MolDX Proposes a Coverage Framework for NGS Testing in Hematologic Malignancies
Short answer: In August 2026, MolDX posted matching draft LCDs (DL40425, DL40427, DL40451) through Palmetto GBA, Noridian, and CGS Administrators proposing conditional coverage for next-generation sequencing panels in confirmed or suspected hematologic malignancies. The draft ties coverage to WHO/ICC classification or immediate treatment decisions, excludes ctDNA, germline, and MRD testing, and remains open for comment — it is not yet effective.
What MolDX just proposed
On August 21, 2026, the CMS Medicare Coverage Database picked up a new set of draft Local Coverage Determinations from three MolDX-aligned Medicare Administrative Contractors, all sharing the same title: "MolDX: Next-Generation Sequencing for Hematologic Malignancies and Suspected Hematologic Malignancies." Palmetto GBA filed it as DL40425, Noridian as DL40427, and CGS Administrators as DL40451. Each carries an effective date of "N/A" in the CMS database, the standard marker for a proposed LCD still in review — this policy has not been finalized and is not yet enforceable.
Health policy analyst Bruce Quinn, who tracks MolDX filings closely at Discoveries in Health Policy, flagged this as part of a broader batch of new hematology and oncology LCDs MolDX released in late August 2026. Two related drafts came out of the same review cycle, and together the three give labs an unusually clear look at where MolDX's evidentiary bar currently sits for genome-scale testing in blood cancers.
What the draft covers — and what it explicitly excludes
According to Quinn's review of the filing, the proposed policy would extend conditional, positive coverage to multigene NGS testing — both hotspot panels and comprehensive genomic profiling — in patients with confirmed or suspected hematologic malignancies, at three clinical moments: initial diagnosis, disease progression or transformation, and clinical relapse. Coverage is tied to a specific purpose: the result must be needed for WHO or International Consensus Classification (ICC) subtyping, or to make an immediate management decision such as selecting targeted therapy, setting treatment intensity, or determining stem-cell transplant eligibility.
The scope exclusions are just as load-bearing as the inclusions. The draft explicitly does not cover solid tumor testing, circulating tumor DNA (ctDNA) assays, germline testing, minimal residual disease (MRD) testing, or therapy-response monitoring. A lab running a heme malignancy panel that also reports MRD or germline findings should not assume this LCD extends coverage to those components — each falls under its own, separate coverage pathway.
This is one of three related proposals in the same batch
MolDX did not release this policy in isolation. In the same late-August 2026 cycle, Quinn's review identified two other draft LCDs touching adjacent territory, and reading them together shows how MolDX is currently weighing evidence for genome-scale hematology and oncology testing.
A second draft, DL40407, addresses genome-wide molecular methods — whole-genome sequencing, optical genome mapping, and genomic proximity mapping — for detecting copy number alterations and structural variants in hematologic neoplasms. It proposes limited positive coverage, but only when equivalent copy-number or structural-variant information "has not already been obtained through another genome-wide test," and it explicitly excludes MRD and therapy-response use. A third, DL40429, addresses transcriptional and proteomic biomarker classifiers for treatment decisions in renal cell carcinoma — and proposes the opposite verdict: noncovered, on the grounds that current evidence is largely retrospective, concentrated in clear-cell histology, and missing complete clinical outcome data.
For a lab weighing whether to invest in validating a new assay against MolDX's Technical Assessment process, the renal biomarker denial is the more instructive data point: MolDX is not rejecting novel biomarker classes outright, but it is consistently asking for independent validation, clinical utility beyond a single histologic subtype, and comparative performance against existing standards before it will pay for them. That is the same bar it has applied in prior cycles — see our coverage of MolDX's approach to MASLD/MASH biomarker coverage for a parallel example outside oncology.
