Microwave Tumor Ablation Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 02|01|2020 POLICY LAST UPDATED: 11|19|2025 OVERVIEW Microwave ablation (MWA) is a technique to destroy tumors and soft tissue using microwave energy to create thermal coagulation and localized tissue necrosis. MWA is used to treat tumors not amenable to resection and to treat individuals ineligible for surgery due to age, comorbidities, or poor general health. MWA may be performed as an open procedure, laparoscopically, percutaneously, or thoracoscopically under image guidance (eg, ultrasound, computed tomography, magnetic resonance imaging) with sedation, or local or general anesthesia. This technique is also referred to as microwave coagulation therapy. MEDICAL CRITERIA Medicare Advantage Plans and Commercial Products Microwave ablation of primary or metastatic hepatic tumors may be considered covered under the following conditions: • The tumor is unresectable due to location of lesion[s] and/or comorbid conditions • A single tumor of ≤5 cm or up to 3 nodules <3 cm each Microwave ablation of primary or metastatic lung tumors may be considered covered under the following conditions: • The tumor is unresectable due to location of lesion and/or comorbid conditions • A single tumor of ≤3 cm PRIOR AUTHORIZATION
Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products. POLICY STATEMENT Medicare Advantage Plans and Commercial Products Microwave ablation is considered medically necessary when the medical criteria above have been met. Microwave ablation of more than a single primary or metastatic tumor in the lung is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Microwave ablation of primary or metastatic tumors other than liver or lung is not covered for Medicare Advantage Plans and not medically necessary for Commercial Products as the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. COVERAGE Medicare Advantage Plans and Commercial Products Benefits may vary between groups/contracts. Please refer to the Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage BACKGROUND Microwave Ablation (MWA) uses microwave energy to induce an ultra-high-speed, 915 MHz or 2.450 MHz (2.45 GHz), alternating electric field, which causes water molecule rotation and creates heat. This results in thermal coagulation and localized tissue necrosis. In MWA, a single microwave antenna or multiple antennas connected to a generator are inserted directly into the tumor or tissue to be ablated; energy from the antennas Medical Coverage Policy | Microwave Tumor Ablation

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generates friction and heat. The local heat coagulates the tissue adjacent to the probe, resulting in a small, 2 to 3 cm elliptical area of tissue ablation. In tumors greater than 2 cm in diameter, two to three antennas may be used simultaneously to increase the targeted area of MWA and shorten the operative time. Multiple antennas may also be used simultaneously to ablate multiple tumors. Tissue ablation occurs quickly, within one minute after a pulse of energy, and multiple pulses may be delivered within a treatment session, depending on tumor size. The cells killed by MWA are typically not removed but are gradually replaced by fibrosis and scar tissue. If there is a local recurrence, it occurs at the margins. Treatment may be repeated as needed. MWA may be used for the following purposes: (1) to control local tumor growth and prevent recurrence; (2) to palliate symptoms; and (3) to prolong survival.

MWA is similar to radiofrequency (RFA) and cryosurgical ablation. However, MWA has potential advantages over RFA and cryosurgical ablation. In MWA, the heating process is active, which produces higher temperatures than the passive heating of RFA and should allow for more complete thermal ablation in less time. The higher temperatures reached with MWA (>100°C) can overcome the “heat sink” effect in which tissue cooling occurs from nearby blood flow in large vessels, potentially resulting in incomplete tumor ablation. MWA does not rely on the conduction of electricity for heating and, therefore, does not flow electrical current through patients and does not require grounding pads, because there is no risk of skin burns. Additionally, MWA does not produce electric noise, which allows ultrasound guidance during the procedure without interference, unlike RFA. Finally, MWA can take 20% to 30% less time than RFA, because multiple antennas can be used simultaneously for multiple ablations. There is no comparable RFA system with the capacity to drive multiple electrically dependent electrodes.

