung cancer, breast cancer, abdominal cancers and cancers of unknown primary, the treatment of primary sites when metastatic disease is already documented, the combined use of IMRT and brachytherapy and any other condition not listed above is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Codes for IMRT planning and therapy delivery are not to be used for services associated with stereotactic radiosurgery.

Rationale:
2012 Update
This policy update focuses on IMRT for thyroid cancer. Studies on the use of IMRT for thyroid cancers are few. In thyroid cancer, radiation therapy is generally used for 2 indications. The first indication is treatment of anaplastic thyroid cancer, and the second indication is potential use for locoregional control in patients with incompletely resected high-risk or recurrent differentiated (papillary, follicular, or mixed papillary-follicular) thyroid cancer. Anaplastic thyroid cancer occurs in a minority (less than 5%) of thyroid cancer. The largest series comparing IMRT to 3D-CRT was published by Bhatia and colleagues (Bhatia, 2010). This study reviewed institutional outcomes for anaplastic thyroid cancer treated with 3D-CRT or IMRT for 53 consecutive patients. Thirty-one (58%) patients were irradiated with curative intent. Median radiation dose was 55 gray (Gy; range, 4-70 Gy). Thirteen (25%) patients received IMRT to a median 60 Gy (range, 39.9-69.0 Gy). The Kaplan-Meier estimate of OS at 1 year for definitively irradiated patients was 29%. Patients without distant metastases receiving 50 Gy or higher had superior survival outcomes; in this series, use of IMRT versus 3D-CRT did not influence toxicity. The authors concluded that outcomes for anaplastic thyroid cancer treated with 3D-CRT or IMRT remain equivalent to historic results and that healthy patients with localized disease who tolerate full-dose irradiation can potentially enjoy prolonged survival. Schwartz and colleagues reviewed institutional outcomes for patients treated for differentiated thyroid cancer with postoperative conformal external beam radiotherapy (Schwartz, 2009).  This was a single-institution retrospective review of 131 consecutive patients with differentiated thyroid cancer who underwent RT between January 1996 and December 2005. Histologic diagnoses included 104 papillary, 21 follicular, and 6 mixed papillary-follicular types. Thirty-four patients (26%) had high-risk histologic types and 76 (58%) had recurrent disease. Extraglandular disease spread was seen in 126 patients (96%), microscopically positive surgical margins were seen in 62 patients (47%), and gross residual disease was seen in 15 patients (11%). Median RT dose was 60 Gy (range, 38-72 Gy). Fifty-seven patients (44%) were treated with IMRT to a median dose of 60 Gy (range, 56-66 Gy). Median follow-up was 38 months (range, 0-134 months). Kaplan-Meier estimates of locoregional relapse-free survival, disease-specific survival, and OS at 4 years were 79%, 76%, and 73%, respectively. On multivariate analysis, high-risk histologic features, M1 (metastatic) disease, and gross residual disease were predictors for inferior disease-specific and OS. IMRT did not impact survival outcomes but was associated with less frequent severe late morbidity (12% vs. 2%, respectively), primarily esophageal stricture. The authors concluded that conformal external beam radiotherapy provides durable locoregional disease control for patients with high-risk differentiated thyroid cancer if disease is reduced to microscopic burden and that IMRT may reduce chronic radiation morbidity, but additional study is required.
 
There are limited data on use of IMRT for thyroid cancer. The published literature consists of small case series with limited comparison among techniques for delivering radiation therapy. Due to the limitations in this evidence, expert opinion was obtained. There was near-uniform consensus that the use of IMRT for thyroid tumors may be appropriate in some circumstances such as for anaplastic thyroid carcinoma or for thyroid tumors that are located near critical structures such as the salivary glands or spinal cord. When possible adverse events could result if nearby critical structures receive toxic radiation doses, the ability to improve dosimetry with IMRT should be accepted as meaningful evidence for its benefit. The expert opinion combined with a strong indirect chain of evidence and the potential to reduce harms, led to the decision that the coverage statement will be change to allow IMRT for thyroid cancer.
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Brain Metastases
A retrospective study published in 2014 was designed to evaluate the feasibility of whole-brain RT (WBRT) plus simultaneous integrated boost (SIB) with intensity-modulated radiotherapy (IMRT) for inoperable brain metastases of NSCLC (Zhou, 2014). Twenty-nine NSCLC patients with 87 inoperable brain metastases were included. All patients received WBRT at a dose of 40 Gy and SIB boost with IMRT at a dose of 20 Gy concurrent with WBRT in the fourth week. Prior to each fraction of IG-IMRT boost, on-line positioning verification and correction were used to ensure that the set-up errors were within 2 mm by cone beam computed tomography in all patients. The one-year intracranial control rate (ICR), local brain failure rate (BFR), and distant BFR were 63%, 14%, and 19%, respectively. The two-year ICR, local BFR, and distant BFR were 42%, 31%, and 36%, respectively. Both median intracranial PFS and median OS were 10 months. Six-month, one-year, and two-year OS rates were 66%, 41%, and 14%. Patients with Score Index for Radiosurgery in Brain Metastases (SIR) >5, number of intracranial lesions <3, and history of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment had better survival. Radiation necrosis was observed in 3 (3.5%) lesions after radiotherapy. Grades 2 and 3 cognitive impairment with grade 2 radiation leukoencephalopathy were observed in 4 (14%) and 4 (14%) patients. No dosimetric parameters were found to be associated with these late toxicities. Patients who received EGFR-TKI treatment had higher incidence of grades 2-3 cognitive impairment with grade leukoencephalopathy. This evidence suggests WBRT plus SIB with IMRT is a tolerable treatment for NSCLC patients with inoperable brain metastases. However, the evidence does not allow conclusions as to its efficacy.
 
