Subject:
Radiation Therapy for Rectal 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.)
External beam photon radiation therapy using three-dimensional conformal radiation therapy (3DCRT) is medically necessary for the treatment of rectal cancer in any of the following clinical situations:
- Surgical candidate
- Preoperative (neoadjuvant)
- Postoperative (adjuvant)
- Intraoperative - for very close or positive margins after resection, as an additional boost, especially for those with T4 lesions or recurrent disease.
- Medically inoperable
- As definitive radiation therapy
- Local recurrence or salvage therapy in an individual with isolated pelvic / anastomotic recurrence when either of the following criteria is met:
- Resectable cases for either of the following:
- Preoperative chemotherapy and radiation therapy
- Postoperative followed by chemotherapy and radiation therapy
- Unresectable cases in conjunction with chemotherapy
- Palliative treatment in a previously un-irradiated individual who meets both of the following criteria:
- Has reasonable life expectancy
- Has unresectable metastatic disease and symptomatic local disease or near-obstructing primary tumors.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for External beam photon radiation therapy (EBRT) or 3DCRT. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for Radiation Treatment of Rectal Cancer.
Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has issued a determination for Intensity-Modulated Radiation Therapy (IMRT). Per LCD L36711 and Local Coverage Article:
Billing and Coding: Intensity Modulated Radiation Therapy (IMRT) (A56725), IMRT is covered for rectal carcinoma when LCD L36711 criteria is met. For additional information and eligibility, 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&.
[RATIONALE: Colorectal cancer is the third most commonly diagnosed cancer in the United States. Surgical resection plays a key role in treatment. The surgical approach depends on the extent and stage of disease. Transanal excisions are used for early stage lesions. Other transabdominal approaches include low anterior resections, total mesorectal excisions, and abdominal perineal resections. The Swedish Rectal Cancer Trial demonstrated an overall survival advantage to preoperative radiation. The German Rectal Cancer Study Group investigated preoperative chemoradiation compared with postoperative therapy. Preoperative chemoradiation showed decreased local recurrence rates and improved sphincter function.
External beam photon radiation therapy is utilized in the neoadjuvant, adjuvant, palliative and medically inoperable settings.
Based upon established criteria, assessment of peer-reviewed literature, and consensus present in established guidelines American College of Radiology/American Society for Radiation Oncologists (ACR/ASTRO), National Comprehensive Cancer Network (NCCN) external beam photon radiation therapy is considered an integral component in the multidisciplinary management of rectal cancer. The rectum extends from the transitional zone of the dentate line to the sigmoid colon. Tumors extending below the peritoneal reflection are considered rectal, while more proximal tumors are considered colonic.
I. Treatment of rectal cancer
A. Treatment of rectal cancer requires interdisciplinary interaction between the radiologist, gastroenterologist, colorectal surgeon, radiation oncologist, and medical oncologist. Surgical treatment can range from polypectomy for selected T1 tumors, transanal local excision for selected individuals with low risk T1/T2 tumors in the absence of positive margins, lymphovascular invasion (LVI), or high grade. For individuals who have T2 primary and negative margins, postoperative chemoradiation is appropriate after transanal excision. For individuals with T3 primary or positive nodes total mesorectal excision (TME) either by low anterior resection (LAR) or abdominoperineal resection (APR), depending on the proximity of the tumor to the anal verge.
Based on earlier randomized trial data, the National Institutes of Health (NIH) Consensus Conference of 1990 recommended postoperative chemoradiotherapy for individuals with T3 and/or node positive disease. More recent trials of preoperative chemoradiation have established that as the preferred approach. Preoperative therapy affords the opportunity for downstaging of the tumor, improved resectability, greater likelihood of sphincter preservation, and improved local control. Individuals who present with synchronous limited metastatic disease amenable to R0 resection may also be candidates for definitive postoperative chemoradiation. Individuals with isolated pelvic or anastomotic recurrence who have not received prior radiation may be appropriately treated with preoperative or postoperative chemoradiation with or without intraoperative external beam photon or electron radiation therapy or with primary chemoradiation if deemed unresectable.
II. External beam photon radiation therapy treatment techniques and schedules for the treatment of rectal cancer
A. External beam photon radiation therapy, preoperative and postoperative
Treatment technique typically involves the use of multiple fields to encompass the regional lymph nodes and primary tumor site. Customized blocking is utilized. 3DCRT is appropriate. Intensity-Modulated Radiation Therapy (IMRT) is not medically necessary (see below). A dose of 45 to 54 Gy in 25 to 30 fractions over 5 to 6 weeks is commonly used.
Various treatment techniques may be used to decrease complications, such as prone positioning, customized immobilization (e.g. belly boards), and the use of multiple fields and incorporation of 3D treatment planning.
IMRT with photons is not medically necessary except in rare extenuating circumstances where higher doses are required (e.g. unresectable cases or those with positive margins) and normal tissues such as small bowel cannot be adequately spared. IMRT with photons in the preoperative and postoperative settings should only be used in the setting of an institutional review board (IRB)-approved clinical trial. Consideration may be given to the use of IMRT with photons in select cases of locally and regionally advanced cancer when higher doses of radiation may be necessary.
For unresectable cancers or individuals who are medically inoperable, doses higher than 54 Gy may be appropriate. In the preoperative setting a dose of 50.4 Gy in 28 fractions is appropriate. A dose of 25 Gy in 5 fractions can also be considered in select individuals. In the postoperative setting with negative margins, 54 Gy in 30 fractions may be appropriate. Individuals with positive margins may require doses higher than 54 Gy.
B. External beam photon radiation therapy, palliative
In previously un-irradiated individuals with unresectable metastatic disease and symptomatic local disease or near obstructing primaries who have reasonable life expectancy, external beam photon radiation therapy may be appropriate. Up to 20 fractions in 1 phase using 3DCRT or radiation planned using a Complex isodose technique with photons is medically necessary. IMRT with photons is not medically necessary.]
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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 Rectal Cancer
Radiation Treatment of Rectal Cancer
Rectal Cancer, Radiation Treatment
References:
1. Goodman KA, Milgrom SA, Herman JM, et al. ACR Appropriateness Criteria® Rectal Cancer – Metastatic Disease at Presentation. Date of origin: 2007. Last review date: 2014.
2. Konski AA, Herman JM, Abdel-Wahab M, et al. ACR Appropriateness Criteria® Recurrent Rectal Cancer. Date of origin: 1998. Last review date: 2014.
3. National Comprehensive Cancer Network (NCCN) Guidelines Version 1.220 – December 19, 2019. Rectal Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Rectal Cancer 1.2020©. 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.
4. NIH consensus conference. Adjuvant therapy for patients with colon and rectal cancer. JAMA. 1990; 264(11):1444-50.
5. Russo S, Blackstock AW, Herman JM, et al. ACR Appropriateness Criteria® Local Excision in Rectal Cancer. Date of origin: 2008. Last review date: 2014.
6. Sauer R, Becker H, Hohenberger W. et al. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21; 351(17):1731-1740.
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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