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Microwave Tumor Ablation

Policy Number: MP-512

Latest Review Date: October 2023

Category: Surgery                                                                  

POLICY:

Microwave ablation may be considered medically necessary for patients with one of the following indications:

  • Hepatocellular carcinoma (HCC)
  • Metastatic liver carcinoma
  • Primary or metastatic lung tumors

Microwave ablation of primary and metastatic tumors, other than those listed above, is considered investigational. 

DESCRIPTION OF PROCEDURE OR SERVICE:

Microwave ablation (MWA) is a technique to destroy tumors and soft tissue using microwave energy to create thermal coagulation and localized tissue necrosis. Microwave ablation is used to treat tumors not amenable to resection and to treat patients ineligible for surgery due to age, comorbidities, or poor general health. Microwave ablation 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.

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 generates friction and heat. The local heat coagulates the tissue adjacent to the probe, resulting in a small, 2 cm to 3 cm elliptical area (5´3 cm) of tissue ablation. In tumors greater than 2 cm in diameter, 2 to 3 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 1 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. Microwave ablation 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.

Microwave ablation 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. Microwave ablation 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 potential complications associated with MWA include those caused by heat damage to normal tissue adjacent to the tumor (e.g., intestinal damage during MWA of the kidney or liver), structural damage along the probe track (e.g., 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 patients since potential risks to the patient and/or fetus have not been established and in patients with implanted electronic devices such as 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 that time, MWA has been used for ablation of tumors and tissue for the treatment of many conditions including: hepatocellular carcinoma, 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 hypothesized advantages of MWA for these cancers include improved local control and those common to any minimally invasive procedure (e.g., preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization). MWA has been investigated as a treatment for unresectable hepatic tumors, both as primary treatment, palliative treatment and as a bridge to liver transplant. In the latter setting, it is thought that MWA will reduce the incidence of tumor progression while awaiting transplantation and thus maintain a patient’s candidacy for liver transplant.

KEY POINTS:

The most recent literature update was performed through August 25, 2023.

Summary of Evidence

For individuals who have an unresectable primary or metastatic hepatic tumor who receive microwave ablation (MWA), the evidence includes randomized controlled trials (RCTs), comparative observational studies, and systematic reviews comparing MWA to radiofrequency ablation (RFA) and to surgical resection. Relevant outcomes are overall survival (OS), 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 that MWA and RFA had similar survival outcomes with up to 5 years of follow-up in patients with a single tumor <5 cm or up to 3 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. Microwave ablation 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 a single RCT, retrospective observational studies, and systematic reviews of these studies. 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, systematic reviews, and meta-analyses of the retrospective reviews (with or without the single RCT) 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=.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. Relevant outcomes are OS, disease-specific survival, symptoms, QOL, and treatment-related mortality and morbidity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Chest Physicians

The American College of Chest Physicians (2013) evidence-based guidelines on the treatment of NSCLC noted that the role of ablative therapies in the treatment of high-risk patients with stage I NSCLC is evolving. The guidelines deal mostly with radiofrequency ablation.

American Urological Association

The American Urological Association (2021) updated its guidelines on renal mass and localized renal cancer, which note that both RFA and cryoablation may be offered as options for patients who elect thermal ablation (Conditional Recommendation;Evidence Level: Grade C). Thermal ablation can be considered as an alternate approach in the management of T1a solid renal masses <3 cm. In these patients, a percutaneous technique is preferred (Moderate Recommendation; Evidence Level:Grade C). The guidelines do not specifically address MWA.

National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN) guidelines on hepatocellular carcinoma (v.1. 2023) lists MWA (along with radiofrequency ablation, cryoablation and percutaneous alcohol injection) as a treatment option for HCC tumors in patients who are not candidates for potential curative treatments (e.g., resection and transplantation) and do not have large-volume extrahepatic disease. Ablation should only be considered when tumors are accessible by percutaneous, laparoscopic or open approaches. The guidelines indicate  " Ablation alone may be curative in treating tumors less than or equal to 3 cm [...] Lesions 3 to 5 cm may be treated to prolong survival using arterially directed therapies, or with combination of an arterially directed therapy and ablation as long as tumor location is accessible for ablation."

The guidelines on non-small cell lung cancer (NSCLC) (v.3.2023) state that image-guided thermal ablation therapies such as cryotherapy, microwave, or radiofrequency may be an option for select medically inoperable patients not receiving stereotactic ablative radiotherapy or definitive radiotherapy. Image-guided thermal ablation therapy is considered an option for the management of NSCLC lesions <3 cm. asAblation for NSCLC lesions >3 cm has been associated with higher rates of local recurrence and complications.

Guidelines on small-cell lung cancer (v.3.2023) state, "stereotactic ablative radiotherapy is an option for certain patients with medically inoperable stage I to IIA small-cell lung cancer."

