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  • Medical Policy

    MP 7.01.95 Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors

    DISCLAIMER/INSTRUCTIONS FOR USE

    Medical Policy provides general guidance for applying Blue Cross of Idaho benefit plans (for purposes of Medical Policy, the terms “benefit plan” and “member contract” are used interchangeably). Coverage decisions must reference the member specific benefit plan document. The terms of the member specific benefit plan document may be different than the standard benefit plan upon which this Medical Policy is based. If there is a conflict between a member specific benefit plan and the Blue Cross of Idaho’s standard benefit plan, the member specific benefit plan supersedes this Medical Policy. Any person applying this Medical Policy must identify member eligibility, the member specific benefit plan, and any related policies or guidelines prior to applying this Medical Policy. Blue Cross of Idaho Medical Policies are designed for informational purposes only and are not an authorization, explanation of benefits or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the member specific benefit plan coverage. Blue Cross of Idaho reserves the sole discretionary right to modify all its Policies and Guidelines at any time. This Medical Policy does not constitute medical advice.

    POLICY

    Radiofrequency 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:

    • When it is necessary to preserve kidney function in patients with significantly impaired renal function (ie, the patient has 1 kidney or renal insufficiency defined by a glomerular filtration rate of

  • Original Policy Date: October 2003 Page: 2

    MP 7.01.95 Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors

    stage of disease, however, medical comorbidity renders the individual unfit for those interventions; AND

    • When the tumor is located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery, and the heart.

    Radiofrequency ablation may be considered medically necessary to treat malignant nonpulmonary tumor(s) metastatic to the lung that are no more than 3 cm in size when the following criteria are met:

    • When it is necessary to preserve lung function because surgical resection or radiotherapy is likely to worsen pulmonary status substantially; OR

    • When the patient is not considered a surgical candidate; AND

    • When there is no evidence of extrapulmonary metastases; AND the tumor is located at least 1 cm from the trachea, main bronchi, esophagus, aorta, aortic arch branches, pulmonary artery, and the heart.

    (See the Policy Guidelines section for additional criteria.)

    Radiofrequency ablation is considered investigational as a technique for ablation of:

    • breast tumors;

    • lung cancer not meeting the criteria above;

    • renal cell cancer not meeting the criteria above;

    • osteoid osteomas that can be managed with medical treatment;

    • painful bony metastases as initial treatment; and

    • all other tumors outside the liver including, but not limited to, the head and neck, thyroid, pancreas, adrenal gland, ovary, and pelvic/abdominal metastases of unspecified origin.

    POLICY GUIDELINES

    The following are additional criteria developed by clinical judgment or consensus and existing guidelines for the use of radiofrequency ablation to treat metastatic tumors to the lung:

    • No more than 3 tumors per lung should be ablated;

    • Tumors should be amenable to complete ablation; AND

    • Twelve months should elapse before a repeat ablation is considered.

    CODING CPT code 76940 (ultrasound guidance for, and monitoring of, parenchymal tissue ablation) might be used to describe the ultrasound guidance for radiofrequency tissue ablation. Code 76940 cannot be reported with code 20982.

    Other than codes listed in the Codes table, there are no specific CPT codes for the other indications mentioned in this policy.

    BENEFIT APPLICATION

    BLUECARD/NATIONAL ACCOUNT ISSUES State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration‒approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

  • Original Policy Date: October 2003 Page: 3

    MP 7.01.95 Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors

    BACKGROUND

    RADIOFREQUENCY ABLATION RFA was initially developed to treat inoperable tumors of the liver (see evidence review 7.01.91). Recently, studies have reported on the 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 (eg, single vs multiple tips). RFA can be performed as an open surgical procedure, laparoscopically or percutaneously, with ultrasound or computed tomography guidance.

    Potential complications associated with RFA include those caused by heat damage to normal tissue adjacent to the tumor (eg, intestinal damage during RFA of kidney), structural damage along the probe track (eg, pneumothorax as a consequence of procedures on the lung), and secondary tumors (if cells seed during probe removal).

    REGULATORY STATUS The U.S. Food and Drug Administration (FDA) issued a statement in September 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 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.

    RATIONALE

    This evidence review was created in October 2003 and has been regularly updated with searches of the MEDLINE database. The most recent literature update was performed through July 8, 2018.

    Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

    To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances,

  • Original Policy Date: October 2003 Page: 4

    MP 7.01.95 Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors

    nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

    Osteolytic Bone Metastases

    Clinical Context and Therapy Purpose

    After lung and liver, bone is the third most common metastatic site and is relatively frequent among p

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