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DESCRIPTIONRadiofrequency ablation (RFA) is being evaluated to treat various tumors, including inoperable tumors or to treat patients ineligible for surgery due to age, presence of comorbidities, or poor general health. 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.
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 tumors, pulmonary cancers (including primary and metastatic lung 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 (preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization).
Breast Tumors. There has been a trend in the treatment of small breast cancers from total mastectomy towards increasingly more conservative treatment options like 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 like 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 killing, 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.
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 upon its location, and although they rarely exceed 1.5 cm, 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. Complete surgical excision has several disadvantages. A substantial incision may be necessary and removal of a considerable amount of bone (especially in the neck of the femur), increasing the need for bone grafting and/or 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 period of 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 there is no incision or sutures needed, and patients may walk on the treated extremity immediately 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.
Palliation for 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 irradiation often is the initial palliative therapy for osteolytic bone metastases. However, pain from bone metastases if 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 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.
Pulmonary Tumors. Surgery is the current treatment of choice in patients with stage 1 primary non-small cell lung carcinoma (NSCLC). (Stage 1 includes 1a: T1N0M0 and 1b: T2N0M0). Only around 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 radiation treatment with curative intent. In the two largest retrospective radiotherapy series, patients with inoperable disease treated with definitive radiation therapy 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 radiotherapy (SRT) has gained more widespread use, as it is a high-precision mode of therapy that allows for delivery of very high doses of radiation. Two- to 3-year local control rates of stage 1 NSCLC with SRT have ranged from 80–95%. Many reports on outcomes with SRT have been in patients unfit to undergo surgery, introducing a large selection bias compared with surgery. However, one study that reported on nearly 100 patients who refused surgery (versus being deemed unfit) had a 5-year overall survival rate of 71% with SRT to treat stage 1 NSCLC, a rate that is at least equivalent to surgical outcome.
RFA is being investigated in patients who are medically inoperable, with small primary lung cancers or lung metastases.
Renal Cell Carcinoma (RCC). Radical nephrectomy remains the principal treatment of RCC, 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 (as in von Hippel-Lindau disease).
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.
FDA issued a statement September 24, 2008, concerning the regulatory status of RFA. FDA has cleared RF ablation 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 are 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 tumors of the breast, lung, renal cell cancer not meeting criteria above, and all other tumors outside the liver including, but not limited to, the head and neck, thyroid, adrenal gland, ovary, and pelvic/abdominal metastases of unspecified origin and for the treatment of osteoid osteomas that can be managed with medical treatment and for initial treatment of painful bony metastases.
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 and include:
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
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.