INDUSTRY BUZZ

FDA Watch: Off-Label Marketing Rule Put Back on Ice & Extra Comment Time for CLIA Waiver Proposals

For the second time in less than a year, the FDA indefinitely delayed a controversial rule expanding its authority to regulate off-label marketing, i.e., promotion of medical products for additional … [Read more...]

ACCREDITATION

Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review

Brace yourself—and your C-suite—for more sweeping legal changes. Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may … [Read more...]

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...]

INDUSTRY BUZZ

FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway

A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including: FoundationOne's CDx (F1CDx) companion diagnostic test for solid tumors; and Memorial … [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...]

INDUSTRY BUZZ

FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval

For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests. On Nov. 6, the agency finally made a move in that direction … [Read more...]

LAB SAFETY

CLIA Corner: FDA 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

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...]

INDUSTRY BUZZ

FDA Watch: New Moves to Boost CLIA 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...]


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