Medical_Policy

Highmark Commercial Medical Policy - Pennsylvania

Medical Policy:	S-147-017
Topic:	Breast Ductal Lavage and Fiberoptic Ductoscopy
Section:	Surgery
Effective Date:	January 1, 2015
Issue Date:	July 9, 2018
Last Reviewed:	June 2018

Ductal lavage is a minimally invasive procedure. A small amount of nipple aspirate fluid (NAF) is elicited to locate fluid-yielding ducts for lavage. Next, a microcatheter is inserted into each NAF-yielding duct through its natural opening on the nipple surface. Saline is infused through the microcatheter into the duct to collect epithelial cells. The ductal fluid is then withdrawn through the catheter The fluid is then analyzed microscopically for cytological abnormalities.

Fiberoptic ductoscopy also referred to as mammary (breast) ductoscopy is a procedure that involves enlargement of the duct at the nipple with small metal wires. A ductoscope which is a small tube with a camera attached is passed into the duct and advanced into the breast. Water may be injected through the scope and examined and/or a very thin wire probe may be passed up to several inches into beast to sample any abnormalities that might be found.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

Breast Ductal Lavage

Breast Ductal Lavage may be considered medically necessary:

When non-lactational nipple discharge is too low to permit adequate cytological analysis.

Breast ductal lavage in combination with ductoscopy for the evaluation of women with ipsilateral breast cancer is considered experimental/investigational due to insufficient evidence in peer reviewed literature:

Breast ductal lavage For the purpose of breast cancer screening, breast cancer risk-assessment and for all other indications is considered experimental/investigational due to insufficient evidence in peer reviewed literature:

Procedure Codes

19499

Fiberoptic Ductoscopy

Fiberoptic ductoscopy may be considered medically necessary:

When combined with cytology testing for diagnosing intra-ductal lesions in women with non-lactational sporadic nipple discharge accompanied by documented positive cytology, or
As a guide for resection of known breast intra ductal cancer.

Due to insufficient evidence in the peer reviewed literature, fiberoptic ductoscopy will be considered experimental/investigational and denied when used for breast cancer screening and all other indications.

Procedure Codes

19499

Breast Ductal Lavage and Fiberoptic Ductoscopy are not to be used as a routine breast cancer diagnostic tool.

Place of Service: Outpatient

The policy position applies to all commercial lines of business

Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Links

Link to References

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

Provides free aids and services to people with disabilities to communicate effectively with us, such as:

Qualified sign language interpreters

Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:

Qualified interpreters

Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.