Connecticut

Yes

Dr. William Gui Woolston
State Medicaid Director
Connecticut Department of Social Services
55 Farmington Avenue
Hartford, CT 06105
Phone: (860) 424-5383

https://portal.ct.gov/-/media/Departments-and-Agencies/DSS/Health-and-Home-Care/Covered-Connecticut-Demonstration-Program/CoveredCT-CMS-Approval-Letter-and-STCs.pdf

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

Genetic testing is typically considered medically necessary when:

1. The member falls within a high-risk group for a particular disease based on personal history, family history, documentation of a genetic mutation, and/or ethnic background; AND
2. The test is ordered by:
   1. A board certified medical geneticist or other board certified physician with specific expertise in clinical genetics who is not employed or contracted with a commercial genetic testing laboratory; OR
   2. A physician, APRN or CNM with expertise in treatment of the targeted disease (for molecular diagnostic testing only); AND
3. Genetic counseling has been performed prior to testing; AND
4. Genetic counseling will be performed post-testing; AND
5. A specific mutation or set of mutations has been identified and broadly accepted by credible medical societies to be reliably associated with the condition (i.e., the genotypes to be detected by a genetic test must be shown by scientifically valid methods to be associated with the occurrence of a specific disease, and the observations must be independently replicated and subject to peer review); AND
6. The genetic disorder cannot be diagnosed or ruled out through means other than genetic testing, including but not limited to: clinical examination, imaging, other laboratory testing or other testing; AND
7. Patient history, physical examination and other diagnostic testing do not result in a definitive diagnosis of the suspected disorder; AND
8. The clinical utility of the requested test has been established. There is reliable evidence in the peer-reviewed scientific literature that the results of the genetic test are likely to materially impact the medical management of the member or current offspring or potential future offspring, with resulting improvement in health outcomes. That is, performing the genetic test has a reasonable likelihood of resulting in improved clinical outcomes as compared with ordinary care without the test, due to any of the following: improving or altering decision-making, preventing unnecessary diagnostic tests, altering therapy, etc.; AND
9. The individual has not previously received genetic testing for the disease/condition. (In general, diagnostic genetic testing for a disease should be performed once in a lifetime.) Exceptions include clinical scenarios whereby repeat testing of somatically-acquired mutations (for example, pre- and post- therapy) may be required to inform appropriate therapeutic decision-making.

The following information is needed to review requests for genetic testing:

1. Fully completed Genetic Testing Prior Authorization
   Note: The prior authorization form is considered a certificate of medical necessity. The form should not be submitted unless it has been fully completed and signed by the ordering physician.
2. Explanation of how the results of genetic testing are necessary to guide treatment decisions relevant to the member’s personal medical history for positive patient outcome (i.e., whether to perform surgery, determine chemotherapy treatment, etc.)
3. Medical records relevant to the testing being performed to include:
   1. A comprehensive history and physical examination by the referring physician
   2. Results of laboratory tests and imaging studies
   3. A three generation pedigree
   4. Conservative treatment provided, if applicable
4. Test information:
   1. The specific name of the test/panel
   2.  Name of performing CLIA-accredited laboratory
   3. The exact gene(s) and/or mutations being tested
5. Other information as requested by CHNCT.

The following are typically not covered but may be covered based on an assessment of the individual and their unique clinical needs:

1. Genetic tests whose clinical utility has not been established
2. Testing for the purposes of confirming a suspected diagnosis of a disorder that can be diagnosed based on clinical evaluation alone
3. Testing for conditions which cannot be altered by treatment or prevented by specific interventions
4. Testing solely for the purpose of informing the care or management of the individual’s family member
5. For testing panels, including but not limited to, multiple genes or multiple conditions, and in cases where a tiered approach/method is clinically available, testing will be covered only for the number of genes or tests deemed medically necessary to establish a diagnosis

Genetic testing provides information that can be used to diagnose genetic diseases and susceptibility to diseases or conditions that are inherited. Such testing includes studying chromosomes to the level of individual genes, biochemical testing for the possible presence of genetic diseases, and identifying mutant forms of genes associated with increased risk of developing genetic disorders. The results of a genetic test can be used to confirm or rule out a genetic condition or to help determine an individual’s chance of developing a genetic condition or passing on a genetic disorder. Results can provide individuals and families with the information necessary to make fully informed health-care decisions and are often used to influence choices about health care and management of an identified genetic disorder or susceptibility to one.

