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

Kentucky Lab Pays $125K to Settle Self-Disclosed SVT False Billing Charges Case: VerraLab JA, LLC, has agreed to pay $125,983 after self-disclosing that it billed Medicare for specimen validity … [Read more...]

ENFORCEMENT

From Blood Screen to Silver Screen: The Theranos Story Goes Hollywood

Clinical labs are not usually the stuff of Hollywood. But the story of Theranos and its charismatic leader has attracted filmmakers the way regular law-abiding labs never do, spawning not one but a … [Read more...]

NEWS

Health Reform: The Latest Twist in the Legal War on Obamacare

The Affordable Care Act, aka Obamacare, remains alive but certainly not well. When last we left the melodrama, a federal district court in Texas had ruled in favor of Republican Governors challenging … [Read more...]

COMPLIANCE

Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]

FOCUS ON

Genomic Data Sharing: From Utopian Principle to Practical Reality

"Publicly available data should be treated as open data, a shared resource with unrestricted use for analysis, interpretation, and publication." --The journal Science report on genomic data … [Read more...]

PAYER CONTRACTS

Three key items to negotiate for successful payer contracts

By Steve Selbst  bio The purpose of this article is to help you, as a provider, to focus on three key items to look for in payer contracts that will help you to get profitable contracts in … [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...]

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...]

ANTI-KICKBACK

CMS Says Big Changes Are in Store for Stark Law by End of Year

The Stark Law is like the weather: Everybody talks about it but nobody does anything about it. But that all may be about to change if CMS Administrator Seema Verma is to be believed. During her recent … [Read more...]


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