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Date Printed: December 16, 2017: 09:12 PM

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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.

02-99221-12

Original Effective Date: 02/15/04

Reviewed: 09/22/16

Revised: 10/15/16

Subject: Cryosurgical Ablation of Solid Tumors Other Than Liver or Prostate 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:

Cryosurgical ablation, or cryosurgery, involves freezing of target tissues, usually by inserting a probe into the tumor through which coolant is circulated. Cryosurgery may be performed as an open surgical technique or as a closed procedure under laparoscopic or ultrasound guidance. This policy addresses the use of cryosurgery for various solid tumors other than tumors of the prostate and liver.

It is believed that the advantages of cryosurgery include improved local control and benefits common to any minimally invasive procedure (e.g., preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization). Potential complications of cryosurgery include those caused by hypothermic damage to normal tissue adjacent to the tumor, structural damage along the probe track, and secondary tumors, if cancerous cells are seeded during probe removal.

Cryosurgical treatment of various tumors including renal cell carcinoma (RCC), malignant and benign breast disease, pancreatic cancer, and lung cancer has been reported in the literature.

Breast Tumors: Early-stage primary breast cancers are treated surgically. The selection of lumpectomy, modified radical mastectomy, or another approach is balanced against the patient’s desire for breast conservation, the need for tumor-free margins in resected tissue, and the patient’s age, hormone receptor status, and other factors. Adjuvant radiotherapy decreases local recurrences, particularly for those who select lumpectomy. Adjuvant hormonal therapy and/or chemotherapy are added, depending on presence and number of involved nodes, hormone receptor status, and other factors. Treatment of metastatic disease includes surgery to remove the primary lesion and combination chemotherapy. Fibroadenomas are common benign tumors of the breast that can present as a palpable mass or a mammographic abnormality. These benign tumors are frequently surgically excised to rule out a malignancy.

Lung Tumors: Early-stage lung tumors are typically treated surgically. Patients with early-stage lung cancer who are not surgical candidates may be candidates for radiation treatment with curative intent. Cryoablation is being investigated in patients who are medically inoperable, with small primary lung cancers or lung metastases. Patients with more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment is rarely curative; rather, it seeks to retard tumor growth or palliate symptoms.

Pancreatic Cancer: Pancreatic cancer is a relatively rare solid tumor that occurs almost exclusively in adults and is almost always fatal. Surgical resection of tumors contained entirely within the pancreas is currently the only potentially curative treatment. However, the nature of the cancer is such that few tumors are found at such an early and potentially curable stage. Patients with more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment is rarely curative; rather, it seeks to retard tumor growth or palliate symptoms.

Renal Cell Carcinomas: Localized RCC is treated by radical nephrectomy or nephron-sparing surgery. Prognosis drops precipitously if the tumor extends outside the kidney capsule, because chemotherapy is relatively ineffective against metastatic RCC.

POSITION STATEMENT

Note: This guideline is not applicable to cryosurgical ablation of solid tumors of the liver or prostate. Refer to section entitled Related Guidelines.

Cryosurgical ablation meets the definition of medical necessity 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 (ie, the member has 1 kidney or renal insufficiency defined by a glomerular filtration rate [GFR] of less than 60 mL/min/m2) and standard surgical approach (ie, resection of renal tissue) is likely to substantially worsen kidney function; OR

The member is not considered a surgical candidate.

Cryosurgical ablation is considered experimental or investigational as a treatment of benign or malignant tumors of the breast, lung, pancreas, or other solid tumors or metastases outside the liver and prostate, and to treat renal cell carcinomas in members who are surgical candidates. The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

19105

Ablation, cryosurgical, of fibroadenomas, including ultrasound guidance, each (investigational)

20983

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

50250

Ablation, open, 1 or more renal mass lesions(s), cryosurgical, including intraoperative ultrasound guidance and monitoring, if performed

50542

Laparoscopy, surgical; ablation of renal mass lesions(s), including intraoperative ultrasound guidance and monitoring, when performed

50593

Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy

0340T

Ablation, pulmonary tumor(s), including pleura or chest wall when involved by tumor extension, percutaneous, cryoablation, unilateral, includes imaging guidance (investigational)

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:

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services (L33777) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Cryoablation of Liver Tumors, 02-40000-22
Cryosurgical Ablation of the Prostate (CSAP), 02-54000-14

Endoscopic Radiofrequency Ablation or Cryosurgical Ablation for Barrett’s Esophagus, 01-91000-10

