Does Not Apply to Commercial Genetic Testing Program effective 6/1/2018
DESCRIPTION
Chromosomal microarray analysis (CMA) of fetal or placental tissue has been proposed as a technique to evaluate the cause of isolated and recurrent early pregnancy loss and intrauterine fetal demise. The evaluation of recurrent and isolated miscarriages and intrauterine fetal demise may involve genetic testing of the products of conception.
Chromosomal microarray analysis can identify submicroscopic genetic abnormalities too small for conventional karyotyping to detect. Because chromosomal microarray analysis does not require dividing cells, it may be useful in the evaluation of fetal demise, in which the culturing of macerated tissue is frequently unsuccessful. In addition, chromosomal microarray analysis is a standardized procedure that involves the use of computerized analysis, whereas karyotyping involves microscopic examination of stained chromosomes and may be more subjective and prone to human error.
POLICY
Chromosomal microarray analysis of products of conception (fetal tissue or placental tissue derived from the fetal genotype) for the evaluation of pregnancy loss is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Chromosomal microarray analysis of fetal tissue following miscarriage or intrauterine fetal demise in all other situations is considered investigational.
MEDICAL APPROPRIATENESS
Chromosomal microarray analysis for evaluation of pregnancy loss is considered medically appropriate if ALL of the following are met:
Pregnancy loss with ANY ONE of the following:
Pregnancy loss occurred at 20 weeks gestation or earlier when there is a maternal history of two or more failed pregnancies
Pregnancy loss occurred after 20 weeks gestation
Testing is accompanied by pre- and post-test genetic counseling
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
SOURCES
American College of Obstetrics and Gynecology. (2016; reaffirmed 2023). ACOG Committee on Genetics, Committee Opinion No. 682: Microarrays and next-generation sequencing technology: The use of advanced genetic diagnostic tools in obstetrics and gynecology. Retrieved April 28, 2023 from www.acog.org.
American Society for Reproductive Medicine. (2012). Evaluation and treatment of recurrent pregnancy loss: a committee opinion. Retrieved October 13, 2015 from https://www.asrm.org.
BlueCross BlueShield Association. Evidence Positioning System. (9:2022). Chromosomal microarray testing for the evaluation of pregnancy loss. (2.04.122). Retrieved April 28, 2023 from https://www.evidencepositioningsystem.com/. (33 articles and/or guidelines reviewed)
Dhillon, R., Hillman, S., Morris, R., McMullan, D., Williams, D., Coomarasamy, A., et al. (2013). Additional information from chromosomal microarray analysis (CMA) over conventional karyotyping when diagnosing chromosomal abnormalities in miscarriage: a systematic review and meta-analysis. British Journal of Obstetrics and Gynaecology, 121 (1), 11-21. (Level 1 evidence)
Lee, J., Shin, S., Kim, G., Kim, W., Wie, J., et al. (2021). Optimizing the Diagnostic Strategy to Identify Genetic Abnormalities in Miscarriage. Molecular Diagnosis & Therapy, 25 (3), 351-359. (Level 2 evidence)
Levy, B., Sigurjonsson, S., Pettersen, B., Maisenbacher, M.K., Hall, M.P., Demko, Z., et al. (2014). Genomic imbalance in products of conception: single-nucleotide polymorphism chromosomal microarray analysis. Obstetrics and Gynecology, 124 (2 Pt 1), 202-209. Abstract retrieved February 9, 2016 from PubMed database.
Martinez-Portilla, R., Pauta, M., Hawkins-Villarreal, A., Rial-Crestelo, M., Paz Y Miño, F., et al. (2019). Added value of chromosomal microarray analysis over conventional karyotyping in stillbirth work-up: systematic review and meta-analysis. Ultrasound in Obstetrics & Gynecology: The Official Journal of the International Society of Ultrasound in Obstetrics and Gynecology, 53 (5), 590-597. (Level 1 evidence)
Pauta, M., Grande, M., Rodriguez-Revenga, L., Kolomietez, E., & Borrell, A. (2018). Added value of chromosomal microarray analysis over karyotyping in early pregnancy loss: systematic review and meta-analysis. Ultrasound in Obstetrics and Gynecology, 51 (4), 453-462. (Level 1 evidence)
Popescu, F., Jaslow, C.R., Kutteh, W.H. (2018). Recurrent pregnancy loss evaluation combined with 24-chromosome microarray of miscarriage tissue provides a probable or definite cause of pregnancy loss in over 90% of patients. Hunan Reproduction, 33 (4), 579-587. (Level 4 evidence)
ORIGINAL EFFECTIVE DATE: 2/8/2015
MOST RECENT REVIEW DATE: 6/8/2023
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.