# Centers for Medicare & Medicaid Services

Type: organization

Source: Biotech Intelligence Brief — https://getbiobrief.com/entity/centers-for-medicare-medicaid-services-organization
Canonical HTML page: https://getbiobrief.com/entity/centers-for-medicare-medicaid-services-organization

## Timeline

- **2026-08-27**: Initial Expiration — The first six-month period ends, at which point CMS may choose to extend the moratorium.
- **2026-03-02**: Q4 2025 Earnings — Company reports 25% total revenue growth and progress in clinical diagnostic pivot.
- **2026-02-27**: Moratorium Effective — CMS officially publishes the notice and the nationwide enrollment freeze begins immediately.
- **2026-01-15**: FDA 510(k) Submission — Premarket notification submitted for Lucent AD Complete diagnostic test.
- **2025-12-31**: CMS Reimbursement Milestone — CMS approves $897 reimbursement rate for Lucent AD Complete, establishing a national reference price.
- **2025-10-31**: Data Review Concludes — CMS finishes a multi-year review of Medicare enrollment and claims data identifying high-risk trends.
- **2025-02-01**: OIG Fraud Warning — HHS OIG highlights billions in improper DME payments over the previous decade.
- **2025-01-01**: Assay Portfolio Expansion — Launch of 13 new assays including pTau-205 and pTau-212 for neurodegenerative research.

## Recent coverage (3 stories)

### $6.5B Fraud Sweep Nabs Genetic Testing Scams: Biotech’s Compliance Wake-Up Call
2026-06-28 04:39:15 · Sentiment: Bullish · Impact: 8/10 · Sources: 31

The DOJ’s operation specifically targeted fraudulent genetic testing schemes, sending shockwaves through biotech and pharma reliant on lab services. A new Data Fusion Center and $48.6M in settlements signal aggressive federal interest in precision medicine marketing.
Full story: https://getbiobrief.com/story/doj-genetic-testing-fraud-bio

### CMS Imposes Unprecedented Nationwide Moratorium on DMEPOS Enrollments
2026-03-06 01:27:47 · Sentiment: Bearish · Impact: 7/10 · Sources: 2

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.
Full story: https://getbiobrief.com/story/cms-nationwide-dmepos-moratorium-2026

### Quanterix Advances Alzheimer’s Strategy Amidst 25% Revenue Growth and FDA Filing
2026-03-04 00:21:33 · Sentiment: Bullish · Impact: 6/10 · Sources: 6

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.
Full story: https://getbiobrief.com/story/quanterix-q4-2025-alzheimers-diagnostic-strategy-fda-filing

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