Radiofrequency Ablation of Liver Tumors, 02-40000-23

Radiofrequency Ablation of Solid Tumors Other Than Liver Tumors, 02-99221-13

OTHER:

Noe Applicable

REFERENCES:

  1. Alberta Provincial Genitourinary Tumour Team. Renal cell carcinoma. Edmonton (Alberta): Alberta Health Services, Cancer Care; 2012 May. 14 p. (Clinical practice guideline; no. GU-003).
  2. American Society of Breast Surgeons. Management of Fibroadenomas of the Breast. Official Statement. Revised 04/29/08. Accessed 08/14/14.
  3. American Society of Breast Surgeons. Position Statement on Ablative and Percutaneous Treatment of Breast Cancer. 04/24/02. Accessed 08/14/14.
  4. American Urological Association Education and Research, Inc. Guideline for management of the clinical stage 1 renal mass. Linthicum (MD).
  5. Bland KL, Gass J, Klimberg VS. Radiofrequency, cryoablation, and other modalities for breast cancer ablation. Surg Clin North Am. 2007 Apr; 87 (2):539-50, xii.
  6. Blue Cross Blue Shield Association Medical Policy Reference 7.01.92, Cryosurgical Ablation of Miscellaneous Solid Tumors Other Than Liver, Prostate Tumors, or Dermatologic Tumors, 08/16.
  7. Cancernetwork.com. Abella HA. Cryoablation proves its palliative power in soft tissue, bone tumors, 08/20/07.
  8. Cancernetwork.com. Moser T, et al. Image-guided ablation eases bone tumor pain. Partial necrosis of malignant boen metastases may help improve cancer patients’ quality of life. Diagnostic Imaging Europe, 10/01/07.
  9. Casalino DD, Remer EM, Bishoff JT, Coursey CA, Dighe M, Harvin HJ, Heilbrun ME, Majd M, Nikolaidis P, Preminger GM, Raman SS, Sheth S, Vikram R, Weinfeld RM, Expert Panel on Urologic Imaging. ACR Appropriateness Criteria® post-treatment follow-up of renal cell carcinoma. [online publication]. Reston (VA): American College of Radiology (ACR); 2013.
  10. Chalaire, D. “On the Move: Efforts Under Way to Improve Outcomes for Patients with Renal Cancer”. OncoLog, MD Anderson’s report to physicians about advances in cancer care and research. December 2003, Vol 48, No 12.
  11. ClinicalTrials.gov: Cryoablation or External Beam Radiation Therapy in Treating Patients with Painful Bone Metastases, NCT00510969; Cryosurgery in Treating Women with Breast Lesions, NCT00020852; Cryotherapy and GM-CSF in Treating Patients with Lung Metastases or Primary Lung Cancer, NCT00514215; Cryotherapy in Treating Patients with Primary Lung Cancer or Lung Metastases That Cannot Be Removed by Surgery, NCT00303901; Study of Ablation for the Pulmonary Focal Pure Ground Glass Opacity (pGGO), NCT01429649. MR Guided Focused Ultrasound Surgery in The Treatment of Breast Fibroadenomas. NCT00147108.
  12. ECRI Health Technology Trends; “Cryoablation may offer long-term control of small kidney tumors”. 07/03.
  13. ECRI Institute Custom Hotline Response article; “Percutaneous cryoablation for renal cell carcinoma”. 11/02/06.
  14. ECRI Institute Custom Hotline Response. “Cryoablation for Renal Cell Carcinoma” (04/29/08).
  15. ECRI Institute Health Technology Forecast. Expanding Indications for Cryosurgery for Malignant Tumors. 06/25/07.
  16. Hayes Alert Newsletter, “Cryosurgery for Renal Masses”, 03/04.
  17. Hayes Brief, “Percutaneous Cryoablation for the Treatment of Renal Cell Cancer” (03/12/07; updated 03/20/08).
  18. Hayes Medical Technology Directory, “Cryoablation for Treatment of Breast Fibroadenomas”, (01/19/07; updated 01/23/08).
  19. Hayes Technology Assessment Brief, “MRI-Guided Cryoablation of Uterine Fibroids”, 01/03.
  20. Hosemann, SN. New Techniques in Tumor Ablation”. OncoLog, MD Anderson’s report to physicians about advances in cancer care and research. July/August 2004, Vol 50 No 7/8.
  21. Hwang J, et al. Laparoscopic renal Cryoablation of Small Renal Tumors: An Alternative Treatment Option in Elderly Patients at High Risk. J Clin Oncol, 23:16S, 2005.
  22. Kawamura M, et al. Local control of lung tumors by percutaneous fluoroscopic computer tomography guided cryoablation. J Clin Oncol 23:16S, 2005.
  23. Keane MG, Bramis K, Pereira SP et al. Systematic review of novel ablative methods in locally advanced pancreatic cancer. World J Gastroenterol 2014; 20(9):2267-78
  24. Lakoma A, Kim ES. Minimally invasive surgical management of benign breast lesions. Gland Surg. May 2014; 3(2): 142–148.
  25. Martin J, Athreya S. Meta-analysis of cryoablation versus microwave ablation for small renal masses: is there a difference in outcome? Diagn Interv Radiol 2013; 19(6):501-7
  26. National Cancer Institute Cancer Bulletin, “Cryoablation for Small Renal Tumors Shows Promising Results”; 05/30/06. Volume 3, No.22, p4.
  27. National Cancer Institute Clinical Trials. Cryotherapy in treating patients with primary stage I non-small cell lung cancer or lung metastasis (NCT00890617).
  28. National Cancer Institute Fact Sheet; Cryosurgery in Cancer Treatment: Questions and Answers (09/10/03).
  29. National Cancer Institute. Breast Cancer Treatment (PDQ®) Health Professional Version. (09/20/07; updated 05/22/09).
  30. National Cancer Institute. Pancreatic Cancer Treatment (PDQ®) Health Professional Version. 01/03/08; updated 07/01/09.
  31. National Cancer Institute. Renal Cell Cancer Treatment (PDQ®) Health Professional Version. 01/03/08; updated 07/01/09.
  32. National Comprehensive Cancer Network Practice Guidelines in Oncology – Non-Small Cell Lung Cancer, version 4.2016.
  33. National Comprehensive Cancer Network Practice Guidelines in Oncology – Kidney Cancer, version 3.2016.
  34. National Institute for Health and Clinical Excellence (NICE). Interventional procedure guidance 207; Cryotherapy for renal cancer. (01/07).
  35. Ratko TA, Vats V, Brock J, Ruffner BW Jr, Aronson N. Local Nonsurgical Therapies for Stage I and Symptomatic Obstructive Non–Small-Cell Lung Cancer. Comparative Effectiveness Review No. 112. (Prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-2007- 10058-I.) AHRQ Publication No. 13-EHC071-EF. Rockville, MD: Agency for Healthcare Research and Quality; June 2013.
  36. National Guideline Clearinghouse. Renal cell carcinoma. NGC 009081. Revised May 2012; accessed at guideline.gov 08/23/16.
  37. Yamauchi Y, et al. Assessment of the safety and efficacy of percutaneous cryoablation for lung tumors. J Clin Oncol 27:15s, 2009.
  38. Yamauchi Y, et al. Percutaneous cryoablation for primary lung cancer: Outcome and prospective future. J Clin Oncol 28, 2010.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/22/16.

