Radiation Therapy for Urethral Cancer and Upper Genitourinary Tract Tumors
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.
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.
(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.)
- External beam photon radiation therapy (EBRT) is considered medically necessary for the following:
- Definitive treatment of urethral cancer in an individual with T2-T4 disease or node positive.
- Postoperative treatment of urethral cancer in an individual with T3-T4 disease, node positive, or positive surgical margins.
- Postoperative radiation therapy is considered medically necessary in the definitive treatment of cancers of the ureter or renal pelvis for advanced T3-T4 disease, positive lymph nodes, or positive surgical margins.
- Palliative treatment for urethral and upper genitourinary tract disease
- Urethral Cancer
- In the definitive setting up to 39 fractions is considered medically necessary
- In the adjuvant setting in an individual with no high risk features, up 30 fractions is considered medically necessary.
- In the adjuvant setting in and individual with positive margins or extra-nodal extension, up to 39 fractions is considered medically necessary.
- In the palliative setting up to 20 fractions is considered medically necessary.
- Upper Genitourinary Tract
- Preoperative or neoadjuvant treatment is considered medically necessary when combined with chemotherapy in an effort to improve resectability. Usual doses are 30 to 45 Gy.
- In the postoperative adjuvant setting, up to 30 fractions is considered medically necessary.
- In the palliative setting, up to 20 fractions is considered medically necessary.
- EBRT with three-dimensional conformal radiation therapy (3DCRT) or intensity-modulated radiation therapy (IMRT) is considered medically necessary in the definitive treatment of urethral cancer. Treatment prescriptions include the pelvic and inguinal lymph nodes to 40 to 45 Gy followed by a boost to 70 Gy to areas of gross disease in 2 to 3 phases of treatment.
- 3DCRT is considered medically necessary in the palliative setting.
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for external beam photon radiation therapy (EBRT). Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for Radiation Therapy for Urethral Cancer and Upper Genitourinary Tract Tumors.
Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has issued a determination for Intensity-Modulated Radiation Therapy (IMRT). Medicare Advantage Products follow LCD L36711 for Intensity Modulated Radiation Therapy (IMRT). For additional information and eligibility, refer to Local Coverage Determination (LCD): Intensity Modulated Radiation Therapy (IMRT) (L36711). 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&.
[RATIONALE: Key Clinical Points
Treatment for urethral cancer is dependent on gender, tumor location and tumor size (Dayyani, 2014). In males, surgical options include a distal urethrectomy, partial penectomy, or a urethrectomy with a cystoprostatectomy in males. In females, surgical options include a urethrectomy with or without a cystectomy.
Adjuvant radiation can be delivered for an individual with a high risk of recurrence including one with positive nodes, positive margins or T3-T4 disease.
In an individual who refuses surgery or one with advanced disease, concurrent chemoradiation can be used (Gakis, 2013; Grivas, 2012). Often the draining lymphatics will include the pelvic and inguinal lymph nodes and appropriate techniques include 3DCRT or IMRT. Brachytherapy can also be utilized and will be considered on a case- by-case basis.
Although the literature is relatively scant on the use of radiation therapy for the treatment of upper genitourinary tract tumors, there are some studies that suggest a survival advantage in an individual with T3-T4 disease of the renal pelvis or ureter receiving postoperative treatment with a median dose of 50 Gy to the tumor bed. Treatment may be considered for an individual with positive surgical margins, positive lymph nodes, or high grade tumors following nephroureterectomy. There is no data, however, to suggest that radiation therapy alone is helpful in the preoperative setting. As these tumors are responsive to chemotherapy, drug combinations currently employing platinum analogues have been found to be helpful in the treatment of this disease and may be used in combination with radiation therapy in an effort to downsize the disease and improve resectability.]
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.
Radiation Therapy for Urethral Cancer and Upper Genitourinary Tract Tumors
Radiation Treatment of Urethral Cancer and Upper Genitourinary Tract Tumors
Urethral Cancer, Radiation Treatment of
Radiation Treatment of Upper Genitourinary Tract Tumors
Upper Genitourinary Tract Tumors, Radiation Treatment of
Genitourinary Tract Tumors, Upper, Radiation Treatment of
1. Dayyani F, Hoffman K, Eifel P, et al. Management of advanced primary urethral cancer. BJU Int. 2014 Jul; 114(1):25-31.
2. Gakis G, Witjes JA, Compérat E, et al. EAU guidelines on primary urethral carcinoma. Euro Urol. 2013. 2013 Nov; 64(5):823-830.
3. Grivas PD, Daignault MS, Tagawa ST, et al. Double-blind, randomized, phase 2 trial of maintenance sunitinib versus placebo after response to chemotherapy in patients with advanced urothelial carcinoma. Cancer. 2014 Mar 1; 120(5):692-701.
4. National Comprehensive Cancer Network (NCCN) Guidelines© Version 2.2020 – January 7, 2020. Bladder Cancer. http://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines©) for Bladder Cancer 2.2020©. 2020 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.
(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 only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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