Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Sentinel Lymph Node Biopsy and Mapping
Policy #:MA11.068d

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.


MEDICALLY NECESSARY

Sentinel lymph node biopsy (SLNB) and mapping are considered medically necessary and, therefore, covered to assist in the accurate staging of the following conditions:
  • Melanoma
  • Breast carcinoma
  • Spindle cell variant squamous cell carcinoma
  • Vulvar carcinoma
  • Merkel cell carcinoma
  • Penile Cancer
  • Uterine-confined endometrial cancer


EXPERIMENTAL INVESTIGATIONAL

All other uses for sentinel lymph node biopsy (SLNB) and mapping are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

There is no Medicare coverage determination addressing this service; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, sentinel lymph node biopsy (SLNB) and mapping are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

BILLING GUIDELINES

A vital dye injection performed in the operating room to visualize sentinel lymph node(s) should be reported by the surgeon/physician who administered it. A vital dye injection should only be reported once, regardless of the number of injections made.

Description

Sentinel lymph node biopsy (SLNB) is a technique used to sample the first lymph node(s) that receive(s) lymphatic drainage directly from a tumor or area of carcinoma. The advantage of this technique is that if the sentinel lymph node(s) is/are negative for metastases, a lymph node dissection (lymphadenectomy) is usually not performed. This spares the individual the risk of morbidity (e.g., neuropathy, lymphedema) that is associated with lymphadenectomy. SLNB may be indicated for individuals who have malignant melanoma, breast carcinoma, spindle cell variant squamous cell carcinoma, vulvar carcinoma, or Merkel cell carcinoma.

Sentinel lymph node mapping (i.e. lymphoscintigraphy) is an imaging technique that is used to identify the lymph drainage basin, determine the number of sentinel nodes, differentiate sentinel nodes from subsequent nodes, locate the sentinel node in an unexpected location, and mark the sentinel node over the skin for biopsy.

There are three methods for mapping sentinel lymph nodes:
  • Injection of blue dye alone
  • Injection of a colloidal preparation (filtered or unfiltered sulfur colloid, nanocolloid, tin colloid, or antimony sulfide), which has been labeled with technetium-99m, a low-level radioactive agent
  • A combination method that uses both blue dye and radioactive colloid

If the vital dye alone is injected, intraoperative mapping of the lymphatic channels is performed by following the blue-dyed lymphatics to the sentinel node(s). If radioactive colloid alone is injected, intraoperative mapping of the lymphatic channels is performed using a stationary gamma camera or a hand-held gamma-detecting probe.

The combination method, which is the most frequently used, has a success rate ranging from 92 to 99 percent. One advantage of the combination method is that the gamma instrument leads the surgeon to the area of greatest radioactivity, while visual identification of the blue-dyed lymphatics decreases the use of dissection to detect the sentinel lymph node(s). Prior to surgery, the surgeon injects the blue dye and a small dose of radioactive colloid near the primary tumor site. Once the radioactive colloid and the dye reach the nodes, the surgeon scans the area with the gamma ray counter. When the radioactive agent is detected, an audible tone is emitted, revealing the exact location of the sentinel lymph node(s). The surgeon then makes a small incision (approximately one-half inch) and removes the affected sentinel lymph node(s).
References

Ahrendt GM, Laud P, Tjoe J, et al. Does breast tumor location influence success of sentinel lymph node biopsy? J Am Coll Surg. 2002;194(3):278-284.

Canavan TP, Cohen D. Vulvar cancer. Am Fam Physician. 2002;66(7):1269-1274.

de Hullu JA, Hollema H, Piers DA, et al. Sentinel lymph node procedure is highly accurate in squamous cell carcinoma of the vulva. J Clin Oncol. 2000;18(15):2811-2816.

Baldwin KM. Sentinel lymph node biopsy for squamous cell carcinoma. [e-Medicine Web site]. 10/02/2014. Available at:http://emedicine.medscape.com/article/854550-overview. Accessed January 25, 2016.

Guler-Nizam E, Metzler G, Breuninger H, et al. Clinical course and prognostic factors of Merkel cell carcinoma of the skin. [Medscape Web site]. 08/27/2009. Available at: http://www.medscape.com/viewarticle/706472_4 [via subscription only]. Accessed January 25, 2016.

Hayes Inc. Hayes Medical Technology Directory. Sentinel node biopsy for the staging of breast cancer. Lansdale, PA: Hayes, Inc.; 2005.

