TAG:

lab risk & compliance

New OIG Advisory Opinion Dubious of ‘Fair Market’

CEO SUMMARY: There is a new advisory opinion from the Office of the Inspector General (OIG). It reviewed a proposal in which a clinical lab network would pay fair market value to hospitals for specimen collection based on volume of patients tested. The OIG said this arrangement woul…

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OIG: 25% of Medicare Inpatients ‘Harmed in Hospitals’ Pre-COVID

CEO SUMMARY: This year’s report to Congress on patient harm in hospitals—prepared by the Office of the Inspector General (OIG)—determined that one in four Medicare beneficiaries suffered harm while an inpatient in a hospital. The report garnered little attention outside the he…

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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. …

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Labs Can Expect COVID-19 Test Audits, Investigations

  CEO SUMMARY: Billions of federal …

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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 …

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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…

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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…

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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…

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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…

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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. …

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