Sentinel Lymph Node Biopsy (L30475)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation
Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402
Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
LCD ID Number
L30475

LCD Title
Sentinel Lymph Node Biopsy

Contractor's Determination Number
GSURG-036

AMA CPT/ADA CDT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. 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.

Primary Geographic Jurisdiction

Oversight Region
 

Original Determination Effective Date
For services performed on or after 07/16/2010

Original Determination Ending Date


Revision Effective Date
For services performed on or after 05/01/2012

Revision Ending Date


CMS National Coverage Policy
Title XVIII of the Social Security Act section 1862 (a)(1)(A). This section allows coverage and payment of those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act section 1862 (a)(7). This section excludes routine physical examinations and services

Title XVIII of the Social Security Act section 1833 (e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Pub. 100-4 Medicare Claims Processing Manual- Chapter 12 - Physicians/Nonphysician Practitioners 20.4.4 - Supplies B3-15900.2. This section prohibits Medicare payment for a radiopharmaceutical agent when the provider has not performed the diagnostic radiologic procedures.

Indications and Limitations of Coverage and/or Medical Necessity
Sentinel lymph node biopsy involves the identification, removal, and evaluation of lymph nodes that drain the area of a malignant tumor. This is for prognostic, not therapeutic purposes. When one or more tumor cells from a primary tumor migrates into lymphatic fluid, they usually lodge in the first node in the lymphatic channel that drains the tumor. This first node is referred to as the sentinel node. If the malignant cells from the tumor have spread to the lymph system, they are most likely to be found in the sentinel node when evaluated by a pathologist.

One or more multiple lymphatic channels or basins, each of which has its own sentinel node, may drain any primary tumor site. When a sentinel node in a given chain is free of tumor cells, it may be assumed that the remainder of the lymph nodes in that lymphatic channel is also free of cancer. When tumor cells are identified in a sentinel node, it suggests that cancer has spread to other nodes, indicating that a regional lymph node dissection may be necessary to assess the extent of metastasis.

Methods used to identify sentinel node include use of lymphoscintigraphy and/or direct visualization during surgery following an injection of vital dye (e.g., isosulfan blue). Lymphoscintigraphy is a nuclear medicine procedure performed prior to the surgical procedure to locate and mark the sentinel node (s) for the surgeon. It is performed by injecting a radioactive tracer under the skin, which flows toward and into the sentinel node and its lymphatic channel, and is imaged by a gamma camera that produces a map of the path of the radioactive tracer and its first appearance in the sentinel node. This is injected several hours before surgery. The vital dye is used during surgery to visualize the lymphatic channels, allowing more effective use of the gamma probe. Thus these techniques are complimentary.

The isosulfan blue dye is selectively taken up by the lymphatic vessels that drain the tumor site and stains them blue. Multiple injections are usually made at equidistant points around the primary lesion shortly before surgery. If a gamma probe is not used, the dissection will begin along the blue-stained vessels that are closest to the primary dye injection site. The surgeon may use a portable, hand-held gamma-ray detection instrument to aid in identification and confirmation of a sentinel node previously identified by nuclear medicine lymphoscintigraphy. When held to the sentinel node, the level of radioactivity registers at very high levels. (This process called intraoperative lymphoscintigraphy, is included in the biopsy procedure and is not reported separately). Once located, the sentinel node is removed and sent to the pathology department for appropriate microscopic evaluation.

Sentinel node biopsy can provide accurate staging information that can be used to determine and refine treatment options. It may also identify the presence of metastasis. An additional advantage of sentinel node biopsy is that if the sentinel node(s) is negative for tumor, a complete lymphadenectomy, with its increased morbidity, may be avoided.

For sentinel biopsy in breast cancer to be adequately predictive of the state of the complete axilla, surgeons sufficiently accomplished in the technique must do the procedure. The literature in this subject indicates that there is a significant learning curve in gaining adequate proficiency in this technique. It is preferable for the procedure to be done using a combination of injection of vital dye and radiopharmaceutical tracer to allow both visual and radioscintigraphic identification of the sentinel node(s). The surgeon, during the operative procedure, typically performs the vital dye injection. The radiopharmaceutical procedure requires the participation of a nuclear medicine physician, or radiologist, or a physician who is licensed in the handling of nuclear materials, and who is trained and experienced in this technique. The radiopharmaceutical injection procedure and the surgical excision of the sentinel node for biopsy are separately reportable services.

