ARCHIVED Radiation Therapy (excludes Proton) 2021-11-07 to 2022-03-12

CLINICAL APPROPRIATENESS GUIDELINES

RADIATION ONCOLOGY

Appropriate Use Criteria: Brachytherapy, Intensity Modulated Radiation Therapy, Stereotactic Body Radiation Therapy, and Stereotactic Radiosurgery

EFFECTIVE NOVEMBER 7, 2021

ARCHIVED MARCH 13, 2022

This document has been archived because it has outdated information. It is for historical information only and should not be consulted for clinical use. Current versions of guidelines are available on the Carelon Medical Benefits Management website here.

Proprietary

RAD02-1121.2

Approval and implementation dates for specific health plans may vary. Please consult the applicable health plan for more details.

Carelon disclaims any responsibility for the completeness or accuracy of the information contained herein.

CLINICAL APPROPRIATENESS GUIDELINES

Description and Application of the Guidelines

General Clinical Guideline

Guidelines for Radiation Oncology

Image Guidance in Radiation Oncology

Special Treatment Procedure and Special Physics Consult

Central Nervous System Cancers: Intracranial, Spinal, Ocular, and Neurologic Indications

Colorectal and Anal Cancers

Gastrointestinal Cancers, Non-Colorectal: Cholangiocarcinoma, Esophageal, Gastric, Liver, Pancreatic

Genitourinary Cancers: Bladder, Penile, and Testicular

Gynecologic Cancers: Cervical, Fallopian Tube, Ovarian, Uterine, and Vulvar/Vaginal

Head and Neck Cancers (including Thyroid)

Lung Cancer: Small Cell and Non-Small Cell

Lymphoma: Hodgkin and Non-Hodgkin

Oligometastatic Extracranial Disease

Other Tumor Types: Sarcoma, Thymoma and Thymic Carcinoma, Pediatric Tumors, and Other Malignancies

Appendix. Procedure Code Groupers

History

Description and Application of the Guidelines

The Carelon Clinical Appropriateness Guidelines (hereinafter “the Carelon Clinical Appropriateness Guidelines” or the “Guidelines”) are designed to assist providers in making the most appropriate treatment decision for a specific clinical condition for an individual. As used by Carelon, the Guidelines establish objective and evidence-based criteria for medical necessity determinations where possible. In the process, multiple functions are accomplished:

To establish criteria for when services are medically necessary
To assist the practitioner as an educational tool
To encourage standardization of medical practice patterns
To curtail the performance of inappropriate and/or duplicate services
To advocate for patient safety concerns
To enhance the quality of health care
To promote the most efficient and cost-effective use of services

The Carelon guideline development process complies with applicable accreditation standards, including the requirement that the Guidelines be developed with involvement from appropriate providers with current clinical expertise relevant to the Guidelines under review and be based on the most up-to-date clinical principles and best practices. Relevant citations are included in the References section attached to each Guideline. Carelon reviews all of its Guidelines at least annually.

Carelon makes its Guidelines publicly available on its website twenty-four hours a day, seven days a week. Copies of the Carelon Clinical Appropriateness Guidelines are also available upon oral or written request. Although the Guidelines are publicly-available, Carelon considers the Guidelines to be important, proprietary information of Carelon, which cannot be sold, assigned, leased, licensed, reproduced or distributed without the written consent of Carelon.

Carelon applies objective and evidence-based criteria, and takes individual circumstances and the local delivery system into account when determining the medical appropriateness of health care services. The Carelon Guidelines are just guidelines for the provision of specialty health services. These criteria are designed to guide both providers and reviewers to the most appropriate services based on a patient’s unique circumstances. In all cases, clinical judgment consistent with the standards of good medical practice should be used when applying the Guidelines. Guideline determinations are made based on the information provided at the time of the request. It is expected that medical necessity decisions may change as new information is provided or based on unique aspects of the patient’s condition. The treating clinician has final authority and responsibility for treatment decisions regarding the care of the patient and for justifying and demonstrating the existence of medical necessity for the requested service. The Guidelines are not a substitute for the experience and judgment of a physician or other health care professionals. Any clinician seeking to apply or consult the Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment.

The Guidelines do not address coverage, benefit or other plan specific issues. Applicable federal and state coverage mandates take precedence over these clinical guidelines. If requested by a health plan, Carelon will review requests based on health plan medical policy/guidelines in lieu of the Carelon Guidelines.

The Guidelines may also be used by the health plan or by Carelon for purposes of provider education, or to review the medical necessity of services by any provider who has been notified of the need for medical necessity review, due to billing practices or claims that are not consistent with other providers in terms of frequency or some other manner.

General Clinical Guideline

Clinical Appropriateness Framework

Critical to any finding of clinical appropriateness under the guidelines for a specific diagnostic or therapeutic intervention are the following elements:

Prior to any intervention, it is essential that the clinician confirm the diagnosis or establish its pretest likelihood based on a complete evaluation of the patient. This includes a history and physical examination and, where applicable, a review of relevant laboratory studies, diagnostic testing, and response to prior therapeutic intervention.
The anticipated benefit of the recommended intervention should outweigh any potential harms that may result (net benefit).
Current literature and/or standards of medical practice should support that the recommended intervention offers the greatest net benefit among competing alternatives.
Based on the clinical evaluation, current literature, and standards of medical practice, there exists a reasonable likelihood that the intervention will change management and/or lead to an improved outcome for the patient.

If these elements are not established with respect to a given request, the determination of appropriateness will most likely require a peer-to-peer conversation to understand the individual and unique facts that would supersede the requirements set forth above. During the peer-to-peer conversation, factors such as patient acuity and setting of service may also be taken into account.

Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions

Requests for multiple diagnostic or therapeutic interventions at the same time will often require a peer-to-peer conversation to understand the individual circumstances that support the medical necessity of performing all interventions simultaneously. This is based on the fact that appropriateness of additional intervention is often dependent on the outcome of the initial intervention.

Additionally, either of the following may apply:

Current literature and/or standards of medical practice support that one of the requested diagnostic or therapeutic interventions is more appropriate in the clinical situation presented; or
One of the diagnostic or therapeutic interventions requested is more likely to improve patient outcomes based on current literature and/or standards of medical practice.

Repeat Diagnostic Intervention

In general, repeated testing of the same anatomic location for the same indication should be limited to evaluation following an intervention, or when there is a change in clinical status such that additional testing is required to determine next steps in management. At times, it may be necessary to repeat a test using different techniques or protocols to clarify a finding or result of the original study.

Repeated testing for the same indication using the same or similar technology may be subject to additional review or require peer-to-peer conversation in the following scenarios:

Repeated diagnostic testing at the same facility due to technical issues
Repeated diagnostic testing requested at a different facility due to provider preference or quality concerns
Repeated diagnostic testing of the same anatomic area based on persistent symptoms with no clinical change, treatment, or intervention since the previous study
Repeated diagnostic testing of the same anatomic area by different providers for the same member over a short period of time

Repeat Therapeutic Intervention

In general, repeated therapeutic intervention in the same anatomic area is considered appropriate when the prior intervention proved effective or beneficial and the expected duration of relief has lapsed. A repeat intervention requested prior to the expected duration of relief is not appropriate unless it can be confirmed that the prior intervention was never administered.

Guidelines for Radiation Oncology

Definitions

Statistical terminology

Confidence interval (CI) describes the amount of uncertainty associated with a sampling method. Confidence intervals are usually reported to help explain how reliable, or precise, a result is.
Hazard ratio (HR) is a measure of how often a particular event happens in one group compared to how often it happens in another group, over time. In cancer research, hazard ratios are often used in clinical trials to measure survival at any point in time in a group of patients who have been given a specific treatment compared to a control group given another treatment or a placebo. A hazard ratio of one means that there is no difference in survival between the two groups. A hazard ratio of greater than one or less than one means that survival was better in one of the groups.
Odds ratio (OR) is a measure of the odds of an event happening in one group compared to the odds of the same event happening in another group. In cancer research, odds ratios are most often used in case-control (backward looking) studies to find out if being exposed to a certain substance or other factor increases the risk of cancer. For example, researchers may study a group of individuals with cancer (cases) and another group without cancer (controls) to see how many people in each group were exposed to a certain substance or factor. They calculate the odds of exposure in both groups and then compare the odds. An odds ratio of one means that both groups had the same odds of exposure and, therefore, the exposure probably does not increase the risk of cancer. An odds ratio of greater than one means that the exposure may increase the risk of cancer, and an odds ratio of less than one means that the exposure may reduce the risk of cancer. Also called relative odds.
Overall survival (OS) is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works.
Overall survival rate is the percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment. Also called survival rate.
Progression-free survival (PFS) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.
Relative risk (RR) is a measure of the risk of a certain event happening in one group compared to the risk of the same event happening in another group. In cancer research, relative risk is used in prospective (forward looking) studies, such as cohort studies and clinical trials. A relative risk of one means there is no difference between two groups in terms of their risk of cancer, based on whether or not they were exposed to a certain substance or factor, or how they responded to two treatments being compared. A relative risk of greater than one or of less than one usually means that being exposed to a certain substance or factor either increases (relative risk greater than one) or decreases (relative risk less than one) the risk of cancer, or that the treatments being compared do not have the same effects. Also called risk ratio.
Response rate is the percentage of patients whose cancer shrinks or disappears after treatment.

