North Carolina

Yes

Jay Ludlam
Deputy Secretary for Medical Assistance
North Carolina Department of Health and Human
Services
1985 Umstead Drive, 2501 Mail Service Center
Raleigh, NC 27699-2501
Phone: (919) 855-4100

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

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

1. The beneficiary displays clinical features or is experiencing current signs and symptoms of a genetic condition; or
2. There is documented reasonable expectation that the beneficiary is at high-risk based on family history, personal history, or ethnicity; or
3. The test yields results that can be used to develop a clinically useful approach or course of treatment, or to cease unnecessary treatments; and
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 or alter recommended screening or monitoring; and
5. The ordering licensed provider shall obtain 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; and
6. Test must be performed by a certified Clinical Laboratories Improvement Amendment (CLIA) laboratory; and
7. A clinically valid test, based on published peer-reviewed literature, is available for the suspected diagnosis; and
8. The test is proven to be scientifically valid for the identification of the specific genetically-linked disease or clinical condition and
9. A certified genetic counselor or ordering provider shall counsel the beneficiary pre- and post-test.

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

1. Any congenital anomalies;
2.  developmental delays; and
3. intellectual disabilities.

Medicaid shall not cover genetic testing when:

1. the beneficiary does not meet the criteria listed
2. the screening is for the general population;
3. the test is being repeated after a negative test result; and
4. 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’s family members;
4. Cell-free DNA based screening in twin pregnancy in the setting of fetal demise, vanishing twin, or one or more anomaly detected in one or both twins.
5. NIPS/NIPT following a CVS or amniocentesis test that was able to yield results;
6. paternity testing;
7.  sex determination of the fetus;
8.  direct-to-consumer tests

Medicaid shall not cover BRCA testing for ANY ONE of the following:

1. Repeat testing for BRCA 1 and 2 prior to Lynparza therapy;
2.  A confirmed diagnosis of breast or ovarian carcinoma, but do not met the criteria in BRCA Testing Coverage
3. Genetic screening in the general population;
4. BRCA 1 and BRCA 2 testing for a beneficiary without a personal or family history of breast, ovarian or other hereditary cancer;
5. Testing of a beneficiary who is under 18 years of age.

Medicaid shall not cover Gene Expression Profiling Assays for the following indications:

1. to predict response to specific chemotherapy regimens;
2.  repeat Gene Expression Profiling Assays testing or testing of multiple tumor sites in the same beneficiary;
3. use of Gene Expression Profiling Assays to determine risk in a beneficiary with primary breast cancer who meets the criteria above but who has already made the decision to undergo or forego chemotherapy; or
4. adjuvant treatment planning for a male beneficiary.

Genetic testing is used to identify changes or abnormalities in chromosomes, genes, or proteins to confirm or rule out suspected genetic conditions. Testing samples include blood, amniotic fluid,
or bodily tissues. 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. In general, three categories of genetic testing—cytogenetic, biochemical, and molecular—are available to detect abnormalities in chromosome structure, protein function, and
DNA sequence, respectively.

Genetic counseling must be provided by a medical provider or 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 beneficiary for whom the counseling service is billed. The services of the Genetic Counselor are billed by the supervising physician.

A certified genetic counselor or ordering provider shall counsel the beneficiary pre- and post-test.

Clinical Coverage Policy No: 5A-3

Oral Nutrition products are covered for beneficiaries’ ages 0 through 20 when required to ameliorate a medical condition, prevent severe health complications, prevent worsening health outcomes, or improve clinical and functional benefits. Metabolic Formulas are covered for beneficiaries aged 0 through 115 for in-born errors of metabolism diagnosed at birth and before the age of 10 years. Oral nutrition products and metabolic formulas include formulas, such as Peptamen, Peptamen Jr., and PhenylAde; modular components, such as thickening agents and single nutrients (used in treatment of inborn errors of metabolism); and feeding systems, such as Pigeon feeding systems. Some conditions that may indicate a need for oral nutrition products are: inborn errors of metabolism, such as phenylketonuria (PKU) or galactosemia; history of prematurity, very low birth weight (VLBW), or low birth weight (LBW); cystic fibrosis; human immunodeficiency virus (HIV); necrotizing enterocolitis (NEC); short bowel syndrome; cleft lip or cleft palate; central nervous system disorders resulting in dysphagia; and Crohn’s disease.

Oral nutrition products are considered medically necessary when all the following conditions are met:

1. There is a documented diagnosis in which caloric or dietary nutrients cannot be safely or adequately consumed, absorbed, or metabolized; and
2. The oral nutrition product is an integral component of a documented medical treatment plan and is ordered in writing by the treating physician, physician’s assistant, or nurse practitioner.

Medical necessity of the oral nutrition product is substantiated by documented physical findings, and laboratory data if available, that demonstrate malnutrition or risk of nutritional depletion.

