FDA Watch

Agency Continues Crack Down on Unauthorized COVID-19 Tests

COVID-19 tests from LuSys Laboratories pose a high risk of false results and should not be used. That was the message the US Food and Drug Administration (FDA) delivered to consumers and laboratories … [Read more...]


Federal Enforcers Crack Down on Fraudulent Billing of Genetic Tests

Genetic tests are becoming a favorite target for federal fraud enforcers. So, if your lab bills Medicare, Medicaid, and other federal health care programs for these tests, you need to pay especially … [Read more...]


Omicron Forces FDA to Temporarily Shut Down Inspections

It’s déjà vu all over again. With new COVID-19 cases surpassing record highs, the FDA announced on Jan. 5 that it is once more calling a temporary halt to domestic and foreign inspections. It’s the … [Read more...]

Labs In Court

Recent Cases and Enforcement Actions Involving the Diagnostics Industry

This month's roundup of cases includes fraud, billing and coding, and HIPAA infractions. Holmes Can’t Use Out-of-Court Statements by Theranos Co-Founder Balwani as Evidence Case: Former Theranos … [Read more...]


The Year in Lab Compliance: The Biggest Stories of 2021

The ongoing COVID-19 public health emergency (PHE) has clearly had an impact on compliance. Enforcement funds have been sequestered, federal fraud recoveries are down and temporary waivers of … [Read more...]

Labs in Court

Florida Treatment Center Settles HIPAA Right of Access Enforcement Action for $160,000

Case: On October 1, 2019, the patient of a Florida eating disorder treatment center requested a copy of her medical records. Seven weeks later, she sent a repeat request. Not until May 22, 2020 did … [Read more...]


CMS Set to Crack Down on Hospitals Over Price Transparency

After fighting against them for so long, including in court, hospitals have been reluctant to comply with the new hospital price transparency rules that officially took effect on January 1, 2021. Of … [Read more...]

FY 2021 OIG Enforcement Outcomes Continue Long-Term Downward Trend

The COVID-19 pandemic continues to take a bite out of the volume of OIG enforcement action. All major metrics were down again in FY 2021, albeit at a less dramatic rate than in FY 2020. That’s one of … [Read more...]

Labs in Court

Ex-CEO of NWPL Settles Urine Drug Test Kickback Claims for $1.1 Million

Case: The former CEO of now-defunct Northwest Physicians Laboratories (NWPL) has agreed to shell out $1.1 million to settle charges of accepting millions in illegal payments for referring Medicare and … [Read more...]

Enforcement Trends

Labs Figure Prominently in Latest DOJ Telemedicine, COVID-19 and Sober Homes Fraud Takedown

Telemedicine was a minor but growing blip on the enforcement radar before the public health emergency. But with the dramatic step up in utilization during the COVID-19 pandemic, it was all but … [Read more...]