CMS Proposes to Modernize CLIA in Broad Rule
What clinical labs need to know about virtual access, director qualifications, and more
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Software as a Medical Service, or SaMS, Takes Spotlight in New CMS Proposal
Clinical labs have until Aug. 31 to submit public comments about the anticipated changes
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New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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How to Stay Ahead of Anticipated CLIA Deficiencies
Consultant Nora Hess offers suggestions for clinical labs to navigate these problems
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Four Federal Efforts to Monitor, Including RESULTS Act Progress
Other proposals aim to increase fraud enforcement, temper prior authorization, and modernize CLIA
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FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously
FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
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RCM Strategies to Explore for Genetic Testing Compliance
Expert Ashley Zarling details nuances for clinical lab directors and compliance teams
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Up Next for Labs: PAMA Reporting Window Opens May 1
Cuts to reimbursement rates under PAMA have been pushed back again by Congress, this time to January 2027
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Attention Lab Directors: Four CLIA Updates from the Past Year to Examine
CMS tweaked its CE, documentation, and on-site visit requirements for directors
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Clinical Lab Training Documentation Becomes More Important with CMS Revision
Third-party verification of lab personnel experience is now a CLIA requirement
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PAMA Cuts Loom and New Lab Reporting Deadline Nears, Both on January 1
However, a proposed bill called the RESULTS Act is racing to thwart the cuts to lab test reimbursement rates
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CMS Clarifies CLIA Personnel Requirements in Rare Memo
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
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A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
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