A search of ClinicalTrials.gov on January 2016 did not identify any ongoing or unpublished trials that would likely alter this policy.
 
2017 Update
A literature search conducted through February 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Radiation therapy targeting axilla and groin lymph nodes improves regional disease control in locally advanced and high-risk skin cancers. However, trials generally used conventional two-dimensional radiotherapy (2D-RT), contributing towards relatively high rates of side effects from treatment. The goal of this study by Mattes and colleagues is to determine if three-dimensional conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), or volumetric-modulated arc therapy (VMAT) may improve radiation delivery to the target while avoiding organs at risk in the clinical context of skin cancer regional nodal irradiation (Mattes, 2016).Twenty patients with locally advanced/high-risk skin cancers underwent computed tomography simulation. The relevant axilla or groin planning target volumes and organs at risk were delineated using standard definitions. Paired t-tests were used to compare the mean values of several dose-volumetric parameters for each of the 4 techniques. In the axilla, the largest improvement for 3D-CRT compared to 2D-RT was for homogeneity index (13.9 vs. 54.3), at the expense of higher lung V20 (28.0% vs. 12.6%). In the groin, the largest improvements for 3D-CRT compared to 2D-RT were for anorectum Dmax (13.6 vs. 38.9 Gy), bowel D200cc (7.3 vs. 23.1 Gy), femur D50 (34.6 vs. 57.2 Gy), and genitalia Dmax (37.6 vs. 51.1 Gy). IMRT had further improvements compared to 3D-CRT for humerus Dmean (16.9 vs. 22.4 Gy), brachial plexus D5 (57.4 vs. 61.3 Gy), bladder D5 (26.8 vs. 36.5 Gy), and femur D50 (18.7 vs. 34.6 Gy). Fewer differences were observed between IMRT and VMAT. Compared to 2D-RT and 3D-CRT, IMRT and VMAT had dosimetric advantages in the treatment of nodal regions of skin cancer patients.
 
Radiotherapy after lymph node dissection is recommended in high-risk melanoma cases. The aim of this study by Adams and colleagues is to assess whether intensity-modulated radiotherapy (IMRT) offers advantages over three-dimensional conformal radiotherapy (3DCRT) in the groin nodal basin (Adams, 2017). Fifteen consecutively treated patients (5 3DCRT and 10 IMRT) were selected. Optimized theoretical plans using the other modality were created - enabling direct comparisons of 3DCRT and IMRT. Target volume and organs at risk constraints were assessed as achieved or as having minor (≤5%) or major (>5%) deviations. The Wilcoxon signed-rank test was used to compare the dose received from each patient plan (3DCRT vs. IMRT), whereas the Mann-Whitney U-test was used to compare clinical plans with theoretical plans. Fisher's exact test was used to compare categorical data. Target coverage was achievable in most patients (major deviations - 1 IMRT and 3 3DCRT). Conformity index improved with IMRT - median 0.65, range 0.48-0.81, versus median 0.44, range 0.29-0.60 for 3DCRT; P value less than 0.001. All 3DCRT plans had major deviations for femoral head/neck constraints. Twelve and 13 IMRT plans achieved the high (V42<5%) and low (V36<35%) constraints; P value less than 0.001. IMRT delivered statistically significant lower doses to small bowel volumes up to 40 ml. There were no differences in beam numbers used nor dosimetric endpoints measured when clinical plans were compared with theoretical plans. IMRT appears to allow superior conformity of dose to the target volume while relatively sparing the adjacent the bowel and femoral head/neck. This may reduce toxicity while maintaining control rates.
 
