Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Ten Indicted for Health Care Kickbacks
Ten people, including two medical doctors, have been indicted in a $300 million health care fraud, announced U.S. Attorney for the Northern District of Texas Chad E. Meacham. The defendants—who stand accused of accused of conspiracy to commit health care fraud,...
Medicare Expands Coverage of LCDT Lung Cancer Screening
No cancer is more deadly than lung cancer. But early detection can save lives and head off costly and invasive treatment. With this in mind, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination (NCD) expanding coverage for...
New Assay Could ID Best Cancer Treatment Earlier and Faster
A recently developed assay could make identifying the best cancer treatment for each patient a quicker and more cost-effective process, compared to current tests. Researchers from the Public Health Research Institute of the New Jersey Medical School of Rutgers...
More Free Content Headed Your Way
Whether you’re signed up for a free or paid membership with G2 Intelligence, you’ll soon have access to more content with the launch of our News section, which we will slowly be rolling out in the next few weeks. This section, which will include a mix of original...
Quick COVID Breathalyzer Could Allow Mass Screening
According to experts, bringing an end to the pandemic will require rapid screening of people attending large gatherings, such as conferences and weddings. Even those who are asymptomatic can still transmit COVID-19 to others, making it important to identify and...
Spike in 2021 FCA Recoveries Belies Decline in Qui Tam Revenues
The False Claims Act (FCA) has become an enforcement cash cow generating billions of dollars for the federal government each year. But FY 2020 was a tough year. Between the pandemic and sequestration of enforcement funds, the Department of Justice (DOJ) was able to...
Recent Case Highlights Importance of Where Whistleblowers Get Info
What happens when a whistleblower’s case is based on information that’s already been publicly disclosed?
FDA Resumes Domestic Surveillance Inspections but Faces Huge Backlogs
They’re baaaack! FDA surveillance inspectors returned to the beat on Monday, at least for domestic operations. On Dec. 31, the agency announced a temporary freeze on all but “mission-critical” inspections to protect inspectors from Omicron. The freeze, the second...
Three Key Changes Your Lab Staff Need to Know About
CMS recently announced some important changes affecting PAMA price reporting, along with a list of 17 new PLA codes that will be recognized.
EC Agrees to Phase in New IV Diagnostic Regulation, Starting in May
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