The new Category I code for constitutional genetic disorders receives crosswalk pricing of $1,263.53, higher than comparable microarray codes.
The Centers for Medicare & Medicaid Services (CMS) has posted a preliminary payment determination for a new Category I Current Procedural Terminology code covering optical genome mapping (OGM) for constitutional genetic disorders.
According to the preliminary determination, the new code 81354 will be crosswalked to a previously established proprietary laboratory analyte code priced at $1,263.53. This pricing is $363.53 higher than code 81228 ($900) and $103.53 higher than code 81229 ($1,160), which apply to microarray testing on the clinical lab fee schedule.
The code covers cytogenomic genome-wide analysis using OGM to detect structural and copy number variations related to constitutional genetic disorders. Pricing becomes effective when the next CPT codebook takes effect on Jan 1, 2026.
This marks the second Category I CPT code established for OGM technology. Code 81195, which covers hematologic malignancy analysis, is expected to receive the same $1,263.53 pricing.
Laboratory Testing Applications
Bionano Laboratories, a subsidiary of Bionano Genomics offering CLIA-certified laboratory-developed tests based on OGM, expects the new code to cover its OGM-Dx Postnatal Whole Genome SV and OGM-Dx Prenatal Whole Genome SV laboratory-developed tests.
The tests are indicated for clinical presentations including developmental delay, intellectual disabilities, and autism spectrum disorder, where studies have shown OGM can outperform legacy cytogenomic methods.
“Pricing at this level, which is higher than the microarray codes, is consistent with the needs of laboratories today seeking to move forward from legacy methods,” says Alka Chaubey, chief medical officer of Bionano, in a release.
Chaubey adds, “We believe that establishing another Category I CPT code can raise the awareness of the utility and support for OGM in the oncology and clinical genetic testing communities, not only in the United States, but around the world as well.”
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