Daily Update

Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test (m) = Multi-analyte Test) Date Manufacturer(s) Test … [Read more...]

Health Care Reform:

New Administration May Not Be Enough to Save the ACA

Patients, payors and health exchanges await nervously as the drama over the Affordable Care Act (ACA, aka Obamacare) continues to play out. It looked like the U.S. Supreme Court had settled the issue … [Read more...]

Industry Buzz

Guardant Health Challenges Exact Sciences’ Leadership of Colorectal Cancer Diagnostics Market

Colorectal cancer diagnostics is a multi-billion-dollar market that, at least before the pandemic, was projected to grow at an annual rate of nearly 6 percent. In recent months, two leading firms have … [Read more...]

Labs in Court

Texas Hospital Pays $48 Million to Settle False Claims and Kickback Charges  

Case: In one of the largest kickback settlements of 2020, Texas Heart Hospital of the Southwest, a partially physician-owned hospital, and its management company subsidiary (which we’ll refer to … [Read more...]

Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Massachusetts Drug Testing Lab Shells Out $84K to Settle SVT False Billing Charges Case: A urine drug testing lab in Massachusetts is the latest to settle self-disclosed charges of falsely billing … [Read more...]

False Claims

The Liability Risks of Failing to Report Tests of Dubious Medical Necessity

What should your lab do if providers order tests that clearly don’t meet coverage criteria for medically necessary coverage criteria? A recent settlement involving Cordant Health Solutions charges of … [Read more...]

Enforcement Trends:

New Administration Continues OCR HIPAA Right of Access Initiative

Although the Biden administration has signaled its intention to revisit just about every healthcare regulatory initiative of its predecessor, one enforcement undertaking seems to be continuing … [Read more...]

Billing & Collections

OIG Targets Pandemic’s Impact on Billing of Medicare Part B Lab Testing

Looking upon Medicare billing and payment of lab services with suspicion is and has always been part of the OIG’s organizational DNA. So, the fact that audits of Medicare Part B lab services during … [Read more...]

FDA Watch

2020 Was a Record Year for New Medical Device Approvals—And Not Just for COVID-19

They say that necessity is the mother of invention. But, historically, invention has never been the problem for creators of novel medical devices; the real challenge for these inventors has been more … [Read more...]

LDTs

FDA Clears Neutralizing Antibodies Detection Test for COVID-19

Innovative new COVID-19 tests continue to emerge from the pipeline. One of the novel diagnostic products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody … [Read more...]


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