MolDX Proposes Non-Coverage for Renal Cell Carcinoma Biomarker Tests
Short answer: MolDX has proposed non-coverage for transcriptional and proteomic biomarker classifiers used in renal cell carcinoma therapeutic decision-making, arguing the tests add prognostic information but not enough proven clinical utility beyond stage, grade, and histology. Two companion hematologic-malignancy LCDs posted in the same batch went the other way. The comment period is open now.
What MolDX Just Proposed
In late August 2026, MolDX — the molecular diagnostics program administered on behalf of four Medicare Administrative Contractors (Palmetto GBA, Noridian Healthcare Solutions, CGS Administrators, and WPS Insurance Corporation) — posted a batch of three near-identical draft Local Coverage Determinations. All three were refreshed again on September 17, 2026, and remain listed as open, proposed policies in the CMS Medicare Coverage Database.
One of the three, titled "MolDX: Transcriptional Biomarkers for Therapeutic Decision-Making in Renal Carcinoma" (posted under contractor-specific IDs including DL40470 at WPS), proposes non-coverage for transcriptional and proteomic biomarker classifiers marketed to guide treatment decisions in renal cell carcinoma (RCC). The request behind the policy was originally filed in May 2022 — meaning laboratories offering these classifiers have waited more than three years for a coverage answer, and the draft answer now on the table is no.
This is not a final decision. It is a proposed LCD, which means the comment period is open and the policy can still change before MolDX issues a final determination — a point worth holding onto, because MolDX has reversed a proposed non-coverage decision before (more on that below).
Why MolDX Says the Evidence Falls Short
The draft policy runs to roughly 8,400 words backed by 38 cited references — a serious evidentiary review, not a cursory pass. MolDX's stated reasoning, per its own draft rationale, comes down to three gaps:
First, the studies behind these RCC classifiers are largely retrospective, and several of the supporting cohorts are described as outdated relative to current treatment paradigms. Second, the evidence base is dominated by clear-cell RCC, leaving open questions about performance across the disease's other histologic subtypes. Third — and most consequential for coverage — MolDX concludes the classifiers demonstrate prognostic association (correlation with outcomes) without demonstrating prognostic value that improves on what a clinician already gets from stage, grade, and standard clinical-pathologic staging.
That distinction between "associated with outcome" and "changes what the physician does" is the same clinical-utility bar MolDX applies across its molecular diagnostics program (see our guide to Medicare coverage for genetic testing under LCD, NCD, and MolDX). The draft policy also sketches what would need to change for a future version of this test class to clear that bar: evidence that results drive a genuine treatment choice, materially improve risk prediction beyond stage/grade/histology, hold up under independent validation, come with peer-reviewed clinical-utility data (not just analytical performance), and outperform any comparator test that already has coverage.
A Split Decision: Two Companion LCDs Got Covered
What makes this batch notable for lab leaders is the contrast. The same MolDX release cycle included two other draft LCDs covering hematologic malignancies — and both landed on the side of conditional, positive coverage.
One, covering multigene next-generation sequencing for confirmed or strongly suspected hematologic malignancies, proposes coverage at initial diagnosis, progression or transformation, and relapse, when results support WHO/ICC classification or drive an immediate management decision such as targeted therapy selection, treatment-intensity adjustment, or transplant eligibility. It explicitly excludes solid tumors, circulating tumor DNA, germline testing, minimal residual disease, and routine response monitoring from that coverage.
The other proposes coverage for genome-wide methodologies — whole-genome sequencing, optical genome mapping, and genomic proximity mapping — that detect copy-number alterations and structural variants in hematologic neoplasms. Notably, MolDX's draft language treats these newer single-workflow tests as potentially replacing traditional cytogenetic bundles (karyotyping, FISH, chromosomal microarray) rather than merely supplementing them. We covered that proposal, and the accompanying CLFS payment increase for CPT 81195, in more detail in our optical genome mapping coverage piece.
Put side by side, the split is instructive. Both hematology LCDs cleared MolDX's bar on a shared framework: a defined intended-use population, avoidance of duplicative testing, validated performance in that population, and demonstrated incremental clinical value. The RCC classifiers, evaluated against the same framework, did not — at least not yet.
What This Means for Labs, Ordering Clinicians, and RCM Teams
For molecular labs currently billing Medicare for RCC transcriptional or proteomic biomarker panels, or in the process of launching one, this draft is a signal to model the downside now rather than after a final notice publishes. A finalized non-coverage policy would put these claims in the same posture as any other MolDX-reviewed test without an active, favorable LCD: technical assessment on file or not, the service is not "reasonable and necessary" under Medicare's own coverage terms, and claims are likely to deny.
