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...]
ENFORCEMENT
Federal Enforcers Crack Down on Fraudulent Billing of Genetic Tests
January 12, 2022
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...]
ENFORCEMENT
Omicron Forces FDA to Temporarily Shut Down Inspections
January 12, 2022
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
December 23, 2021
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...]
COMPLIANCE BRIEFING
The Year in Lab Compliance: The Biggest Stories of 2021
December 21, 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
December 21, 2021
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...]
ENFORCEMENT NEWS
CMS Set to Crack Down on Hospitals Over Price Transparency
December 20, 2021
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
December 16, 2021
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
November 24, 2021
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
October 18, 2021
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...]
