Policy and Regulation

Lagging claims payment disputes with providers to cost Anthem $8.5M
By LabPulse.com staff writers
The California Department of Managed Health Care has fined Anthem Blue Cross $8.5 million for failing to address claims payment disputes in a timely manner from doctors, hospitals, and other healthcare providers.
October 1, 2024
Claim Denied Form
CDC lab division restructure bolsters quality, technical roles
By LabPulse.com staff writers
The U.S. Centers for Disease Control and Prevention's (CDC) Office of Laboratory Science and Safety has been retitled, plus other updates were announced.
September 23, 2024
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Humana, UnitedHealthcare change Z-code requirements for molecular diagnostic test claims
By LabPulse.com staff writers
Among the tests in focus are certain RNA- and DNA-based tests.
September 19, 2024
Blood Test Samples Lab Social
Multiregional clinical trial data on FDA watch for U.S. applicability
By LabPulse.com staff writers
Pivotal trials drawing on foreign clinical data in focus.
September 16, 2024
Fda Sign Dc Social
FDA clears marketing T2 Biosystems Candida test for pediatrics
By LabPulse.com staff writers
T2Candida Panel may get a boost.
September 16, 2024
Candida Candidiasis Social
Hospital labs targeted in proposed Calif. hospital licensing regulations
By Liz Carey
Proposed changes could require some hospitals to materially alter their current operations, according to advisers.
September 11, 2024
Regulation Wheel Social
ADLM releases guidance for blood lipid assessment, lipoprotein testing
By LabPulse.com staff writers
Document outlines recommendations for standardizing clinical lipid testing workflows.
September 4, 2024
Blood Test Samples Lab Social
Upcoming lung cancer molecular testing guidelines address 7 questions
By Liz Carey
Revised guideline addresses next-generation sequencing and expanded biomarker testing.
August 28, 2024
Lung Cancer Hotspot Social
FDA approves Illumina IVD kit as CDx
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Illumina's TruSight Oncology Comprehensive cancer biomarker IVD kit for use as a companion diagnostic to match patients to two targeted therapies, Bayer's Vitrakvi and Lilly's Retevmo.
August 27, 2024
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Missing your CLIA certificate?
By LabPulse.com staff writers
CMS might not have sent you a paper document.
August 27, 2024
Cms Clia Application Snippet82724
FDA issues draft guidance for PCCPs for medical devices
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a draft guidance document for its proposed policies for predetermined change control plans (PCCPs) for medical devices.
August 23, 2024
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BioMérieux receives 510(k) certification for antimicrobial testing system
By LabPulse.com staff writers
BioMérieux has received 510(k) clearance from the U.S. Food and Drug Administration for its Vitek Reveal AST system, which reports antimicrobial susceptibility testing (AST) results directly from positive blood cultures.
August 21, 2024
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