Oklahoma

Melody Anthony State Medicaid Director and Chief Operating Officer Oklahoma Health Care Authority
4345 N. Lincoln Blvd.
Oklahoma City, OK 73105
(405)-522-7300

Genetic testing is covered when medically necessary. Genetic testing may be considered medically necessary when the following conditions are met:

1. The member displays clinical features of a suspected genetic condition or is at direct risk of inheriting the genetic condition in question (e.g., a causative familial variant has been identified); and
2. Clinical studies published in peer-reviewed literature have established strong evidence that the result of the test will positively impact the clinical decision-making or clinical outcome for the member; and
3. The testing method is proven to be scientifically valid for the identification of a specific genetically-linked inheritable disease or clinically important molecular marker; and
4. Documentation is provided from a licensed genetic counselor or physician with genetic expertise that supports the recommendation for testing based on a review of risk factors, clinical scenario, and family history.

Carrier screening is not considered medically necessary for routine screening of pregnant women or general population screening.

Genetic counseling services are covered for SoonerCare members who meet the criteria for receiving medically necessary genetic testing. Services for pregnant/postpartum SoonerCare members must be referred by a provider involved in the provision of obstetric or pediatric care. Members are eligible for genetic counseling during pregnancy which includes 60 days postpartum. Reasons for genetic counseling include but are not limited to the following:

1. Advanced maternal age;
2. Abnormal maternal serum first or second screening;
3. Previous child or current fetus/infant with an abnormality;
4. Consanguinity/incest;
5. Parent is a known carrier or has a family history of a genetic condition;
6. Parent was exposed to a known or suspected reproductive hazard;
7. Previous fetal demise, stillbirth, or neonatal death involving known/suspected abnormalities;
8. History of recurrent pregnancy loss; or
9. Parent(s) are in an ethnic or racial group associated with an increased risk for specific genetic conditions.

These services may be provided in an office or outpatient setting.

Some molecular pathology CPT codes require prior authorization. Documentation should support the medical necessity of the genetic test and may include information regarding:

1. The gene(s) being tested;
2. The type of testing performed (e.g., full gene sequencing, deletion/duplication, microarray, individual variants, multi-gene panel), and the rationale for choosing this particular test;
3. Clinical findings, family history, and any previous test results that support the need for the test; and/or
4. Information on how the genetic test results will change or impact the future medical management of the member.

Coverage is available.

Comprehensive BRCA1 and BRCA2 full sequencing analysis and deletion/duplication analysis may be considered necessary for members meeting at least one of the following NCCN criteria:

• Personal history of breast cancer and one or more of the following:
  • Diagnosed at age ≤ 45
  • Diagnosed at age ≤ 50 with at least one of the following:
    • An additional breast cancer primary
    • ≥ 1 close blood relative with breast cancer at any age
    • ≥ 1 close blood relative with prostate cancer (Gleason score ≥ 7)
    • An unknown or limited family history
• Diagnosed at age ≤ 60 with a triple negative breast cancer
• Diagnosed at any age with at least one of the following
  • ≥ 1 close blood relative with breast cancer diagnosed ≤ 50
  • ≥ 1 close blood relative with ovarian carcinoma
  • ≥ 1 close male blood relative with breast cancer
  • ≥ 1 close blood relative with metastatic prostate cancer or pancreatic cancer
  • ≥ 2 additional diagnoses of breast cancer at any age in patient and/or in close blood relatives
  • Ashkenazi Jewish ethnicity with a negative test for common variants (CPT 81212)
• Personal history of ovarian carcinoma
• Personal history of male breast cancer
• Personal history of metastatic prostate cancer
• Personal history of pancreatic cancer
• Personal history of high-grade prostate cancer (Gleason score ≥ 7) at any age with at least one of the following
  • ≥ 1 close blood relative with ovarian carcinoma, pancreatic cancer, or metastatic prostate cancer
  • ≥ 1 close blood relative with breast cancer ≤ 50
  • Two or more relatives with breast or prostate cancer (any grade)
  • Ashkenazi Jewish ancestry
• Coverage for testing of unaffected family members is limited to testing for the identified familial variant (CPT 81215 or CPT 81217) unless no affected family member is available for testing and one of the following applies:
• The member has a first or second degree relative that meets any of the above criteria

When more than one gene is analysed, coverage is limited to the single, most appropriate panel testing.