Whole Exome Sequencing (WES) may be considered medically necessary for the evaluation of unexplained congenital or neurodevelopmental disorders, multiple genetic anomalies, moderate to severe intellectual disability or epilepsy/seizure disorder in children < 21 years of age when ALL of the WES criteria are met.

In order to be eligible for a genetic counselor license, an applicant must have earned certification as a genetic counselor from the American Board of Genetic Counseling (ABGC) or the American Board of Medical Genetics and Genomics (ABMGG).Applications are only accepted online. Please select the following link to submit an online application: https://www.elicense.ct.gov/Login.aspx?ReturnUrl=/Activities/Listing.aspx&ID=10.
The application fee is $315.

Applicants must arrange for the following to be submitted directly to this office from the source:
a. Written verification of ABGC or ABMGG certification;
b. If applicable, verification of all out of state genetic counselor licenses held, current or expired.

All supporting documents should be mailed to:
Connecticut Department of Public Health
Genetic Counselor Certification
410 Capitol Ave. MS# 12 APP
PO Box 340308
Hartford, CT 06134
Fax: (860) 509-8457
email: oplc.dph@ct.gov

Testing for the purpose of diagnosing a genetic disorder or identifying an individual who is at risk for a late onset or slowly evolving genetic disorder may be considered medically necessary when testing is accompanied by genetic counseling.

Connecticut
CGSA §19a‐55,59a
CGSA §38a‐492c
CGSA §38a‐518c

HUSKY A, C, and D Members: Nutritional supplements for members age 21 or older will only be covered for members who require tube feeding or for members that can not safely ingest nutrition in any other form.
Coverage Under Medical Benefit Prior Authorization Required For: specialized foods formulas for inherited metabolic disease e.g., PKU (Code S9435)

HUSKY B Members: 100% covered, no co-pay. Benefit limited to medically necessary amino acid modified preparations and low protein
modified food products for the treatment of inherited metabolic disease when ordered by a participating physician.
Coverage Under Medical Benefit Prior Authorization Required for: specialized foods for inherited metabolic disease e.g.PKU (Code S9435)

Prior authorization is required for genetic testing with the exception of those tests used for cystic fibrosis screening* (CPT codes 81220-81224), spinal muscular atrophy gene analysis** (CPT code 81329), and fetal aneuploidy screening (CPT codes 81420 and 81507) during pregnancy.

https://www.huskyhealthct.org/providers/provider_postings/provider_forms/Genetic_Testing_Prior_Authorization_Form.pdfhttps://www.huskyhealthct.org/providers/provider_manual.html

https://www.ctdssmap.com/ctportal/provider/provider-fee-schedule-download

Yes, it is covered. The use of genetic testing for point mutations in the BRCA1 and BRCA2 genes may influence individual management in a variety of ways. The results of BRCA Mutation Testing can provide individuals with the information necessary to make fully informed health-care decisions. Individuals with point gene mutation may consider increased surveillance for breast cancer, or consider a prophylactic mastectomy or oophorectomy. Family members of an individual with a known point mutation, who test negative for a mutation, can forego increased surveillance and/or consideration of prophylactic surgery. Genetic testing for point mutations BRCA1 and BRCA2 genes has emerged as a widely accepted test, when accompanied by genetic counseling

BRCA Mutation Testing may be considered medically necessary for individuals who meet criteria in any one of the following categories:

