Bionano Laboratories Gains 47% CMS Reimbursement Increase For OGM Blood-Cancer Test Code 81195 In 2026

Bionano Laboratories, a wholly-owned subsidiary of Bionano Genomics, Inc. (NASDAQ:BNGO) offering CLIA-certified laboratory developed tests (LDTs) based on optical genome mapping (OGM), announced today that the clinical lab fee schedule (CLFS) for 2026 posted by Centers for Medicare & Medicaid Services (CMS) indicates an increase of 47%, from $1263.53 to $1853.22, for the payment for the Category I Current Procedural Terminology (CPT®) code 81195. This code applies to use of OGM in cytogenomic genome-wide analysis to detect structural and copy number variations related to hematologic malignancies, or blood cancers.

CMS previously established a payment determination, effective January 1, 2025, for the Category 1 CPT code 81195 at $1263.53 based on a crosswalk to an existing code. A request for reconsideration and crosswalk to a different code with a higher payment rate was made. The clinical diagnostic laboratory test (CDLT) committee that reviews such applications voted unanimously in favor of the proposed crosswalk by a vote of 10-0 with no abstentions. CMS subsequently agreed with the panel and the OGM users who commented as part of the process and re-priced code 81195 to $1853.22, effective January 1, 2026.

CPT codes for OGM are key components for obtaining reimbursement from third party payers for the OGM-based LDTs developed by Bionano Laboratories and used as alternatives to legacy cytogenetics methods such as karyotyping, fluorescence in-situ hybridization (FISH) and microarrays. There are now two such codes, 81195 for use of OGM in hematologic malignancy analysis and 81354 for use of OGM in constitutional genetic disease. Bionano Laboratories has offered OGM-Dx™ HemeOne, OGM-Dx™ Postnatal Whole Genome SV and OGM-Dx™ Prenatal Whole Genome SV, all of which would be expected to be covered by these two codes.