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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Radiology
Policy Number:179
Effective Date: 01/01/2020
Original Policy Date:01/29/2019
Last Review Date:04/14/2020
Date Published to Web: 01/30/2019
Subject:
Radiation Therapy for Multiple Myeloma and Solitary Plasmacytomas

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. External beam photon radiation therapy

      A. External beam photon radiation therapy is considered medically necessary for the following:
        1. Solitary osseous plasmacytoma or solitary extraosseous plasmacytoma
        2. As palliative treatment for multiple myeloma

II. Fractionation
      A. Plasmacytoma
        1. 40 to 50 Gy in 1.8 to 2.0 Gy fractions to involved field with or without surgery
      B. Multiple myeloma
        1. 10 to 30 Gy in 5 to 10 fractions for pain, impending fracture, and/or impending spinal cord compression
        2. 8 Gy in a single fraction is preferred for members with poor prospects for survival
        3. Up to 15 fractions for retreatment

III. Techniques
      A. Three-dimensional conformal radiation therapy (3DCRT) is considered medically necessary for the definitive treatment of solitary osseous or solitary extraosseous plasmacytoma.
      B. Intensity-modulated radiation therapy (IMRT) is considered medically necessary for the definitive treatment of a solitary plasmacytoma presenting in the head and neck region.
      C. Radiation planned using a Complex isodose technique (CPT® 77307) is considered medically necessary for the palliative treatment for multiple myeloma.


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 Multiple Myeloma and Solitary Plasmacytomas using (EBRT) or 3DCRT.

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:
I. Solitary Plasmacytoma
    These lesions are diagnosed by a complete multiple myeloma evaluation to rule out the presence of other lesions or systemic disease. Solitary plasmacytomas of the bone generally involve the axial skeleton and account for almost seventy percent of clinical presentations. The remaining are extramedullary lesions generally presenting in the upper aerodigestive tract.

    The optimal radiation dose for the treatment of these lesions is not well known, with doses ranging from 30 Gy to 60 Gy in the published literature. The largest series, with 258 patients, reported is the European Multicenter Rare Cancer Network study (Ozsahin et al., 2006) which included 206 patients with solitary plasmacytoma of bone and 52 patients with extramedullary plasmacytoma. Two hundred and fifteen patients were treated only with radiation therapy. Thirty-three were treated with a combination of radiation therapy and chemotherapy. Eight patients were treated only with surgery. One was treated with chemotherapy alone. One died before radiation therapy. The median dose of radiation administered was 40 Gy with a range of 20 to 66 Gy. At median follow up of 56 months, 14% developed a local recurrence. Sixty percent of the patients who did not receive radiation therapy relapsed locally, while only 12% of the radiation therapy group experienced local relapse. Overall survival (OS) was 74% with disease free survival (DFS) of 50%. A 10-year probability of disease progression to multiple myeloma was 36% for extramedullary plasmacytoma and 72% for solitary plasmacytoma of bone.

    Considerable care must be taken in the workup of a suspected solitary plasmacytoma to ensure that other lesions and hence, a diagnosis of multiple myeloma, are not present. Following a positive biopsy of the lesion, a full multiple myeloma evaluation should be performed. CBC, peripheral smear, serum BUN, creatinine, electrolytes, albumin, calcium, uric acid, LDH and Beta2 microglobulin are part of the basic blood workup. Serum quantitative immunoglobulins, serum protein electrophoresis (SPEP) and serum immunofixation electrophoresis should be ordered as well as a serum free light chain assay. Urine for creatinine clearance and a 24-hour urine for total protein electrophoresis (UPEP), urine immunofixation electrophoresis (UIFE) should be performed. Bone marrow aspirate and biopsy are mandatory to document the lack of clonal cells for a diagnosis of solitary plasmacytoma. A variant of solitary plasmacytoma, when there are fewer than 10% of clonal plasma cells is termed solitary plasmacytoma with minimal bone marrow involvement.

