Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

September 4, 2020

NIPT Lab Company Pays $49 Million to Settle False Billing and Kickback Charges Case: A month after going public, Progenity agreed to shell out $49 million to settle claims of overbilling and … [Read more...]

Enforcement Trends

Granston Memo Whistleblower Dismissals May Be Tougher than DOJ Thought

September 3, 2020

In 2018, the Justice Department sent an internal memorandum ordering US Attorneys to aggressively seek to dismiss False Claims Act (FCA) whistleblower qui tam lawsuits that lack merit or don’t serve … [Read more...]

Labs In Court

Connecticut Methadone Clinic Settles Urine Drug Test False Billing Charges for $345.3K

August 29, 2020

Case: A methadone clinic settled claims of overbilling the Connecticut Medicaid Program for urine drug tests for $354,367. Under state rules, methadone clinics receive a bundled weekly per patient … [Read more...]

Enforcement Trends

Granston Memo Whistleblower Dismissals May Be Tougher than DOJ Thought

August 29, 2020

In 2018, the Justice Department sent an internal memorandum ordering US Attorneys to aggressively seek to dismiss False Claims Act (FCA) whistleblower qui tam lawsuits that lack merit or don’t serve … [Read more...]

Beyond COVID-19

The 6 Hottest Lab Compliance Stories That Almost Nobody Is Paying Attention To

July 20, 2020

If not burnout, you may be suffering from a case of COVID-19 fatigue right now. And you’re not alone. The monster virus has seemingly consumed everything in its path over the past six months, … [Read more...]

FDA Watch

First Warning Letters Issued for Improper Marketing of SARS-CoV-2 Antibody Tests

July 14, 2020

No more Mr. Nice Guy. For the first time, the FDA has exercised its enforcement powers to crack down on makers of unproven serologic SARS-CoV-2 antibody tests. A 180⁰ Pivot When the public … [Read more...]

Case of the Month

Feds Launch First COVID-19 Testing Fraud Prosecution

July 3, 2020

Stop me if you’ve heard this one before. The DOJ has charged a publicly traded Silicon Valley med tech firm and its CEO with touting a sham finger stick blood test to defraud payors and rip off … [Read more...]

FDA Watch

First Enforcement Action for Improper Marketing of SARS-CoV-2 Antibody Tests

June 25, 2020

After initially allowing producers of serologic SARS-CoV-2 antibodies tests free access to the market, the US Food and Drug Administration (FDA) is now cracking down on unproven and inaccurate … [Read more...]

Labs In Court

Florida Lab, Execs Settle False Billing of Urine Drug Test Charges for $41 Million

June 19, 2020

Case: Prosecutors accused a Tampa reference lab, pain clinic and two former executives of billing Medicare, Medicaid and TRICARE for medically unnecessary presumptive and definitive Urine Drug Testing … [Read more...]

Feds Charge Silicon Valley Med Tech Executive with Massive COVID-19 Stockholder Swindle

June 17, 2020

The executive of a publicly traded Silicon Valley medical tech firm has been charged with swindling investors and insurers by misrepresenting the diagnostic capabilities of a test using finger stick … [Read more...]


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