The decision to use IMRT requires a clear understanding of accepted clinical practices that consider the risks and benefits of such therapy when compared to conventional and 3D conformal treatment.

IMRT is considered medically necessary when all the following criteria are met:

• IMRT should not be used as a substitute for conventional radiation therapy methods;
• Sparing surrounding normal tissue is of added benefit; and
• One or more of the following conditions are met:
  • The target volume is in close proximity to critical structures that must be protected.
  • The volume of interest must be covered with narrow margins to adequately protect immediately adjacent structures.
  • An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision.
  • Dose escalation is planned to deliver radiation doses in excess of those commonly utilized for similar tumors with conventional treatment.

Intensity modulated radiation therapy (IMRT) is considered reasonable in some clinical situations for the following conditions:

• Primary bone and articular cartilage cancer of the skull and face, vertebral column, sacrum and coccyx as related to dose needed to be delivered.
• Primary, metastatic, or benign tumors of the central nervous system including the brain, brain stem, and spinal cord.
• Primary, metastatic, or benign tumors of the spine where the spinal cord tolerance may be exceeded with conventional treatment.
• Primary, metastatic, or benign lesions to the head and neck area including any of the following sites: lip; eye; thyroid; salivary glands; hypopharynx; oropharynx; nasopharynx; other parts of the pharynx not explicitly identified here; oral cavity; tongue; nasal cavities; middle ear; accessory sinuses; larynx; lymph nodes of the head, face and neck; pituitary gland, pineal gland, carotid body; and skin of lip, eyelid, ear and external auditory canal.
• Primary small cell and non-small cell lung cancer.
• Carcinoma of the prostate.
• Pelvic and retroperitoneal malignancies.
• Squamous cell cancer of the anus/anal canal.
• Locally advanced rectal adenocarcinoma when dosimetric planning predicts the risk of small intestine injury with standard 3D conformal treatment would be unacceptable.
• Gynecological cancer may be given consideration when one or more of the following conditions are met:
  • When the planned dose will be higher than the standard 45-50.4 Gy;
  • A positive margin will be treated concomitantly;
  • An extended field will be treated;
  • There has been a history of adhesions or small bowel complications;
  • Imaging confirms an excessive amount of small bowel in the treatment field.
• The use of IMRT for breast cancer will be reviewed on a case by case basis (e.g., IMRT may be indicated if the breast cancer cannot be adequately covered using 3D conformal therapy).

The medical necessity criteria only applies to the 3D rendering procedures (76376, 76377) when reported in conjunction with IMRT services.

All uses for IMRT that do not meet the above criteria are considered not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

The list of approved anatomic sites for IMRT in not all inclusive. It is not possible to preclude cancers solely based on their primary site of origin. Therefore, requests for conditions other than those listed will be reviewed on a case-by-case basis as to medical necessity.

The reason IMRT is chosen over other radiation therapy methods should be documented in the patient’s medical record by including the following information:

• The prescription, defining the goals and requirements of the treatment plan, including the specific dose constraints for the target(s) and nearby critical structures;
• A statement by the treating physician documenting the medical necessity for performing IMRT on the patient in question, rather than performing conventional or 3-dimensional treatment planning and delivery;
• A signed IMRT inverse plan that meets prescribed dose constraints for the planning target volume and surrounding normal tissue using either dynamic multi-leaf collimator or segmented multi-leaf collimator (average number of ‘steps’ required to meet IMRT delivery is 5) to achieve intensity modulation radiation delivery;
• The target verification methodology which must include the following:
  • documentation of the clinical treatment volume and the planning target volume;
  • documentation of immobilization and patient positioning;
  • means of dose verification and secondary means of verification;
• An independent check of the monitor units generated by the IMRT treatment plan, prior to the patient’s first treatment;
• Fluence distributions re-computed in a phantom; and
• Plan to account for structures moving in and out of high and low dose regions created by respiration. Voluntary breath holding is not considered appropriate and the solution for movement can best be accomplished with gating technology.

For reimbursement purposes, the treating physician (for example, radiation oncologist) must be on-site during treatment, in the event his or her personal assistance is required to care for the patient.

Codes 77418 or 0073T represent IMRT treatment delivery, as appropriate.

