State Laws

New Legislative Efforts Aim to Keep Payors from Denying Patients’ Access to Genetic Biomarker Testing

Payor use of preauthorization requirements to hold up providers and deny patients medically necessary care has come under fire not only within the Department of Health and Human Services and US … [Read more...]

State Laws

New Legislative Efforts Aim to Keep Payors from Denying Patients’ Access to Genetic Biomarker Testing

Payor use of preauthorization requirements to hold up providers and deny patients medically necessary care has come under fire not only within the Department of Health and Human Services and US … [Read more...]

Enforcement Trends

Labs Figure Prominently in Latest DOJ Telemedicine, COVID-19 and Sober Homes Fraud Takedown

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...]

Labs In Court

Fort Worth Hospital Settles Upcoding Charges for $3.3 Million

Case: A compliance officer morphed into a whistleblower when hospital leaders ignored her warnings about widespread billing and coding abuses. Specifically, she sounded the alarm that the hospital was … [Read more...]

HARASSMENT

Compliance Perspectives: How to Give Your Analog Workplace Harassment Policy a Digital Makeover

One of the only nice things about the pandemic is the relief it’s provided from workplace harassment. After all, employees are far less vulnerable to workplace harassment when they work from … [Read more...]

TECHNOLOGY

Telehealth Utilization Plateaus but Pandemic Surges Are Still a Game Changer

Digital technology has laid the groundwork for the long-term shift of medical care from in-person to virtual settings. And while it didn’t start the movement, the COVID-19 pandemic certainly … [Read more...]

EMERGING TESTS

Delta Surge Lifts Demand for COVID-19 Tests & Profits of Laboratories that Produce Them

Remember back in the spring when Abbott, Quest and other COVID-19 testing laboratories announcing that test demand was falling fast and cautioning Wall Street investors to tone down their revenue … [Read more...]

EUA

FDA Requires EUA SARS-CoV-2 Test Developers to Account for Viral Mutations

New rules from the U.S. Food and Drug Administration (FDA) require producers of SARS-CoV-2 tests that have received Emergency Use Authorization (EUA) to take additional steps to account for viral … [Read more...]

FDA Watch

Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs

On Aug. 2, 2021, the U.S. Food and Drug Administration (FDA) published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here is a quick briefing of … [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...]


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