Industry Buzz

HHS to FDA: Resume EUA Review of COVID-19 LDTs, And Do It Fast

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

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

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

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

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

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...]

Special Report

Final Rules Offer Real Stark and Kickback Relief but Largely Exclude Labs

With its time apparently running out, the Trump administration completed one of its pet projects by finalizing the kickback reform rules it proposed in October 2019. Issued on Nov. 20, the new final … [Read more...]

Labs in Court

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 pair of toxicology labs who then filed a lawsuit to against United under the federal Employee Benefits … [Read more...]

Innovation

New Artificial Intelligence-Based Risk Score May Help Avoid Unnecessary COVID-19 Hospitalizations

Researchers at Massachusetts General Hospital (MGH) have developed a diagnostic tool that uses artificial intelligence to generate a score to assess the prognosis of individual patients diagnosed with … [Read more...]

Emerging Tests

Qiagen Launches Portable COVID-19 Antigen Digital Testing Hub

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...]


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