Requirements for coverage

1.  A beneficiary shall be under the care of the ordering physician, physician’s assistant, or nurse practitioner who develops a medical treatment plan that incorporates oral nutrition products.
2. The prescriber may order a nutritional assessment to aid if it aids in the development of a comprehensive oral nutrition therapy plan.
3. If a nutritional assessment is ordered, it must be conducted by a licensed dietitian/nutritionist (LDN) or registered dietitian (RD).
4. The prescriber may order a feeding or swallowing evaluation performed by a licensed therapist (SLP-CCC or OTR/L).

The above-mentioned assessments must be maintained within the health record as supporting documentation to substantiate medical necessity. Medical necessity of oral nutrition product use must be re-established at specific intervals:

1. For beneficiaries with a diagnosed inborn error of metabolism, the provider shall complete and keep on file a new CMN/PA form every 12 months.
2. For beneficiaries with other medical conditions necessitating oral nutrition supplementation, the provider shall complete and keep on file a new CMN/PA form every six months with documentation supporting the effectiveness of the oral nutrition supplementation.
3. For beneficiaries receiving modular components and feeding devices, the provider shall submit a new CMN/PA form at either the 6-month or 12- month interval, depending on the approved certification period.

Medicaid shall not require prior approval for Genetic Testing, except as when exceeding the limitations.

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

https://medicaid.ncdhhs.gov/document-collection/fee-schedules

Yes, there is coverage. The BRCA (BReast CAncer) gene test uses DNA (deoxyribonucleic acid) analysis to identify harmful changes (mutations) in either one of the two cancer susceptibility genes known as BRCA1 and 2. These mutations increase a beneficiary’s susceptibility to certain types of cancer.

Medicaid 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:

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

Medicaid 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:

1. Known deleterious BRCA1 or BRCA2 gene mutation with one of the following:
   1. First or second-degree blood relative meeting ANY of the criteria above; or
   2. 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;
2. Two or more primary breast cancers (asynchronous, synchronous, bilateral, or metacentric) in a single-family member;
3. Two or more relatives on the same side of the family with breast, prostate, or pancreatic cancer;
4. Epithelial ovarian, fallopian tube or primary peritoneal cancer;
5. Male breast cancer;
6. Known mutation carrier

Medicaid shall cover genetic and cytogenetic testing for the diagnosis and treatment of cystic fibrosis (CF) when the following criteria are met:

1. The beneficiary has signs or symptoms of cystic fibrosis;
2. The beneficiary or guardian has undergone genetic counseling;
3. When the symptomatic beneficiary has a known familial variant, the test that is ordered should be for that specific variant;
4. If no mutation is found when testing for common variants and the beneficiary is symptomatic, full gene sequencing can be ordered; or
5. After completing the full gene sequencing, if no mutation is found, testing may be done for duplication/deletion variants

Medicaid shall cover carrier testing for cystic fibrosis (CF) when the beneficiary meets any of the criteria below:

1. Beneficiary is pregnant or considering pregnancy;
2. Beneficiary has a biological parent with CF or both biological parents are CF carrier status;
3. The beneficiary has a family history or first-degree relative with CF; or
4. Echogenic bowel has been identified on fetal ultrasound; and
5.  After genetic counseling has been provided, informed consent is obtained prior to, and beneficiary agrees to voluntary carrier testing

This testing is covered for familial breast cancer.

No coverage

Medicaid shall cover Oncotype Dx® Breast Cancer Assay or EndoPredict ®EPClin when the female beneficiary meets all of the following specific criteria:

1. diagnosis of early stage (Stage 1 or 2) breast cancer;
2. primary tumor is unilateral non-fixed;
3. estrogen- receptor positive (ER+) or progesterone-receptor positive;
4. node negative or node positive (1-3 nodes) tumor cells isolated less than 2 millimeters in size. If there is more than one tumor, then a specimen with the most aggressive histological characteristics should be submitted;
5. HER2- negative;
6. primary tumor cell is greater than 0.5 centimeters;
7.  results will aid in the decision for or against chemotherapy;
8. beneficiary will be treated with adjuvant endocrine therapy such as tamoxifen or aromatase inhibitors;
9.  the gene expression profile is ordered by the treating physician or surgeon; and
10.  the assay must be ordered within six months following diagnosis of Stage 1 or 2 breast cancer

Genotype and phenotype testing for HIV drug resistance is considered medically necessary when either process is used to assist in the selection of a new treatment
regimen. A new regimen may be necessary if the beneficiary has experienced any of the following:

1. virologically failed the prescribed regimen;
2. achieved a suboptimal response after the initiation of ART (optimal response is defined as reduction of plasma HIV RNA to less than 50 copies/ml);
3. has been found to have acute HIV infection;
4. has been infected with HIV for less than 12 months;
5. is initiating the first ART regimen regardless of duration of infection; or
6. Is pregnant and has detectable HIV RNA in plasma.

Genotype or phenotype testing is recommended prior to changing therapy for treatment failure. Resistance assays shall be obtained when beneficiaries have a viral load greater than 1,000 copies/ml and are still on the failing regimen. It is recommended that testing for HLA-B*5701 be done to detect hypersensitivity prior to initiation of nucleoside reverse transcriptase inhibitors.

