Oregon

Yes

Dana Hittle, Interim Medicaid Director (503)-945-5768

Genetic tests are covered as diagnostic, unless they are listed below in section F1 as excluded or have other restrictions listed in this guideline. To be covered, initial screening (e.g. physical exam, medical history, family history, laboratory studies, imaging studies) must indicate that the chance of genetic abnormality is > 10% and results would do at least one of the following:

1. Change treatment;
2. Change health monitoring;
3. Provide prognosis; or
4. Provide information needed for genetic counseling for patient; or patient’s parents, siblings, or children.

• A more expensive genetic test (generally one with a wider scope or more detailed testing) is not covered if a cheaper (smaller scope) test is available and has, in this clinical context, a substantially similar sensitivity.
• Certain genetic tests have not been found to have proven clinical benefit; interventions that have no clinically important benefit or have harms that outweigh benefits for certain conditions; unproven interventions.
• In regards to testing of coagulation factors: “CPT 81240. F2 (prothrombin, coagulation factor II) (eg, hereditary hypercoagulability) gene analysis, 20210G>A variant: Factor 2 20210G>A testing should not be covered for adults with idiopathic venous thromoboembolism; for asymptomatic family members of patients with venous thromboembolism and a Factor V Leiden or Prothrombin 20210G>A mutation; or for determining the etiology of recurrent fetal loss or placental abruption. CPT 81241. F5 (coagulation Factor V) (eg, hereditary hypercoagulability) gene analysis, Leiden variant: Factor Leiden testing should not be covered for: adults with idiopathic venous thromoboembolism; for asymptomatic family members of patients with venous thromboembolism and a Factor V Leiden or Prothrombin 20210G>A mutation; or for determining the etiology of recurrent fetal loss or placental abruption.
• In regards to gene expression profiling for prostate cancer: Gene expression profiling tests for prostate cancer (including Prolaris, Oncotype DX, and Decipher) are not recommended for coverage (strong recommendation).

Pretest and posttest genetic counseling is required for presymptomatic and predisposition genetic testing. Pretest and posttest genetic evaluation (which includes genetic counseling) is covered when provided by a suitable trained health professional with expertise and experience in genetics.

https://www.oregon.gov/oha/hsd/ohp/tools/Prior%20Authorization%20Handbook.pdf

https://www.oregon.gov/oha/HSD/OHP/pages/fee-schedule.aspx

Coverage is available.

Annual screening mammography and annual screening MRI are covered only for women at above-average risk of breast cancer. This coverage, beginning at 30 years of age, includes women who have one or more of the following:

1. Greater than 20% lifetime risk of breast cancer;
2. BRCA1 or BRCA2 gene mutation; or
3. Who have not been tested for BRCA but have a first-degree relative who is a BRCA carrier.

Diagnostic and carrier testing is covered under certain criteria.

Medicaid (Oregon Health Plan) covers cancer genetic counseling and testing for people with signs of HBOC and Lynch Syndrome according to NCCN guidelines.

Specific microarray tests are covered.

1. Hearing loss (eg, nonsyndromic hearing loss, Usher syndrome, Pendred syndrome); genomic sequence analysis panel: Testing for mutations in GJB2 and GJB6 need to be done first and be negative in non-syndromic patients prior to panel testing.
2. Ashkenazi Jewish carrier testing panel: panel testing is only covered when the panel would replace and would be similar or lower cost than individual gene testing including CF carrier testing.

Pharmacogenetics testing for management of psychiatric medications is not a covered service.

The following types of prenatal genetic testing and genetic counseling are covered for pregnant women:

