Texas

Stephanie Stephens, Chief of Medicaid and CHIP Services and State Medicaid Director for the Texas Health and Human Services Commission

If a client is found to screen positive for any genetic disorders, confirmatory testing and treatment may be needed. If confirmatory testing or immediate treatment is needed, DSHS case management staff will contact the provider about next steps. Typically, confirmatory testing and treatment are recommended by metabolic specialists. The confirmatory laboratory tests are conducted by private laboratories, and are later billed to the health plans. Contracted CHIP or CHIP perinatal providers should contact the CHIP health plan for more information.

Genetic counseling must be provided by a trained genetic counselor, nurse specialist in genetics, or other medical provider possessing expertise in genetic counseling that is not affiliated with the genetic testing laboratory for clients before and after BRCA gene mutation testing.

Both pre- and post-test counseling must provide the depth of content and time for the client to make an informed testing decision. The genetic counseling must be nondirective, and information about the purpose and nature of the tests must be provided to the client.

Pre-test genetic counseling must include:

1. The risks and benefits of the specific genetic testing; and
2. The limitations of the specific genetic testing to be performed and the limitations of interpreting test results for an unaffected individual.”

Prior authorization is required for initial BRCA testing. If the client is of Ashkenazi Jewish, Icelandic, Swedish, or Hungarian descent, testing for the three known founder variants should be performed first. The prior authorization request must include documentation that indicates that the client meets one or more of the criteria below:

• An individual (male or female) from a family with a known deleterious BRCA1/BRCA2 mutation;
• A female with a personal history of breast cancer, including invasive or ductal carcinoma in situ (DCIS), diagnosed at age 45 years or younger;
• A female with a personal history of breast cancer, including DCIS, diagnosed at any age and of an ethnicity associated with higher mutation frequency, such as: Ashkenazi Jewish, Icelandic, Swedish, or Hungarian descent;
• A female with a personal history of epithelial ovarian cancer, including fallopian tube and primary peritoneal cancers, diagnosed at any age;
• A male with a personal history of breast cancer, including DCIS, diagnosed at any age;
• A female with a personal history of breast cancer, including DCIS, diagnosed at age 50 years or younger, and has one of the following:
  • An additional primary (2 primary sites, including bilateral or clearly separate ipsilateral) tumors occurring either synchronously or asynchronously;
  • At least one close blood relative with breast cancer at any age; or
  • An unknown or limited family history.
• A female with a personal history of breast cancer, including DCIS, diagnosed at age 60 years or younger with triple negative breast cancer;
• A female with a personal history of breast cancer, including DCIS, diagnosed at any age, and has one of the following:
  • At least one close blood relative with breast cancer diagnosed at age 50 years or younger;
  • At least two close blood relatives with breast cancer at any age;
  • At least one close blood relative with epithelial ovarian cancer, including fallopian tube and primary peritoneal cancers; or
  • At least two close blood relatives with pancreatic cancer or prostate cancer (Gleason score 7 or greater) at any age.

Coverage is available.

BRCA testing services are benefits of Texas Medicaid. BRCA gene mutation analysis testing must be ordered based on familial medical history and the availability of previous familial gene mutation analysis testing results and only if the test results will affect treatment decisions or provide prognostic information.

Unaffected male or females with a family history of breast cancer, including diagnosis of ductal carcinoma in situ (DCIS), should only be considered for testing when the appropriate affected family member is unavailable. Clinical judgment should be used to determine if the client has a reasonable likelihood of a mutation, considering the client’s current age and the age of the unaffected female relatives who link the client with the affected relatives.

It is mandatory that a client who is at risk for BRCA1, BRCA2, or BRCA large rearrangement genetic mutation receive genetic counseling before and after BRCA gene mutation testing.

BRCA gene mutation analysis testing is limited to once per lifetime.

Genetic testing is provided to clients who have a first- or second-degree relative who has or has had colorectal cancer in order to determine if the client may have increased risk for developing colorectal cancer. The documentation that is maintained in the client’s medical record must reflect that the client or family member has been given information on the nature, inheritance, and implications of genetic disorders to help them make informed medical and personal decisions prior to the genetic testing. The testing must be medically necessary and supported by documentation with a clear rationale for testing, which must be retained in the client’s medical record and made available upon request.

Providers must maintain the following documentation in the client’s medical record for genetic testing for colorectal cancer:

• Documentation of formal pre-test counseling, including assessment of the client’s ability to understand the risks and limitations of the test; and
• The client’s informed choice to proceed with the genetic testing for colorectal cancer.
• The provider must order the test based on the familial medical history and the availability of previous family testing results. The medical record is subject to retrospective review.

Prior authorization is required for gene mutation analysis. Prior authorized services may be reimbursed once per lifetime when billed by any provider. Additional services will not be prior authorized. Prior authorization requests may be considered for Familial Adenomatous Polyposis (FAP) testing for clients of any age with well defined hereditary cancer syndromes and for which either a positive or negative result will change medical care. The client for whom the request is made must have more than 20 polyps or a first-degree relative with FAP and a documented mutation.

Prior authorization requests may be considered for Hereditary Nonpolyposis Colorectal Cancer (HNPCC) testing for clients of any age. Testing for HNPCC is used to determine whether an individual has an increased risk for colorectal cancer or other HNPCC-associated cancers. Results of the test may influence clinical management decisions. The request must include one or more of the following criteria for testing:

1. The client has three or more family members (at least one must be a first-degree relative) who have colorectal cancer, and FAP has been ruled out. Two successive generations were affected, and one or more of the relatives was diagnosed with colorectal cancer at 50 years of age or younger.
2. The client has had two HNPCC cancers.
3. The client has colorectal cancer and a first-degree relative who also has colorectal cancer or HNPCC extracolonic cancer at 50 years of age or younger or colorectal adenoma at 40 years of age or younger.
4. The client has had colorectal cancer or endometrial cancer at 50 years of age or younger.
5. The client has had right-sided colorectal cancer with an undifferentiated pattern on histology at 50 years of age or younger.
6. The client has had signet-cell type colorectal cancer at 50 years of age or younger.
7. The client has had colorectal adenoma at 40 years of age or younger.
8. The client is an asymptomatic individual with a first- or second-degree relative with a documented HNPCC mutation.

