Vermont

Yes

Monica Ogelby, RN
Deputy Commissioner Department of Vermont Health Access
280 State Drive Waterbury, VT 05671
Phone: (802) 879-5901

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

Chromosomal microarray analysis is not considered medically necessary when:

1. Biologic parents have known chromosomal rearrangements* OR
2. There is a maternal history of recurrent miscarriages**
   *Karyotyping is the test of choice when the individual has a family history of balanced chromosomal rearrangement
   **Balanced translocation is a common reason for recurrent miscarriages and cannot be detected on cytogenetic microarrays. Karyotyping is the test of choice.

Non-invasive prenatal testing is not covered for:

1. Sex chromosome aneuploidy.
2. Screening for single gene disorders.
3. Screening for average or low-risk pregnancy.
4.  Routine cell-free DNA screening for microdeletion syndromes.
5. When Karyotyping aneuploidy FISH and/or array CGH have already been performed within 10 weeks of the cell-free fetal DNA test.

Vermont Medicaid will provide comprehensive services and furnish all Medicaid coverable, appropriate, and medically necessary services needed to correct and ameliorate health conditions for Medicaid members under age 21.

Genetic testing for Huntington’s disease may be covered for children when symptoms are suggestive, and Huntington’s disease is suspected based on family history and clinical phenotype. Testing of a child with the clinical phenotype, in the absence of a family history, should be done after ruling out other causes. It is not appropriate to presymptomatically test children < 18 years of age, when a parent has been diagnosed with adult-onset Huntington’s disease.

The majority of genetic testing criteria state the following: “Providers requesting this test should provide pre- and post-test genetic counseling for the member and family, if applicable.”

State Statute- 8 V.S.A. § 4089e

Metabolic nutrition may be covered for a beneficiary who:

1. Has a diagnosis of an inherited metabolic disease caused by an inherited abnormality of body chemistry. AND
2. Requires a low protein modified food product:
   1. which is specifically formulated to have less than one gram of protein per serving and
   2. is intended to be used under the direction of a physician for the treatment of the inherited metabolic disease OR
3. Requires an amino acid modified food that is intended to be used under the direction of a physician for the dietary treatment of an inherited metabolic disease.

Prior Authorization is required for products that are not found on this list.

Some genetic tests require prior authorization. Information can be found on the Vermont Medicaid Fee Schedule: http://www.vtmedicaid.com/#/feeSchedule.

https://dvha.vermont.gov/sites/dvha/files/doc_library/Genetic%20testing%20form_for%20web.docx

http://www.vtmedicaid.com/#/feeSchedule/labOtherRadiology

Yes

BRCA 1 and 2, and HBOC genetic testing may be covered for members:

1. When the genetic testing for hereditary breast and ovarian cancer is prescribed by a licensed medical provider, enrolled in the Vermont Medicaid program, operating within their scope of practice as described on the Vermont Office of Professional Regulation’s website*, Statute, or rule who is knowledgeable regarding the gene test and who provides medical care to the member AND
2.  When the clinical criteria below are met: DVHA covers testing for breast and/or ovarian cancer susceptibility genes in alignment with NCCN testing criteria for high-penetrance breast and ovarian cancer susceptibility genes.
   Considerations: Providers requesting this test should provide pre- and post-test genetic counseling for the member and family, if applicable.

Cystic fibrosis testing may be covered for beneficiaries who:

1. Have clinical symptoms characteristic of CF (pancreatic insufficiency, lung function abnormalities and high sweat chloride test)
2. Have a family history of CF
3.  Are couples planning a pregnancy and wish to know if either is a CF carrier
4. Are reproductive partners of persons with CF
5. Desire a prenatal diagnosis to identify a fetus or embryo with CF for purposes of post-delivery care of the newborn.

Providers requesting this test should provide pre- and post-test genetic counseling for the beneficiary and family, if applicable.

