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Ablation of Lung Tumors
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Policy

MEDICALLY NECESSARY

RADIOFREQUENCY ABLATION
Radiofrequency ablation (RFA) is considered medically necessary and, therefore, covered for the treatment of either of the following types of small (≤3 cm) pulmonary lesions:
  • When the intent for treatment is curative; however, the individual has a primary malignant stage I lung tumor and is not a candidate for surgical resection or radiotherapy AND the tumor is located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery, and the heart. 
    • ​A comprehensive evaluation by a thoracic surgeon is required to evaluate pulmonary function, comorbidities, and other factors to determine if the individual is declared to be inoperable for surgical resection, and is a candidate for RFA.
  • Slow-growing metastases restricted to the lungs in an individual who is not a candidate for surgical resection ​or in whom resection, external beam irradiation, and chemotherapy have failed or when it is necessary to preserve lung function because surgical resection or radiotherapy is likely to worsen pulmonary status AND the tumor is located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery, and the heart.
    • A comprehensive evaluation by a thoracic surgeon is required to evaluate pulmonary function, comorbidities, and other factors to determine if the individual is declared to be inoperable for surgical resection, and is a candidate for RFA.
CRYOSURGICAL ABLATION
Cryosurgical ablation is considered medically necessary and, therefore, covered for the treatment of lung cancer when either of the following criteria is met:
  • The individual has early-stage non–small cell lung cancer and is a poor surgical candidate.
    • A comprehensive evaluation by a thoracic surgeon is required to evaluate pulmonary function, comorbidities, and other factors to determine if the individual is declared to be a poor candidate for surgical resection, and is a candidate for cryosurgical ablation.
  • The individual requires palliation for a central airway–​obstructing lesion.
MICROWAVE ABLATION
Microwave ablation is considered medically necessary and, therefore, covered for the treatment of a primary or metastatic single lung tumor (≤​3 cm) when the tumor is unresectable due to location of the lesion and/or comorbid conditions.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for RFA, and cryosurgical and microwave ablation of lung tumors are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of these services cannot be established by review of the available peer-reviewed published literature.​

PULSED ELECTRIC FIELD ABLATION

Pulsed electric field ablation (i.e., irreversible electroporation) of lung tumors is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by a review of the available peer-reviewed published literature.​

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, ablation of lung tumors is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in the medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA issued a Public Health Notification entitled Radiofrequency Ablation of Lung Tumors, Clarification of Regulatory Status on September 24, 2008. This notification concerns the regulatory status of RFA devices that are used to treat lung tumors, the regulatory basis for the FDA's clearance of these devices for the indication of general soft tissue ablation, and the public health concerns related to the specific use of RFA to treat lung tumors.

Description

Primary lung cancer is the second most frequent malignancy for men and women and the leading cause of cancer death in the United States. Primary lung tumor types include small cell lung cancer (SCLC) and non–small cell lung cancer (NSCLC). Additionally, the lungs are a frequent site for metastases of other solid tumors.

Surgical resection is the most effective method for treating NSCLC and is considered the gold standard for early-stage NSCLC. Unfortunately, only 20% of individuals who present with pulmonary malignancies are surgical candidates, due to large tumor mass, end-stage disease, or various comorbidities. Alternatives to surgery, including radiotherapy and chemotherapy, produce substantial increases in survival, but only in small subsets of highly selected cases. Survival rates for unresectable primary pulmonary neoplasms are less than 1 year for individuals who receive either chemotherapy or radiation therapy. The survival rates do not greatly improve with combined therapy. In addition, there are risks associated with radiation therapy, such as injury to surrounding tissues and radiation pneumonitis.

RADIOFREQUENCY ABLATION

Radiofrequency ablation (RFA) involves placement of an electrode into tumor tissue under the guidance of ultrasound or computed tomography (CT). RFA uses a high-frequency alternating current similar to microwave heating to induce coagulation, necrosis, and tumor cell death within the targeted area. RFA systems include three components: a radiofrequency generator, needle electrodes, and grounding pads. RFA may be performed percutaneously, laparoscopically, or during open surgery.

