Radiation Therapy for Bone Metastases
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).
(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. Up to 10 fractions of radiation planned using a complex isodose technique is considered medically necessary in the palliative treatment of bone metastases.
II. For the palliative treatment of multiple sites of bone metastases, all lesions requiring treatment must be treated concurrently.
III. Three Dimensional Conformal Radiation Therapy (3DCRT) is not considered medically necessary for the treatment of bone metastasis. 3DCRT is considered medically necessary when there is a significant complex extraosseous component to the target volume.
IV. Intensity Modulated Radiation Therapy (IMRT) is not considered medically necessary for the treatment of bone metastasis. IMRT is considered medically necessary in cases where overlap with previous radiotherapy fields is likely to cause complications.
V. Stereotactic Body Radiation Therapy (SBRT) is not considered medically necessary for the treatment of bone metastasis. SBRT is considered medically necessary for the following clinical scenarios:
For oligometastatic disease, please refer to a separate policy on 'Radiation Treatment of Oligometastases' (Policy #147 in the Radiology Section).
A. Treatment to a portion of the spine that has been previously irradiated.
B. Treatment of sarcoma, melanoma, and renal cell carcinoma that have metastasized to the spine.
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for Three-dimensional (3D) Conformal Radiation Therapy (3DCRT), Stereotactic Body Radiosurgery (SBRT) and Radium-223 (Xofigo®). Therefore, Medicare Advantage Products will follow the Horizon Policy for these services.
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). 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&.
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: Bone is a common site of metastatic cancer. Photon techniques are the mainstay of treatment for symptomatic bone metastases. Local field radiotherapy is highly effective in relieving pain and preventing fractures and is typically associated with minimal side effects. Eighteen trials assessing fractionation and dose of radiotherapy for painful bone metastases have been published (Hartsell et al., 2003; Wu et al., 2003). Randomized trials comparing single fraction of 8 Gy with multiple fraction radiotherapy regimens (20 to 30 Gy in 5 to 10 fractions) reveal similar overall response rates. Pain relief is typically achieved 1 to 4 weeks after treatment and the duration of response is 12 to 24 weeks. In a pooled analysis of patients with bone metastases, approximately one-third of patients will have complete pain relief and an additional one-third of patients will have partial relief of pain, irrespective of the dose-fractionation used. ROTG trial 9714 included 949 patients who were randomly assigned between 8 Gy in a single dose or 30 Gy in 10 fractions. Pain response rates were similar with 8 Gy in 1 fraction compared with 30 Gy in 10 fractions (66% in each group). A British trial (Yarnold et al., 1999) randomized 765 patients with painful bony metastases to 8 Gy as a single fraction, 20 Gy in 5 fractions, or 30 Gy in 10 fractions. There were no differences in pain endpoints among the groups. A Dutch trial (van der Linden et al., 2004) randomized 1171 patients with bone metastases to 8 Gy in 1 fraction or 24 Gy in 6 fractions and found no difference in pain relief or toxicity. While retreatment was higher with patients treated with a single fraction (18% vs. 9%), a reanalysis revealed this was because physicians were only more willing to treat after a single fraction. The study concluded that with or without the effect of retreatment, single fraction and multi-fraction radiation provided equal palliation.
At the 2019 ASTRO meeting, Ryu and colleagues presented the results of RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis. RTOG 0631 is a phase III multicenter, randomized clinical trial comparing stereotactic radiosurgery (SRS)/stereotactic body radiotherapy (SBRT) vs. conventional fractionation. 339 patients with one to three spine metastases were randomized to SBRT (16 or 18 Gy in one fraction) or conventional external beam radiation therapy (8Gy in one fraction) and 215 patients were available for analysis. Radioresistant histologies including soft tissue sarcomas, melanomas, and renal cell carcinomas were included. The primary endpoint was pain response at three months. Pain response at three months was 40.3% in radiosurgery vs. 57.9% in conventional external beam radiation therapy, p=0.99. There was no difference in the patient pain response at one, three, and six months in patients with localized spine metastases in the radiosurgery arm compared to the conventional treatment arm. There was no difference in quality of life measures. The authors concluded that while radiosurgery was safely performed without causing any increase in adverse effects there was no difference in pain response rate with conventional palliative EBRT compared to stereotactic radiation therapy for spinal metastases.
