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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Articles and Reports
ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
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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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CMS Divides PT Sanctions Into 3 Categories, Limits Reach of Ban
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Stakeholder Group Calls for Reform of CLIA Waiver Process
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LDT Guidance Unlikely to Be Released Anytime Soon
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FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development
In its July 31 notice to Congress, the agency says it would phase in oversight requirements over nine years.
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Lab Execs Air Concerns Over FDA Regulation of LDTs
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Labs Urged to Coordinate With CDC on Ebola Testing
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Lab Sector Goes to Big Legal Guns in Grapple With FDA Over Test Regulation
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CMS Releases New CLIA-Waived Tests, Billing Codes
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ACLA Issues White Paper Arguing Against FDA Regulation of LDT
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