The percutaneous approach of RFA is the least invasive, with fewer complications, which makes it an option for individuals who are unable to tolerate open surgery. Although pneumothorax is a common complication, fewer than 20% of individuals undergoing percutaneous RFA require treatment with needle aspiration or chest tube placement. The procedure can be performed in an outpatient setting with conscious sedation, or it can be performed under general anesthesia with a 1- to 2-day hospital stay. In general, the procedure results in lower morbidity and an improved quality of life for individuals who have few treatment options. Compared with surgery, RFA spares normal lung tissue and causes less impairment of pulmonary function. Moreover, the procedure can be repeated in the event of incomplete ablation or in cases of pulmonary recurrence.

At this time, no randomized controlled trials (RCTs) have been reported that directly compare RFA with radiotherapy or chemotherapy for the treatment of unresectable lung tumors. Few of the current RFA studies report histologic proof after treatment. Some, but not all, RFA studies report survival or progression-free survival in individuals who have received RFA treatment. When survival rates are reported, they compare favorably with or surpass those achieved by chemotherapy and radiation. However, there is great variability in the duration of follow-up after treatment. Unlike radiation or chemotherapy, RFA requires only one or two sessions, and side effects are minimal.


The National Comprehensive Cancer Network (NCCN) Guidelines on NSCLC (v3.2025) state that image-guided thermal ablation therapies such as radiofrequency may be an option for select medically inoperable individuals. Image-guided thermal ablation therapy is considered an option for the management of NSCLC lesions smaller than 3 cm as ablation for NSCLC lesions larger than 3 cm has been associated with higher rates of local recurrence and complications.

CRYOABLATION

Cryoablation involves freezing of target tissues; this procedure is most often performed by inserting a coolant-carrying probe into the tumor. Cryosurgery may be performed as an open surgical technique or as a closed procedure under laparoscopic or ultrasound guidance.

EARLY-STAGE NON–SMALL CELL LUNG CANCER
Surgical resection is the preferred local treatment modality for early-stage lung tumors. Individuals with early-stage lung cancer who are not surgical candidates may be candidates for radiotherapy with curative intent. Cryoablation is being investigated in individuals who are medically inoperable, with small primary lung cancers or lung metastases. Individuals with more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment is rarely curative; rather, it seeks to retard tumor growth or palliate symptoms.

The ECLIPSE trial (de Baère et al., 2015) is a prospective, multicenter trial of cryoablation for metastatic disease in the lungs. The trial enrolled 40 participants with 60 metastatic lung lesions who were treated with cryoablation and had at least 12 months of follow-up. Outcomes included survival, local tumor control, quality of life, and complications. Local tumor control was achieved in 94.2% of treated lesions, and 1-year survival was 97.5%. There were no significant changes in quality of life during the 12-month study. The most common adverse advent was pneumothorax requiring chest tube insertion in 18.8%.

In 2015, Moore et al. reported a retrospective case review of 45 individuals (47 tumors) treated with cryoablation during a 5-year period between 2006 and 2011. All of the individuals had biopsy-proven early-stage (T1a and T1b) primary lung tumors and had been assessed by a tumor board to be medically inoperable. Lesions were as small as 5 mm but the average was 1.9 cm (0.5–3 cm range). Cryoablation procedures were performed under general anesthesia. The primary endpoint was completion of freeze-thaw cycle. Mean follow-up was 51 months ±10 with observed 5-year survival rate of 67.8% ± 15.3, cancer-specific survival rate at 5 years of 56.6% ± 16.5, and 5-year progression-free survival rate of 87.9% ± 9. There were seven (14.8%) local recurrences; two had device failure and retreatment and another had retreatment for a recurrence at 1 year after initial treatment. The ablation zone was less than 5 mm outside the margin of the tumor in five of the 47 treatments and four of these five had local recurrences. Complications primarily included 19 individuals (40%) with hemoptysis, two of which required bronchoscopy, and 24 cases (51%) of pneumothorax, one of which required surgical chest tube with prolonged placement and mechanical sclerosis. These three (6.4%) individuals were considered major complications, but 30-day mortality was zero. The authors propose that cryoablation is associated with a good overall long-term survival with minimally significant complications. Cryoablation is a potentially curative, viable therapeutic option for individuals with stage I NSCLC who are deemed medically inoperable.


The evidence on cryosurgery for lung cancer consists of studies that use cryosurgery for inoperable or metastatic disease. The available studies are small cohort studies and nonrandomized studies with relatively short-term follow-up. There is a lack of high-quality comparative studies to determine the efficacy and comparative effectiveness of cryoablation. Despite the weaknesses in the published clinical evidence, contextual factors contributing to its support include the lack of treatment alternatives and the potential for reduced harm compared to surgery.


