Outcome of LDT Regulation Controversy Defies Forecasting

Few, if any, device regulatory issues are as controversial or as important as FDA's proposal to regulate Laboratory-Developed Tests (LDTs). If FDA LDT regulation does occur, it would represent the … [Read more...]

Don’t Overlook Free Resources When Preparing Your Laboratory for ICD-10

The transition to ICD-10 is approaching fast and laboratories need to ensure they are prepared. While the Centers for Medicare and Medicaid Services (CMS) has indicated in answers to Frequently Asked … [Read more...]

Don’t Overlook Varying State Requirements Applicable to Independent Clinical Labs

Through acquisition, merger, or organic growth, labs may find their operations expanding regionally or nationally. If your lab is operating facilities in multiple states or testing specimens … [Read more...]

Ohio State Medical Center Reaches Settlement Over PT Violations; Lab to Stay Open

Ohio State University’s Wexner Medical Center will pay the federal government $268,000 to settle allegations that its lab violated proficiency testing laws. The agreement will allow the lab to stay … [Read more...]

New Webinar Just Announced!

Keeping Ahead of the Curve: CLIA Compliance 2013 June 19, 2013 2 p.m.-3:30 p.m.Speaker: Judy Yost, MA, MT(ASCP), Director, Division of Laboratory Services, Centers for Medicare and Medicaid … [Read more...]

Texas Laboratory Has Certificate Revoked For Proficiency Testing Violations

The Health and Human Services Departmental Appeals Board recently upheld the revocation of a clinic laboratory’s Clinical Laboratory Improvement Amendments certificate after it was found in violation … [Read more...]

Compliance Perspectives: The Two Faces of Government Advice: Reliance on Agency Counsel May Not Always Be Reasonable

Clinical laboratories and pathologists frequently struggle with issues related to Medicare payment and compliance. It’s no wonder. One court stated recently, “Picture a law written by James Joyce and … [Read more...]

G2 Compliance Perspectives: Clinical Laboratories Face Expanded Exposure To False Claims and Overpayment Demands

RRecently, amendments to the Medicare statute, evolving False Claims Act (FCA) jurisprudence, and subtle changes in Medicare regulatory requirements and interpretations have expanded the potential for … [Read more...]

Lab Institute Addresses Key Regulatory, Reimbursement Topics for Clinical Laboratories

Attendees at G2 Intelligence’s 31st annual Lab Institute (Oct. 16-18, Arlington, Va.) gleaned insight on issues vital to their survival as they navigate the rough waters of government regulations and … [Read more...]

G2 Compliance Perspectives: Direct Patient Access to Laboratory Test Results: Keeping the Doctor in the Picture

On Sept. 19, 2013, the Department of Health and Human Services (HHS) announced its postponement of the Sept. 23, 2013, deadline under the Health Insurance Portability and Accountability Act (HIPAA) … [Read more...]