Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Infertility.
Treatment: genetic testing for aneuploidy (PGT-A).
The insurer denied genetic testing for aneuploidy (PGT-A). 
The determination is upheld.

The patient is a female with a diagnosis of infertility. She underwent in vitro fertilization with preimplantation genetic testing of blastocyst embryos. The health plan has denied coverage of the requested preimplantation genetic testing for aneuploidy (PGT-A) as not medically necessary. At issue is the medical necessity of the requested testing.
The requested testing is not medically necessary.
This patient underwent preimplantation genetic testing of her embryos. According to Society guidelines, the current standard of care does not support the routine use of preimplantation testing for aneuploidy. Therefore, the testing is not medically necessary. The medical literature and health plan documentation were thoroughly reviewed. The American Society of Reproductive Medicine (ASRM), in its Practice Committee Opinion, states: "Since 24-chromosome techniques have become available, there have been few well-designed studies providing Level-I evidence regarding in vitro fertilization (IVF) pregnancy outcomes in select populations with these techniques. Several opinion pieces have discussed the advantages and disadvantages of PGT-A... Other potential advantages and disadvantages exist with PGT-A, though there are limited data to support or refute these. The retrospective nature, inclusion criteria, and small numbers limit these studies; in particular, one study stratified groups by age, thus comparing only eight cycles per group in the oldest age cohort, while another only included women with euploid embryos to transfer (only 76 of 145 patients had euploid blastocysts to transfer [52.4%]). There is potential bias because only good prognosis patients who were able to have a biopsy would have been included in the PGT-A group. The authors in both groups believe the improved pregnancy success demonstrates a benefit of PGT-A; however, the study methodologies leave questions regarding these conclusions. Also, identifying euploid embryos may decrease the time to pregnancy by focusing embryo transfer cycles only using euploid embryos to select populations; this may be helpful in older women...One randomized controlled trial (RCT) in patients aged 38-41 demonstrated improved live-birth rates per cycle with a day-3 single-blastomere biopsy and PGT-A...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 in vitro fertilization (IVF) population are needed to determine not only the effectiveness but also the safety and potential risks of these technologies. PGT-A 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 value of PGT-A as a universal screening test for all IVF patients has yet to be determined.