Coverage Policy Manual
Policy #: 2005025
Category: Surgery
Initiated: July 2005
Last Review: October 2018
  Radiofrequency Ablation, Bony Metastases

Description:
Radiofrequency ablation (RFA) is used to treat inoperable tumors or to treat patients ineligible for surgery due to age, presence of comorbidities, or poor general health. Goal(s) of RFA may include 1) controlling local tumor growth and preventing recurrence; 2) palliating symptoms; and 3) extending survival duration for patients with certain tumors. The procedure kills cells (cancerous and normal) by applying a heat-generating rapidly alternating current through probes inserted into the tumor. The effective volume of RFA depends on the frequency and duration of applied current, local tissue characteristics, and probe configuration (e.g., single versus multiple tips). RFA can be performed as an open surgical procedure, laparoscopically, or percutaneously with ultrasound or computed tomography (CT) guidance.
 
Potential complications associated with RFA include those caused by heat damage to normal tissue adjacent to the tumor (e.g., intestinal damage during RFA of kidney), structural damage along the probe track (e.g., pneumothorax as a consequence of procedures on the lung), or secondary tumors if cells seed during probe removal.
 
RFA was developed initially to treat inoperable tumors of the liver.  Recently, reports have been published on use of RFA to treat renal cell carcinomas, breast cancer, pulmonary (primary lung cancers or metastatic tumors), bone, and other tumors. For some of these, RFA is being investigated as an alternative to surgery for operable tumors. Well-established local or systemic treatment alternatives are available for each of these malignancies. The hypothesized advantages of RFA 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).
 
After lung and liver, bone is the third most common metastatic site and is relatively frequent among patients with primary malignancies of the breast, prostate, and lung. Bone metastases often cause osteolysis (bone breakdown), resulting in pain, fractures, decreased mobility, and reduced quality of life. External beam irradiation often is the initial palliative therapy for osteolytic bone metastases. However, pain from bone metastases is refractory to radiation therapy in 20% to 30% of patients, while recurrent pain at previously irradiated sites may be ineligible for additional radiation due to risks of normal tissue damage. Other alternatives include hormonal therapy, radiopharmaceuticals such as strontium-89, and bisphosphonates. Less often, surgery or chemotherapy may be used for palliation and intractable pain may require opioid medications. RFA has been investigated as another alternative for palliating pain from bone metastases
 
CPT codes 47380 and 47382 describe open and percutaneous radiofrequency of liver tumors, respectively. In 2003, CPT code 20982 was introduced that specifically describes radiofrequency ablation of osteoid osteoma and other primary or metastatic bone tumors. There are no specific CPT codes for other targets of extrahepatic tumors. In addition, CPT code 76940 (ultrasound guidance for, and monitoring of, visceral tissue ablation) might be used to describe the ultrasound guidance for radiofrequency ablation for both intra- and extrahepatic targets.
 
Other policies addressing radiofrequency ablation:
    • Breast tumors - #2004004;
    • Osteoid Osteomas - #2001011;
    • Pulmonary Tumors - #2004003;
    • Renal Tumors - #2004007.

Policy/
Coverage:
Effective July 2005
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Radiofrequency ablation to palliate pain in patients with osteolytic bone metastases who have failed or are poor candidates for standard treatments such as radiation or opioids 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 as a technique for the initial treatment of painful bony metastases 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 as a technique for the initial treatment of painful bony metastases is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
This policy is based on an analysis of relevant literature identified in a MEDLINE/PubMed search performed in June 2003 and updated in December 2005. The identified studies were uncontrolled, retrospective case series or case reports. Furthermore, the reviewed studies generally reported only immediate or short-term effects of RFA that did not permit conclusions regarding the net health benefit of RFA for patients with these tumors.
 
The following section summarize the evidence for those applications of RFA with evidence available from at least1 case series of 10 or more patients.
 
