Medical_Policy

Highmark Commercial Medical Policy - Pennsylvania

Medical Policy:	L-180-005
Topic:	4Kscore for Prostate Cancer Risk Assessment
Section:	Laboratory
Effective Date:	November 13, 2017
Issue Date:	November 13, 2017
Last Reviewed:	June 2017

The 4Kscore Test (OPKO Lab) is an assay that uses total PSA, free PSA, intact PSA, and Human Kallikrein 2 in the blood and clinical factors to come up with a risk score that is associated with a person’s risk of aggressive prostate cancer.

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.

4Kscore may be considered medically necessary when the following criteria are met:

No previous 4Kscore testing performed after the most recent negative biopsy when a result was successfully obtained; and
No previous ConfirmMDx testing on the most recent negative biopsy when a result was successfully obtained; and
Member is not under active surveillance for low stage prostate cancer; and
Negative prostate biopsy within the past 24 months; and
Member is considered at higher risk for prostate cancer by one or more of the following:
- Family history of 1st degree relative with prostate cancer diagnosed younger than age 65 years; and/or
- African American race; and/or
- Known mutation in a gene associated with increased risk of prostate cancer (e.g. BRCA1/2, MLH1, MSH2, MSH6, PMS2, EPCAM).

Procedure Codes

81539

Professional Statements and Societal Positions

The National Comprehensive Cancer Network (NCCN) 2016 Clinical Practice Guidelines for Prostate Cancer Early Detection state the following:

“Those patients with negative prostate biopsies should be followed with DRE and PSA. Tests that improve specificity in the post-biopsy state-including 4Kscore, PHI, percent free PSA, PCA3, and ConfirmMDx-should be considered in patients thought to be higher risk despite a negative prostate biopsy.”
“Biomarkers that improve the specificity of detection are not recommended as first line screening tests. However, there may be some patients who meet PSA standard for consideration of prostate biopsy, but for whom the patient and/or physician wish to further define the probability of high-grade cancer. A percent free PSA less than 10%, PHI greater than 35 or 4K score (which provides an estimate of the probability of high-grade prostate cancer) are potentially informative in patients who have never undergone biopsy or after a negative biopsy; a PCA3 score greater than 35 is potentially informative after a negative biopsy.”

Place of Service: Outpatient

4Kscore for prostate cancer risk assessment is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

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.

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.