South Carolina

Yes

Robert M. Kerr
Director
South Carolina Department of Health & Human Services
1801 Main Street, PO Box 8206
Columbia, SC 29201-8206
Phone: (803) 898-2504

https://medicaiddirectors.org/wp-content/uploads/2023/06/Public_DirectorsList_June2023-1.pdf

Medicaid will reimburse for genetic studies if ordered by an attending physician and requested as a direct diagnosis and treatment tool. The genetic study may be ordered as a preventive measure; however, the prevention must have a direct correlation with the treatment of the patient and the patient’s family or serve as an inhibitor to institutionalization.

Medicaid will not reimburse for genetic research.

Genetic Studies Covered by Medicaid for Children:

1. Amino Acid Analysis for Infants and Children.
2. Organic Acid Analysis for Infants.
3.  Carbohydrate Analysis for infants and Children.
4. Other Tests for Infants and Children. These tests include the following:
   1.  Metabolic screen
   2. Alpha fetoprotein
   3.  Sialic acid
   4. Sulfate incorporation

No genetic counselor licensure requirement.

Genetic counseling must be received before and after genetic testing for BRCA1, BRCA2 and BRCA large cell rearrangement. Pre- and post-genetic counseling are considered medically necessary and is a covered service in addition to genetic testing. Genetic counseling is required to inform beneficiaries about the risks and benefits of genetic testing. Genetic counseling must be performed by an appropriately trained genetic counselor.

No specific legislation.

Enteral nutrition is the delivery of nutrients through a feeding tube to a normally functioning gastrointestinal tract. A feeding tube must be in place for the provision of nutrients.
The formula in enteral feeding must provide nutrition that will maintain the beneficiary’s body weight and/or provide nutrition for weight gain or healing. Special nutrient formulas
are produced to meet unique nutrient needs for specific disease conditions. Documentation maintained in the beneficiary’s medical record must document the specific condition and substantiate the need for the special nutrient. This information must be made available to SCDHHS upon request. Enteral feedings are reimbursed based on 100-calorie units. The number of units reimbursed per diem must not exceed the quantity prescribed. When billing for enteral nutrition, providers must use the formula listed below. Please note that enteral nutrients are billed in units (100 calories = 1 unit). Coverage is also provided for parenteral nutrition, which is the delivery of macronutrients (i.e., proteins, fats and carbohydrates) and micronutrients (i.e., vitamins, minerals and trace elements) intravenously.

Some genetic testing requires prior authorization. When services requiring prior authorization are necessary for a member, the health care professional or provider should submit a prior authorization request via the NaviNet provider portal.

https://southcarolina.fhsc.com/downloads/provider/scrx_paform_general.pdf

https://img1.scdhhs.gov/fees/fee_LABXRY.xlsx

Coverage is available.

The SCDHHS may cover BRCA genetic testing for eligible men and women who meet medical necessity criteria. Medical necessity criteria are based on the current National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology — Genetic/Familial High-Risk Assessment: Breast and Ovarian SCDHHS policy guidelines. To review the current NCCN guidelines you may visit:
https://www.nccn.org/professionals/physician_gls/pdf/genetics_screening.pdf

Meeting one or more of the breast and ovarian cancer criteria warrants further personalized risk assessment, genetic counseling and oftentimes, genetic testing and management. Testing of an individual without a cancer diagnosis should only be considered when an appropriate affected family member is unavailable for testing. Recipients of BRCA genetic testing must be 18 years of age or older. SCDHHS will not cover BRCA testing or associated genetic counseling for minors.

A blood test is performed on an individual to identify mutations in either of the two breast cancer susceptibility genes. The test will determine if an individual carries a mutated BRCA1 or BRCA2 gene. Generally, genetic testing for a particular disease is limited to once in a lifetime; however, there may be exceptional instances that permit genetic testing more than once in a lifetime. SCDHHS will cover cases for additional BRCA testing for beneficiaries who:

1. Have previously been tested for BRCA1 and BRCA2 comprehensive sequencing gene mutation analysis testing and received negative results. Documentation of negative results for BRCA1 and BRCA2 comprehensive sequencing gene mutation analysis is required for medically necessary BRCA large cell rearrangement gene mutation testing.
2. Results are not available, and every reasonable attempt has been made to obtain the results. Documentation of reasonable attempts to obtain results from the genetic testing physician or the testing laboratory must be submitted to QIO when requesting prior authorization.

Effective August 1, 2019, prior authorization must be obtained from QIO prior to initial or subsequent BRCA testing. One or more of the NCCN Clinical Practice Guidelines in Oncology — Genetic/Familial High-Risk Assessment: Breast and Ovarian criteria must be met. A completed Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Prior Authorization Request Form must be submitted to QIO. The form must be completed in its entirety, signed and dated by the referring provider. The provider’s signature submitted on the HBOC is their attestation, to the best of their knowledge, that the information provided in the document is true, accurate and complete.
The physician must indicate one of the following on the HBOC form:

1. The request is for initial BRCA1 and BRCA2 testing.
2. The request is for repeat BRCA1 and BRCA2 comprehensive sequencing testing for the beneficiary because initial results are negative, or are not available, and large cell rearrangement testing is necessary.

