Texas

Stephanie Stephens
Associate Commissioner, Medicaid/CHIP
Medical and Social Services Division
Texas Health and Human Services Commission
4900 Lamar Boulevard
Austin, TX 78751
Phone: (512) 707-6096

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

Diagnostic tests to check for genetic abnormalities must be performed only if the test results will affect treatment decisions or provide prognostic information. Tests for conditions that are treated symptomatically are not appropriate since the treatment would not change. Providers who are uncertain whether a test is appropriate are encouraged to contact a geneticist or other specialist to discuss the client’s needs. Any genetic testing and screening procedure must be accompanied by appropriate non-directive counseling, both before and after the procedure. Information must be provided to the client and family (if appropriate) about the possible risks and purpose and nature of the tests being performed. The interpretation of certain tests, such as nuchal translucency, requires additional education and experience. Texas Medicaid supports national certification standards when available.

The following services are not a benefit of Texas Medicaid:

• Pharmacogenetics tests of polymorphisms in a p450 superfamily other than 2D6, 2C19, or 2C9, which are performed for the purpose of aiding in the choice of drug or dose to increase efficacy or avoid toxicity, as they are considered experimental and investigational
• The routine clinical use of genetic testing to screen patients treated with clopidogrel who are undergoing percutaneous coronary intervention (PCI)
• The use of any of the 2D6, 2C19, or 2C9 tests for the following conditions, drugs, or treatments:
• Opioid pain medicines (codeine, oxycodone, hydrocodone, tramadol, fentanyl, and methadone)
• Selective serotonin reuptake inhibitors (SSRIs)
•  Selective norepinephrine reuptake inhibitors (SNRIs)
• Beta blockers
• Selective tricyclic antidepressants
• Selective antipsychotic drugs
• Efavirenz and other antiretroviral therapies for human immunodeficiency virus (HIV) infection
• Immunosuppressants for organ transplantation
• Aricept® (donepezil) for individuals with Alzheimer’s disease
• p450 polymorphisms test panels for any of the 3 alleles 2C19, 2D6, or 2C9

Texas currently has no enforceable standards for the practice or training of genetic counselors. State Licensure is in progress.

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:

• The risks and benefits of the specific genetic testing.
• The limitations of the specific genetic

Texas
Insurance Code
§1359.001 et seq.
Health and Safety
Code §33.031 et
seq.
TAC Health
Services §38

Medical nutrition therapy and nutrition counseling may be considered beneficial for disease states for which dietary adjustment has a therapeutic role. Such disease states include inherited metabolic disorders.
Medical nutritional products including enteral formulas and food thickener, may be approved for clients who have specialized nutritional requirements. Medical nutritional products must be prescribed by a physician and be medically necessary.
Enteral nutritional products are those food products that are included in an enteral treatment protocol. They serve as a therapeutic agent for health maintenance and are required to treat an identified medical condition. Nutritional products, supplies, and equipment may be a benefit when provided in the home under Home Health Services. For clients who are 20 years of age and younger and do not meet criteria through Home Health Services, products, supplies, and equipment can be considered through the Comprehensive Care Program (CCP).
Enteral nutritional products and related feeding supplies and equipment are a benefit through Home Health Services for clients who are 21 years of age and older and require tube feeding as their primary source of nutrition. The enteral product, supply, or equipment must be part of the medical POC outlined and maintained by the treating physician.
Enteral formulas require prior authorization.
Enteral formulas consisting of semi-synthetic intact protein or protein isolates (procedure codes B4150 and B4152) are appropriate for the majority of clients requiring enteral nutrition. Special enteral formulas or additives (procedure code B4104) may be considered for prior authorization with supporting documentation submitted by the client’s physician indicating the client’s medical needs for these special enteral formulas.
Pediatric nutritional products (procedure codes B4103, B4158, B4159, B4160, B4161, and B4162) are restricted to clients who are 20 years of age and younger.
Food thickener may be considered for clients with a swallowing disorder.
Enteral nutrition and related supplies and equipment may be considered for prior authorization for clients who are 21 years of age and older when all or part of the client’s nutritional intake is received through a feeding tube, and the enteral formula is:

1. The client’s sole source of nutrition
2.  The client’s primary source of nutrition
3. An enteral tube feeding is considered the primary source of nutrition when it comprises more than 70 percent of the caloric intake needed to maintain the client’s weight.
4. The percent of calories provided by an enteral formula may be calculated by dividing the client’s daily calories supplied by the enteral formula by the daily caloric intake ordered by the physician to maintain the client’s weight. The result is multiplied by 100 to determine the percentage of calories provided by the enteral formula.