1. Individuals with a personal history of cancer, genetic testing for a BRCA1 or BRCA2 mutation,
   associated with genetic counseling, when:
   1. The individual has a history of breast cancer and at least 1 relative with breast cancer diagnosed prior to age 45; OR
   2. The individual was diagnosed with breast cancer prior to age 50; OR
   3. The individual has multiple primary breast cancers or bilateral breast cancer; OR
   4. The individual is a male with breast cancer; OR
   5. The individual has triple negative breast cancer diagnosed prior to age 60; OR
   6. The individual has a history of breast cancer and 2 or more first-, second- or third-degree relatives with pancreatic cancer; OR
   7. The individual has a history of ovarian, fallopian tube or primary peritoneal cancer; OR
   8.  The individual has a history of pancreatic cancer and 2 or more first-, second-, or third-degree relatives with breast and/or ovarian and/or pancreatic cancer; OR
   9. The individual has a history of breast cancer and 2 or more first-, second- or third-degree relatives with breast or ovarian, fallopian tube, or primary peritoneal cancer; OR
   10. The individual has a history of breast cancer and belongs to a population at risk for specific mutations due to ethnic background (for example, Ashkenazi Jewish, Icelandic, Swedish, Hungarian or Dutch descent).
2. Individuals with a family history of cancer, genetic testing for a BRCA1 or BRCA2 mutation, associated with genetic counseling, who have a relative who would meet ANY of the following, but that relative is not available for testing:
   1. The individual has a first- or second-degree relative with breast cancer who also had at least 1 relative with breast cancer diagnosed prior to age 45; OR
   2. The individual has a first- or second-degree relative who had breast cancer diagnosed prior to age 50; OR
   3. The individual has a first- or second-degree relative who had multiple primary breast cancers or bilateral breast cancer; OR
   4. The individual has a first- or second-degree relative who has a history of ovarian, fallopian tube, or primary peritoneal cancer; OR
   5. The individual has a first- or second-degree male relative who developed breast cancer; OR
   6. The individual has a first- or second-degree relative who had triple negative breast cancer diagnosed prior to age 60; OR
   7. The individual has a first- or second-degree relative with a history of breast cancer and 2 or more first-, second-, or third-degree relatives with pancreatic cancer; OR
   8. The individual has a first- or second-degree relative who has a history of ovarian cancer and 2 or more first- second- or third-degree relatives with pancreatic cancer; OR
   9. The individual has a first- or second-degree relative with a history of pancreatic cancer and 2 or more first-, second-, or third-degree relatives with breast and/or ovarian and/or pancreatic cancer.
3. Individuals with a family history of 3 or more first-, second- or third-degree relatives with ovarian, fallopian tube or primary peritoneal cancer or breast cancer, (at least one of which has breast cancer at or before age 50), genetic testing for a BRCA1 or BRCA2 mutation, associated with genetic counseling.

Cystic fibrosis transmembrane conductance regulator (CFTR) gene analysis:
Prior authorization will NOT be required for cystic fibrosis testing (CPT codes 81220-81224) occurring
during the prenatal period when billed with one of the pregnancy diagnosis codes listed in Table 11 of the Connecticut Department of Social Services Fee Schedule Instructions located at www.ctdssmap.com → Provider → Provider Fee Schedule Download → Fee Schedule Instructions → Table 11.

Testing for the purpose of diagnosing a genetic disorder or identifying an individual who is at risk for a late onset or slowly evolving genetic disorder may be considered medically necessary when:

1. A specific mutation or set of mutations has been identified and broadly accepted by credible
   medical societies to be reliably associated with the condition; and
2. The genetic disorder cannot be identified through biological or other testing; and
3. The individual displays clinical features of or may be at increased risk of inheriting the mutation in question; and
4. The results of the genetic test would materially impact the medical management of the individual with resulting improvement in health outcomes; and
5. Testing is accompanied by genetic counseling.

Hereditary Non-Polyposis Colorectal Cancer (HNPCC [Lynch Syndrome])
Genetic testing to detect mutations in the HNPCC genes, associated with genetic counseling may be
considered medically necessary when any of the following criteria are met:
Personal History of:

