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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-99221-13

Original Effective Date: 03/15/04

Reviewed: 10/23/14

Revised: 01/01/15

Subject: Radiofrequency Ablation of Solid Tumors Other Than Liver Tumors

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates  

DESCRIPTION:

This policy addresses radiofrequency ablation (RFA) of tumors located outside the liver. RFA of liver tumors is discussed in a separate policy.

Radiofrequency 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. 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 (normal and abnormal) 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 vs. 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 (see policy No. 7.01.91). 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 (e.g., preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization).

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 is refractory to radiation therapy in 20 – 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.

Osteoid osteomas – Osteomas are the most common benign bone tumor, comprising 10 – 20% of benign and 2 – 3% of all bone tumors. (1) 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/enbloc 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.

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).

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.

Pulmonary (lung) 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. (6) Postsurgical recurrence rates of stage 1 NSCLC have been reported 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 radiation therapy 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%. Stereotactic radiation therapy (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.

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.

The U.S. Food and Drug Administration (FDA) issued a statement September 24, 2008 concerning the regulatory status of radiofrequency ablation. The FDA has cleared RFA devices for the general indication of soft tissue cutting, coagulation, and ablation by thermal coagulation necrosis. Some RFA devices have been cleared for additional specific treatment indications, including partial or complete ablation of non-resectable 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.

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 (e.g., RFA and microwave ablation) are being investigated.

POSITION STATEMENT:

Radiofrequency ablation (RFA) meets the definition of medical necessity for the following indications:

Radiofrequency ablation is considered experimental or investigational, as there is insufficient clinical evidence to support the use of RFA for all other indications, and specifically for the following conditions:

Scientific evidence regarding RFA for the treatment of breast cancer and breast fibroadenomas is limited to small study populations having variable outcomes and also lack long-term follow-up and comparison to other standard therapies.

Although there are ongoing clinical studies on the use of RFA for treating lung tumors, the evidence is insufficient to permit conclusions on net health outcomes. Clinical studies are small case series or uncontrolled cohort studies which focused primarily on technical feasibility and initial tumor response. Study quality concerns include the lack of long-tem follow-up, study design, patient populations, RFA methods and non-uniformity of reporting and efficacy scoring criteria.

For all other tumors outside the liver, the available evidence is insufficient to permit conclusions on net health outcomes of RFA.

BILLING/CODING INFORMATION:

CPT Coding:

20982

Ablation therapy for reduction or eradication of 1 or more bone tumors (e.g., metastasis), including adjacent soft tissue when involved by tumor extension, percutaneous, including imaging guidance when performed; radiofrequency

32998

Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, radiofrequency, unilateral

50542

Laparoscopy, surgical; ablation of renal mass lesion(s)

50592

Ablation, one or more renal tumor(s), percutaneous, unilateral, radiofrequency

76940

Ultrasound guidance for, and monitoring of, tissue ablation (Alert: this code is also used for reporting ultrasound guidance for radiofrequency ablation of intra- and extrahepatic targets)

LOINC Codes:

The following information may be required documentation to support medical necessity: Physician history and physical, initial assessment, procedure note, visit note.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician Initial Assessment

18736-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician procedure note

11505-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Ablation: removal of a body part or destruction of its function.

Osteoid osteomas: benign tumors of the bone typically seen in children and young adults. They cause inflammation, local effects on normal tissue from tumor expansion, and secondary effects and complications (e.g., scoliosis, osteoarthritis).

Radiofrequency ablation (RFA): uses high-energy radio waves for treatment. A thin, needle-like probe temporarily placed into the tumor releases these radio waves. Placement of the probe is accurately guided by ultrasound or CT scans. The probe releases high frequency alternating current that creates frictional heating and destroys the cancer cells.

Unresectable: a property of a tumor where it is unable to be removed surgically.

RELATED GUIDELINES:

Radiofrequency Ablation of Liver Tumors, 02-40000-23

OTHER:

None applicable.

