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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Lab Compliance Advisor
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
FDA Watch: Agency Restructures Submission Protocols for Several ISH Tests
The FDA is reclassifying product codes NYQ, MVD, OWE, and PNK so they can be approved using the 510(k) submission process
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What New Prior Authorization Metrics Mean for Clinical Labs
KFF looks into payer claims denials, which continue to be scrutinized
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FDA Watch: Truvian Health Obtains 10 Additional FDA Clearances for TruVerus Platform
TruVerus is designed to perform a slew of clinical laboratory tests on as few as eight drops of blood
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CMS Ends Paper CLIA Certificates and Coupons Effective March 1
Laboratories must register for email-only communications and submit all CLIA fees electronically
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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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PAMA Delay Proposed Until 2027 Under a New Federal Spending Bill
However, attorney Danielle Sloane urges labs to be proactive about potential PAMA reporting requirements on Jan. 31 if the bill doesn’t pass quickly
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FDA Watch: Truvian Health Receives Initial FDA Clearance for 34-Test Platform
San Diego-based healthcare diagnostics company is trying to succeed where Theranos failed
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ACLA Head Pushes RESULTS Act Passage During House Subcommittee Testimony
Better clinical laboratory test data reporting would allow ‘Medicare rates to be more appropriately set,’ says Susan Van Meter
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FDA Watch: Agency Takes Steps to Downgrade Some Nucleic Acid-Based Tests to Class II
The change is expected to dramatically cut the costs of developing new tests
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Genetic Testing Kickback Scheme Results in 46-Month Prison Term
Federal prosecutors continue to target situations where third-party recruiters influence test ordering
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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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Prospective Changes to HIPAA Rules Would Affect Clinical Labs
With new modifications to HIPAA potentially on the horizon, we hear from experts on HHS’ proposal
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