• The individual has 2 or more HNPCC-related tumors, (colorectal, endometrial, biliary tract,
  thyroid, pancreas, ureter or renal pelvis, ovarian, brain, gastric, or small intestinal cancers,
  sebaceous gland adenomas or keratocanthomas), including synchronous and metachronous
  tumors; OR
• The individual has a history of colorectal cancer and a first-degree relative with colorectal cancer
  diagnosed prior to age 50 ; OR
• The individual has a history of colorectal cancer and a first-degree relative with an HNPCCrelated cancer diagnosed prior to age 50; OR
• The individual has a history of colorectal cancer and a first-degree relative with colorectal
  adenoma diagnosed prior to age 40; OR
• The individual has colorectal cancer or endometrial cancer diagnosed prior to age 50; OR
• The individual has a colorectal adenoma diagnosed prior to age 40; OR
• The individual has a first- or second-degree relative with a known HNPCC mutation (Lynch
  syndrome in family); OR
• The individual has a personal history of colorectal or endometrial cancer and tumor shows high micro-satellite instability (MSI). Family History of:
• The individual has a first-or second-degree relative with a known HNPCC mutation (Lynch
  Syndrome in family); or
• For individuals with a family history of potentially HNPCC related cancer, genetic testing to detect mutations in the HNPCC genes, associated with genetic counseling, may be considered
  medically necessary when an individual has a relative who would meet any of the following
  criteria, but that relative is not available for testing:
• The individual for whom the test is requested, has a first – or second-degree relative with
  2 or more HNPCC-related tumors (colorectal, endometrial, biliary tract, pancreas, ureter or
  renal pelvis, ovarian, brain, gastric, or small intestinal cancers, or sebaceous gland
  adenomas or keratocanthomas), including synchronous and metachronous tumors; OR
• The individual for whom the test is requested, has a first- or second-degree relative with a
  history of colorectal cancer and that relative has a first-degree relative with colorectal
  cancer diagnosed prior to age 50; OR
• The individual for whom the test is requested, has a first-or second-degree relative with a
  history of colorectal cancer and that relative has a first-degree relative with an HNPCC related cancer diagnosed prior to age 50; OR
• The individual for whom the test is requested, has a first- or second-degree relative with a
  history of colorectal cancer and that relative has a first-degree relative with colorectal
  adenoma diagnosed prior to age 40; OR
• The individual for whom the test is requested, has a first-or second-degree relative with
  colorectal cancer or endometrial cancer diagnosed prior to age 50; OR
• The individual, for whom the test is requested, has a first-or second-degree relative with a
  colorectal adenoma diagnosed prior to age 40.

Genetic testing for EPCAM mutations may be considered medically necessary to make a diagnosis of Lynch Syndrome in an individual with colorectal or endometrial cancer when both a) the tumor is
negative for MSH2 and MSH6 expression as demonstrated by immunohistochemistry (IHC) and b) the individual tested negative for a MSH2 germline mutation.

Typical clinical circumstances where array comparative genomic hybridization (aCGH) testing may be considered medically necessary as a first-line test in the initial post-natal evaluation include individuals with:

1. Multiple anomalies not specific to a well-delineated genetic syndrome; or
2.  Apparently non-syndromic developmental delay/intellectual disability; or
3. Autism spectrum disorders.

Genetic testing panels are typically considered investigational based on a lack of evidence supporting the clinical validity and clinical utility of these tests and are therefore not medically necessary but may be considered medically necessary when the following criteria are met:

1. Criteria 1-9 above are met; AND
2.  All components of the genetic testing panel demonstrate clinical utility for the condition being evaluated*; AND
3. All components of the panel offer significant advantages in efficiency compared to sequential
   analysis of individual genes; AND
4. The provider has had a discussion with the patient regarding the scope of the genetic testing
   panel being ordered and the impact of variants of unknown significance.

The ordering provider must validate the clinical utility by considering all of the following:

• Will the panel testing offer significant advantages compared to sequential analysis of individual genes (i.e., a genetic testing panel that addresses the disorder in question, rather than the disorder in question plus other disorders)?
• How will the panel testing results be used in patient care decision making?
• Will the ancillary findings lead to further testing or management changes?
• Is there reliable evidence in the peer-reviewed scientific literature that health outcomes will be improved as a result of treatment decisions based on molecular genetic testing findings?
  Note: If a genetic testing panel was previously performed for medically necessary indications and a larger panel is developed and requested, only the testing for previously untested genes will be considered medically necessary if the above criteria are met.

Typical clinical circumstances when cell-free fetal DNA-based prenatal screening for fetal aneuploidy
(trisomy 13, 18 and 21) may be considered medically necessary include:

1. The individual to be tested is carrying a single gestation; and
2. The individual is considered at high risk for fetal aneuploidy due to ANY of the following:
   1. The expectant mother will be 35 years or older at the time of delivery; or
   2.  The fetus has ultrasonographic findings that indicate an increased risk of aneuploidy; or
   3. The expectant mother has a history of a prior pregnancy with trisomy; or
   4. The expectant mother has a positive first or second-trimester standard biomarker screening test; or
   5. Either parent has been identified as having a balanced Robertsonian translocation with an increased risk of fetal trisomy 13 or trisomy 21.

