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Violating EKRA Earns Lab Owner an Eight-Year Prison Sentence
By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue
THIS MAY BE THE MOST HIGH-PROFILE CASE involving a clinical laboratory and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Former Arrayit Corporation president Mark Schena was sentenced in October 2023 to eight years in federal prison and ordered to pay $24 million in resti…
Whole Genome Sequencing for Newborns Gains Favor
By Robert Michel | From the Volume XXX, Number 16 – November 13, 2023 Issue
CEO SUMMARY: Evidence is swiftly accumulating that use of rapid Whole Genome Sequencing (rWGS) for certain children in NICUs can enable diagnostic insights that guide effective interventions. Further, these pilot rWGS programs in childrens’ hospitals are showing a solid return on invest…
Hospitals, Pharmacies Struggle to Be Profitable
By Robert Michel | From the Volume XXX, Number 15 – October 23, 2023 Issue
CEO SUMMARY: Pharmaceutical companies may be posting strong growth in revenue and profits. But that’s not true for the nation’s largest retail pharmacy chains. Rite Aid’s Chapter 11 bankruptcy filing earlier this month put a spotlight on financial stress at all the retail pharmacy c…
Lab News Briefs: Joint Commission, Bon Secours, Anthem, Walmart
By Scott Wallask | From the Volume XXX, No. 13 – September 11, 2023 Issue
Joint Commission Looks at Cyberattacks The Joint Commission issued a Sentinel Event Alert for hospitals to address cyberattacks. The alert pr…
Provider Price Transparency Trend Has New Twist
By R. Lewis Dark | From the Volume XXX, No. 12 – August 21, 2023 Issue
IT’S NOT JUST PATIENTS WHO ARE TYPICALLY UNABLE TO SEE PRICES FOR THEIR MEDICAL CARE IN ADVANCE OF SERVICE. Guess who else is unhappy that they cannot access the prices charged by hospitals, physicians, and other pro…
Digital Pathology Sales Put Gestalt on Inc. 5000’s Fast Growth List
By Scott Wallask | From the Volume XXX, No. 12 – August 21, 2023 Issue
Digital pathology workflow provider Gestalt Diagnostics earned a place on the Inc. 5000 2023 list of the fastest growing p…
Expect More Z-code Requirements for Genetic Tests
By R. Lewis Dark | From the Volume XXX, No. 9 – June 19, 2023 Issue
GENETIC TESTING COMPANIES ARE STILL REACTING TO LAST MONTH’S NEWS that one of the nation’s largest health insurers—UnitedHealthcare (UHC)—will require Z-codes for molecular test claims submitte…
February 13, 2023, Intelligence: Late-Breaking Lab News
By Scott Wallask | From the Volume XXX No. 3 – February 13, 2023 Issue
Laboratory leaders should prepare now for the end of the federal public health emergency (PHE) for SARS-CoV-2. The White House announced the PHE would cease on May 11. One big change is that patients covered by Medicare, Medicaid, or private insurance may pay higher costs for COVID-19 t…
Eight Macro Trends for Clinical Labs in 2023
By Robert Michel | From the Volume XXX, No. 1 – January 3, 2023 Issue
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
Labs Face Powerful and Unwelcome Forces
By R. Lewis Dark | From the Volume XXIX, No. 11 – August 8, 2022 Issue
OVER THE PAST 25 YEARS, THERE HAS BEEN WIDESPREAD RECOGNITION THAT HEALTHCARE IN THE UNITED STATES is on an unsustainable path. The obvious argument was that year-over-year increases in healthcare costs would eventually overcome the ability of employers (private health plans) and the government (Medi…
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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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