Description
Radiotherapy (RT) is an integral component of the treatment of lung cancers. Intensity-modulated radiotherapy (IMRT) has been proposed as a method of RT that allows adequate radiation to the tumor while minimizing the radiation dose to surrounding normal tissues and critical structures.

For individuals who have lung cancer who receive IMRT, the evidence includes nonrandomized, retrospective, comparative studies. Relevant outcomes are OS, locoregional control, and treatment-related morbidity. Dosimetry studies have shown that IMRT can reduce radiation exposure to critical surrounding structures, especially in large lung tumors. Based on nonrandomized comparative studies, IMRT appears to produce survival outcomes comparable to those of 3D-CRT and reduce toxicity. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Clinical vetting also provided strong support for IMRT when alternative RT dosimetry exceeds a threshold of 20-Gy dose-volume (V20) to at least 35% of normal lung tissue. Based on available evidence, clinical vetting, a strong chain of evidence, and the potential to reduce harms, IMRT may be considered medically necessary for lung cancer when: (1) RT is given with curative intent, (2) alternative RT dosimetry demonstrates radiation dose exceeding V20 for at least 35% of normal lung tissue, and (3) IMRT reduces the V20 of radiation to the lung at least 10% below the V20 of 3D-CRT (e.g., 40% reduced to 30%).

Background
For certain stages of many cancers, including lung, randomized controlled trials have shown that postoperative radiotherapy (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.

RADIOTHERAPY TECHNIQUES
Conventional External-Beam Radiotherapy
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 two or three intersecting axes. Collectively, these methods are termed conventional external-beam radiotherapy.

Three-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, which uses computer software along with CT and magnetic resonance imaging images, offers better conformality than 3D-CRT because it modulates the intensity of the overlapping radiation beams projected on the target and uses multiple shaped treatment fields. Treatment planning and delivery are more complex, time-consuming, and labor-intensive for IMRT than for 3D-CRT. The technique uses a multi-leaf collimator (MLC), which, when coupled with 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, surrounding tissues, and organs at risk, computer software optimizes the location, shape, and intensities of the beam 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.

Technologic developments have produced advanced techniques that may further improve RT treatment by improving dose distribution. These techniques are considered variations of IMRT. Volumetric modulated arc therapy delivers radiation from a continuous rotation of the radiation source. The principal advantage of volumetric modulated therapy is its efficiency in treatment delivery time, reducing radiation exposure and improving target radiation delivery due to less patient motion. Image-guided RT involves the incorporation of imaging before and/or during treatment to deliver RT to the target volume more precisely.

IMRT methods to plan and deliver RT are not uniform. IMRT may use beams that remain on as MLCs move around the patient (dynamic MLC) or that are off during movement and turn on once the MLC reaches prespecified positions ("step and shoot" technique). A third alternative uses a very narrow single beam that moves spirally around the patient (tomotherapy). Each method uses different computer algorithms to plan treatment and yields somewhat different dose distributions in and outside the target. Patient position can alter target shape and thus affect treatment plans. Treatment plans are usually based on one imaging scan, a static 3D-CT image. Current methods seek to reduce positional uncertainty for tumors and adjacent normal tissues by various techniques. Patient immobilization cradles and skin or bony markers are used to minimize day-to-day variability in patient positioning. In addition, many tumors have irregular edges that preclude drawing tight margins on CT scan slices when radiation oncologists contour the tumor volume. It is unknown whether omitting some tumor cells or including some normal cells in the resulting target affects outcomes of IMRT.

Regulatory Status 
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.

Related Policies
80147 Intensity-Modulated Radiotherapy of the Prostate
80148 Intensity-Modulated Radiotherapy: Cancer of the Head and Neck or Thyroid
80149 Intensity-Modulated Radiation Therapy (IMRT): Abdomen and Pelvis
80159 Intensity-Modulated Radiotherapy: Central Nervous System Tumors

Policy:
Intensity-modulated radiation therapy (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:

• Radiation therapy is being given with curative intent
• 3-D conformal will expose > 35 percent of normal lung tissue to more than 20 Gy dose-volume (V20)
• IMRT dosimetry demonstrates reduction in the V20 to at least 10 percent below the V20 that is achieved with the 3-D plan (e.g., from 40 percent down to 30 percent or lower)

Intensity-modulated radiation therapy (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 lung cancer for all indications not meeting the criteria above.

