ENFORCEMENT

FDA Watch: Agency Moves to Boost CLIA Waiver Transparency

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs. Test … [Read more...]

ENFORCEMENT

Theranos Announces Settlement Agreements with CMS and Arizona Attorney General

After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to … [Read more...]

ENFORCEMENT

Theranos Settles with CMS and Arizona Attorney General

After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to … [Read more...]

LEGISLATION

Labs Stop VA from Allowing APRNs to Perform Lab Tests

The laboratory sector has successfully fought a Department of Veterans Affairs (VA) rule that would have allowed advanced practice registered nurses (APRNs) to "perform and supervise" lab testing. … [Read more...]

CLIA

CMS Grants International CLIA Certificate to ImmunID for Laboratory in France

Recognizing a trend in the diagnostics industry with an increasing number of global transactions, deals and partnerships, (see “Inside the Laboratory Industry,” Laboratory Industry Report, p. 4, … [Read more...]

CLIA

CLIA Certificate Granted for Laboratory in France

By Kelly A. Briganti, Editorial Director, G2 Intelligence As recently reported in Laboratory Industry Report (see "Inside the Laboratory Industry," Laboratory Industry Report, p. 4, 3/17/16), the … [Read more...]

ENFORCEMENT

Government Scrutiny of Theranos Increases

Theranos continues to face challenges concerning its Newark, Calif., laboratory as its initial response to Centers for Medicare & Medicaid Services (CMS) failed to resolve inspection issues and … [Read more...]

CMS Releases New CLIA-Waived Tests, Billing Codes

CMS notified contractors of new CLIA-waived tests effective Oct 1, 2015. There are 36 newly waived complexity tests, the latest approved by the FDA. Once again, the list is dominated by drug-related … [Read more...]

ACMG and AMA Coalition Make LDT Oversight Recommendations to Congress

A coalition of organizations including the American Medical Association (AMA) and American College of Medical Genetics and Genomics (ACMG) have recommended to Congress that oversight of laboratory … [Read more...]

FDA and CMS Address LDT Regulation Before Energy and Commerce Committee

Last week, the U.S. House of Representatives Energy and Commerce Committee heard testimony about oversight of laboratory developed tests (LDTs) from representatives of the U.S. Food and Drug … [Read more...]


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