References

National Cancer Institute (NCI). NCI dictionary of cancer terms [Internet] [cited 2021 July 13]. Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms.
National Institutes of Health (NIH). U.S. National Library of Medicine (NLM). Course: finding and using health statistics: glossary [Internet] [cited 2021 July 13]. Available from: https://www.nlm.nih.gov/nichsr/usestats/glossary.html.

Image Guidance in Radiation Oncology

General Information

Modalities used in Image Guidance

Ultrasound-based guidance
Stereoscopic x-ray guidance
CT based image guidance
Real-time intrafraction guidance

Radiation Oncology Considerations

Image guidance, also known as image-guided radiation therapy (IGRT), refers to pretreatment imaging used to verify correct patient positioning in cases where sub-centimeter accuracy is needed. There are multiple different technologies which can be utilized for IGRT including ultrasound visualization, stereoscopic x-ray guidance, computed tomography based guidance and continuous intra-fraction position monitoring. Both the American Society for Radiation Oncology (ASTRO) and the American College of Radiology (ACR) have published descriptive overviews and guidance related to the available methods, performance, quality assurance, limitations and safety aspects of image-guided therapy.

IGRT is an integral part of the delivery of highly conformal treatments such as intensity modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT), and stereotactic radiosurgery (SRS). Recognition of this fact has resulted in changes to the current procedural terminology (CPT) definitions such that the technical aspect of IGRT is now bundled with IMRT delivery. Similarly, image guidance procedures have always been bundled for SBRT and SRS.

When highly tailored dose distributions such as IMRT and stereotactic radiation therapy are not being utilized, sub-centimeter precision is not generally needed and accurate patient setup is achieved with other techniques. These include patient immobilization with custom treatment devices like body molds or thermoplastic masks, placement of tattoos aligned to a 3-dimentional laser array in the treatment room and offline review of port verification films. Small daily setup uncertainties exist and these are taken into account in the target expansion process where an additional margin is added to the gross tumor volume (GTV) to create the clinical target volume (CTV) and ultimately the planning target volume (PTV) during the treatment planning process.

Pretreatment image acquisition and isocenter shifting has been suggested as a strategy to allow a safe reduction in PTV margins. By decreasing the volume of normal tissue exposed to radiation, the use of IGRT with 3D conformal radiation or IMRT has been suggested as a way to reduce toxicity, allow an increase in the radiation dose, or both. This has been most extensively studied in prostate cancer, where evidence of a dose response and improved freedom from failure with dose escalation from 70 Gy to 78 Gy was demonstrated in a randomized trial of intermediate to high-risk patients treated with radiotherapy. The higher dose treatment was associated with increased rectal toxicity and this was correlated with the proportion of the rectal volume receiving > 70 Gy. This prompted efforts to dose escalate beyond 78 Gy and simultaneously decrease normal tissue toxicity by using IGRT, IMRT, and ultimately image-guided IMRT.

When used with 3D conformal radiation, IGRT has been shown to reduce late toxicities after prostate cancer radiotherapy. A study by Gill showed that patients treated with IGRT had significantly lower rates of > grade 3 urinary frequency (7% vs 23%), > grade 2 diarrhea (3% vs 15%) and fatigue (8% vs 23%) compared to patients treated without IGRT despite higher dose treatment in the IGRT patients. Another report by Singh demonstrated that treatment with IGRT significantly decreased reports of post-treatment rectal pain (OR 0.07), urgency (OR 0.27), diarrhea (OR 0.009) and change in bowel habits (OR 0.18) compared to patients treated without IGRT. There was no difference in genitourinary symptoms reported in that study.

Multiple reports have also shown reduced late toxicities after high dose IMRT for prostate cancer compared to 3D conformal radiotherapy. Zelefsky reported 10-year follow-up comparing toxicity for prostate patient s treated with IMRT vs 3D conformal radiotherapy and found that > grade 2 gastrointestinal complaints were significantly lower in the IMRT group (5% vs 13%). One criticism of these studies is that they were performed in the pre-IGRT era and it is unclear whether IGRT and IMRT both independently reduce toxicity. Comparing 3D and IMRT for patients who were all treated with implanted fiducial based image-guidance, IMRT resulted in significantly lower rectal doses and subsequent late rectal toxicity. Finally, the use of image-guided IMRT (IG-IMRT) with implanted fiducial markers has been shown to improve 3-year biochemical control and decrease late urinary toxicity in high-risk prostate patients compared to patients treated to the same dose (86.4 Gy) with IMRT but without IGRT.

Daily IGRT has been compared to weekly IGRT for definitive treatment of prostate cancer. Patients treated with daily image guidance experienced decreased treatment-related toxicity and improved biochemical disease-free survival compared to weekly IGRT.

Studies of post-prostatectomy IMRT have demonstrated superior dose distribution to the target volume with the use of IMRT, as compared with 3D conformal radiation delivery, with better sparing of nearby critical healthy tissue structures and less severe toxicity-related morbidity. The use of pretreatment cone beam CT image-guidance to a median dose of 68.4 Gy has been compared to post-operative radiotherapy using weekly port films to a dose of 64.8 Gy. Despite treatment to a higher dose, the IGRT group was noted to have similar genitourinary and gastrointestinal toxicities. Pretreatment corrective left-right, anteroposterior, and superoinferior shifts were required in 15%, 6%, and 19% of cases, respectively, supporting the use of pretreatment imaging.

The ACR-ASTRO practice parameter for IGRT indicates that “when the target is not clearly visible and bony anatomy is not sufficient for adequate target alignment, fiducial markers may be needed.” For soft tissue targets such as the prostate, implanted fiducial markers have been validated as an accurate way to localize the target when using orthogonal imaging. Based on this research in prostate cancer, use of implanted fiducial markers for other soft tissue targets located in close proximity to critical structures is appropriate when needed to safely reduce PTV margins and reduce the risk of late complications.

In the setting of head and neck cancer, IGRT has been shown to allow a safe reduction of margin expansion and the ability to detect significant anatomic changes which might benefit from re-planning. Chen has reported a series of 225 consecutively treated head and neck cancer patients treated with image-guided IMRT. IGRT was performed with either kilovoltage or megavoltage volumetric imaging prior to each treatment. The first 95 patients were treated with a 5 mm CTV to PTV expansion and the following 130 patients were treated with a 3 mm expansion. Two-year local control was equal for the two groups. Examination of the treatment failures did not reveal any marginal recurrences in either cohort. The authors concluded that when IGRT is used, the CTV to PTV margin can safely be reduced to 3 mm. A subsequent report included an additional 134 patients with 3 mm margin expansions (264 total) and found that the 3-year locoregional control was equal in the two groups. Compared to the 5 mm margin group, the 3 mm margin patients had a lower incidence of gastrostomy-tube dependence at 1 year (10% vs 3%; P = .001) and esophageal stricture (14% vs 7%; P = .01). IGRT can also help identify patients who would benefit from adaptive replanning to prevent overdose of critical structures such as the spinal cord if significant weight loss occurs during treatment. Essentially all of the research around IGRT for head and neck cancer has been performed in the setting of IMRT. There are no data supporting the use of IGRT for head and neck cancer patients treated with 3D conformal radiotherapy.

IGRT in the non-IMRT setting can be justified in cases where the use of surface tattoos and standard immobilization techniques are known to be inadequate. In obese patients with deep seated tumors of the abdomen and pelvis, surface landmarks are known to be inaccurate. In a study performed before the term image-guidance was coined, the authors report the need to shift an average of 11.4 mm in left-right axis and 7.2 mm in the superior-inferior axis in order to properly align obese patients receiving pelvic radiotherapy for prostate cancer based on pretreatment portal imaging. Wong has also reported that using computed tomography based IGRT, shifts of greater than 10 mm were needed 21.2% of the time to correctly position the prostate in moderately to severely obese patients (BMI > 35). This was significantly more than shifts needed in normal weight, overweight and mildly obese patients. ASTRO has used this scenario as an example of where IGRT may be required in conjunction with three-dimensional conformal radiotherapy in their Health Policy Coding Guidance document.

A recent study of the setup accuracy for lung cancer treatment showed that when compared to tattoos, using cone beam CT registration to the spine and carina improved target coverage approximately 50% of the time. Even using skin tattoos, however, the combined lung and nodal targets were found to be within the PTV over 97% of the time.

Tumor motion during the breathing cycle needs to be evaluated and managed when highly conformal radiation techniques are used to treat lung cancer. Liu evaluated respiratory related tumor motion in 152 patients with lung cancer and found that motion in the superoinferior (SI) axis was > 0.5 cm in 39% of patients and > 1 cm in 11% of patients. The degree of respiratory cycle related motion was more pronounced with smaller lesions and with tumors further from the lung apex. Four dimensional CT (4DCT) scan planning coupled with IMRT is associated with improved overall survival (HR 0.64) and a decreased risk of > grade 3 pneumonitis (HR 0.33) compared to 3D conformal radiotherapy. The volume of lung receiving 20 Gy (V20) was significantly lower in the 4DCT/IMRT group. The American Association of Physicists in Medicine (AAPM) Task Group 76 guidelines summarized the adequate methods to account for this respiratory motion including 4DCT, slow CT, inhale/ exhale/breath-hold CT, respiratory gating with internal fiducial markers or external markers to signal respiration, breath hold, abdominal compression for shallow breathing and real time tracking. There are no studies supporting the use of IGRT for lung cancer in the 3D conformal setting.

