Coverage Policy Manual
Policy #: 2001011
Category: Medicine
Initiated: April 2001
Last Review: May 2023
  Radiofrequency Ablation, Osteoid Osteoma
Description:
Osteomas are the most common benign bone tumor, comprising 10% to 20% of benign and 2% to 3% of all bone tumors. They are typically seen in children and young adults, with most diagnosed in patients between 5 and 20 years of age. Osteomas are most common in the lower extremity (usually the long bones, mainly the femur) and less common in the spine. These tumors typically have a characteristic clinical presentation and radiologic appearance, with pain that is usually continuous and worse at night and commonly relieved by aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). The natural history of the osteoid osteoma varies based on location, and although they rarely exceed 1.5 cm in diameter, may produce bone widening and deformation, limb length inequality, or angular deviations when near a growth plate. When located in the spine, these lesions may lead to painful scoliosis or torticollis. Sometimes they heal spontaneously after 3 to 7 years.
 
Treatment options include medical management with NSAIDs, surgical excision (wide/en bloc excision or curetting), or the use of computed tomography (CT)- or magnetic resonance imaging-guided minimally invasive procedures including core drill excision, laser photocoagulation, or RFA. For many years, complete surgical excision was the classic treatment of osteomas, usually performed in patients with pain despite medical management. However, a substantial incision may be necessary, with the removal of a considerable amount of bone (especially in the neck of the femur). This increases the need for bone grafting plus internal fixation (which often necessitates a second procedure to remove the metalwork). Other possible risks include avascular necrosis of the femoral head and postoperative pathologic fracture. In addition, surgical excision leads to a lengthier convalescence and postoperative immobilization. Anatomically inaccessible tumors may not be completely resectable and may recur. RFA of osteoid osteoma is done with a needle puncture, so no incision or sutures are needed; further, patients may immediately walk on the treated extremity and return to daily activities when the anesthetic effect wears off. The risk of recurrence with RFA of an osteoma is 5% to 10%, and recurrent tumors can be retreated with RFA. In general, RFA is not performed in many spinal osteomas because of possible thermal-related nerve damage.
Policy/
Coverage:
Effective May 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Radiofrequency ablation of osteoid osteoma for the treatment of painful lesions of long bones that cannot be managed successfully with medical treatment meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Radiofrequency ablation of osteoid osteoma for any indication not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, radiofrequency ablation of osteoid osteoma for any indication not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
Effective prior to May 2021
Radiofrequency ablation of osteoid osteoma meets primary coverage criteria for effectiveness and is covered for the treatment of painful lesions of long bones, refractory to medical management.
Rationale:
2008 Update
Review of peer reviewed medical literature through July 2008 provided no information which would change the above coverage policy.
 
2012 Update
A literature search was conducted through April 2012, on the use of radiofrequency ablation of osteoid osteomas. There was no new information identified that would prompt a change in the coverage statement.
 
2013 Update
A literature search was conducted through April 2013. One new study was identified that supported the existing coverage statement. In 2012, Rimondi and colleagues reported on a retrospective study of 557 patients treated with CT-guided RFA as primary treatment for non-spinal osteoid osteomas (Rimondi, 2012). All patients were followed for a mean of 3.5 years (0.5-9 years). Pain relief occurred in all 557 patients within the first week after RFA and continued in 533 patients (96%) who remained asymptomatic through their last follow-up. Pain recurrence occurred in 24 patients (4%). Complications occurred in 5 patients and included thrombophlebitis, a skin burn, a broken electrode and 2 procedures in which the RFA generator didn’t reach maximum temperature.
 
2014 Update
A literature search conducted through April 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted using the MEDLINE database through April 2015 did not reveal any new information that would prompt a change in the coverage statement.
    
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Clinical Studies
An observational study published in 2015 evaluated long-term clinical outcomes after computed tomography (CT)􀯅guided RFA in patients diagnosed with osteoid osteoma located in the upper and lower extremities (Knudsen, 2015).  The study population included 52 patients with a typical clinical history and radiologically confirmed osteoid osteoma who received CT-guided RFA treatment from 1998 to February 2014 at Aarhus University Hospital, Denmark. The clinical outcome was evaluated based on patient-reported outcome measures and medical record review. The response rate was 52 of 60 (87%). After 1 RFA treatment 46 of 52 (88%) of the patients experienced pain relief, and 51 of 52 (98%) of the patients had pain relief after re-RFA. One patient underwent open resection after RFA. No major complications were reported; 4 patients reported minor complications including small skin burn, minor skin infection and hypoesthesia at the entry point. In all, 50 of 52 (96%) patients were reported to be "very satisfied" with the RFA treatment.
 