Prior authorization for nutritional products is not required for a client who is 20 years of age and younger and who meets at least one of the following criteria:

1.  Client receives all or part of their nutritional intake through a tube.
2.  Client has a metabolic disorder that has been documented

Prior authorization is required for gene mutation analysis.

Prior authorization is not required for services billed by a geneticist.

Prior authorization is required for requests for pharmacogenetic testing for more than once in a lifetime.

Yes

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. The ordering provider is responsible for ordering the appropriate BRCA test (e.g., BRCA1 versus BRCA2) based on medical necessity of the testing criteria and genetic counseling results. If a client’s BRCA test has a positive result, any further BRCA testing services requested with documentation of medical necessity will be considered on a case-by-case basis by Medical Director review for prior authorization.

Prior authorization is required for initial BRCA testing (procedure codes 81162, 81163, 81164, 81165, 81166, 81167, 81212, 81215, 81216, 81217). For clients with a known familial BRCA variant, targeted testing for BRCA1 (procedure code 81215) and BRCA2 (procedure 81217) for the specific variant must be performed before utilizing more comprehensive tests. If the client is of Ashkenazi Jewish, Icelandic, Swedish, or Hungarian descent, testing for the three known founder variants (procedure code 81212) should be performed first. The prior authorization request must include documentation that indicates that the client meets one or more of the criteria below:

1. An individual (male or female) from a family with a known deleterious BRCA1/BRCA2 mutation
2.  A female with a personal history of breast cancer, including invasive or ductal carcinoma in situ (DCIS), diagnosed at age 45 years or younger
3. 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
4. A female with a personal history of epithelial ovarian cancer, including fallopian tube and primary peritoneal cancers, diagnosed at any age
5.  A male with a personal history of breast cancer, including DCIS, diagnosed at any age
6. A female with a personal history of breast cancer, including DCIS, diagnosed at age 50 years or younger, and has one of the following:
   1.  An additional primary (2 primary sites, including bilateral or clearly separate ipsilateral) tumors occurring either synchronously or asynchronously
   2.  At least one close blood relative with breast cancer at any age
   3.  An unknown or limited family history
7. A female with a personal history of breast cancer, including DCIS, diagnosed at age 60 years or younger with triple negative breast cancer
8.  A female with a personal history of breast cancer, including DCIS, diagnosed at any age, and has one of the following:
   1. At least one close blood relative with breast cancer diagnosed at age 50 years or younger
   2. At least two close blood relatives with breast cancer at any age
   3.  At least one close blood relative with epithelial ovarian cancer, including fallopian tube and primary peritoneal cancers
   4.  At least two close blood relatives with pancreatic cancer or prostate cancer (Gleason score 7 or
      greater) at any age
   5.  A close male blood relative with breast cancer at any age
9.  A male or female with a personal history of pancreatic cancer or prostate cancer (Gleason score 7 or greater) at any age regardless of ancestry with at least two close blood relatives with one of the following:
   1. Breast cancer
   2. Ovarian cancer, including fallopian tube and primary peritoneal cancers
   3. Prostate cancer (Gleason score 7 or greater)
   4. Pancreatic cancer
10. A male or female with a personal history of pancreatic cancer at any age and of an ethnicity associated with higher mutation frequency, such as Ashkenazi Jewish, Icelandic, Swedish, or Hungarian descent and one or more close blood relatives with pancreatic cancer
11.  A male or female with a family history of breast or ovarian cancer, including DCIS with one of the following:
    1. At least one first or second degree blood relative meeting any of the criteria above; or
    2. At least one third degree blood relative who has breast cancer, including DCIS, or ovarian cancer, including fallopian tube and primary peritoneal cancers, and at least two close blood relatives with one of the following:
       1. Breast cancer, including DCIS, of which at least one with breast cancer was diagnosed at 50 years of age or younger
       2. Ovarian cancer, including fallopian tube and primary peritoneal cancers

Prior authorization for additional BRCA testing may be considered on a case-by-case basis by Medical Director review when testing criteria for these studies are met for clients who:

1. Have previously been tested for BRCA sequencing gene mutation analysis testing and received negative results. Documentation of negative results for all previous BRCA1 sequencing gene mutation analysis testing is required.
2. Every reasonable effort and documentation of the specific efforts made to obtain the previous BRCA sequencing gene mutation analysis test results from the client’s genetic testing physician or the testing laboratory.

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.
Note: A first-degree relative is defined as: sibling, parent, or offspring. A second-degree relative is defined as: uncle, aunt, grandparent, nephew, niece, or half-sibling.
Interpretation of gene mutation analysis results are part of the evaluation and management service and will not be reimbursed separately. Genetic test results, when informative, may influence clinical management decisions. 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.

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. 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.

