Bionano Genomics announces CMS posted preliminary payment determination for OGM

Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics (BNGO), announced that Centers for Medicare & Medicaid Services, CMS, posted the preliminary payment determination for the Category I Current Procedural Terminology, CPT, code for use of OGM in cytogenomic genome-wide analysis to detect structural and copy number variations related to constitutional genetic disorders. According to the preliminary determination, CMS will crosswalk to a previously established proprietary laboratory analyte code for OGM, which is priced at $1263.53. Pricing at this level is $363.53 higher than 81228 and $103.53 higher than 81229, comparative codes that apply to use of microarrays and is listed on the clinical lab fee schedule at $900 and $1160. “We believe this second Category I CPT code for OGM, in this case for constitutional genetic disorders, is another game-changer for clinical OGM testing,” said Alka Chaubey, chief medical officer of Bionano. “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. LDTs like OGM-Dx Postnatal Whole Genome SV and OGM-Dx Prenatal Whole Genome SV are indicated for use with clinical presentations like developmental delay, intellectual disabilities, autism spectrum disorder and others, where studies have shown that OGM can outperform legacy cytogenomic methods.”