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 woman who underwent IVF (in vitro fertilization) with preimplantation genetic screening for advanced reproductive age and male sex selection.

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

The medical records and medical literature were thoroughly reviewed. Traditionally, morphology-based grading had been the primary technique used in in vitro fertilization (IVF) to evaluate and select the most competent embryos for transfer. Technologies have been developed in the fields of genomics, transcriptomics, proteomics, metabolomics, and time-lapse imaging to try to assist in the selection of the best embryos. However, a focus has been on analysis of 24-chromosome copy number for evaluation and transfer of only diagnosed euploid embryos, also known as preimplantation genetic testing for aneuploidy (PGT-A) Since 24-chromosome techniques have become available, there have been few well-designed studies providing Level-I evidence regarding IVF (in vitro fertilization) pregnancy out-comes in select populations with these techniques.

In an RCT (randomized controlled trial) evaluating the treatment, patients participating in the RCT (randomized controlled trial) were generally favorably responding subjects who have produced blastocysts for biopsy and analysis. A broader selection of patients with randomization at cycle start rather than blastulation would more appropriately address the applicability of wider use of this technology. The randomized trials were performed in centers with broad and deep experience in embryo biopsy and specimen preparation. The ability to expand these techniques to centers with less experience has yet to be established.

One RCT (randomized controlled trial) in patients aged 38-41 demonstrated improved live-birth rates per cycle with a day-3 single-blastomere biopsy, which is not the proposed service, and PGT-A (preimplantation genetic testing for aneuploidy). The extremely challenging questions of false-positive testing, embryonic damage, and loss of euploid embryos between day 3 and blastulation remain unanswered.

The ASRM (American Society for Reproductive Medicine), in its Practice Committee Opinion, states, "To date, there are very few studies directly comparing the specific laboratory techniques for assessing ploidy. Future studies are warranted to determine if any platforms are superior. Other important considerations about PGT-A [preimplantation genetic testing for aneuploidy] that must be addressed by further research include: cost-effectiveness; the role and effect of cryopreservation, time to pregnancy, utility in specific subgroups (such as recurrent loss, prior implantation failure, advanced maternal age, etc.); cumulative success rates over time; and total reproductive potential per intervention. Unfortunately, at the time of this publication, there are currently very few randomized trials registered to elucidate these answers. Large, prospective, well-controlled studies evaluating the combination of multiple approaches (genomics, time-lapse imaging, transcriptomics, proteomics, metabolomics, etc.) for enhanced embryo selection applicable in a more inclusive IVF [in vitro fertilization] population are needed to determine not only the effectiveness, but also the safety and potential risks of these technologies. PGT-A [preimplantation genetic testing for aneuploidy] will likely be part of a future multidimensional approach to embryo screening and selection. At present, however, there is insufficient evidence to recommend the routine use of blastocyst biopsy with aneuploidy testing in all infertile patients."

The patient appeal note references "genetic issues" diagnosed, including those related to patient age. Both partners underwent expanded genetic carrier testing, and each was found to be heterozygous for various disorders, with none matching. Therefore there is no risk for subsequent affected offspring.

Therefore, given the above, the health plan should not cover the requested service, as it is not medically appropriate.

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