Sentinel Lymph node biopsy is generally covered by Medicare for the following:
1. Clinical Stage I Breast carcinoma stage I or II with no palpable lymph nodes in the axilla)
2. Clinical Stage I or II malignant melanoma of the skin.


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.

011x Hospital Inpatient (Including Medicare Part A)
012x Hospital Inpatient (Medicare Part B only)
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.


036X Operating Room Services - General Classification
051X Clinic - General Classification
052X Free-Standing Clinic - General Classification
0761 Specialty Services - Treatment Room

CPT/HCPCS Codes

38500BIOPSY OR EXCISION OF LYMPH NODE(S); OPEN, SUPERFICIAL
38505BIOPSY OR EXCISION OF LYMPH NODE(S); BY NEEDLE, SUPERFICIAL (EG, CERVICAL, INGUINAL, AXILLARY)
38510BIOPSY OR EXCISION OF LYMPH NODE(S); OPEN, DEEP CERVICAL NODE(S)
38520BIOPSY OR EXCISION OF LYMPH NODE(S); OPEN, DEEP CERVICAL NODE(S) WITH EXCISION SCALENE FAT PAD
38525BIOPSY OR EXCISION OF LYMPH NODE(S); OPEN, DEEP AXILLARY NODE(S)
38530BIOPSY OR EXCISION OF LYMPH NODE(S); OPEN, INTERNAL MAMMARY NODE(S)
38542DISSECTION, DEEP JUGULAR NODE(S)
38792INJECTION PROCEDURE; RADIOACTIVE TRACER FOR IDENTIFICATION OF SENTINEL NODE
78195LYMPHATICS AND LYMPH NODES IMAGING

ICD-9 Codes that Support Medical Necessity

Note: ICD-9 codes must be coded to the highest level of specificity.

The correct use of an ICD-9-CM code listed above does not assure coverage of a service. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this policy.

172.0MALIGNANT MELANOMA OF SKIN OF LIP
172.1MALIGNANT MELANOMA OF SKIN OF EYELID INCLUDING CANTHUS
172.2MALIGNANT MELANOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL
172.3MALIGNANT MELANOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE
172.4MALIGNANT MELANOMA OF SKIN OF SCALP AND NECK
172.5MALIGNANT MELANOMA OF SKIN OF TRUNK EXCEPT SCROTUM
172.6MALIGNANT MELANOMA OF SKIN OF UPPER LIMB INCLUDING SHOULDER
172.7MALIGNANT MELANOMA OF SKIN OF LOWER LIMB INCLUDING HIP
172.8MALIGNANT MELANOMA OF OTHER SPECIFIED SITES OF SKIN
172.9MELANOMA OF SKIN SITE UNSPECIFIED
174.0MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST
174.1MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST
174.2MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST
174.3MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST
174.4MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST
174.5MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST
174.6MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST
174.8MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST
174.9MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE
175.0MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST
175.9MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST
217BENIGN NEOPLASM OF BREAST
229.0BENIGN NEOPLASM OF LYMPH NODES
233.0CARCINOMA IN SITU OF BREAST
611.71MASTODYNIA
611.72LUMP OR MASS IN BREAST
784.2SWELLING MASS OR LUMP IN HEAD AND NECK
785.6ENLARGEMENT OF LYMPH NODES

Diagnoses that Support Medical Necessity
ICD-9 codes listed above
ICD-9 Codes that DO NOT Support Medical Necessity
Those that are not listed in this policy

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

Diagnoses that DO NOT Support Medical Necessity
Those that are not listed in this policy

General Information

Documentations Requirements
Documentation supporting the medical necessity for sentinel lymph node biopsy such as ICD-9 codes must be submitted with each claim. Claims submitted without such evidence will be denied as not medically necessary. The patient's medical records must contain documentation that fully supports the medical necessity for sentinel lymph node biopsy. This documentation includes, but not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. This documentation must be available to the carrier upon request.

Sentinel lymph node biopsy performed prior to but during the same operative session of an axillary node dissection may not be reported separately unless the results change the planned procedure. Documentation showing that the sentinel lymph node biopsy was a diagnostic procedure must be available to support the medical necessity of additional procedures performed during the same operative session.

Appendices

Utilization Guidelines
NA
Sources of Information and Basis for Decision
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from Surgery, Nuclear Medicine, Medical and Radiation Oncology.

Cochran AJ, Roberts AA, Saida T. The place of lymphatic mapping and sentinel node biopsy in oncology. International Journal of Clinical Oncology 2003; 8:139-150.

