Case of the Month

Feds Launch First COVID-19 Testing Fraud Prosecution

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

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

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

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...]

Labs In Court

Colorado MDs Pay $55K for Taking Specimen Processing Fee Kickbacks from HDL and Singulex

Case: Two physicians and their family medical practice have agreed to fork over $54,982 to the OIG to settle claims of soliciting and accepting illegal remuneration from lab companies Health … [Read more...]


HHS Puts Information Blocking and EHI Operability on Hold Due to COVID-19 Crisis

On March 9, 2020, the HHS Office of the National Coordinator for Health Information Technology (ONC) and CMS issued but didn’t publish final rules designed to improve patient access to their own … [Read more...]

Medicare Reimbursement

New CMS Waivers Dramatically Expand Coverage Rules for COVID-19 Testing

CMS doesn’t want the usual compliance red tape to stand in the way of desperately needed COVID-19 testing. So, on May 1, the agency issued regulatory waivers temporarily expanding coverage of testing … [Read more...]

Labs In Court

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

Texas Lab Loses $30.6 Million Whistleblower Suit over False Billing of Technician Travel Mileage Case: A case that began as a whistleblower complaint by a competing lab ended with a $30.6 million … [Read more...]

CMS Increases 2020 Maximum Civil Monetary Penalties

Every year, HHS adjusts for inflation the maximum civil monetary penalty (CMP) amounts that a lab or other provider can be fined. In 2020, CMP maximums will increase by 2.522%. The new higher CMP … [Read more...]

Enforcement Trends: OCR Continues to Crack Down on HIPAA Right of Access Violations

On Sept. 9, 2019, the Office for Civil Rights (OCR), the HHS agency in charge of federal HIPAA enforcement, did something it had never done before by entering into a monetary settlement with a … [Read more...]