MolDX's August 2026 LCD Wave: New Coverage, a Denial, and a Bigger Fraud Fight
Short answer: In late August 2026, MolDX (Palmetto GBA) proposed three new Local Coverage Determinations covering hematologic-malignancy testing: positive coverage for multigene NGS panels, limited positive coverage for genome-wide copy-number/structural-variant methods, and a full denial for transcriptional biomarkers in renal cell carcinoma. The moves land as CMS's broader "CRUSH" anti-fraud rule sits with the White House budget office, with a proposed regulation on molecular-testing oversight expected around October 2026.
Three New MolDX LCDs, Three Different Outcomes
Palmetto GBA's MolDX program issued a cluster of proposed Local Coverage Determinations (LCDs) in late August 2026, each addressing a different corner of hematologic oncology testing — and each landing on a different side of the coverage line, according to health-policy analysis from Discoveries in Health Policy, which tracks MolDX activity closely.
DL40425 — NGS for hematologic malignancies (positive). This proposal covers multigene next-generation sequencing — including comprehensive genomic profiling panels — for patients with confirmed or suspected hematologic malignancies, when results are needed for WHO/ICC classification or to guide immediate treatment decisions at initial diagnosis, progression, or relapse. Solid tumor testing and germline testing fall outside its scope. The companion billing-and-coding article for this policy is published as CMS document DA60490.
DL40407 — genome-wide copy number and structural variant detection (limited positive). This policy addresses genome-wide methods — including whole genome sequencing and optical genome mapping — for detecting copy number alterations and structural variants in hematologic neoplasms. Notably, MolDX's proposed language treats these newer single-workflow techniques as potential replacements for, rather than supplements to, traditional karyotyping and FISH panels — a meaningful shift for labs that have built reimbursement models around combination cytogenetic testing.
DL40429 — transcriptional biomarkers for renal cell carcinoma (noncovered). MolDX proposed to deny coverage here, writing that "prognostic association alone is not enough" and that a test must demonstrate incremental information that changes therapeutic decisions and improves patient outcomes. It's a reminder that MolDX's bar for novel biomarkers keeps rising even where the underlying biology is well published.
The Bigger Picture: CRUSH and the Push to Nationalize MolDX
The August LCD cluster is not happening in isolation. CMS's "Comprehensive Regulations to Uncover Suspicious Healthcare" initiative — CRUSH — has been moving through the federal rulemaking pipeline since early 2026, and molecular diagnostics are explicitly in its crosshairs.
CRUSH began as a request for information published in the Federal Register on February 27, 2026, following a February 25 announcement from CMS leadership. It sought public input on strengthening fraud detection across Medicare, Medicaid, CHIP, and the ACA marketplaces, and the comment period closed March 30, 2026. The RFI singled out genomic testing fraud by name, citing billions of dollars in fraudulent billing since 2018 tied to labs in Texas and Florida — including claims for genetically implausible hereditary-disease panels billed to elderly nursing-home patients, and labs shifting billing to adjacent codes after specific ones were flagged.
The RFI also asked directly whether requiring labs to register with MolDX — the molecular diagnostic program Palmetto GBA administers across 28 states — reduces fraud risk, and why commercial payers increasingly require MolDX registration even outside MolDX's home jurisdictions. CMS now has the proposal in front of the Office of Information and Regulatory Affairs, having submitted it August 7, 2026; publication of a formal Notice of Proposed Rulemaking is projected around October 2026, which would open a standard 30-to-60-day comment window before any requirement takes effect.
Separately, several Blue Cross Blue Shield plans have pushed CMS to expand MolDX nationwide as an anti-fraud backstop. The American Clinical Laboratory Association has pushed back, arguing MolDX is "imperfect as an anti-fraud tool, useful when it yields clear LCDs, and problematic when delay turns new tests into non-covered services for long periods" — pointing to MolDX technical assessments that can take six to twelve months, and some coverage requests that have stalled more than two years.
Why Genetic Testing Draws Outsized Fraud Scrutiny
The scrutiny tracks the dollars. According to CMS spending data cited in CRUSH-related reporting, genetic testing accounts for roughly 5% of Medicare Part B clinical laboratory test volume but approximately 43% — about $3.6 billion — of Part B lab spending.