With left sided breast cancers, there is concern about cardiac toxicity due to the proximity of the heart to the treatment field. Intensity modulated radiation therapy (IMRT) has been used to decrease the cardiac dose during left sided radiation treatment. Image-guided deep inspiration breath hold (DIBH) techniques have been demonstrated to reduce cardiac exposure to radiation. A feasibility of IGRT for cardiac sparing in patients with left-sided breast cancer was investigated in a prospective study authored by Borst. Nineteen patients with left-sided breast cancer were treated with the deep inspiration breath hold (DIBH) technique during IGRT. Use of DIBH in these patients reduced mean cardiac dose (1.7 Gy vs 5.1 Gy), the maximum dose (37 Gy vs 49 Gy) and the volume of heart receiving 30 Gy (0.3 cc vs 6.3 cc) compared with the free breathing technique. Similar results have been described in a larger series of 50 patients recently published by Cosma. Patients were eligible for inclusion in this study if an absolute volume of 10cc received more than 50% of the prescription dose (D10cc > 50%) based on criteria described by Wang. In these patients, the D10cc was reduced from 34.8 Gy for the free breathing group to 6.7 Gy for the DIBH group (P < .001).

For the majority of cases treated with 3D conformal radiotherapy, there is no evidence that the routine use of IGRT results in clinical benefit. Regarding clinical outcomes associated with IGRT, a recent review article concluded that “results of current and future clinical trials will hopefully demonstrate the net gain in therapeutic ratio from application of IGRT technologies and the onus lies on the radiation oncology community to take up the challenge of demonstrating the benefit of expensive IGRT approaches.”

Multiple publications have documented the additional radiation exposure which occurs in conjunction with IGRT. Patient doses range from 1-3 mGy for gantry mounted kV systems to between 10 and 50 mGy per image for cone beam and fan beam CT scans. As with any medical procedure, the risks of radiation exposure must be weighed against the benefits of daily imaging. In situations where there is a lack of demonstrable benefit, concern about potential harms of this technology are relevant. Even in clinical scenarios where IGRT is considered medically necessary, the technique chosen should expose the patient to the minimum amount of radiation needed to achieve adequate visualization.

The National Comprehensive Cancer Network (NCCN) recommends using IGRT when using stereotactic body radiation therapy (SBRT) and when 3D conformal radiation or IMRT is used with steep dose gradients around the target, organs at risk are in close proximity to target tissues and when utilizing gating or other motion management techniques.

For breast cancer, NCCN states that routine use of daily imaging is not recommended.

Society Recommendations

ASTRO/ACR – The American Society of Radiation Oncology (ASTRO) and The American College of Radiology (ACR) have published practice guidelines for image-guided radiation therapy (IGRT). The technologies for performing IGRT are described. The document also reviews suggested qualifications and responsibilities of the personnel involved in the performance of IGRT. The authors note that IGRT can be used to enhance either 3D conformal radiotherapy or intensity modulated radiation therapy (IMRT) but do not elaborate on clinical necessity for IGRT with either of these modalities. IGRT is noted to be a necessary and integral part of stereotactic body radiation therapy (SBRT). Elements of interfraction and intrafraction target motion are discussed. Fiducial marker placement and migration are reviewed. As part of the process of IGRT implementation, it is suggested that the radiation oncologist develop clinical guidelines outlining when physician involvement in verification of patient positioning is needed. No clinical outcomes are discussed.

Clinical Indications

Image guidance, any modality, is appropriate when ANY of the following conditions are met:

Intensity modulated radiation therapy (IMRT) is being utilized
Proton beam therapy is being utilized
Use of IGRT will allow significant reduction of radiation dose to sensitive normal structures, for example:
- Left-sided breast cancer treatment with deep inspiration breath hold technique (DIBH) for cardiac sparing is being utilized
Implanted fiducial markers have been placed
Bony anatomy fails to accurately delineate a tumor location and fiducial markers or intensity modulated radiation therapy (IMRT) are not indicated (for example, head and neck cancer or prone breast radiotherapy)
The treatment field abuts a previously irradiated field
There is significant setup variation affecting the treatment target, for example:
- Individual is morbidly obese (BMI > 35) and receiving treatment of tumors in the mediastinum, abdomen or pelvis
- There is significant organ movement due to respiration and a 4D planning CT scan was performed with documentation demonstrating that the treatment plan addresses tumor motion that is both accounted for and managed

Note: Image guidance not meeting any of the above criteria is considered not medically necessary.

Frequency

When authorized, image guidance should be performed at the minimum frequency needed to assure proper patient positioning.

Codes

CPT® (Current Procedural Terminology) is a registered trademark of the American Medical Association (AMA). CPT® five digit codes, nomenclature and other data are copyright by the American Medical Association. All Rights Reserved. AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for the data contained herein or not contained herein.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

The following code list is not meant to be all-inclusive. Authorization requirements will vary by health plan. Please consult the applicable health plan for guidance on specific procedure codes.

Specific CPT codes for services should be used when available. Nonspecific or not otherwise classified codes may be subject to additional documentation requirements and review.

CPT/HCPCS

Note: The work associated with CT scan acquisition for 3D or IMRT planning is bundled with codes 77295 and 77301, respectively. CPT code 77014 should NOT be billed in this setting.

77014 CT guidance for placement of radiation therapy fields

77387 Guidance for localization of target volume for delivery of radiation treatment delivery, includes intrafraction tracking, when performed

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

G6017 Intra-fraction localization and tracking of target or patient motion during delivery of radiation therapy (e.g., 3D positional tracking, gating, 3D surface tracking), each fraction of treatment

