Coverage Policy Manual
Policy #: 2001011
Category: Medicine
Initiated: April 2001
Last Review: May 2018
  Radiofrequency Ablation, Osteoid Osteoma

Description: Osteoid osteomas are benign tumors of bone that occur in long bones, but also in the spine.  Most are discovered because of pain at the site.  Many can be treated with aspirin or non-steroidal anti-inflammatory agents, but for some, surgical removal has been required.  

The data supporting radiofrequency ablation of osteoid osteoma is based on two small phase II studies and one larger retrospective case series.  The results are “promising”.  It is unlikely, due to the small number of patients, that a controlled trial comparing surgery to radiofrequency ablation will ever be done.

Policy/
Coverage:
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 ultrasoundguided percutaneous radiofrequency ablation for benign thyroid nodules is adequate to support the use of this procedure….” (Nice, 2016).

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: 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

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.

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.

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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