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"CPT codes, descriptions and other data only are copyright 1999 American Medical Association (or other such date of publication of CPT). All right reserved. Applicable FARS/DFARS apply."

MARYLAND MEDICARE PART A

Beginning Effective Date
June 26, 2000.

Ending Effective Date
Not applicable at this time.

Description
Sentinel lymph node biopsy in breast carcinoma is a technique that allows sampling of the lymph node or nodes that directly form the drainage system of the area of the breast containing the carcinoma. The advantage of this technique is that if the sentinel lymph node(s) is negative for metastases, a complete axillary lymphadenectomy with its increased morbidity, can be avoided.

For sentinel lymph node biopsy to adequately predict the presence of the metastases in the axilla, the procedure must be meticulously performed by surgeons accomplished in the technique. The literature on this subject indicates that a significant learning curve exists in surgeons gaining proficiency in this technique. Also, the procedure should be performed using a combination of injection of vital dye and radiopharmaceutical tracer to allow both visual and radioscintigraphic identification of the sentinel node(s).

Policy Type
Local Medical Review Policy

• Clinical Stage I carcinoma of the breast (primary tumor equal to or less than 2.0cm. in size with no palpable lymph nodes in the axilla); and,
• If the sentinel lymph node biopsy is negative, an axillary lymphadenectomy is not planned.

• Advanced stages of breast carcinoma with either palpable axillary lymphadenopathy on the ipsilateral side of the breast cancer or a large primary mass (greater than 2.0cm. in size);
• An axillary lymphadenectomy will be performed, regardless of the findings of the sentinel lymph node biopsy; and,
• The patient has received neoadjuvant chemotherapy for breast cancer or previous radiation therapy to the axillary nodes to be biopsied.

• Completion of an adequate course of training in this technique, either in an approved residency program or a post-residency training program, that meets at least the standards of the American College of Surgeons training program that has been established for sentinel lymph node biopsy; and;
• Performance of an established number of sentinel lymph node biopsy procedures under the direction of a surgeon already credentialed in the procedure. The number of procedures performed under direction of another credentialed surgeon should be established by the credentialing committee, but should be adequate to ensure proficiency in the technique.

HCPCS Section(s)
Surgery
Radiology

Type(s) of Bill
11X, 21X (HCPCS not required)
13X, 18X, 83X, 85X (HCPCS required)

Revenue Code(s)
36X, 49X
32X, 333, 34X, 35X, 40X, 61X

ICD-9-CM Codes That Support Medical Necessity
When procedure codes 38500, 38525, 38530, 38792, and 78195 are used to report sentinel node biopsy as described within this policy, the following diagnosis code(s) will be considered by Medicare to support medical necessity:

Non-covered ICD-9-CM Code(s)
     All diagnoses not listed in "ICD-9-CM Codes That Support Medical Necessity."

• Establishment of national policy supercedes all previous contractor policy statements, including Local Medical Policy coverage guidelines.
• Title XVIII of the Social Security Act, section 1862 (a) (7). This section excludes routine physical examinations.
• Title XVIII of the Social Security Act, section 1862 (a) (1) (A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

• The medical record does not verify that the service described by the HCPCS code was provided.
• The procedure was not documented in the medical record.
• The documentation did not support the medical necessity for this service.
• The service was performed for a diagnosis other than those identified under "ICD-9-CM Codes That Support Medical Necessity."
• Guidelines for this policy were not followed.

Sources of Information
TrailBlazer Health Enterprises, LLC^SM, Medicare Part B Newsletters, No. 00-001 October 11, 1999 and No. 00-003 February 7, 2000. Carrier Medical Director (CMD) New Technology-Surgery Workgroup Consultants in Surgical Oncology.
Albertini, John J., M.D., et al. 1996. "Lymphatic Mapping and Sentinel Node Biopsy in the Patient with Breast Cancer." Journal of the American Medical Association Vol. 276: (no.22) pp. 1818-1822.
Krag, David, M.D., et al. 1998. "The Sentinel Node in Breast Cancer." The New England Journal of Medicine Vol. 339: (No. 14) pp. 941-946.

• Use the appropriate HCPCS code to report this service.
• All of the coverage criteria must be met before Medicare can reimburse this service.
• Diagnosis must be present on any claim submitted.
• The diagnosis code must be representative of the patient's condition.

• Documentation should be legible, maintained in the patient's medical records, and must be available to Medicare upon request.
• The medical necessity for the procedure must be documented in the patient's medical record.

Other Comments
This policy does not apply to sentinel lymph node biopsy performed for melanoma, which is well established and covered already by Medicare on a reasonable and medically necessary basis.

This policy does not reflect the sole opinion of the intermediary, carrier, or Intermediary/Carrier Medical Directors. Although the final decision rests with the intermediary/carrier, this policy was developed in cooperation with the Carrier Advisory Committee (CAC), which includes representatives from the appropriate specialties.

Start Date of Comment Period
April 5, 2000

Start Date of Notice Period
May 26, 2000.

Revision Date

Revision Number

THIS BULLETIN SHOULD BE SHARED WITH ALL HEALTH CARE PRACTITIONERS AND MANAGERIAL MEMBERS OF THE PROVIDER/SUPPLIER STAFF. BULLETINS ISSUED AFTER OCTOBER 1, 1999 ARE AVAILABLE AT NO-COST FROM OUR WEBSITE AT www.marylandmedicare.com

©CPT American Medical Association