REFERENCES:

  1. American Cancer Society (ACS) website. Accessed 09/06/12.
  2. American College of Radiology. ACR Appropriateness Criteria – Nonsurgical Treatment for Non-Small-Cell Lung Cancer: Good Performance Status/Definitive Intent. Last reviewed 2010.
  3. American Medical Association CPT Coding (current edition).
  4. American Society of Clinical Oncology. “Percutaneous radiofrequency ablation of lung tumours: Results in first 100 consecutive patients.”Abstract No: 7714. Citation: Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 7714. Author(s): J. C. ZHU, T. D. Yan, K. Ng, D. Glenn, D. L. Morris.
  5. American Urological Association Policy Statement. Ablation of Renal Masses. 10/06.
  6. Blue Cross Blue Shield Association Medical Policy Reference 7.01.95, Radiofrequency Ablation of Miscellaneous Solid Tumors Excluding Liver Tumors, (10/10/13).
  7. Burak WE Jr, et al. Radiofrequency ablation of invasive breast carcinoma followed by delayed surgical excision. Cancer 10/01/03; 98(7): 1369-76.
  8. Chua TC, Sarkar A, Saxena A, Glenn D, Zhao J, Morris DL. Long-term outcome of image-guided percutaneous radiofrequency ablation of lung metastases: an open-labeled prospective trial of 148 patients. Ann Oncol. 2010 Oct;21(10):2017-22. Epub 2010 Mar 24.
  9. Clinical Trials.gov.
  1. ECRI Health Technology Trends. “Radio-frequency ablation may offer new option to control inoperable lung tumors” (06/03).
  2. ECRI Institute Health Technology Forecast. “Radiofrequency ablation for breast cancer”. 04/27/07.
  3. ECRI Institute Health Technology Forecast. “Reports of deaths prompt FDA to issue warning on RFA dev ices to treat lung cancers”. 12/28/07.
  4. ECRI. Palliative procedure may offer relief from intractable pain of metastatic bone tumors [Health Technology Trends]. 2003; 3 p.
  5. ECRI. Radiofrequency Ablation for Bone Metastases [Hotline]. 2003.
  6. ECRI. Radiofrequency Ablation for Kidney Cancer [Hotline]. 2002.
  7. ECRI. Radiofrequency Ablation for Lung Cancer [Hotline]. 03/13/08.
  8. Goetz MP, et al. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol 2004; 22(2): 300-306.
  9. Hayashi AH, et al. Treatment of invasive breast carcinoma with ultrasound-guided radiofrequency ablation. AM J Surg 05/03; 185(5): 429-35.
  10. HAYES Brief. “Radiofrequency Ablation For Renal Tumors”. 06/13/07.
  11. HAYES Medical Technology Directory: Radiofrequency Ablation for Chronic Spinal Pain, RADI0801.17 (01/22/05).
  12. HAYES Medical Technology Directory: Radiofrequency Ablation for Osteoid Osteoma, RADI0102.26 (03/04; updated 05/16/07).
  13. HAYES Search and Summary. “Radiofrequency Ablation of Malignant Pulmonary Tumors in Nonsurgical Candidates”. 02/25/08.
  14. Hess A, Palussière J, Goyers JF, Guth A, Aupérin A, de Baère T. Pulmonary radiofrequency ablation in patients with a single lung: feasibility, efficacy, and tolerance. Radiology. 2011 Feb;258(2):635-42.
  15. Huh JY, Baek JH, Choi H, Kim JK, Lee JH.Symptomatic benign thyroid nodules: efficacy of additional radiofrequency ablation treatment session--prospective randomized study. Radiology. 2012 Jun;263(3):909-16.
  16. King J, Glenn D., Clark W et al. Percutaneous radiofrequency ablation of pulmonary metastases in patients with colorectal cancer. Br J Surg 2004; 91:217-23.
  17. Lee JM, et al. Percutaneous radiofrequency ablation for inoperable non-small cell lung cancer and metastases: Preliminary report. Radiology 2004; 230: 125-34.
  18. Matlaga BR, et al. Radiofrequency ablation of renal tumors. Curr Urol Rep 02/04; 5(1): 39-44.
  19. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines on Non-Small Cell Lung Cancer. April 2012.
  20. National Comprehensive Cancer Network (NCCN) Practice Guideline Version 1.2012 on Head and Neck Cancers. April 2012.
  21. National Comprehensive Cancer Network (NCCN) Practice Guideline Version 2.2012 on Kidney Cancer. 02/16/12.
  22. National Comprehensive Cancer Network (NCCN) Practice Guideline Version 2.2012 on Pancreatic Adenocarcinoma. 02/07/12.