Adverse Events Complications from MWA may include pain and fever. Other complications associated with MWA include those caused by heat damage to normal tissue adjacent to the tumor (eg, intestinal damage during MWA of the kidney or liver), structural damage along the probe track (eg, pneumothorax as a consequence of procedures on the lung), liver enzyme elevation, liver abscess, ascites, pleural effusion, diaphragm injury, or secondary tumors if cells seed during probe removal. MWA should be avoided in pregnant women because potential risks to the patient and/or fetus have not been established, and in patients with implanted electronic devices (eg, implantable pacemakers) that may be adversely affected by microwave power output.

Applications MWA was first used percutaneously in 1986 as an adjunct to liver biopsy. Since then, MWA has been used to ablate tumors and tissue to treat many conditions including hepatocellular carcinoma, breast cancer, colorectal cancer metastatic to the liver, renal cell carcinoma, renal hamartoma, adrenal malignant carcinoma, non-small- cell lung cancer, intrahepatic primary cholangiocarcinoma, secondary splenomegaly and hypersplenism, abdominal tumors, and other tumors not amenable to resection. Well-established local or systemic treatment alternatives are available for each of these malignancies. The potential advantages of MWA for these cancers include improved local control and other advantages common to any minimally invasive procedure (eg, preserving normal organ tissue, decreasing morbidity, shortening length of hospitalization). MWA also has been investigated as a treatment for unresectable hepatic tumors, as both primary and palliative treatment, and as a bridge to a liver transplant. In the latter setting, MWA is being assessed to determine whether it can reduce the incidence of tumor progression while awaiting transplantation and thus maintain a patient’s candidacy while awaiting a liver transplant.

Regulatory Status Multiple MWA devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. These devices are indicated for soft tissue ablation, including partial or complete ablation of nonresectable liver tumors. Some devices are specifically cleared for use in open surgical ablation, percutaneous ablation or laparoscopic procedures.

For individuals who have an unresectable primary or metastatic hepatic tumor who receive MWA, the evidence includes randomized controlled trials (RCTs), comparative observational studies, and systematic reviews comparing MWA to RFA and to surgical resection. Relevant outcomes are overall survival (OS),

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disease-specific survival, symptoms, quality of life (QOL), and treatment-related mortality and morbidity. The body of evidence indicates that MWA is an effective option in patients for whom resection is not an option. Although studies had methodological limitations, results consistently showed that MWA and RFA had similar survival outcomes with up to five years of follow-up in patients with a single tumor <5 cm or up to three nodules <3 cm each. In a meta-analysis of observational studies, patients receiving MWA had higher local recurrence rates and lower survival than those who received resection, but the patient populations were not limited to those who had unresectable tumors. MWA was associated with lower complications, intraoperative blood loss, and hospital length of stay. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have an unresectable primary or metastatic lung tumor who receive MWA, the evidence includes one RCT, retrospective observational studies, and systematic reviews of these studies. The relevant outcomes are OS, disease-specific survival, symptoms, QOL, and treatment-related mortality and morbidity. The body of evidence indicates that MWA is an effective option in patients for whom resection is not an option. In the RCT, direct comparison of MWA and RFA in patients with primary or metastatic lung cancer (mean tumor size 1.90 cm [± 0.89] at baseline) found similar mortality rates up to 12 months of follow-up. In the first of 3 systematic reviews that included 12 retrospective observational studies, local recurrence rates were similar for MWA and RFA at a range of 9 to 47 months of follow-up. In the second systematic review with a meta-analysis, there was lower OS with MWA compared to RFA, but studies were not directly comparable due to clinical and methodological heterogeneity. However, the authors concluded that percutaneous RFA and MWA were both effective with a high safety profile. In the third systematic review using a network meta-analysis, the weighted average OS rates for MWA were 82.5%, 54.6%, 35.7% 29.6%, and 16.6% at 1, 2, 3, 4, and 5 years, respectively. Limitations of the body of evidence included a lack of controlled studies and heterogeneity across studies. The RCT did not report results by tumor size or the number of metastases. The observational studies included in the systematic reviews did not report sufficient information to assess the effectiveness or safety of MWA in subgroups based on the presence of multiple tumors or total tumor burden. Therefore, conclusions about the evidence sufficiency can only be made about patients with single tumors. For this population, the evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have an unresectable primary or metastatic renal tumor who receive MWA, the evidence includes a single RCT that compared MWA to partial nephrectomy retrospective reviews, and case series. Relevant outcomes are OS, disease-specific survival, symptoms, QOL, and treatment-related mortality and morbidity. In the RCT, overall local recurrence-free survival at 3 years was 91.3% for MWA and 96.0% for partial nephrectomy (p=0.54). This positive outcome should be replicated in additional RCTs. There are also no controlled studies comparing MWA to other ablation techniques in patients with renal tumors. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have unresectable primary or metastatic solid tumors other than hepatic, lung, or renal who receive MWA, the evidence includes systematic reviews and case series. No RCTs on the use of MWA for other tumors or conditions were identified. Relevant outcomes are OS, disease-specific survival, symptoms, quality of life, and treatment-related mortality and morbidity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

