Medical policy: Radiofrequency Ablation of Thyroid Tumors

Número de política: MP 1.165

Fecha de entrada en vigor: 5/1/2026

Política

Radiofrequency ablation is considered medically necessary for symptomatic nonfunctioning thyroid nodules when all of the following are met:

• Nodule causes compressive symptoms (i.e., pain, difficulty breathing or swallowing or hoarseness); and
• Nodule has been confirmed to be benign as evidenced by one of the following:
  • Benign cytology on two fine needle or core biopsies; or
  • Benign cytology on a fine needle or core biopsy and nodule is considered low to intermediate risk

Radiofrequency ablation is considered medically necessary for autonomously functioning thyroid nodule (AFTN) when all of the following criteria are met:

• Subclinical or overt hyperthyroidism; and
• Radioactive uptake scan confirmation of a hyperfunctioning nodule; and
• Nodule has been confirmed to be benign as evidenced by one of the following:
  • Benign cytology on two fine needle or core biopsies; or
  • Benign cytology on a fine needle or core biopsy and nodule is considered low to intermediate risk

Radiofrequency ablation is considered investigational for all other thyroid indications not meeting the above criteria, including thyroid carcinoma. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure for these indications.

Directrices de la política

The American Thyroid Association (ATA) statement on the general principles regarding ablation of benign thyroid nodules lists minimum necessary criteria:

• Dominant nodule contributing to cosmetic or compressive disturbance; or autonomously functioning nodule causing subclinical or clinical hyperthyroidism
• Benign cytology on fine needle or core biopsy
• Ultrasound risk stratification for malignancy categorized as very low to intermediate
• Lack of personal risk factors for malignancy
• Clear comprehension and realistic expectations of the ablation procedure, expected outcomes, potential complications, and alternatives

Thyroid nodules categorized at ultrasound examination as very low or low suspicion of malignancy according to the ATA classification system and nodules classified as intermediate suspicion according to the ATA (class 4) with benign cytology can be considered candidates for ablation, provided cytology is benign.

Two benign biopsies are usually recommended. A single benign biopsy may be sufficient for:

• Nodules with very low sonographic suspicion
• Autonomously functioning nodules with low to intermediate sonographic suspicion

An American Association of Clinical Endocrinology (AACE) clinical review of minimally invasive interventional procedures states that a thyroid nodule's benign nature should be defined by two ultrasound-guided Bethesda II fine-needle aspirations (FNAs) or one FNAC and one benign core needle biopsy (CNB). Autonomously functioning nodules and American Thyroid Association low- or very-low-risk nodules could be ablated after one Bethesda II FNAC or a benign CNB.

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/antecedentes

The optimal therapy for patients with thyroid nodules varies with the lesion that is found and whether or not it is functioning.

Symptomatic nonfunctioning benign thyroid nodules

The majority of benign thyroid nodules are asymptomatic, with symptomatic cases often attributed to their size or anatomical location. Compressive or obstructive symptoms may include dysphagia, dyspnea, neck pressure, foreign body sensation, pain or a cough. While benign thyroid nodules smaller than 2 centimeters generally cause symptoms. The goal of thermal ablation treatment is to reduce nodule size and promote resolution of symptoms. The primary objective of thermal ablation is to decrease nodule size and facilitate the resolution of associated symptoms.

Autonomously functioning thyroid nodule (AFTN)

AFTNs are benign nodules that produce thyroid hormones without the regulation of thyroid stimulating hormone (TSH). AFTNs can result in hyperthyroidism even when TSH levels are low or normal. Hyperthyroidism affects approximately 1.2% of the United States, with 0.5% of cases categorized as overt and 0.7% categorized as subclinical (Doubleday, 2020). AFTNs are cases frequently identified through scintigraphy showing increased radioactive iodine uptake. Common causes of hyperthyroidism include Graves' disease, non-toxic nodular goiters and toxic adenomas. The presence of an AFTN is the second most common cause of hyperthyroidism. The standard therapy options of AFTNs are surgery or radioactive iodine ablation (RAI).

The 2022 international consensus statement document (Orloff) includes a recommendation that ablation procedures may be used as a first-line alternative to surgery in individuals with benign thyroid nodules. This recommendation is based upon individual international guideline documents. The document notes that thermal ablation procedures can be a safe alternative to treat AFTNs in individuals with contraindications to first-line therapies.

Fundamento

Radiofrequency ablation (RFA) is the most studied thyroid lesion ablative technique. Cerit and associates (2023) compared the efficacy of two ablative techniques in treating individuals with benign thyroid nodules. Individuals were treated with RFA (n=37) or MWA (n=43). The primary comparison endpoint was the efficacy at reducing the volume nodules at 1, 3, 6 and 12 months post-procedure. The RFA group reported significantly higher volume reduction rates, compared to the MWA group (77.9% vs. 65%, p<0.001, respectively). The authors concluded that both RFA and MWA are effective in treating benign thyroid nodules, but RFA provides superior volume reduction.

