Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Female infertility
Treatment: 89290 - Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic screening); less than or equal to five embryos
89291 - Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic screening); greater than five embryos
The insurer denied the 89290 - Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic screening); less than or equal to five embryos
89291 - Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic screening); greater than five embryos.
The denial us upheld.

The health plan should not cover the proposed treatment.

The requested service is not likely to be more beneficial.

The patient is a woman with a diagnosis of infertility. She consulted a reproductive endocrinologist and underwent two fresh IVF (in vitro fertilization) cycles. The first cycle resulted in no blastocyst embryos available for transfer. A second cycle was performed with preimplantation genetic testing for aneuploidy (PGT-A). One of three blastocysts was euploid, and a subsequent frozen embryo transfer resulted in no pregnancy. Another IVF cycle with PGT-A has been recommended.

The medical records and medical literature were thoroughly reviewed. Since 24 chromosome techniques have become available, there have been few well-designed studies providing Level-I evidence regarding IVF pregnancy outcomes in select populations with these techniques. Several opinion pieces have discussed 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. For example, PGT-A testing may lower the risk of aneuploidy detected during pregnancy or after birth. Another consideration is that identification and discard of aneuploid embryos could potentially lessen the burden of excess embryos cryopreserved. 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 RCT (randomized controlled trial) in patients aged 38 to 41 demonstrated improved live-birth rates per cycle with a day three 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 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. Therefore, at this time, PGT-A is considered experimental/investigational. 

The ASRM, in its Practice Committee Opinion, states: "The mechanism of first-trimester pregnancy loss is largely due to aneuploidy, providing biologic plausibility for PGT-A. An analysis of a retrospective cohort study (118 PGT-A vs 188 expectant management) demonstrated similar clinical pregnancy rates and miscarriage rates between the two groups, though time to successful pregnancy was statistically shorter in the expectant-management group (3.0 vs 6.5 months, respectively). Of the PGT-A cohort, 77% were able to create embryos that were tested and, of those, 74% had at least one euploid embryo to transfer. This study is limited by its retrospective design, which makes it difficult to interpret potentially different clinical prognoses for those who did or did not pursue PGT-A. A prospective study explored the relationship between ovarian reserve in recurrent pregnancy loss (RPL) patients and found that in women younger than 38 years, decreased ovarian reserve (defined as a cycle day-3 follicle-stimulating hormone level >10 IU/mL and/or antimullerian hormone <1 ng/mL) resulted in a significantly lower likelihood of having a euploid embryo to transfer compared with women with normal ovarian reserve testing. These studies can assist in personalizing the counseling for patients considering PGT-A, regarding one's likelihood of successfully obtaining a euploid embryo from the technology. It is worth noting that the increased rate of aneuploidy with decreased ovarian reserve is likely not unique to the RPL population. However, to date, the literature has not suggested an improved live-birthrate using PGT-A in RPL patients." 

The technique of PGT-A is performed by applying the technique of blastomere biopsy (CPT 89290 and 89291). Therefore, the requested health service or procedure is not medically appropriate, and it is not likely to be more beneficial than any standard treatment or treatments for the insured's condition.