Pathology And Laboratory
Chapter 6
Section 3.1
Genetic
Testing And Counseling
Issue Date: March 10, 2000
Copyright: CPT only © 2006 American Medical
Association (or such other date of publication of CPT).
All Rights Reserved.
Revision:
1.0 DESCRIPTION
Genetic testing includes tests
that are intended to be confirmatory of a clinical diagnosis which
is already suspected based on the patient’s symptoms or risk status.
Additionally, genetic tests may be performed to aid in the treatment
of a disease or they may influence the medical management of the
individual or pregnancy. Under the family planning benefit, genetic
testing may also be performed in certain high risk individuals and
pregnancies.
2.0 POLICY
2.1 Genetic
counseling provided by an otherwise authorized provider is covered.
2.2 Genetic tests that have received
United States (US) Food and Drug Administration (FDA) medical device 510(k)
clearance or premarket approval that are medically necessary for
the diagnosis and treatment of an illness or injury and have demonstrated
clinical utility are a TRICARE benefit.
Note: Non-FDA approved genetic tests
that are covered under the Defense Health Agency (DHA) Evaluation
of Non-FDA Approved Laboratory Developed Tests (LDTs) Demonstration
Project may be found in the TRICARE Operations Manual (TOM),
Chapter 18, Section 3.
2.3 Coverage of FDA approved genetic
tests that represent a preventive service (e.g., Cologuard™) must
be based on recommendations from the US Department of Health and
Human Services (HHS). This includes recommendations from the United
States Preventive Services Task Force (USPSTF) and the Health Resources
and Services Administration (HRSA). (See
Chapter 7, Sections 2.1 and
2.2.)
2.4 Genetic
counseling services shall be billed using the appropriate Evaluation
and Management (E/M) codes.
3.0 Exclusions
3.1 Genetic
testing that is not medically necessary and does not influence the
beneficiary’s medical management including, but not limited to:
the Agendia® Breast Cancer Test Suite (MammaPrint®, TargetPrint®
and BluePrint® tests) and, the 23andMe Personal Genome Service (PGS)
test.
3.2 Current Procedural Terminology
(CPT) code 96040 medical genetics and genetic counseling services, each
30 minutes face-to-face with patient/family, as this code is limited
to genetic counselors that are not recognized as TRICARE authorized
providers.
3.3 FDA approved
tests that represent preventive services that are not recommended
by HHS.
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