Optical Genome Mapping Coverage: MolDX's New Proposal for Blood Cancers
Short answer: MolDX has proposed Medicare coverage for genome-wide optical genome mapping (OGM), whole-genome sequencing, and genomic proximity mapping in blood cancers, via three parallel draft LCDs open for comment through October 11, 2026. It follows CMS's decision to raise CY2026 payment for the hematologic-malignancy OGM code (CPT 81195) 47%, to $1,853.22, and precedes Memorial Sloan Kettering's clinical launch of OGM testing this month.
What MolDX actually proposed
On September 10, 2026, the three MolDX-aligned Medicare Administrative Contractors — Palmetto GBA, CGS Administrators, and Noridian Healthcare Solutions — each posted an identically titled draft local coverage determination: "MolDX: Genome-Wide Molecular Methodologies for the Detection of Copy Number Alterations and Structural Variants in Hematologic Neoplasms" (draft IDs DL40407, DL40431, and DL40411, respectively), according to the CMS Medicare Coverage Database. The public comment period runs through October 11, 2026.
The proposal would extend limited positive coverage to genome-wide assays — explicitly including optical genome mapping, whole-genome sequencing, and genomic proximity mapping — for leukemias, lymphomas, and myelomas at initial diagnosis, progression, or relapse, when the result would change WHO/ICC classification or immediate management, according to an analysis of the draft language published by health-policy blog Discoveries in Health Policy. The draft coverage rationale states that "a single test may provide equivalent or greater clinically valid and useful genetic information as could be achieved by the combination of multiple traditional methodologies (including CBA, FISH, and CMA)," per reporting by Clinical Lab Products and a September 10 announcement from Bionano Laboratories, whose OGM-Dx HemeOne assay is among the tests the policy would affect.
Why "genome-wide" is the operative word
The distinction matters for coding and workflow planning. This proposal is not about targeted next-generation sequencing gene panels — MolDX finalized separate NGS coverage for hematologic malignancies earlier in 2026 (see our coverage of that LCD). It is about methods designed to replace the traditional cytogenetic workup — chromosome banding analysis (karyotyping), fluorescence in situ hybridization (FISH), and chromosomal microarray (CMA) — with a single genome-wide assay that detects copy number alterations and structural variants across the whole genome in one pass.
The reimbursement side moved first
Coverage policy is catching up to a payment rate that already jumped. CPT 81195 — the Category I code specific to optical genome mapping for hematologic malignancies — carried a Clinical Laboratory Fee Schedule (CLFS) rate of $1,263.53 through 2025. In its final CY2026 CLFS determination, CMS raised that rate 47%, to $1,853.22, effective January 1, 2026, Bionano Genomics disclosed in a December 3, 2025 announcement. Bionano's chief medical officer, Alka Chaubey, said the increase "will make it easier to offer OGM-based LDTs for hematologic malignancies due to the potentially more favorable reimbursement from payers." A second, newer Category I OGM code, CPT 81354, covers whole-genome cytogenomic analysis for constitutional (germline) genetic disorders — a separate clinical use case with its own crosswalk-based preliminary pricing, according to Clinical Lab Products.
Real-world adoption is already moving
The proposed LCD isn't arriving in a vacuum. On September 23, 2026, Bionano Laboratories announced that Memorial Sloan Kettering Cancer Center had launched OGM-based testing for hematologic malignancies — including acute leukemias, myelodysplastic syndromes, plasma cell neoplasms, and lymphoid malignancies — following New York State Department of Health approval. MSK cytogeneticist Yanming Zhang said hematologic malignancies "often contain complex chromosomal abnormalities that require sophisticated approaches to detect and interpret," and Bionano's Hastie called the launch "a powerful validation of this technique's role in modern cancer diagnostics." A major academic center standing up clinical OGM testing the same month MolDX's comment period is open is a signal ordering clinicians and lab directors should not treat as coincidental.
What this means for labs and ordering clinicians right now
The LCDs are drafts, not final policy, which creates a specific near-term planning problem: Medicare has already set a materially higher payment rate for OGM in hematologic malignancies, but coverage — the determination of whether that payment actually gets triggered for a given claim — is still open for comment. Labs currently offering or validating OGM-based laboratory-developed tests for leukemias, lymphomas, or myelomas should read the full draft text on the CMS Medicare Coverage Database (search DL40407, DL40431, or DL40411 depending on jurisdiction), confirm their assay's validation and documentation would meet the proposed criteria, and submit comments before October 11, 2026 if the draft's clinical scope, exclusions, or documentation requirements would affect their test. Revenue cycle teams should not assume commercial payers will follow a Medicare LCD on the same timeline; medical directors negotiating payer contracts for OGM testing should treat the proposed LCD language as a preview of the evidentiary bar, not yet an enforceable standard. For broader context on how Medicare coverage determinations for genetic tests generally move from proposal to enforcement, see our guide to LCD, NCD, and MolDX coverage basics.
Frequently asked questions
Is optical genome mapping covered by Medicare for blood cancers right now?
Not yet as a matter of formal LCD policy. The relevant coverage criteria are in draft form (DL40407, DL40431, DL40411) with comments open through October 11, 2026. Medicare has, however, already set a payment rate for CPT 81195 that would apply once a claim is deemed coverable.
What is the difference between this LCD and MolDX's NGS coverage for hematologic malignancies?
The NGS LCD covers targeted, multigene next-generation sequencing panels for hematologic malignancies. This proposal covers genome-wide methods — OGM, whole-genome sequencing, and genomic proximity mapping — aimed at replacing karyotyping, FISH, and chromosomal microarray as a single test.
Why did CMS raise the payment rate for CPT 81195 by 47% for 2026?
CMS's final CY2026 Clinical Laboratory Fee Schedule determination set the new rate; the agency's underlying rationale for the specific increase was not detailed in Bionano's public disclosure of the change, which reported the rate moving from $1,263.53 to $1,853.22 effective January 1, 2026.
Does this proposed LCD affect CPT 81354?
No. CPT 81354 covers whole-genome cytogenomic OGM analysis for constitutional (germline) genetic disorders, a distinct clinical use case from the hematologic neoplasm proposal discussed here, and is priced and reviewed separately.
How can a lab submit a comment on the draft LCDs?
Comments are submitted through the standard MolDX/MAC public comment process listed on each draft LCD's page in the CMS Medicare Coverage Database (search DL40407, DL40431, or DL40411), before the stated October 11, 2026 deadline.
This article summarizes publicly available regulatory filings, Medicare coverage database records, and company disclosures as of September 23, 2026, for general informational purposes for laboratory, revenue cycle, and clinical decision-support audiences. It is not coding, billing, legal, or reimbursement advice. Draft LCDs are subject to change before finalization, and coverage and payment policies vary by Medicare Administrative Contractor and commercial payer. Confirm current policy directly with the relevant MAC or payer before making coverage, billing, or clinical decisions.
Sources: CMS Medicare Coverage Database (draft LCDs DL40407, DL40431, DL40411, accessed Sept. 23, 2026); Bionano Laboratories/Bionano Genomics press releases via GlobeNewswire (Sept. 10, 2026; Sept. 23, 2026) and investor relations (Dec. 3, 2025 final CY2026 CLFS announcement); Clinical Lab Products, "MolDX Proposes Medicare Coverage for Optical Genome Mapping in Hematologic Neoplasms" and "CMS Sets Preliminary Payment Rate for Optical Genome Mapping CPT Code"; Discoveries in Health Policy, "MolDx Issues Bonanza of New LCDs in Late August 2026."