TAG:
lab risk & compliance
Passage of FDA Regulation of LDTs Inches Closer in the Senate
CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …
Labs Can Expect COVID-19 Test Audits, Investigations
CEO SUMMARY: Billions of federal …
Another 10 Doctors Settle Laboratory Kickback Cases, Pay Back $1.68m
FALLOUT CONTINUES FROM A LARGE LABORATORY KICKBACK INVESTIGATION in Texas, as another 10 physicians and one healthcare executive agreed to settle with the government and pay back $1.68 million. Clinical lab sales teams throughout the United States will …
Questions Remain about California’s Valencia Lab
CEO SUMMARY: Despite multiple investigations citing more than 60 deficiencies, including some that caused immediate jeopardy to patient safety according to state inspectors, the Valencia Branch Laboratory never closed. The California Department of Public health said the state lab no…
Labs Should Be Cautious about ‘Surprising’ EKRA Ruling
CONFUSION ABOUT WHEN IT IS LEGAL UNDER TWO FEDERAL LAWS to pay commissions to sales reps based on volume and/or revenue has existed since the passage of the federal Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Now, a district court judge in Hawaii has surprisingly ruled that payments of perc…
Non-COVID Part B Lab Spend Declined by 15.9% in 2020
MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE CUTS mandated by PAMA continue to bite deeply. A new government report shows that during fiscal 2020, the Medicare program spent 15.9% less for lab tests, when COVID-19 test payments are excluded. The fed…
Expert Lists Strategies to Cope with Cyber Attacks
CEO SUMMARY: Class action lawsuits filed by patients whose protected health information (PHI) was breached during a cyber attack may be one additional unwelcome consequence for clinical laboratories and anatomic pathology groups hit by a ransomware or cyber attack. This is what happ…
Labs, Pathology Groups Face Reduced Revenue
CEO SUMMARY: In recent years, certain clinical laboratories and pathology groups found they can generate more revenue by remaining out of network whenever possible. But when the No Surprises Act goes into effect Jan. 1, labs and pathologists may find advantages in being in network. …
Major CLIA Deficiencies Found at California’s COVID-19 Lab Facility
MIGHT THERE BE DIFFERENT STANDARDS IN HOW government regulators enforce CLIA requirements on privately-owned clinical laboratories compared to a government-owned lab? This question is being asked after the California Department of Public Health (…
CLIA Lab Director Testimony Shows Risks to Pathologists
CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improve…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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