Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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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
Should Certain Racial Groups be Screened for Diabetes at Lower BMIs?
Recent study shows that different diabetes screening guidelines are required to produce equal benefits for certain racial groups.
Labs in Court Weekly Roundup
Recent health care industry-related cases involved a variety of fraud types, including kickbacks and fake vaccine card distribution.
World Leaders Promise More Funds to Fight Pandemic at COVID-19 Summit
Meeting for the second Global COVID-19 Summit, leaders from around the world made additional financial commitments to fighting the disease
Lab Compliance Will Change When the Public Health Emergency Ends
The relaxed regulatory environment labs have provided during the COVID-19 pandemic is set to come to and end soon.
How the End of the COVID-19 PHE Will Impact Lab Compliance
A briefing on how labs should prepare for the inevitable end of the PHE after more than two years of unprecedented relief.
Millions Will Lose Medicaid Coverage When the PHE Ends: Report
New report says between 5.3 and 14.2 million people will lose their Medicaid coverage when the COVID-19 public health emergency ends.
New Resource Aims to Improve Diagnosis of Patients with Hearing Loss
Guidance from the American College of Medical Genetics and Genomics shares the importance of a genetic evaluation for hearing loss.
FDA Recalls More COVID-19 Tests
Recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test the latest in string of recent Class I events.
Recent Recall a Reminder to Check Which COVID-19 Tests Your Lab Can Use
Celltrion’s recall was labeled by the FDA as Class I, due to the kits possibly being distributed to non-CLIA certified users.
OIG Green Lights Free Genetic Testing Arrangement
The OIG recently issued an Advisory Opinion approving a proposed arrangement involving the offering of free genetic tests.