WES may be considered medically necessary for the evaluation of unexplained congenital or
neurodevelopmental disorders, multiple genetic anomalies, moderate to severe intellectual disability or epilepsy/seizure disorder in children < 21 years of age when ALL of the following criteria are met:

1. The test is ordered by a board certified medical geneticist or other board certified physician with specialty specific expertise in clinical genetics who is not employed by or contracted with a commercial genetic testing laboratory;
2. The child has been evaluated by a board-certified medical geneticist or other board-certified
   physician specialist with expertise in the conditions and genes for which testing is being
   considered;
3. Genetic counseling has been completed by a board certified medical geneticist or other board
   certified physician with expertise in clinical genetics;
4. A genetic etiology is considered the most likely explanation for the phenotype;
5. The previous genetic testing (e.g., CGA, CMA, FISH analysis, single-gene or targeted panel
   testing) has failed to yield a diagnosis (a differential diagnosis and comprehensive testing
   algorithm must be submitted with all prior authorization requests);
6. Clinical picture does not fit a well-described syndrome;
7. A diagnosis cannot be made by standard clinical work-up; excluding invasive procedures such as muscle biopsy;
8. No other causative circumstances (e.g. environmental exposures, injury, infection) have been
   identified;
9. There is a predicted impact on health outcomes including:
   1. Reducing diagnostic uncertainty (e.g., eliminating lower yield testing and additional
      screening tests that may later be proved unnecessary once a diagnosis is achieved);
   2. Guiding prognosis and improving clinical decision making;
   3.  Application of specific treatments;
   4.  Withholding of contraindicated treatments; and
   5. Surveillance for later-onset comorbidities; or initiation of palliative care; or modification of care; and
10. WES results may preclude the need for multiple and/or invasive procedures (e.g., muscle biopsy) that would be recommended in the absence of WES testing.

Genetic testing to detect mutations in the FAP genes, associated with genetic counseling, may be
considered medically necessary in individuals who meet any of the following criteria:

• Individuals with greater than 20 adenomatous colonic polyps during their lifetime; OR
• First- or second-degree relatives of individuals diagnosed with Familial Adenomatous Polyposis (FAP); OR
• First- or second-degree relatives of individuals with a known FAP gene mutation.

MYH (Human MutY homolog)-associated Polyposis (MAP)
Genetic testing for MYH (also known as MUTYH)–associated polyposis (MAP), associated with genetic counseling, may be considered medically necessary when any of the following criteria are met:

• The individual has greater than 10 adenomatous colonic polyps and a recessive inheritance
  (family history positive only for siblings); OR
• The individual has greater than 10 adenomatous colonic polyps and had adenomatous polyposis coli (APC) testing with negative results; OR
• The individual has greater than 15 cumulative adenomas in 10 years and a recessive inheritance (family history positive only for siblings); OR
• The individual had greater than 15 cumulative adenomas in 10 years and had adenomatous
  polyposis coli (APC) testing with negative results; OR
• The individual is asymptomatic and has a sibling with known MYH-associated polyposis (MAP).

https://www.huskyhealthct.org/providers/provider_postings/policies_procedures/GeneticTestingPolicy.pdf

https://www.huskyhealthct.org/providers/provider_postings/policies_procedures/Whole_Exome_and_Whole_Genome_Sequencing_Policy.pdf

https://www.huskyhealthct.org/providers/provider_postings/policies_procedures/Provider_Policy_BRCA_Testing.pdf

https://www.huskyhealthct.org/providers/provider_postings/policies_procedures/Genetic_testing-Colorectal_Cancer_Susceptibility.pdf

https://www.huskyhealthct.org/providers/provider_postings/policies_procedures/Genetic_Testing-DD_ASD_and_MR.pdf

https://portal.ct.gov/DPH/Practitioner-Licensing–Investigations/Genetic-Counselor/Licensing-Requirements

https://www.huskyhealthct.org/providers/provider_postings/policies_procedures/Fetal_Aneuploidy_DNA_Sequence_Analysis_Policy.pdf

https://www.huskyhealthct.org/providers/provider_postings/benefits_grids/dme_grid.pdf

https://www.huskyhealthct.org/providers/provider_postings/HUSKY_Health_Provider_Guide.pdf

https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/heritable-disorders/reports-recommendations/state-laws-medical-foods-tab.pdf