L28756-LCD

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Local Coverage Determination (LCD) for Accelerated Partial Breast Irradiation (APBI) (L28756)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28756

LCD Title

Accelerated Partial Breast Irradiation (APBI)

Contractor's Determination Number APBI

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009 Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy N/A

Indications and Limitations of Coverage and/or Medical Necessity

Prior to breast conservation procedures, virtually all women with operable breast cancer underwent a mastectomy. Long-term studies now demonstrate equivalent local control and overall survival with lumpectomy followed by radiation compared to mastectomy. Accelerated partial breast irradiation (APBI) uses radiation that targets only a segment surrounding the tumor rather than the entire breast. The duration of treatment is 4 to 5 days and is delivered in fewer fractions at larger doses per fraction.

APBI after breast-conserving surgery is considered medically necessary for patients with early stage breast cancer when all of the following criteria is met:

Diagnosis: Invasive carcinoma or ductal carcinoma in situ of the breast Size: < 3cm

Margin status: Negative - at least 2 mm in all directions

Nodal status: Negative axillary lymph node dissection or sentinel lymph node evaluation

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

013x Hospital Outpatient 085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0333 Radiology - Therapeutic and/or Chemotherapy Administration - Radiation Therapy

CPT/HCPCS Codes

PLACEMENT OF RADIOTHERAPY AFTERLOADING EXPANDABLE CATHETER (SINGLE OR MULTICHANNEL) 19296 INTO THE BREAST FOR INTERSTITIAL RADIOELEMENT APPLICATION FOLLOWING PARTIAL MASTECTOMY,

INCLUDES IMAGING GUIDANCE; ON DATE SEPARATE FROM PARTIAL MASTECTOMY

PLACEMENT OF RADIOTHERAPY AFTERLOADING EXPANDABLE CATHETER (SINGLE OR MULTICHANNEL) 19297 INTO THE BREAST FOR INTERSTITIAL RADIOELEMENT APPLICATION FOLLOWING PARTIAL MASTECTOMY,

INCLUDES IMAGING GUIDANCE; CONCURRENT WITH PARTIAL MASTECTOMY (LIST SEPARATELY IN

ADDITION TO CODE FOR PRIMARY PROCEDURE)

ICD-9 Codes that Support Medical Necessity

174.0 - 174.9 opens in new window

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

233.0 CARCINOMA IN SITU OF BREAST

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

The following information must be clearly documented in the patient’s medical record; per the selection criteria listed in the Indications and Limitations of Coverage section:

Diagnosis: Invasive carcinoma or ductal carcinoma in situ of the breast Size: < 3cm

Margin status: Negative - at least 2 mm in all directions

Nodal status: Negative axillary lymph node dissection or sentinel lymph node evaluation

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review.

Sources of Information and Basis for Decision ACR/ASTRO Whitepaper, December, 2003.

Arthur D, Vicini F, Kuske RR, et al. Accelerated partial breast irradiation: An updated report from the American Brachytherapy Society. Brachytherapy 2002; 1(4):184-190.

BlueCross BlueShield Association Technology Evaluation Center (TEC) Assessment. Brachytherapy for accelerated partial breast irradiation after breast-conserving surgery for early stage breast cancer. 2002 Dec;17(8).

Coleman, C. N., P. E. Wallner, et al. (2003). "Inflammatory breast issue." J Natl Cancer Inst 95(16): 1182-3.

Consensus statement for Accelerated Parial Breast Irradiation form the American Society of Breast Surgeons – http://www.breastsurgeons.org/officialstmts/officialstmt3.html

FDA Talk Paper. FDA Clears New Device for Radiation Treatment for breast cancer – http://www.fda.gov/bbs/topics/answers/2002/ANS01150.html

Fischer B, Anderson S, Bryant J, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002; 347:1233-1241.

Keisch M, Vicini F, Kuske RR, et al. Initial clinical experience with the MammoSite breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy. Int J Radiat Oncol Biol Phys 2003 Feb 1;55(2):289-93.

King TA, Bolton JS, Kuske RR, et al. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for T1,2 breast cancer. Am J Surg 2000 Oct;180(4):299-304.

Kuerer HM. The case for accelerated partial-breast irradiation for breast cancer. Contemporary Surgery 2003;59:508-517.

Morrow M. Rational local therapy for breast cancer. N Engl J Med 2002;347:1270-1271.

Newman, L. A. and T. A. Washington (2003). "New trends in breast conservation therapy." Surg Clin North Am 83(4): 841-83.

Polgar C, Sulyok Z, Fodor J, et al. Sole brachytherapy of the tumor bed after conservative surgery for T1 breast cancer: five-year results of a phase I-II study and initial findings of a randomized phase III trial. J Surg Oncol 2002 Jul;80(3):121-8.

Veronesi U, Cascinelli N, Mariani L, et al. Twenty-year follow-up of randomized study comparing breast- conserving surgery with radical (Halstead) mastectomy for early breast cancer. N Engl J Med. 2002; 347:1227- 1232.

Vicini FA, Kestin L, Chen P, et al. Limited-field radiation therapy in the management of early-stage breast cancer. J Natl Cancer Inst 2003;95:1205-1211.

Wallner, P., D. Arthur, et al. (2004). "Workshop on partial breast irradiation: state of the art and the science, Bethesda, MD, December 8-10, 2002." J Natl Cancer Inst 96(3): 175-84.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision reses with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A\

Start Date of Notice Period: 12/04/2008 Original Effective Date:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28756) replaces LCD L18914 as the policy in notice. This document (L28756) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0333 was changed

Reason for Change