Only three of the four MolDX MACs have filed so far
MolDX operates through four Medicare Administrative Contractors that jointly administer its molecular diagnostics program: Palmetto GBA, Noridian Healthcare Solutions, CGS Administrators, and WPS Government Health Administrators. As of this writing, the CMS Medicare Coverage Database shows matching draft LCDs from Palmetto GBA, Noridian, and CGS — but no corresponding filing from WPS. That is not unusual; MolDX MACs frequently stagger draft postings by a few weeks, and a fourth filing carrying the same coverage language would not be a surprise. Labs and RCM teams billing into WPS jurisdictions should not assume this policy doesn't apply to them yet — they should watch for it.
What labs and RCM teams should do now
Three concrete steps make sense before this LCD finalizes. First, if your lab or reference lab runs NGS panels for hematologic malignancies, review the draft's scope language against your current test menu and reporting practice — specifically whether any panel commingles the covered diagnostic/classification use case with an MRD or ctDNA component that would fall outside this policy. Second, use the open comment period to flag ambiguities before they harden into final coverage language; MolDX's response-to-comments documents on recent LCDs (its transplant rejection policy ran 194 pages) show it does incorporate substantive commenter feedback. Third, confirm your test has a completed or in-progress MolDX Technical Assessment, since that remains the gating requirement across essentially every MolDX molecular policy — see our overview of MolDX's expanding national footprint for how the Technical Assessment process fits into the broader program.
None of this changes billing today. Until a final LCD posts with an effective date, existing coverage determinations — including MolDX's general Molecular Diagnostic Tests LCD — continue to govern claims for hematologic malignancy NGS testing. Labs that jump ahead and bill against draft criteria risk denials under whatever policy is actually in force on the date of service. For the broader denial-prevention picture, see our guide to why genetic testing claims get denied.
Frequently asked questions
Is this LCD already in effect?
No. All three filings (DL40425, DL40427, DL40451) show an effective date of "N/A" in the CMS Medicare Coverage Database, the standard designation for a proposed LCD still in its comment period. Existing coverage policy continues to apply until MolDX finalizes and posts an effective date.
Which Medicare jurisdictions does this affect?
Currently, the jurisdictions served by Palmetto GBA, Noridian Healthcare Solutions, and CGS Administrators. WPS Government Health Administrators, the fourth MolDX-aligned MAC, has not yet posted a matching draft as of this writing, though one may follow.
Does this policy cover minimal residual disease (MRD) testing?
No. The draft explicitly excludes MRD testing, along with solid tumor testing, ctDNA assays, germline testing, and therapy-response monitoring. Each of those use cases falls under its own separate MolDX coverage pathway, not this policy.
What does a lab need to do to get a new heme NGS panel covered under this policy once finalized?
Complete a MolDX Technical Assessment demonstrating the panel's analytical and clinical validity for the specific diagnostic, classification, or immediate-management use case described in the LCD. The Technical Assessment requirement is consistent across MolDX's molecular policies and is not unique to this draft.
How does this relate to MolDX's existing Molecular Diagnostic Tests LCD?
It narrows and specifies coverage for one test category — heme malignancy NGS — that previously sat under MolDX's more general molecular diagnostics policy. Once finalized, the more specific LCD would govern coverage determinations for this use case.
This article is educational information for laboratory, revenue cycle, and clinical professionals. It is not medical advice, legal advice, coding advice, or a guarantee of payment. Coverage policies are proposals until finalized, and code sets, criteria, and effective dates can change during the comment process — always verify current status against the CMS Medicare Coverage Database and your MAC's published guidance before submitting claims or making clinical decisions. ScreenMyGene does not determine coverage for any individual claim. Learn more about our work at ScreenMyGene.
Sources: CMS Medicare Coverage Database, proposed LCD search results for DL40425 (Palmetto GBA), DL40427 (Noridian Healthcare Solutions), and DL40451 (CGS Administrators), “MolDX: Next-Generation Sequencing for Hematologic Malignancies and Suspected Hematologic Malignancies,” updated 08/21/2026; Quinn B., “MolDx Issues Bonanza of New LCDs in Late August 2026,” Discoveries in Health Policy, September 2026; CMS Medicare Coverage Database, LCD L38966 — MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer (Palmetto GBA), for scope-boundary reference.