Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Female Infertility (n97.8).
Treatment: Embryo Biopsy (BX OOCYTE MICROTQ and BX OOCYTE MICROTQ >5 EMBRY) (89290 & 89291).

The insurer denied the Embryo Biopsy (BX OOCYTE MICROTQ and BX OOCYTE MICROTQ >5 EMBRY) (89290 & 89291).  The denial is upheld.

The patient is a female requesting coverage for preimplantation genetic testing for aneuploidy due to advanced maternal age and her wish for a male child.

No, the health plan should not cover the requested health service.

Embryo aneuploidies may be responsible for implantation failures, miscarriages and affects IVF (in vitro fertilization) outcomes. A variety of technologies have been implemented to evaluate euploid embryos in IVF (in vitro fertilization) treatments, (preimplantation genetic testing for aneuploidies [PGT-A]).

According to this strategy, a better embryo selection should increase IVF (in vitro fertilization) 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 for the sake of improved clinical outcomes.

The diagnosis of embryo aneuploidies in IVF (in vitro fertilization) cycles should be considered as a research tool, and systematic implementation in clinical practice is evidenced to be potentially unjustified.

Note that PGT-A (preimplantation genetic testing for aneuploidies) is not indicated for advanced maternal age or recurrent pregnancy loss or for recurrent implantation failures. ACOG (American College of Obstetricians and Gynecologists) stated, "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."

ASRM (American Society for Reproductive Medicine) also stated, "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 PGS/PGT (preimplantation genetic screening/preimplantation genetic testing) 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%.

While the patient is a carrier of certain conditions, her partner is not. The fact that she is a carrier of these conditions will not affect the baby. As such, her carrier status has no implication in her management and not a reason to perform Biopsy. Only if her partner is positive for these conditions will the testing to be indicated, but he is not.

In summary, this patient does not have any indication for PGT-A (preimplantation genetic testing for aneuploidies).

No, the requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.

The standard treatment is for this patient to conceive and then, like every pregnant woman, she will undergo testing to rule out any chromosomal abnormality of the fetus.