On July 7, 2016, the Centers for Medicare and Medicaid Services ("CMS") imposed several administrative penalties on Theranos, a clinical laboratory company that proposed to revolutionize the clinical laboratory business by performing multiple blood tests using a few drops of blood drawn from a finger rather than from a traditional blood draw that relies on needles and tubes. However, after inspecting the laboratory, CMS concluded that the company failed to comply with federal law and regulations governing clinical laboratories and it posed an immediate jeopardy to patient ...
Recent Updates
- Comment Period Closes on California OHCA’s Proposed Emergency Regulations Expanding Private Equity, Hedge Fund, and MSO Reporting in Health Care Transactions
- DOJ Revises Justice Manual on Non-Binding Guidance and Qui Tam Dismissals: Practical Considerations
- Additional SBA Crackdown on Pandemic-Era Fraud Leads to Program and Loan Suspensions, Possible FCA Enforcement
- Federal Regulatory Views on Cybersecurity and AI Amidst a Growing Threat Landscape
- Remote Monitoring Services Under the 2027 PFS Proposed Rule: Epstein Becker Green Submits Comments to CMS