NEWS

FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform

April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for new devices and diagnostic tests. But last week, the … [Read more...]

ENFORCEMENT

Case of the Month: Milwaukee Clinic the Latest MD-Owned Lab Busted for Urine Drug Test Abuses

Fraudulent utilization and billing of urine drug screening has become a priority for federal enforcers since the $256 million Millennium settlement of 2016. Subsequent cases have targeted abuses … [Read more...]

FALSE CLAIMS

Compliance Perspectives: How to Spot & Avoid Kickback Risks under New EKRA Law

A new law passed to deal with the opioid epidemic has significant ramifications for labs including but not limited to those involved in drug addiction and recovery programs. Specifically, the … [Read more...]

DRUG TESTING

Enforcement Trends: CMS Looks to Recover $66.3 Million in Improper Specimen Validity Test Payments

The opioid crackdown has made urine drug testing an even greater priority for federal health fraud enforcers. One principle target is specimen validity testing (SVT) billed in combination with urine … [Read more...]

FALSE CLAIMS

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

56 Months' Jail for Lab Technician Caught in Texas Toxicology ScamĀ  Case: A former toxicology testing company account rep pled guilty to conspiring with a medical clinic lab technician to steal … [Read more...]

INDUSTRY BUZZ

FDA Watch: Gottlieb Resignation Costs Lab Industry a Valuable Frenemy

Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. Although his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]

DIAGNOSTIC DEALS

Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

Spring has sprung with the announcement of a king-size deal: Danaher's $21.4 billion cash acquisition of GE Life Sciences, known as GE Biopharma, from General Electric Company (GE). Here's a quick … [Read more...]

COURT CASES

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

$1.99 Million Settlement for False Billing of Genetic Tests Case: In a case that began as a whistleblower suit filed by two ex-employees, GenomeDx Biosciences has agreed to shell out $1.99 … [Read more...]

NEWS

Gottlieb Resigns as FDA Chief: Lab Industry Loses a Good Frenemy

Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. But while his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]

WHISTLEBLOWERS

Case of the Month: Facing 3 against 1, Texas Lab Settles EHR Consulting Kickback Charges

Question: What happens when multiple whistleblowers bring separate qui tam lawsuits against a lab for the same offense? Answer: Under the False Claims Act (FCA), only the first whistleblower to … [Read more...]


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