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:

• 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.
• The client has had two HNPCC cancers.
• 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.
• The client has had colorectal cancer or endometrial cancer at 50 years of age or younger.
• The client has had right-sided colorectal cancer with an undifferentiated pattern on histology at 50 years of age or younger.
• The client has had signet-cell type colorectal cancer at 50 years of age or younger.
• The client has had colorectal adenoma at 40 years of age or younger.
• The client is an asymptomatic individual with a first- or second-degree relative with a documented HNPCC mutation.

Effective for dates of service on or after September 1, 2021, procedure code 81229 for cytogenetic constitutional microarray analysis, also called genomic or chromosomal microarray (CMA), will become a benefit of Texas Medicaid for laboratory providers.

CMA detects chromosomal abnormalities for clients who have a chromosomal disorder that often requires complex medical management.

Procedure code 81229 for CMA is a benefit once per lifetime for diagnostic purposes, when appropriate, for children with developmental disabilities or congenital anomalies, women who undergo prenatal diagnostic procedures, and products of conception resulting from recurrent miscarriage. Exceptions to the one-per-lifetime limitation will be made with documentation of medical necessity (e.g., subsequent pregnancies).

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 drug treatments: Clopidogrel, Eliglustat, Tetrabenzine in a dosage greater than 50mg per day, or 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
  Note: The routine use of genetic testing to screen patients treated with clopidogrel who are undergoing percutaneous coronary intervention (PCI) is not a benefit of Texas Medicaid.

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

• Group one:
  • 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
• Group two:
  • The client has never received genetic testing of the 2D6 alleles
  • 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)

Noninvasive prenatal screening (NIPS) is a benefit of Texas Medicaid when medically necessary for the advanced screening of fetal chromosomal abnormalities in pregnant women who meet specific
screening criteria. Genetic screening results, when informative, may influence clinical management
decisions.

NIPS may be performed as early as ten weeks gestation for specific fetal aneuploidy screening, restricted to Trisomy 13, Trisomy 18, Trisomy 21, and fetal sex chromosome aneuploidy (SCA). To determine NIPS appropriateness, a baseline ultrasound, if not previously performed, is strongly recommended to confirm viability, the number of fetuses, and gestational dating.
If NIPS provides an abnormal screening result, invasive prenatal confirmatory diagnostic testing is
strongly encouraged due to the potential risk of a false-positive result from NIPS. Confirmatory
diagnostic tests include chorionic villus sampling (CVS) or amniocentesis.
It is recommended that clients who receive an indeterminate result be offered further genetic counseling, comprehensive evaluation with ultrasound, and diagnostic testing due to the increased risk of aneuploidy. Higher body mass index (BMI) may affect NIPS results. Clients weighing more than 250 pounds are at risk of having an inconclusive result from NIPS.
NIPS does not assess the risk for fetal anomalies such as neural tube defects or ventral wall defects. Ultrasound evaluation and maternal serum alpha-fetoprotein screening should be offered for these risk assessments.

If a fetal structural anomaly (e.g. hydrops, cystic hygroma, cardiac malformations, abdominal wall
defects, or skeletal abnormalities) is identified upon ultrasound examination, it is recommended that diagnostic testing be offered rather than NIPS.
NIPS is a benefit for a confirmed intrauterine singleton pregnancy when serum analyte testing with any of the following screening tests were previously elected for the current pregnancy instead of NIPS, the results indicate an increased risk of Trisomy 13, Trisomy 18, or Trisomy 21, and the client wishes to postpone invasive diagnostic testing:

• First trimester screen
• Sequential screen
• Integrated screen
• Quadruple screen

NIPS must be ordered by the medical provider rendering direct care to the client. The provider must
order the most appropriate screening based on the client’s medical history and the results of previous screenings, if available. The provider must clarify for the client the option to decline, and the provider must document that the option to decline was clearly provided in the client’s medical record.

DSHS 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.

https://www.tmhp.com/sites/default/files/file-library/resources/provider-manuals/tmppm/pdf-chapters/2023/2023-08-august/2_17_Radiology_and_Lab_Srvs.pdf

https://www.tsgc.org/licensure

https://www.tmhp.com/sites/default/files/file-library/resources/provider-manuals/tmppm/archives/2023-08-TMPPM_0.pdf

https://www.tmhp.com/news/2021-07-16-effective-september-1-2021-chromosomal-microarray-become-benefit-texas-medicaid#:~:text=order%20to%20continue.-,Effective%20September%201%2C%202021%2C%20Chromosomal%20Microarray%20to%20Become,A%20Benefit%20of%20Texas%20Medicaid&text=Note%3A%20Texas%20Medicaid%20managed%20care,covered%20services%20to%20eligible%20clients

https://www.dshs.texas.gov/genetic-services/guide-to-genetic-services/access-to-direct-health

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