FOCUS ON

CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look

"May you live in interesting times." If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very … [Read more...]

REIMBURSEMENT

Medicare Reimbursement: CMS Finalizes Controversial PAMA Fee Schedule

It's official. CMS is going forward with its controversial 2018 PAMA Clinical Laboratory Fee Schedule (CLFS). Regrettably, the final version closely tracks the preliminary one (See GCA, Oct. 24, 2017, … [Read more...]

PRODUCT DEVELOPMENT

FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval

The FDA's longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to lab tests, the policy … [Read more...]

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...]


(-00000g2)