Pharmacogenetic testing of cytochrome p450 (CYP450) metabolic pathway may be considered medically necessary only if the results of the testing are necessary to differentiate between treatment options. The use of pharmacogenetics may be considered medically necessary once in a lifetime to determine effective response to drug therapy for the following: Clopidogrel, Eliglustat, Tetrabenzine in a dosage greater than 50mg per day, and Warfarin.
Pharmacogenetics testing of polymorphic 2C9 (procedure code 81227) may be considered for clopi­dogrel treatment and requires prior authorization and may be considered medically necessary when all of the following conditions are met:

• The client has never received genetic testing of the 2C19 alleles.
• The client has never received clopidogrel treatment.
• The clopidogrel treatment will be used for one of the following diseases or conditions:
• ST elevated and non-ST elevated myocardial infarction (STEMI and NSTEMI)
• Subsequent STEMI and NSTEMI
• Dressler’s syndrome
• Unstable angina
• Cerebral infarction due to embolism of cerebral arteries
• Occlusion and stenosis of cerebral arteries, not resulting in cerebral infarction
• Peripheral vascular disease, including unspecified

Pharmacogenetics testing of polymorphic 2D6 (procedure code 81226) may be considered medically necessary when all of the following conditions are met:

• The client has never received genetic testing of the 2D6 alleles
• The client has a diagnosis of Gaucher disease type 1
• Treatment with eliglustat (Cerdelga®) is being considered
• The client has a diagnosis of Huntington’s disease
• Treatment with tetrabenzine (Xenazine®) is being considered in a dosage greater than 50mg per day.
• Prior authorization is not required for the initial pharmacogenetic testing of polymorphic 2D6 (procedure code 81226) that is performed on a client. Prior authorization is required for repeat testing.

Pharmacogenetics testing of polymorphic 2C9 (procedure code 81227) requires prior authorization and may be considered for warfarin treatment and may be considered medically necessary when all of the following conditions are met:

• The client has never received genetic testing of the 2C9 alleles
• The client has never received warfarin (vitamin K antagonists) treatment
• The warfarin treatment will be used for one of the following diseases or conditions:
  • Irregular heartbeat or rhythm
  • Prosthetic (replacement or mechanical) heart valves
  • Myocardial infarction
  • Risk of venous thrombosis (swelling and blood clot in a vein)
  • Risk of pulmonary embolism (a blood clot in the lung).

WES (including trio testing) is considered medically necessary for the evaluation of neurodevelopmental disorders, multiple congenital anomalies, or epilepsy/seizure disorders when ALL of the following are met:

• Member is 17 years of age or younger; AND
• Pretest genetic counseling has been completed by a qualified health provider such as a board certified genetic counselor or physician with expertise in clinical genetics; AND
• A letter supporting medical necessity of requested testing has been submitted, which contains ALL of the following:
  • Differential diagnosis; AND
  • Results of previous testing; AND
  • Statement that a genetic etiology is the most likely explanation of the members symptoms; AND d. Predicted impact on the member’s plan of care; AND
• A genetic etiology is the most likely explanation for the phenotype as demonstrated by TWO or more of the following:
  • Presence of multiple congenital abnormalities; AND
  • Presence of developmental delay or intellectual disability for which first tier testing has not established a diagnosis (single gene testing or chromosomal microarray analysis); AND
  • Presence of a severe neuropsychiatric condition (schizophrenia, bipolar disorder, Tourette syndrome); AND
  • Periods of unexplained developmental regression in which the member loses an acquired function or fails to progress beyond a plateau following a period of normal development; AND
  • Presence of epilepsy or a seizure disorder for which a genetic etiology is suspected and standard medical evaluation has not been diagnostic; AND
• No other causative circumstance such as environmental exposure, injury, or infection can account for the clinical presentation; AND
• The testing would result in an impact on the members health outcomes.

WES reanalysis of previously obtained standard WES for one of the above medically necessary indications (i.e., unexplained neurodevelopmental disorders, multiple congenital anomalies, or epilepsy/seizure disorder in children) is considered medically necessary when ONE of the following criteria is met:

• Additional symptoms have presented in the member that broaden the phenotype assessed during the original exome evaluation; OR
• The birth or diagnosis of a similarly affected first-degree relative that has expanded the clinical picture

Texas Department of State Health Services “provides access to genetic health care services by funding and providing oversight to nine genetics clinics throughout the state.

Title V Fee-for-Service funds selected public and private contractors to provide specified allowable genetic services through established rates. These services are provided to Texas residents with family incomes at or less than 185% of the most current Federal Poverty Income Level (FPIL) who are not eligible for other programs providing the same services. Title V funded contracts serve as safety net providers of genetic services for eligible women and children and their families.

DSHS Genetic Services maintains a complete list of genetic service providers throughout the state. Provider List or call 1-800-252-8023 or access https://www.dshs.texas.gov/genetics/access-to-srvs.shtm.

• Texas Medicaid Lab Procedure
  • https://www.tmhp.com/sites/default/files/file-library/resources/provider-manuals/tmppm/pdf-chapters/2021/2021-10-october/2_Radiology_and_Lab_Srvs.pdf