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
Partnership to Create New Tool for Rapid SARS-CoV-2 Variant Detection
Thermo Fisher, Helix, and Rosalind collaborate on an NIH-supported project to develop a new genotyping method to ID virus variants faster.
The Government Is Running Out of Money for COVID-19 Testing
The White House recently wrote that without restoring COVID-19 funding, the country won’t be able to buy enough supplies to combat the virus.
Malpractice Premiums Rise but Medicare Reimbursement Doesn’t
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Ellume Faces Class Action Lawsuit Over At-Home COVID-19 Test Kits
Back in October and November, Ellume voluntarily recalled two separate lots of its Rapid Antigen At-Home COVID-19 Test Kits due to the risk of providing false positive results. The U.S. Food & Drug Administration classed the November recall as Class I, the most...
Illumina Wins Decisive Victory in Patent Infringement Case Against BGI
After prevailing in its patent infringement lawsuit against BGI Genomics, Illumina cemented its victory by getting a permanent injunction barring the Chinese sequencing firm and its subsidiaries, including MGI Tech, from selling its sequencers and reagents in the...
Labs in Court Weekly Roundup
In enforcement actions involving the health care industry listed by the U.S. Department of Justice (DOJ) from March 22 to March 25, most cases involved billing for services that were never provided, as well as a more elaborate scheme involving a fake housing...
Thermo Fisher Teams with Rosalind & Helix for Rapid SARS-CoV-2 Variant Detection
Thermo Fisher Scientific announced that it has teamed with Helix and Rosalind, Inc. on a National Institutes of Health (NIH)-supported project to develop a new SARS-CoV-2 genotyping method allowing for more rapid and cost-effective identification of virus variants...
How to Comply with Medicare Signature & Documentation Requirements
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A Model Signature Log for Laboratories
If the signatures of ordering physicians or non-physician practitioners aren’t legible or done correctly, Medicare may not pay for lab tests.
Will We Be Better Prepared for the Next Pandemic?
The current COVID-19 pandemic exposed just how unprepared the world was to handle such a biological threat on a massive scale. One key contributor to that lack of preparedness was the reactionary approach most governments took to biological threats, failing to...