When a familial variant has already been identified, coverage for unaffected family member is limited to testing for the identified familial variant.

CFTR common variant testing is covered as a first-line diagnostic test in infants with an elevated immunoreactive trypsinogen (IRT) value on newborn screening.
CFTR full gene sequencing and/or duplication/deletion testing may be considered medically necessary for confirmatory diagnostic testing in members meeting at least one of the following criteria:

1. Infants with suspected Cystic Fibrosis (CF) based on elevated IRT value on newborn screening when the CFTR common mutation test identified less than two pathogenic CFTR mutations; or
2. Members with clinical signs and symptoms suggestive of CF when the CFTR common mutation test identified less than two pathogenic CFTR mutations.

Testing of at-risk relatives for the familial variant only may be considered medically necessary when a pathogenic familial variant has already been identified.

Multi-gene panel testing for hereditary cancer syndromes may be considered medically necessary for Lynch Syndrome or Hereditary Breast and Ovarian Cancer Syndrome testing.

Comprehensive Lynch Syndrome testing, including full sequencing analysis and deletion/duplication analysis of MLH1, MSH2, MSH6, and PMS2, may be considered necessary under certain criteria.

Microarray testing may be considered medically necessary as a first-line test for the following indications:

• At least one major congenital anomaly or multiple congenital anomalies, other than those associated with an obvious, specific and well-defined genetic syndrome.
• Developmental delay (DD) or Intellectual Disability (ID) when all of the following are met:
  • There is no known etiology for the DD/ID (e.g., trauma or infection)
  • The DD/ID is not suspected to be related to an obvious, specific, and well-defined genetic syndrome
  • The member shows evidence of at least one major congenital anomaly
• Autism spectrum disorders when accompanied by at least one major congenital anomaly.

Certain single gene pharmacogenetic tests are covered.

CYP2D6 testing may be considered medically necessary for members meeting at least one of the following criteria:

1. Members receiving doses (or considering receiving doses) of Pimozide of more than 4 mg/day in adults or 0.05mg/kg/day for children
2. Members receiving doses (or considering receiving doses) of tetrabenazine (Xenazine) of more than 50 mg/day
3. Members with Gaucher disease type 1 who are considering treatment with eliglustat (Cerdelga)”

Multi-gene pharmacogenetic testing panels are not considered medically necessary.

Non-invasive prenatal testing for trisomy 21, 18, and 13 may be considered medically necessary for pregnant women at a high risk of aneuploidy as defined by one or more of the following criteria:

1. Maternal age 35 years or older;
2. Fetal ultrasound finding indication an increased risk of aneuploidy, specifically for trisomies 13, 18, or 21;
3. History of prior pregnancy with trisomy detectable by cfDNA screening (trisomies 13, 18, or 21);
4. Positive screening results for aneuploidy including first trimester, sequential, integrated, or quadruple screening;
5. Parental balanced Robertsonian translocation with increased risk of fetal trisomy 13 or 21.

Non-invasive prenatal testing for any indication besides trisomy 21, 18, and 13 is not considered medically necessary.

Testing for Cowden Syndrome may be approved if individual meets necessary criteria found in Molecular Pathology Guidelines. The guidelines also include criteria needed for testing of Coagulation Factor V.

Fragile X diagnostic testing and premutation carrier testing may be considered medically necessary if certain criteria are met. Fragile X carrier testing is not approved for general population screening.

Additional coverage information can be found in the Molecular Pathology Guidelines.

• 317:30-5-210.2. Coverage for children
  • https://www.okhca.org/xPolicySection.aspx?id=7110&number=317:30-5-210.2.&title=Coverage%20for%20children
• 317:30-5-221 Coverage of Genetic Counseling Services
  • https://www.okhca.org/xPolicySection.aspx?id=6261&number=317:30-5-221.&title=Coverage
• Molecular Pathology Guidelines
  • http://www.okhca.org/providers.aspx?id=15125