Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
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LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
CLIA: CMS Proposes 20% Fee Increase—and Further Increases Could Follow
From - National Intelligence Report
As if Year 2 of PAMA lab fees wasn't enough, CMS dished out another dose of agita to the lab industry: CLIA fees will…
CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look
From - National Intelligence Report
If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very…
Medicare Reimbursement: CMS Finalizes Controversial PAMA Fee Schedule
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FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval
From - National Intelligence Report
The FDA's longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to…
FDA Watch: Agency Moves to Boost CLIA Waiver Transparency
From - National Intelligence Report
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it…
Theranos Settles with CMS and Arizona Attorney General
From - National Intelligence Report
After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to…
Labs Stop VA from Allowing APRNs to Perform Lab Tests
From - National Intelligence Report
The laboratory sector has successfully fought a Department of Veterans Affairs (VA) rule that would have allowed advance practice registered nurses (APRNs) to "perform and supervise" lab testing. Numerous organizations, including…
CMS Grants International CLIA Certificate to ImmunID for Laboratory in France
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CLIA Certificate Granted for Laboratory in France
From - National Intelligence Report
As recently reported in Laboratory Industry Report (see "Inside the Laboratory Industry," Laboratory Industry Report, p. 4, 3/17/16), the diagnostics industry is going…