Volume XXIX, No. 5 - April 4, 2022 Archives

Decline in COVID-19 Test Orders Signals a Shift

Commentary and Opinion by R. Lewis Dark / By Robert Michel

MIGHT THE FEDERAL HEALTHCARE ESTABLISHMENT BE CLOSE TO DECLARING AN END TO THE SARS-COV2 PANDEMIC and—given the ongoing decline in the daily number of new cases and deaths—that COVID-19 is expected to become an endemic disease? The SARS-CoV-2 statistics posted daily by the federal Centers for Disease Control and Prevention (CDC) show that, as of …

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California Agency Problems Deepened Valencia Branch Laboratory Saga

Laboratory Compliance / By Robert Michel

CEO SUMMARY: Adding a new twist in the ongoing saga of the CLIA compliance failures at the Valencia Branch Laboratory in California are insights from a former clinical laboratory director familiar with the industry in California. He observed that problems at California’s Laboratory Field Services (LFS) office are known to the state legislature, following an …

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PerkinElmer Says California Terminated COVID-19 Contract

ACCORDING TO A NEW SECURITIES FILING FROM PERKINELMER, the State of California served notice of termination of the company’s contract to run the beleaguered Valencia Branch Laboratory (VBL). PerkinElmer, a diagnostics firm based in Waltham, Mass., made the surprising announcement about the early termination on March 31 in a filing to the U.S. Securities and …

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Judge Vacates Provision in No Surprises Act

Laboratory Compliance / By Robert Michel

CEO SUMMARY: It did not take long for providers to go to court to challenge the new federal No Surprises Act. A district court judge has vacated a provision in the No Surprises Act that emphasized one criterion during arbitration which put the dispute process in conflict with the wording of the Act. The …

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Federal Healthcare Fraud Enforcement Turns to Emerging Areas

Laboratory Compliance / By Robert Michel

CEO SUMMARY: Healthcare compliance attorneys say the Department of Justice (DOJ) is turning its focus to fraudulent activity related to COVID-19 testing. But that’s not the only area attracting greater scrutiny by the DOJ. Fraud stemming from opioid treatment has snared clinical laboratory companies that ordered medically-unnecessary diagnostic tests. Further, prosecutors have been ordered to …

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Another 10 Doctors Settle Laboratory Kickback Cases, Pay Back $1.68m

Laboratory Billing, Laboratory Compliance / By Robert Michel

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 be interested in this news. Account representatives can take copies of these settlements to prospective customers as …

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COLA Re-enters CLIA Accreditation for Pathology

Laboratory Compliance, Pathology Trends / By Robert Michel

CEO SUMMARY: COLA again has deemed authority by the Centers for Medicare and Medicaid Services to accredit clinical labs and pathology groups for the pathology specialty. The organization’s CEO says the move will help meet current and future lab customer needs. It’s a reversal from 12 years earlier when COLA bowed out of pathology accreditation …

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April 4, 2022, Intelligence: Late-Breaking Lab News

Late Breaking Lab News, People / By Robert Michel

On March 22, the U.S. Health Resources and Services Administration (HRSA) announced that its COVID-19 Uninsured Program had stopped accepting claims for related laboratory testing due to lack of sufficient funds. This development potentially affects 8.6% of the nation’s population which doesn’t have medical insurance, according to the U.S. Census Bureau. Clinical labs may face …

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