Chemokine receptor 5 (CCR5) and chemokine receptor 4 (CXCR4) are the major chemokine coreceptors used by the human immunodeficiency virus (HIV) to enter into human cells. The HIV tropism assay is a diagnostic test used to determine the viral tropism of HIV-1. The assay can determine whether the HIV infection is CCR5, CXCR4, or dual-or mixed-tropic (D-/Mtropic). Using a small blood sample, this assay amplifies a beneficiary’s HIV genome to make HIV particles specific to the individual beneficiary.

Medicaid shall cover HIV tropism (phenotypic) assay when the beneficiary meets any of the following specific criteria:

1. Beneficiary has treatment failure of at least two other Highly Active Antiretroviral Therapy (HAART) regimens;
2. Beneficiary has limited or no other treatment options available to them due to resistance or treatment intolerance and they must be failing to achieve adequate virologic suppression on their current regimen;
3. The assay is used to confirm CCR5-tropic HIV-1 infection prior to initiation of CCR5 co-receptor antagonist;
4.  Viral load is at least 1,000 copies/ml; or
5. Assay may be considered for a beneficiary exhibiting virologic failure on a CCR5 coreceptor antagonist.

Medicaid shall cover screening (serum screening with or without nuchal translucency ultrasound or cell-free DNA screening) and diagnostic testing (CVS or amniocentesis) for chromosomal abnormalities after counseling the beneficiary shall be offered to all beneficiaries early in pregnancy regardless of maternal age or baseline risk.

Medicaid shall cover whole exome sequencing (WES) for the identification and treatment of ill-defined symptoms when the following criteria are met:

1. Phenotype is suspicious for a genetic diagnosis;
2. beneficiary has multiple major structural or functional congenital anomalies affecting unrelated organ systems, including metabolic disorders;
3. beneficiary has one major structural congenital anomaly and two or more minor structural anomalies; or
4. the beneficiary has at least 2 of the following:
   1. major structural congenital anomaly affecting a single organ system;
   2. neurological features including either significant intellectual disability, global developmental delay or autism;
   3. severe psychological or psychiatric disturbance or severe neuropsychiatric condition;
   4. symptoms of a complex neurodevelopmental disorder;
   5. family history strongly implicating a genetic etiology; or
   6. period of unexplained developmental regression unrelated to autism or epilepsy; and
5. The beneficiary is evaluated and counseled by a certified geneticist or provider with genetic counseling experience prior to the test being ordered and when the results are reviewed;
6. Test ordered will be used to guide treatment; and
7. The beneficiary is age 21 or younger.

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

1. Chronic Myelogenous Leukemia (CML);
2. Acute Lymphoblastic (also known as lymphocytic) Leukemia (ALL);
3. Acute Myeloid Leukemia (AML);
4. Myelodysplastic syndromes (MDS);
5. Lymphomas (solid tumors); and
6. Multiple myeloma.

 

Medicaid shall cover genetic and cytogenetic testing for the diagnosis and treatment of spinal muscular atrophy (SMA) when the following criteria are met:

1. The beneficiary has signs or symptoms of SMA;
2. The beneficiary or guardian has undergone genetic counseling;
3. When the symptomatic beneficiary has a known familial variant, the test that is ordered should be for that specific variant;
4. If no mutation is found when testing for common variants and the beneficiary is symptomatic, full gene sequencing can be ordered; or
5. After completing the full gene sequencing, if no mutation is found, testing may be done for duplication/deletion variants

 

Medicaid shall cover carrier testing for spinal muscular atrophy (SMA) when the beneficiary meets the criteria below:

1. Beneficiary is pregnant or considering pregnancy and has not previously been tested for SMA:
2. After genetic counseling has been provided, informed consent is obtained prior to, and beneficiary agrees to voluntary carrier testing.

 

Medicaid shall cover carrier testing for Ashkenazi Jewish associated disorders (e.g., Bloom syndrome, Canavan disease, cystic fibrosis, familial dysautonomia, Fanconi anemia group C, Gaucher disease, Tay-Sachs disease) when the beneficiary meets the criteria below:

1. At least one partner is Ashkenazi Jewish or at least one partner is a known carrier of an Ashkenazi Jewish associated disorder;
2. History of a previous child born with an Ashkenazi Jewish associated disorder; or
3. One or both partners have a first or second-degree relative affected with an Ashkenazi Jewish associated disorder; and
4. Test will guide plan of care for current and future pregnancies.

https://medicaid.ncdhhs.gov/1s-1-genotyping-and-phenotyping-hiv-drug-resistance-testing/download?attachment

https://medicaid.ncdhhs.gov/1s-2-hiv-tropism-assay/download?attachment

https://medicaid.ncdhhs.gov/1s-5-genetic-testing-susceptibility-breast-and-ovarian-cancer-brca/download?attachment

https://medicaid.ncdhhs.gov/1s-4-genetic-testing/download?attachment

https://medicaid.ncdhhs.gov/1s-7-gene-expression-profiling-breast-cancer/download?attachment

https://medicaid.ncdhhs.gov/5a-3-nursing-equipment-and-supplies/download?attachment