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Cell Free Fetal DNA Testing Medical Policy

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Cell Free Fetal DNA Testing Medical Policy Cell Free Fetal DNA Testing Medical Policy Service: Cell-Free Fetal DNA Testing, Expanded Non-invasive Prenatal Testing Panels, NIPT Panels, Maternal Cell Free DNA tests for Fetal Aneuploidies: MaterniT21Plus (Sequenom), Prequel Screen (Myriad), Panorama (Natera), Harmony (Ariosa Laboratories), Verify (Illumina), QNatal Advanced (Quest) PUM 250-0038 Medical Policy Committee Approval 07/29/2021 Effective Date 12/01/2021 Prior Authorization Needed Yes Description: Aneuploidy is an abnormal number of chromosomes. Trisomy syndromes are aneuploidies involving 3 copies of chromosomes which can result in multiple congenital abnormalities, morbidities, and fetal demise. The most common aneuploidy is trisomy 21 (Down Syndrome); while Trisomy 18 (Edwards Syndrome) and trisomy 13 (Patau Syndrome) occur much less frequently. Traditional/conventional methods of screening for aneuploidy during early pregnancy include combinations of maternal serum blood tests [e.g. Beta-HCG levels and pregnancy- associated plasma protein-A (PAPP-A), AFP, uE3, inhibin-A] and ultrasound (including fetal nuchal translucency) performed at specific times during the first two trimesters. In mid-August 2020, the American College of Obstetricians and Gynecologists (ACOG) and the Society of Maternal and Fetal Medicine (SMFM) released Practice bulletin 226: Screening for Fetal Chromosomal Abnormalities. The Practice Bulletin states: 1) Prenatal genetic screening (serum screening with or without nuchal translucency [NT] ultra-sound or cell-free DNA screening) and diagnostic testing (chorionic villus sampling [CVS] or amniocentesis) for chromosomal abnormalities should be discussed and offered to all patients early in pregnancy regardless of maternal age or baseline risk. 2) A patient’s baseline risk for chromosomal abnormalities should not limit testing options. 3) Cell-free DNA is the most sensitive and specific screening test for the common fetal aneuploidies. Page 1 of 4 Indications of Coverage: Cell-free fetal DNA testing is medically necessary when ALL of the following are present: 1. Testing performed for ANY of the following: a. Trisomy 21 (Down syndrome) b. Trisomy 18 (Edwards syndrome) c. Trisomy 13 (Patau syndrome) 2. Single-gestation pregnancy and EITHER of the following: a. Conventional screening tests positive for aneuploidy b. Prenatal testing to evaluate risk of fetal aneuploidy Limitations of Coverage: Cell-free fetal DNA testing for ANY of the following is considered experimental, investigational, or unproven to affect outcomes due to insufficient published evidence, lower predictive value, and increased rates of false positive and false negative results: 1. Multiple (e.g., twin, triplet, quadruplet) gestation pregnancy. 2. Sex chromosome related disorders-single or multiple gestation pregnancy. 3. Microdeletion testing--single or multiple gestation pregnancy. 4. Monogenic disorders, including but not limited to, beta thalassemia, hemophilia, sickle cell anemia, and congenital adrenal hyperplasia --single or multiple gestation pregnancy. 5. Performing a repeat cell-free DNA screen during the same pregnancy, because of an indeterminate, uninterpretable, or “no call” initial result. 6. PreTRM is considered experimental and investigational as it is not identified as widely used and generally accepted for the proposed uses as reported in peer- reviewed literature. Page 2 of 4 Documentation Required: • Office notes from the ordering physician including summary of pertinent history, laboratory tests, or ultrasounds Disclaimer: This policy is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may not provide coverage for all services listed in this policy. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical policy in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information. Medical policies are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical policy and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, email [email protected]. Approved by the Medical Director Review History: Implemented 07/01/17, 07/01/18, 07/01/19, 05/01/2021, 12/01/2021 Medical Policy 03/17/17, 03/16/18, 03/15/19, 07/31/2020, 04/29/2021, 07/29/2021 Committee Approval Reviewed 03/17/17, 03/16/18, 03/15/19, 07/31/2020, 04/29/2021, 07/29/2021 Developed 03/17/17 Page 3 of 4 Page 4 of 4 .
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