TAG:
pathology groups
Managing Labs in Two Dimensions in 2021
EXPECT 2021 TO BE JUST AS CHALLENGING A YEAR for lab management as was 2020. This will be true not only because of the SARS-CoV-2 pandemic. Other important factors will complicate the operation of clinical laboratories and anatomic pathology groups in the new year….
2020’s Top 10 Lab Stories Are Without Precedent!
CEO SUMMARY: There are several surprises in The Dark Report’s list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social…
THE DARK REPORT’s Ranking of 2019’s Top 10 IVD Companies
One trend continues to reshape the in vitro diagnostics (IVD) industry year after year: acquisitions. Since the 1990s, the biggest IVD companies have frequently used acquisitions to boost their revenue and keep shareholders happy. But acquisition…
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. …
New Twist: HHS Exerts Authority Over FDA on LDTs
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…
Medicare COVID Test Coding May Become a ‘Logistical Nightmare’
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…
Medicare Pays 500% More for Molecular Test Claims
CEO SUMMARY: Rapid growth in what Medicare spent for molecular tests in recent years may lead federal investigators to increase scrutiny of fraudulent billing for clinical laboratory and molecular pathology tests, according to a lab consultant who has tracked such spending in recent y…
UnitedHealth Sets More Billing Rules for Labs, Pathologists
SUBMITTING CLINICAL LABORATORY AND PATHOLOGY TEST CLAIMS to UnitedHealthcare (UHC) will be more complex after the nation’s largest health insurer announced three significant changes in its claims processing procedures. The three changes involve: • Requests for refunds from anatomic pa…
Understanding COVID-19’s Changes to Lab Industry
CEO SUMMARY: With the SARS-CoV-2 pandemic about to enter its eighth month in the United States, it remains difficult to predict whether the pandemic will strengthen with the fall influenza season or steadily diminish. What is clear to most pathologists and clinical laboratory executiv…
Wisconsin Lab Network Feeds Valuable Data to State Health Lab
CEO SUMMARY: From the earliest days of the COVID-19 pandemic, the 138-member Wisconsin Clinical Laboratory Network has reported to the state health lab the number of COVID-19 tests, the number of positive results, as well as other data that includes data on lab testing supplies and ca…
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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