Dossing and colleagues (2019) reported on the long-term efficacy of laser therapy to treat benign complex thyroid nodules. Individuals with recurrent cytologically benign cystic thyroid nodules causing local discomfort were treated with laser therapy. Follow-up was completed at 1, 3 and 6 months after treatment, then annually. Following laser therapy, 17% (19/110) underwent surgery due to dissatisfaction with the laser ablation results. The median follow-up in the nonsurgical group was 45 months (12-134 months). In the individuals who did not undergo surgery, the overall median nodule volume decreased by 85% over the course of follow-up.

In a retrospective review, Pacella and colleagues (2015) reported on the effectiveness, tolerability, and complications associated with laser ablation therapy. One hundred individuals with solid or mixed nodules treated with laser ablation were included (n=1531). The mean nodule volume reduction was 72% ± 11% (range 48%-96%) at 12 months after treatment. The authors reported 17 complications, 8 of them categorized as major and 9 categorized as minor.

In a retrospective review, Cervelli and associates (2019) compared the efficacy of RFA and radioactive iodine (RAI) in treating AFTNs. Individuals with a single AFTN treated with RFA (n=25) or RAI (n=25) were treated in a single session. The primary outcome was normalizing thyroid function and reducing nodule volume over 12 months. At 12 months, RFA reduced nodule volume by 79.7% and had a lower incidence of hypothyroidism requiring hormone replacement (n=1) compared to RAI (20%-32% risk of hypothyroidism and a 68.4% volume reduction).

Las pruebas son suficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definitions/background

Autonomously functioning nodule refers to a nodule that secretes thyroid hormones independent of thyroid stimulating hormone (TSH), resulting in excess thyroid hormone (hyperthyroidism). (Also known as a hyperfunctioning, toxic or hot nodule.)

Radiofrequency ablation (RFA) is a surgical procedure where cancerous or diseased cells are destroyed using heat produced by high-frequency radio waves.

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios del miembro, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: Es posible que esta lista de códigos no sea exhaustiva y que los códigos estén sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

RFA for benign thyroid nodules is medically necessary when criteria is met:

Referencias

1. Sinclair C, Baek JH, Hands KE, et al. General principles for the safe performance, training, and adoption of ablation techniques for benign thyroid nodules: An American Thyroid Association statement. Thyroid. 2023;33(10):1150-1170. doi:10.1089/thy.2023.0281
2. Haugen BR, Alexander EK, Bible KC, et al. 2015 American Thyroid Association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer: The American Thyroid Association guidelines task force on thyroid nodules and differentiated thyroid cancer. Thyroid. 2016;26(1):1-133. doi:10.1089/thy.2015.0020
3. Orloff LA, Noel JE, Stack BC Jr, et al. Radiofrequency ablation and related ultrasound-guided ablation technologies for treatment of benign and malignant thyroid disease: An international multidisciplinary consensus statement of the American Head and Neck Society, Asia Pacific Society of Thyroid Surgery, Associazione Medici Endocrinologi, British Association of Endocrine and Thyroid Surgeons, European Thyroid Association, Italian Society of Endocrine Surgery Units, Korean Society of Thyroid Radiology, Latin American Thyroid Society, and Thyroid Nodules Therapies Association. Head Neck. 2022;44(3):633-660.
4. Noel JE, Sinclair CF. Radiofrequency ablation for benign thyroid nodules. J Clin Endocrinol Metab. 2023;109(1):e12-e17. doi:10.1210/clinem/dgad357
5. American Association of Clinical Endocrinology Disease State Clinical Review: The Clinical Utility of Minimally Invasive Interventional Procedures in the Management of Benign and Malignant Thyroid Lesions.
6. Lui MS, Patel KN. Current guidelines for the application of radiofrequency ablation for thyroid nodules: a narrative review. Gland Surg. 2024;13(1):59-69.
7. Pappal E, Moppessnin F, Rasuli H, Hegedus L. 2020 European Thyroid Association Clinical Practice Guideline for the Use of Image-Guided Ablation in Benign Thyroid Nodules. Eur Thyroid J.
8. American College of Radiology. ACR Thyroid Imaging Reporting and Data System (TI-RADS). ACR. Published 2025.
9. Cerit MN, Yücel C, Cerit ET, et al. Comparison of the efficiency of radiofrequency and microwave ablation methods in the treatment of benign thyroid nodules. Acad Radiol. 2023;30(10):2172-2180.
10. Dossing H, Bennedbæk FN, Hegedüs L. Long-term outcome following laser therapy of benign cystic-solid thyroid nodules. Endocr Connect. 2019;8(7):846-852.
11. Pacella CM, Mauri G, Achille G, et al. Outcomes and risk factors for complications of laser ablation for thyroid nodules: a multicenter study on 1531 patients. J Clin Endocrinol Metab. 2015; 100(10):3903-3910.
12. Cervelli R, Mazzeo S, Boni G, et al. Comparison between radioiodine therapy and single-session radiofrequency ablation of autonomously functioning thyroid nodules: a retrospective study. Clin Endocrinol (Oxf). 2019;90(4):608-616.
13. Chung SR, Suh CH, Baek JH, et al. Safety of radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: a systematic review and meta-analysis. Int J Hyperthermia. 2017;33(8):920-930.
14. Instituto Nacional para la Salud y la Excelencia Asistencial (NICE). Ultrasound-guided percutaneous radiofrequency ablation for benign thyroid nodules. IPG562. 2016.
15. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Thyroid Carcinoma. Version 1.2025.