Utah

Jennifer Strohecker, Integrated Healthcare Division and Medicaid Director
(801) 538-6155

Genetic testing may require Prior Authorization (PA). Specific coverage on CPT or HCPCS codes are found in the Utah Medicaid Coverage and Reimbursement Code Lookup. Coverage of genetic testing by Medicaid is determined by using an evidence-based criteria tool and may require review by a Medicaid Consultant. Genetic tests are laboratory studies of human deoxyribonucleic acid (DNA), chromosomes, genes or gene products to diagnose the presence of a genetic variation associated with a high risk of having or transmitting a specific genetic disorder. Genetic testing must be medically necessary and ordered by a Medicaid enrolled provider, within the scope of their practice.

Providers must be able to counsel clients on the particular genetic test ordered, and the results of that particular test, as it applies to the member, in consultation with genetic specialist as needed If a Provider is unable to counsel a member regarding genetic testing, they must refer the member to a provider capable of providing genetic counseling prior to ordering the test.

The following criteria applies only if there is not specific criteria, located in Medicaid’s evidence based criteria tool, for testing. If criteria does exist, then the criteria for medical necessity will supersede the criteria in this policy. For the specific categories of testing where criteria does not exist, the following criteria must be met:

• Testing of an affected (symptomatic) individual’s germline DNA to benefit the member (excluding reproductive testing)
• Diagnostic
  • An association of the marker with the disorder has been established; and
  • Symptoms of the disease are present; and
  • A definitive diagnosis cannot be made based on history, physical examination, pedigree analysis, standard diagnostic studies/tests; and
  • The clinical efficacy of identifying the mutation has been established:
• Prognostic
  • n association of the marker with the natural history of the disease has been established And
  • Clinical efficacy of identifying the mutation has been established:
  • Provides incremental prognostic information above that of standard testing; and
  • Reclassifies patients into clinically relevant prognostic categories for which there are different treatment strategies; and
  • Reclassification leads to changes in medical management that improve clinical outcomes
• Therapeutic
  • Genetic testing identifies variants of a phenotype/metabolic state that relate to different pharmacokinetics, drug efficacy or adverse drug reactions; and
  • Clinical efficacy of identifying the mutation has been established.

Genetic Testing is not covered when:

• Experimental and/or investigational;
• Tests for screening purposes only (excluding newborn screening as defined in Utah Administrative Code R398-2. Newborn Hearing Screening), including:
  • Preimplantation genetic diagnosis (PGD); or
  • Prenatal genetic screening; or
  • In the absence of signs and/or symptoms.
• Tests, for the member or family members, performed solely for the purposes of genetic counseling, family planning, or health screening;
• Tests for research to find a rare or new gene not previously identified or of unclear clinical significance;
• Direct-to-consumer (DTC) genetic tests;
• Tests of a member’s germline DNA is done to benefit family member(s), rather than to benefit the member being tested;
• Establishment of paternity; or
• Genetic testing is considered not medically necessary when performed entirely for nonmedical reasons (e.g., a general interest in genetic test results).

Genetic testing: Genetic testing involves the analysis of chromosomes, DNA (deoxyribonucleic acid), RNA (ribonucleic acid), genes or gene products to detect inherited (germline) or noninherited (somatic) genetic variants related to disease or health.

Genetic testing is medically necessary for EPSDT eligible members when there is a reasonable expectation based on family history, risk factors, and/or symptomatology that a genetically inherited condition exists, and any of the following clinical scenarios also exist:

1. Clinical presentation fits a well-defined syndrome for which a specific or targeted gene test is available; or
2. A definitive diagnosis cannot be made based on history, physical examination, pedigree analysis, and/or standard diagnostic studies or tests; or
3. There is a clinical syndrome with a broad number of potential diagnoses, and without a specific diagnosis, the medical management will include unnecessary monitoring, testing, hospitalizations, and/or medical setbacks; or
4. There is a clinical syndrome with a broad number of potential diagnoses, and a specific diagnosis will determine prognosis and appropriate medical management.

Genetic testing requires a mandatory review by a Utah Medicaid physician for prior authorization. To help establish medical necessity, the documentation listed below must be submitted with all requests for genetic testing, in addition to any other pertinent supporting documentation:

1. Any previous biochemical and metabolic disease testing;
2. Diagnosis of non-syndromic Development Delay/Intellectual Disability or Autism Spectrum Disorder;
3. Malformations;
4. Documentation describing how chromosomal microarray analysis (CMA) testing results will specifically impact clinical management of the patient; and
5. Documentation verifying attendance of genetic counseling by the patient’s parent(s) or legal guardian(s) with a Utah Licensed Genetic Counselor.

Coverage is available.

BRCA1/BRCA2 are covered when the client meets criteria for the covered codes and a screening panel customized to follow panels completed on other family members is advised. Criteria includes:

• Women affected with breast cancer, ovarian cancer, cancer of the fallopian tube, or primary peritoneal cancer, and are from families with a high risk of BRCA1 or BRCA2 mutation as defined in the policy guidelines.
• Women who at 50 years of age or less (regardless of family history), are affected with one of the following:
  • Early onset breast or ovarian cancer – Multiple primary breast or ovarian cancers – bilateral breast, ovarian, or fallopian tube cancers – breast with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
  • Men affected with breast cancer at any age.
• An unaffected adult may be considered under one of the following circumstances:
  • Unaffected individuals (male or female) from families with a known BRCA1 or BRCA2 mutation;
  • Unaffected individuals from families with a high risk of BRCA1 or BRCA2 mutation based on a family history where it is not possible to test an affected family member for a mutation;
  • Unaffected individuals in populations at risk for specific founder mutations due to ethnic background (e.g., Ashkenazi Jewish descent, Norwegians, Dutch, and Icelanders with one or more relatives with breast or ovarian cancer at any age).

Genetic testing may be considered when there are family members with Lynch Syndrome (data suggests that there is a 50% risk of Lynch Syndrome when a first-degree relative has the disease). Testing for hereditary non-polyposis colon cancer requires at least three family members with a history of this, one of which must be a first-degree relative.

WES is considered medically necessary for the evaluation of unexplained congenital or neurodevelopmental disorders in EPSDT eligible members when all of the following criteria are met:

1. After all other appropriate diagnostic testing (e.g. targeted single gene testing, panel testing, MRI, etc.) has been performed and the member remains undiagnosed; and
2. Results of such testing are expected to directly influence medical management and clinical outcomes.

• Medicaid Provider Manual DME
  • https://medicaid.utah.gov/utah-medicaid-official-publications?p=Medicaid%20Provider%20Manuals/Medical%20Supplies%20And%20Durable%20Medical%20Equipment/
• Physician Services Manual
  • https://medicaid.utah.gov/utah-medicaid-official-publications?p=Medicaid%20Provider%20Manuals/Physician%20Services/Physician%20Services%20Manual/
• Newborn Screening Resources
  • https://medicaid.utah.gov/utah-medicaid-official-publications/
  • https://www.aap.org/en-us/professional-resources/practice-transformation/managing-patients/Pages/Periodicity-Schedule.aspx
  • https://medicaid.utah.gov/Documents/manuals/pdfs/Medicaid%20Provider%20Manuals/Archives/Laboratory%20(Archived%20July%202017)/Archive/2017/LaboratoryServices1-17.pdf