ICD-10 Diagnoses

All inclusive

References

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American Society for Radiation Oncology (ASTRO). IGRT [Internet] [cited 2021 July 14]. Available from: https://www.astro.org/Daily-Practice/Coding/Coding-Guidance/FAQ-IGRT/.
American Society for Radiation Oncology (ASTRO). Image guided radiation therapy (IGRT) coding guidance [Internet] [cited 2021 July 14]. Available from: https://www.astro.org/Daily-Practice/Coding/Coding-Guidance/Coding-Guidance-Articles/IGRT-in-2016.
Borst GR, Sonke JJ, den Hollander S, et al. Clinical results of image-guided deep inspiration breath hold breast irradiation. Int J Radiat Oncol Biol Phys. 2010;78(5):1345-51.
Chen AM, Farwell DG, Luu Q, et al. Evaluation of the planning target volume in the treatment of head and neck cancer with intensity-modulated radiotherapy: what is the appropriate expansion margin in the setting of daily image guidance? Int J Radiat Oncol Biol Phys. 2011;81(4):943-9.
Chen AM, Yu Y, Daly ME, et al. Long-term experience with reduced planning target volume margins and intensity-modulated radiotherapy with daily image-guidance for head and neck cancer. Head Neck. 2014;36(12):1766-72.
Chung HT, Xia P, Chan LW, et al. Does image-guided radiotherapy improve toxicity profile in whole pelvic-treated high-risk prostate cancer? Comparison between IG-IMRT and IMRT. Int J Radiat Oncol Biol Phys. 2009;73(1):53-60.
Comsa D, Barnett E, Le K, et al. Introduction of moderate deep inspiration breath hold for radiation therapy of left breast: Initial experience of a regional cancer center. Pract Radiat Oncol. 2014;4(5):298-305.
Dawson LA, Jaffray DA. Advances in image-guided radiation therapy. J Clin Oncol. 2007;25(8):938-46.
de Crevoisier R, Bayar MA, Pommier P, et al. Daily versus weekly prostate cancer image guided radiation therapy: phase 3 multicenter randomized trial. Int J Radiat Oncol Biol Phys. 2018;102(5):1420-9.
Dearnaley D, Syndikus I, Mossop H, et al. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016;17(8):1047-60.
Eldredge HB, Studenski M, Keith SW, et al. Post-prostatectomy image-guided radiation therapy: evaluation of toxicity and inter-fraction variation using online cone-beam CT. J Med Imaging Radiat Oncol. 2011;55(5):507-15.
Goyal S, Kataria T. Image guidance in radiation therapy: techniques and applications. Radiol Res Pract. 2014;2014:705604.
Graff P, Hu W, Yom SS, et al. Does IGRT ensure target dose coverage of head and neck IMRT patients? Radiother Oncol. 2012;104(1):83-90.
Hsieh CH, Shueng PW, Wang LY, et al. Impact of postoperative daily image-guided intensity-modulated radiotherapy on overall and local progression-free survival in patients with oral cavity cancer. BMC Cancer. 2016;16:139.
Jaffray D, Kupelian P, Djemil T, et al. Review of image-guided radiation therapy. Expert Rev Anticancer Ther. 2007;7(1):89-103.
Jaffray DA, Langen KM, Mageras G, et al. Safety considerations for IGRT: executive summary. Pract Radiat Oncol. 2013;3(3):167-70.
Kan MW, Leung LH, Wong W, et al. Radiation dose from cone beam computed tomography for image-guided radiation therapy. Int J Radiat Oncol Biol Phys. 2008;70(1):272-9.
Keall PJ, Mageras GS, Balter JM, et al. The management of respiratory motion in radiation oncology report of AAPM Task Group 76. Med Phys. 2006;33(10):3874-900.
Lavoie C, Higgins J, Bissonnette JP, et al. Volumetric image guidance using carina vs spine as registration landmarks for conventionally fractionated lung radiotherapy. Int J Radiat Oncol Biol Phys. 2012;84(5):1086-92.
Lemanski C, Thariat J, Ampil FL, et al. Image-guided radiotherapy for cardiac sparing in patients with left-sided breast cancer. Front Oncol. 2014;4:257.
Liao ZX, Komaki RR, Thames HD, Jr., 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. 2010;76(3):775-81.
Liu HH, Balter P, Tutt T, et al. Assessing respiration-induced tumor motion and internal target volume using four-dimensional computed tomography for radiotherapy of lung cancer. Int J Radiat Oncol Biol Phys. 2007;68(2):531-40.
Lohr F, El-Haddad M, Dobler B, et al. Potential effect of robust and simple IMRT approach for left-sided breast cancer on cardiac mortality. Int J Radiat Oncol Biol Phys. 2009;74(1):73-80.
Millender LE, Aubin M, Pouliot J, et al. Daily electronic portal imaging for morbidly obese men undergoing radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2004;59(1):6-10.
Murphy MJ, Balter J, Balter S, et al. The management of imaging dose during image-guided radiotherapy: report of the AAPM Task Group 75. Med Phys. 2007;34(10):4041-63.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer (Version 5.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer (Version 5.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
Osman SO, de Boer HC, Astreinidou E, et al. On-line cone beam CT image guidance for vocal cord tumor targeting. Radiother Oncol. 2009;93(1):8-13.
Ploquin N, Song W, Lau H, et al. Intensity modulated radiation therapy for oropharyngeal cancer: the sensitivity of plan objectives and constraints to set-up uncertainty. Phys Med Biol. 2005;50(15):3515-33.
Pollack A, Zagars GK, Starkschall G, et al. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002;53(5):1097-105.
Potters L, Gaspar LE, Kavanagh B, et al. American Society for Therapeutic Radiology and Oncology (ASTRO) and American College of Radiology (ACR) practice guidelines for image-guided radiation therapy (IGRT). Int J Radiat Oncol Biol Phys. 2010;76(2):319-25.
Potters L, Kavanagh B, Galvin JM, et al. American Society for Therapeutic Radiology and Oncology (ASTRO) and American College of Radiology (ACR) practice guideline for the performance of stereotactic body radiation therapy. Int J Radiat Oncol Biol Phys. 2010;76(2):326-32.
Ratnayake G, Martin J, Plank A, et al. Incremental changes verses a technological quantum leap: the additional value of intensity-modulated radiotherapy beyond image-guided radiotherapy for prostate irradiation. J Med Imaging Radiat Oncol. 2014;58(4):503-10.
Rock K, Huang SH, Tiong A, et al. Partial laryngeal IMRT for T2N0 glottic cancer: impact of image guidance and radiation therapy intensification. Int J Radiat Oncol Biol Phys. 2018;102(4):941-9.
Schallenkamp JM, Herman MG, Kruse JJ, et al. Prostate position relative to pelvic bony anatomy based on intraprostatic gold markers and electronic portal imaging. Int J Radiat Oncol Biol Phys. 2005;63(3):800-11.
Shah A, Aird E, Shekhdar J. Contribution to normal tissue dose from concomitant radiation for two common kV-CBCT systems and one MVCT system used in radiotherapy. Radiother Oncol. 2012;105(1):139-44.
Singh J, Greer PB, White MA, et al. Treatment-related morbidity in prostate cancer: a comparison of 3-dimensional conformal radiation therapy with and without image guidance using implanted fiducial markers. Int J Radiat Oncol Biol Phys. 2013;85(4):1018-23.
Veldeman L, Madani I, Hulstaert F, et al. Evidence behind use of intensity-modulated radiotherapy: a systematic review of comparative clinical studies. Lancet Oncol. 2008;9(4):367-75.
Wang D, Zhang Q, Eisenberg BL, et al. Significant reduction of late toxicities in patients with extremity sarcoma treated with image-guided radiation therapy to a reduced target volume: results of Radiation Therapy Oncology Group RTOG-0630 Trial. J Clin Oncol. 2015;33(20):2231-8.
Wang W, Purdie TG, Rahman M, et al. Rapid automated treatment planning process to select breast cancer patients for active breathing control to achieve cardiac dose reduction. Int J Radiat Oncol Biol Phys. 2012;82(1):386-93.
Wong JR, Gao Z, Merrick S, et al. Potential for higher treatment failure in obese patients: correlation of elevated body mass index and increased daily prostate deviations from the radiation beam isocenters in an analysis of 1,465 computed tomographic images. Int J Radiat Oncol Biol Phys. 2009;75(1):49-55.
Wortel RC, Incrocci L, Pos FJ, et al. Acute toxicity after image-guided intensity modulated radiation therapy compared to 3D conformal radiation therapy in prostate cancer patients. Int J Radiat Oncol Biol Phys. 2015;91(4):737-44.
Zelefsky MJ, Kollmeier M, Cox B, et al. Improved clinical outcomes with high-dose image guided radiotherapy compared with non-IGRT for the treatment of clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2012;84(1):125-9.
Zelefsky MJ, Levin EJ, Hunt M, et al. Incidence of late rectal and urinary toxicities after three-dimensional conformal radiotherapy and intensity-modulated radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008;70(4):1124-9.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V5.2021 and Breast Cancer V5.2021. Available at: http://www.nccn.org. Accessed July 14, 2021. ©National Comprehensive Cancer Network, 2021.

These Guidelines are a work in progress that may be refined as often as new significant data becomes available.

The NCCN Guidelines® are a statement of consensus of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Special Treatment Procedure and Special Physics Consult

General Information

Radiation Oncology Considerations

Special treatment procedure, CPT® code 77470, describes the extra time, effort and resources associated with complex radiation therapy procedures and situations which are not reimbursed by another CPT® code. Several of these procedures are specifically described in the CPT® code definition including total body irradiation, hemibody radiation and per oral or endocavitary radiation. This code may also be used to report additional work and effort when a patient receives brachytherapy or concurrent chemotherapy along with a course of external beam radiation therapy. This code should not be used to report the work effort which is specifically described another CPT® code including but not limited to intensity modulated radiation therapy (IMRT), stereotactic radiosurgery (SRS) or intraoperative radiation therapy (IORT).

Special physics consult, CPT® code 77370, describes work performed by a qualified medical physicist to address a specific question or problem related to a complex radiation therapy plan. This only applies when the query to the physicist is beyond the scope of the routine physics work effort associated with radiation therapy planning and delivery. In response to a physician request, the physicist prepares a customized written report specifically addressing the issue in question. A special physics consult may be appropriate in cases of brachytherapy where the physicist is directly involved or when an a composite plan is generated by the physicist to reflect cumulative doses from different radiation modalities such as photons, electrons, charges particles and gamma rays. A special physics consult is also medically necessary when radiation dose to a fetus or medical device such as pacemaker needs to be measured. Special physics consult is appropriate when the physicist performs a fusion multiple images sets with or without associated dose distributions to be used by the physician in the development or analysis of a treatment plan. This code should not be used when fusion is performed by a non-physicist. A special physics consult may also apply to other specific treatment-related questions when ordered by the radiation oncologist and appropriate documentation is provided.

Clinical Indications

Special treatment procedure is indicated when extra planning time and effort can be documented for ANY of the following:

Concurrent chemotherapy
Brachytherapy
Proton therapy
Total body or hemibody radiation
Pediatric patient requiring anesthesia
Hyperthermia
Reconstruction of previous radiation plan
Stereotactic body radiation therapy (SBRT)
Other (documentation of special circumstances or time consuming plan required)

Special physics consult is indicated when requested by physician for ANY of the following:

Brachytherapy
Fusion of multiple image sets (CT, MRI, PET) when performed by the medical physicist
Dosimetric analysis of previous radiation field overlapping or abutting current field
Analysis of dose to a fetus
Analysis of dose to a pacemaker
Stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT) with report of dosimetric parameters and specific organ tolerances met or exceeded
Other specific physics work not described by another CPT code, at request of radiation oncologist

Frequency

Special treatment procedure and special physics consults may each only be billed once per course of therapy

Codes

The following code list is not meant to be all-inclusive. Authorization requirements will vary by health plan. Please consult the applicable health plan for guidance on specific procedure codes.

Specific CPT codes for services should be used when available. Nonspecific or not otherwise classified codes may be subject to additional documentation requirements and review.

CPT/HCPCS

77370 Special medical radiation physics consultation

77470 Special treatment procedure

ICD-10 Diagnoses

All inclusive

References

American Society for Radiation Oncology (ASTRO). 2021 radiation oncology coding resource [Internet] 2021 [cited 2021 July 14]. Available from: https://www.astro.org/Daily-Practice/Coding/Coding-Resource.

Bone Metastases

General Information

Commonly Used Modalities

External Beam Radiation Therapy

2D and 3D conformal (EBRT)
Intensity Modulated Radiation Therapy (IMRT)
Stereotactic Body Radiation Therapy (SBRT)

Radiation Oncology Considerations

Initial treatment

Metastasis to the bony skeleton is a common site of spread for many solid tumors including breast, prostate and lung cancers. Bone metastases can be seen with any cancer histology and affects more than 250,000 patients per year in the U.S. It has been estimated that up to 80% of patients with solid cancers will develop painful bone metastases to the pelvis, spine or extremities during the course of their illness. Metastases to the bone can cause accelerated bone breakdown which may result in pain, pathologic fracture and nerve or spinal cord compression resulting in sensory loss or motor weakness. Laboratory abnormalities may include hypercalcemia and myelosuppression. Radiation therapy has long been used to palliate pain and other symptoms of bone metastases with excellent results.