Ordering clinicians — urologists and oncologists using these classifiers to inform adjuvant therapy or surveillance decisions in RCC patients — should expect increased scrutiny and potential prior-authorization friction on these codes even before a final LCD is published, since payers often track MolDX's proposed positions closely. RCM and billing teams should flag renal cell carcinoma biomarker claims (diagnosis codes C64.1, C64.2, and C64.9 for malignant neoplasm of the right, left, or unspecified kidney, respectively, under the FY2026 ICD-10-CM set) for a coverage-status review before the LCD finalizes, and should be ready to issue Advance Beneficiary Notices where appropriate once a final policy is in place.
For genetic counselors and medical directors fielding questions from ordering physicians, the useful framing is this: the draft policy does not say the biology is wrong, or that the classifiers don't correlate with outcomes. It says the current evidence doesn't yet show that using the test changes management in a way that improves on standard staging — which is a narrower, and more demanding, bar than most clinicians assume Medicare applies.
How to Respond While the Comment Period Is Open
MolDX's proposed LCDs go through a formal public comment process before finalization, and the comment period on this RCC policy is open now. Laboratories, professional societies, and ordering physicians can submit evidence directly — including newer prospective data, independent validation studies, or peer-reviewed clinical-utility findings that address the specific gaps MolDX identified — through the contractor's LCD comment process listed on the CMS Medicare Coverage Database record for each contractor-specific version of the policy.
It's also worth noting MolDX doesn't treat every proposed non-coverage decision as final. In 2022, MolDX proposed non-coverage for PRISM-RA, a test used to guide advanced rheumatoid arthritis therapy selection, and reversed course to a favorable final LCD in 2023 after the comment period — though even that final policy characterized portions of the supporting evidence as marginal. That reversal is the exception rather than the rule, but it's a real precedent, and it underscores why the comment window matters more than a draft headline.
Frequently Asked Questions
Is Medicare coverage for RCC biomarker tests actually being cut off right now?
Not yet. This is a proposed LCD, not a final policy — coverage doesn't change until MolDX publishes a final determination after the comment period closes. Existing claims aren't affected by the draft itself, but labs should track the record for a final notice.
Which specific tests does the proposed noncoverage LCD apply to?
The draft policy is written at the level of "transcriptional and proteomic biomarker classifiers for therapeutic decision-making in renal cell carcinoma" rather than naming individual branded assays. Labs should check whether their specific RCC classifier falls within that scope by reviewing the full LCD language for their MAC jurisdiction.
Why did the hematology LCDs get approved while the RCC one didn't?
MolDX applied the same evaluation framework to all three — intended-use population, avoidance of duplicative testing, validated clinical performance, and incremental clinical value over existing tools. The hematology proposals had evidence MolDX judged sufficient on all points; the RCC proposal's evidence was judged largely retrospective, clear-cell-dominated, and not yet shown to outperform standard clinical-pathologic staging.
Can a proposed noncoverage LCD still change before finalization?
Yes. MolDX has reversed a proposed noncoverage decision before — the PRISM-RA rheumatoid arthritis test went from proposed noncoverage in 2022 to a favorable final LCD in 2023 after public comment. It's uncommon, but the comment period exists precisely because new evidence can shift the outcome.
What should a lab do right now if it bills for one of these RCC tests?
Pull recent claims data for the relevant CPT/PLA codes and diagnosis codes (C64.1, C64.2, C64.9), confirm whether a technical assessment is on file with MolDX, and prepare both a comment-period submission (if supporting evidence exists) and an internal contingency plan for Advance Beneficiary Notices should the policy finalize as proposed.
This article is provided for general informational and educational purposes for laboratory, billing, and clinical professionals. It is not legal, coding, or reimbursement advice for any specific claim, and coverage policies can change after publication — always verify current LCD status directly with the relevant Medicare Administrative Contractor before making billing decisions.
Sources: CMS Medicare Coverage Database, Proposed LCD "MolDX: Transcriptional Biomarkers for Therapeutic Decision-Making in Renal Carcinoma" (DL40470 and contractor equivalents, updated 09/17/2026); CMS Medicare Coverage Database, Proposed LCDs "MolDX: Next-Generation Sequencing for Hematologic Malignancies and Suspected Hematologic Malignancies" and "MolDX: Genome-Wide Molecular Methodologies for the Detection of Copy Number Alterations and Structural Variants in Hematologic Neoplasms"; Discoveries in Health Policy, "MolDx Issues Bonanza of New LCDs in Late August 2026" (September 2026); Discoveries in Health Policy, "When Does MolDx Change Its Mind? The Prelude Papers" (September 2026); ICD-10-CM FY2026 code set.