Subject:
Radiation Therapy for Head and Neck Cancer
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Over the past several decades, methods to plan and deliver radiation therapy have evolved in ways that permit more precise targeting of tumors with complex geometries. Earlier methods involved two-dimensional treatment planning based on flat images, and radiation beams with cross-sections of uniform intensity that were sequentially aimed at the tumor along 2 or 3 intersecting axes. These methods were collectively termed conventional external beam radiation therapy (EBRT).
Subsequent enhancement evolved using 3-dimensional images, usually from computed tomography (CT) scans, to delineate the tumor, its boundaries with adjacent normal tissue, and organs at risk for radiation damage. Radiation oncologists used these images, displayed from a "beam's-eye-view", to shape each of several beams (e.g., with compensators, blocks, or wedges) to conform to the patient's tumor geometry perpendicular to the beam's axis. Computer algorithms were developed to estimate cumulative radiation dose delivered to each volume of interest by summing the contribution from each shaped beam. Methods also were developed to position the patient and the radiation portal reproducibly for each fraction, and immobilize the patient, thus maintaining consistent beam axes across treatment sessions. However, "forward" planning used a trial and error process to select treatment parameters (the number of beams and the intensity, shape, and incident axis of each beam). The planner/radiotherapist modified one or more parameters and recalculated dose distributions, if analysis predicted underdosing for part of the tumor or overdosing of nearby normal tissue. Furthermore, since beams had uniform cross-sectional intensity wherever they bypassed shaping devices, it was difficult to match certain geometries (e.g., concave surfaces). Collectively, these methods are termed 3-dimensional conformal radiation therapy (3D-CRT).
Other methods were subsequently developed to permit beam delivery with non-uniform cross-sectional intensity. This often relies on a device (multi-leaf collimator, MLC) situated between the beam source and patient that moves along an arc around the patient. As it moves, a computer varies aperture size independently and continuously for each leaf. Thus, MLCs divide beams into narrow "beamlets", with intensities that range from zero to 100% of the incident beam. Beams may remain on as MLCs move around the patient (dynamic MLC), or they may be off during movement and turned on once the MLC reaches prespecified positions ("step and shoot" technique). Another method of delivering radiation beam uses a small radiation portal emitting a single narrow beam that moves spirally around the patient, with intensity varying as it moved. This method, also known as tomotherapy or helical tomotherapy, is described as the use of a linear accelerator inside a large "donut" that spirals around the body while the patient laid on the table during treatment. Each method (MLC-based or tomotherapy) is coupled to a computer algorithm for "inverse" treatment planning. The planner/radiotherapist delineates the target on each slice of a CT scan, and specifies that target's prescribed radiation dose, acceptable limits of dose heterogeneity within the target volume, adjacent normal tissue volumes to avoid, and acceptable dose limits within the normal tissues. Based on these parameters and a digitally-reconstructed radiographic image of the tumor and surrounding tissues and organs at risk, computer software optimizes the location and shape of beam ports, and beam and beamlet intensities, to achieve the treatment plan's goals. Collectively, these methods are termed intensity-modulated radiation therapy (IMRT).
According to ECRI Institute, there are two different approaches to image-guided radiation therapy that are in current use: pre-treatment imaging and real-time guidance. IMRT is an example of a method that uses pre-treatment imaging to prepare a treatment plan. In contrast, real-time guidance utilizes real-time imaging (at the time of treatment) to guide treatment. It provides real-time, online images of the radiation target area from a computed tomography (CT) scanner before, during, and after therapy. Patient positioning, radiation field alignment, and collimator positioning can be verified and adjusted before and during irradiation. This approach should, in theory, provide more accurate radiation delivery than conventional IMRT. Organ motion, day-to-day variations in tumor position, and differences in patient positioning in each treatment session could be taken into account with real-time imaging.
Policy:
(NOTE: This policy only applies to adult members. It does not apply to pediatric members.
For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
I. Radiation therapy techniques
A. Three-dimensional conformal radiation therapy (3DCRT) and Intensity-Modulated Radiation Therapy (IMRT) techniques are medically necessary.