The Network guidelines on neuroendocrine tumors (v.1.2023) state that cytoreductive surgery or ablative therapies (eg, radiofrequency, cryotherapy, microwave) may be considered in patients with progressive hepatic-predominant metastatic disease to reduce tumor bulk and relieve symptoms of hormone hypersecretion (category 2B). Additionally, although prospective data for ablative therapy interventions are limited, the guideline notes that "percutaneous thermal ablation, often using microwave energy, can be considered for oligometastatic liver disease, generally up to 4 lesions each smaller than 3 cm.

The guidelines on kidney cancer (v.1.2024) do not specifically address the role of MWA, but state that other thermal ablation techniques (RFA and cryotherapy) may be an option for T1 renal lesions, particularly for masses <3 cm.

The guidelines on breast cancer (v.4.2023) do not address thermal ablation techniques such as MWA.

Thyroid cancer guidelines from NCCN (v.4.2023) recommend ablation techniques such as cryoablation or RFA as an option formetastatic disease in select patients. There is not specific mention of MWA.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2016) updated its guidance on MWA for treatment of metastases in the liver. The revised guidance states:

  • Current evidence on MWA for treating liver metastases raises no major safety concerns and the evidence on efficacy is adequate in terms of tumor ablation. Therefore this procedure may be used provided that standard arrangements are in place for clinical governance, consent and audit.
  • Patient selection should be carried out by a hepatobiliary cancer multidisciplinary team.
  • Further research would be useful for guiding selection of patients for this procedure. This should document the site and type of the primary tumor being treated, the intention of treatment (palliative or curative), imaging techniques used to assess the efficacy of the procedure, long-term outcomes and survival.

The Institute also published guidance on MWA for HCC in 2007. This guidance indicated: “Current evidence on the safety and efficacy of MWA of hepatocellular carcinoma appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.” The guidance also stated there are no major concerns about the efficacy of MWA, but noted that limited, long-term survival data are available.

The Institute (2022) has published guidance on MWA for lung tumors as well. This guidance indicated that "Evidence on the safety of microwave ablation for treating primary lung cancer and metastases in the lung is adequate but shows it can cause infrequent serious complications. Evidence on its efficacy shows it reduces tumour size. But the evidence on improvement in survival, long-term outcomes and quality of life is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research." The guidance encourages further research.

U.S. Preventitive Services Task Force Recommendations

Microwave tumor ablation is not a preventive service.

KEY WORDS:

Microwave tumor ablation, Microwave coagulation therapy, Tumor microwave ablation, MWA, breast microwave ablation, breast tumor, metastatic tumors, microwave coagulation therapy, primary tumors, pulmonary microwave ablation, pulmonary tumor, renal microwave ablation, renal tumor, secondary tumors, tumor microwave ablation, urinary system microwave ablation

APPROVED BY GOVERNING BODIES:

Multiple MWA devices have been cleared for marketing by the U.S. Food and Drug Administration 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. Table 1 is a summary of selected MWA devices cleared by FDA.

The Food and Drug Administration used determinations of substantial equivalence to existing radiofrequency and MWA devices to clear these devices.

This evidence review does not address MWA for the treatment of splenomegaly or ulcers for cardiac applications, or as a surgical coagulation tool.

Table 1. Selected Microwave Ablation Devices Cleared by FDA

Device

Indication

Manufacturer

Date Cleared

510(k) No

MedWaves Microwave Coagulation/Ablation System

General surgery use in open procedures for the coagulation and ablation of soft tissues

MedWaves Incorporated

12/2007

K070356

Acculis Accu2i pMTA Microwave Tissue Ablation Applicator

Acculis Accu2i pMTA Applicator and SulisV pMTA Generator

Intraoperative coagulation of soft tissue

 

Software addition

Microsoulis Holdings, Ltd

8/2010

 

11/2012

K094021

 

K122762

MicroThermX Microwave Ablation System

Coagulation (ablation) of soft tissue.Mmay be used in open surgical as well as percutaneous ablation procedures.

BSD Medical Corporation

8/2010

K100786

Emprint™ Ablation System

Emprint™ Ablation System

Emprint™ SX Ablation Platform with Thermosphere™ Technology

Emprint™ Ablation Platform with Thermosphere™ Technology and Emprint™ SX Ablation Platform with Thermosphere™ Technology

Percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.

Same with design modification of device antenna for percutaneous use

3-D navigation feature assists in the placement of antenna using real-time image guidance during intraoperative and laparoscopic ablation procedures.

 

Antenna modification and update to instructions for use

Medtronic

4/2014

 

12/2016

 

9/2017

 

2/2020

K133821

 

K163105

 

K171358

 

K193232

Certus 140 2.45 GHz Ablation System and Accessories

Certus 140™ 2.45 GHz Ablation System and Accessories

CertuSurgGT Surgical Tool

Certus 140™ 2.45 GHz Ablation System and Accessories

Certus 140 2.45GHz Ablation System

Ablation (coagulation) of soft tissue.

Ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings.

Surgical coagulation (including Planar Coagulation) in open surgical settings. Same indication with probe redesign

Ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of nonresectable liver tumors.

Johnson & Johnson

10/2010

 

01/2012

 

7/2013

 

5/2016

 

10/2018

K100744

 

K113237

 

K130399

 

K160936

 

K173756

NEUWAVE Flex Microwave Ablation System (FLEX)

Ablation (coagulation) of soft tissue. Design evolution of Certus 140 2.45GHz Ablation System (K160936)

 

Johnson & Johnson

3/2017

 

K163118

Solero Microwave Tissue Ablation (MTA) System and Accessories

Ablation of soft tissue during open procedures

Angiodynamics, Inc.

5/2017

K162449

Microwave Ablation System

Coagulation (ablation) of soft tissue

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd

7/2019

K183153

NEUWAVE Microwave Ablation System and Accessories

Ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors; not intended for use in cardiac procedures.

Johnson & Johnson

11/2020

K200081

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING:

CPT Codes:

As of 01/01/2018, there are no specific CPT codes for microwave ablation.

The unlisted CPT code for the anatomic area should be reported such as code 47399- unlisted procedure liver; 53899- unlisted procedure urinary system (for renal tumors); 32999- unlisted procedure lung; 19499- unlisted procedure breast.

This procedure may also be billed with radiofrequency ablation codes for the anatomic area, such as code 32998- pulmonary, 47382- liver, and 50592- renal.

REFERENCES:

  1. 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.
  2. Abdelaziz AO, Nabeel MM, Elbaz TM, et al. Microwave ablation versus transarterial chemoembolization in large hepatocellular carcinoma: prospective analysis. Scand J Gastroenterol. Apr 2015; 50(4):479-484.
  3. Abdelaziz A, Elbaz T, Shousha HI, et al. Efficacy and survival analysis of percutaneous radiofrequency versus microwave ablation for hepatocellular carcinoma: an Egyptian multidisciplinary clinic experience. Surg Endosc. Dec 2014; 28(12):3429-34.
  4. Acksteiner C, Steinke K. Percutaneous microwave ablation for early-stage non-small cell lung cancer (NSCLC) in the elderly: a promising outlook. J Med Imaging Radiat Oncol. Feb 2015; 59(1):82-90.
  5. Bala MM, Riemsma RP, Wolff R, et al. Microwave coagulation for liver metastases. Cochrane Database Syst Rev. Oct 13 2013; 10: CD010163.
  6. Belfiore G, Ronza F, Belfiore MP et al. Patients' survival in lung malignancies treated by microwave ablation: our experience on 56 patients. Eur J Radiol 2013; 82(1): 177-81.
  7. Campbell SC, Clark PE, Chang SS, et al. Renal Mass and Localized Renal Cancer: Evaluation, Management, and Follow-Up: AUA Guideline: Part I. J Urol. Aug 2021; 206(2): 199-208.
  8. Carberry GA, Smolock AR, Cristescu M et al. Safety and Efficacy of Percutaneous Microwave Hepatic Ablation Near the Heart.. J Vasc Interv Radiol, 2017 Feb 14;28(4).
  9. Carrafiello G, Mangini M, Fontana F et al. Complications of microwave and radiofrequency lung ablation: personal experience and review of the literature. Radiol Med 2012; 117(2): 201-13.
  10. Carrafiello G, Mangini M, Fontana F et al. Microwave ablation of lung tumours: single centre preliminary experience. Radiol Med Jan 2014; 119(1): 75-82.
  11. Chiang J, Cristescu M, Lee MH et al. Effects of Microwave Ablation on Arterial and Venous Vasculature after Treatment of Hepatocellular Carcinoma.. Radiology, 2016 Oct 19;281(2).
  12. Chinnaratha MA, Chuang MA, Fraser RJ, et al. Percutaneous thermal ablation for primary hepatocellular carcinoma: a systematic review and meta-analysis. J Gastroenterol Hepatol. Feb 2016; 31(2): 294-301.
  13. Chinnaratha MA, Sathananthan D, Pateria P, Tse E, MacQuillan G, Wigg AJ. Predictors of hepatocellular carcinoma recurrence post thermal ablation. J Gastroenterol Hepatol. 2013;28(Suppl. 2):66-67.
  14. Chong CCN, Lee KF, Cheung SYS, et al. Prospective double-blinded randomized controlled trial of Microwave versus RadioFrequency Ablation for hepatocellular carcinoma (McRFA trial). HPB (Oxford). Aug 2020; 22(8): 1121-1127.
  15. Chong CCN, Lee KF, Chu CM, et al. Microwave ablation provides better survival than liver resection for hepatocellular carcinoma in patients with borderline liver function: application of ALBI score to patient selection. HPB (Oxford). Jun 2018; 20(6): 546-554.
  16. Cillo U, Noaro G, Vitale A, et al. Laparoscopic microwave ablation in patients with hepatocellular carcinoma: a prospective cohort study. HPB (Oxford). Nov 2014; 16(11): 979-86.
  17. Correa-Gallego C, Fong Y, Gonen M, et al. A retrospective comparison of microwave ablation vs. radiofrequency ablation for colorectal cancer hepatic metastases. Ann Surg Oncol. Dec 2014; 21(13): 4278-83.
  18. Cui R, Yu J, Kuang M, et al. Microwave ablation versus other interventions for hepatocellular carcinoma: A systematic review and meta-analysis. J Cancer Res Ther. 2020; 16(2): 379-386.
  19. De Cobelli F, Papa M, Panzeri M, et al. Percutaneous Microwave Ablation Versus Cryoablation in the Treatment of T1a Renal Tumors. Cardiovasc Intervent Radiol. Jan 2020; 43(1): 76-83.
  20. Ding J, Jing X, Liu J et al. Comparison of two different thermal techniques for the treatment of hepatocellular carcinoma. Eur J Radiol 2013; 82(9):1379-84.
  21. Ding J, Jing X, Liu J et al. Complications of thermal ablation of hepatic tumours: comparison of radiofrequency and microwave ablative techniques. Clin Radiol 2013; 68(6):608-15.
  22. Di Vece F, Tombesi P, Ermili F, et al. Coagulation areas produced by cool-tip radiofrequency ablation and microwave ablation using a device to decrease back-heating effects: a prospective pilot study. Cardiovasc Intervent Radiol. Jun 2014;37(3): 723-9.
  23. Dou Z, Lu F, Ren L, et al. Efficacy and safety of microwave ablation and radiofrequency ablation in the treatment of hepatocellular carcinoma: A systematic review and meta-analysis. Medicine (Baltimore). Jul 29 2022; 101(30): e29321. 
  24. Egashira Y, Singh S, Bandula S, et al. Percutaneous High-Energy Microwave Ablation for the Treatment of Pulmonary Tumors: A Retrospective Single-Center Experience. J Vasc Interv Radiol. Apr 2016; 27(4): 474-9.
  25. 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.
  26. Floridi C, De Bernardi I, et al. Microwave ablation of renal tumors: state of the art and development trends. Radiol med 2014; (119): 533-540.
  27. Giorgio A, Gatti P, Montesarchio L et al. Microwave Ablation in Intermediate Hepatocellular Carcinoma in Cirrhosis: An Italian Multicenter Prospective Study.. J Clin Transl Hepatol, 2018 Oct 3;6(3).
  28. Glassberg MB, Ghosh S, Clymer JW et al. Microwave ablation compared with hepatic resection for the treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis.. World J Surg Oncol, 2019 Jun 10;17(1): 98.
  29. Groeschl RT, Pilgrim CH, Hanna EM et al. Microwave ablation for hepatic malignancies: a multiinstitutional analysis.. Ann. Surg., 2013 Oct 8;259(6).
  30. Guan W, Bai J, Liu J et al. Microwave ablation versus partial nephrectomy for small renal tumors: intermediate-term results. J Surg Oncol Sep 01 2012; 106(3):316-21.