GUIDELINE UPDATE INFORMATION:

02/15/04

New Medical Coverage Guideline

03/15/05

Scheduled review; no change in coverage statement.

01/01/06

Annual HCPCS coding update (added 0120T, 0135T and 50250; deleted S2090 and S2091).

02/15/06

Scheduled review; no change in coverage statement.

01/01/07

Annual HCPCS coding update (added 19105; deleted 0120T.)

02/15/07

Scheduled review; no change in coverage statement.

04/15/07

Revision consisting of adding CPT code 50542.

06/15/07

Reformatted guideline.

10/15/07

Revision to Position Statement, changing verbiage from “breast cancer…” to “…tumors of the breast…”

01/01/08

Annual HCPCS coding update: added 50593, and deleted 0135T.

02/15/08

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

09/15/08

Reviewed guideline; revised position statement to include renal cell carcinoma criteria for coverage; updated references.

09/15/09

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

10/15/10

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

01/01/11

Annual HCPCS coding update: revised descriptors for 50250 and 50542.

09/15/11

Revision; formatting changes.

09/15/12

Annual review; position statement updated to address tumors of the lung; references updated.

10/15/13

Annual review; position statement unchanged; updated Description section with information regarding lung tumors; Program Exceptions section updated; references updated.

01/01/14

Annual HCPCS coding update: added 0340T.

10/15/14

Annual review; position statement unchanged; Program Exceptions section updated; references updated.

01/01/15

Annual coding update. Added 20983.

11/01/15

Revision: ICD-9 Codes deleted.

10/15/16

Revision; description, position statement, and references updated.

Date Printed: December 16, 2017: 09:12 PM