    In addition to the previous workup, diagnostic imaging plays an important role in securing the diagnosis. Skeletal survey or whole body low-dose Computed Tomography (CT) scan may reveal other lesions. If abnormal, Magnetic Resonance Imaging (MRI) of the spine or whole body MRI can be utilized as the clinical presentation dictates. Positron Emission Tomography (PET)/CT may be needed to distinguish between smoldering and active myeloma. It has proven helpful in finding additional lesions in approximately 30% of cases diagnosed by MRI as solitary plasmacytoma.

    Following confirmation of the diagnosis, surgery may play a role in certain definitive clinical presentations or is performed for clinical presentations requiring neurologic decompression or stabilization of a weight-bearing bone prior to the performance of radiation therapy. The optimal radiation dose for a solitary plasmacytoma of bone (SBP) is not known due to the lack of phase III studies with differing recommendations from the NCCN and ILROG (International Lymphoma Radiation Oncology Group). While the NCCN has a dose range of 40 to 50 Gy that is independent of tumor size, ILROG recommends 35 Gy to 40 Gy for a SBP < 5 cm. Tumors ≥ 5 cm have a dose range of 40 to 50 Gy. For Solitary Extramedullary Plasmacytoma (SEP), ILROG recommends a dose range of 40 to 50 Gy. Lesions excised with positive margins or small, well-defined lesions may be treated with 40 Gy.

    Anatomic location, tumor size, surgical resection, older age at diagnosis and persistence of myeloma protein for one year post radiation treatment have all been postulated to be of prognostic significance but none have been definitely proven due to contrasting studies. Monoclonal protein has been noted to disappear in up to 50% of cases. The reappearance of the protein herald recurrence.

II. Multiple Myeloma
    The role of radiation therapy in multiple myeloma is largely palliative with use of radiation dose regimens as listed in the Policy section. Total Body Irradiation (TBI) can be performed prior to autologous stem cell transplant, but is no longer commonly used as it has a higher toxicity profile compared to melphalan alone. Helical tomographic total marrow irradiation is currently investigational.]
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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 Multiple Myeloma and Solitary Plasmacytomas
Radiation Treatment of Multiple Myeloma and Solitary Plasmacytomas
Multiple Myeloma, Radiation Treatment for
Solitary Plasmacytomas, Radiation Treatment for

References:
1. Hu K and Yahalom J. Radiotherapy in the management of plasma cell tumors. Oncology (Williston Park). 2000 Jan;14(1):101-108, 111; discussion 111-112, 115.

2. Mahindra A and Ng AK. Multiple Myeloma and Other Plasma Cell Neoplasms Gunderson L, Tepper J, editors. Clinical Radiation Oncology. 4th edition. Philadelphia, PA:Elsevier; 2016; (78):1547-1555.

3. Munshi NC, Anderson KC. Chapter 112: Plasma Cell Neoplasms. In: Devita VT Jr., Lawrence TS, Rosenberg SA, eds.Devita, Hellman, and Rosenberg’s Cancer Principles & Practice of Oncology. 10th edition. Philadelphia, PA:Wolters Kluwer Health; 2015 (112):1682-1719.

4. Ozsahin M, Tsang RW, Poortmans P, et al. Outcomes and patterns of failure in solitary plamacytoma: A multicenter rare cancer network study of 258 patients. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):210-217.

5. National Comprehensive Cancer Network (NCCN) Guidelines® Version 2.2020 – October 9, 2019. Multiple Myeloma. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma 2.2020. 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.

6. Rades D, Segedin B, Conde-Moreno AJ, et al. Radiotherapy with 4 Gy x 5 versus 3 Gy x 10 for metastatic epidural spinal cord compression: Final results of the SCORE-2 trial (ARO 2009/01). J Clin Oncol. 2016 Feb 20;34(6):597-602.

7. Tsang RW, Campbell BA, Goda JS, et al. Radiation therapy for solitary plasmacytoma and multiple myeloma: Guidelines from the International Lymphoma Radiation Oncology Group. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):794-808.

8. Tsang RW, Gospodarowicz MK, Pintilie M, et al. Solitary plasmacytoma treated with radiotherapy: Impact of tumor size on outcome. Int J Radiat Oncol Biol Phys. 2001 May 1;50(1):113-120.

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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