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In radiofrequency ablation (RFA), a probe is inserted into the center of a tumor and the noninsulated electrodes, which are shaped like prongs, are projected into the tumor; heat is then generated locally by a high-frequency, alternating current through the electrodes. The local heat treats the tissue adjacent to the probe, resulting in a 3- to 5.5-cm sphere of dead tissue. The cells killed by RFA are not removed but are gradually replaced by fibrosis and scar tissue. If there is local recurrence, it occurs at the edge and, in some cases, may be retreated. RFA may be performed percutaneously, laparoscopically, or as an open procedure.
Radiofrequency ablation (RFA) was initially developed to treat inoperable tumors of the liver. Recently, studies have reported on use of RFA to treat 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 (eg, preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization).
Goals 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 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.
Osteolytic Bone Metastases. 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 radiotherapy often is the initial palliative therapy for osteolytic bone metastases. However, pain from bone metastases is refractory to radiotherapy 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 (eg, 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 an alternative for palliation of bone metastases.
Osteoid Osteomas. Osteomas are the most common benign bone tumor, comprising 10–20% of benign and 2–3% of all bone tumors. They are typically seen in children and young adults, with most diagnosed in patients between 5–20 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, usually continuous and worse at night, and usually relieved by aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). The natural history of the osteoid osteoma varies 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 3–7 years.
Treatment options include medical management with NSAIDs, surgical excision (wide/en bloc excision or curetting), or the use of CT- or MRI-guided minimally invasive procedures including core drill excision, laser photocoagulation, or radiofrequency ablation. 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 and 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 metal work). 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, and patients may immediately walk on the treated extremity and return to daily activities as soon as the anesthetic effect wears off. The risk of recurrence with RFA of an osteoma is 5–10%, 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.
Localized Renal Cell Carcinoma. Radical nephrectomy remains the principal treatment of renal cell carcinoma; however, partial nephrectomy or nephron-sparing surgery has been shown to be as effective as radical nephrectomy, with comparable long-term recurrence-free survival rates, in a select group of patients. Alternative therapy such as RFA is of interest in patients with small renal tumors when preservation of renal function is necessary (e.g., in patients with marginal renal function, a solitary kidney, bilateral tumors), and in patients with comorbidities that would render them unfit for surgery. Another consideration would be in patients at high risk of developing additional renal cancers (eg, von Hippel-Lindau disease).
Primary Pulmonary Tumors and Nonpulmonary Metastases. Surgery is the current treatment of choice in patients with stage 1 primary non-small-cell lung cancer (NSCLC; Stage 1 includes 1a: T1N0M0 and 1b: T2N0M0). Approximately 20% of patients present with stage 1 disease, although this number is expected to increase as a result of screening programs, advances in imaging modalities, and widespread use of CT scans for other indications. Postsurgical recurrence rates of stage 1 NSCLC have been reported as between 20% and 30%, with most occurring at distant sites; locoregional recurrences occur in approximately 12%. Large differences in survival outcome are observed after surgery in stage 1 patients, with 5-year overall survival rates ranging from 77% for small T1 tumors to 35% for large T2 tumors. Untreated, stage 1 NSCLC has a 5-year overall survival rate of 6–14%.
Patients with early stage NSCLC who are not surgical candidates may be candidates for radiotherapy with curative intent. In the two largest retrospective radiotherapy series, patients with inoperable disease treated with definitive radiotherapy achieved 5-year survival rates of 10% and 27%. In both studies, patients with T1N0 tumors had better 5-year survival rates of 60% and 32%, respectively.
Stereotactic whole body radiotherapy (SBRT) has gained more widespread use, as it is a high-precision mode of therapy that delivers very high doses of radiation. Two- to 3-year local control rates of stage 1 NSCLC with SBRT have ranged from 80–95%. SBRT has been investigated in patients unfit to undergo surgery, with survival rates similar to surgical outcomes.
RFA also is being investigated in patients with small primary lung cancers or lung metastases who are deemed medically inoperable.
Thyroid Tumors. Surgical resection is the primary treatment choice for medically unresponsive, symptomatic benign thyroid tumors and thyroid carcinomas. However, techniques for ablation of thyroid tumors (eg, RFA, microwave ablation) are being investigated.
Miscellaneous Tumors. Radiofrequency ablation has been investigated for use in individuals with a number of different lesions in different anatomic sites. They include, but are not limited to, breast, head, and neck.
Breast Tumors. The treatment of small cancers of the breast has evolved from total mastectomy to more conservative treatment options such as lumpectomy, with more acceptable cosmetic outcomes and preservation of the breast. The selection of surgical approach balances the patient’s desire for breast conservation and the need for tumor-free margins in resected tissue. Minimally invasive nonsurgical techniques such as RFA are appealing if they can produce local control and survival equivalent to breast-conserving surgical alternatives. Nonsurgical ablative techniques pose difficulties such as the inability to determine tumor size, complete tumor cell death, and local recurrence. Additionally, RFA can cause burning of the skin or damage to muscle, possibly limiting the use in patients with tumors near the skin or chest wall.
Head and Neck Cancer. In patients with head and neck cancer with recurrent disease, surgical salvage attempts are poor in terms of local control, survival and quality of life, and these recurrent tumors are often untreatable with standard salvage therapies. Palliative chemotherapy or comfort measures may be offered. The safety and efficacy of RFA has been investigated as an option for palliative treatment in these situations.
