Diagnostics
Medicare's molecular test program, NCCN panels and commercial plans look for peer-reviewed evidence of analytical validity, clinical validity and clinical utility. Silogram produces the validation manuscript, the abstracts and the payer dossier from one analysis, so your team spends less time on the part it controls.
registered diagnostic accuracy studies were published within 30 months of completion.9
for a MolDX technical assessment once the evidence is in place, or up to 60 days if more documents are needed.1
before an NCCN panel's annual meeting is the deadline for outside submissions.5
Each of these decisions waits for peer-reviewed evidence. Medicare payment for a MolDX-covered test starts only when the technical assessment succeeds.
Before Medicare pays for a molecular test in the MolDX program, it must pass a technical assessment of analytical validity, clinical validity and clinical utility. Payment is effective from the date MolDX received the successful assessment.1
Medicare's minimal residual disease policy requires clinical validity to be established in a study published in the peer-reviewed literature for the intended use and population.2
Local coverage decisions rest on public evidence such as peer-reviewed articles. Proprietary information that is not public is not considered.3
Panels start each annual update from a search of the peer-reviewed literature, and the update is published about 5 to 6 months after the panel meets. Interim updates are possible for important new publications.45
Plans weigh peer-reviewed evidence; one Blue plan's technology assessment criteria, for example, ask for well-designed studies published in peer-reviewed journals. And one large Medicare contractor now asks each test to show its own validity and utility.67
25 states have enacted laws requiring some plans to cover biomarker testing supported by evidence such as FDA labels, Medicare coverage or national guidelines. Scope varies by state.13
ADLT pricing window. An Advanced Diagnostic Laboratory Test is paid at its list price for three quarters, starting after the later of Medicare coverage or ADLT status, so earlier coverage can start that window sooner.8
Public precedent
The first coverage expansion under Medicare's foundational MRD policy, for muscle-invasive bladder cancer, cited a phase 3 ctDNA analysis published in Nature.10
Phase 3 ctDNA analysis online in Nature.
MolDX coverage for the new tumor type.
About 10 months after the paperThe company announces the expansion.
About 13 months after the paperPublic precedent from a tumor-informed MRD test's press releases and PubMed; the company has no affiliation with Silogram. Coverage decisions usually cite several studies, so no single paper causes one. The rule is what matters: the published evidence has to exist first.
Sensitivity, specificity, predictive values and hazard ratios link to the code and commit that produced them, in the manuscript, the abstracts and the technical assessment package alike.
A runner inside your lab's network re-runs the validation analysis and confirms every reported figure regenerates, with the data never leaving your network.
How reproduction worksEach document carries a most-likely and a 90% date, linked to the decision it supports, such as an NCCN submission or a MolDX assessment, with the value of a week.
How the access plan worksWhen the analysis is updated, every downstream document shows which numbers moved, as tracked changes for the writer to accept.
What we don't claim. No study measures how much sooner coverage comes when a paper comes sooner. What is documented is that coverage decisions need published evidence, and that the paper often takes years. Silogram shortens the part your team controls: drafting, checking numbers and review.12
A 90-day paid pilot on a live manuscript, abstract, CSR or dossier, connected to its analysis repository with a read-only token.