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 Maternal Genetic Testing: Fetal Aneuploidy Testing Using Noninvasive Cell-Free Fetal DNA.

Definitions

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

The following tests are commercially available:

·         HarmonyTM Prenatal Test

·       MaterniT21TM Plus

·       Verifi^® Prenatal Test

·          Panorama

·          informaSeqSE

These tests are considered eligible as advanced screening technology for pregnant women at high risk, as determined by the following medical necessity:

·       Advanced maternal age (pregnant women age 35 years and older at expected time of delivery); and

·       Testing is offered between 9- and 13-weeks gestational age in women with singleton gestation; or

·       Fetal ultrasonography findings predictive of increased risk of fetal aneuploidy (i.e., absent or hypoplastic nasal bone, choroid plexus cyst, echogenic bowel, echogenic intracardiac focus, fetal pyelectasis, nuchal translucency, nuchal fold, ventriculomegaly, and shortened femur or humerus); or

·       Positive screening test for an aneuploidy, including first trimester, sequential, or integrated screen, or a positive quadruple screen; or

·       History of a prior maternal pregnancy with an aneuploidy; or

·       Parental balanced Robertsonian translocation with increased risk for fetal trisomy 13 or trisomy 21.

·       Use of noninvasive prenatal testing using the cell free DNA test for trisomies 21, 18 and 13 is to be used in pregnant women at increased risk in lieu of amniocentesis.

·       Use of noninvasive prenatal testing using the cell free DNA test for the determination of fetal sex, fetal RHD genotyping is typically not medically necessary and will require case-by-case review.

·       Women with positive cfDNA tests should be offered invasive prenatal diagnostic tests with amniocentesis or chorionic villus sampling.

·       Genetic counseling is strongly recommended prior to this test in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person.

Services for DNA-based noninvasive tests of fetal aneuploidy in pregnant women who do not meet the above criteria or women are pregnant with multiple gestations are unproven and will require case-by case review.

 Governing bodies approval

The cell free DNA tests are laboratory developed tests that do not require premarket approval by the FDA. These types of tests are regulated by the Centers for Medicare & Medicaid as part of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The regulations of the CLIA Amendments do not include validation of specific tests but rather that there is procedural compliance.

Additional information is available online at:

http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm124105.htm.

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:

Inpatient/Outpatient. Please be advised that medical records will be reviewed to determine if conditions are hospital acquired.

REIMBURSEMENT

Participating facilities will be reimbursed per their Highmark Health Options contract.