Case of Month: Judge Takes Back Ruling that Labs Must Independently Verify Medical Necessity

Thanks for clearing that up. As if the lab industry doesn't already have enough legal agita to deal with, last June a federal D.C. District Court upheld a whistleblower's right to sue Boston Heart … [Read more...]


EHR: Private Whistleblowers Getting in on “Meaningful Use” Crackdown

Wrongful payment of electronic health records (EHR) "meaningful use" incentives has become a growth area in federal health care fraud enforcement. And now private whistleblowers are getting … [Read more...]


FDA Watch: Labs Warned that Biotin Interferes with Test Accuracy

In late November, the FDA issued a safety communication warning that the supplement biotin (Vitamin B7) may interfere with lab testing results. Biotin Concerns… Over-the-counter (OTC) use … [Read more...]


Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Standing Orders Not Enough to Justify Urine Specimen Validity Testing Case: A Vermont lab has agreed to pay $815K to settle false claims charges. Over a five-year period, the lab routinely billed … [Read more...]


Lab Industry Report: The Year in Diagnostics Mergers & Acquisitions

Continuing recent trends, most of the wheeling and dealing that took place in the lab industry in 2017 involved strategic alliances rather than mergers and acquisitions. Thus alliances outpaced … [Read more...]


PAMA-geddon: Lab Industry Goes to Court to Stop 2018 Medicare Fee Schedule

With CMS refusing to back down, the lab industry has escalated the dispute and asked a U.S. District Court to step in and prevent enforcement of the 2018 PAMA-inspired Part B Clinical Lab Fee Schedule … [Read more...]


LDTs: Top 10 New FDA Diagnostic Approvals of 2017

While the FDA remains glacial in its tempo, jealous of its authority and suspicious of the industry, it is also, ever so slowly, changing its ways. While the new administration's dedication to cutting … [Read more...]


CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look

"May you live in interesting times." If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very … [Read more...]


Labs Figure Prominently in OIG’s Newest Top 10 Challenges List

Although the OIG has its flaws, lack of transparency is not among them. Exhibit A: the agency's ongoing list of top 10 management and performance challenges facing the Department of Health and Human … [Read more...]


New Lawsuit Tests Limits of Medical Malpractice in Age of Precision Medicine

Is a health care provider's failure to refer a cancer patient for genetic counseling grounds for medical malpractice? One patient claims it is and wants $1.8 million in damages because she never … [Read more...]