Labs in Court

Did Cigna Wait Too Long to Sue Reference Labs for Fraudulent Billing?

Case: Health service company Cigna sued five labs for fraudulent billing of tests that were farmed out to reference labs. The federal court dismissed some of the claims as being barred by the statute … [Read more...]


Congress Acts to Delay 2022 PAMA Price Cuts at the Eleventh Hour

Dec. 2 was a disappointing day for the lab industry when Congress passed a stopgap spending bill without a provision that would have delayed the upcoming 2022 PAMA price cuts. After dodging a bullet … [Read more...]


Blue Cross Blue Shield Sues National Lab for COVID-19 Test Price Gouging

The clash between labs and private insurers over reimbursement for COVID-19 testing is getting louder and uglier by the moment. Labs have accused insurers of evading the Families First Coronavirus … [Read more...]

PAMA Reporting Alert

New Rules for CDLTs that Aren’t ADLTs Take Effect Jan. 1

Be aware of the new reporting requirements that apply for the next PAMA data reporting period starting in January 2022. Explanation: Section 3718 of the Coronavirus Aid, Relief and Economic Security … [Read more...]

Personalized Medicine

23andMe Moves into Telehealth via $400 Million Lemonaid Acquisition

It’s been a busy year for 23andMe. Consumer DNA testing giant 23andMe. Less than five months after going public, the consumer genetic testing giant has made a major move to establish its position as a … [Read more...]

Testing Trends

Tapping AI and Deep Learning to Personalize Breast Cancer Screening for Women

A new study suggests that use of an artificial intelligence (AI) algorithm may provide the key to creating personalized breast cancer screening protocols for women based on the results of their … [Read more...]


OCR Continues HIPAA Right of Access Crackdown, but at a Much Slower Pace

Twenty different providers have been hit with fines since the Department of Health and Human Services’ Office for Civil Rights (OCR) launched its HIPAA Right of Access Initiative in April 2019. … [Read more...]


FDA Hikes Premarket Application User Fees by 2.5 Percent

Applying for FDA premarket review of medical devices will be more expensive next year. On August 2, the agency announced that it’s raising premarket approval (PMA) user fees by 2.5 percent in FY … [Read more...]


Biden Pulls Plug on Automatic Medicare Coverage for MCIT “Breakthrough” Devices

In a reminder of why politics and presidential elections matter so much, the Biden administration announced that it’s scrapping a Trump regulation that would have automatically provided initial … [Read more...]


White House requires all private-sector employers with 100 or more employees to mandate vaccination or a weekly negative COVID-19 test

By Mike O'Brien President Biden spoke from the White House Sept. 9 to announce his new Path Out of the Pandemic Plan. Among other things, President Biden has instructed the Occupational Safety and … [Read more...]