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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Radiology
Policy Number:107
Effective Date: 03/01/2019
Original Policy Date:09/25/2012
Last Review Date:04/14/2020
Date Published to Web: 03/26/2013
Subject:
Radiation Therapy for Non-Hodgkin's Lymphoma

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.

Please refer to a separate policy on 'Radioimmunotherapy with Zevalin' - Policy #022 in the Drugs Section.

For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
  1. Photon and/or electron techniques for the treatment of non-Hodgkin's lymphoma (NHL) are medically necessary, generally using involved-site radiation therapy (ISRT)
      1. Complex and three dimensional (3D)-conformal radiation therapy (3DCRT) techniques
      2. Intensity-Modulated Radiation Therapy (IMRT) for an individual with disease located above the diaphragm. Respiratory gating techniques and image guidance techniques may be appropriate to minimize the amount of critical tissue (such as lung) that is exposed to the full doses of radiation
      3. In sub-diaphragmatic presentations, IMRT will be approved when comparative 3D and IMRT plans demonstrate that a 3D plan does not meet the “Acceptable” normal tissue constraints using standard metrics published by the Radiation Therapy Oncology Group (RTOG)/National Comprehensive Cancer Network (NCCN)
      4. Photon and/or electron beam radiation therapy
      5. The treatment of lymphomas with radiation is generally done using relatively low doses in the range of 15 to 36 Gy at standard fractionation, sometimes with doses as low as 4 Gy in 2 fractions
      6. IMRT is not considered medically necessary for the treatment of an individual with low dose radiation, i.e., 2 Gy in 2 fractions
  2. Definitive radiation therapy
      1. As sole therapy is medically necessary for an individual with Staage I-IIA low grade NHL
        1. Doses up to 36 Gy, directed at a single site in a single phase
        2. Complex or 3D techniques with image guidance
      2. Mucosa-associated lymphoid tissue (MALT) -lymphomas of gastric or non-gastric origin, that are confined to the organs of involvement
        1. Doses of 36 Gy directed at a single site in a single phase
        2. Complex or 3D techniques with image guidance
      3. Extranodal NK/T-cell lymphoma, nasal lymphoma
        1. Doses of 54 Gy
        2. 3D or IMRT techniques
        3. 30 fractions in 2 phases
      4. Consolidative radiotherapy after initial chemotherapy
        1. Doses of 36 Gy to the original extent of disease for the following histologies:
          1. Mantle cell lymphoma
          2. Diffuse large cell B-cell lymphoma (DLBCL)
          3. Burkitt's lymphoma
          4. Lymphoblastic lymphoma
          5. Primary cutaneous B-cell lymphoma
          6. Peripheral T-cell lymphoma
  3. Radioimmunotherapy
    (    NOTE: Please refer to a separate policy on 'Radioimmunotherapy with Zevalin' - Policy #022 in the Drugs Section.)
  4. Adjuvant radiation after chemotherapy
      1. Areas of initial involvement
        1. In an individual with stage I-IIB disease to areas of initial involvement
          1. Doses of up to 36 Gy
          2. Up to 20 fractions with a conventional schedule
        2. Supra-diaphragmatic presentations
          1. Complex, 3DCRT or IMRT techniques, with image guidance
          2. Directed at a single site in 1 phase
        3. Sub-diaphragmatic presentations
          1. Complex, or 3DCRT techniques
      2. Areas of less than a complete response (CR)
        1. In an individual with stage III-IV disease, to areas of less than a CR
          1. Doses of up to 36 Gy
          2. Up to 20 fractions with conventional schedule
        2. Supra-diaphragmatic presentations
          1. Complex, 3DCRT or IMRT techniques, with image guidance
          2. Directed at up to 4 separate sites in one 1 phase a piece
        3. Sub-diaphragmatic presentations
          1. Complex, or 3DCRT techniques
      3. Sequential chemotherapy carries a high toxicity burden and requires substantial supportive care and the expertise of an experienced multidisciplinary team.
  5. Radiation therapy, palliative
      1. In an individual with advanced or recurrent disease that is felt not to be curative and who is experiencing symptomatic local disease, photon and/or electron techniques are indicated for symptom control.
        1. Supra-diaphragmatic presentations
          1. Complex, 3DCRT, or IMRT techniques
          2. Up to 10 fractions in 1 phase
        2. Sub-diaphragmatic presentations
          1. Complex, or 3DCRT techniques
          2. Up to 10 fractions in 1 phase


Medicare Coverage:
There is no National Coverage Determination (NCD) for Radiation Treatment for Non-Hodgkin's Lymphoma. In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination radiation therapy for Non-Hodgkin's Lymphoma. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for complex, three-dimensional conformal radiation therapy (3DCRT) and photon and/or electron beam radiation therapy for Non-Hodgkin's Lymphoma.

Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has issued a determination for Intensity-Modulated Radiation Therapy (IMRT). IMRT is covered when LCD L36711 and Local Coverage Article (A56725) criteria is met. 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&.


[RATIONALE: Based upon established criteria, assessment of peer-reviewed literature, and consensus present in established guidelines (American College of Radiology [ACR]/American Society of Radiation Oncologists [ASTRO], NCCN), radiation therapy is considered an integral component in the multidisciplinary management of NHL. Proper management of the disease requires the cooperation of a complex multidisciplinary team that includes experts in diagnostic imaging, pathology, radiation oncology and medical oncology. NHL treatment is based on the pathologic subtype of the disease, initial stage of disease as well as the medical condition of the individual. Pathology and stage have a critical role in the planning process.

Treatment decisions are preceded by workup and staging and planned in conjunction with the appropriate members of the multidisciplinary team.