Policy Guidelines
Table PG1 outlines radiation doses generally considered tolerance thresholds for these normal structures for the chest and abdomen. Dosimetry plans may be used to demonstrate that radiation by 3-dimensional conformal radiotherapy (3D-CRT) would exceed tolerance doses to structures at risk. 

Table PG1. Radiation Tolerance Doses for Normal Tissues of the Chest and Abdomen   

Site	TD 5/5, Graya			TD 50/5, Grayb			Complication End Point
	Portion of organ involved			Portion of organ involved
	1/3	2/3	3/3	1/3	2/3	3/3
Heart	60	45	40	70	55	50	Pericarditis
Lung	45	30	17.5	65	40	24.5	Pneumonitis
Spinal cord	50	50	47	70	70	NP	Myelitis, necrosis

Compiled from: (1) Morgan MA (2011). Radiation oncology. In DeVita, Lawrence, and Rosenberg, Cancer (p.308). Philadelphia: Lippincott Williams and Wilkins; and (2) Kehwar TS, Sharma SC. Use of normal tissue tolerance doses into linear quadratic equation to estimate normal tissue complication probability. Available at: http://www.rooj.com/Radiation%20Tissue%20Tolerance.htm. NP: not provided; TD: tolerance dose. 
^a TD 5/5 is the average dose that results in a 5% complication risk within 5 years.
^b TD 50/5 is the average dose that results in a 50% complication risk within 5 years.  

CODING
The following CPT codes are used for simple and complex IMRT delivery:

77385 Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; simple
77386 Complex.

The Centers for Medicare & Medicaid Services did not implement these CPT codes and instead created HCPCS G codes with the language of the previous CPT codes. Therefore, the following codes may be used for IMRT:

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.

Code 77301 (Intensity-modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specifications) remains valid.

The following CPT code may also be used and is to be reported only once per IMRT plan:

77338 Multi-leaf collimator (MLC) device(s) for intensity-modulated radiation therapy (IMRT), design and construction per IMRT plan. 

Benefit Application
BlueCard^®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational, and, thus, these devices may be assessed only on the basis of their medical necessity.

For contracts that do not use this definition of medical necessity, other contract provisions, including contract language concerning use of out of network providers and services, may be applied. That is, if the alternative therapies (e.g., 3-D-conformal treatments) are available in-network but IMRT therapy is not, IMRT would not be considered an in-network benefit. In addition, benefit or contract language describing the "least costly alternative" may also be applicable for this choice of treatment.

Rationale 
This evidence review was created in December 2005 and has been regularly updated with searches of the PubMed database. The most recent literature update was performed through May 25, 2021.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Multiple-dose planning studies generate 3-dimensional (3D) conformal radiotherapy (3D-CRT) and intensity-modulated radiotherapy (IMRT) treatment plans from the same scans and then compare predicted dose distributions within the target area and adjacent organs. Results of such planning studies have shown that IMRT is better than 3D-CRT with respect to conformality to, and dose homogeneity within, the target. Results have also demonstrated that IMRT delivers less radiation to nontarget areas. Dosimetry studies using stationary targets generally confirm these predictions. However, because patients move during treatment, dosimetry with stationary targets only approximate actual radiation doses received. Based on these dosimetry studies, radiation oncologists expect IMRT to improve treatment outcomes compared with those of 3D-CRT.

Comparative studies of radiation-induced adverse events from IMRT versus alternative radiation delivery would constitute definitive evidence of establishing the benefit of IMRT. Single-arm series of IMRT can give insights into the potential for benefit, particularly if an adverse event 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, absent such comparative trials, it is likely that the benefit from IMRT is at least as good as with other types of delivery.

In general, when the indication for IMRT is to avoid radiation to sensitive areas, dosimetry studies have been considered sufficient evidence to demonstrate that harm would be avoided by using IMRT. For other indications, such as using IMRT to provide better tumor control, comparative studies of health outcomes are needed to demonstrate such a benefit.

Lung Cancer
Clinical Context and Therapy Purpose
The purpose of IMRT in patients who have lung cancer is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of IMRT improve the net health outcome in patients with lung cancer?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with lung cancer.

Interventions
The therapy being considered is IMRT. Radiotherapy is an integral component of the treatment of lung cancer; IMRT has been proposed as a method of RT that allows adequate radiation to the tumor while minimizing the radiation dose to surrounding normal tissues and critical structures.

