LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Quick COVID Breathalyzer Could Allow Mass Screening
According to...
Three Key Changes Your Lab Staff Need to Know About
CMS recently announced some important changes affecting PAMA price reporting, along with a list of 17 new PLA codes that will be recognized.
LabX Media Group Acquires G2 Intelligence
For those who...
Agency Continues Crack Down on Unauthorized COVID-19 Tests
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.
Opening a Safety Can of Worms
By Dan Scungio...
Florida Treatment Center Settles HIPAA Right of Access Enforcement Action for $160,000
Recent case shows that you better respond promptly when patients request access to their medical records.
FY 2021 OIG Enforcement Outcomes Continue Long-Term Downward Trend
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CMS Recognizes 3 New CLIA-Waived (CW) Tests
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