The NCCN Guidelines on NSCLC (v3.2025) state that image-guided thermal ablation therapies such as cryotherapy may be an option for select medically inoperable individuals. Image-guided thermal ablation therapy is considered an option for the management of NSCLC lesions smaller than 3 cm, as ablation for NSCLC lesions larger than 3 cm has been associated with higher rates of local recurrence and complications.

OBSTRUCTIVE ENDOBRONCHIAL CANCER
Lung cancer is often diagnosed when it is at an advanced stage, and half of new diagnoses involve the central airways. Malignant airway obstruction causes dyspnea, cough, hemoptysis, and (as the tumor progresses) life-threatening suffocation. Treatment modalities such as external beam radiation and chemotherapy may lead to complications (e.g., endobronchial inflammation and swelling) that further compromise the airways.

Therapeutic bronchoscopic cryotherapy is an option that palliates symptoms caused by malignant airway obstruction and is now being provided more frequently in large medical centers in the United States. A cryosurgical probe, which is inserted into tumor tissue, causes rapid freeze-and-thaw cycles, resulting in tumor necrosis. Although it has been suggested that a drawback to the procedure is the need to return to the lesion to remove the necrotized material, studies have shown that, in most cases, individuals are able to expectorate it.

A large study found that 86% of individuals with advanced disease and respiratory manifestations associated with obstructive endobronchial cancer improved in one or more symptoms and quality-of-life scores when treated with endobronchial cryotherapy. Cryosurgery uses a rigid or flexible bronchoscope. General anesthesia is commonly required with the rigid bronchoscope, whereas local anesthesia may be used with the flexible bronchoscope. According to experts, the procedure is straightforward and safe; neither airway wall hemorrhage nor other major hemorrhage has been reported. Cryoablation is considered safe and efficacious in the treatment of obstructing bronchial tumors. However, cryosurgery for the treatment of lung tumors is in need of additional trials.

The National Institute for Health and Care Excellence (NICE) published guidance on the safety and efficacy of cryosurgery for malignant endobronchial obstruction. Noting that obstruction of the major airways can lead to gradual asphyxiation, the group found adequate evidence to support the use of the procedure as a palliative measure to control symptoms. It was noted that, because immediate relief is not provided, cryosurgery is not suitable for treatment of acute respiratory distress.


MICROWAVE ABLATION


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 individuals 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 (e.g., ultrasound, CT, magnetic resonance imaging) with sedation, or local or general anesthesia. This technique is also referred to as microwave coagulation therapy.

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. MWA does not rely on the conduction of electricity for heating and, therefore, does not flow electrical current through individuals 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.

Nelson et al. (2019) included 12 retrospective observational studies of MWA in individuals with primary or metastatic lung tumors. The reviewers did not pool results due to clinical and methodological heterogeneity across the studies. The studies varied with regard to participant characteristics (tumor size, histology, number of treated nodules), outcome measures, and technical experience of surgeons performing the procedures. The primary outcome was local recurrence, and survival outcomes were not assessed. Overall, local recurrence rates ranged from 9% to 37% across the studies. Newer reports and those that targeted smaller tumors showed more favorable efficacy rates. Results in individuals with multiple tumors were not reported separately. Four studies reported results by tumor size; the local recurrence rate for large tumors (>3 or 4 cm depending on the study) were 50%, 75%, 36%, and 26%. In the same four studies, for small tumors (<3 or 3.5 cm depending on the study), local recurrence rates were 19%, 18%, 18%, and 5%, respectively. The most frequent adverse event with MWA was a pneumothorax requiring a chest tube. The reviewers concluded that MWA may be a useful tool in selected individuals who are not ideal surgical candidates.


In a meta-analysis of observational studies, Yuan et al. (2019) found higher OS for individuals who received RFA compared to those who received MWA. However, these estimates were not directly comparable because they came from different sets of studies, and the reviewers concluded that percutaneous RFA and MWA were both effective with a high safety profile. The studies used different patient eligibility criteria (e.g., tumor size, lesion number, age, follow-up). Subgroup analyses by tumor size or tumor number were not possible from the data reported.

Jiang et al. (2018) conducted a network meta-analysis to determine the effectiveness of different ablation techniques in individuals with lung tumors. Tumor size, stage of the disease, and primary versus metastatic disease were not accounted for in the analysis. For MWA, weighted average OS rates were 82.5%, 54.6%, 35.7%, 29.6%, and 16.6% at 1, 2, 3, 4, and 5 years, respectively.