CODING Medicare Advantage Plans and Commercial Products There are no CPT code(s) specific to microwave tumor ablation. Report the unlisted CPT code(s) for the anatomic area. The following related HCPCS code(s) is covered if the medical criteria are met:
C9751 Bronchoscopy, rigid or flexible, transbronchial ablation of lesion(s) by microwave energy, including
fluoroscopic guidance, when performed, with computed tomography acquisition(s) and 3-d rendering, computer-assisted, image-guided navigation, and endobronchial ultrasound (ebus) guided transtracheal and/or transbronchial sampling (e.g., aspiration[s]/biopsy[ies]) and all mediastinal

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and/or hilar lymph node stations or structures and therapeutic intervention(s) (Code Deleted Effective 12/31/2025)

RELATED POLICIES Prior Authorization of Services, Treatments or Procedures
Unlisted Procedures

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76. Vogl TJ, Worst TS, Naguib NN, et al. Factors influencing local tumor control in patients with neoplastic pulmonary nodules treated with microwave ablation: a risk-factor analysis. AJR Am J Roentgenol. Mar 2013; 200(3): 665-72. PMID 23436860
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86. Macchi M, Belfiore MP, Floridi C, et al. Radiofrequency versus microwave ablation for treatment of the lung tumours: LUMIRA (lung microwave radiofrequency) randomized trial. Med Oncol. May 2017; 34(5):
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89. Vogl TJ, Eckert R, Naguib NN, et al. Thermal Ablation of Colorectal Lung Metastases: Retrospective Comparison Among Laser-Induced Thermotherapy, Radiofrequency Ablation, and Microwave Ablation. AJR Am J Roentgenol. Dec 2016; 207(6): 1340-1349. PMID 27680945
90. Zheng A, Ye X, Yang X, et al. Local Efficacy and Survival after Microwave Ablation of Lung Tumors: A Retrospective Study in 183 Patients. J Vasc Interv Radiol. Dec 2016; 27(12): 1806-1814. PMID 27789077
91. Healey TT, March BT, Baird G, et al. Microwave Ablation for Lung Neoplasms: A Retrospective Analysis of Long-Term Results. J Vasc Interv Radiol. Feb 2017; 28(2): 206-211. PMID 27993505
92. Nour-Eldin NA, Exner S, Al-Subhi M, et al. Ablation therapy of non-colorectal cancer lung metastases: retrospective analysis of tumour response post-laser-induced interstitial thermotherapy (LITT), radiofrequency ablation (RFA) and microwave ablation (MWA). Int J Hyperthermia. Nov 2017; 33(7): 820-829. PMID 28540791
93. Wei Z, Ye X, Yang X, et al. Advanced non small cell lung cancer: response to microwave ablation and EGFR Status. Eur Radiol. Apr 2017; 27(4): 1685-1694. PMID 27436020
94. Yang X, Ye X, Huang G, et al. Repeated percutaneous microwave ablation for local recurrence of inoperable Stage I nonsmall cell lung cancer. J Cancer Res Ther. 2017; 13(4): 683-688. PMID 28901314
95. Zhong L, Sun S, Shi J, et al. Clinical analysis on 113 patients with lung cancer treated by percutaneous CT-guided microwave ablation. J Thorac Dis. Mar 2017; 9(3): 590-597. PMID 28449467
96. Uhlig J, Strauss A, Rücker G, et al. Partial nephrectomy versus ablative techniques for small renal masses: a systematic review and network meta-analysis. Eur Radiol. Mar 2019; 29(3): 1293-1307. PMID 30255245
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96. Katsanos K, Mailli L, Krokidis M, et al. Systematic review and meta-analysis of thermal ablation versus surgical nephrectomy for small renal tumours. Cardiovasc Intervent Radiol. Apr 2014; 37(2): 427-37. PMID 24482030
97. Martin J, Athreya S. Meta-analysis of cryoablation versus microwave ablation for small renal masses: is there a difference in outcome?. Diagn Interv Radiol. 2013; 19(6): 501-7. PMID 24084196