APC and MUYTH genetic testing may be covered for members who have clinical symptoms consistent with FAP, AFAP, Gardener’s syndrome or Turcot’s Syndrome, or MAP in accordance with the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology for genetic/familial high-risk assessment of colorectal cancers. APC and MUTYH gene testing for members suspected to have FAP, AFAP, or MAP may be considered
when the following conditions are met:

1. Personal history of greater than or equal to 20 cumulative adenomas
2. When familial variant is known, deletion/duplication genetic testing is considered medically necessary for the specific APC or MUTYH variant. APC genetic testing is considered medically necessary for first degree relatives of an individual with FAP, etc.
3. Multifocal/bilateral congenital hypertrophy of retinal pigment epithelium (CHRPE)
4. Additionally testing may be considered for personal history of between 10-19 cumulative adenomas, desmoid tumor, hepatoblastoma, cribriform-morular variant of papillary thyroid cancer, unilateral CHRPE, or serrated polyposis syndrome (previously know as hyperplastic polyposis) with at least some adenomas. All clinical history should be taken into account when these findings are present.

Consider which gene should be tested when heritability pattern is clear. For example, if only one sibling is exhibiting colonic polyposis, consider recessive inheritance, which would point to MUTYH testing. When there is a known familial mutation in the APC gene and familial history of FAP, genetic testing should be completed by 10 years of age to align with initiation of cancer screening. This should similarly be considered for family history of AFAP.

Providers requesting this test should provide pre- and post-test genetic counseling for the member and family, if applicable

Prenatal diagnosis or pre-implantation genetic testing may be considered if a pathogenic variant has been identified in an affected family member.

The Department of Vermont Health Access (DVHA) considers genetic testing for Hereditary Non-Polyposis Colorectal Cancer (HNPCC) and FAP medically necessary to establish a molecular diagnosis of an inheritable disease in accordance with current National Comprehensive Cancer Network (NCCN) guidelines. These can be found at https://www.nccn.org/guidelines/category_2. The NCCN endorses universal immunohistochemical (IHC) and microsatellite instability (MSI) testing on all newly diagnosed colorectal and rectal cancers regardless of family history to determine which patients should have genetic testing for Lynch Syndrome.

Providers requesting this test should provide pre- and post-test genetic counseling for the member and family, if applicable.

Chromosomal microarray analysis may be considered medically necessary as first-line testing in the initial postnatal evaluation of members age 17 years or younger with clinical documentation of a developmental delay, autism spectrum disorder (ASD), or intellectual disability or when multiple congenital anomalies are present since birth, when the following conditions are met:

1. If warranted by the clinical presentation, biochemical testing for metabolic diseases has been performed and is negative AND
2. Targeted genetic testing if warranted by the clinical presentation and family history is negative AND
3. If no clinical features or family history suggestive of Fragile X Syndrome, negative FMR is not required AND
4. The individual’s clinical presentation is not specific to a well delineated genetic syndrome

Considerations: Providers requesting this test should provide pre- and post-test genetic counseling for the member and family, if applicable.

Gene expression profiling is covered by Vermont Medicaid in accordance with the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology for breast cancer for the following tests:

1. Oncotype DX®
2.  EndoPredict®
3. Breast Cancer Index®
4.  MammaPrint®
   Please find this guideline at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

DVHA covers testing for prostate cancer genomic assays in alignment with the National Comprehensive Cancer Network (NCCN) guidelines for treatment of prostate cancer. Prior authorization is required for prostate cancer genomic assays. These include Prolaris®, Decipher®, and OncotypeDX®. These tests are utilized to determine risk related to disease progression and the results are used to guide treatment.
Decipher® molecular assay should be considered if not previously performed to inform adjuvant treatment if adverse features are found post radical prostatectomy. NCCN Guidelines for Prostate Cancer can be found at:
https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf

NIPT CPT code 81420 (Fetal chromosomal aneuploidy (e.g., trisomy 21, monosomy X) genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18, and 21) is a screening test, and a positive result requires confirmation by invasive testing (e.g., CVS, AMC). Testing may be covered for members with a singleton pregnancy after 10 weeks gestation and who will receive pre- and post-counseling for ANY of the following indications:

1. Maternal age 35 years or older at delivery
2. Fetal ultrasonographic findings indicating increased risk of aneuploidy
3. History of previous pregnancy with a trisomy
4. Standard serum screening test positive for aneuploidy or
5. Parental balanced Robertsonian translocation with increased risk of fetal trisomy 13 or trisomy 21

NIPT CPT code 81507 (Harmony®) (Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy) is also a screening test and utilizes DNA sequence analysis of selected regions using maternal plasma and an algorithm and is reported as a risk score for each trisomy. This test is for all pregnant women regardless of age, includes any of the criteria listed above, and is appropriate for twin pregnancies.

