CMS Proposes Coverage Decision Regarding HIV Screening

The Centers for Medicare and Medicaid Services (CMS) proposes increased coverage of HIV screenings with changes to the Medicare National Coverage Determinations Manual, Section 210.7. The CMS … [Read more...]

January Update of CLIA-Waived Tests, Billing Codes

The Jan. 1, 2013, update to the list of tests waived under the Clinical Laboratory Improvement Amendments (CLIA) includes 36 more devices, the latest approved by the Food and Drug Administration for … [Read more...]

Ohio State Lab Settles CLIA PT Referral Case

The Wexner Medical Center at Ohio State University (OSU) in Columbus has avoided the worst that can happen to a clinical laboratory for violating proficiency testing (PT) referral rules under the … [Read more...]

CMS Proposes Changes to CLIA Proficiency Testing Rules

The Centers for Medicare and Medicaid Services (CMS) has proposed important changes and clarifications to the regulations governing proficiency testing (PT) samples under the Clinical Laboratory … [Read more...]

CLIA Update: Whatever Happened to . . .

The proposed rule giving patients (and their authorized representatives) direct access to their own laboratory test results? It was issued in the Sept. 14, 2011, Federal Register to modify … [Read more...]

April Update of CLIA-Waived Tests, Billing Codes

The April 1, 2013, update to the list of tests waived under the Clinical Laboratory Improvement Amendments (CLIA) includes 24 more devices, the latest approved by the Food and Drug Administration for … [Read more...]

Focus On: Clinical Lab Regulation: CLIA PT Changes Get ‘Thumbs Up,’ but With Caveats

Proposals that would modify rules under the Clinical Laboratory Improvement Amendments (CLIA) that govern the referral of proficiency testing (PT) samples won support from leading clinical laboratory … [Read more...]

Upcoming G2 Events

Webinar (2 p.m.-3:30 p.m. Eastern) May 30 Blood Management for the Lab: Collaboration for Better Patient Outcomes and Fewer Transfusions www.G2Intelligence/BloodManagement June 19 Keeping Ahead of … [Read more...]

Lab Industry Files Petition Against FDA Regulation of Laboratory-Developed Tests

After several years of threats by the Food and Drug Administration (FDA) that it intends to regulate laboratory-developed tests (LDTs), the lab industry has taken the matter into its own hands. The … [Read more...]

Focus On: Clinical Lab Regulation: CLIA Update: What’s on the Agenda for 2013?

Almost two years after first being proposed, a rule allowing patients to have direct access to their laboratory test results is expected to be finalized by late summer or early fall, according to Judy … [Read more...]


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