Last mentioned: 3d ago
Initial Expiration
The first six-month period ends, at which point CMS may choose to extend the moratorium.
Q4 2025 Earnings
Company reports 25% total revenue growth and progress in clinical diagnostic pivot.
Moratorium Effective
CMS officially publishes the notice and the nationwide enrollment freeze begins immediately.
FDA 510(k) Submission
Premarket notification submitted for Lucent AD Complete diagnostic test.
CMS Reimbursement Milestone
CMS approves $897 reimbursement rate for Lucent AD Complete, establishing a national reference price.
Data Review Concludes
CMS finishes a multi-year review of Medicare enrollment and claims data identifying high-risk trends.
OIG Fraud Warning
HHS OIG highlights billions in improper DME payments over the previous decade.
Assay Portfolio Expansion
Launch of 13 new assays including pTau-205 and pTau-212 for neurodegenerative research.
The Centers for Medicare & Medicaid Services (CMS) has implemented a six-month nationwide freeze on new Medicare enrollments for seven categories of medical supply companies. This aggressive regulatory move, effective February 27, 2026, aims to curb systemic fraud and billions in improper payments within the DMEPOS sector.
Quanterix reported Q4 2025 revenue of $43.9 million, driven by a 25% year-over-year increase and significant progress in its Alzheimer’s diagnostic portfolio. Despite organic declines in its core Simoa and Spatial segments, the company secured a $897 CMS reimbursement rate for its Lucent AD Complete test and submitted its 510(k) to the FDA.