The controversy over FDA Emergency Use Authorization (EUA) of laboratory developed tests (LDTs) for COVID-19 is on high boil once more. A month after the agency announced it would no longer review … [Read more...]
Kickbacks
OIG Issues Fraud Alert on Pharmaceutical Company In-Person Speaker Programs
November 27, 2020
Before the pandemic put the chill on live conference events, it was fairly common for pharmaceutical companies, device makers and diagnostics companies to offer healthcare professionals fees for … [Read more...]
Labs In Court
A roundup of recent cases and enforcement actions involving the diagnostics industry
November 27, 2020
Texas Court Nixes Toxicology Labs’ ERISA Beneficiary Unpaid Claims Lawsuit against United Healthcare Case: After United Healthcare denied their claims, plan members assigned their benefits to a … [Read more...]
Genetic Testing
The Quest Case and Medical Malpractice Liability Risks of Genetic Testing Labs
November 27, 2020
For years, Quest Diagnostics has been embroiled in a poignant lawsuit testing the liability of genetic labs for faulty DNA test results. In 2018, Quest struck a decisive blow by getting the South … [Read more...]
REIMBURSEMENT
Labs and Private Payors Clash Over Reimbursement of COVID-19 Testing
November 27, 2020
Things are getting ugly. The unfortunate convergence of resurgent COVID-19 cases, lingering testing supply bottlenecks and Thanksgiving are once more stretching labs to the breaking point and fraying … [Read more...]
Consumer Fraud
OIG Warns Medicare Beneficiaries Not to Fall for COVID-19 Scams
November 27, 2020
Pharma companies, diagnostics manufacturers, labs and other parts of the healthcare industry have done a commendable job in pivoting in response to the current public health industry. Sadly, it seems … [Read more...]
Emerging Tests
Qiagen Launches Portable COVID-19 Antigen Digital Testing Hub
November 24, 2020
The rapid evolution of COVID-19 testing in response to the need for speed and mobility continues. One notable development on the antigen testing front is Qiagen’s U.S. rollout of a portable digital … [Read more...]
