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.