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Date Printed: October 20, 2017: 08:41 AM

Private Property of Blue Cross and Blue Shield of Florida.
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.

02-99221-16

Original Effective Date: 04/15/10

Reviewed: 03/27/14

Revised: 11/01/15

Subject: Interstitial Laser Therapy for Breast 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  

DESCRIPTION:

Interstitial laser therapy (ILT) is a minimally invasive procedure that has been investigated for treating small localized benign and malignant tumors of the breast (i.e., fibroadenoma and carcinoma). It is an alternative to surgical excision (i.e., lumpectomy) using image-guided needle probes to delivery laser beams into the tumor, thus destroying the tumor cells.

POSITION STATEMENT:

Interstitial laser therapy for the treatment of breast tumors is considered experimental or investigational, as there is insufficient clinical evidence to support its effectiveness compared to surgical excision of benign or malignant breast tumors. Additional large randomized controlled studies are needed to assess the long-term effects of ILT in the treatment of breast tumors.

BILLING/CODING INFORMATION:

There is no specific procedure code for reporting interstitial laser therapy (ILT).

REIMBURSEMENT INFORMATION:

Refer to POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Laser Procedures (140.5) located at cms.gov.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Cryosurgical Ablation of Solid Tumors Other Than Liver or Prostate Tumors, 02-99221-12
Radiofrequency Ablation of Solid Tumors Other Than Liver Tumors, 02-99221-13

OTHER:

Other indexing terms for ILT:

Note: 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.

Interstitial laser ablation
Kelsey Interstitial Laser Therapy System
Novilase™ Interstitial Laser Therapy System

REFERENCES:

  1. About.com Breast Cancer [website]. Novilase Laser Ablation for Breast Fibroadenomas. Fast Laser Procedure Gives Great Results and Speedy Recovery. By Pam Stephan, About.com Guide. Updated January 18, 2010 Accessed 02/08/11.
  2. American Cancer Society. Making Treatment Decisions. Photodynamic Therapy. Accessed 02/24/10.
  3. American Cancer Society. Breast Cancer Facts & Figures 2011-2012. Atlanta: American Cancer Society, Inc. Accessed 02/09/12.
  4. American Society of Clinical Oncology. In-Situ laser ablation of mammographically detected breast cancers (2003).
  5. Bloom K. Pathologic changes after interstitial laser therapy of infiltrating breast carcinoma. The American Journal of Surgery 182 (2001) 384–388.
  6. breastresearch.com. “On the Horizon” by Kambiz Dowlat, MD. Accessed 02/18/10.
  7. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Laser Procedures (140.5). Effective Date of this Version 05/01/97.
  8. ClinicalTrials.gov (Accessed 02/13/14)

NCT01478438.

NCT00807924

NCT01791998

  1. Dowlatshahi K. Interstitial Laser Therapy of Breast Fibroadenomas with 6 and 8 year follow-up. The Breast Journal, Volume 16 Number 1, 2010 73–76.
  2. Dowlatshahi K. Laser Therapy of Breast Cancer with 3-Year Follow-up. The Breast Journal, Volume 10, Number 3, 2004 240–243.
  3. Haraldsdottir K. Interstitial laser thermotherapy (ILT) of breast cancer. EISO 34(2008) 739-745.
  4. National Cancer Institute. Breast Cancer Treatment PDQ, Health Professional Version (02/18/10).
  5. National Cancer Institute. Male Breast Cancer Treatment PDQ. Health Professional Version (12/14/09).
  6. National Cancer Institute. Lasers in Cancer Treatment Fact Sheet (Reviewed 09/13/11). Accessed 02/09/12.
  7. National Institute for Clinical Excellence (NICE). Interstitial laser therapy for fibroadenomas of the breast. Interventional Procedure Guidance No. 131. London, UK: NICE; June 2005. Accessed 02/11.
  8. National Institute for Clinical Excellence (NICE). Interstitial laser therapy for breast cancer. Interventional Procedure Guidance No. 89. London, UK: NICE; September 2004. Accessed 02/11.
  9. Novian Health, Inc. Novilase [website]. Chicago, IL: Novian Health; 2009. Accessed 02/08/11.
  10. U.S. Food and Drug Administration (FDA) 510k Summary. Kelsey Interstitial Laser Therapy System. K070353. (05/02/07).
  11. U.S. Food and Drug Administration (FDA). The Novilase Interstitial Laser Therapy (Novian Health, Inc., Chicago, IL). 2007.
  12. Vlastos G. Minimally Invasive approaches for diagnosis and treatment of Early-stage Breast Cancer. The Oncologist 2007; 12:1–10.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 03/27/14.

GUIDELINE UPDATE INFORMATION:

04/15/10

New Medical Coverage Guideline.

04/15/11

Scheduled review; position statement unchanged; references updated.

04/15/12

Scheduled review with literature search; position statement unchanged.

04/15/13

Scheduled review with literature search; position statement unchanged; references updated; Program Exceptions section updated.

04/15/14

Scheduled annual review with literature search; position statement unchanged; references updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: October 20, 2017: 08:41 AM