98. McClure T, Lansing A, Ferko N, et al. A Comparison of Microwave Ablation and Cryoablation for the Treatment of Renal Cell Carcinoma: A Systematic Literature Review and Meta-analysis. Urology. Jun 17
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101. Aarts BM, Prevoo W, Meier MAJ, et al. Percutaneous Microwave Ablation of Histologically Proven T1 Renal Cell Carcinoma. Cardiovasc Intervent Radiol. Jul 2020; 43(7): 1025-1033. PMID 32052093
102. Zhao Z, Wu F. Minimally-invasive thermal ablation of early-stage breast cancer: a systemic review. Eur J Surg Oncol. Dec 2010; 36(12): 1149-55. PMID 20889281
103. Zhou W, Zha X, Liu X, et al. US-guided percutaneous microwave coagulation of small breast cancers: a clinical study. Radiology. May 2012; 263(2): 364-73. PMID 22438362
104. Keane MG, Bramis K, Pereira SP, et al. Systematic review of novel ablative methods in locally advanced pancreatic cancer. World J Gastroenterol. Mar 07 2014; 20(9): 2267-78. PMID 24605026
105. Cui T, Jin C, Jiao D, et al. Safety and efficacy of microwave ablation for benign thyroid nodules and papillary thyroid microcarcinomas: A systematic review and meta-analysis. Eur J Radiol. Sep 2019; 118: 58-64. PMID 31439259
106. Wu X, Jiang Z, Liu J, et al. The efficacy and safety of microwave ablation versus conventional open surgery for the treatment of papillary thyroid microcarcinoma: a systematic review and meta-analysis. Gland Surg. Jun 2022; 11(6): 1003-1014. PMID 35800741
107. Li X, Fan W, Zhang L, et al. CT-guided percutaneous microwave ablation of adrenal malignant carcinoma: preliminary results. Cancer. Nov 15 2011; 117(22): 5182-8. PMID 21523760
108. Pusceddu C, Sotgia B, Fele RM, et al. Treatment of bone metastases with microwave thermal ablation. J Vasc Interv Radiol. Feb 2013; 24(2): 229-33. PMID 23200605
109. Yu MA, Liang P, Yu XL, et al. Sonography-guided percutaneous microwave ablation of intrahepatic primary cholangiocarcinoma. Eur J Radiol. Nov 2011; 80(2): 548-52. PMID 21300500
110. Egorov AV, Vasilyev IA, Musayev GH, et al. The role of microwave ablation in management of functioning pancreatic neuroendocrine tumors. Gland Surg. Dec 2019; 8(6): 766-772. PMID 32042685
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113. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Hepatocellular Carcinoma. Version 1.2023. https://www.nccn.org/guidelines/guidelines- detail?category=1&id=1514. Accessed August 2, 2024.
114. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 3.2023. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed August 6, 2024.
115. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Small Cell Lung Cancer. Version 3.2023. https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. Accessed August 7, 2024.
116. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Neuroendocrine and Adrenal Tumors. Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Accessed August 5, 2024.
117. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Version 1.2024. https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed August 3, 2024.

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117. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2023. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed August 1, 2024.
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122. Ceppa EP, Collings AT, Abdalla M, et al. SAGES/AHPBA guidelines for the use of microwave and radiofrequency liver ablation for the surgical treatment of hepatocellular carcinoma or colorectal liver metastases less than 5 cm. Surg Endosc. Dec 2023; 37(12): 8991-9000. PMID 37957297 i

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     This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association.

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