July 2022

Might LDT Regulation Bill Support Be Waning in Congress?

This is an excerpt of an 833-word article in the July 18, 2022 issue of THE DARK REPORT. The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Just weeks ago, events seemed to indicate that the Verifying Accurate Leading-edge IVCT Development (VALID) Act including an LDT regulation bill was …

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Important Court Rulings & Pending New Federal Law

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

IMPORTANT THINGS ARE HAPPENING WITH COURT DECISIONS AND PROPOSED FEDERAL LEGISLATION that will affect a substantial number of the nation’s clinical laboratories and anatomic pathology groups. In this issue of The Dark Report, you’ll be alerted to those developments we think will have the biggest impact on laboratory compliance and legal risk. The first of …

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Might VALID Act Support Be Waning in Congress?

Lab Intelligence, Laboratory Management / By Robert Michel

CEO SUMMARY: Just weeks ago, events seemed to indicate that the Verifying Accurate Leading-edge IVCT Development (VALID) Act was going to sail through Congress as part of a bill to reauthorize the FDA. However, momentum has shifted, at least in part because pathologists from academic medical centers spoke up in opposition to the VALID Act. …

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New OIG Advisory Opinion Dubious of ‘Fair Market’

Laboratory Compliance / By Robert Michel

CEO SUMMARY: There is a new advisory opinion from the Office of the Inspector General (OIG). It reviewed a proposal in which a clinical lab network would pay fair market value to hospitals for specimen collection based on volume of patients tested. The OIG said this arrangement would violate the federal Anti-Kickback Statute, because hospitals …

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Balwani Guilty! Sentencing Is Next for Theranos Execs

Clinical Laboratory / By Robert Michel

CEO SUMMARY: The trial of former Theranos President and Chief Operating Officer Ramesh “Sunny” Balwani ended with convictions by a jury on 12 counts of wire fraud and conspiracy. Now all eyes are looking ahead to the sentencing of Balwani and Elizabeth Holmes, the founder and former CEO of Theranos, who was found guilty on …

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In Post-COVID-19 Market, IVD Manufacturers Face Supply, Staff Challenges

In Vitro Diagnostics / By Robert Michel

CEO SUMMARY: After making billions during the COVID-19 pandemic, in vitro diagnostics (IVD) manufacturers must now adjust their strategies and relationships with clinical laboratory customers. Because many contracts for automated instruments are coming due, some IVD companies have the opportunity to grab additional market share at the expense of their competitors. IVD firms are also …

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New Percentage-Based Commissions Ruling

Laboratory Compliance / By Robert Michel

CEO SUMMARY: In denying a motion to dismiss certain charges against a clinical laboratory owner, a federal court in California has declared that the Eliminating Kickbacks in Recovery Act (EKRA) of 2018 applies to payments for marketing to physicians and other referral sources. This ruling diverges from a prior EKRA-based decision in a Hawaii court. …

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July 18, 2022 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Given that monkeypox cases continue to rise, the federal government likewise is ramping up its response. In June, the federal Centers for Disease Control and Prevention (CDC) began shipping monkeypox tests to five commercial laboratories: Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare. The government has also been building up its supply …

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