CMS Approves 47% Payment Increase for Optical Genome Mapping in Blood Cancer Diagnostics
核心洞察
The Centers for Medicare & Medicaid Services (搜索) increased reimbursement for optical genome mapping (搜索) in hematologic malignancies (搜索) by 47%, from $1,263.53 to $1,853.22 for CPT code 81195, effective January 1, 2026.
The clinical diagnostic laboratory test committee voted unanimously 10-0 in favor of the payment increase following a reconsideration request and crosswalk to a higher-paying code.
Bionano Genomics expects the enhanced reimbursement to improve adoption of OGM-based laboratory developed tests as alternatives to traditional cytogenetic methods like karyotyping and FISH.
The Centers for Medicare & Medicaid Services (搜索) (CMS) has approved a substantial 47% increase in reimbursement rates for optical genome mapping (搜索) (OGM) technology used in diagnosing blood cancers (搜索), marking a significant milestone for genomic testing accessibility. The payment determination for CPT code 81195 will rise from $1,263.53 to $1,853.22, effective January 1, 2026.
Unanimous Committee Support Drives Payment Revision
The payment increase follows a successful reconsideration process initiated after CMS initially established the lower rate in January 2025. The clinical diagnostic laboratory test (CDLT) committee, which reviews such applications, voted unanimously in favor of the proposed crosswalk by a vote of 10-0 with no abstentions. CMS subsequently agreed with both the panel recommendation and comments from OGM users who participated in the review process.
CPT code 81195 specifically applies to OGM use in cytogenomic genome-wide analysis to detect structural and copy number variations related to hematologic malignancies (搜索). This represents one of two established CPT codes for OGM technology, with code 81354 covering constitutional genetic disease applications.
Enhanced Access to Advanced Genomic Testing
"We believe the increase in the CLFS for the Category 1 CPT code 81195 will make it easier to offer OGM-based LDTs for hematologic malignancies (搜索) due to the potentially more favorable reimbursement from payers," said Alka Chaubey, chief medical officer of Bionano Genomics. The company emphasized that the higher payment level appropriately reflects the additional data collection, interpretation and reporting requirements when using OGM for blood cancer analysis.
The reimbursement enhancement is expected to benefit Bionano Laboratories (搜索)' portfolio of CLIA-certified laboratory developed tests (LDTs), including OGM-Dx HemeOne (搜索), OGM-Dx Postnatal Whole Genome SV (搜索), and OGM-Dx Prenatal Whole Genome SV (搜索). These tests serve as alternatives to legacy cytogenetics methods such as karyotyping, fluorescence in-situ hybridization (FISH), and microarrays.
Technology Positioning and Market Impact
OGM technology enables comprehensive genome-wide analysis to identify structural variations that may be missed by traditional cytogenetic approaches. The establishment of Category I CPT codes represents a crucial step for clinical adoption, as these codes facilitate reimbursement from third-party payers and increase awareness within the oncology and clinical genetic testing communities.
Chaubey noted that establishing Category I CPT codes "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." The company views this development as potentially transformative for expanding access to advanced genomic analysis in hematologic malignancy diagnosis and monitoring.
The payment determination reflects CMS recognition of the clinical value and complexity associated with OGM-based testing, positioning the technology as a viable alternative to conventional cytogenetic methods in blood cancer care.