FDA issued a statement September 24, 2008, concerning the regulatory status of RFA. FDA has cleared RFA devices for the general indication of soft tissue cutting, coagulation, and ablation by thermal coagulation necrosis. Under this general indication, RFA can be used as a tool to ablate tumors, including lung tumors. Some RFA devices have been cleared for additional specific treatment indications, including partial or complete ablation of nonresectable liver lesions and palliation of pain associated with metastatic lesions involving bone. FDA has not cleared any RFA devices for the specific treatment indication of partial or complete ablation of lung tumors, citing lack of sufficient clinical data to establish safety and effectiveness for this purpose. FDA has received reports of death and serious injuries associated with the use of RFA devices in the treatment of lung tumors.
Note: This policy addresses radiofrequency ablation of tumors located outside the liver. For liver tumors, refer to the Radiofrequency Ablation of Primary and Metastatic Liver Tumors medical policy.
Related medical policies are -
POLICYRadiofrequency ablation may be considered medically necessary to palliate pain in patients with osteolytic bone metastases who have failed or are poor candidates for standard treatments such as radiation or opioids.
Radiofrequency ablation may be considered medically necessary to treat osteoid osteomas that cannot be managed successfully with medical treatment.
Radiofrequency ablation may be considered medically necessary to treat localized renal cell carcinoma that is no more than 4 cm in size when either of the following criteria is met:
Radiofrequency ablation may be considered medically necessary to treat an isolated peripheral non-small cell lung cancer lesion that is no more than 3 cm in size when the following criteria are met:
Radiofrequency ablation may be considered medically necessary to treat malignant non-pulmonary tumor(s) metastatic to the lung that are no more than 3 cm in size when the following criteria are met:
(See the Policy Guidelines section for additional criteria)
Radiofrequency ablation is considered investigational as a technique for ablation of:
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
The following are additional criteria that have been developed by clinical judgment/consensus and existing guidelines for the use of RFA in metastatic tumors to the lung:
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY3/25/2004: Approved by Medical Policy Advisory Committee (MPAC)
5/3/2004: Code Reference section completed
1/5/2005: Code Reference section updated, non-covered table added, CPT codes 19499, 22899, 27299, 32999, 38589, 42699, 43659, 43999, 48999, 49999, 58679, 60659, 60699 added non-covered codes
3/14/2006: Coding updated. CPT4 2006 revisions added to policy
5/18/2006: Policy revised. Revisions approved per Medical Policy Advisory Committee (MPAC)
6/21/2006.Coding reference section updated, 76940 added to covered table, 50549, 50592, 53899, 55.39 moved to non-covered table. 85.20 added to non-covered table. 189.0 deleted.
9/22/2006: Coding updated. ICD9 2006 revisions added to policy
1/3/2007: Code reference section updated per the 2007 CPT/HCPCS revisions
6/20/2007: Policy reviewed, no changes
7/19/2007: Reviewed and approved by MPAC
7/18/2008: Anesthesia Coding Policy hyperlink added
07/30/2010: Policy description updated regarding new treatment approaches and recent research findings. Added links to related medical policies. Policy statement revised to add that treatment of renal cell cancer may be considered medically necessary when specific criteria are met. Policy statement also added to indicate that use of RFA as treatment of osteoid osteomas that cannot be managed successfully with medical treatment may be considered medically necessary. Investigational statement re-worded due to the new policy statements. Based on the revised policy statement, the Code Reference section updated to add ICD-9 code 189.0 to the Covered Codes table. Moved procedure codes 50549, 50592, 55.32, 55.33, 55.34, 55.35, and 55.39 from non-covered to covered.
12/30/2010: Policy reviewed; no changes.
01/17/2012: Policy statement revised to state that radiofrequency ablation may be considered medically necessary to treat an isolated peripheral non-small cell lung cancer lesion that is no more than 3 cm in size and to treat malignant non-pulmonary tumor(s) metastatic to the lung that are no more than 3 cm in size when certain criteria are met.
12/13/2012: Added thyroid cancer to the investigational policy statement.
01/22/2014: Policy reviewed; no changes.
12/04/2014: Policy reviewed; description updated regarding thyroid tumors and RF ablation devices. Policy statements unchanged. Policy guidelines section updated to add additional criteria for the use of RFA in metastatic tumors to the lung.
12/31/2014: Code Reference section updated to revise the description of the following CPT code: 20982. Effective 1/1/15. Added the following new 2015 CPT code: 20983.
09/01/2015: Policy statement updated to add verbiage clarifying that the procedure is considered investigational for lung tumors not meeting criteria in the medically necessary statements. Code Reference section updated for ICD-10. Moved CPT code 32998 and ICD-9 procedure codes 32.26 and 32.29 to the Covered Codes table. Added ICD-9 diagnosis codes 162.2 - 162.9 to the Covered Codes table. Removed ICD-9 procedure codes 32.23 - 32.25 and 85.20 from the Investigational Codes table.
11/16/2015: Policy description updated regarding radiofrequency ablation and miscellaneous tumors. Investigational statement updated to list criteria. Policy guidelines updated to add medically necessary and investigational definitions.
05/31/2016: Policy number A.7.01.95 added.
10/14/2016: Policy description updated. Policy statements unchanged.
SOURCE(S)Blue Cross Blue Shield Association policy #7.01.95
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Unlisted procedure, breast
Unlisted procedure, spine
Unlisted procedure, pelvis or hip joint
Unlisted procedure, lungs and pleura
Unlisted laparoscopy procedure, lymphatic system
Unlisted procedure, salivary glands or ducts
Unlisted laparoscopy procedure, stomach
Unlisted procedure, stomach
Unlisted procedure, pancreas
Unlisted procedure, abdomen, peritoneum and omentum
Unlisted procedure, urinary system
Unlisted laparoscopy procedure, oviduct, ovary
Unlisted laparoscopy procedure, endocrine system
Unlisted procedure, endocrine system