There have been multiple prospective, randomized, controlled clinical trials comparing different radiation fractionation schemes for bony metastases. Most of these trials have excluded patients with spinal cord compression or pathologic fracture at presentation. All of these trials, as well as several subsequent meta-analyses of these data, have concluded that for uncomplicated patients a single fraction of 8 Gy provides equivalent palliation to more prolonged fractionation over 1 to 4 weeks. The overall response rate with either regimen was approximately 60% with about 24% of patients demonstrating a complete response to treatment. Acute toxicity was found to be equivalent or better in the single fraction arms. There was no significant difference in pathologic fracture risk or subsequent spinal cord compression. The main difference which has been demonstrated is a higher rate of re-treatment with single fraction treatment vs more prolonged fractionation (20% vs 8%).

Because of the higher rate of re-treatment with single fraction radiotherapy, the use of fractionated regimens has been suggested for patients with bony metastasis from prostate and breast cancers. Analysis of the Dutch Bone Metastasis Study found equal pain relief and duration in patients with favorable prognosis. This has also been studied prospectively by the RTOG which looked specifically at whether prolonged fractionation resulted in superior palliation in patients with breast and prostate cancers. It was concluded that both single fraction and multifraction regimens were equally effective even in this favorable group of patients. The breast cancer expert panel of the German Society for Radiation Oncology (DEGRO) recommends fractionated regimens for breast cancer patients with oligometastatic bony metastasis and when the therapeutic goal is stabilization of disease as opposed to pain control. The NCCN guidelines for prostate cancer recommend that 8 Gy as a single dose be used instead of 30 Gy in 10 fractions for non-vertebral metastases.

In 2011, ASTRO published a guideline providing recommendations for palliative radiotherapy as a treatment for bone metastases. ASTRO’s recommendations were based on the findings of their systematic review of the peer-reviewed literature on palliative RT for bone metastases combined with the expert opinion of the Task Force members. With regards to the most effective fractionation scheme for the treatment of painful and/or prevention of morbidity from peripheral bone metastases, the ASTRO task force indicated that: “Multiple prospective randomized trials have shown pain relief equivalency for dosing schema, including 30 Gy in 10 fractions, 24 Gy in 6 fractions, 20 Gy in 5 fractions, and a single 8-Gy fraction for patients with previously unirradiated painful bone metastases. Fractionated RT courses have been associated with an 8% repeat treatment rate to the same anatomic site because of recurrent pain vs. 20% after a single fraction; however, the single fraction treatment approach optimizes patient and caregiver convenience.”

ASTRO recently published an update of their evidence-based guideline which reviewed 20 new randomized trials, 32 new prospective non-randomized trials and 4 meta-analyses. The literature continues to support the equivalent pain relief of a single 8 Gy treatment compared to multifraction therapy.

Special circumstances have been suggested where more prolonged fractionation may be preferable. These include individuals with soft tissue involvement causing neuropathic symptoms, spinal metastases, impending or outright spinal cord compression, and presence of oligometastatic disease. Most of these trials exploring different radiation fractionation schemes for bony metastases have excluded subjects with spinal cord compression or pathologic fracture at presentation.

The study by Roos et al. looked at single fraction vs fractionated radiotherapy for patients with neuropathic pain and found that the time to treatment failure was shorter in the single fraction regimen. The risk of developing spinal cord compression in patients with vertebral bony metastasis has been found to be slightly higher with single fraction treatment, although this did not reach statistical significance and the overall risk of cord compression was less than 6% in both groups. Recently published results of the SCORAD randomized trial of 8 Gy single fraction treatment vs 20 Gy in five fractions in patients with spinal cord compression demonstrated that the single fraction treatment was non-inferior in terms of return to ambulatory status and survival.

ASTRO indicated that while many of the peer-reviewed studies did not make a distinction between treatment relief for spinal vs non-spinal metastases, the task force was able to conclude that there was no evidence to suggest that a single 8-Gy fraction was less effective in providing pain relief than a more prolonged RT course in painful spinal sites. The authors also concluded that there were not “any suggestions from the available data that single-fraction therapy produces unacceptable rates of long-term side effects that might limit this fractionation schedule for patients with painful bone metastases.”

A recent report by Lam explores factors affecting adverse outcomes in 299 patients receiving palliative radiotherapy for uncomplicated spine metastases. The cumulative incidence of first skeletal adverse event (SAE) at 180 days was 23.6% for single fraction (SF) radiation vs 9.2% for multiple fraction (MF) treatment. On multivariate analysis, singe fraction treatment (HR 2.8, P = .001) and baseline spine instability score (HR 2.5, P = .007) were significant predictors of the incidence of first SAE. To account for baseline differences, outcomes were compared using a propensity score matched analysis. They found that the 90 day incidence of SAEs was 22% for patients treated with SF radiotherapy vs 6% for patients treated with a MF regimen (HR 3.9, P = .003). Spinal adverse events were defined as a symptomatic fracture, hospitalization for site-related pain, salvage surgery, interventional procedure, new neurologic symptoms or cord compression.

Radiation therapy is a common treatment for metastatic spinal cord compression. In patients with a single site of compression and life expectancy of at least 3 months, surgical decompression should be considered as it has been shown to preserve neurologic function better than radiotherapy alone in a phase III randomized study. Post-operative radiotherapy should be given in these patients. 30 Gy in 10 fractions has been the most commonly used. No reports have been published regarding the use of single fraction palliative EBRT in the post-operative setting. For patients who are not candidates for surgery, radiation therapy should be given after initiation of corticosteroid therapy. A recent review of radiation therapy for metastatic spinal cord compression concluded that for patients with a poor prognosis, a single fraction of 8 Gy should be given. For those with patients with a good prognosis, consideration of 30 Gy in 10 fractions was recommended.

When a metastasis results in a pathologic compression fracture, percutaneous kyphoplasty may be of benefit. The ASTRO evidence based guideline concluded that no prospective data are available to suggest that the use of either kyphoplasty or vertebroplasty obviates the need for EBRT in the management of painful bone metastases.

Stereotactic body radiation therapy (SBRT) or stereotactic ablative body radiotherapy (SABR) is being studied in the treatment of bony metastatic disease. Proposed indications for this modality include standalone or postoperative treatment in patients with progressive or recurrent disease following conventional external beam radiotherapy (cEBRT) and in the treatment of tumors traditionally considered radioresistant to cEBRT such as sarcoma, melanoma and renal cell carcinoma. The RTOG is currently conducting a comparison of SBRT with a single fraction of 8 Gy for painful vertebral metastasis. The updated ASTRO evidence-based guideline maintains that: “Advanced RT techniques such as SBRT as the primary treatment for painful spine bone lesions or for spinal cord compression should be considered in the setting of a clinical trial or with data collected in a registry given that insufficient data are available to routinely support this treatment currently.”

Repeat treatment

Following initial treatment with radiation therapy for bony metastasis, some patients will develop recurrent or progressive symptoms for which additional radiation therapy is indicated. Studies have shown repeat radiation therapy to be effective in reducing pain in approximately 48% of patients. Responders have been shown to have improved quality of life. When a given site is re-treated, the effect of prior irradiation on the surrounding normal tissues must be taken into account. This is especially important when treating vertebral lesions where to cumulative dose to the spinal cord must be minimized. The generally accepted maximum cumulative dose to the spinal cord is 50 Gy in 2 Gy fractions (or equivalent). If repeat radiation using 2D or 3D techniques would result in a cumulative dose to the spinal cord greater than 50 Gy in 2 Gy fractions then consideration should be given to intensity modulated radiation therapy (IMRT), stereotactic radiosurgery (SRS), or stereotactic body radiation therapy (SBRT).

Society Recommendations

ASTRO – The 2013 Choosing Wisely campaign included as one of its 5 recommendations that fractionation beyond 10 treatments should not be routinely used to treat bone metastases. They noted that 8 Gy in a single fraction results in equivalent pain relief compared to 20 Gy in 5 fractions or 30 Gy in 10 fractions. They suggested that strong consideration be given to 8 Gy in a single fraction for patient with poor prognosis or transportation difficulties.

ACR – The American College of Radiology has published Appropriateness Criteria for both spinal and non-spinal bone metastases. They note that radiation therapy is the mainstay of treatment for bony metastatic lesions. They list several fractionation regimens including 30 Gy in 10 fractions, 24 Gy in 6 fractions, 20 Gy in 5 fractions, or a single 8 Gy fraction. They note that randomized clinical trials have shown equivalent pain relief for all of these regimens.

Clinical Indications

2D or 3D Conformal External Beam Radiation Therapy (EBRT) is appropriate for bone metastases when ANY one of the following conditions are met:

Pain at the site of metastasis
Lytic lesion involving a weight bearing bone
Spinal cord compression
Post-operative treatment following surgical stabilization

Intensity Modulated Radiation Therapy (IMRT) is appropriate for bone metastases when ALL of the following conditions are met:

To treat a previously irradiated field
Re-treatment with EBRT would result in significant risk of adjacent organ injury

Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiation Therapy (SBRT) is appropriate for bone metastasis when ALL of the following conditions are met:

To treat a previously irradiated field
Re-treatment with EBRT would result in significant risk of adjacent organ injury

Note: When SRS/SBRT is being requested to treat a patient with oligometastatic disease with potentially curative intent, please refer to separate criteria in the Oligometastatic Extracranial Disease section of the Guidelines.

