Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Polycystic Ovarian Syndrome. 

Treatment: Embryo Biopsy (codes 89290 and 89291). 

The insurer denied coverage for embryo biopsy (codes 89290 and 89291). 

The denial is upheld. 

The patient is a female with a history of polycystic ovarian syndrome. She presented to the obstetrician's office for an intrauterine insemination procedure. The patient became pregnant and had a miscarriage. She had 5 unsuccessful intrauterine insemination procedures before this one. The physician recommended proceeding with in vitro fertilization (IVF). The plan was to transfer a single embryo into the uterus with preimplantation genetic testing for aneuploidy (PGT-A) to increase the chances of carrying a healthy pregnancy to term. 

The provider and the patient are requesting coverage for embryo biopsy for PGT-A. Embryo aneuploidies may be responsible for implantation failures, miscarriages and affects IVF outcomes. 

According to this strategy, a better embryo selection should increase IVF results. In reality, several issues remain unaddressed including the sampling strategy, involving the test outcomes, and the frequent occurrence of embryo mosaicism, affecting the criteria for selection of supposed viable embryos. Safety issues are in place, including peri-and post-natal consequences of embryo sampling and the epigenetic weaknesses from a prolonged in vitro culture. On the other side, chromosome number mistakes are progressively recognized as physiologic events in the early pre-implantation embryo with many corrective mechanisms in place and their destiny in the post-implantation development is unclear. Accordingly, the increasing precision of the diagnostic tools should be used to investigate the effect of such interventions within rigorous research programs in the sake of improved clinical outcomes. The diagnosis of embryo aneuploidies in IVF cycles should be considered as a research tool and systematic implementation in clinical practice may appear unjustified. 

Note that PGT-A is not indicated for advanced maternal age or recurrent pregnancy loss or for recurrent implantation failures. The American College of Obstetricians and Gynecologists (ACOG) stated the following: 

"At this time there are no data to support preimplantation genetic screening for recurrent unexplained miscarriage and recurrent implantation failures; its use for these indications should be restricted to research studies with appropriate informed consent." 

The American Society for Reproductive Medicine (ASRM) also stated the following: "A study of women with recurrent miscarriages found no evidence of benefit of preimplantation genetic screening in women of any age."  

It is important to note that preimplantation genetic screening (PGS)/ preimplantation genetic testing (PGT) may lead to damage to the embryo and may have long-lasting health issues for the newborn. 

Note that neither the sensitivity nor the specificity of the test is 100%. 

This patient does not have any genetic anomaly and is not a carrier of a genetic condition or chromosomal anomaly known to cause the birth of a child with a genetic condition. In summary, this patient does not have any indication for an embryo biopsy. 

The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient. 

The insurer's denial of coverage for an embryo biopsy (codes 89290 and 89291) is upheld. Medical necessity is not substantiated.