There is one RCT of MWA compared to RFA for lung tumors, conducted by Macchi et al. (2017). Individuals were eligible for the study if they had a single tumor up to 5 cm, and up to 5 metastases up to 5 cm. However, at baseline, the mean tumor size was 2.21 cm (standard deviation [SD], 0.89) in the MWA group and 1.64 cm (SD, 0.80) in the RFA group. Mortality rates at 6 and 12 months did not differ between groups, and complications were significantly lower in the MWA group. Limitations of this study are summarized in Tables 16 and 17 of the published study, and include its small sample size, lack of reporting on blinding, and relatively short follow-up period (12 months). Results were not reported by tumor size or the number of metastases.

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 body of evidence indicates that MWA is an effective option in individuals for whom resection is not an option. In the RCT, direct comparison of MWA and RFA in individuals 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 three 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 individuals with single tumors.

The NCCN Guidelines on NSCLC (v3.2025) state that image-guided thermal ablation therapies such as microwave may be an option for select medically inoperable individuals. Image-guided thermal ablation therapy is considered an option for the management of NSCLC lesions smaller than 3 cm as ablation for NSCLC lesions larger than 3 cm has been associated with higher rates of local recurrence and complications.


PULSED ELECTRIC FIELD ABLATION


Unlike the thermal ablation techniques described above, pulsed electric field (PEF) ablation, or irreversible electroporation, is a nonthermal technique. PEF uses electric energy to cause cell death, likely by disrupting the cellular membrane, but the exact mechanism is not well understood. PEF allows for the extracellular matrix, tumor antigens, and nearby structures (e.g., nerves, vasculature) to remain intact. This allows for a potentially safer option, while also potentially preserving (or even boosting) immune response.

 

The INUMITM Flex Needle (Galvanize Therapeutics, Redwood City, CA) received 510(k) clearance from the FDA in 2024. This device is to be used with their AliyaTM system. Both devices have been indicated for the surgical ablation of soft tissue. INUMI allows for endoscopic ablation, specifically. The NanoKnife System (AngioDynamics, Marlborough, MA) received 501(k) clearance from the FDA in 2008, indicated for surgical ablation of soft tissue. Subsequently, in 2024, the system was indicated for prostate tissue ablation.

 

Although neither device is specifically indicated for lung tumor ablation, they have both been studied for this purpose, albeit minimally.


ALIYA (AND INUMI) SYSTEMS​


The Aliya system can be used percutaneously, or bronchoscopically when INUMI is attached. Both methods are included in the subsequent review.


Jimenez et al. (2025) conducted a safety and feasibility study using Aliya for both methods (bronchoscopically or percutaneously). The trial consisted of 36 individuals with suspected or early-stage NSCLC approximately 20 days before resection. The primary safety analyses were device- and procedure-related serious adverse events from procedure date through resection. There were no device- or procedure-related adverse events. Additionally, histopathological analyses revealed resected tumors demonstrated a cellular depletion zone characterized by decrease or absence of tumor cellularity and a variable degree of inflammation.


Additional peer-reviewed publications consist of case series/reports, animal models, or studies of which lung tumors are one of many malignancies studied. Results of clinical trials, such as NCT05890872 (AFFINITY [Aliya™ Pulsed Electric Fields (PEF) for Advanced Cancer]) and NCT05555342 (A Novel Method for Treating Lung Met W/​Combo of Electric Fields & Rad Therapy) may provide additional insight into the safety and effectiveness of Aliya for lung tumor ablation.


NANOKNIFE


In 2015, Ricke et al. reported interim results of the ALICE trial, which was investigating the use of NanoKnife on lung malignancies. The trial ended early, as a result of a failure to meet the interim efficacy endpoint. Of the 23 individuals in the trial, 14 showed progressive disease at 1 year. Additional peer-reviewed publications consist of case series/reports, animal models, or studies of which lung tumors are one of many malignancies studied.

 

The NCCN Guideline on NSCLC (V3.2025) does not mention PEF ablation as a treatment option. Additionally, no other professional guideline specifically supports the use of PEF for the ablation of lung tumors.


While it appears that PEF ablation via Aliya appears safe, the effectiveness cannot be established due a lack of long-term trials studying relevant health outcomes. Additional literature is needed to understand the advantages and disadvantages of PEF ablation compared to other, established techniques.​


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Lanuti M, Sharma A, Digumarthy SR, et al. Radiofrequency ablation for treatment of medically inoperable stage I non-small cell lung cancer. J Thorac Cardiovasc Surg. 2009;137(1):160-166.

