10.20.280 Genetic Testing.
(1) General Approach to Genetic Testing. Genetic tests are commercially available lab tests performed on blood and other tissue for the purpose of obtaining information on individuals who either have symptoms of a condition or have no symptoms whatsoever. This policy provides assistance in determining whether a genetic test would be useful for such questions as whether individuals are at risk for future disorders, to predict the prognosis of diagnosed diseases, or to predict treatment response.
(2) Application.
(a) A request for genetic testing must be authorized by the PRC Resource Panel.
(b) Authorization for genetic testing must be based on medical necessity as described below.
(3) Definition of “Medical Necessity.” Genetic testing is considered medically necessary when one of the following is met:
(a) Testing an individual because they have a health problem that needs to have a diagnosis, treatment, or prognosis and DNA testing may provide helpful information for that individual;
(b) Testing an individual who is feeling well and does not have health problems, but has certain risk factors and DNA testing may determine future risk of disease for that individual;
(c) Testing an affected individual who is feeling well but may have family members who have been identified with a health problem and DNA testing of the healthy individual could determine what other current or future family members could be at risk.
(4) Definition of “Not Medically Necessary.” Genetic testing is considered “not medically necessary” when any of the following applies:
(a) Testing is not considered standard of care, such as the clinical diagnosis can be made without the use of a genetic test;
(b) Testing is not clinically appropriate for the patient’s condition/disease; for example, when it will not change diagnosis and/or management. Other situations where testing is not clinically appropriate include, but are not limited to:
(i) Testing is performed entirely for nonmedical (e.g., social) reasons;
(ii) Testing is not expected to provide a definitive diagnosis that would obviate the need for further testing;
(c) Testing is performed primarily for the convenience of the patient, physician, or other provider;
(d) Testing would result in outcomes that are equivalent to outcomes using an alternative strategy, and the genetic test is a higher cost.
(5) Policy Guidance.
(a) The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible impact of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.
(b) There are limitations to the outcomes of genetic testing. Different genes may cause similar diseases. Some tests may identify variations of genetic mutations that may have unknown relevance to the clinical situation. Not all genes that cause diseases have been identified. Genetic testing is subject to laboratory errors.
(c) DNA test results are protected medical information and will be treated according to standards set by the federal Health Insurance Portability and Accountability Act (HIPAA). The Genetic Information Nondiscrimination Act protects against access to genetic information and against genetic discrimination in employment and health insurance settings. This Act does not address genetic discrimination in the areas of life insurance, disability insurance, or long-term care insurance, and the providers and facilities who order testing cannot be responsible for how an individual manages their own personal information. Secure management by patients of their own information will be emphasized. [Res. 2020-10-013 § 2, 2020.]