The American Society for Radiation Oncology (ASTRO) Choosing Wisely® campaign has recommended not to use extended fractionation schemes (> 10 fractions) for palliation of bone metastases. It also states that, “…strong consideration should be given to a single 8 Gy fraction for patients with limited prognosis or with transportation difficulties.” The NCCN Guidelines™ for prostate non-vertebral metastases also state that, “…8 Gy as a single dose should be used instead of 30 Gy in 10 fractions.”
The American College of Radiology (ACR) Appropriateness Criteria® panel recommends fractionation schedules ranging from a single 8 Gy fraction to 30 Gy in 10 fractions for the palliation of long bone involvement, whereas 35 Gy in 14 or 15 fractions and 40 Gy in 20 fractions is considered less appropriate due to the protracted length of therapy. A shorter course of radiation offers equivalent palliation and increased convenience for the individual and caregivers.
Surgery may be appropriate to establish a diagnosis, if uncertain, in an individual with acceptable performance status. In individuals where bony retropulsion is likely to be the primary cause of neurologic deficit or those with rapid deterioration of neurologic function or with high grade cervical cord compression, surgery can be considered based on the results of a randomized trial comparing surgery and postoperative radiotherapy versus radiotherapy alone. Vertebral body resection and radical decompressive surgery with postoperative radiotherapy was found to be superior to radiotherapy alone in the only randomized trial of spinal cord compression conducted to date (Regine et al., 2003). Patients with a single site of cord compression and a minimum three-month life expectancy were enrolled. The trial was stopped early after 101 patients were enrolled. Patients who received surgery plus conventional radiation therapy retained the ability to walk significantly longer (126 days vs. 35 days with conventional radiation therapy alone). In a total of 32 patients who could not walk at the time of enrollment, 56% of those who received surgery and conventional radiation therapy recovered the ability to walk versus 19% who received conventional radiation therapy alone. Functional scores, maintenance of continence, and use of steroids and narcotics were all improved in patients undergoing decompressive surgery versus radiotherapy alone. Survival was slightly better in patients undergoing surgery (median 4.2 months vs. 3.3 months, p = 0.08). An individual with neurologic deficit and life expectancy of at least 3 months should be considered for surgery based on the results of this phase III study.
The ASTRO Task Force on radiotherapy for bone metastases published its guidelines in 2017. The task force clearly states that dosing and target volume have yet to be fully defined for SBRT and that SBRT should be considered investigational. Further, the task force states that SBRT should not be the primary treatment of vertebral bone lesions causing spinal cord compression. For recurrent painful lesions, the task force recommends that SBRT should be limited to clinical trials. The summary of the task force is that SBRT “…holds theoretical promise in the treatment of new or recurrent spine lesions… (and that)…its use be limited to highly selected patients and preferably within a prospective trial.”
Complex isodose technique: According to the 2020 Radiation Oncology Coding Resource published by the American Society for Radiation Oncology (ASTRO), “…a teletherapy isodose plan (CPT® code 77306 and CPT® code 77307) determines the radiation dose within the target and surrounding normal tissues.” CPT® code 77306 describes a simple teletherapy isodose plan (using 1 or 2 unmodified ports), while CPT® code 77307 describes a complex teletherapy isodose plan. The latter code may be used when the ports (or beams) are modified. An ‘example clinical scenario’ for CPT® code 77306 described in this Resource is “…a 65 year-old man with advanced lung cancer (who) presents with a painful metastasis to the lumbar spine. Following simulation, a teletherapy isodose plan and monitor unit calculation is performed.” As the ports (beams) used to target and treat the metastasis are often modified, a complex teletherapy isodose plan (CPT® code 77307) is considered medically necessary for the treatment of bone metastasis.]
