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: C-18,
February 21, 2018
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 (U.S.) 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 U.S.
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) procedure
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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