Subject:
Radiation Therapy for Kidney and Adrenal 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. External beam photon radiation therapy is medically necessary for the following:
A. In the adjuvant setting for a high risk individual with adrenal cancer
B. In the palliative setting
C. Radiation is not medically necessary in the definitive or adjuvant treatment of renal cell cancer
II. Fractionation
A. In the adjuvant setting for adrenal cancer, up to 30 fractions is medically necessary
B. In the palliative setting, up to 20 fractions is medically necessary
III. Techniques
A. 3D conformal technique is medically necessary in the adjuvant or palliative setting
B. In the adjuvant setting, intensity-modulated radiation therapy (IMRT) may be indicated when dose to critical organs is of concern. 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 radiation therapy criteria from the Radiation Therapy Oncology Group (RTOG) or National Comprehensive Cancer Network (NCCN).
Medicare Coverage:
There is no National Coverage Determination (NCD) on these services. 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 determined that Intensity Modulated Radiation Therapy (IMRT) is covered when LCD L36711 criteria is met. 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&.
Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for External beam photon radiation therapy (EBRT) for Kidney and Adrenal Cancer. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for EBRT for Kidney and Adrenal Cancer.
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:
Standard of care for localized renal cell cancer is surgical resection. A partial nephrectomy can be used in the treatment of early stage renal cell cancer while an open radical nephrectomy is used with locally advanced disease. There is no benefit with radiotherapy in the adjuvant or neo-adjuvant setting in the treatment of renal cell cancer (Escudier, 2014). In an individual with unresectable disease or recurrent disease, radiation can be utilized to improve local control (Mourad, 2014). There are preliminary reports examining the use of stereotactic body radiotherapy (SBRT) in the treatment of early stage inoperable renal cancer. However, there are no prospective studies examining this issue, and current standard of care for patients with inoperable localized renal cell cancer include radio-frequency or cryo-ablative therapies (Mourad, 2014).
Adrenal cancers include adrenocortical carcinoma and malignant pheochromocytoma. Surgical resection of adrenal tumors remains the standard of care. For nonmetastatic adrenocortical cancer, adjuvant radiation can be considered for an individual with high risk of recurrence including one with positive margins, ruptured capsule, large size (> 7 cm), or high grade (Sabolch, 2015). Adjuvant mitotane can also be considered in this setting (Terzolo, 2007).]
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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 Kidney and Adrenal Cancer
Radiation Treatment of Kidney and Adrenal Cancer
Kidney Cancer, Radiation Treatment of
Radiation Treatment of Adrenal Cancer
Adrenal Cancer, Radiation Treatment of
References:
1. Escudier B, Eisen T, Porta C, et al. Renal cell carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct; 23(suppl 7):vii65-vii71.
2. Mourad WF, Dutcher J, Ennis RD. State-of-the-art management of renal cell carcinoma. Am J Clin Oncol. 2014 Oct; 37(5):498-505.
3. Sabolch A, Else T, Griffith KA, et al. Adjuvant radiation therapy improves local control after surgical resection in patients with localized adrenocortical carcinoma. Int J Radiat Oncol Biol Phys. 2015 Jun 1; 92(2):242-259.
4. Terzolo M, Angeli A, Fassnacht M, et al. Adjuvant mitotane treatment for adrenocortical carcinoma. NEJM. 2007 Jun 7; 356(23):2372-2380.
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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