• Genetic counseling for high risk women who have family history of inheritable disorder or carrier state, ultrasound abnormality, previous pregnancy with aneuploidy, or elevated risk of neural tube defect.
• Genetic counseling prior to consideration of chorionic villus sampling (CVS), amniocentesis, microarray testing, Fragile X, and spinal muscular atrophy screening.
• Validated questionnaire to assess genetic risk in all pregnant women.
• Screening high risk ethnic groups for hemoglobinopathies.
• Screening for aneuploidy with any of five screening strategies [first trimester (nuchal translucency, beta-HCG and PAPPA), integrated, serum integrated, stepwise sequential, and contingency].
• Cell free fetal DNA testing for evaluation of aneuploidy in women who have an elevated risk of a fetus with aneuploidy (maternal age >34, family history or elevated risk based on screening).
• Ultrasound for structural anomalies between 18 and 20 weeks gestation.
• CVS or amniocentesis for a positive aneuploidy screen, maternal age >34, fetal structural anomalies, family history of inheritable chromosomal disorder or elevated risk of neural tube defect.
• Array CGH when major fetal congenital anomalies are apparent on imaging, or with normal imaging when array CGH would replace karyotyping performed with CVS or amniocentesis in #8 above.
• FISH testing only if karyotyping is not possible due a need for rapid turnaround for reasons of reproductive decision-making (i.e. at 22w4d gestation or beyond).
• Screening for Tay-Sachs carrier status (CPT 81255) in high risk populations. First step is hex A, and then additional DNA analysis in individuals with ambiguous Hex A test results, suspected variant form of TSD or suspected pseudodeficiency of Hex A.
• Screening for cystic fibrosis carrier status once in a lifetime
• Screening for fragile X status in patients with a personal or family history of:
  • Fragile X tremor/ataxia syndrome;
  • Premature ovarian failure;
  • Unexplained early onset intellectual disability;
  • Fragile X intellectual disability
  • Unexplained autism through the pregnant woman’s maternal line
• Screening for spinal muscular atrophy once in a lifetime
• Screening those with Ashkenazi Jewish heritage for Canavan disease, familial dysautonomia, and Tay-Sachs carrier status. Ashkenazi Jewish carrier paneltesting is covered if the panel would replace and would be of similar or lower cost than individual gene testing including CF carrier testing.
• Expanded carrier screening only for those genetic conditions identified above

The following genetic screening tests are not covered:

• Serum triple screen;
• Screening for thrombophilia in the general population or for recurrent pregnancy loss;
• Expanded carrier screening which includes results for conditions not explicitly recommended for coverage.

Coverage related to diagnostic evaluation of individuals with:

1. Intellectual disability (defined as a full scale or verbal IQ < 70 in an individual > age 5);
2. Developmental delay (defined as a cognitive index <70 on a standardized test appropriate for children < 5 years of age);
3. Autism Spectrum Disorder; or
4. Multiple congenital anomalies.

Oregon ScreenWise Program: “The Oregon ScreenWise Program works with a statewide network of providers that offer a variety of breast cancer, cervical cancer, and genetics services for uninsured and underinsured patients.”

• Guideline 173, containing a list non covered services
  • https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Searchable-List.aspx
• The Prioritized List of Health Services, See The Diagnostic Guideline D1; Non-Prenatal Genetic Testing Guideline start on page AD-2; DIAGNOSTIC GUIDELINE D17, PRENATAL GENETIC TESTING starts on page AD-8
  • https://www.oregon.gov/oha/HPA/DSI-HERC/PrioritizedList/1-1-2019%20Prioritized%20List%20of%20Health%20Services.pdf
• Searchable list
  • https://www.oregon.gov/oha/HPA/DSI-HERC/PrioritizedList/2-1-2021%20Prioritized%20List%20of%20Health%20Services.pdf Health Evidence
• Review Commission (HERC) Coverage Guidance: Genome Expression Profiling for Breast Cancer
  • https://www.oregon.gov/oha/HPA/DSI-HERC/Pages/Evidence-based-Reports-Blog.aspx?View=%7b2905450B-49B8-4A9B-AF175E1E03AB8B6B%7d&SelectedID=256 Health Evidence Review Commission (HERC) Coverage
• Guidance: Gene Expression Profiling for Prostate Cancer Oregon ScreenWise:
  • https://www.oregon.gov/oha/PH/HealthyPeopleFamilies/Women/HealthScreening/Pages/Index.aspx
  • https://www.oregon.gov/oha/PH/HEALTHYPEOPLEFAMILIES/WOMEN/HEALTHSCREENING/Documents/GEN_HowDoIPayforGeneticServices.pdf
• BRCA Guidelines
• • • https://www.oregon.gov/oha/HPA/DSI-HERC/EvidenceBasedReports/Prioritization%20Changes-AboveAvgRiskBreastCancerScreen.pdf