The Dark Report Archives

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

Anatomic Pathology / Robert Michel

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

Laboratory Compliance / Robert Michel

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

Late Breaking Lab News / Robert Michel

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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Using AI to Predict Outcomes in FDA LDT Lawsuits

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

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

Laboratory Compliance / Robert Michel

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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Multi-year Prison Sentence for Genetic Test Fraud

Laboratory Compliance / Robert Michel

CEO SUMMARY: In recent years, federal prosecutors are filing ever greater numbers of civil actions and criminal indictments against individuals accused of healthcare fraud and abuse. This includes prosecutions of doctors alleged to have received illegal kickbacks from lab companies in exchange for referring medically unnecessary tests. Last month, one lab fraudster received a 15-year

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Pathology Compensation in Different Settings, including Hospitals

Pathology Trends / Robert Michel

CEO SUMMARY: This second installment on the series about boosting pathologist compensation uses data collected during a survey of 1,400 pathologists in 230 pathology practices by the Panel of National Pathology Leaders (PNPL). Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with

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Review of Genetic Testing Companies During 2024

Genetic Testing / Robert Michel

CEO SUMMARY: Investors in genetic testing companies are taking it on the chin these days. During 2024, a number of the nation’s largest firms providing genetic test services reported significant losses. Other genetic testing companies are dealing with class action lawsuits claiming that internet tracking on their websites violates certain state and federal laws. Added

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January 6, 2025, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

In response to the 2021 federal law requiring all medical test results to be released to a patient’s electronic medical record upon availability, a team of researchers at Michigan Medicine recently conducted a study to learn whether patients could understand the standard pathology reports given to their physicians. The study involved 2,238 males between the

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