  31. Guo J, Arellano RS. Percutaneous Microwave Ablation of Category T1a Renal Cell Carcinoma: Intermediate Results on Safety, Technical Feasibility, and Clinical Outcomes of 119 Tumors. AJR Am J Roentgenol. Jan 2021; 216(1): 117-124.
  32. Guo J, Arellano RS. Percutaneous Microwave Ablation of Stage T1a Renal Cell Carcinoma: Intermediate Results on Safety, Technical Feasibility and Clinical Outcomes of 119 Tumors. AJR Am J Roentgenol. Jun 29 2020.
  33. 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.
  34. Howington J, Blum M, Chang A, et al. Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest May 2013; 143 (5 Suppl):e278S-313S.
  35. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  36. Jiang B, Mcclure MA, Chen T et al. Efficacy and safety of thermal ablation of lung malignancies: A Network meta-analysis.. Ann Thorac Med, 2018 Nov 13;(4): 243-250.
  37. Kamal A, Elmoety AAA, Rostom YAM, et al. Percutaneous radiofrequency versus microwave ablation for management of hepatocellular carcinoma: a randomized controlled trial. J Gastrointest Oncol. Jun 2019; 10(3): 562-571.
  38. 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):427-437.
  39. Keane MG, Bramis K, Pereira SP, et al. Systematic review of novel ablative methods in locally advanced pancreatic cancer. World J Gastroenterol. Mar 7 2014; 20 (9):2267-2278.
  40. Kitchin D, Lubner M, Ziemlewicz T et al. Microwave ablation of malignant hepatic tumours: intraperitoneal fluid instillation prevents collateral damage and allows more aggressive case selection.. Int J Hyperthermia, 2014 Aug 22;30(5).
  41. Ko WC, Lee YF, Chen YC, et al. CT-guided percutaneous microwave ablation of pulmonary malignant tumors. J Thorac Dis. Oct 2016; 8(Suppl 9): S659-S665.
  42. Lee KF, Wong J, Hui JW, et al. Long-term outcomes of microwave versus radiofrequency ablation for hepatocellular carcinoma by surgical approach: A retrospective comparative study. Asian J Surg. Jul 2017; 40(4): 301-308.
  43. Li B, Wang Z, Zhou K, et al. Safety and feasibility within 24 h of discharge in patents with inoperable malignant lung nodules after percutaneous microwave ablation. J Cancer Res Ther. Dec 2016; 12(Supplement): C171-C175.
  44. Li W, Zhou X, Huang Z, et al. Short-term and long-term outcomes of laparoscopic hepatectomy, microwave ablation, and open hepatectomy for small hepatocellular carcinoma: a 5-year experience in a single center. Hepatol Res. Jun 2017; 47(7): 650-657.
  45. Lin Y, Liang P, et al. Percutaneous microwave ablation of renal cell carcinoma is safe in patients with a solitary kidney. Urology 2014; 83 (2): 357-363.
  46. Liu H, Steinke K. High-powered percutaneous microwave ablation of stage I medically inoperable non-small cell lung cancer: a preliminary study. J Med Imaging Radiat Oncol. Aug 2013; 57(4): 466-74.
  47. Liu W, Zheng Y, He W, et al. Microwave vs radiofrequency ablation for hepatocellular carcinoma within the Milan criteria: a propensity score analysis. Aliment Pharmacol Ther. Sep 2018; 48(6): 671-681.
  48. Liu Y, Li S, Wan X et al. Efficacy and safety of thermal ablation in patients with liver metastases. Eur J Gastroenterol Hepatol Apr 2013; 25(4):442-6.
  49. Loveman E, Jones J, Clegg AJ, et al. The clinical effectiveness and cost-effectiveness of ablative therapies in the management of liver metastases: systematic review and economic evaluation. Health Technol Assess. Jan 2014; 18 (7): vii-viii, 1-283.
  50. Lu Q, Cao W, Huang L et al. CT-guided percutaneous microwave ablation of pulmonary malignancies: results in 69 cases. World J Surg Oncol May 07 2012; 10:80.
  51. 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):96.
  52. 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):501-507.
  53. Maxwell AW, Healey TT, Dupuy DE. Percutaneous Thermal Ablation for Small-Cell Lung Cancer: Initial Experience with Ten Tumors in Nine Patients. J Vasc Interv Radiol. Dec 2016; 27(12): 1815-1821.
  54. Mimmo A, Pegoraro F, Rhaiem R, et al. Microwave Ablation for Colorectal Liver Metastases: A Systematic Review and Pooled Oncological Analyses. Cancers (Basel). Mar 03 2022; 14(5). 
  55. Moreland AJ, Ziemlewicz MD, Best SL, et al. High-powered microwave ablation of T1a renal cell carcinoma: safety and initial clinical evaluation. Journal of Endourology 2014; 28 (9): 1046-1052.
  56. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Hepatocellular Carcinoma. Version 1.2023. www.nccn.org/guidelines/guidelines-detail?category=1&id=1514.
  57. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Hepatobiliary Cancers. Version 3.2021. www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. 
  58. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 3.2023. www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. 
  59. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Small Cell Lung Cancer. Version 3.2023. www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. 
  60. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Neuroendocrine and Adrenal Tumors. Version 1.2023. www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. 
  61. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Version 1.2024. www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. 
  62. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2023. www.nccn.org/professionals/physician_gls/pdf/breast.pdf. 
  63. National Comprehensive Cancer Network (NCCN). Neuroendocrine Tumors. Clinical practice guidelines in oncology, v.2.2018. Available online at: www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. 
  64. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Thyroid Cancer.Version 4.2023. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/ www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf.
