South Dakota

Sarah Aker, South Dakota Medicaid Director
(605)773-3495

Diagnostic genetic testing must meet the following criteria:

1. The recipient displays clinical features of a suspected genetic condition; or
2. The genetic condition must be associated with a significant medical condition; and
3. The results of the genetic testing must result in an evidence-based change in the active treatment plan.

Tests for conditions that are treated symptomatically are not appropriate because the treatment plan would not change as a result of the genetic testing. Genetic testing is not covered to determine the risk of occurrence of the disease in other family members.

Most genetic tests require a prior authorization. To obtain authorization, the provider must complete the applicable genetic testing prior authorization form available on the department’s website. The department will determine whether the test meets the prior authorization criteria.
Some medically necessary genetic tests are covered without a prior authorization. This includes:

1. Newborn Metabolic Screenings;
2. Routine Triple/Quad Prenatal Screenings;
3. Fragile X Screening;
4. Cologuard; and
5. Factor V.

Coverage is available.

BRCA genetic mutation testing will be covered for breast/ovarian cancer in women and breast cancer in men will be approved in cases where the results will impact the care of the patient.

Coverage is available.

Coverage is available.

Prior authorization coverage includes Lynch syndrome and other inherited colon cancer syndromes for people with a significant risk. Prior authorization must be obtained before the service is provided.

Microarray-based Comparative Genomic Hybridization (aCGH) testing is covered with a prior authorization when the criteria below has been met in addition to the general genetic testing criteria. All of the following conditions must be met:

• Any indicated biochemical tests for metabolic disease have been performed, and results are nondiagnostic.
• FMR1 gene analysis for (for Fragile X), when clinically indicated, is negative.
• In addition to a diagnosis of nonsyndromic Developmental Disability, Intellectual Disability, or Autism Spectrum Disorder, the child has one or more of the following:
  • Two or more major malformations.
  • A single major malformation or multiple minor malformations in an infant or child who is also small-for-dates.
  • A single major malformation and multiple minor malformations.
  • The results for genetic testing have the potential to impact clinical management of the patient through an evidence based change to the treatment plan.

Factor V Leiden testing is covered without prior authorization. For pregnant women, the testing will be covered for a primigravida who also has a first degree relative with a history of thromboembolism and a positive Factor V Leiden test, or if she has had a previous thromboembolism and no previous Factor V Leiden testing. For all other nonpregnant recipients, the testing will be covered if the recipient meets one of the following criteria:

• Age less than 50 with any venous thrombosis; or
• Myocardial infarction in female smokers under age of 50; or
• Recurrent venous thrombosis; or
• Relatives of individuals with venous thrombosis under age of 50; or
• Venous thrombosis and a strong family history of thrombotic disease; or
• Venous thrombosis in women taking oral contraceptives; or
• Venous thrombosis in unusual sites (such as hepatic, mesenteric, and cerebral veins.

Cologuard (CPT 81528) is covered without prior authorization once every three years for recipients who meet all of the following criteria:

• Age 50 to 85 years;
• Asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test); and
• At average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or an adenomatous polyp, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).”

Fragile X detection is covered without prior authorization when the recipient meets the following criteria:

• The individual is age 0 to 20; and
• The results of the test will affect the individual’s plan of care; and
• The individual has an intellectual disability, developmental delay, or autism spectrum disorders.

• Professional Services Billing Manual
  • https://dss.sd.gov/medicaid/providers/billingmanuals/ Prior Authorization Manual
  • https://dss.sd.gov/docs/medicaid/providers/billingmanuals/Prior%20Authorization%20Manual.pdf
• SD legislature CHAPTER 67:16:42
  • https://sdlegislature.gov/Rules/DisplayRule.aspx?Rule=67:16:42 Laboratory and pathology services
  • https://dss.sd.gov/docs/medicaid/providers/billingmanuals/LaboratoryandPathologyServices.pdf