Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Volume XXVII, Number 16 - November 16, 2020

Pooled COVID Testing a Success for New York Hospital Lab

Clinical Laboratory / By Robert Michel

This is an excerpt of a 1,552-word article in the November 16, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled COVID testing helps the clinical lab staff at the hospital in Saratoga Springs, N.Y., do more COVID-19 tests when supplies might …

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COVID-19 or Not, Lab Market Enters ‘Twilight Zone’

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

Our healthcare system is in a most remarkable state. Even as all providers—including clinical laboratories and anatomic pathology groups—continue to devote considerable resources to meeting the urgent need for SARS-CoV-2 testing, health insurers and regulators continue to issue new requirements governing all aspects of “normal” lab testing activities. Today, all clinical labs and pathology groups …

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California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?

Clinical Laboratory / By Robert Michel

CEO SUMMARY: California dropped a bomb on the state’s existing network of hospital labs and independent clinical labs when, on Oct. 30, it announced it had built and opened a new laboratory facility in Valencia designed to perform 150,000 COVID-19 tests per day. Now, existing labs in the Golden State must compete against their state …

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UnitedHealthcare Delays Its New Test Registry Protocol Until April 1

Laboratory Billing / By Robert Michel

CLINICAL LABORATORIES AND ANATOMIC PATHOLOGY GROUPS working to register their tests with UnitedHealthcare’s (UHC) new Laboratory Test Registry Protocol just got a 90-day reprieve. UHC has delayed the start date to April 1, 2021. “There is no truth to the rumor that UHC has ended the program before it began,” said Leigh Polk, Director of …

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NY Hospital Lab Succeeds with Pooled COVID-19 Testing

Clinical Laboratory / By Robert Michel

CEO SUMMARY: Pooled testing helps the clinical lab staff at the hospital in Saratoga Springs, N.Y., do more COVID-19 tests when supplies might otherwise run short. Lab managers estimate this method has saved 5,000 test cartridges since May. Pooled testing also helps the physician staff in the emergency department identify patients who may be positive …

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Palmetto GBA Tells Consultant to Take Down Test Price Data

Clinical Laboratory / By Robert Michel

CEO SUMMARY: Lawyers for Medicare contractor Palmetto GBA sent a cease and desist letter in September to a respected lab consultant, telling him to delete from his health policy blog a document containing Medicare genetic test price and coding data. In the letter, Quinn was directed to delete the information from his own professional files …

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New Twist: HHS Exerts Authority Over FDA on LDTs

Laboratory Compliance / By Robert Michel

CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through guidance documents as it previously did, the HHS legal opinion …

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IVD Firms Report Robust Growth In Third Quarter Financial Reports

In Vitro Diagnostics / By Robert Michel

FOR THE BIGGER IN VITRO (IVD) COMPANIES, the third quarter (Q3) ending Sept. 30 was a time when diagnostic sales rose—molecular testing is skyrocketing, actually—while other corporate divisions continued to lag amid the COVID-19 pandemic. Here are recaps of Q3 earnings reports and investor calls from leading companies serving clinical laboratories with instrument platforms, diagnostic …

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Medicare COVID Test Coding May Become a ‘Logistical Nightmare’

Clinical Laboratory Trends, Laboratory Billing, Laboratory Compliance / By Robert Michel

STARTING JAN. 1, 2021, clinical laboratories performing COVID-19 tests using high-throughput systems for Medicare patients must comply with a complex new coding rule when submitting claims for these tests. The federal Centers for Medicare and Medicaid Services (CMS) will pay $100 for COVID-19 test claims if labs can document that the tests were completed within …

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CLIA Lab Inspections Different Because of COVID-19 Pandemic

Laboratory Compliance / By Robert Michel

WITH THE ONSET OF THE COVID-19 PANDEMIC IN MARCH, three of the major organizations deemed to have CLIA status suspended inspections of clinical laboratories for several months. Inspections and assessments of laboratories have restarted, but with significant changes because of the SARS-CoV-2 outbreak. These changes to the CLIA lab assessment and accreditation process were the …

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