Comparators
The following therapy is currently being used to make decisions about lung cancer: 3D-CRT.

Outcomes
The general outcomes of interest are OS, disease-specific survival, locoregional control, quality of life, and treatment-related adverse events.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:  

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Bezjak et al. (2012) conducted a systematic review that examined the evidence on the use of IMRT for the treatment of lung cancer to quantify its potential benefits and make recommendations for RT programs considering adopting this technique in Ontario, Canada.²¹ This review consisted of 2 retrospective cohort studies (through March 2010) reporting on cancer outcomes, which was considered insufficient evidence on which to make evidence-based recommendations. These 2 cohort studies reported on data from the same institution; the study by Liao et al. (2010; reported below)²² indicated that patients assessed in their cohort (N = 409) were previously reported in another cohort involving 290 subjects, but it is not clear exactly how many patients were added in the second report. However, due to the known dosimetric properties of IMRT and extrapolating from clinical outcomes from other disease sites, reviewers recommended that IMRT be considered for lung cancer patients when the tumor is proximate to an organ at risk, where the target volume includes a large volume of an organ at risk, or where dose escalation would be potentially beneficial while minimizing normal tissue toxicity.²¹

Nonrandomized Comparative Studies
Liao et al. (2010) compared patients who received RT, along with chemotherapy, for inoperable non-small-cell lung cancer (NSCLC) at a single institution.²² This study retrospectively compared 318 patients who received CT plus 3D-CRT and chemotherapy from 1999 to 2004 (mean follow-up, 2.1 years) with 91 patients who received 4-dimensional CT plus IMRT and chemotherapy from 2004 to 2006 (mean follow-up, 1.3 years). Both groups received a median dose of 63 Gy. Disease endpoints were locoregional progression, distant metastasis, and OS. Disease covariates were gross tumor volume, nodal status, and histology. The toxicity endpoint was grade 3, 4, or 5 radiation pneumonitis; toxicity covariates were gross tumor volume, smoking status, and dosimetric factors. Using Cox proportional hazards models, the hazard ratios (HRs) for IMRT were less than 1 for all disease endpoints; the difference was significant only for OS. The median survival was 1.40 years for the IMRT group and 0.85 years for the 3D-CRT group. The toxicity rate was significantly lower in the IMRT group than in the 3D-CRT group. The volume of the lung receiving 20 Gy was higher in the 3D-CRT group and was a factor in determining toxicity. Freedom from distant metastasis was nearly identical in both groups. The authors concluded that treatment with 4-dimensional CT plus IMRT was at least as good as that with 3D-CRT in terms of the rates of freedom from locoregional progression and metastasis. This retrospective study found significant reductions in toxicity and improvement in survival. The nonrandomized, retrospective aspects of this study from a single center limit the ability to draw definitive treatment conclusions about IMRT.

Shirvani et al. (2013) reported on a U.S. cancer center study that assessed the use of definitive IMRT in limited-stage small-cell lung cancer treated with definitive RT.²³ In this study of 223 patients treated from 2000 to 2009, 104 received IMRT and 119 received 3D-CRT. Median follow-up times were 22 months (range, 4 to 83 months) for IMRT and 27 months (range, 2 to 147 months) for 3D-CRT. In both multivariable and propensity score-matched analyses, OS and disease-free survival did not differ between IMRT and 3D-CRT. However, rates of esophagitis-related percutaneous feeding tube placements were lower with IMRT (5%) than with 3D-CRT (17%; p = .005).

Harris et al. (2014) compared the effectiveness of IMRT, 3D-CRT, or 2D-RT in treating stage III NSCLC using a cohort of patients from the Surveillance, Epidemiology, and End Results-Medicare database treated between 2002 and 2009.²⁴ Overall survival was better with IMRT and 3D-CRT than with 2D-CRT. In univariate analysis, improvements in OS (HR, 0.90, p = .02) and cancer-specific survival (HR, 0.89, p = .02) were associated with IMRT. However, IMRT was similar to 3D-CRT after controlling for confounders in OS (HR, 0.94, p = .23) and cancer-specific survival (HR, 0.94, p = .28). On multivariate analysis, toxicity risks with IMRT and 3D-CRT were also similar. Likewise, results were similar for the propensity score-matched models and the adjusted models.