  23. National Comprehensive Cancer Network (NCCN) Practice Guideline Version 3.2012 on Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. 04/02/12.
  24. National Cancer Institute. NCI Cancer Bulletin. Radiofrequency Ablation Making Inroads as Cancer Treatment. July 19, 2005. Volume 2I; Number 29; p.3. Accessed 03/22/11.
  25. National Guideline Clearinghouse. Treatment of non-small cell lung cancer stage I and stage II: ACCP evidence-based clinical practice guidelines (2nd Edition) – Summary completed by ECRI 08/22/03; verified 12/21/07.
  26. National Guideline Clearinghouse. Guideline Summary NGC-7946. ACR Appropriateness Criteria® nonsurgical treatment for non-small-cell lung cancer: good performance status/definitive intent (2010).
  27. National Guideline Clearinghouse. Guideline Summary NCG-7797. ACR Appropriateness Criteria® follow-up of renal cell carcinoma (2009).
  28. National Institute for Clinical Excellence. Percutaneous radiofrequency ablation for primary and secondary lung cancers – guidance. 07/06.
  29. National Institute for Clinical Excellence. Percutaneous radiofrequency ablation of renal cancer – guidance. 09/04.
  30. National Institute for Health and Clinical Excellence (NICE). Percutaneous radiofrequency ablation for primary and secondary lung cancers (01/06).
  31. National Institutes of Health (NIH) Clinical Center. Radiofrequency Ablation FAQ. Accessed 02/12/09.
  32. National Institutes of Health (NIH). Phase II Pilot Study of RFA in high-risk patients with state IA non-small cell lung cancer (first published 04/23/05; last modified 02/04/09).
  33. Pautler, Stephen E MC, et al. Retroperitoneoscopic-guided radiofrequency ablation of renal tumors. Urologic Oncology Branch, National Cancer Institute and the Diagnostic Radiology Department, Warren G. Magnuson Clinical Center, NIH, Bethesda, Maryland. The Canadian Journal of Urology; 8(4); 08/01.
  34. Schaefer O, et al. CT-guided radiofrequency heat ablation of malignant lung tumors. Med Sci Monit 11/03; 9(11): MT127-31.
  35. Shah DR, Green S, Elliot A, McGahan JP, Khatri VP.Current oncologic applications of radiofrequency ablation therapies. World J Gastrointest Oncol. 2013 Apr 15;5(4):71-80.
  36. Singletary ES. Feasibility of radiofrequency ablation for primary breast cancer. Breast Cancer 2003; 10(1): 4-9.
  37. Singletary SE. Radiofrequency ablation of breast cancer. Am Surg 01/03; 69(1): 37-40.
  38. von Meyenfeldt EM, Prevoo W, Peyrot D, Lai A Fat N, Burgers SJ, Wouters MW, Klomp HM. Local progression after radiofrequency ablation for pulmonary metastases. Cancer. 2011 Aug 15;117(16):3781-7. doi: 10.1002/cncr.25958. Epub 2011 Feb 11.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/23/14.

GUIDELINE UPDATE INFORMATION:

03/15/04

New Medical Coverage Guideline.

03/15/05

Scheduled review with revisions consisting of adding coverage criteria regarding palliation of osteolytic bone lesions and osteomas.

01/01/06

Annual HCPCS coding update (added 50592).

03/15/06

Scheduled review; no change in coverage statement.

01/01/07

Annual HCPCS coding update (added 32998).

04/15/07

Scheduled review; added inoperable renal masses as a covered indication; added CPT code 50542.

05/15/07

Reformatted guideline.

04/15/08

Scheduled review; no change in position statement; references updated.

04/15/09

Scheduled review; description section revised; no change in position statement; references updated.

01/01/10

Annual HCPCS coding update: simple revision of descriptor for code 32998.

05/15/11

Scheduled review; position statement unchanged; references updated; formatting changes.

09/15/11

Revision; formatting changes.

11/15/12

Annual review; position statement and references updated; formatting changes.

11/15/13

Annual review; position statement updated to include reference to thyroid tumors; Program Exceptions section updated; references updated; other formatting changes.

11/15/14

Annual review; position statement unchanged; references updated.

01/01/15

Annual coding update: revised 20982.

Date Printed: October 23, 2017: 07:18 AM