DISCLAIMER

Highmark Health Options medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.

POLICY STATEMENT

Highmark Health Options may provide coverage under medical surgical benefits of the Company’s Medicaid products for medically necessary. Refer to the Noncovered Services policy for more information.

This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.

The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the West Virginia Department of Health and Human Resources (DHHR) and all applicable state and federal regulations.

Purpose 

This medical policy outlines Highmark Health Options services for Genetic Testing for Congenital Abnormalities 

Definitions

Congenital Anomalies – Structural or functional anomalies (for example, metabolic disorders) that occur during intrauterine life and can be identified prenatally, at birth, or sometimes may only be detected later in infancy, such as hearing defects.

 

Genetic Testing – The analysis of chromosomes, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), genes or gene products to detect inherited (germline) or non-inherited (somatic) genetic variants related to disease or health.

 

Genetic Counseling – Provides information about how genetic conditions, birth defects and other medical conditions run in families, and how they can affect the pregnant mother and baby’s health.

 

Highmark Health Options (HHO)- Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services WV Mountain Health Trust (MHT) and West Virginia Health Bridge (WVHB) including an expansion plan (WVHB ABP Alternative Benefit Plan) and WVCHIP members.

 

Prior Authorization

Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool

https://wv.highmarkhealthoptions.com/providers/prior-authorization-code-lookup.html

Procedures

Genetic and cytogenetic testing is medically necessary when the following criteria are met:

 

·       One of the following :

 

·       The beneficiary displays clinical features or is experiencing current signs and

·       symptoms of a genetic condition; OR

 

·       there is documented reasonable expectation that the beneficiary is at high-risk based on family history, personal history, or ethnicity, OR

 

·       The test yields results that can be used to develop a clinical useful approach or course of treatment, or to cease unnecessary treatments AND

 

·       The results of the test allow providers to treat current symptoms affecting the beneficiary’s health, or manage the treatable progress of an established disease or alter recommended screening or monitoring; AND

 

·       The ordering licensed provider shall obtain informed consent (indicating understanding of the testing procedure, the benefits and limitations of the test, and the possible consequences of the test results) from the beneficiary, parent, legal guardian, or authorized representative, prior to the genetic test; AND

 

·       Test must be performed by a certified Clinical Laboratories Improvement Amendment (CLIA) laboratory; AND

 

·       A clinically valid test, based on published peer-reviewed literature, is available for the suspected diagnosis; AND

 

·       The test is proven to be scientifically valid for the identification of the specific genetically linked disease or clinical condition; AND

 

·       A certified genetic counselor or ordering provider shall counsel the beneficiary pre and post-test.

 

Genetic and cytogenetic testing is medically necessary for the diagnosis and treatment of genetic abnormalities or syndromes such as:

·       Any congenital anomalies.

·       Developmental delays; and

·       Intellectual disabilities.

 

Cytogenetic testing is medically necessary for the diagnosis and treatment of the following neoplastic chromosome abnormalities or syndromes:

·       Chronic Myelogenous Leukemia (CML);

·       Acute Lymphoblastic (also known as lymphocytic) Leukemia (ALL);

·       Acute Myeloid Leukemia (AML);

·       Myelodysplastic syndromes (MDS);

·       Lymphomas (solid tumors); and

·       Multiple myeloma

Genetic and cytogenetic testing is medically necessary for the diagnosis and treatment of cystic fibrosis when the following criteria are met:

·       The beneficiary has signs or symptoms of cystic fibrosis;

·       The beneficiary or guardian has undergone genetic counseling;

·       When the symptomatic beneficiary has a known familial variant, the test that is ordered should be for that specific variant;

·       If no mutation is found when testing for common variants and the beneficiary is symptomatic, full gene sequencing can be ordered; or

·       After completing the full gene sequencing, if no mutation is found, testing may be done for duplication/deletion variants.

 

Medicaid and shall cover genetic and cytogenetic testing for the diagnosis and treatment of spinal muscular atrophy (SMA) when the following criteria are met:

·       The beneficiary has signs or symptoms of SMA;

·       The beneficiary or guardian has undergone genetic counseling;

·       When the symptomatic beneficiary has a known familial variant, the test that is ordered should be for that specific variant;

·       If no mutation is found when testing for common variants and the beneficiary is symptomatic, full gene sequencing can be ordered; or

·       After completing the full gene sequencing, if no mutation is found, testing may be done for duplication/deletion variants.