Ling et al. (2016) compared IMRT with 3D-CRT in patients who had stage III NSCLC treated with definitive RT.²⁵ In this study of 145 consecutive patients treated between 1994 and 2014, the choice of treatment was at the treating physician's discretion but all IMRT treatments were performed in the last 5 years. The authors found no significant differences between the groups for any measure of acute toxicity (grade ≥ 2 esophagitis, grade ≥ 2 pneumonitis, percutaneous endoscopic gastrostomy, narcotics, hospitalization, or weight loss). There were no significant differences in oncologic and survival outcomes.

Chun et al. (2017) reported on a secondary analysis of a trial that assessed the addition of cetuximab to a standard chemotherapy regimen and radiation dose escalation.²⁶ Use of IMRT or 3D-CRT was a stratification factor in the 2 x 2 design. Of 482 patients in the trial, 53% were treated with 3D-CRT and 47% were treated with IMRT, though treatment allocation was not randomized. Compared with the 3D-CRT group, the IMRT group had larger planning treatment volumes (486 mL vs. 427 mL, p = .005), larger planning treatment volume/volume of lung ratio (median, 0.15 vs. 0.13; p = .13), and more stage IIIB breast cancer patients (38.6% vs. 30.3%, p = .056). Even though there was an increase in treatment volume, IMRT was associated with less grade 3 or greater pneumonitis (3.5% vs. 7.9%, p = .039) and a reduced risk (odds ratio [OR], 0.41; 95% CI, 0.171 to 0.986; p = .046), with no significant differences between the groups in 2-year OS, progression-free survival, local failure, or distant metastasis-free survival.

Koshy et al. (2017) published a retrospective cohort analysis of patients with stage III NSCLC, comparing those treated with IMRT and with non-IMRT.²⁷ Using the National Cancer Database, 7,493 patients treated between 2004 and 2011 were assessed. Main outcomes were OS and the likelihood and effects of radiation treatment interruption, defined as a break in the treatment of 4 or more days. Overall survival for non-IMRT and IMRT patients, respectively, were 18.2 months and 20 months (p < .001) (Table 4). Median survival with and without a radiation treatment interruption was 16.1 and 19.8 months, respectively (p < .001), and IMRT significantly reduced the likelihood of a radiation treatment interruption (OR, 0.84; p = .04). The study was limited by unavailable information regarding RT planning and potential mechanisms affecting survival, and by a possible prescription bias, causing patients with better performance status to be given IMRT.

Appel et al. (2019) conducted another retrospective, single institution cohort evaluating the impact of radiation technique on pathological and clinical outcomes in 74 patients with locally advanced NSCLC managed with a trimodality strategy. Key study characteristics and results are presented in Tables 3 and 4. The 2-year overall local control rate was 81.6% (95% CI, 69% to 89.4%), disease-free survival was 58.3% (95% CI, 45.5% to 69%), and 3-year OS was 70% (95% CI, 57% to 80%). When comparing radiation techniques for these outcomes, there were no significant differences in local control (p = .94), disease-free survival (p = .33), or OS (p = .72). Grade 2 esophageal toxicity was non-significantly reduced with IMRT as compared to 3D-CRT (32% vs. 37%; p = .66). As with other studies, the retrospective design and single-center nature of this cohort make generalizability of the results to other cancer centers limited.

Table 2. Summary of Key Observational Comparative Study Characteristics 

Study	Study Type	Country	Dates	Participants	Treatment	Comparator	FU
Koshy et al. (2017)27	Cohort	U.S.	2004 – 2011	7493	IMRT	Non-IMRT	32 mo
Appel et al. (2019)28	Cohort	Israel	2012 – 2018	74	IMRT	3D-CRT	3.6 years (median)

3D-CRT; 3-dimensional conformal radiotherapy; FU: follow-up; IMRT: intensity-modulated radiotherapy. 

Table 3. Summary of Key Observational Comparative Study Results

Study	OS	Major Pathologic Response Rate	Pathologic Complete Response Rate
Koshy et al. (2017)27	Months
IMRT	20.0
Non-IMRT	18.2
p	< .001
Appel et al. (2019)28	2-year
IMRT % (95% CI)	85% (60 to 95)	65.2%	34.8%
3D-CRT % (95% CI)	82% (68 to 90)	62.7%	33.3%
p	.72	.83	.9

3D-CRT; 3-dimensional conformal radiotherapy; CI: confidence interval; IMRT: intensity-modulated radiotherapy; OS: overall survival.