2018 Update
A literature search was conducted through January 2018. There was no new information that would prompt a change in the coverage statement.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The goal of the study by Mattes et al was to determine if three-dimensional conformal radiation therapy (3D-DRT), intensity-modulated radiation therapy (IMRT), or volumetric-modulated arc therapy (VMAT) improve radiation delivery to the target while avoiding organs at risk in the clinical context of skin cancer regional nodal irradiation (Mattes, 2016).
 
Twenty patients with locally advanced/high-risk skin cancers received computed tomography simulation. The relevant axilla or groin planning target volumes and organs at risk were delineated using standard definitions. Paired t-tests were used to compare the mean values of several dose-volumetric parameters for each of the 4 techniques (Mattes, 2016).
 
In the axilla, the largest improvement for 3D-CRT compared to 2D-RT was for homogeneity index (13.9 vs. 54.3), at the expense of higher lung V20 (28.0% vs. 12.6%). In the groin, the largest improvements for 3D-CRT compared to 2D-RT were for anorectum Dmax (13.6 vs. 38.9 Gy), bowel D200cc (7.3 vs. 23.1 Gy), femur D50 (34.6 vs. 57.2 Gy), and genitalia Dmax (37.6 vs. 51.1 Gy). IMRT had further improvements compared to 3D-CRT for humerus Dmean (16.9 vs. 22.4 Gy), brachial plexus D5 (57.4 vs. 61.3 Gy), bladder D5 (26.8 vs. 36.5 Gy), and femur D50 (18.7 vs. 34.6 Gy). Fewer differences were observed between IMRT and VMAT (Mattes, 2016).
 
In conclusuion, 3D-CRT, IMRT and VMAT had dosimetric advantages in the treatment of nodal regions of skin cancer patients compared to 2D-RT (Mattes, 2016).

CPT/HCPCS:
77301Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specifications
77338Multi-leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and construction per IMRT plan
77385Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; simple
77386Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; complex
77387Guidance for localization of target volume for delivery of radiation treatment delivery, includes intrafraction tracking, when performed
G6015Intensity modulated treatment delivery, single or multiple fields/arcs, via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session
G6016Compensator-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

References: Bhatia A, Rao A, Ang KK et al.(2010) Anaplastic thyroid cancer: Clinical outcomes with conformal radiotherapy. Head Neck 2010; 32(7):829-36.

Adams EJ, Nutting CM, Convery DJ, et al.(2001) Potential role of intensity modulated radiotherapy in the treatment of tumors of the maxillary sinus. Int J Radiat Oncol Biol Phys 2001; 51:579-88.

Adams G, Foote M, Brown S, et al.(2017) Adjuvant external beam radiotherapy after therapeutic groin lymphadenectomy for patients with melanoma: a dosimetric comparison of three-dimensional conformal and intensity-modulated radiotherapy techniques. Melanoma Res. 2017 Feb;27(1):50-56.

Arthur DW, Morris MM, Vicini FA.(2004) Breast cancer: new radiation treatment options. Oncology 2004; 18:1621-9.

Ashman JB, Zelefsky MJ, et al.(2005) Whole pelvic radiotherapy for prostate cancer using 3D conformal and intensity modulated radiotherapy. Int J Radiat Oncol Biol 2005; May 20[Epub ahead print].

Bhatnagar AK, Brandner E, et al.(2004) Intensity-modulated radiation therapy (IMRT) reduces the dose to the contralateral breast when compared to conventional tangential fields for primary breast irradiation: initial report. Cancer J 2004; 10:381-5.

Bucci, MK, Bevan, A, Roach III, M.(2005) Advances in Radiation Therapy: Conventional to 3D, to IMRT, to 4D, and Beyond. CA Cancer J Clin 2005; 55(2):117-34.

Chao KS, Majhail N, Huang CJ, et al.(2001) Intensity modulated radiation therapy reduces late salivary toxicity without compromising tumor control in patients with oropharyngeal carcinoma: A comparison with conventional techniques. Radiother Oncol 2001; 61:275-80.

Cozzi L, Fogliata A, Lomax A, et al.(2001) A treatment planning comparison of 3D conformal therapy, intensity modulated photon therapy and proton therapy for treatment of advanced head and neck tumors. Radiother Oncol 2001; 61:287-97.

Eisbruch A, Kim HM, Terrell JE, et al.(2001) Xerostomia and its predictors following parotid-sparing irradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys 2001; 50:695-704.

Guerrero M, Li XA, et al.(2004) Simultaneous integrated boost for breast cancer using IMRT: a radiobiological and treatment planning study. Int J Radiat Oncol Biol Phys 2004; 59:1513-22.