Other Miscellaneous Tumors
A large series in 2015 evaluated the effectiveness and safety of RFA for uterine myomas in a 10-year retrospective cohort study (Yin, 2015).  From July 2001 to July 2011, a total of 1216 patients treated for uterine myomas were divided into 2 groups. Group A consisted of 476 premenopausal patients (average age 36±8 years) who had an average 1.7±0.9 myomas with average diameter of 4.5±1.5 cm. Group B consisted of 740 menopausal patients (average age, 48±4 years) with an average 2.6±1.3 myomas with average diameter of 5.0±2.5 cm. Patients were followed for a mean of 36±12 months. At 1, 3, 6, 12, and
24 months after RFA, the average diameters of myomas in group A were 3.8, 3.0, 2.7, 2.4, and 2.2 cm, respectively; 48% (227/476) of patients had residual tumor at 12 months after RFA. In group B, myoma diameters were 4.7, 3.7, 3.3, 2.3, and 2.3 cm, respectively; 59% (435/740) of patients had trace disease at 12 months after RFA. Three months after treatment, myoma volumes were significantly reduced in both the groups (p<0.01), although group B had a higher rate of residual tumor at 12 months after RFA than group A (p<0.05). Clinical symptoms and health-related quality of life were significantly improved after RFA in both groups. The postoperative recurrence rate of uterine myomas was significantly higher in group A at 10.7% (51/476) than group B at 2.4% (18/740; p<0.05).
 
A recent systematic review examined studies of ablative therapies, including RFA, in patients with locally advanced pancreatic cancer (Rombouts, 2015).  No RCTs were identified in this review, and conclusions are limited by the sparse evidence available on RFA in this setting.
 
2017 Update
A literature search conducted through March 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
PRACTICE GUIDELINES AND POSITION STATEMENTS
NICE guidance issued in 2016 stated “Current evidence on the safety and efficacy of ultrasound‑guided percutaneous radiofrequency ablation for benign thyroid nodules is adequate to support the use of this procedure….” (Nice, 2016).
 
2019 Update
A literature search was conducted through April 2019.  There was no new information identified that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Retrospective Studies
In their retrospective study of the efficacy and complications of computed tomography (CT)-guided RFA of spinal osteoid osteoma, Albisinni et al concluded that CT-guided RFA is effective as first-line therapy for the disease (Albisinni, 2017). After RFA, clinical symptoms were evaluated at 3, 6, and 12 months, with a final evaluation at the end of the study. Results showed that complete regression of osteoid osteoma symptoms in 57 (93.4%) of 61 (p=0.001) for patients observed between 2002 and 2012. Study limitations included the retrospective design and focus on a single treatment.
 
Lassalle et al conducted a single-center retrospective analysis of long-term outcomes for CT-guided RFA in 126 patients with suspected osteoid osteoma (Lassalle, 2017). The study was conducted from 2008 to 2015. Phone evaluations were performed. The overall success rate was 94.3% among the 88 patients who participated in the follow-up calls. The study was limited by its retrospective design, imprecision of patients’ memory over follow-up, the lack of clinical and imaging follow-up, and an inability to perform multivariate statistical analysis of factors associated with treatment failure.
 
Rimondi et al reported on a retrospective study of 557 patients treated with CT-guided RFA as primary treatment for nonspinal osteoid osteomas (Rimondi, 2012). All patients were followed for a mean of 3.5 years (range, 0.5-9 years). Pain relief occurred in all 557 patients within the first week after RFA and continued in 533 (96%) patients who remained asymptomatic through their last follow-up. Pain recurrence occurred in 24 (4%) patients. Complications occurred in 5 patients and included thrombophlebitis, skin burn, broken electrode, and 2 procedures in which the RFA generator failed to reach maximum temperature.
 
2020 Update
A literature search was conducted through April 2020.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Tordjman et al conducted a systematic review on CT-guided RFA for osteoid osteomas (Tordjman, 2020). The review included 69 studies (43 retrospective and 12 prospective studies; rest of study designs were not identifiable) comprising 3,023 patients. The weighted overall failure rate was 8.3% for the entire cohort. When studies were analyzed by time period conducted the failure rate was significantly lower in studies conducted between 2011 and 2019 compared to those conducted between 2002 and 2010 (7% vs 14%, p=0.004). The complication rate for the entire cohort was 3%, with skin burns (0.7%) and infections (0.5%) as the most commonly reported.
 