The following documentation must be maintained in the beneficiary’s medical record:

1. The HBOC Genetic Testing Prior Authorization Form.
2.  Pre-testing genetic counseling clinical notes, to include but not limited to the following:
   1. Pre-test counseling date with the name and qualifications of the counseling professional.
   2. The risks, benefits and limitations discussed with the beneficiary.
   3.  The beneficiary’s consent to proceed with specific gene mutation testing to be performed as attested by the beneficiary’s signature on the consent form.
3. The beneficiary’s BRCA test results.
4. Post-testing genetic counseling clinical notes, to include, but not limited to, the following:
   1. Post-test counseling date with the name and qualifications of the counseling professional.
   2. The beneficiary’s acknowledgment of the test results.

Coverage is available.

Coverage is available.

Coverage is available.

Coverage is available.

Amniocentesis for Prenatal Diagnosis. Allowable for the following categories of patient:

1. Women over 35 years of age
2. Previous child with chromosomal disorder
3. Multiple spontaneous abortions
4. Patients with neural tube defects
5. Patients at risk for having children with X-linked disorder (i.e., hemophilia or Duchenne muscular dystrophy, or metabolic disorders such as Tay-Sachs disease)

Genetic centers are permitted to fragment chromosome charges into the “tissue culture for chromosome analysis” charge and the analysis charge. Chromosome studies must be medically
necessary. In addition, reimbursement may be allowed for the following expanded services: extended chromosome analysis, R-Bands, and Fragile X DNA analysis.
The following conditions may be used as indications of analysis:

1. Intellectual disabilities
2.  Dysmorphic fractures
3. Multiple congenital abnormalities
4. Abnormal sexual development
5. Abnormalities of growth
6. Certain types of malignancies

Genetic Studies Also Covered by Medicaid:

1.  Lysosomal Enzyme Analysis for Developmental Regression (e.g., Tay-Sachs Disease). The following indications must be present:
   1. Growth failure
   2.  Development regression
   3. Clouding of corneas
   4. Hepatosplenomegaly
   5.  Coarsening of facial features
   6. Abnormalities of skeletal system
2. Amino Acid Analysis for Infants and Children. The following indications must be present:
   1.  Feeding abnormalities
   2. Growth failure
   3. Development failure
   4.  Seizures
   5. Uncommon acidosis
3. Organic Acid Analysis for Infants. The following indications must be present:
   1. Feeding abnormalities
   2. Unexplained acidosis
   3. Growth failure
   4. Seizures
4. Carbohydrate Analysis for infants and Children. One of the following indications must be present:
   1. Cataracts
   2. Hepatosplenomegaly
   3. Jaundice
   4. Growth failure
   5. Acidosis
   6. Seizures
5. Other Tests for Infants and Children. These tests include the following:
   1. Metabolic screen
   2. Alpha fetoprotein
   3. Sialic acid
   4. Sulfate incorporation
6. Tests for the Detection of Other Genetic Diseases. These tests include the following:
   1. Skeletal Dysplasias
   2. Huntington’s disease
   3. Sickle Cell
   4. Hemoglobinopathies

The USPSTF recommends that primary care providers screen women who have family members with breast, ovarian, tubal or peritoneal cancer or have an ethnicity or ancestry associated with
BRCA1 or BRCA2 gene mutations with one of the several screening tools designed to identify a family history that may be associated with an increased risk for potentially harmful mutations in breast cancer susceptibility genes (BRCA1 or BRCA2). Women with positive screening results should receive genetic counseling, and if indicated after counseling, BRCA genetic testing. Based on the results of the BRCA test, beneficiaries may select a treatment that may reduce their chances of developing cancer. Medical necessity must be established for the selected risk reducing treatment option in accordance with the NCCN Guidelines for Genetic/Familial High-Risk Assessment: Breast and Ovarian. The specific guidelines may be accessed through this link: https://www.nccn.org/professionals/physician_gls/pdf/genetics_screening.pdf
Note: Beneficiaries may also elect not to pursue treatment options.

The South Carolina Department of Health and Human Services (SCDHHS) will add the multi-targeted stool DNA (MT-sDNA) test, also known as Cologuard®, in the covered preventive screenings beginning July 1, 2023. This change aligns with the United States Preventive Services Task Force (USPSTF) recommendation for colorectal screening. This coverage applies to full-benefitHealthy Connections Medicaid members and those enrolled in the Family Planning limited benefit program.
Clinical Criteria:

1. The MT-sDNA test is recommended every three years for asymptomatic, low-average risk members, aged 45 to 75 years who:
   1.  Have not had any colorectal screening in the past, or
   2.  Have had a negative colonoscopy at least seven years prior.
2. The MT-sDNA test is not recommendedfor high-risk individuals who:
   1. Have a personal history of colorectal cancer and adenomas;
   2. Have had a positive result from another colorectal cancer screening at any time; or,
   3.  Have been diagnosed with a condition associated with high risk for colorectal cancer such as inflammatory bowel disease, chronic ulcerative colitis, or Crohn’s disease; or have a family history of colorectal cancer, or certain hereditary syndromes.

https://www.scdhhs.gov/sites/default/files/manuals/Physician%20Services%20Provider%20Manual%2010-01-2023.pdf
https://www.scdhhs.gov/communications/coverage-mt-sdna-test-cologuardr-colorectal-screening
https://www.scdhhs.gov/internet/pdf/manuals-archive/dme/Manual.pdf
https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/heritable-disorders/reports-recommendations/state-laws-medical-foods-tab.pdf