  65. National Institute for Clinical Excellence (NICE). Microwave Ablation for the Treatment of Metastases in the Liver. 2017. Available online at: www.nice.org.uk/nicemedia/live/11333/56036/56036.pdf. 
  66. National Institute for Health and Care Excellence (NICE). Microwave ablation for treating liver metastases [IPG553]. 2016; www.nice.org.uk/guidance/ipg553.
  67. National Institute for Health and Care Excellence (NICE). Microwave Ablation of Hepatocellular Carcinoma [IPG214]. 2007; www.nice.org.uk/guidance/ipg214. 
  68. National Institute for Health and Care Excellence (NICE). Microwave ablation for treating primary lung cancer and metastases in the lung [IPG469]. 2022; www.nice.org.uk/guidance/ipg469. 
  69. Nelson DB, Tam AL, Mitchell KG, et al. Local Recurrence After Microwave Ablation of Lung Malignancies: A Systematic Review. Ann Thorac Surg. Jun 2019; 107(6): 1876-1883.
  70. 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.
  71. Pathak S, Jones R, Tang JM, et al. Ablative therapies for colorectal liver metastases: a systematic review. Colorectal Dis.Sep 2011; 13(9): e252-65.
  72. Philips P, Scoggins CR, Rostas JK, et al. Safety and advantages of combined resection and microwave ablation in patients with bilobar hepatic malignancies. Int J Hyperthermia. Feb 2017; 33(1): 43-50.
  73. Potretzke TA, Ziemlewicz TJ, Hinshaw JL, et al. Microwave versus Radiofrequency Ablation Treatment for Hepatocellular Carcinoma: A Comparison of Efficacy at a Single Center. J Vasc Interv Radiol. May 2016; 27(5): 631-8.
  74. 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.
  75. Qian GJ, Wang N, Shen Q, et al. Efficacy of microwave versus radiofrequency ablation for treatment of small hepatocellular carcinoma: experimental and clinical studies. Eur Radiol. Sep 2012; 22(9): 1983-90.
  76. Qin S, Liu GJ, Huang M et al. The local efficacy and influencing factors of ultrasound-guided percutaneous microwave ablation in colorectal liver metastases: a review of a 4-year experience at a single center.. Int J Hyperthermia, 2018 Nov 30;36(1).
  77. Ryu T, Takami Y, Wada Y, et al. Oncological outcomes after hepatic resection and/or surgical microwave ablation for liver metastasis from gastric cancer. Asian J Surg. Jan 2019; 42(1): 100-105.
  78. Santambrogio R, Chiang J, Barabino M, et al. Comparison of Laparoscopic Microwave to Radiofrequency Ablation of Small Hepatocellular Carcinoma (≤3 cm). Ann Surg Oncol. Jan 2017; 24(1): 257-263.
  79. Sever I H, Sucu M, Biyikli E. Radiofrequency and Microwave Ablation in the Treatment of Hepatocellular Carcinoma. Iran J Radiol. 2018;15(3):e62396.
  80. Shady W, Petre EN, Do KG, et al. Percutaneous Microwave versus Radiofrequency Ablation of Colorectal Liver Metastases: Ablation with Clear Margins (A0) Provides the Best Local Tumor Control. J Vasc Interv Radiol. Feb2018; 29(2): 268-275.e1.
  81. Shen X, Ma S, Tang X et al. Clinical outcome in elderly Chinese patients with primary hepatocellular carcinoma treated with percutaneous microwave coagulation therapy (PMCT): A Strobe-compliant observational study.. Medicine (Baltimore), 2018 Sep 2;97(35).
  82. Shi J, Sun Q, Wang Y, et al. Comparison of microwave ablation and surgical resection for treatment of hepatocellular carcinomas conforming to Milan criteria. J Gastroenterol Hepatol. 2014; 29(7): 1500-7.
  83. Simo KA, Sereika SE, Newton KN, et al. Laparoscopic-assisted microwave ablation for hepatocellular carcinoma: safety and efficacy in comparison with radiofrequency ablation. J Surg Oncol. Dec 2011; 104(7): 822-9.
  84. Smolock AR, Lubner MG, Ziemlewicz TJ et al. Microwave ablation of hepatic tumors abutting the diaphragm is safe and effective.. AJR Am J Roentgenol, 2014 Dec 30;204(1).
  85. Soliman AF, Abouelkhair MM, Hasab Allah MS et al. Efficacy and Safety of Microwave Ablation (MWA) for Hepatocellular Carcinoma (HCC) in Difficult Anatomical Sites in Egyptian Patients with Liver Cirrhosis. Asian Pac. J. Cancer Prev., 2019 Jan 27;20(1).
  86. Song P, Sheng L, Sun Y, et al. The clinical utility and outcomes of microwave ablation for colorectal cancer liver metastases. Oncotarget. Aug 01 2017; 8(31): 51792-51799.
  87. Sparchez Z, Mocan T, Hajjar NA, et al. Percutaneous ultrasound guided radiofrequency and microwave ablation in the treatment of hepatic metastases. A monocentric initial experience. Med Ultrason. Aug 31 2019; 21(3): 217-224.
  88. Stättner S, Jones RP, Yip VS, et al. Microwave ablation with or without resection for colorectal liver metastases. Eur JSurg Oncol. Aug 2013; 39(8): 844-9.
  89. Sun YH, Song PY, Guo Y, et al. Computed tomography-guided percutaneous microwave ablation therapy for lung cancer. Genet Mol Res. 2015; 14(2):4858-4864.
  90. Swietlik JF, Longo KC, Knott EA et al. Percutaneous Microwave Tumor Ablation Is Safe in Patients with Cardiovascular Implantable Electronic Devices: A Single-Institutional Retrospective Review.. J Vasc Interv Radiol, 2019 Mar 2;30(3).
  91. Takami Y, Ryu T, Wada Y et al. Evaluation of intraoperative microwave coagulo-necrotic therapy (MCN) for hepatocellular carcinoma: a single center experience of 719 consecutive cases. J Hepatobiliary Pancreat Sci Mar 2013; 20(3): 332-41.
  92. Tan K, DU X, Yin J, et al. Microwave tissue coagulation technique in anatomical liver resection. Biomed Rep. Mar 2014; 2(2): 177-182.
  93. Thamtorawat S, Hicks RM, Yu J et al. Preliminary Outcome of Microwave Ablation of Hepatocellular Carcinoma: Breaking the 3-cm Barrier?. J Vasc Interv Radiol, 2016 Mar 26;27(5).