Proportion of fetal to maternal cell-free DNA levels in maternal plasma greatly impacts test reliability. Fetal cell-free DNA increases throughout gestation. Studies have identified that increased maternal weight is associated with lower levels of fetal cell-free DNA. Fraction of fetal cell-free DNA in maternal blood decreases with increased maternal weight and this is correlated to increased NIPT test failure. In considering this testing, patients with increased maternal weight should be informed of this risk. It is important to inform and discuss alternative screening with patients who decline second attempt for testing.

Cardiology (heart transplant) gene expression profiling testing (AlloMap®) may be covered for members who:

1. Are age 15 years or older
2.  Are not pregnant
3. Are between 6 months and 5 years post-heart transplant.
4. Do not show signs or symptoms of cardiac allograft dysfunction including:
   1. Absence of signs or symptoms of congestive heart failure
   2. Left ventricular ejection fraction (LVEF) ≥45% by echocardiography
   3. Absence of severe cardiac allograft vasculopathy (CAV)
      5.
5. Have a low probability of moderate or severe acute cellular rejection as demonstrated by BOTH of the following:
   1. International Society for Heart and Lung Transplantation rejection status Grade 0R or 1R on all previous endomyocardial biopsies
   2. No history or evidence of antibody medicated rejection
6. Have no history of elevated genetic expression profile that prompted subsequent endomyocardial biopsy to clarify rejection status. Providers requesting this test should provide pre- and post-test genetic counseling for the member and family, if applicable.

FMRI genetic testing may be covered for members when:

1. The individual is age 20 years or younger and has clinical documentation of a developmental delay, intellectual disability, or autism spectrum disorder OR
2. The individual is seeking reproductive counseling and has a family history of Fragile X syndrome or autism spectrum disorder OR
3. Prenatal testing of fetus(es) of known carrier mothers OR
4. Individuals who have ovarian failure before the age of 40 in whom Fragile X-associated ovarian failure is suspected OR
5. Individuals with neurologic symptoms and findings consistent with FXTAS OR
6. Affected individuals or relatives of affected individuals who have had a positive cytogenetic Fragile X test result who are seeking further counseling related to the risk of carrier status.
   Providers requesting this test should provide pre- and post-test genetic counseling for the member and family, if applicable.

Genetic Testing of Tumor Protein 53 for Li-Fraumeni syndrome is covered by Vermont Medicaid in accordance with the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology
for Genetic/Familial High-Risk Assessment of Breast, Ovarian, and Pancreatic Cancers. This guideline may be found at: https://www.nccn.org/professionals/physician_gls/pdf/genetics_bop.pdf
Providers requesting this test should provide pre- and post-test genetic counseling for the member and family, if applicable.

Hereditary hemochromatosis (HH) may be covered for a member with one or more of the following:

1. Who have abnormal iron study results indicating iron overload, even in the absence of symptoms. OR
2. With suggestive symptoms (examples: abdominal pain, weakness, lethargy, arthralgias, impotence, weight loss), physical findings (examples: cirrhosis of the liver, liver cancer, diabetes, heart disease or failure, joint disease. osteoporosis) AND an elevated transferrin saturation or serum ferritin test. OR
3. A family history of HH in a first degree relative. OR
4. Recommended screening (iron studies and HFE mutation analysis) of first-degree relatives of member’s with HFE-related HH or evidence of active liver disease to detect early disease and prevent complications.
5. Definition: A first degree blood relative shares 50 % DNA (father, mother, brother, sister, daughter, or son). Both genotype (HFE mutation analysis) and phenotype (ferritin and Transferrin saturation (TS) should be performed simultaneously at a single visit.
   Considerations: Providers requesting this test should provide pre- and post-test genetic counseling for the member and family, if applicable.

Human Platelet Antigen Genotyping may be covered for:
Fetal or neonatal testing:

1. Either parent has had a prior affected pregnancy, OR
2. An unexplained intracranial hemorrhage is detected, OR
3. When thrombocytopenia is discovered

Maternal and paternal testing:

1. Should be performed when the fetus or neonate is suspected of having NAIT

Female members:

1. When planning a pregnancy, and the sister has had a previously affected pregnancy or a pregnancy with posttransfusion purpura
2. Who have had an adverse reaction (severe thrombocytopenia) to a blood or platelet transfusion. Considerations: Providers requesting this test should provide pre- and post-test genetic counseling for the member and family, if applicable