Intensity modulated radiotherapy treatment planning (code 77301) should be reported once for each treatment volume during a course of therapy. If code 77301 is reported more than once for the same tumor, the patient’s medical record must document the medical necessity for the additional service and be available for review upon request.

Simultaneous or planned sequential treatment of multiple targets within a region is considered a single treatment plan (for example, when multiple lesions of the brain or prostate and seminal vesicles are treated). Code 77301 should be reported using the date that the plan was approved by the radiation oncologist or physicist.

Code 77338 should be used to report the design and construction of multi-leaf collimator (MLC) device(s) for IMRT according to the IMRT treatment plan.

If the following services are reported on the same day as IMRT treatment planning (code 77301), they are not eligible for separate payment. A participating, preferred, or network provider cannot bill the member for the denied service in this instance.

• CT guidance for replacement of radiation therapy fields (code 77014)
• Coronal, sagittal, multiplanar, oblique, 3-dimensional and/or holographic reconstruction (code 76376, 76377)
• Simulation-aided field setting (codes 77280, 77285, 77290, 77295)
• Teletherapy, isodose planning (codes 77305, 77310,77315)

Description

IMRT is an advanced form of three-dimensional conformal radiation therapy (3D CRT) that uses varying intensities of radiation to produce dose distributions that are more conformal than those possible with standard 3D CRT. The beam intensity is varied across the treatment field. That is, instead of using a single, large, uniform beam, the patient is treated with many very small beams of varying intensities. This method of irradiation delivers a more uniform dose of radiation to the tumor, while protecting surrounding tissue from unnecessarily high doses of radiation.

IMRT delivers radiation more precisely to a tumor while sparing the surrounding normal tissues and/or organs. When a tumor is not well separated from surrounding organs at risk (for example, when a tumor wraps itself around an organ), there may be no combination of radiation beams of the same intensity that will safely separate the tumor from the healthy organ and/or tissue. In such instances, IMRT allows more intense treatment directed to the tumor, while limiting the radiation dose to adjacent healthy organs and/or tissue.

For additional information on other radiation therapy services, refer to Medical Policy Bulletin R-4.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

02/2003, Intensity Modulated Radiation Therapy (IMRT)
12/2011, New criteria for the utilization of intensity modulated radiation therapy (IMRT)

Facility Bulletin

04/2012, Commercial Medical Policy on Intensity Modulated Therapy Applies to Facility Business Effective April 2, 2012

Intensity Modulation Using Multileaf Collimators: Current Status, Medical Dosimetry, Volume 26, No. 2, Summer 2001

Treatment Planning and Delivery of Intensity-Modulated Radiation Therapy for Primary Nasopharynx Cancer, International Journal of Radiation Oncology, Biology, Physics, Volume 49, No. 3, March 2001

Intensity-Modulated Radiation Therapy (IMRT) for Prostate Cancer with the Use of a Rectal Balloon for Prostate Immobilization: Acute Toxicity and Dose-Volume Analysis, International Journal of Radiation Oncology, Biology, Physics, (Clinical Investigation), Volume 49, No. 3, March 2001

Intensity-Modulated Radiation Therapy in Head and Neck Cancers: The Mallinckrodt Experience, International Journal of Cancer, Volume 20, No. 2, April 2000

The Theory & Practice of Intensity Modulated Radiation Therapy, A Monograph by Edward S. Sternick, Ph.D., Editor, Advanced Medical Publishing, Madison, WI.

Søndergaard J, Høyer M, Petersen J. et al. The normal tissue sparing obtained with simultaneous treatment of pelvic lymph nodes and bladder using intensity-modulated radiotherapy. Acta Oncol. 2009;48:238-244.

Yang G, McClosky, Khushalani N. Principles of modern radiation techniques for esophageal and gastroesophageal junction cancers. Gastrointest Cancer Res. 2009;3(suppl 1):S6-S10.

Alani S, Soyfer V, Strauss N, Schifter D, Corn B. Limited advantages of intensity-modulated radiotherapy over 3D conformal radiation therapy in the adjuvant management of gastric cancer. Int J Radiat Oncol. 2009 June;74(2):562-566.

Wong W, Vora S, Schild S, et al. Radiation dose escalation for localized prostate cancer: intensity-modulated radiotherapy versus permanent transperineal brachytherapy. Cancer. 2009;115:5596-606.

