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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