North Carolina

Yes

Dave Richard
Deputy Secretary for NC

Medicaid Contact
Jay Ludlam
919-855-4100

Medicaid and NCHC shall cover the procedure, product, or service related to this policy when medically necessary, and:

1. The procedure, product, or service is individualized, specific, and consistent with symptoms or confirmed diagnosis of the illness or injury under treatment, and not in
2. excess of the beneficiary’s needs;
3. The procedure, product, or service can be safely furnished, and no equally effective and more conservative or less costly treatment is available statewide; and
4. The procedure, product, or service is furnished in a manner not primarily intended for the convenience of the beneficiary, the beneficiary’s caretaker, or the provider.

Medicaid and NCHC shall cover genetic and cytogenetic testing for the diagnosis and treatment of a genetic condition when all of the following criteria are met:

1. The beneficiary displays clinical features or is experiencing current signs and symptoms of a genetic condition;
2. There is documented reasonable expectation that the beneficiary is at high-risk based on family history, personal history, or ethnicity;
3. The test yields results that can be used to develop a clinical useful approach or course of treatment, or to cease unnecessary treatments;
4. The results of the test allow providers to treat current symptoms affecting the beneficiary’s health, or manage the treatable progress of an established disease;
5. The ordering licensed physician shall obtain written informed consent (indicating understanding of the testing procedure, the benefits and limitations of the test, and the possible consequences of the test results) from the beneficiary, parent, legal guardian or authorized representative, prior to the genetic test;
6. Test must be performed by a certified Clinical Laboratories Improvement Amendment (CLIA) laboratory;
7. A clinically valid test, based on published peer-reviewed literature, is available for the suspected diagnosis;
8. There is sufficient evidence in scientific literature to support the validity and predictive accuracy of the test; and
9. There is genetic counseling both pre- and post-test.

Medicaid and NCHC shall not cover genetic testing when:

1. There is no symptomatic evidence;
2. The beneficiary does not meet the criteria listed in Subsection 3.2;
3. The purpose is to identify a carrier for a genetic disorder;
4. The screening is for the general population and ethnic groups;
5. The test is being repeated after a negative test result; and
6. A test is repeated when limited to once in a lifetime testing.

Medicaid shall not cover genetic testing for:

1. Reproductive decision-making;
2. Male or female infertility;
3. Beneficiary family members;
4. Non-invasive prenatal testing by cell-free DNA, for low-risk pregnant women and for multiple gestations (except for the indications listed in Subsection 3.2.2.a)
5. Paternity testing;
6. Sex determination of the fetus;
7. Direct-to-consumer tests;
8. Molecular panels; and
9. Molecular profile tests

A genetic test involves an analysis of human chromosomes, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or gene products to establish a diagnosis of a genetic condition. A genetic test is a diagnostic test used to identify a single gene or genomic condition.

Genetic counseling is provided “incident to” the services of a physician. Genetic counseling must be provided by a genetic counselor that is certified by the American Board of Genetic Counseling or has an Active Candidate Status. A genetic counselor shall be employed by or under contract to hospitals or other entities that employ licensed physicians. Licensed physicians shall be responsible for providing on-site clinical supervision and be directly involved in the care of an NC Medicaid or NCHC beneficiary for whom the counseling service is billed.

Medicaid and NCHC shall not require prior approval for Genetic Testing,

https://www.nctracks.nc.gov/content/public/providers/prior-approval.html

https://medicaid.ncdhhs.gov/providers/fee-schedule/laboratory-fee-schedules

Yes

Medicaid and NCHC shall cover BRCA 1 and 2 genetic testing when medically necessary for a beneficiary with a personal history of one or more of the following:

• Breast cancer with one or more of the following:
• Diagnosed age 45 years or younger;
• Diagnosed age 50 years or younger with one or more of the following:
  • i. An additional breast cancer primary;
  • ii. One or more close blood relatives with breast cancer at any age;
  • iii. One or more relatives with pancreatic cancer;
  • iv. One or more relatives with prostate cancer; or
  • v. An unknown or limited family history.
• Diagnosed age less than or equal to 60 years with triple negative breast cancer; or
• Diagnosed at any age with one or more of the following:
  • Two or more close blood relatives with breast cancer, pancreatic cancer or, prostate cancer (Gleason score 7 or greater) at any age;
  • One or more close blood relative with breast cancer at age 50 years old or older;
  • One or more close (first, second, or third degree on same side of family) blood relatives with ovarian carcinoma;
  • Close male blood relative with breast cancer; or
  • Ethnicity associated with higher mutation frequency such Ashkenazi Jewish.
• Epithelial ovarian, fallopian tube or primary peritoneal cancer;
• Male breast cancer;
• Prostate cancer (Gleason score seven or greater) at any age and one of the following:
  • One or more close blood relatives with ovarian cancer at any age or breast cancer at age 50 years old or younger; or
  • Two relatives with breast, ovarian, or prostate cancer (Gleason score seven or greater) at any age;
• Metastatic prostate cancer (radiographic evidence);
• Pancreatic cancer at any age and one of the following:
  • One or more close blood relatives with ovarian carcinoma at any age or breast cancer at fifty years old or older;
  • Two relatives with breast, ovarian, or prostate cancer (Gleason score seven or greater) at any age; or
  • Ashkenazi Jewish heritage; or
• BRCA 1 and 2 mutation detected by tumor profiling on any tumor type in the absence of germline mutation analysis.

Medicaid and NCHC shall cover BRCA 1 and 2 genetic testing when medically necessary for a beneficiary with a family history of one or more of the following:

• Known deleterious BRCA1 or BRCA2 gene mutation with one of the following:
  • First or second-degree blood relative meeting ANY of the criteria in Section 3.2.1; or
  • Third-degree relative with breast cancer or ovarian carcinoma and who has two or more close blood relatives with breast cancer (at least one before 50
    years old) or ovarian carcinoma;
• Two or more primary breast cancers (asynchronous, synchronous, bilateral, or metacentric) in a single-family member;
• Two or more relatives on the same side of the family with breast, prostate, or pancreatic cancer;
• Epithelial ovarian, fallopian tube or primary peritoneal cancer;
• Male breast cancer; OR
• Known mutation carrier.

Testing for common variants of the cystic fibrosis gene is covered when a beneficiary has signs or symptoms of cystic fibrosis.

When the symptomatic beneficiary has a known familial variant, the test that is ordered should be for that specific variant. If no mutation is found when testing for common variants, and the beneficiary is symptomatic, full gene sequencing can be ordered after obtaining prior approval. After completing the full gene sequencing, if no mutation is found, testing may be done for duplication/deletion variants after obtaining prior approval

Coverage for breast cancer testing is available.

No coverage is available.

Panel testing is not a covered service.

Medicaid shall cover non-invasive prenatal genetic testing for diagnosis of fetal abnormalities using cell-free DNA when a beneficiary with a high-risk singleton pregnancy has:

• Advanced maternal age;
• A targeted obstetrical ultrasound that detects a fetal structural abnormality;
• A history of a prior pregnancy with a trisomy; or
• Parental balanced robertsonian translocation with increased risk of fetal trisomy 13 or 21.

Medicaid shall cover prenatal cytogenetic testing for diagnosis and treatment when the beneficiary has:

• Advanced maternal age;
• A targeted obstetrical ultrasound that detects a fetal structural abnormality;
• A history of a prior pregnancy with a trisomy; or
• Parental balanced robertsonian translocation with increased risk of fetal trisomy 13 or 21.

Medicaid and NCHC shall cover genetic and cytogenetic testing for the diagnosis and treatment of genetic abnormalities or syndromes such as:

• Multiple congenital anomalies;
• Developmental delays; and
• Intellectual disabilities.

Medicaid and NCHC shall cover cytogenetic testing for the diagnosis and treatment of the following neoplastic chromosome abnormalities or syndromes:

• Chronic Myelogenous Leukemia (CML);
• Acute Lymphoblastic(also known as lymphocytic) Leukemia (ALL);
• Acute Myeloid Leukemia (AML);
• Myelodysplastic syndromes (MDS);
• Lymphomas (solid tumors); and
• Multiple myeloma.

There are certain limitations to certain tests that can be found in the Genetic testing manual in section C. Code(s)

• Medical Equipment Clinical Coverage Policy 5A-3
  • https://medicaid.ncdhhs.gov/providers/clinical-coverage-policies/medical-equipment-clinical-coverage-policies
• NC Medicaid and Health Choice Clinical Coverage Policy 1S-4 Genetic Testing
  • https://files.nc.gov/ncdma/documents/files/1S-4_4.pdf
• BRCA Test Requirement
  • https://medicaid.ncdhhs.gov/media/9847/open