Designed to retrieve more tissue samples from a prostate than a standard biopsy, a saturation biopsy, either initial or repeat, for a high-risk individual provides pathologists with an extensive selection of cells to test and can be used to help diagnose and stage prostate cancer when previous conventional prostate biopsies have been negative.
Saturation biopsy of the prostate (taking 20 or more core tissue samples at one time) may be considered medically necessary for ANY ONE of the following indications in individuals with two (2) prior extended transrectal prostate biopsies (up to 12 core tissue samples) negative for invasive cancer:
Saturation needle biopsy of the prostatenot meeting the criteria as indicated in this policy is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
55700 |
55706 |
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Refer to Medical Policy S-16, Assistant Surgery Eligibility Criteria, for additional information.
National Comprehensive Cancer Network Guidelines – 2019/2020
The National Comprehensive Cancer Network guidelines (v.2.2019) on early detection of prostate cancer state that routine use of advanced biopsy techniques, including saturation biopsy, is not recommended for initial biopsy. However, based on emerging evidence the guidelines state that saturation biopsy can be considered for "very high-risk" men with previous negative biopsies. The guidelines do not specify a definition of "very high-risk", but state that men with persistently elevated or rising PSA after 1 or more negative TRUS biopsies are considered at "high risk". The guidelines also note that alternative strategies using MRI or biomarkers may avoid the use of biopsy altogether.
NCCN guidelines on prostate cancer (v.2.2020) states for [individuals] who choose active surveillance, an appropriate active surveillance schedule includes PSA measurement no more often than every six (6) months unless clinically indicated, and repeat prostate biopsy no more often than every twelve (12) months unless clinically indicated. A repeat prostate biopsy within six (6) months of diagnosis is indicated if the initial biopsy was less than 10 cores or if assessment results show discordance…Repeat biopsies are not indicated when life expectancy is [greater than] 10 years or when men are on observation.
C61 |
D07.5 |
D40.0 |
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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 or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
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, and subject to the applicable laws of your state.
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.
Discrimination is Against the Law
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:
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.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
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:
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.