B. The use of neutron beam therapy is medically necessary in select cases of salivary gland tumors. (Refer to a separate policy on 'Neutron Beam Radiation Therapy' Policy #133 in the Radiology Section)
C. Pre-operative radiation therapy is medically necessary in select cases
1. May be given in up to 35 fractions in 3 phases
2. May use Complex, 3DCRT, or IMRT techniques
II. Radiation therapy treatment intent/timing
A. Definitive radiation therapy
1. Is medically necessary for selected T1-2, N0 cases as monotherapy
2. May employ up to 42 fractions in a maximum of 2 phases
3. Depending on the simplicity or complexity of the case, Complex, 3DCRT, or IMRT techniques may be necessary
B. Definitive radiation therapy as monotherapy
1. Is medically necessary for selected T1N1 and T2N0-1 cases
2. Radiation may be given utilizing any of several schedules including conventional daily fractionation, concomitant boost accelerated fractionation, and hyperfractionation (twice-daily radiation)
3. Up to 68 fractions may be medically necessary, in 2 phases
C. Definitive concurrent chemoradiation
1. Is medically necessary in unresected T2-4a, N0-3 cases utilizing up to 42 fractions with conventional schedule
2. 3DCRT, or IMRT techniques are medically necessary, in up to 4 phases
3. Concurrent chemotherapy carries a high toxicity burden and requires substantial supportive care and the expertise of an experienced multidisciplinary team
D. Post-operative radiation therapy
1. Is medically necessary for cases which have any of the following high risk factors:
a. pT3 or pT4 primary tumors
b. N2 or N3 nodal disease
c. Positive nodes in levels IV or V
d. Perineural invasion
e. Vascular tumor embolism
f. Positive surgical margins or residual gross disease
2. 35 fractions are medically necessary
3. 3DCRT or IMRT techniques are medically necessary, in up to three 3 phases
4. Chemotherapy may be added concurrently with post-operative radiation and is medically necessary in cases with positive margins or extracapsular nodal extension
5. Concurrent chemotherapy also may be considered in cases with the other high risk factors mentioned above, in which up to 40 fractions in 2 phases are medically necessary
6. Concurrent chemotherapy carries a high toxicity burden and requires substantial supportive care and the expertise of an experienced multidisciplinary team
III. Radiation therapy, brachytherapy
A. Low Dose Rate (LDR) or High Dose Rate (HDR) brachytherapy is medically necessary in select cases of epithelial tumors of the head and neck region. In appropriate early cases, it is medically necessary as monotherapy. In more advanced cases, it may be substituted for one phase of 3DCRT or IMRT
B. Brachytherapy for head and neck malignancies should be performed only by those radiation oncologists specifically trained in its use
IV. Radiation therapy, palliative
A. In a previously un-irradiated individual with symptomatic local disease, Complex, 3DCRT or IMRT techniques are indicated for symptom control
B. Up to 20 fractions are medically necessary, in 1 phase
V. Re-treatment for salvage after prior radiation
A. Re-irradiation may be indicated in cases of recurrent or persistent disease, or for in-field new primary tumors, in cases in which there are no known distant metastases.
B. Reirradiation carries increased risk. Per the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Head and Neck Cancers, “In general, the reirradiated population of head and neck cancer patients as described in the current literature represents a diverse but highly selected group of patients treated in centers where there is a high level of expertise and systems in place for managing acute and long-term toxicities. When the goal of treatment is curative and surgery is not an option, reirradiation strategies can be considered for patients who: develop locoregional failures or second primaries at > 6 months after the initial radiotherapy; can receive additional doses of radiotherapy of at least 60 Gy; and can tolerate concurrent chemotherapy. Organs at risk for toxicity should be carefully and analyzed through review of dose volume histograms, and consideration for acceptable doses should be made on the basis of time interval since original radiotherapy, anticipated volumes to be included, and patient’s life expectancy.”
C. Stereotactic Body Radiation Therapy (SBRT) may be medically necessary for retreatment in patients who have no evidence of metastatic disease
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for Three-dimensional (3D) Conformal Radiation Therapy (3DCRT), Neutron Beam, and brachytherapy. Therefore, Medicare Advantage Products will follow the Horizon Policy for these services.
Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has issued a determination for Intensity-Modulated Radiation Therapy (IMRT). For additional information and eligibility for IMRT, refer to Local Coverage Determination (LCD): Intensity Modulated Radiation Therapy (IMRT) (L36711) and Local Coverage Article: Billing and Coding: Intensity Modulated Radiation Therapy (IMRT) (A56725). Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36711&ver=18&name=314*1&UpdatePeriod=749&bc=AAAAEAAAAAAAAA%3d%3d&.
[INFORMATIONAL NOTE: Based upon established criteria, assessment of peer-reviewed literature, and consensus present in established guidelines (American College of Radiology [ACR]/American Society for Radiation Oncology [ASTRO], NCCN®, radiation therapy is considered an integral component in the multidisciplinary management of malignancies of the head and neck region. Primary anatomic sites included in this category include paranasal sinuses (ethmoid and maxillary), salivary glands, the lip, oral cavity, oropharynx, hypopharynx, glottic larynx, supraglottic larynx, nasopharynx, and occult/unknown head and neck primary sites. The preponderance of literature addresses tumors of epithelial origin. Non-epithelial malignancies of the head and neck region (e.g. tumors arising in bone, cartilage, soft tissues, and lymphomas) are not covered by this policy.
