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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
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
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Whatever Happened to Those Part B Lab Test Spending Reductions?
The Protecting Access to Medicare Act (PAMA) was supposed to significantly reduce Medicare Part B lab tests spending. But it hasn’t happened. In FY 2018 and 2019, the first two years under the PAMA system, Medicare payments under the Clinical Laboratory Fee...
Genomenon Awarded NIH Grant to Curate the Human Genome
Ann Arbor, MI — February 15, 2022 — Genomenon, Inc., an AI-driven genomics company, today announced that it was awarded a $1.7 million grant by the National Institutes of Health (NIH) through the Small Business Innovation Research (SBIR) program. The grant is to...
Labcorp Enters Comprehensive, Long-Term Lab Relationship With Ascension
BURLINGTON, NC — (BUSINESS WIRE) — Labcorp (NYSE: LH), a leading global life sciences company, today announced that it has entered into agreements to create a comprehensive strategic relationship with Ascension, one of the nation’s leading Catholic and non-profit...
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...