Keidan RD. Sentinel lymph node biopsy in patients with melanoma. [e-Medicine Web site]. 04/28/2014. Available at: http://emedicine.medscape.com/article/854424-overview. Accessed January 25, 2016.

Levenback CF, Tian C, Coleman RL, et al. Sentinel node (SN) biopsy in patients with vulvar cancer: A Gynecologic Oncology Group (GOG) study. 2009 American Society of Clinical Oncology (ASCO) Annual Meeting. [ASCO Web site]. Available at: http://meeting.ascopubs.org/cgi/content/short/27/15S/5505. Accessed January 25, 2016.

Lyman GH, Temin S, Edge SB, et al. Sentinel Lymph Node Biopsy for Patients With Early-Stage Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2014;32(13):1365-1383. Also available on the J Clin Oncol. Web site at:
http://www.asco.org/ASCOv2/Practice+%26+Guidelines/Guidelines/Clinical+Practice+Guidelines/American+Society+of+Clinical+Oncology+Guideline+Recommendations+for+Sentinel+Lymph+Node+Biopsy+in+Early-Stage+Breast+Cancer. Accessed January 25, 2016.

Merisio C, Berretta R, Gualdi M, et al. Radioguided sentinel lymph node detection in vulvar cancer. Int J Gynecol Cancer. 2005;15(3):493-497.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Breast Cancer. Latest version as of the access date. [NCCN Web site]. Available at: http://www.nccn.org. Accessed April 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Melanoma. Latest version as of the access date. [NCCN Web site]. Available at: http://www.nccn.org. Accessed April 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Merkel Cell Carcinoma. Latest version as of the access date. [NCCN Web site]. Available at: http://www.nccn.org. Accessed April 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Penile Cancer. Latest version as of the access date. [NCCN Web site]. Available at: http://www.nccn.org. Accessed April 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Squamous Cell Skin Cancer. Latest version as of the access date. [NCCN Web site]. Available at: http://www.nccn.org. Accessed April 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Uterine Neoplasms.Latest version as of the access date. [NCCN Web site]. Available at: http://www.nccn.org. Accessed April 23, 2019.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Vulvar Cancer (Squamous Cell Carcinoma).Latest version as of the access date. [NCCN Web site]. 01/14/2016. Available at: http://www.nccn.org. Accessed April 23, 2019.

Veronesi U, Paganelli G, Viale G, et al. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med. 2003;349(6):546-553.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

38500, 38505, 38510, 38520, 38525, 38530, 38531, 38792, 38900, 78195


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Sentinel Lymph Node Biopsy and Mapping
Description: ICD-10 Codes







Policy History

MA11.068d:
05/31/2019This version of the policy is effective as of 05/31/2019.

The title of policy was changed from Sentinel Lymph Node Biopsy to Sentinel Lymph Node Biopsy and Mapping.

This policy update communicates that sentinel lymph node biopsy (SLNB) and mapping are now considered medically necessary and, therefore, covered to assist in the accurate staging of the following conditions:
  • Penile Cancer
  • Uterine-confined endometrial cancer

Uses, other than those listed as medically necessary in this medical policy bulletin, for sentinel lymph node biopsy (SLNB) and mapping are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

MA11.068c
01/01/2019This policy has been identified for the CPT code update, effective 01/01/2019.

The following CPT code has been added to this policy: 38531

MA11.068b
10/01/2018This policy has been identified for the ICD-10 CM code update, effective 10/01/2018.

The following ICD-10 CM codes have been added to Attachment A of this policy:
    C43.111, C43.112, C43.121, C43.122, C44.1221, C44.1222, C44.1291, C44.1292, C4A.111, C4A.112, C4A.121, C4A.122, D03.111, D03.112, D03.121, D03.122

The following ICD-10 CM codes have been removed from Attachment A of this policy:
    C43.11, C43.12, C44.122, C44.129, C4A.11, C4A.12, D03.11, D03.12

MA11.068a
06/21/2017This policy has been reissued in accordance with the Company's annual review process.
03/02/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Sentinel Lymph Node Biopsy.
01/28/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Sentinel Lymph Node Biopsy.

MA11.068
01/01/2015This is a new policy.






Version Effective Date: 05/31/2019
Version Issued Date: 05/31/2019
Version Reissued Date: N/A