Guerrero Urbano MT, Nutting CM.(2004) Clinical use of intensity-modulated radiotherapy: part 1. Br J Radiol 2004; 77:88-96.

Haffty BG, Buchholz TA, McCormick B.(2008) Should IMRT be the standard of care in the conservatively managed breast care patient. J Clin Oncol, 2008; 26:[epub 2/19/08].

Harris EER, Correa C, Hwang W, et al.(2006) Late Cardiac Mortality and Morbidity in Early-Stage Breast Cancer Patients After Breast-Conservation Treatment. J Clin Oncol 2006; 24.

Li JS, Freedman GM, et al.(2004) Clinical implementation of intensity-modulated tangential beam irradiation for breast cancer. Med Phys 2004; 31:1023-31.

Mattes MD, Zhou Y, Berry SL, et al.(2016) Dosimetric comparison of axilla and groin radiotherapy techniques for high-risk and locally advanced skin cancer. Radiat Oncol J. 2016 Jun;34(2):145-55. doi: 10.3857/roj.2015.01592. Epub 2016 Jun 17.

Mattes MD, Zhou Y, Berry SL, et al.(2016) Dosimetric comparison of axilla and groin radiotherapy techniques for high-risk and locally advanced skin cancer. Radiat Oncol J. 2016 Jun;34(2):145-55. doi: 10.3857/roj.2015.01592. Epub 2016 Jun 17.

Mattes MD, Zhou Y, Berry SL, et. al.(2005) The National Cancer Institute Guidelines for the Use of Intensity-Modulated Radiation Therapy in Clinical Trials. National Cancer Institute Guidelines; 2005.

Murshed H, Liu HH, et al.(2004) Dose and volume reduction for normal lung using intensity-modulated radiotherapy for advanced stage non-small-cell lung cancer. Int J Radiat Oncol Biol Phys 2004; 58:1258-67.

Nutting CM, Convery DJ, Cosgrove VP, et al.(2001) Improvements in target coverage and reduced spinal cord irradiation using intensity-modulated radiotherapy in patients with carcinoma of the thyroid gland. Radiother Oncol 2001; 60:173-80.

Nutting CM, Rowbottom CG, Cosgrove VP, et al.(2001) Optimization of radiotherapy for carcinoma of the parotid gland: A comparison of conventional, three dimensional conformal and intensity-modulated technique. Radiother Oncol 2001; 60:163-70.

Patel RR, Das RK.(2006) Image-guided breast brachytherapy: an alternative to whole-breast radiotherapy. Lancet Oncol 2006; 7:407-15.

Pignol JP, Olivotto I, et al.(2008) A multicenter randomized trial of breast intenstiy-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol, 2008; 26:[epub 2/19/08].

Recht A.(2005) Lessons of Studies of Breast-Conserving Therapy With and Without Whole-Breast Irradiation for Patient Selection for Partial-Breast Irradiation. Semin Radiat Oncol 2005; 15:123-132.

Schwartz DL, Lobo MJ, Ang KK et al.(2009) Postoperative external beam radiotherapy for differentiated thyroid cancer: outcomes and morbidity with conformal treatment. Int J Radiat Oncol Biol Phys 2009; 74(4):1083-91.

Schwartz GF, Veronesi U, Clough KB, et al.(2006) Consensus Conference on Breast Conservation. American College of Surgeons 2006; 203(2);198-207.

Taghian AG, Kozak KR, Doppke KP, et al.(2006) Initial dosimetric experience using simple three-dimensional conformal external-beam accelerated partial-breast irradiation. Int J Radiat Oncol Biol Phys Mar 15 2006; 64(4):1092-9.

Vicini F, Winter K, Straube W, et al.(2005) A phase I/II trial to evaluate three-dimensional conformal radiation therapy confined to the region of the lumpectomy cavity for Stage I/II breast carcinoma: initial report of feasibility and reproducibility of Radiation Therapy Oncology Group (RTOG) Stu3 Int J Radiat Oncol Biol Phys 2005; 63(5):1531-7.

Weed DW, Edmundson GK, Vicini FA, et al.(2005) Accelerated partial breast irradiation: a dosimetric comparison of three different techniques. Brachytherapy 2005; 4(2):121-9.

Zelefsky MJ, Fuks Z, Hunt M, et al.(2001) High dose radiation delivered by intensity modulated conformal radiotherapy improves the outcomes of localized prostate cancer. J Urol 2001:166:876-881.

Zhou L, Liu J, Xue J, et al.(2014) Whole brain radiotherapy plus simultaneous in-field boost with image guided intensitymodulated radiotherapy for brain metastases of non-small cell lung cancer. Radiat Oncol. 2014;9:117. PMID 24884773


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2019 American Medical Association.