Genetic Services Biomarker Testing Benefits for Texas Medicaid

Date: September 10, 2024

Attention: All Providers

Effective Date: September 1, 2024

Call to action: Texas Children’s Health Plan (TCHP) would like to inform providers that effective for dates of service on or after September 1, 2024, biomarker-testing benefits, including whole genome sequencing (WGS) and expanded carrier screening is now a benefit of Texas Medicaid. This includes the following procedure codes: 81279, 81305, 81307, 81320, 81345, 81425, 81426, 81427, and 81443. These procedure codes may be reimbursed to an in network laboratory provider and will be limited to one service per lifetime to any provider. 

Procedure codes 81425, 81426, 81427, and 81443 may be reimbursed with a prior authorization.

As a reminder, all genetic testing requires a prior authorization, with the exception of Cystic Fibrosis and Spinal Muscular Atrophy Screening, even when processed by an in-network laboratory. 

How this impacts providers:Texas Medicaid & Healthcare Partnership (TMHP) will update the Texas Medicaid Provider Procedures Manual (TMPPM), Medical and Nursing Specialists, Physicians, and Physician Assistants Handbook, section 5.2.2, “Genetic Tests,” to add language outlining coverage of biomarker testing required by Senate Bill (S.B.) 989 (88th Legislature, Regular Session, 2023).

Criteria for each genetic tests are as follows:

Biomarker Testing

Biomarker testing that is supported by medical and scientific evidence as outlined in Chapter 1372 of Subtitle E, Title 8 of the Texas Insurance Code (TIC), as added by S.B. 989, is considered medically necessary when the use of the test informs a patient’s outcome and a provider’s clinical decision. The test must meet one or more of the following criteria:

• A United States Food and Drug Administration (FDA)-labeled indication for the test or an indicated test for a drug approved by the FDA
• A national coverage determination made by the Centers for Medicare and Medicaid Services (CMS), or a local coverage determination by a Medicare administrative contractor
• Nationally recognized clinical practice guidelines
• Consensus statement recommendations for specific clinical circumstances when biomarker testing may optimize clinical care outcomes

Genetic biomarkers procedure codes

Exclusions

The following service will not be reimbursed by Texas Medicaid:

• Biomarker testing not supported by medical and scientific evidence as outlined in Section 1372.003(a) (1-5) of TIC, or that does not show evidence of impact on patient outcomes and a provider’s clinical decision

Whole Genome Sequencing 

• Whole genome sequencing (WGS) is defined as the sequencing of the entire human genome, including protein-coding regions (exons) and noncoding regions. 
• WGS captures most genomic variation in a single test and is useful for patients with rare disorders where hypothesis-driven approaches have failed to produce a diagnosis. 
• WGS can identify or confirm the genetic etiology of a disorder in patients (procedure code 81425). 
• When needed for additional diagnostic insight, comparator genomes can be used from a relative such as parents or siblings (procedure code 81426). 
• Reevaluation of the genome is also available when needed for additional diagnostic yield (procedure code 81427). 
• Procedure codes 81425 and 81427 may be a benefit once per lifetime with any provider. 
• Procedure code 81426 may be a benefit up to a maximum of twice per lifetime.

Whole Genome Sequencing procedures codes

Carrier Screening 

• Carrier screening is a genetic test that identifies whether a person carries a genetic mutation that could increase the risk of their children inheriting a genetic disorder. 
• Carrier screening targets genetic disorders inherited through autosomal recessive or X-linked patterns.
• Individuals are considered carriers if they are asymptomatic but carry the genetic variant responsible for the disorder. 
• Children can inherit autosomal recessive disorders when receiving two copies of the gene associated with the disorder, one from each parent, while X-linked disorders are caused by mutations in genes on the X chromosome.
• Carrier screening may be performed in the preconception or prenatal periods. 
• Risk-based carrier screening is performed on individuals with an increased risk of being a carrier of a specific disorder, based on population carrier frequency, family history, or ethnicity. 
• Carrier screening typically tests for a single gene, or a small number of genes, known to have the disorder-causing variant(s).
• Expanded Carrier Screening (ECS) uses a panel test that simultaneously screens for many genes linked to disorders that are present in the general population and may have increased frequency in specific populations. 
• The genes tested in an ECS panel vary by laboratory and may not all test for the same genes. ECS panels can test for as few as five genes or as many as several hundred.
• A targeted screening approach may be appropriate instead of ECS. Instances when targeted screening would be appropriate include but are not limited to:
• The individual or their reproductive partner is a known carrier for one or more conditions being screened.
• The individual or their reproductive partner has a first- or second-degree relative who is affected by a condition being screened.
• The individual or their reproductive partner has a first-degree relative with offspring affected by the condition being screened.
• The individual or their reproductive partner is a member of a population known to have a carrier frequency rate that exceeds the threshold for American College of Medical Genetics and Genomics (ACMG) Tier 1 risk-based screening.
• ECS, procedure code 81443, is limited to once per lifetime with any provider.

Expanded carrier screening procedure code 

Prior Authorization Requirementsfor Expanded Carrier Screening

Prior authorization may be granted for ECS using procedure code 81443 when the following criteria are met:

• The individual being tested is female, between 10 and 55 years of age, and pregnant or considering pregnancy.
• Pre-screening genetic counseling has been performed by one of the following provider types:
• A physician board-certified in one or more of the following:
• Medical genetics
• Maternal-fetal medicine
• Obstetrics/gynecology
• Family medicine
• A board-certified genetic counselor
• A physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife with training and expertise in genetics and genetic counseling
• The ECS panel meets all the specifications in the following section.

ECS Panel Specifications

• The ECS panel must screen for conditions having all the following characteristics:
• Childhood onset
• Can be diagnosed prenatally
• Possess a well-defined phenotype
• Known to cause cognitive or physical impairment
• Associated with a known pathogenic or likely pathogenic gene variant
• The ECS panel must include sequencing of at least 15 genes, including:
• Conditions in ACMG Tier 2, with a carrier frequency of 1 in 100 or greater
• Conditions in ACMG Tier 1
• X-linked conditions
• The ECS panel must not include genes associated with known adult-onset conditions, including but not limited to hereditary cancers, dementia, or blood clotting disorders (e.g., hereditary breast and ovarian cancer, Lynch Syndrome, Alzheimer's Disease, Huntington's Disease, or Factor V Leiden).

Uses of an ECS Panel

• Knowledge of the pathogenic variant(s) may be used for the management of:
  Pregnancy or antenatal interventions
• Delivery or other care planning for the potentially affected fetus of a pregnant individual
• Preconception family planning

Next steps for providers: Providers should share this information with their staff.

If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org. 

For access to all provider alerts,log into:
www.texaschildrenshealthplan.org/providers/provider-news/provider-alertsor www.texaschildrenshealthplan.org/for-providers.