REIMBURSEMENT

PAMAgeddon: Congress Tables Bill to Delay Next Round of Price Reporting for One Year

The PAMA data collection process has been a lightning rod for criticism from almost the moment CMS unveiled it. And now Congress may be getting ready to intervene. A newly proposed bill called … [Read more...]

HEALTH CARE REFORM

Industry Buzz: Obamacare Appeal Set for Round 2

Seven months after a Texas U.S. District Court striking down Affordable Care Act, aka Obamacare, unconstitutional, the case is going back to court on appeal. The betting is that the Fifth Circuit, … [Read more...]

COURT CASES

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Feds Salvage $2.5 Million from $90 Million Genetic Testing Scam Case: The feds accused Nevada Heart & Vascular Center (NHVC) of taking kickbacks from a pair of now defunct genetic testing … [Read more...]

FDA

New FDA Guidance Tells IVD Makers How to Test for Biotin Interference

On June 13, the FDA issued a draft guidance explaining how makers of in vitro diagnostic devices (IVDs) should perform biotin interference testing and communicate testing results to labs, clinicians … [Read more...]

FOCUS ON

Surviving PAMA: Keep an Eye on Industry Disruptors

A talking point of a G2 Lab Institute 2018 presentation deserves closer attention, especially given its implications for the lab industry. "Advantages and Disadvantages Confronting Labs in a … [Read more...]

GENETIC TESTING

OIG Issues Genetic Testing Fraud Alert

On June 3, the OIG issued a fraud alert warning of a genetic testing fraud scheme. According to the OIG, scammers are using telemarketing calls, booths at health fairs and public events and … [Read more...]

STARK LAW

Compliance Heads Up: New Kickback Safe Harbors Rule Is Almost Ready

After months of promises, posturing and public consultation, the Department of Health and Human Services is getting ready to unveil a proposed rule to liberate labs and other providers from the … [Read more...]

TECHNOLOGY

Top 4 trends shaping the healthcare industry

By Leora Borgenicht  bio Before the healthcare industry can ambitiously transform to offer more accurate and personalized patient care, certain stepping stones must be reached. These four … [Read more...]

FOCUS ON

New Project Aims to Provide Legal Guidance Needed to Do Business in Genomics

Technology changes faster than the laws designed to regulate it. Thus, while DNA testing has changed medicine and fueled growth in the lab industry, it has also created new legal challenges that few … [Read more...]

NEWS

FDA Watch: Agency Okays Marketing of Zika Test for First Time

Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It … [Read more...]


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