Genetic testing for Huntington’s disease may be covered for members based on the following:

1. Adults:
   1. To confirm or rule out the diagnosis when symptoms strongly suggest the diagnosis of Huntington’s disease but there is no known family history.
   2. Testing in asymptomatic relatives of a person with a genetically confirmed diagnosis of HD
2. Children:
   1. When symptoms are suggestive, and Huntington’s disease is suspected based on family history and clinical phenotype. Testing of a child with the clinical phenotype, in the absence of a family history, should be done after ruling out other causes. It is not appropriate to presymptomatically test children < 18 years of age, when a parent has been diagnosed with adult-onset Huntington’s disease.
3. Presymptomatic testing for an individual at risk to provide reproductive and recurrence information.
4. Prenatal testing in fetuses from families in which there is a history of HD and
   1. The results will directly impact the treatment plan of the member.
   2. Genetic counseling has been conducted.

JAK2 genetic testing may be covered for members who:

1. Are 18 years or older, AND
2. Meet criteria for polycythemia vera (PV), essential thrombocythemia (ET) or primary myelofibrosis (PMF) in accordance with the World Health Organization’s diagnostic criteria for myeloproliferative neoplasms, AND
3. Medical management will be impacted by this genetic testing.

myPath® Melanoma assay is a clinically validated test to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. The test measures the expression of 23 genes and accurately distinguishes melanoma from benign nevi. Medicaid will provide limited coverage for the myPath® Melanoma assay for the diagnosis or exclusion of melanoma from a biopsy when all of the following clinical conditions are met:

1. The test is ordered by a board-certified dermatopathologist and;
2. The specimen is a primary cutaneous melanocytic neoplasm for which the diagnosis is equivocal/uncertain (i.e. clear distinction between benign or malignant cannot be achieved using clinical and/or histopathological features alone) and;
3. The patient may be subjected to additional intervention, such as re-excision and/or sentinel lymph node biopsy, as a result of the diagnostic uncertainty

The Trofile® Assay lab test may be covered for members who meet all the following criteria:

1. The member is 18 years old or older and is HIV-infected with HIV-1 strains that are resistant to multiple antiretroviral agents, AND
2. The member must have a viral load greater than 1,000 copies/ml, AND
3. Has evidence of viral replication, AND
4. Is being considered for treatment with a CCR5 antagonist such as Maraviroc, AND
5. The Trofile® test is being prescribed by a participating Medicaid provider with expertise in the treatment and management of HIV-1, AND
6. The Trofile® test is (to be) performed by a qualified laboratory enrolled with Vermont Medicaid.

https://dvha.vermont.gov/sites/dvha/files/doc_library/COU%20Allomap%20for%20web_0.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Chromosomal%20Microarray%20for%20web_0.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Colon%20cancer%20Lynch%20syndrome%20for%20web.pdf

https://dvha.vermont.gov/sites/dvha/files/documents/providers/Forms/Cystic%20Fibrosis%20Genetic%20Test%20for%20web.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Familial%20Adenomatous%20Polyposis%20for%20web.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Fragile%20X%20FMR1_050523.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Gene%20Expression%20Profiling%20for%20Managing%20Breast%20Cancer%20for%20web_0.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/GENE%20ANALYSIS%20TUMOR%20PROTEIN%2053%20for%20web.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Hereditary%20Hemochromatosis%20for%20web.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Hereditary%20Breast%20and%20Ovarian%20Cancer%20criteria%20for%20web.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/COU%20Human%20Platelet%20Antigen%20Genotyping%20for%20web_0.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Huntingtons%20Disease%20Genetic%20Testing%20for_web.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/COU%20JAK%202%20Genetic%20Test%20for%20web_0.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Melanoma%20genetic%20test%20myPATH%20for%20web.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Noninvasive%20Prenatal%20Testing%20or%20Serum%20Marker%20Screening%20for%20Down%20Syndrome%20for%20web.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/Prostate%20Cancer%20Genomic%20Assay%20for%20web_0.pdf

https://dvha.vermont.gov/sites/dvha/files/doc_library/COU%20Trofile%20Assay_for%20web_0.pdf

https://dvha.vermont.gov/members/vermont-medicaid-programs/medicaid/epsdt

https://dvha.vermont.gov/sites/dvha/files/documents/providers/Pharmacy/1metabolic-nutrition-080118.pdf