Fractionation

Single fraction treatment is appropriate in individuals who meet the following criterion:

Goal of therapy is pain relief

Fractionated radiotherapy, 2 to 10 fractions, is only appropriate in individuals who meet the following criteria:

Fair to good performance status, defined as ECOG status 0-2 and any of the following:
Pathologic fracture
Soft tissue involvement by tumor
Spinal cord compression
Spine metastasis
Presence of oligometastatic disease (1-5 lesions) when the goal of treatment is long term stabilization of disease

Fractionation beyond 10 treatments is not medically necessary

Codes

The following code list is not meant to be all-inclusive. Authorization requirements will vary by health plan. Please consult the applicable health plan for guidance on specific procedure codes.

Specific CPT codes for services should be used when available. Nonspecific or not otherwise classified codes may be subject to additional documentation requirements and review.

2D and 3D Conformal

CPT/HCPCS

77295 3-dimensional radiotherapy plan, including dose-volume histograms (3D Conformal treatment plan)

77402 Radiation treatment delivery, > 1 MeV; simple.

77407 Radiation treatment delivery, > 1 MeV; intermediate.

77412 Radiation treatment delivery, > 1 MeV; complex.

G6003 Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: up to 5 MeV

G6004 Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: 6-10 MeV

G6005 Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: 11-19 MeV

G6006 Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: 20 MeV or greater

G6007 Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple blocks: up to 5 MeV

G6008 Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple blocks: 6-10 MeV

G6009 Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple blocks: 11-19 MeV

G6010 Radiation treatment delivery, 2 separate treatment areas, 3 or more ports on a single treatment area, use of multiple blocks: 20 MeV or greater

G6011 Radiation treatment delivery, 3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; up to 5 MeV

G6012 Radiation treatment delivery, 3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; 6-10 MeV

G6013 Radiation treatment delivery, 3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; 11-19 MeV

G6014 Radiation treatment delivery, 3 or more separate treatment areas, custom blocking, tangential ports, wedges, rotational beam, compensators, electron beam; 20 MeV or greater

Intensity Modulated Radiation Therapy

CPT/HCPCS

77301 Intensity modulated radiation therapy plan, including dose volume histogram for target and critical structure partial tolerance specifications (IMRT treatment plan)

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

77386 Intensity modulated radiation treatment delivery (IMRT), includes guidance and tracking when performed; complex

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

Stereotactic Body Radiation Therapy

CPT/HCPCS

63620 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); one spinal lesion

63621 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each add’l spinal lesion

77295 3-dimensional radiotherapy plan, including dose-volume histograms (3D Conformal treatment plan)

77301 Intensity modulated radiation therapy plan, including dose volume histogram for target and critical structure partial tolerance specifications (IMRT treatment plan)

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

77370 Special medical radiation physics consultation

77373 Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions

77435 Stereotactic body radiation therapy, treatment management, per treatment course, to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions

77470 Special treatment procedure

G0339 Image-guided robotic linear accelerator-based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment

G0340 Image-guided robotic linear accelerator based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions; maximum five sessions per course of treatment

Stereotactic Radiosurgery

CPT/HCPCS

63620 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); one spinal lesion

63621 Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); each add’l spinal lesion

77295 3-dimensional radiotherapy plan, including dose-volume histograms

77301 Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specifications (Listed once only)

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

77370 Special medical radiation physics consultation

77371 Radiation treatment delivery, stereotactic radiosurgery (SRS) complete course of treatment of cranial lesion(s) consisting of 1 session; multi-source Cobalt 60 based

77372 Radiation treatment delivery, stereotactic radiosurgery (SRS) complete course of treatment of cranial lesion(s) consisting of 1 session; linear accelerator based

77432 Stereotactic radiation treatment management of cranial lesion(s) (complete course of treatment consisting of 1 session)

G0339 Image-guided robotic linear accelerator-based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment

All Modalities

ICD-10 Diagnoses

C79.51 – C79.52 Secondary malignant neoplasm of bone and bone marrow

References

Anonymous. 8 Gy single fraction radiotherapy for the treatment of metastatic skeletal pain: randomised comparison with a multifraction schedule over 12 months of patient follow-up. Bone Pain Trial Working Party. Radiother Oncol. 1999;52(2):111-21.
Chan NK, Abdullah KG, Lubelski D, et al. Stereotactic radiosurgery for metastatic spine tumors. J Neurosurg Sci. 2014;58(1):37-44.
Chow E, Meyer RM, Chen BE, et al. Impact of reirradiation of painful osseous metastases on quality of life and function: a secondary analysis of the NCIC CTG SC.20 randomized trial. J Clin Oncol. 2014;32(34):3867-73.
Chow E, Zeng L, Salvo N, et al. Update on the systematic review of palliative radiotherapy trials for bone metastases. Clin Oncol (R Coll Radiol). 2012;24(2):112-24.
Dennis K, Makhani L, Zeng L, et al. Single fraction conventional external beam radiation therapy for bone metastases: a systematic review of randomised controlled trials. Radiother Oncol. 2013;106(1):5-14.
Expert Panel on Radiation Oncology-Bone M, Lo SS, Lutz ST, et al. ACR Appropriateness Criteria® spinal bone metastases. J Palliat Med. 2013;16(1):9-19.
Foro Arnalot P, Fontanals AV, Galceran JC, et al. Randomized clinical trial with two palliative radiotherapy regimens in painful bone metastases: 30 Gy in 10 fractions compared with 8 Gy in single fraction. Radiother Oncol. 2008;89(2):150-5.
Gaze MN, Kelly CG, Kerr GR, et al. Pain relief and quality of life following radiotherapy for bone metastases: a randomised trial of two fractionation schedules. Radiother Oncol. 1997;45(2):109-16.
Hartsell WF, Scott CB, Bruner DW, et al. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005;97(11):798-804.
Hoskin PJ, Grover A, Bhana R. Metastatic spinal cord compression: radiotherapy outcome and dose fractionation. Radiother Oncol. 2003;68(2):175-80.
Hoskin PJ, Hopkins K, Misra V, et al. Effect of single-fraction vs multifraction radiotherapy on ambulatory status among patients with spinal canal compression from metastatic cancer: the SCORAD randomized clinical trial. JAMA. 2019;322(21):2084-94.
Husain ZA, Sahgal A, De Salles A, et al. Stereotactic body radiotherapy for de novo spinal metastases: systematic review. J Neurosurg Spine. 2017;27(3):295-302.
Jeremic B, Shibamoto Y, Acimovic L, et al. A randomized trial of three single-dose radiation therapy regimens in the treatment of metastatic bone pain. Int J Radiat Oncol Biol Phys. 1998;42(1):161-7.
Kaasa S, Brenne E, Lund JA, et al. Prospective randomised multicenter trial on single fraction radiotherapy (8 Gy x 1) versus multiple fractions (3 Gy x 10) in the treatment of painful bone metastases. Radiother Oncol. 2006;79(3):278-84.
Kim EY, Chapman TR, Ryu S, et al. ACR Appropriateness Criteria® non-spine bone metastases. J Palliat Med. 2015;18(1):11-7.
Lam TC, Uno H, Krishnan M, et al. Adverse outcomes after palliative radiation therapy for uncomplicated spine metastases: role of spinal instability and single-fraction radiation therapy. Int J Radiat Oncol Biol Phys. 2015;93(2):373-81.
Li S, Peng Y, Weinhandl ED, et al. Estimated number of prevalent cases of metastatic bone disease in the US adult population. Clin Epidemiol. 2012;4:87-93.
Loblaw DA, Mitera G, Ford M, et al. A 2011 updated systematic review and clinical practice guideline for the management of malignant extradural spinal cord compression. Int J Radiat Oncol Biol Phys. 2012;84(2):312-7.
Lutz S, Balboni T, Jones J, et al. Palliative radiation therapy for bone metastases: Update of an ASTRO Evidence-Based Guideline. Pract Radiat Oncol. 2017;7(1):4-12.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer (Version 2.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
Nielsen OS, Bentzen SM, Sandberg E, et al. Randomized trial of single dose versus fractionated palliative radiotherapy of bone metastases. Radiother Oncol. 1998;47(3):233-40.
Ogawa H, Ito K, Shimizuguchi T, et al. Re-irradiation for painful bone metastases using stereotactic body radiotherapy. Acta Oncol. 2018;57(12):1700-4.
Patchell RA, Tibbs PA, Regine WF, et al. Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial. Lancet. 2005;366(9486):643-8.
Pielkenrood BJ, van der Velden JM, van der Linden YM, et al. Pain response after stereotactic body radiation therapy versus conventional radiotherapy in patients with bone metastases – a phase II, randomized controlled trial within a prospective cohort. Int J Radiat Oncol Biol Phys. 2020;110(2):358-67.
Roos DE, Turner SL, O’Brien PC, et al. Randomized trial of 8 Gy in 1 versus 20 Gy in 5 fractions of radiotherapy for neuropathic pain due to bone metastases (Trans-Tasman Radiation Oncology Group, TROG 96.05). Radiother Oncol. 2005;75(1):54-63.
Schulman KL, Kohles J. Economic burden of metastatic bone disease in the U.S. Cancer. 2007;109(11):2334-42.
Singh D, Yi WS, Brasacchio RA, et al. Is there a favorable subset of patients with prostate cancer who develop oligometastases? Int J Radiat Oncol Biol Phys. 2004;58(1):3-10.
Souchon R, Feyer P, Thomssen C, et al. Clinical recommendations of DEGRO and AGO on preferred standard palliative radiotherapy of bone and cerebral metastases, metastatic spinal cord compression, and leptomeningeal carcinomatosis in breast cancer. Breast Care (Basel). 2010;5(6):401-7.
Sprave T, Verma V, Forster R, et al. Randomized phase II trial evaluating pain response in patients with spinal metastases following stereotactic body radiotherapy versus three-dimensional conformal radiotherapy. Radiother Oncol. 2018;128(2):274-82.
Sprave T, Verma V, Forster R, et al. Local response and pathologic fractures following stereotactic body radiotherapy versus three-dimensional conformal radiotherapy for spinal metastases – a randomized controlled trial. BMC Cancer. 2018;18(1):859.
Steenland E, Leer JW, van Houwelingen H, et al. The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study. Radiother Oncol. 1999;52(2):101-9.
Sze WM, Shelley M, Held I, et al. Palliation of metastatic bone pain: single fraction versus multifraction radiotherapy – a systematic review of the randomised trials. Cochrane Database Syst Rev. 2004(2):CD004721.
van de Ven S, van den Bongard D, Pielkenrood B, et al. Patient-reported outcomes of oligometastatic patients after conventional or stereotactic radiation therapy to bone metastases: an analysis of the PRESENT cohort. Int J Radiat Oncol Biol Phys. 2020;107(1):39-47.
van der Linden YM, Steenland E, van Houwelingen HC, et al. Patients with a favourable prognosis are equally palliated with single and multiple fraction radiotherapy: results on survival in the Dutch Bone Metastasis Study. Radiother Oncol. 2006;78(3):245-53.
Wu JS, Wong R, Johnston M, et al. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003;55(3):594-605.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V2.2021. Available at: http://www.nccn.org. Accessed July 14, 2021. ©National Comprehensive Cancer Network, 2021. To view the most recent and complete version of the Guideline, go online to www.nccn.org.