DeVita VT Jr., Hellman S, Rosenberg SA, editors. Cancer: Principles and Practice of Oncology. Vol. 1 and 2. 6th ed. Philadelphia: Lippincott Williams and Wilkins, 2001.

Gipponi M, Solari N, Di Somma FC, Bertoglio S, Cafiero F. New fields of application of the sentinel lymph node biopsy in the pathologic staging of solid neoplasms: Review of literature and surgical perspectives. Journal of Surgical Oncology 2004; 85:171-179.

Harris JR, Lippman ME, Morrow M, Osborne CK, editors. Diseases of the Breast. 3rd ed. Philadelphia: Lippincott Williams & Wilkins, 2004.

Journal of the National Cancer Institute, Sentinel Node Biopsy Improves Quality of Life in Early-Stage Breast Cancer, May 3, 2006, http://www.cancer.gov/clinicaltrials/results/snb0506

National Cancer Institute Fact Sheet 1.4, Clinical Trials Cooperative Group Program
(http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group)

National Cancer Institute Fact Sheet 5.14, Improving Methods for Breast Cancer Detection and Diagnosis
(http://www.cancer.gov/cancertopics/factsheet/Detection/breast-cancer)

National Cancer Institute Fact Sheet 5.32, Staging: Questions and Answers
(http://www.cancer.gov/cancertopics/factsheet/Detection/staging)

National Cancer Institute Fact Sheet 7.47, How To Find a Doctor or Treatment Facility If You Have Cancer
(http://www.cancer.gov/cancertopics/factsheet/Therapy/doctor-facility)

Ota DM. What's new in general surgery: Surgical oncology. Journal of the American College of Surgeons 2003; 196(6):926-932.

Sentinel Node Biopsy Helps Some Melanoma Patients Live Longer http://www.cancer.gov/clinicaltrials/results/melanoma-and-SNB0505

Sentinel Node Biopsy Improves Quality of Life in Early-Stage Breast Cancer
http://www.cancer.gov/clinicaltrials/results/snb0506

Advisory Committee Meeting Notes
Meeting Date:
Illinois 09/16/2009
Michigan 09/09/2009
Minnesota 09/24/2009
Wisconsin 09/25/2009
J5 MAC 10/08/2009

Open Meeting
08/19/2009

Start Date of Comment Period
10/08/2009

End Date of Comment Period
11/23/2009

Start Date of Notice Period
06/01/2010

Revision History Number
X

Revision History Explanation
8/1/2010 - The description for Bill Type Code 12 was changed
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 0360 was changed
8/1/2010 - The description for Revenue code 0361 was changed
8/1/2010 - The description for Revenue code 0362 was changed
8/1/2010 - The description for Revenue code 0367 was changed
8/1/2010 - The description for Revenue code 0369 was changed
8/1/2010 - The description for Revenue code 0510 was changed
8/1/2010 - The description for Revenue code 0511 was changed
8/1/2010 - The description for Revenue code 0512 was changed
8/1/2010 - The description for Revenue code 0513 was changed
8/1/2010 - The description for Revenue code 0514 was changed
8/1/2010 - The description for Revenue code 0515 was changed
8/1/2010 - The description for Revenue code 0516 was changed
8/1/2010 - The description for Revenue code 0517 was changed
8/1/2010 - The description for Revenue code 0519 was changed
8/1/2010 - The description for Revenue code 0520 was changed
8/1/2010 - The description for Revenue code 0521 was changed
8/1/2010 - The description for Revenue code 0522 was changed
8/1/2010 - The description for Revenue code 0523 was changed
8/1/2010 - The description for Revenue code 0524 was changed
8/1/2010 - The description for Revenue code 0525 was changed
8/1/2010 - The description for Revenue code 0526 was changed
8/1/2010 - The description for Revenue code 0527 was changed
8/1/2010 - The description for Revenue code 0528 was changed
8/1/2010 - The description for Revenue code 0529 was changed
8/1/2010 - The description for Revenue code 0761 was changed

10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901).

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:
38500 descriptor was changed in Group 1
38505 descriptor was changed in Group 1
38510 descriptor was changed in Group 1
38520 descriptor was changed in Group 1
38525 descriptor was changed in Group 1
38530 descriptor was changed in Group 1
38542 descriptor was changed in Group 1

02/21/2011 — In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:
38792 descriptor was changed in Group 1

05/01/2012, annual review, no update

Reason for Change
Maintenance (annual review with new changes, formatting, etc.)

Related Documents
This LCD has no Related Documents.

LCD Attachments

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Page Last Updated: Thursday, 03-May-2012 15:14:04 CDT