Lee H, Jin GY, Han YM, et al. Comparison of survival rate in primary non-small-cell lung cancer among elderly patients treated with radiofrequency ablation, surgery, or chemotherapy. Cardiovasc Intervent Radiol. 2012;35(2):343-350.

Lee JM, Jin GY, Goldberg SN, et al. Percutaneous radiofrequency ablation for inoperable non-small cell lung cancer and metastases: preliminary report. Radiology. 2004;230(1):125-134.

Lee SH, Choi WJ, Sung SW, et al. Endoscopic cryotherapy of lung and bronchial tumors: a systematic review. Korean J Intern Med. 2011;26(2):137-144.

Lencioni R, Crocetti L, Cioni R, et al. Response to radiofrequency ablation of pulmonary tumours: a prospective, intention-to-treat, multicentre clinical trial (the RAPTURE study). Lancet Oncol. 2008;9(7):621-628.

Liapi E, Geschwind JF. Transcatheter and ablative therapeutic approaches for solid malignancies. J Clin Oncol. 2007;25(8):978-986.

 

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. 2017;34(5):96.


Maiwand MO, Asimakopoulos G. Cryosurgery for lung cancer: clinical results and technical aspects. Technol Cancer Res Treat. 2004;3(2):143-150.

Mathur PN, Wolf KM, Busk MF, et al. Fiberoptic bronchoscopic cryotherapy in the management of tracheobronchial obstruction. Chest. 1996;110(3):718-723.

MLN Matters. Hospital Outpatient Prospective Payment System: April 2025 Update. Available at: https://www.cms.gov/files/document/mm13993-hospital-outpatient-prospective-payment-system-april-2025-update.pdf Accessed April 21, 2025.


Moore W, Talati R, Bhattacharji P, et al. Five-year survival after cryoablation of stage I non-small cell lung cancer in medically inoperable patients. J Vasc Interv Radiol. 2015;26(3):312-319.


Murphy MC, Wrobel MM, Fisher DA, et al. Update on Image-Guided Thermal Lung Ablation: Society Guidelines, Therapeutic Alternatives, and Postablation Imaging Findings. AJR Am J Roentgenol. 2022;219(3):471-485. Available at: Update on Image-Guided Thermal Lung Ablation: Society Guidelines, Therapeutic Alternatives, and Postablation Imaging Findings | AJR (ajronline.org). Accessed April 21, 2025.


Nakamura T, Matsumine A, Yamakado K, et al. Lung radiofrequency ablation in patients with pulmonary metastases from musculoskeletal sarcomas [corrected]. Cancer. 2009;115(16):3774-3781.


National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Non-small cell lung cancer. v.5.2024. [NCCN Web site]. 03/16/2022. Available at: Login (nccn.org) (via subscription only). Accessed April 21, 2025.

National Institute for Health and Care Excellence (NICE). Interventional Procedure Guidance (IPG). IPG 142: Cryosurgery for malignant endobronchial obstruction. [NICE Web site]. 11/01/2005. Available at: http://guidance.nice.org.uk/IPG142Accessed April 21, 2025.


National Institute for Health and Care Excellence (NICE). Interventional Procedure Guidance (IPG). IPG 372: Percutaneous radiofrequency ablation for primary or secondary lung cancers. [NICE Web site]. 12/15/2010 (last update June 2, 2012). Available at: https://www.nice.org.uk/guidance/ipg372 /chapter/1-GuidanceAccessed April 21, 2025.


National Institute for Health and Care Excellence (NICE). Microwave ablation for primary or metastatic cancer in the lung [IPG716]. 2022. Available at: Overview | Microwave ablation for primary or metastatic cancer in the lung | Guidance | NICE . Accessed April 21, 2025.

Nelson DB, Tam AL, Mitchell KG, et al. Local Recurrence After Microwave Ablation of Lung Malignancies: A Systematic Review. Ann Thorac Surg. 2019;107(6):1876-1883. 


Niu L, Xu K, Mu F. Cryosurgery for lung cancer. J Thorac Dis. 2012;4(4):408-419.


Noppen M, Meysman M, Van Herreweghe R, et al. Bronchoscopic cryotherapy: preliminary experience. Acta Clin Belg. 2001;56(2):73-77.