Utilization of radiation therapy should be preceded by workup and staging, and planned in conjunction with the appropriate members of a multi-disciplinary team that also includes: diagnostic imaging, pathology, medical oncology; otorhinological, oral, plastic and reconstructive, neuro- and ophthalmologic surgeons; psychiatry; addiction services; audiology and speech therapy; rehabilitation and nutritional medicine; pain management, dentists, prosthodontists, xerostomia management, smoking and alcohol cessation, tracheostomy and wound management, social workers and case management. Participation in a national clinical trial is encouraged.
Initial management may require surgery, chemotherapy, and radiation therapy in various combinations and sequences.
Radiation treatment schedules
Radiation therapy treatment schedules published in peer-reviewed consensus documents such as NCCN Guidelines® include regimens that encompass a broad range of doses that must be customized to an individual's circumstance. These schedules are based on the extent of the primary and nodal disease as well as the treatment intent, such as definitive, preoperative or post-operative. The additional therapeutic strategies such as concurrent chemotherapy or brachytherapy is described in the NCCN Guidelines®.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Radiation Therapy for Head and Neck Cancer
Radiation Treatment of Head and Neck Cancer
Head and Neck Cancer, Radiation Treatment of
Neck Cancer, Radiation Treatment of Head and
Head and Neck Cancer, Stereotactic Radiotherapy
Neck Cancer, Stereotactic Radiotherapy
SBRT, Head and Neck Cancer
Stereotactic Radiotherapy of Head and Neck Cancer
References:
1. ACR-ABS Practice Parameter for the Performance of Low-Dose-Rate Brachytherapy. Revised 2015 (CSC/BOC).
2. ACR-ABS Practice Parameter for the Performance of Radionuclide-Based High-Dose-Rate Brachytherapy. Revised 2015 (CSC/BOC).
3. Bernier J, Domenge C, Ozsahin M, et al. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6; 350(19):1945-1952.
4. Bernier J, Cooper JS, Pajuk TF, et al. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (#9501). Head Neck. 2005 Oct; 27(10):843-850.
5. Cooper JS, Pajak TF, Forastiere AA, et al. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous cell carcinoma of the head and neck. N Engl J Med. 2004 May 6: 350:1937-1944.
6. Dogan N, King S, Emami B, et al. Assessment of different IMRT boost delivery methods on target coverage and normal-tissue sparing. Int J Radiat Oncol Biol Phys. 2003 Dec 1; 57(5):1480-1491.
7. Eisbruch A, Foote R, Beitler J, et al. Intensity-modulated radiation therapy for head and neck cancer: emphasis on the selection and delineation of targets. Seminars in Radiation Oncology. 2002 Jul: 12(3):238-49.
8. Lee NY, de Arruda FF, Puri DR, et al. A comparison of intensity-modulated radiation therapy and concomitant boost radiotherapy in the setting of concurrent chemotherapy for locally advanced oropharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2006 Nov; 66(4):966-974.
9. Lee NY, O'Meara w, Chan K, et al. Concurrent chemotherapy and intensity-modulated radiotherapy for locoregionally advanced laryngeal and hypopharyngeal cancers. Int J Radiat Oncol Biol Phys. 2007 Oct 1; 69(2):459-468.
10. Mohan R, Wu Q, Morris M, et al. “Simultaneous Integrated Boost” (SIB) IMRT of advanced head and neck squamous cell carcinomas-dosimetric analysis. Int J Radiat Oncol Biol Phys. 2001 Nov 1; 51(3):180-181.
11. National Comprehensive Cancer Network (NCCN) Guidelines®. Head and Neck Cancers Version 3.2019 – September 16, 2019. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Head and Neck Cancers Version 3.2019. ©2019 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN®. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org.
12. O’Sullivan B, Huang SH, Siu LL, et al. Deintensification candidate subgroups in human papillomavirus-related oropharyngeal cancer according to minimal risk of distant metastasis. J Clin Oncol. 2013 Feb 10; 31:543-550.
13. Overgaard J, Hansen HS, Specht L, et al. Five compared with six fractions per week of conventional radiotherapy of squamous cell carcinoma of head and neck: DAHANCA 6 and 7 randomised control trial. Lancet. 2003; 362(9388):933-940.
14. Schoenfeld GO, Amdur RJ, Morris CG, et al. Patterns of failure and toxicity after intensity-modulated radiotherapy for head and neck cancer. Int J Radiat Oncol Biol Phys. 2008 Jun 1; 71(2):377-385.
15. Wolden SL, Chen WC, Pfister DG, et al. Intensity-modulated radiation therapy (IMRT) for nasopharynx cancer: update of the Memorial Sloan-Kettering experience. Int J Radiat Oncol Biol Phys. 2006 Jan 1; 64(1):57-62.
16. Wu Q, Manning M, Schmidt-Ullrich, Mohan R. The potential for sparing of parotids and escalation of biologically effective dose with intensity-modulated radiation treatments of head and neck cancers: a treatment design study. Int J Radiat Oncol Biol Phys. 2000 Jan 1; 46(1):195-205.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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