These Guidelines are a work in progress that may be refined as often as new significant data becomes available.

Breast Cancer

General Information

Commonly Used Modalities

Internal Radiation Therapy (Brachytherapy)

External Beam Radiation Therapy

2D and 3D conformal
Intensity Modulated Radiation Therapy (IMRT)

Radiation Oncology Considerations

General Considerations

Whole breast irradiation (WBI) is a well-established and integral component of breast conservation therapy (BCT). When given after lumpectomy, WBI has been shown to result in equivalent survival when compared to mastectomy. When compared to lumpectomy alone, the addition of radiation therapy significantly reduces the risk of local recurrence and has even been shown to improve overall survival in some patients. Conventionally fractioned WBI usually consists of treatment to doses of 45 to 50 Gy in daily doses of 1.8-2 Gy. Additional “boost” treatment to the tumor bed has been shown to further decrease the risk of local recurrence in several randomized trials, especially in younger women and those with high-grade lesions.

Adjuvant radiotherapy is an important component of treatment for ductal carcinoma in situ (DCIS). Several large randomized controlled clinical trials have demonstrated the benefit of postoperative radiotherapy after excision of DCIS. These have shown a reduction in overall local recurrences and have also shown a decrease in the proportion of recurrences which are invasive. Except where otherwise noted, guidelines for breast cancer radiotherapy will also apply to patients with DCIS.

In patients treated with mastectomy for invasive breast cancer, adjuvant radiation therapy has been shown to benefit patients with high-risk pathologic features including tumors greater than 5 cm, positive lymph nodes and when the surgical margin is positive. Radiotherapy may also be considered in patients with a constellation of high-risk features including but not limited to tumor greater than 2 cm, extensive lymphovascular invasion and close surgical margins.

Treatment Planning

For external beam WBI, 3D conformal planning techniques are commonly used to achieve a uniform dose distribution throughout the breast. Reasonable cosmesis can be achieved and toxicity can be limited using standard wedges, electronic compensation or forward planned field-in-field segments with custom blocking. Several randomized trials of “simple IMRT” for early stage breast cancer have been reported and have shown a decrease in moist desquamation, overall cosmesis and telangiectasia when compared to 2D conventionally wedged techniques. Of note, both of these studies employed field-in-field techniques to achieve homogeneity which do not meet the CPT definition for IMRT planning and delivery.

There is evidence that radiation dose to the heart contributes to late cardiac toxicity in patients with left sided breast cancer. Gagliardi et al. have developed dose response model to predict the risk of cardiac mortality using data sets from several trials of radiotherapy for both Hodgkin’s disease and breast cancer. They predict that using the most conservative model, when the volume of heart receiving 25 Gy is less than 10% that the risk cardiac mortality from radiation is less than 1% at 15 years. Whenever possible, care should be taken to exclude the heart from the primary radiation beam. Cardiac exposure can be limited through alternate patient positioning (such as the prone position) or through the use of deep inspiration breath hold technique. Limitations that would require inverse-planned IMRT or volumetric arc therapy should be rare. IMRT may be of benefit in highly selected cases where the anatomy is unfavorable or the targets closely approximate the heart, however, the use of this technology has not demonstrated a significant clinical advantage in routine cases.

Radiation to the high axilla and supraclavicular region should be considered in cases where there are involved axillary lymph nodes. Treatment of the internal mammary node chain should be considered when those nodes are pathologically enlarged and/or PET avid on imaging studies. Inclusion of the internal mammary nodes in the treatment field may also be indicated when there are four or more positive axillary nodes or when the primary tumor is located in the medial portion of the breast.

Accelerated Whole Breast Irradiation (AWBI)

There is a growing body of evidence that selected women with early stage breast cancer and favorable anatomy are suitable candidates for accelerated whole breast irradiation (AWBI). This approach has been studied in several randomized prospective clinical trials as well as a large meta-analysis. Included patients were mostly age 50 or greater, had tumors less than 4 cm, frequently did not receive chemotherapy, were generally node-negative and had a chest wall separation of < 25 cm. Patients were randomized to receive either 40-42.5 Gy in 15-16 fractions or standard radiation consisting of 50 Gy in 25 fractions. With a median follow-up of 10-12 years, there were no significant differences seen in local control, disease-free survival or overall survival. The most recent report from the UK START trials as well as the meta-analysis have demonstrated that some hypofractionated regimens yielded improved cosmetic outcome including reduced incidence of breast shrinkage, telangiectasias and breast edema in the AWBI patients compared to standard fractionation. Additional benefits of AWBI include a decrease in the number of visits for daily treatment and a reduction in the overall cost of care. These results have prompted recommendations that AWBI should be favored for the endorsed cohort and considered for other selected patients. There is evidence that administration of concurrent trastuzumab increases the risk of left ventricular dysfunction and it is unknown if this effect is more pronounced in patients treated with AWBI. For patients treated with prior chemotherapy, higher acute toxicity has been documented only in individuals whose radiotherapy began less than 20 days after chemotherapy was completed. In 2013, the American Society for Radiation Oncology (ASTRO) included AWBI as one of its featured recommendations as part of the 2013 Choosing Wisely campaign. ASTRO recently published updated consensus criteria for who should be treated with AWBI to include all age groups, any stage as long as a separate nodal field is not used, and patients who have received chemotherapy. The dose inhomogeneity exclusion has also been restated to indicated that the volume of breast tissue receiving > 105% should be minimized regardless of dose-fractionation.

Ultrahypofractionated regimens have also been studied for whole breast irradiation. The FAST-Forward trial compared 26 and 27 Gy treatments given over one week with moderately hypofractionated treatment of 40 Gy over 3 weeks. A total of 2,018 women with early stage breast cancer were randomized 1:1:1 to the three arms. The median follow-up was 71 months. Both one week treatments were non-inferior compared to 3 week WBI with local recurrence rates slightly lower than the 2.1% rate at 5 years seen with 3 week treatment. The higher dose 27 Gy arm showed worse cosmesis than the 40 Gy in 3 weeks arm while the 26 Gy arm was not statistically different.

Accelerated Partial Breast Irradiation (APBI)

Although the randomized clinical trials supporting radiotherapy have relied on whole breast irradiation, the majority of the benefit came from reducing recurrence in and immediately adjacent to the lumpectomy site. This observation has prompted investigation of whether local radiation, delivered only to the tumor bed and immediately adjacent tissue, could achieve similar results in selected patients. Accelerated partial breast irradiation (APBI) describes the treatment of the tumor bed alone with an accelerated treatment delivery schedule. Treatment can be given with brachytherapy delivered via implanted single or multilumen catheters, with external beam radiotherapy, or with intraoperative radiotherapy given at the time of surgery.

A large cohort of patients who received APBI using the MammoSite applicator has been studied, and the 5-year actuarial rate of ipsilateral breast tumor recurrence was 3.8%. More than 90% of patients in this study reported good to excellent cosmesis. Long term high-quality data for APBI is currently lacking. Results from the prospective, randomized, phase III NSABP B-39/RTOG 0413 trial were recently reported. The study randomized patients to WBI or APBI delivered via brachytherapy or with 3D conformal techniques. The primary outcome was ipsilateral breast-tumor recurrence. With a median follow-up of 10.2 years, ipsilateral breast-tumor recurrence was 3% in the WBI group vs 4% for APBI. Survival and toxicities were similar. Although APBI did not meet the statistical criteria for equivalence to WBI and the overall difference in recurrence rate was 1%, the authors concluded that ABPI might be an acceptable alternative for some women. In the RAPID trial comparing WBI with 3D conformal APBI, Canadian investigators found that 17% of WBI patients vs 29% of 3D conformal APBI patients had adverse cosmetic outcomes. In contrast, fewer adverse events were reported from women treated with lower dose and partial breast irradiation compared to whole breast irradiation in a longitudinal analysis of the IMPORT LOW phase III randomized controlled trial.