Okuma T, Matsuoka T, Yamamoto A, et al. Determinants of local progression after computed tomography-guided percutaneous radiofrequency ablation for unresectable lung tumors: 9-year experience in a single institution. Cardiovasc Intervent Radiol. 2010;33(4):787-793.

Onishi H, Shirato H, Nagata Y, et al. Hypofractionated stereotactic radiotherapy (HypoFXSRT) for stage I non-small cell lung cancer: updated results of 257 patients in a Japanese multi-institutional study. J Thorac Oncol. 2007;2(7 Suppl 3):S94-100.


Pastori C, Nafie EHO, Wagh MS, Mammarappallil JG, Neal RE 2nd. Pulsed Electric Field Ablation versus Radiofrequency Thermal Ablation in Murine Breast Cancer Models: Anticancer Immune Stimulation, Tumor Response, and Abscopal Effects. J Vasc Interv Radiol. 2024;35(3):442-451.e7.

Palussière J, Italiano A, Descat E, et al. Sarcoma Lung Metastases Treated with Percutaneous Radiofrequency Ablation: Results from 29 Patients. Ann Surg Oncol. 2011;18(13):3771-3777.

Pennathur A, Abbas G, Gooding WE, et al. Image-guided radiofrequency ablation of lung neoplasm in 100 consecutive patients by a thoracic surgical service. Ann Thorac Surg. 2009;88(5):1601-1606.

Pennathur A, Abbas G, Qureshi I, et al. Radiofrequency ablation for the treatment of pulmonary metastases. Ann Thorac Surg. 2009;87(4):1030-1036.

Pennathur A, Luketich JD, Abbas G, et al. Radiofrequency ablation for the treatment of stage I non-small cell lung cancer in high-risk patients. J Thorac Cardiovasc Surg. 2007;134(4):857-864.

Pereira PL, Masala S; Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Standards of practice: guidelines for thermal ablation of primary and secondary lung tumors. Cardiovasc Intervent Radiol. 2012;35(2):247-254.

Physician Data Query (PDQ). General Information about Non-Small Cell Lung Cancer (NSCLC) (PDQ®). 05/08/2024. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-lung/HealthProfessionalAccessed April 21, 2025.

Ratko TA, Vats V, Brock J et al. Local Nonsurgical Therapies for Stage I and Symptomatic Obstructive Non-Small-Cell Lung Cancer. Rockville (MD); Agency for Healthcare Research and Quality, June 2013.


Ricke J, Jürgens JH, Deschamps F, et al. Irreversible electroporation (IRE) fails to demonstrate efficacy in a prospective multicenter phase II trial on lung malignancies: the ALICE trial. Cardiovasc Intervent Radiol. 2015;38(2):401-408. doi:10.1007/s00270-014-1049-0.

Rose SC, Thistlethwaite PA, Sewell PE, Vance RB. Lung cancer and radiofrequency ablation. J Vasc Interv Radiol. 2006;17(6):927-951.

Rossi S, Dore R, Cascina A, et al. Percutaneous computed tomography-guided radiofrequency thermal ablation of small unresectable lung tumours. Eur Respir J. 2006;27(3):556-563.


Rouhezamin MR, Fintelmann FJ, Huang AJ, et al. Limited Effectiveness in Early Human Clinical Experience with Pulsed Electrical Field Ablation. J Vasc Interv Radiol. 2025;36(2):274-281.

Sanderson DR, Neel HB, Fontana RS. Bronchoscopic cryotherapy. Ann Otol Rhinol Laryngol. 1981;90(4 Pt 1):354-358.

Sano Y, Kanazawa S, Gobara H, et al. Feasibility of percutaneous radiofrequency ablation for intrathoracic malignancies: a large single-center experience. Cancer. 2007;109(7):1397-1405.

Schlijper RC, Grutters JP, Houben R, et al. What to choose as radical local treatment for lung metastases from colo-rectal cancer: Surgery or radiofrequency ablation? Cancer Treat Rev. 2014;40(1):60-67.

Scott WJ, Howington J, Feigenberg S, et al.; American College of Chest Physicians. Treatment of non-small cell lung cancer stage I and stage II ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007;132(3 Suppl):234S-242S.

Sher DJ, Wee JO, Punglia RS. Cost-effectiveness analysis of stereotactic body radiotherapy and radiofrequency ablation for medically inoperable, early-stage non-small cell lung cancer. Int J Radiat Oncol Biol Phys. 2011;81(5):e767-74.