Section Summary: Lung Cancer
For the treatment of lung cancer, no RCTs were identified that compared IMRT with 3D-CRT. Dosimetry studies have reported that IMRT can reduce radiation exposure to critical surrounding structures, especially for large lung tumors. Based on nonrandomized comparative studies, IMRT appears to produce survival outcomes comparable with those of 3D-CRT, with a reduction in adverse events.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

National Comprehensive Cancer Network
Lung Cancer
Current NCCN guidelines (v.4.2021) for non-small-cell lung cancer indicate that "More advanced technologies are appropriate when needed to deliver curative RT safely. These technologies include (but are not limited to) … IMRT/VMAT [volumetric modulated arc therapy]. … Nonrandomized comparisons of using advanced technologies versus older techniques demonstrate reduced toxicity and improved survival."³⁰

Current NCCN guidelines (v.3.2021) for small-cell lung cancer indicate that "Use of more advanced technologies is appropriate when needed to deliver adequate tumor doses while respecting normal tissue dose constraints."³¹ Intensity-modulated RT is included in the technologies listed. The guidelines also state that "IMRT is preferred over 3D conformal external-beam RT on the basis of reduced toxicity in the setting of concurrent chemotherapy/RT."

American Society for Radiation Oncology
Lung Cancer
In 2018, the American Society for Radiation Oncology also published evidence-based guidelines on RT for lung cancer. The guidelines recommended "moderately hypofractionated palliative thoracic radiation therapy" with chemotherapy as palliative care for stage III and IV incurable non-small-cell lung cancer.³³

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed in Table 4. 

Table 4. Summary of Key Trials 

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT02635009	Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer	392	April 2027
NCT01185132	A Phase III Randomized Study Comparing Intensity Modulated Planning vs 3-dimensional Planning for Accelerated Partial Breast Radiotherapy	660	July 2028
Unpublished
NCT00520702	A Randomized Trial to Compare Time To Common Toxicity Criteria for Adverse Effect (CTC AEC) 3.0 Grade Treatment Related Pneumonitis (TRP) in Patients With Locally Advanced Non-Small Cell Carcinoma (NSCLC) Receiving Concurrent Chemoradiation Radiation Treated With 3-Dimensional Conformal Radiation Therapy (3D CRT, ARM 1) vs Intensity Modulated Radiation (IMRT, ARM 2) Using 4 Dimensional CT Planning and Image-Guided Adaptive Radiation Therapy (IGART)	168	October 2018

NCT: national clinical trial.

References:   