  94. Tian W, Kuang M, Lv M, et al. A randomised comparative trial on liver tumors treated with ultrasound-guided percutaneous radiofrequency versus microwave ablation. Chin J Hepatobiliary Surg 2014;20:11922.
  95. Uhlig J, Strauss A, Rucker 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.
  96. van Tilborg AA, Scheffer HJ, de Jong MC, et al. MWA Versus RFA for Perivascular and Peribiliary CRLM: A Retrospective Patient- and Lesion-Based Analysis of Two Historical Cohorts. Cardiovasc Intervent Radiol. Oct 2016; 39(10): 1438-46.
  97. Vietti Violi N, Duran R, Guiu B et al. Efficacy of microwave ablation versus radiofrequency ablation for the treatment of hepatocellular carcinoma in patients with chronic liver disease: a randomised controlled phase 2 trial.. Lancet Gastroenterol Hepatol, May 2018; 3(5): 317-325.
  98. 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.
  99. Vogl TJ, Farshid P, Naguib NN, et al. Ablation therapy of hepatocellular carcinoma: a comparative study between radiofrequency and microwave ablation. Abdom Imaging. Aug 2015; 40(6):1829-1837.
  100. 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.
  101. Vogl TJ, Naguib NN, Gruber-Rouh T, et al. Microwave ablation therapy: clinical utility in treatment of pulmonary metastases. Radiology. Nov 2011; 261(2): 643-51.
  102. Wei Z, Ye X, Yang X, et al. Advanced non small cell lung cancer: response to microwave ablation and EGFR Status. EurRadiol. Apr 2017; 27(4): 1685-1694.
  103. Wei Z, Ye X, Yang X, et al. Microwave ablation in combination with chemotherapy for the treatment of advanced non-small cell lung cancer. Cardiovasc Intervent Radiol. Feb 2015; 38(1): 135-42.
  104. Wei Z, Ye X, Yang X, et al. Microwave ablation plus chemotherapy improved progression-free survival of advanced non-small cell lung cancer compared to chemotherapy alone. Med Oncol. Feb 2015; 32(2): 464.
  105. 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. 
  106. Xu J, Zhao Y. Comparison of percutaneous microwave ablation and laparoscopic resection in the prognosis of liver cancer.. Int J Clin Exp Pathol, 2015;8(9): 11665-9.
  107. Xu Y, Shen Q, Wang N, et al. Microwave ablation is as effective as radiofrequency ablation for very-early-stage hepatocellular carcinoma. Chin J Cancer. Jan 19 2017; 36(1): 14.
  108. Yang B, Li Y. A comparative study of laparoscopic microwave ablation with laparoscopic radiofrequency ablation for colorectal liver metastasis. J BUON. 2017; 22(3): 667-672.
  109. 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
  110. Yang X, Xin YE, Zheng A et al. Percutaneous microwave ablation of stage I medically inoperable non-small cell lung cancer: clinical evaluation of 47 cases. Journal of Surgical Oncology Nov 2014; 110(6): 758-63.
  111. Yu J, Liang P, et al. US-guided percutaneous microwave ablation versus open radical nephrectomy for small renal cell carcinoma: intermediate-term results. Radiology 2014; 270 (3): 880-887.
  112. Yu J, Liang P, Yu XL et al. Needle track seeding after percutaneous microwave ablation of malignant liver tumors under ultrasound guidance: analysis of 14-year experience with 1462 patients at a single center. Eur J Radiol 2012; 81(10):2495-9.
  113. Yu J, Liang P, Yu XL et al. US-guided percutaneous microwave ablation of renal cell carcinoma: intermediate-term results. Radiology 2012; 263(3):900-8.
  114. Yu J, Yu XL, Han ZY et al. Percutaneous cooled-probe microwave versus radiofrequency ablation in early-stage hepatocellular carcinoma: a phase III randomised controlled trial.. Gut, Jun 2017; 66(6): 1172-1173.
  115. 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.
  116. Yuan Z, Wang Y, Zhang J et al. A Meta-Analysis of Clinical Outcomes After Radiofrequency Ablation and Microwave Ablation for Lung Cancer and Pulmonary Metastases.. J Am Coll Radiol, 2019 Jan 16;16(3).
  117. Yue W, Wang S, Wang B et al. Ultrasound guided percutaneous microwave ablation of benign thyroid nodules: Safety and imaging follow-up in 222 patients. Eur J Radiol 2013 Jan; 82(1):e11-6.
  118. Zaitoun MMA, Elsayed SB, Zaitoun NA, et al. Combined therapy with conventional trans-arterial chemoembolization (cTACE) and microwave ablation (MWA) for hepatocellular carcinoma 3- 5 cm. Int J Hyperthermia. 2021; 38(1): 248-256.
  119. Zhang L, Wang N, Shen Q, et al. Therapeutic efficacy of percutaneous radiofrequency ablation versus microwave ablation for hepatocellular carcinoma. PLoS One. 2013; 8(10): e76119.
  120. Zhang NN, Cheng XJ, Liu JY. Comparison of high-powered MWA and RFA in treating larger hepatocellular carcinoma. JPract Oncol. 2014;29:349-356.
  121. Zhang EL, Yang F, Wu ZB, et al. Therapeutic efficacy of percutaneous microwave coagulation versus liver resection for single hepatocellular carcinoma ≤3 cm with Child-Pugh A cirrhosis. Eur J Surg Oncol. May 2016; 42(5): 690-7.
  122. Zhang QB, Zhang XG, Jiang RD, et al. Microwave ablation versus hepatic resection for the treatment of hepatocellular carcinoma and oesophageal variceal bleeding in cirrhotic patients. Int J Hyperthermia. May 2017; 33(3): 255-262.
  123. 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.
  124. Zheng A, Wang X, Yang X, et al. Major complications after lung microwave ablation: a single-center experience on 204 sessions. Ann Thorac Surg. Jul 2014; 98(1): 243-8.
  125. 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.
  126. Zhou W, Zha X, Liu X et al. US-guided percutaneous microwave coagulation of small breast cancers: a clinical study. Radiology 2012; 263(2):364-73.
  127. Ziemlewicz TJ, Hinshaw JL, Lubner MG et al. Percutaneous microwave ablation of hepatocellular carcinoma with a gas-cooled system: initial clinical results with 107 tumors.. J Vasc Interv Radiol, 2014 Dec 3;26(1).