Sahin et al conducted a single-center retrospective study that evaluated clinical pain symptoms to demonstrate the rapid relief of pain symptoms after CT-guided RFA for osteoid osteomas (Sahin, 2019). A total of 116 patients were included and the efficacy success rate in the study was 98%. All patients reported immediate pain relief following the procedure, with scores of 0 or 1 on a 10-point visual analog pain scale within 24 hours. Mean duration of follow-up was 23 months and pain relapse was reported in 2 of 108 patients available for follow-up. Seven minor complications were reported after the procedure with superficial skin burns as the most common complication (n=4).
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
20982Ablation therapy for reduction or eradication of 1 or more bone tumors (eg, metastasis) including adjacent soft tissue when involved by tumor extension, percutaneous, including imaging guidance when performed; radiofrequency
References: Albisinni U, Facchini G, Spinnato P, et al.(2017) Spinal osteoid osteoma: efficacy and safety of radiofrequency ablation. Skeletal Radiol. Aug 2017;46(8):1087-1094. PMID 28497160

Barei DP, Moreau G, Scarborough MT, et al.(2000) Percutaneous radiofrequency ablation of osteoid osteoma. Clinical Orthopaedics and Related Research 2000; 343:115-124.

de Berg JC, Pattynama PMT, Obermann WR, et al.(1995) Percutaneous computed-tomography-guided thermocoagulation for osteoid osteomas. Lancet 1995; 346:350-351.

Knudsen M, Riishede A, Lucke A, et al.(2015) Computed tomography-guided radiofrequency ablation is a safe and effective treatment of osteoid osteoma located outside the spine. Dan Med J. May 2015;62(5). PMID 26050823

Lassalle L, Campagna R, Corcos G, et al.(2017) Therapeutic outcome of CT-guided radiofrequency ablation in patients with osteoid osteoma. Skeletal Radiol. Jul 2017;46(7):949-956. PMID 28429047

National Institute for Health and Care Excellence (NICE).(2016) Ultrasound-guided percutaneous radiofrequency ablation for benign thyroid nodules [IPG562). https://www.nice.org.uk/guidance/IPG562/chapter/1-Recommendations. Accessed August 23, 2017.

Rimondi E, Mavrogenis AF, Rossi G et al.(2012) Radiofrequency ablation for non-spinal osteoid osteomas in 557 patients. Eur Radiol 2012; 22(1):181-8.

Rimondi E, Mavrogenis AF, Rossi G, et al.(2012) Radiofrequency ablation for non-spinal osteoid osteomas in 557 patients. Eur Radiol. Jan 2012;22(1):181-188. PMID 21842430

Rombouts SJ, Vogel JA, van Santvoort HC, et al.(2015) Systematic review of innovative ablative therapies for the treatment of locally advanced pancreatic cancer. Br J Surg. Feb 2015;102(3):182-193. PMID 25524417

Rosenthal DI, Alexander A, Rosenberg AE, et al.(1992) Ablation of osteoid osteomas with a percutaneously placed electrode: A new procedure. Radiology 1992; 183:29-33.

Rosenthal DI, Hornicek FJ, Wolfe MW, et al.(1998) Percutaneous radiofrequency coagulation of osteoid osteoma compared with operative treatment. J Bone Jt Surg 1998; 80-A:815-821.

Rosenthal DI, Springfield DA, Gebhardt MC, et al.(1995) Osteoid osteoma: Percutaneous radio-frequency ablation. Radiology 1995; 197:451-454.

Sahin C, Oc Y, Ediz N, et al.(2019) The safety and the efficacy of computed tomography guided percutaneous radiofrequency ablation of osteoid osteoma. Acta Orthop Traumatol Turc. Sep 2019; 53(5): 360-365. PMID 31371131

Tordjman M, Perronne L, Madelin G, et al.(2020) CT-guided radiofrequency ablation for osteoid osteomas: a systematic review. Eur Radiol. Jun 09 2020. PMID 32518986

Yin G, Chen M, Yang S, et al.(2015) Treatment of uterine myomas by radiofrequency thermal ablation: a 10-year retrospective cohort study. Reprod Sci. May 2015;22(5):609-614. PMID 25355802
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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