 

Whole exome sequencing (WES) is medically necessary for the identification and treatment of ill-defined symptoms when the following criteria are met:

·       Phenotype is suspicious for a genetic diagnosis;

·       Beneficiary has multiple major structural or functional congenital anomalies affecting unrelated organ systems, including metabolic disorders;

·       Beneficiary has one major structural congenital anomaly and two or more minor

·       structural anomalies; or

·       The beneficiary has at least 2 of the following:

o   Major structural congenital anomaly affecting a single organ system;

o   Neurological features including either significant intellectual disability, global developmental delay or autism;

o   Severe psychological/psychiatric disturbance or severe neuropsychiatric condition;

o   Symptoms of a complex neurodevelopmental disorder;

o   Family history strongly implicating a genetic etiology; or

o   Period of unexplained developmental regression unrelated to autism or epilepsy; and

·       The beneficiary is evaluated and counseled by a certified geneticist or provider with genetic counseling experience prior to the test being ordered and when the results are reviewed; and

·       Test ordered will be used to guide treatment; and

·       The beneficiary is age 21 or younger.

In addition to the specific criteria covered above, HHO shall cover:

·       Serum screening with or without nuchal translucency ultrasound or cell-free DNA screening and diagnostic testing (CVS or amniocentesis) for chromosomal abnormalities after counseling shall be offered to all beneficiaries early in pregnancy regardless of maternal age or baseline risk.

·       Carrier testing for cystic fibrosis (CF) when the beneficiary meets any of the criteria below:

o   Beneficiary is pregnant or considering pregnancy;

o   Beneficiary has a biological parent with CF or both biological parents are CF carrier status;

o   The beneficiary has a family history or first-degree relative with CF; or

o   Echogenic bowel has been identified on fetal ultrasound; and

o   After genetic counseling has been provided, informed consent is obtained prior to, and beneficiary agrees to voluntary carrier testing.

·       Medicaid shall cover carrier testing for spinal muscular atrophy (SMA) when the beneficiary meets any of the criteria below:

o   Beneficiary is pregnant or considering pregnancy and has not previously been tested for SMA.

o   After genetic counseling has been provided, informed consent is obtained prior to, and beneficiary agrees to voluntary carrier testing

·       Carrier testing for Ashkenazi Jewish associated disorders (e.g., Bloom syndrome, Canavan disease, cystic fibrosis, familial dysautonomia, Fanconi anemia group C, Gaucher disease, Tay-Sachs disease) when the beneficiary meets the criteria below:

o   At least one partner is Ashkenazi Jewish or at least one partner is a known carrier of an Ashkenazi Jewish associated disorder;

o   History of a previous child born with an Ashkenazi Jewish associated disorder; or

o   One or both partners have a first or second-degree relative affected with an Ashkenazi Jewish associated disorder; and

o   Test will guide plan of care for current and future pregnancies.

 

Genetic testing is not medically necessary when:

·       The screening is for the general population;

·       The test is being repeated after a negative test result; and

·       A test is repeated when limited to once in a lifetime testing

 

In addition to Section VII, WellCare of North Carolina® shall not cover genetic testing for:

·       Reproductive decision-making;

·       Male or female infertility ;

·       Beneficiary family members;

·       Cell-free DNA based screening in twin pregnancy in the setting of fetal demise, vanishing twin, or one or more anomaly detected in one or both twins;

·       NIPS/NIPT following a CVS or amniocentesis test that was able to yield results;

·       Paternity testing.

·       Sex determination of the fetus

 

Genetic counseling is generally provided in conjunction with genetic testing. Counseling usually occurs when the results of the tests are provided to the patient and intervention strategies are discussed. Coverage for genetic counseling is determined according to individual or group customer benefits. When genetic testing is noncovered, the counseling performed in conjunction with the testing is also noncovered.

Post-payment Audit Statement

The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement.

Place of Service:

Genetic testing is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a comorbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

 

REIMBURSEMENT

Participating facilities will be reimbursed per their Highmark Health Options contract