Palliation of pain from bone metastases Goetz et al.  reported an international study (n=43) conducted at 9 centers in which patients with painful osteolytic bone metastases were treated palliatively with RFA. The study’s primary outcome measure was the Brief Pain Inventory-Short Form, a validated scale from 0 for no pain to 10 for worst pain imaginable. Patient eligibility required baseline values >4 from <2 painful sites. Thirty-nine (91%) of the patients had previously received opioids to control pain from the lesion(s) treated with RFA, and 32 (74%) had prior radiation therapy to the same lesion. Mean pain score at baseline was 7.9 (range, 4 to 10). At 4, 12, and 24 weeks after RFA, average pain scores decreased to 4.5, 3.0, and 1.4, respectively (all p <0.0005). Forty-one (95%) of the patients achieved a clinically significant improvement in pain scores, prospectively defined as a decrease of 2 units from baseline. Investigators also reported statistically significant (p=0.01) decreases in opioid use at weeks 8 (by 59%) and 12 (by 54%). While this uncontrolled study includes only a limited number of patients, the patient population focused on those with limited other treatment options and in whom short-term patient relief is an appropriate outcome. Therefore, this indication is considered medically necessary. However, data were unavailable on use of RFA as initial therapy for pain from bone metastases.
 
2009 Update
A search of the MEDLINE database through August 2009 did not reveal any published literature that would prompt a change in the coverage statement.   There are currently two ongoing studies evaluating the effectiveness of radiofrequency ablation in relieving pain in patients with bony metastases. (NCT00029029)(NCT00026247).
 
Data is unavailable on the use of RFA as initial therapy for pain for bone metastatases.  Therefore, the coverage statement remains unchanged.
 
2012 Update
Dupuy, et al (2010) published the results of a multicenter, phase 2, prospective  trial on radiofrequency treatment of pain from bony metastases, sponsored by the American College of Radiology Imaging Network and the National Cancer Institute, which was initiated in Nov 2001 and scheduled for completion in Feb 2011.  The trial excluded patients with pain due to weight-bearing long bone metastases.  Fifty-five (55) patients completed the trial, and the authors concluded, “This study demonstrates that RFA for bone metastases can be safely performed and achieves palliation for bone pain metastases in a cooperative group setting. It represents a novel treatment option for patients with solid tumors that have metastasized to the bone and further analysis in a randomized controlled trial is warranted.”
 
No randomized trials have been found.  The data from the Dupuy trial is encouraging, but the available data limits the use to those patients with pain unresponsive to radiation and/or chemotherapy treatment.  
 
NCT 00029029, another trial on radiofrequency ablation of painful bony metastases and listed as ongoing in Jan 2002 on clinicaltiral.gov, does not appear to have been reported, and no update has been posted since Dec 2002.  The Study Chair of this trial, Dr. J.W. Charboneau of the Mayo Clinic has published a multicenter study of RF ablation of painful metastases from October 2000 through 2002 (22 patients), and another 21 patients were enrolled at 4 other centers in the U.S. and Europe.  The authors concluded, “RFA of painful osteolytic metastases provides significant pain relief for cancer patients who have failed standard treatments.” (Goetz, 2004)
 
2013 Update
A literature search of the MEDLINE database was conducted through September 2013. There was no new literature identified that would prompt a change in the coverage statement.
 
2014 Update
A literature search using the MEDLINE database through September 2014 did not reveal any new information that would prompt a change in the coverage statement.
  
2015 Update
A literature search conducted through September 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
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.
 
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.
 
2016 Update
A literature search conducted through September 2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2017 Update
A literature search conducted through September 2017 did not reveal any new information that would prompt a change in the coverage statement.  
 
2018 Update
A literature search was conducted through September 2018.  There was no new information 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

Dupuy DE, Liu D, Harfeil D, et al.(2010) Percutaneous radiofrequency ablation of painful osseus metastases: A multi-center American College of Radiology Imaging Network Trial. Cancer, 2010; 116:989-997.

Goetz MP, Callstrom MR, et al.(2004) Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol 2004; 22:300-306.

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

Kojima H, Tanigawa N, Kariya S et al.(2006) Clinical assessment of percutaneous radiofrequency ablation for painful metastatic bone tumors. Cardiovasc Intervent Radiol 2006; 29(6):1022-6.

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

Radiofrequency Ablation in Relieving Pain in Patients with Bone Metastatses www.clinicaltrials.gov (NCT00029029). Last accessed September 2009.

Radiofrequency Ablation in Treating Patients with Bone Metastases. www.clinicaltrials.gov (NCT00026247). Last accessed September 2009.

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

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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