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January 2025

OIG Issues New Report on Medicare 2023 Lab Spending

WITHIN THE LATEST REPORT ON MEDICARE PART A CLINICAL LABORATORY SPENDING during 2023 is information about the financial impact that price cuts to the Clinical Laboratory Fee Schedule (CLFS) have had on clinical laboratories. As mandated by the Protecting Access to Medicare Act of 2014 (PAMA), the report is prepared annually by the Office of […]

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Labs: Why it Pays to Know Your Customers

WOULD IT SURPRISE YOU TO LEARN THAT THERE ARE DOCTORS WHO ARE SERIAL WHISTLEBLOWERS? Given the ongoing amount of fraud in healthcare—particularly involving genetic and clinical laboratory tests—there is opportunity for physicians in private practice to recognize arrangements that involve illegal inducements and the ordering of medically unnecessary procedures. This realization came about as the

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OIG Issues New Report on Medicare 2023 Lab Spend

CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such as compliance with the FDA’s LDT rule—are getting more attention at

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HHS Revises HIPAA Privacy, Security Rule

CEO SUMMARY: Officials at the Department of Health and Human Services (HHS) are proposing significant changes in what observers are calling a major revision to HIPAA’s requirements for protected health information (PHI) and cybersecurity. HHS issued a statement that the objective of these changes was to ease provider compliance and update cybersecurity in response to

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Negotiating Path Contracts with Hospitals, Third Parties

PART THREE OF A SERIES TO HELP ANATOMIC PATHOLOGY GROUPS THRIVE AND PROSPER during these challenging times, The Dark Report presents this third installment in a series that identifies clinical, operational, and financial strategies pathology groups can use to grow case referrals, boost revenue, and increase pathologists’ compensation. Any pathology practice can enjoy this  trifecta

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Federal Lawsuit Favors Lab Accused of AKS Violations

CEO SUMMARY: This whistleblower lawsuit initially charged a clinical lab with, among other things, violating the Anti-Kickback Statute and EKRA. After the judge ruled to exclude the AKS and EKRA claims, the whistleblower refiled the case and included claims the lab paid commissions for the lab’s employed sales reps and independent contractors that violated the

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January 27, 2025, Intelligence: Late-Breaking Lab News

On Jan. 16, 2025, Paul Mango died at the age of 65. With his passing, the profession of laboratory medicine lost an ally and a friend. In the mid-1990s, while at the Institute for Transfusion Medicine in Pittsburgh, Mango convinced the CEOs of 40 hospitals to collaborate and create the Reference Laboratory Alliance (RLA). It

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Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome

On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final rule. Both chatbots answered that a favorable ruling for

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Using AI to Predict Outcomes in FDA LDT Lawsuits

Given the popular sentiment that artificial intelligence (AI) is now working its way into all sorts of lab analyzers, automation, and information systems, no one should be surprised that an astute pathologist would find it interesting to use artificial intelligence (AI) to analyze the legal briefs in the two ongoing federal court cases challenging the

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Pathologist Asks ChatGPT to Predict LDT Trial Outcome

CEO SUMMARY: On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final rule. Both chatbots answered that a favorable

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Pathologist Asks ChatGPT to Predict LDT Trial Outcome Read More »

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