The results of the APBI-IMRT Florence trial were recently reported. Eligible patients were over 40 and had tumors measuring 2.5 cm or less. A total of 520 patients were randomized to receive 50 Gy whole breast irradiation in 25 fractions or 30 Gy in 5 fractions using IMRT-based APBI. The 10 year ipsilateral breast tumor recurrence rates were 2.5% for WBI vs 3.7% for APBI (p = .4). The overall 10-year survival was similar in both arms at 92%. Of note, the APBI treatment was associated with lower acute toxicity and improved cosmesis compared to WBI (p = .0001).

Intraoperative radiotherapy (IORT) is aform of APBI in which the entire partial breast treatment is delivered at the time of lumpectomy. Several systems have been approved to deliver treatment with either electrons or 50 kV x-rays. Two large randomized trials of this approach have been published. The ELIOT trial compared electron-based IORT to WBI in women 48 years or older and tumors less than 2.5 cm. For all patients, the ipsilateral breast tumor recurrence rate was 4.4% for the IORT patients vs 0.4% for the WBI patients (P < .0001). A subsequent subset analysis looking only at patients who qualify as “suitable” for APBI using the ASTRO criteria revealed more favorable recurrence rates of 1.5% with electron IORT. Results of the TARGIT-A trial were recently updated and with a shorter median follow-up of 29 months, they reported a local recurrence rate of 3.3% for IORT vs 1.3% for WBI. When only the patients treated at the time of lumpectomy are considered, the local recurrence rates were 2.1% for IORT vs 1.1% for WBI. In these patients, if high-risk features such as positive margins, extensive intraductal component, lobular histology, high-grade histology, lymphovascular invasion or positive nodes were present on the final pathology, WBI was often added to the treatment. Survival was similar in both arms.

It is recommended that individuals considering APBI as an alternative to whole breast irradiation be counseled that whole breast irradiation is the more well-established treatment with documented long-term effectiveness and safety, and that treatment with APBI may be associated with an increased risk of local recurrence and need for mastectomy. Society recommendations regarding patient suitability have been published, but are not all in agreement.

Regarding electronic brachytherapy, the American Brachytherapy Society states that “it is not recommended that electronic brachytherapy be utilized for accelerated partial breast irradiation, non-melanomatous skin cancers, or vaginal cuff brachytherapy outside prospective clinical trials at this time.”

Society Recommendations for AWBI

ASTRO – An update to the 2011 Guideline was published in early 2018. The new recommendations support the use of AWBI for all ages, all stages when nodes will not be treated separately, and in patients who have received any type chemotherapy. The consensus was that when a boost is not given, a dose of 40 Gy in 15 fractions or 42.5 Gy in 16 fractions is favored. In homogeneity greater that 107% in the central axis is no longer an exclusion. The panel recommended that the volume of tissue receiving >105% should be minimized irrespective of dose schedule.

Society Recommendations for APBI

The National Comprehensive Cancer Network® (NCCN, 2020) – Guideline indicates that preliminary studies have shown that APBI may result in similar rates of local control in early breast cancer compared to WBI. They also note that cosmesis may be inferior and follow-up is limited. NCCN recommends treatment with APBI to be provided in a prospective clinical trial when possible. If APBI is provided off trial, then brachytherapy is recommended for those with a low risk of recurrence. They cite the ASTRO criteria for suitable candidates for APBI.

ASTRO – An update to the Evidence-Based Consensus statement was published in 2017. There were several changes in the criteria for who are “suitable” candidates for APBI. The age for the suitable group was lowered to 50 or older. The criteria were also broadened to include ductal carcinoma in situ (DCIS). The criteria are summarized below:

Age > 50 years
Surgical margins > 2 mm for invasive ductal cancer and > 3 mm for DCIS
Size < 2 cm for invasive ductal cancer and < 2.5 cm for DCIS
DCIS must be low to intermediate grade and non-palpable
No lymphovascular invasion
ER positive
No invasive lobular cancer

American College of Breast Surgeons – The American Society of Breast Surgeons recommends the following selection criteria when considering patients for treatment with APBI, as a sole form of radiation therapy in lieu of whole breast irradiation:

Age 45 years old or older for invasive cancer and age 50 years or older for DCIS
Invasive carcinoma or ductal carcinoma in situ
Total tumor size (invasive and DCIS) less than or equal to 3 cm in size
Negative microscopic surgical margins of excision
Sentinel lymph node negative

Clinical Indications

2D or 3D Conformal is appropriate for breast cancer when ANY one of the following conditions are met:

As an adjunct to surgical treatment after lumpectomy for localized breast cancer or DCIS
As an adjunct to surgical treatment after mastectomy for locally advanced breast cancer
To treat recurrent disease
Palliative treatment of metastatic disease, including symptomatic breast or chest wall disease

Intensity Modulated Radiation Therapy (IMRT) is appropriate for breast cancer when ANY one of the following conditions are met:

For individuals with left-sided breast lesions where the risk of cardiac exposure would be excessive with 3D conformal treatment and when ALL of the following are met:
- 3D planning has been done, with appropriate techniques to limit toxicity
- Despite the use of all appropriate techniques, the dose-volume constraints would lead to unacceptable risk of cardiac toxicity (EITHER constraint below is exceeded):
  - More than 10% of the heart would receive 25 Gy or more (V25 > 10%)
  - More than 10% of the left anterior descending (LAD) artery would receive 15 Gy (V15 > 10%)
- IMRT plan demonstrates improvement to tissue exposure to within safe ranges
For individuals who will receive internal mammary node irradiation based on ANY one of the following:
- Pathologically enlarged (as reported based on imaging technique utilized) internal mammary lymph node(s) by CT, MRI, PET/CT, or CXR
- Pathologically involved internal mammary lymph node(s) (based on aspiration cytology or tissue biopsy pathology)
- For individuals at high risk of internal mammary lymph node involvement based on ANY one of the following:
  - Four or more positive axillary lymph nodes
  - Medial quadrant tumor with at least one positive axillary lymph node
  - Medial quadrant T3 tumor
For individuals where the 3D conformal plan results in hot spots (> 2 cm³) receiving more than to 110% of the prescription dose despite the use of forward planned field-in-field blocking and/or mixed beam energy (6 MV and 10 MV/15 MV)
For individuals being treated with accelerated partial breast irradiation (APBI)
To treat a previously irradiated field

Note: “Forward planning IMRT” is a term used to describe field-in-field 3D conformal radiation therapy and should not be reviewed under IMRT constraints.

Brachytherapy is appropriate for breast cancer only when used to deliver ANY one of the following:

Intraoperative radiation therapy (IORT) is appropriate only for individuals who meet ALL of the following criteria:
- Age 50 or greater
- Tumor less than or equal to 3 cm with grossly uninvolved surgical margins
- Lymph nodes are grossly negative and negative on intraoperative frozen section if performed
- Distance between the edge of the applicator and the skin will be at least 6 mm

Note: If intraoperative radiotherapy was used at the time of surgery but the final pathologic evaluation reveals indications for whole breast irradiation, the IORT will be considered the boost portion of the treatment.

Accelerated partial breast irradiation (APBI) is appropriate only for individuals who meet ALL of the following criteria:
- Age 45 or greater for invasive disease or greater than 50 for DCIS
- Tumor less than or equal to 3 cm with pathologically negative surgical margins
- Lymph nodes are negative or show only immunohistochemical involvement, N0 or N0(i+)
- Distance between the edge of the applicator and the skin is at least 6 mm

Note: Electronic brachytherapy is considered not medically necessary.

Hyperthermia is appropriate for breast cancer when the following condition is met:

For individuals with a chest wall recurrence after prior radiation therapy to the chest or breast.

Fractionation

Whole breast irradiation (WBI) – 17 to 28 fractions of WBI are appropriate only for individuals who meet ANY one of the following criteria:

Lymph node involvement requiring treatment the supraclavicular or internal mammary nodal regions.
Mastectomy or breast reconstruction have been performed
Treatment will be delivered with 3D conformal radiotherapy and the treatment plan results in dose inhomogeneity of greater than 7% in the central axis (for example, if the plan is normalized to 95%, the maximum dose is greater than 112%)
Concurrent chemotherapy will be administered (does not include trastuzumab or endocrine therapy)

For individuals not meeting one of these criteria, up to 16 fractions of WBI are medically necessary.

Breast boost irradiation

An additional boost of up to 8 fractions is appropriate when the individual has fulfilled the above criteria for 17-28 fractions of WBI
For individuals not meeting the above criteria, an additional boost of up to 5 fractions is appropriate

More than 36 fractions, including whole breast irradiation and boost irradiation, are not medically necessary.

Accelerated partial breast irradiation (APBI) delivered with up to 10 fractions delivered twice daily. More than 10 fractions are not medically necessary.

Intraoperative radiation therapy (IORT) is given as a single fraction. More than one fraction is not medically necessary.

Codes

The following code list is not meant to be all-inclusive. Authorization requirements will vary by health plan. Please consult the applicable health plan for guidance on specific procedure codes.

Specific CPT codes for services should be used when available. Nonspecific or not otherwise classified codes may be subject to additional documentation requirements and review.

2D and 3D Conformal

CPT/HCPCS

77295 3-dimensional radiotherapy plan, including dose-volume histograms (3D Conformal treatment plan)

77402 Radiation treatment delivery, >1 MeV; simple.