Shu Yan Huo A, Lawson Morris D, King J, et al. Use of percutaneous radiofrequency ablation in pulmonary metastases from renal cell carcinoma. Ann Surg Oncol. 2009;16(11):3169-3175.

Simoff MJ. Endobronchial management of advanced lung cancer. Cancer Control. 2001;8(4):337-343.

Simon CJ, Dupuy DE, DiPetrillo TA, et al. Pulmonary radiofrequency ablation: long-term safety and efficacy in 153 patients. Radiology. 2007;243(1):268-335.

Soga N, Yamakado K, Gohara H, et al. Percutaneous radiofrequency ablation for unresectable pulmonary metastases from renal cell carcinoma. BJU Int. 2009;104(6):790-794.

Steinke K, Glenn D, King J, et al. Percutaneous imaging-guided radiofrequency ablation in patients with colorectal pulmonary metastases: 1-year follow-up. Ann Surg Oncol. 2004;11(4):207-212.

Steinke K, Sewell PE, Dupuy D, et al. Pulmonary radiofrequency ablation - an international study survey. Anticancer Res. 2004;24(1):339-343.

Suh R, Reckamp K, Zeidler M, Cameron R. Radiofrequency ablation in lung cancer: promising results in safety and efficacy. Oncology (Williston Park). 2005;19(11Suppl 4):12-21.

Suh RD, Wallace AB, Sheehan RE, et al. Unresectable pulmonary malignancies: CT-guided percutaneous radiofrequency ablation--preliminary results. Radiology. 2003;229(3):821-829.

Tanoue LT, Gettinger S. Treatment of lung cancer in older patients. Clin Chest Med. 2007;28(4):735-749.

Thanos L, Mylona S, Pomoni M, et al. Percutaneous radiofrequency thermal ablation of primary and metastatic lung tumors. Eur J Cardiothorac Surg. 2006;30(5):797-800.

Thanos L, Mylona S, Ptohis N, et al. Percutaneous radiofrequency thermal ablation in the management of lung tumors: presentation of clinical experience on a series of 35 patients. Diagn Interv Radiol. 2009;15(4):290-296.

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Wood DE. Management of malignant tracheobronchial obstruction. Surg Clin North Am. 2002;82(3):621-642.

Yamagami T, Kato T, Hirota T, et al. Risk factors for occurrence of local tumor progression after percutaneous radiofrequency ablation for lung neoplasms. Diagn Interv Radiol. 2007;13(4):199-203.

Yamakado K, Hase S, Matsuoka T, et al. Radiofrequency ablation for the treatment of unresectable lung metastases in patients with colorectal cancer: a multicenter study in Japan. J Vasc Interv Radiol. 2007;18(3):393-398.

Yamakado K, Inoue Y, Takao M, et al. Long-term results of radiofrequency ablation in colorectal lung metastases: single center experience. Oncol Rep. 2009;22(4):885-891.

Yan TD, King J, Ebrahimi A, et al. Hepatectomy and lung radiofrequency ablation for hepatic and subsequent pulmonary metastases from colorectal carcinoma. J Surg Oncol. 2007;96(5):367-373.

 

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; 16(3): 302-314.

 

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Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY

31641, 32994, 32998

EXERIMENTAL/INVESTIGATIONAL

0600T, 0601T

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)

​C34.01Malignant neoplasm of right main bronchus
C34.02Malignant neoplasm of left main bronchus
C34.11Malignant neoplasm of upper lobe, right bronchus or lung
C34.12Malignant neoplasm of upper lobe, left bronchus or lung
C34.2Malignant neoplasm of middle lobe, bronchus or lung​
C34.31Malignant neoplasm of lower lobe, right bronchus or lung
C34.32Malignant neoplasm of lower lobe, left bronchus or lung
C34.81Malignant neoplasm of overlapping sites of right bronchus and lung
C34.82Malignant neoplasm of overlapping sites of left bronchus and lung
C34.91Malignant neoplasm of unspecified part of right bronchus or lung
C34.92Malignant neoplasm of unspecified part of left bronchus or lung
C7A.090​Malignant carcinoid tumor of the bronchus and lung
C78.01 Secondary malignant neoplasm of right lung
C78.02 Secondary malignant neoplasm of left lung



