TAG:
clinical laboratory industry
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…
One Genetic Test CPT Code Earns ‘Fraudomatic’ Title
CEO SUMMARY: Several genetic testing companies have noticed that some of the nation’s Medicare Administrative Contractors (MAC) pay about $2,000 for test claims billed with CPT code 81408. From 2018 through and 2019, the number of 81408 claims rose dramatically at just two of thes…
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 g…
Palmetto GBA Tells Consultant to Take Down Test Price Data
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…
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…
$481 Mil Federal COVID Contract Awarded to Young IVD Company
IN THEIR FIGHT AGAINST THE PANDEMIC, federal officials are boosting the fortunes of some little-known or emerging in vitro diagnostics (IVD) companies. One example is the recent award of a $481 million COVID-19 test contract to Cue Health Inc., of San Diego. Earlie…
Labs, AP Groups Confused about UnitedHealthcare’s Test Registry
CONFUSION CONTINUES among clinical laboratories and anatomic pathology groups about how they should comply with UnitedHealthcare’s new Laboratory Test Registry Program. The program goes into effect on Jan. 1, 2021, but labs and pathology groups must register all tests and testing procedure…
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…
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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