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
Compliance Tool: Whistleblower Non-Retaliation Policy
How to create a written policy banning retaliation for whistleblowing and for investigating retaliation complaints.
When Qui Tam Retaliation Lawsuits Get Tricky
What happens when a compliance officer is the whistleblower in a qui tam retaliation lawsuit?
Model Policy on Employee Time Theft
This useful template can be used to develop a clear written policy on time theft for your lab in order to help prevent it.
Managing Lab Staff: How to Crack Down on Employee Time Theft
Six common forms of time theft to be on the lookout for, and how lab leaders can stop each one.
Lab Institute Who’s Who: Danielle Tangorre
Learn about the current state of the No Surprises Act, challenges in compliance, and how to navigate the law.
New Study Supports Accuracy of Diagnoses from Video Visits
Video telehealth during the early period of the COVID-19 quarantine was actually highly effective in providing accurate diagnoses, research shows.
Polygenic Risk Scores Can Predict Chance of Sudden Cardiac Death
Recent study shows scores capable of assessing genetic risk of coronary artery disease can also ID those at high risk of death.
ACLA: Low Reimbursement Jeopardizes Monkeypox Lab Testing Effort
Medicare Administrative Contractors are shortchanging labs on monkeypox test reimbursement, association says.
Sutter Health Pays Millions to Settle Improper Billing Claims
The healthcare services provider will be on the hook for $13 million for alleged improper billing of lab tests.
November 2022 FDA Watch: Pace of New Approvals Slows
Though there were fewer new approvals last month, the impact of the products that did gain approval more than made up for the drop in volume.
