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Medical Policy: 04.02.02
Original Effective Date: April 2006
Reviewed: November 2011
Revised: May 2009
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Preimplantation genetic testing (PGT) describes a variety of adjuncts to an assisted reproductive procedure in which either maternal or embryonic DNA is sampled and genetically analyzed, thus permitting deselection of embryos harboring a genetic defect prior to implantation of the embryo into the uterus. The ability to identify preimplantation embryos with genetic defects before the initiation of pregnancy provides an alternative to amniocentesis or chorionic villous sampling. Preimplantation genetic testing can be viewed as either diagnostic (PGD) or screening (PGS). PGD is used to detect genetic evidence of a specific inherited disorder in the oocyte or embryo. PGS is not sued to detect a specific abnormality but instead uses similar techniques to identify genetic abnormalities to identify embryos at risk.
Two different sources of genetic material may be sampled in preimplantation genetic testing; either the first or second polar body of the oocyte may be sampled or the preimplantation embryo may be biopsied. The first or second polar bodies are extruded from the oocyte as it completes meiotic division after ovulation (first polar body) and fertilization (second polar body). This strategy thus focuses on maternal chromosomal abnormalities. If the mother is a known carrier of a genetic defect, and genetic analysis f the polar body is normal, then it is assumed that the genetic defect was transferred to the oocyte during meiosis. Alternatively, single cells from the preimplantation embryo can be sampled. Typically, pre-embryos are biopsied after the first few cleavage divisions, although some researchers have performed biopsies of blastocytes containing 120 cells. At both of these stages, the cells are totipotent such that there is no damage to the resulting embryo. Biopsy of pre-embryos or blastocytes can detect genetic abnormalities arising from the maternal or paternal genetic material.
The biopsied material can be analyzed in a variety of ways. Polymerase chain reaction (PCR) or other amplification techniques can be used to amplify the harvested DNA with subsequent analysis for single genetic defects. This technique is most commonly used when the embryo is at risk for a specific genetic disorder such as Tay Sach’s disease or cystic fibrosis. Fluorescent in situ hybridization (FISH) is a technique that allows direct visualization of specific (but not all) chromosomes to determine the number or absence of chromosomes. This technique is most commonly used to screen for aneuploidy, gender determination, or identify chromosomal translocations. FISH cannot be used to diagnose single genetic defect disorders. However, molecular techniques can be applied with FISH (such as microdeletion and duplications) and thus, single gene defects can be recognized with this technique.
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Prior Approval:
Not applicable
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Policy:
Preimplantation genetic diagnosis may be considered medically necessary as an adjunct to IVF in otherwise fertile couples who meet one of the following criteria:
For evaluation of an embryo at an identified elevated risk of a genetic disorder such as:
- Both partners are known carriers of a single gene autosomal recessive disorder
- One partner is a known carrier of a single gene autosomal dominant disorder
- One partner is a known carrier of a single X-linked disorder
- One partner is a known carrier of a single-gene autosomal recessive disorder and the partners have one offspring that has been diagnosed with that recessive disorder
For evaluation of an embryo at an identified risk of chromosomal abnormality such as:
- Parent with balanced or unbalanced chromosomal translocation
Preimplantation genetic diagnosis as an adjunct to in vitro fertilization (IVF) may be considered medically necessary in the following patients/couples who are undergoing IVF due to infertility and who meet ONE of the following criteria:
- A history of three failed IVF cycles
- Maternal age is greater than 35 years
- One of the partner is known to harbor a balanced translocation
Preimplantation genetic screening to improve live-birth rates in patients with advanced maternal age is considered investigational.
Preimplantation genetic screening to improve live-birth rates in patients with previous implantation failure is considered investigational.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 89290 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); less than or equal to 5 embryos
- 89291 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); greater than 5 embryos
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Selected References:
- Verlinsy Y, Rechitisky S, Sharapova T et al. Preimplantation HLA Testing. JAMA 2004; 291(17)2079-85.
- Preimplantation Genetic Diagnosis. A Discussion of Challenges, Concerns, and Preliminary Policy Options Related to the Genetic Testing of Human Embryos. The Genetics and Public Policy Center at the Phoebe R. Berman Bioethics Institute, Johns Hopkins University. 2004.
- Kuliev A, Verlinsky Y. The role of preimplantation genetic diagnosis in women of advanced reproductive age. Curr Opin Obstet Gynecol 2003; 15:233-38.
- Towner D, Loewy RS. Ethics of preimplantation diagnosis for a woman destined to develop early-onset Alzheimer disease. JAMA 2002; 287(8):1038-40.
- Gianaroli L, Maglin MC, Ferraretti AP et al. The beneficial effects of preimplantation genetic diagnosis for aneuploidy support extensive clinical application. Reprod Med Online 2005; 10:633-40.
- Kanavakis E, Traeger-Synodinos J. Preimplantation genetic diagnosis in clinical practice. J Med Genet. 2002; 39(1):6-11.
- Mastenbroek S, Twisk M, van Echten-Arends J et al. In Vitro Fertilization with Preimplantation Genetic Screening. N Engl J Med. 2007. July 5;357:9-17.
- ECRI. Preimplantation Genetic Diagnosis for the Prevention of Congenital Disorders. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2006 January 18. 9p. (ECRI Hotline Response). Also available: http://www.ecri.org.
- Mastenbroek S, Twisk M, van Echten-Arends J et al. In Vitro Fertilization with Preimplantation Genetic Screening. N Engl J Med. 2007. July 5;357:9-17.
- Practice Committee of the Society for Assisted Reproductive Technology and Practice Committee of the American Society for Reproductive Medicine. Preimplantation genetic testing: a practice committee opinion. Fertil Steril 2007; 88(6): 1497-504.
- Fritz MA. Perspective on the efficacy and indications for preimplantation genetic screening: where are we now? Hum Reprod 2008; 23(12):2617-21.
- Fauser BC. Preimplantation genetic screening: the end of an affair? Hum Reprod 2008; 23 (12): 2622-5.
- Debrock S, Melotte C, Spiessens C et al. Preimplantation genetic screening for aneuploidy of embryos after in vitro fertilization in women aged at least 35 years: a prospective randomized trial. Fertil Steril. 2010 Feb;93(2):364-73. Epub 2009 Feb 26.
- Meyer LR, Klipstein S, Hazlett WD et al. A prospective randomized controlled trial of preimplantation genetic screening in the “good prognosis” patient. Fertil Steril. 2009 May;91(5):1731-8. Epub 2008 Sep 18.
- Checa MA, Alonso-Coello P, Sola I et al. IVF/ICSI with or without preimplantation genetic screening for aneuploidy in couples without genetic disorders: a systematic review and meta-analysis. J Assist Reprod Genet. 2009 May;26(5):273-83. Epub 2009 Jul 24.
- Mastenbroek S, Twisk M, van der Veen F et al. Preimplantation genetic screening: a systematic review and meta-analysis of RCTs. Hum Reprod Update. 2011 Jul-Aug; 17(4):454-66. Epub 2011 Apr 29.
- Brezina PR, Benner A, Rechitsky S et al. Single-gene testing combined with single nucleotide polymorphism microarray preimplantation genetic diagnosis for aneuploidy: a novel approach in optimizing pregnancy outcome. Fertil Steril. 2011 Apr; 95(5): 1786.e5-8. Epub 2010 Dec 8.
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Policy History:
Date Reason Renewed
December 2010 Annual review Policy renewed
November 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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