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 Bone Metastases
Radiation Treatment of Bone Metastases
Bone Metastases, Radiation Treatment
Radiotherapy of Bone Metastases
Stereotactic Radiosurgery of Bone Metastases
Bone, Metastases, Stereotactic Radiotherapy
SBRT, Bone Metastases
1. ASTRO 2020 Radiation Oncology coding Resource. American Society for Radiation Oncology (ASTRO). 2020.
2. ASTRO release list of five radiation oncology treatments to question as part of national Choosing Wisely® campaign. 2013 Sep 23.
3. Bayer Press Release. Bayer to showcase latest oncology research at ESMO 2018 Congress. 2018 Oct 9.
4. Chander SS, Sarin R. Single fraction radiotherapy for bone metastases: are all questions answered? Radiother Oncol. 1999 Aug 1; 52(2):191-193.
5. Chow E, van der Linden YM, Roos D et al. Single versus multiple fractions of repeat radiation for painful bone metastases: a randomised, controlled, non-inferiority trial. Lancet Oncol. 2014 Feb; 15(2):164-71.
6. Hartsell WF, Scott C, Bruner DW et al. Phase III randomized trial of 8 Gy in 1 fraction vs. 30 Gy in 10 fractions for palliation of painful bone metastases: preliminary results of RTOG 97-14. Int J Radiat Oncol Biol Phys. 2003; 57(2 Suppl):S124.
7. Hartsell WF, Scott CB, Bruner DW et al. Randomized trial of short-versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1; 97(11):798–804.
8. Hoskin PJ, Grover A, Bhana R. Metastatic spinal cord compression: radiotherapy outcome and dose fractionation. Radiother Oncol. 2003 Aug; 68(2):175-189.
9. Kim EY, Chapman TR, Ryu S et al. Expert panel on radiation oncology. ACR Appropriateness Criteria® Non-Spinal Bone Metastases. Date of Origin: 1996. Last review date: 2014.
10. Lo SS, Lutz ST, Chang EL et al. Expert panel on radiation oncology. ACR Appropriateness Criteria® Spinal Bone Metastases J Palliat Med. 2013 Jan; 16(1):9-19. Published at ACR website. Date of Origin: 1996. Last review date: 2012.
11. Lutz S, Berk L, Chang E et al. Palliative radiotherapy for bone metastases: an ASTRO evidence-based guideline. Int J Radiat Oncol Biol Phys. 2011; 79(4): 965-976.
12. Maranzano E, Bellavita R, Rossi R et al. Short-course versus split-course radiotherapy in metastatic spinal cord compression: results of a phase III, randomized, multicenter trial. J Clin Oncol. 2005 May 20; 23(15):3358-65.
13. National Comprehensive Cancer Network (NCCN) Guidelines Version 4.2019 – August 19, 2019. Prostate Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Prostate Cancer 4.2019. 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.
14. Pope K, Fitzpatrick D, Potter A et al. Dosimetric and clinical impact of 3D vs. 2D planning in palliative radiotherapy for bone metastases. Support Care Cancer. 2013 Aug; 21(8):2229-35.
15. Regine WF, Tibbs PA, Young A et al. Metastatic spinal cord compression: a randomized trial of direct decompressive surgical resection plus radiotherapy vs. radiotherapy alone. Int J Radiat Oncol Biol Phys. 2003 Oct 1; 57(2 Suppl):S125.
16. Sahgal A, Bilsky M, Chang EL et al. Stereotactic body radiotherapy for spinal metastases: current status, with a focus on its application in the postoperative patient. J Neurosurg Spine. 2011 Feb; 14(2):151–166.
17. van der Linden YM, Lok JJ, Steenland E et al. Single fraction radiotherapy is efficacious: a further analysis of the Dutch Bone Metastasis Study controlling for the influence of retreatment. Int J Radiat Oncol Biol Phys. 2004 Jun 1; 59(2):528-37.
18. Wu JS, Wong R, Johnston M et al. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1; 55(3):594-605.
19. Yarnold JR. on behalf of the Bone Pain Trial Working Party. 8 Gy single fraction radiotherapy for the treatment of metastatic skeletal pain: randomised comparison with a multifraction schedule over 12 months of patient follow-up. Radiother Oncol. 1999 Aug 1; 52(2):111-21.
(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.)
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