Medical_Policy

Highmark Commercial Medical Policy - Pennsylvania

Medical Policy:	L-110-001
Topic:	Genetic Testing for the Screening, Diagnosis, and Monitoring of Cancer
Section:	Laboratory
Effective Date:	September 5, 2016
Issue Date:	September 5, 2016
Last Reviewed:	August 2016

Genetic testing for screening, diagnosis and monitoring of cancer refers to molecular diagnostic tests whose purposes include identifying the possible presence of cancer in asymptomatic, average risk individuals; confirming the absence or presence of cancer; and monitoring the absence or presence of cancer after a prior diagnosis and treatment.

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.

Screening
The goal of cancer screening is to identify the possible presence of cancer before symptoms appear. Screening tests cannot diagnose cancer, but typically determine if there is an increased chance cancer is present, and triages individuals for more invasive, diagnostic testing. Most cancer screening does not include genetic testing, but instead relies on physical exam, radiological exams, or non-genetic laboratory tests. Advances in human genetics, however, have identified several molecular diagnostic tests that may provide clues for early cancer detection.

Diagnosis
When cancer is suspected because of an abnormal screening test or symptoms, blood tests for tumor markers or molecular testing on tissue samples can aid in confirming a diagnosis of cancer. These tests may contribute information to helping the clinician understand prognosis and treatment options.

Monitoring
During treatment, or after an apparently successful treatment, active monitoring is often recommended to identify if the cancer is responding to treatment or has returned or spread, before any symptoms appear. Monitoring may include increased surveillance or routine blood tests for tumor markers, and increasingly, molecular genetic tests.

Genetic testing for screening, diagnosing, or monitoring cancer may be considered medically necessary when ALL of the following conditions are met:

Technical and clinical validity: The test must be accurate, sensitive and specific, based on sufficient, quality scientific evidence to support the claims of the test; and
Clinical utility: Healthcare providers can use the test results to provide significantly better medical care for the individual; and
Reasonable use: The usefulness of the test is not significantly offset by negative factors, such as expense, clinical risk, or social or ethical challenges.

Limits:

Testing may be considered medically necessary only for the number of genes or tests necessary. A tiered approach to testing, with reflex to more detailed testing and/or different genes, will be required when clinically possible.
For tests that look for changes in germline DNA (i.e., not tumor DNA or viral DNA), testing will be allowed once per lifetime per gene. Exceptions may be considered medically necessary if technical advances in testing demonstrate significant advantages that would support a medical need to retest.

Test-specific Policies

Policies are available for the following tests designed to screen for, diagnose, or monitor cancer. See the individual policy.

Afirma Gene Expression Classifier for Thyroid Cancer
CellSearch Circulating Tumor Cell Count for Breast Cancer Prognosis
Chromosome Analysis for Blood, Bone Marrow, and Solid Tumor Cancers
Cologuard Screening for Colorectal Cancer
Confirm MDx for Prostate Cancer Risk Assessment
Mammaprint 70-Gene Breast Cancer Recurrence Assay
Mammostrat Breast Cancer Recurrence Assay
OncotypeDX for Breast Cancer Prognosis
OncotypeDX for Colorectal Cancer Recurrence Risk
PCA3 Testing for Prostate Cancer
Prolaris® for Prostate Cancer Prognosis
Tissue of Origin Testing for Cancer of Unknown Primary
UroVysion® FISH for Bladder Cancer

Tests used to determine hereditary cancer risk are covered separately under L-106, Genetic Testing for Cancer Susceptibility and Hereditary Cancer Syndromes.

This policy does not address drug response to cancer, or testing to determine which therapies to use. Please refer to L-114, Pharmacogenomic Testing for Drug Toxicity and Response for that purpose.

This policy does not address diagnostic or predictive testing for conditions other than non-inherited cancer. Refer to L-111, Genetic Testing to Diagnose Non-Cancer Conditions and L-112, Genetic Testing to Predict Disease Risk for those purposes.

Place of Service: Outpatient

Genetic Testing for the Screening, Diagnosis, and Monitoring of Cancer 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

FEP Guidelines

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.

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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.

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:

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.