That imbalance is exactly the pattern fraud investigators look for, and it's why compliant labs are getting swept into heightened documentation and audit expectations even when their billing is clean. The RFI's own language — that some of the fraud patterns "could be detected by a ten-year old with Excel" — suggests CMS believes better data analytics, not just new LCDs, will be part of the eventual rule.
What This Means for Labs, RCM Teams, and Ordering Clinicians
For molecular labs billing hematologic-oncology panels, DL40425 and DL40407 are worth reading in full before your MAC's proposed comment period closes — proposed LCDs typically carry a 45-day comment window, and coverage language finalized now will govern claims for years. RCM and coding teams should map current CPT/PLA billing for NGS heme panels and genome-wide CNA/SV methods against the draft medical-necessity criteria in DA60490 and DA60475, since documentation gaps are the most common reason MolDX claims deny even under a "positive" LCD.
Ordering clinicians and medical directors evaluating a renal cell carcinoma biomarker panel should treat DL40429's proposed noncoverage as a signal: without evidence that a result changes treatment and improves outcomes, expect a denial, not just a slow adjudication. And every lab currently relying on MolDX registration as a competitive or compliance signal should watch for the CRUSH NPRM this fall — an expansion of MolDX authority or DEX registry oversight, if it survives to publication, would touch labs well outside hematology and renal oncology. For background on how MolDX, NCDs, and LCDs interact more broadly, see our Medicare coverage guide for genetic testing, and for what to do when a claim is denied under an existing LCD, see our guide to genetic testing denials.
Frequently Asked Questions
What is MolDX, and who does it apply to?
MolDX is Palmetto GBA's molecular diagnostic program, which sets coverage and billing rules for genetic and genomic tests across 28 Medicare Administrative Contractor states. Many commercial payers also reference MolDX Z-codes and coverage determinations, so its LCDs affect billing well beyond traditional Medicare fee-for-service.
Are DL40425, DL40407, and DL40429 final policy yet?
No. All three are proposed LCDs as of early September 2026, open for public comment before Palmetto GBA finalizes them. Coverage terms, effective dates, and specific criteria can still change based on stakeholder input before a final LCD is published.
What is the CRUSH initiative, and does it target genetic testing specifically?
CRUSH ("Comprehensive Regulations to Uncover Suspicious Healthcare") is CMS's broader anti-fraud rulemaking effort, submitted to White House budget reviewers on August 7, 2026. Its originating request for information explicitly named genomic and molecular test fraud, and reporting indicates the eventual rule includes a section on clinical laboratory testing.
Could CMS require MolDX registration nationwide?
It's under active debate. Some Blue Cross Blue Shield plans have urged CMS to nationalize MolDX as a fraud control, while laboratory trade groups like ACLA oppose blanket expansion, citing coverage delays of a year or more for some technology assessments. No nationalization decision has been finalized.
What should a lab do while these policies are still proposed?
Read the draft LCDs and billing articles in full, submit comments through your MAC's proposed-LCD process if the criteria would affect your test menu, and audit current documentation practices against the draft medical-necessity language now rather than after a policy finalizes.
This article is provided for general educational and business-operations purposes for laboratory, billing, and clinical-decision-support audiences. It is not legal, coding, reimbursement, or medical advice, and coverage policy can change before or after finalization. Confirm current LCD status and criteria directly with the applicable Medicare Administrative Contractor before making billing or clinical decisions, and consult qualified compliance or legal counsel for guidance specific to your organization. Learn more about how ScreenMyGene supports genetic testing decision workflows.
Sources: CMS Medicare Coverage Database, draft billing and coding articles DA60490 and DA60475 (cms.gov); Discoveries in Health Policy, "MolDx Issues Bonanza of New LCDs in Late August 2026" (Sept. 2026); Discoveries in Health Policy, "CRUSH Reaches White House/OMB Before..." (Aug. 2026); Discoveries in Health Policy, "CMS Issues RFI on 'Fraud' — Highlighting Genomic Test Fraud; MolDx Controls Featured" (Feb. 2026); Discoveries in Health Policy, "Will CMS Nationalize MOLDX? Coverage at 360Dx" (Apr. 2026); Medical Economics, "CMS launches three-pronged plan to CRUSH health care fraud."