Initial management requires chemotherapy as the cornerstone of therapy (in a variety of different acceptable regimens), followed by assessment of response leading to an appropriate choice of radiation therapy technique, dose, and use of radioimmunotherapy as clinically indicated.

  1. Radiation treatment schedules
    1. Radiation therapy treatment schedules published in peer-reviewed consensus documents such as NCCN Practice Guidelines in Oncology include regimens that encompass a relatively limited range of doses and fields that may be influenced by the histology, initial stage, bulk of the disease at each site, the choice of chemotherapy regimens, and the response to initial chemotherapy. Using current combined modality approaches, the fields covered are usually confined to the initial areas of documented involvement, ISRT.
    2. Histology specific recommendations
      1. Chronic lymphocytic leukemia (CLL)
        1. Will not require radiation routinely
      2. Follicular low-grade lymphoma, stage I-II
        1. Radiation alone may be considered adequate therapy, or
        2. Radiation treatment may be given after initial chemotherapy to the original extent of disease
          1. Omitting sites that had no clear involvement in an effort to minimize toxicity
          2. To doses that range from 20 to 36 Gy
          3. Generally encompassable in a single site setup, requiring the use of Complex or 3D techniques with image guidance
          4. Under some circumstances IMRT may be appropriate
          5. Radioimmunotherapy may be appropriate
      3. Follicular lymphoma, stage III-IV
        1. Systemic chemotherapy is the standard of care
        2. Radiation may be considered for an individual with a sub-optimal response to therapy
      4. Transformed lymphoma, i.e., an individual with an original diagnosis of follicular lymphoma that has transformed to a more malignant subtype
        1. Systemic chemotherapy is the mainstay of therapy
        2. Radiation may be considered as an adjunct for locally uncontrolled disease
        3. Radioimmunotherapy may be considered for the management of this disease
      5. MALT-lymphoma (gastric or non-gastric)
        1. Radiation may be appropriate as curative therapy
        2. Doses of up to 36 Gy
      6. Extranodal natural killer (NK)/T-cell lymphoma, nasal lymphoma
        1. Definitive radiation therapy to a dose of 54 Gy
      7. Consolidative radiation therapy after initial chemotherapy to a dose of 36 Gy to the original extent of disease for the following histologies:
        1. Mantle cell lymphoma
        2. DLBCL
        3. Burkitt’s lymphoma
        4. Lymphoblastic lymphoma
        5. Primary cutaneous B-cell lymphoma
        6. Peripheral T-cell lymphoma
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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 Non-Hodgkin's Lymphoma
Radiation Treatment for Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma, Radiation Treatment for
Non-Hodgkin's Lymphoma, Radiation Therapy for

References:
  1. Campbell BA, Voss N, Woods R, et al. Long-term outcomes for patients with limited stage follicular lymphoma: involved regional radiotherapy versus involved node radiotherapy. Cancer. 2010; 116(16):3797-3806.
  2. Goda JS, Gospodarowicz M, Pintilie M, et al. Long-term outcome in localized extranodal mucosa-associated lymphoid tissue lymphomas treated with radiotherapy. Cancer. 2010; 116(16):3815-3824.
  3. Haas RLM, Poortmans PH, de Jong D, et al. High response rates and lasting remissions after low-dose involved field radiotherapy in indolent lymphomas. J Clin Oncol. 2003 Jul 1; 21(13):2474-2480.
  4. Horning SJ, Weller E, Kim K, et al. Chemotherapy with or without radiotherapy in limited-stage diffuse aggressive non-Hodgkins lymphoma: Eastern Cooperative Oncology Group Study 1484. J Clin Oncol. 2004 Jun 21; 22(15):3032-3038.
  5. Illidge t, Specht L, Yahalom J, et al. Modern radiation therapy for nodal non-Hodgkin lymphoma—target definition and dosing guidelines from the International Lymphoma Radiation Oncology Group (ILROG). Int J Radiat Oncol Biol Phys. 2014 May 1; 89(1):49-58.
  6. Miller TP, Dahlberg S, Cassady JR, et al. Chemotherapy alone compared with chemotherapy plus radiotherapy for localized intermediate- and high-grade non-Hodgkin’s lymphoma. N Engl J Med. 1998 Jul 2; 339(1):21-26.
  7. Morschhauser F, Radford J, Van Hoof A, et al. Phase III trial of consolidation therapy with yttrium-90-ibritumomab tiuxetan compared with no additional therapy after first remission in advanced follicular lymphoma. J Clin Oncol. 2008 Nov 10; 26(32):5156-5164.
  8. National Comprehensive Cancer Network (NCCN) Guidelines®. Version 4.2020 – December 20, 2019. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Version 4.2020. 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.
  9. National Comprehensive Cancer Network (NCCN) Guidelines®. Version 7.2019 – December 18, 2019. B-cell Lymphomas. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-cell Lymphomas Version 7.2019. 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.
  10. National Comprehensive Cancer Network (NCCN) Guidelines®. Version 1.2020 – January 6, 2020. Primary Cutaneous B-cell Lymphomas. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Primary Cutaneous B-cell Lymphomas Version 1.2020. 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.
  11. National Comprehensive Cancer Network (NCCN) Guidelines®. Version 1.2020 – January 6, 2020. T-cell Lymphomas. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for T-cell Lymphomas Version 1.2020. 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.
  12. Phan J, Mazloom A, Medeiros LJ, et al. Benefit of consolidative radiation therapy in patients with diffuse large B-cell lymphoma treated with R-CHOP chemotherapy. J Clin Oncol. 2010 Sep 20; 28(27):4170-4176.
  13. Witzig TE, Gordon LI, Cabanillas F, et al: Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma. J Clin Oncol. 2002 May 15; 20(10):2453-2463.




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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