Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors

POLICY NUMBER

A.7.01.95

DESCRIPTION

In radiofrequency ablation (RFA), a probe is inserted into the center of a tumor; then, prong-shaped, non-insulated electrodes are projected into the tumor. Next, heat is generated locally by an alternating, high-frequency current that travels through the electrodes. The localized heat treats the tissue adjacent to the probe, resulting in a 3 cm 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 a local recurrence, it occurs at the edge and can sometimes be retreated. RFA may be performed percutaneously, laparoscopically, or as an open procedure.

Health Disparities in Certain Solid Tumor Types

Based on data from 2014 through 2018, age-adjusted breast cancer mortality is approximately 40% higher among Black women compared to non-Hispanic White women in the United States (27.7 vs 20.0 deaths per 100,000 women), despite a lower overall incidence of breast cancer among Black women (125.8 vs 139.2 cases per 100,000 women). Experts postulate that this divergence in mortality may be related to access issues– Black women are more likely than White women to lack health insurance, limiting access to screening and appropriate therapies. Socioeconomic status is also a driver in health and health outcome disparities related to breast cancer. Women with low incomes have significantly lower rates of breast cancer screening, a higher probability of late-stage diagnosis, and are less likely to receive high-quality care, resulting in higher mortality from breast cancer.

Based on data from 2017 through 2021, kidney cancer is more common in men than women and occurs more often in American Indian and Alaskan Native individuals, followed by Black and Hispanic individuals. American Indians and Alaska Natives have higher death rates from kidney cancer than any other racial or ethnic group. A cohort study by Howard et al (2021) included 158,445 patients with localized kidney cancer from the National Cancer Database between 2010 and 2017. Investigators found that female patients were treated more aggressively compared with male patients, with lower adjusted odds of undertreatment and higher adjusted odds of overtreatment. They also found that Black and Hispanic patients had higher adjusted odds of undertreatment and overtreatment compared to White patients, and uninsured status was associated with lower adjusted odds of overtreatment and higher adjusted odds of undertreatment. These results suggest that sex, race and ethnicity, and socioeconomic status are associated with disparities in guideline-based treatment for localized kidney cancer, specifically, with increased rates of non-guideline-based treatment for women and Black and Hispanic patients.

Radiofrequency Ablation

Radiofrequency ablation (RFA) was initially developed to treat inoperable tumors of the liver (see the Radiofrequency Ablation of Primary or Metastatic Liver Tumors medical policy). 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 (e.g., single versus 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 (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), and secondary tumors (if cells seed during probe removal).

The U.S. Food and Drug Administration (FDA) issued a statement in September 2008, concerning the regulatory status of RFA. The 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. The 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. The 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 (RFA) of Primary or Metastatic Liver Tumors  medical policy.

Related medical policies are -

• Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT)

• Cryosurgical Ablation of Miscellaneous Solid Tumors Other Than Liver, Prostate, or Dermatologic Tumors

POLICY

Osteolytic Bone Metastases

Radiofrequency ablation may be considered medically necessary to palliate pain in individuals with osteolytic bone metastases who have failed or are poor candidates for standard treatments such as radiation or opioids. 

Osteoid Osteomas

Radiofrequency ablation may be considered medically necessary to treat osteoid osteomas that cannot be managed successfully with medical treatment.

Renal Cell Carcinoma

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:

• Preservation of kidney function is necessary (i.e., the individual has one kidney or renal insufficiency defined by a glomerular filtration rate (GFR) of less than 60 mL/min per m²) and standard surgical approach (i.e., resection of renal tissue) is likely to substantially worsen kidney function; or

• Individual is not considered a surgical candidate.

Non-Small-Cell Lung Cancer

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:

• Surgical resection or radiotherapy with curative intent is considered appropriate based on stage of disease, however, medical co-morbidity renders the individual unfit for those interventions; AND

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

Nonpulmonary Tumor(s) Metastatic to the Lung

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:

• In order to preserve lung function when surgical resection or radiotherapy is likely to substantially worsen pulmonary status OR the individual is not considered a surgical candidate; AND

• 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:

• tumors of the breast;

• lungcancernot meeting the criteria above;

• renal cell cancer not meeting criteria above;

• osteoid osteomas that can be managed with medical treatment;

• initial treatment of painful bony metastases;

  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 EXCEPTIONS

None

POLICY GUIDELINES

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 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.

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 Mental Health Disorders, 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 medical necessity, “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 HISTORY

3/25/2004: 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.

10/19/2017: Policy description updated. Medically necessary policy statements updated to change "radiation treatment" to "radiotherapy."

11/29/2017: Code Reference section updated to add ICD-10 diagnosis codes C78.00 - C78.02 and C79.51 - C79.52.

12/22/2017: Code Reference section updated to revise description for CPT code 32998 effective 01/01/2018.

11/09/2018: Policy description updated. Added tumors of the pancreas to the investigational statement.

06/01/2019: Code Reference section updated to remove CPT code 20983.

11/01/2019: Policy description revised to remove information regarding tumors and treatments. Policy statements unchanged.

10/15/2020: Policy reviewed; no changes.

01/12/2022: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

12/05/2022: Policy description updated regarding health disparities in certain solid tumor types. Policy section updated to add section headings and to change "patients" to "individuals."

10/16/2023: Policy description updated regarding kidney cancer. Policy statements unchanged.

12/05/2024: Policy description updated. Policy statements unchanged.

12/31/2024: Code Reference section updated to add new CPT codes 60660 and 60661 effective 01/01/2025.

SOURCE(S)

Blue Cross Blue Shield Association policy #7.01.95

CODE REFERENCE

This 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.

Covered Codes

Investigational Codes

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