Issue: Volume XXIX, No. 10 - July 18, 2022

Important Court Rulings & Pending New Federal Law 

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?

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’

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

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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July 18, 2022 Intelligence: Late-Breaking Lab News

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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