POLICY HISTORY:

 Medical Policy Group, October 2012 (4)

Medical Policy Administration Committee, October 2012

Available for comment October 24 through December 10, 2012

Medical Policy Panel, February 2013

Medical Policy Group, June 2013 (1): Addition of coverage statement for hepatocellular carcinoma and metastatic liver carcinoma from policy #070, which was initially effective 07/09/2009; Key Points and References updated, also.

Medical Policy Panel, October 2013

Medical Policy Group, October 2013 (1): Update to Key Points and References; no change to policy statement

Medical Policy Panel, October 2014

Medical Policy Group, January 2015 (4): 2014 and ad hoc review updates to Description, Key Points and References. No change to policy statement.

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (4): Updates to Description, Key Points, Key Words, Approved Governing Bodies, Coding and References. No change to policy statement.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (4): Updates to Key Points, Coding, and References.  No change to policy statement. Added CPT code 0301T to coding section. For further history on microwave ablation, see Policy History section on MP# 070.

Medical Policy Group, December 2017: Annual Coding Update 2018.  Created previous coding section and moved deleted code 0301T to this section.

Medical Policy Panel, September 2018

Medical Policy Group, September 2018 (4): Updates to Key Points and Governing Bodies. No change to policy statement.

Medical Policy Panel, September 2019

Medical Poliocy Group, September 2019 (5): Updates to, Key Points, Approved by Governing Bodies, and References. Policy Statement updated to include coverage for primary and metastatic lung tumors effective 10/04/2019. Available for comment October 03,2019 through November 17, 2019. 

Medical Policy Panel, September 2020

Medical Policy Group, September 2020 (5): Updates to Description, Key Points, Approved by Governing Bodies, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, October 2020

Medical Policy Group, October 2020 (5): Update to Key Points and References. No change to Policy Statement.

Medical Policy Panel, October 2021

Medical Policy Group, October 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, October 2022

Medical Policy Group, November 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, October 2023

Medical Policy Group, October 2023 (11): Updates to Key Points, Benefit Application, and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.