Schwartz D, Lobo M, Ang K, et al. Post-operative external beam radiotherapy for differentiated thyroid cancer-outcomes and morbidity with conformal treatment. Int J Radiat Oncol Biol Phys. 2009 July;74(4):1083-1091.

Pepek J, Willett C, Wu Q, et al. Intensity-modulated radiation therapy for anal malignancies: a preliminary toxicity and disease outcomes analysis. Int J Radiat Oncol. 2010 Dec;78(5):1413-1419.

Barnett G, Wilkinson J, Moody A, et al. Randomized controlled trial of forward-planned intensity-modulated radiotherapy for early breast cancer: interim results at 2 years. Int. J Radiat Oncol Biol Phys. 2011; doi:10.1016/j.ijrobp.2010.10.068.

Loiselle, C. The Emerging Use of IMRT for Treatment of Cervical Cancer. J Natl Compr Canc Netw. 2010;8(12):1425-1434.

Kuijper I, Dahele M, Senan S, Verbakel W. Volumetric modulated arc therapy versus conventional intensity modulated radiation therapy for stereotactic spine radiotherapy: a planning study and early clinical data. Radiother Oncol. 2010; 94(2010): 224-228.

Arbea L, Ramos L, Martinez-Monge R, Moreno M, Aristu J. Intensity-modulated radiation therapy (IMRT) vs. 3D conformal radiotherapy (3D CRT) in locally advanced rectal cancer (LARC): dosimetric comparison and clinical implications. Radiat Oncol. 2010;5(17).

Du X, Sheng X, Jiang T, et al. Intensity-modulated radiation therapy versus para-aortic field radiotherapy to treat para-aortic lymph node metastasis in cervical cancer: prospective study. Clin Sci. 2010;S1:229-36.

Patil V, Kapoor R, Chakraborty S, et al. Dosimetric risk estimates of radiation-induced malignancies after intensity modulated radiotherapy. J Canc Res Thera. 2010;6(4):442-447.

Liao Z, Komaki R, Thames H, 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. 2010 Mar;76(3):775-781.

American Society for Therapeutic Radiation and Oncology (ASTRO) and American College of Radiology (ACR). The ASTRO/ACR Guide to Radiation Oncology Coding 2010. Fairfax, VA: ASTRO.

Morales-Paliza M, Coffey C, Ding G. Evaluation of the dynamic conformal arc therapy in comparison to intensity-modulated radiation therapy in prostate, brain, head-and-neck and spine tumors. J Appl Clin Med Phys. 2011;12(2):5-19.

Pignol J, Keller B, Ravi A. Doses to internal organs for various breast radiation techniques-implications on the risk of secondary cancers and cardiomyopathy. Radiat Oncol. 2011;6(5).

Rochet N, Kieser M, Sterzing F, et al. Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy (IMRT) in patients with advanced ovarian cancer stage FIGO III- the OVAR-IMRT-02 study. BMC Cancer. 2011;11(41).

Nutting C, Morden J, Harrington K, et al. Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomized controlled trial. Lancet Oncol. 2011 Feb;12(2):127-136.

Palmeri M, Pipas J, Ripple G, et al. Neoadjuvant intensity-modulated radiotherapy (IMRT) in pancreatic adenocarcinoma: the darthmouth experience. J Clin Oncol. 2011;S4(274).

Alektiar K, Brennan M, Singer S. Local control comparison of adjuvant brachytherapy to intensity-modulated radiotherapy in primary high-grade sarcoma of the extremity. Cancer. 2011 Jan;doi:10.1002/cncr.25882.

Kachnic L, Powell S. IMRT for Breast Cancer—Balancing Outcomes, Patient Selection, and Resource Utilization. J Natl Cancer Inst. 2011;103(10):777-779.

Jensen A, Münter M, Bischoff H, et al. Combined treatment of nonsmall cell lung cancer NSCLC stage III with intensity-modulated RT radiotherapy and cetuximab: The NEAR trial. Cancer. 2011 July;117(13):2986-2994.

Kuo Y, Chiu YM, Shih WP, et al. Volumetric intensity-modulated Arc (RapidArc) therapy for primary hepatocellular carcinoma: comparison with intensity-modulated radiotherapy and 3-D conformal radiotherapy. Radiat Oncol. 2011;6:76.