HCPCS Level II Code Number(s)
EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE REPRESENTS PULSED ELECTRIC FIELD ABLATION OF LUNG TUMORS
C8005 Bronchoscopy, rigid or flexible, non-thermal transbronchial ablation of lesion(s) by pulsed electric field (pef) energy, including fluoroscopic and/or ultrasound guidance, when performed, w ith computed tomography acquisition(s) and 3d rendering, computer-assisted, image-guided navigation, and endobronchial ultrasound (ebus) guided transtracheal and/or transbronchial sampling (e.g., aspiration[s]/biopsy[ies]) of lung(s) and all mediastinal and/or hilar lymph node stations or structures, and therapeutic intervention(s)


Revenue Code Number(s)
N/A




Coding and Billing Requirements


Policy History

Revisions From 11.00.16k
01/01/2026

​​This policy has been identified and updated for the HCPCS/CPT code update effective 01/01/2026.

The following CPT code narrative has been revised​:
0600T

The following HCPCS​ ​code has been termed​:
C9751

​Revisions From 11.00.16j:​
07/28/2025

​​This version of the policy will become effective 07/28/2025.

The intent of this policy remains unchanged; however, t
he following criterion has been added to this policy for Pulsed Electric Field ablation as experimental/investigational:​​
  • Pulsed electric field ablation (i.e., irreversible electroporation) of lung tumors is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by a review of the available peer-reviewed published literature.
​In addition, the title of this policy was revised.

Title Change: Ablation of Lung Tumors

The following HCPCS and CPT codes have been added​ to the policy as experimental/investigational:
C8005​ 
Bronchoscopy, rigid or flexible, non-thermal transbronchial ablation of lesion(s) by pulsed electric field (pef) energy, including fluoroscopic and/or ultrasound guidance, when performed, w​ith computed tomography acquisition(s) and 3d rendering, computer-assisted, image-guided navigation, and endobronchial ultrasound (ebus) guided transtracheal and/or transbronchial sampling (e.g., aspiration[s]/biopsy[ies]) of lung(s) and all mediastinal and/or hilar lymph node stations or structures, and therapeutic intervention(s)

0600T, 0601T

Revisions From 11.00.16i:
08/26/2024

​​This version of the policy will become effective 08/26/2024.

The intent of this policy remains unchanged; however, the criteria for radiofrequency ablation was revised to clarify when this service is considered medically necessary for primary and metastatic pulmonary tumors. 

The following ICD-10 codes were removed from this policy: 

C34.00 Malignant neoplasm of unspecified main bronchus

C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung

C78.00 Secondary malignant neoplasm of unspecified lung


Revisions From 11.00.16h:
​08/23/2023
This policy has been reissued in accordance with the Company's annual review process.
08/15/2022

​​This version of the policy will become effective 08/15/2022.

The intent of this policy remains unchanged, however, t
he following criteria has been added to this policy for Microwave Ablation:
  • ​​Microwave ablation is considered medically necessary and, therefore, covered for the treatment of a primary or metastatic single lung tumor (of less than or equal to 3 cm) when the tumor is unresectable due to location of the lesion and/or comorbid conditions.​
In addition, the Title of this policy was revised to incorporate Microwave Ablation.
Title Change: Radiofrequency, Cryosurgical and Microwave Ablation of Lung Tumors

Revisions From 11.00.16g:
11/03/2021

​​The policy has been reviewed and reissued to communicate the Company’s continuing position on Radiofrequency Ablation and Cryosurgical Ablation of Lung Tumors​.​
​11/04/2020

The policy has been reviewed and reissued to communicate the Company’s continuing position on Radiofrequency Ablation and Cryosurgical Ablation of Lung Tumors​.​
​12/18/2019

This policy has been reissued in accordance with the Company's annual review process.
​04/09/2018
This policy has undergone a routine review, and the coverage position for cryosurgical ablation for lung cancer has been revised from experimental/investigational to medically necessary with the following associated criterion: 
  • The individual has early-stage non-small cell lung cancer and is a poor surgical candidate
 
Revisions From 11.00.16f:
01/01/2018This policy has been identified for the CPT code update, effective 01/01/2018.

The following CPT code has been termed from this policy: 0340T
The following CPT has been added to this policy: (experimental/investigational) 32994
The following CPT code narrative has been revised in this policy: 32998

Effective 10/05/2017 this policy has been updated to the new policy template format.
1/1/2026
1/2/2026
11.00.16
Medical Policy Bulletin
Commercial
No