1. Shinohara E, Whaley JT. Radiation therapy: which type is right for me? Last reviewed: March 3, 2020. https://www.oncolink.org/cancer-treatment/radiation/introduction-to-radiation-therapy/radiation-therapy-which-type-is-right-for-me. Accessed June 2, 2020
2. Kaza E, Dunlop A, Panek R, et al. Lung volume reproducibility under ABC control and self-sustained breath-holding. J Appl Clin Med Phys. Mar 2017; 18(2): 154-162. PMID 28300372
3. Kivanc H, Gultekin M, Gurkaynak M, et al. Dosimetric comparison of three-dimensional conformal radiotherapy and intensity-modulated radiotherapy for left-sided chest wall and lymphatic irradiation. J Appl Clin Med Phys. Dec 2019; 20(12): 36-44. PMID 31680445
4. Bezjak A, Rumble RB, Rodrigues G, et al. Intensity-modulated radiotherapy in the treatment of lung cancer. Clin Oncol (R Coll Radiol). Sep 2012; 24(7): 508-20. PMID 22726417
5. Liao ZX, Komaki RR, Thames HD, et al. Influence of technologic advances on outcomes in patients with unresectable, locally advanced non-small-cell lung cancer receiving concomitant chemoradiotherapy. Int J Radiat Oncol Biol Phys. Mar 01 2010; 76(3): 775-81. PMID 19515503
6. Shirvani SM, Juloori A, Allen PK, et al. Comparison of 2 common radiation therapy techniques for definitive treatment of small cell lung cancer. Int J Radiat Oncol Biol Phys. Sep 01 2013; 87(1): 139-47. PMID 23920393
7. Harris JP, Murphy JD, Hanlon AL, et al. A population-based comparative effectiveness study of radiation therapy techniques in stage III non-small cell lung cancer. Int J Radiat Oncol Biol Phys. Mar 15 2014; 88(4): 872-84. PMID 24495591
8. Ling DC, Hess CB, Chen AM, et al. Comparison of Toxicity Between Intensity-Modulated Radiotherapy and 3-Dimensional Conformal Radiotherapy for Locally Advanced Non-small-cell Lung Cancer. Clin Lung Cancer. Jan 2016; 17(1): 18-23. PMID 26303127
9. Chun SG, Hu C, Choy H, et al. Impact of Intensity-Modulated Radiation Therapy Technique for Locally Advanced Non-Small-Cell Lung Cancer: A Secondary Analysis of the NRG Oncology RTOG 0617 Randomized Clinical Trial. J Clin Oncol. Jan 2017; 35(1): 56-62. PMID 28034064
10. Koshy M, Malik R, Spiotto M, et al. Association between intensity modulated radiotherapy and survival in patients with stage III non-small cell lung cancer treated with chemoradiotherapy. Lung Cancer. Jun 2017; 108: 222-227. PMID 28625640
11. Appel S, Bar J, Ben-Nun A, et al. Comparative effectiveness of intensity modulated radiation therapy to 3-dimensional conformal radiation in locally advanced lung cancer: pathological and clinical outcomes. Br J Radiol. May 2019; 92(1097): 20180960. PMID 30864828
12. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Non-Small Cell Lung Cancer, Version 4.2021. Updated March 3, 2021. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed May 24, 2021.
13. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Small Cell Lung Cancer, Version 3.2021. Updated March 23, 2021 https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. Accessed May 23, 2021.
14. Moeller B, Balagamwala EH, Chen A, et al. Palliative thoracic radiation therapy for non-small cell lung cancer: 2018 Update of an American Society for Radiation Oncology (ASTRO) Evidence-Based Guideline. Pract Radiat Oncol. Jul 2018; 8(4): 245-250. PMID 29625898
15. Recht A, Comen EA, Fine RE, et al. Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update. Pract Radiat Oncol. Nov 2016; 6(6): e219-e234. PMID 27659727

Coding Section

Codes	Number	Description
CPT	77301	Intensity modulated radiotherapy plan, including dose volume histograms for target and critical structure partial tolerance specifications
	77338	Multi-leaf collimator (MLC) device(s) for intensity modulated radiation therapy (IMRT), design and construction per IMRT plan
	77385	Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking, when performed; simple (new code 01/01/15)
	77386	complex (new code 01/01/15)
HCPCS	G6015	Intensity modulated treatment delivery, single or multiple fields/arcs, via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session (new code 01/01/15)
	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 (new code 01/01/15)
ICD-10-CM (effective 10/01/15)	C34.00-C34.92	Malignant neoplasm of bronchus and lung code range
ICD-10-PCS (effective 10/01/15)		ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this therapy.
	DB020ZZ, DB021ZZ, DB022ZZ	Radiation oncology, respiratory system, beam radiation lung, codes by modality (photons < 1 MeV, photons 1-10 MeV and photons > 10 MeV)
Type of Service
Place of Service

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved." 

History From 2014 Forward     

04/01/2024	Annual review, no change to policy intent.
03/13/2023	Interim review, removing coverage criteria related to breast cancer treatment and migrating it to a new policy. Breast Cancer Radiation oncology. All areas of the policy has been updated.
08/23/2022	Annual review, no change to policy intent
08/12/2021	Annual review, no change to policy intent. Updating rationale and references.
08/05/2020	Annual review, no change to policy intent. Updating description, rationale and references.
08/01/2019	Annual review, no change to policy intent. Updating references.
08/15/2018	Annual review, no change to policy intent. Updating coding section of guidelines, background, rationale and references.
10/18/2017	Interim review, removing "left side" criteria related to breast cancer use of this technology. The policy is now neutral as to the right or left side use for breast cancer treatment. No other changes made.
08/15/2017	Annual review, no change to policy intent. Updating background, description, guidelines, rationale and references.
08/02/2016	Annual review, no change to policy intent.
08/26/2015	Annual review, no change to policy intent. Updated title, background, description, guidelines, rationale and references. Added coding.
08/06/2014	Annual review. Added policy verbiage to indicate this is not medically necessary if the stated criteria is not met. Added related policies. Updated guidelines, rationale and references. No change to policy intent.