Top Articles

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

In first week of operation, news outlets reported the lab produced inconclusive SARS-CoV-2 results

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...

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Coding/Billing Update UnitedHealthcare Delays Its New Test Registry Protocol Until April 1

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.  ...

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NY Hospital Lab Succeeds with Pooled COVID-19 Testing

171-bed Saratoga Hospital is in eighth month using pooled tests in ER for inpatient admissions

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 st...

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Palmetto GBA Tells Consultant to Take Down Test Price Data

Molecular data and lab-strategy expert used federal records to inform public about potential fraud

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...

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New Twist: HHS Exerts Authority Over FDA on LDTs

In legal memo, Health and Human Services says it is governing agency and intervenes on LDT regulation

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 gui...

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IVD Update IVD Firms Report Robust Growth In Third Quarter Financial Reports

Demand for COVID-19 molecular tests exceeds ability of companies to manufacture enough tests

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. ...

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Compliance Update Medicare COVID Test Coding May Become a ‘Logistical Nightmare’

CMS adds more billing codes to implement new 48-hour payment rule for COVID-19 tests

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 Med...

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Lab Regulatory Update CLIA Lab Inspections Different Because of COVID-19 Pandemic

CAP, COLA, The Joint Commission provide updates during session at last month’s Executive War College

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....

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

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....

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