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
New Urine Test Can Detect Synthetic Cannabinoids in Marijuana
Recent study shows the new test can identify a widespread and dangerous class of synthetic cannabinoids called BZO-CHMOXIZID.
SCOTUS Won’t Weigh in on How Whistleblowers Make Valid FCA Claims
The court recently denied the petition to hear a case that would have helped offer clarity on what evidence whistleblowers need to file qui tam lawsuits under the FCA.
White House Unveils New “Bill of Rights” for Responsible Use of AI
The US has taken its first steps to establish legal limits over AI use by publishing a voluntary code to ensure responsible corporate use of AI.
Weekly Enforcement Report: Doctors in Hot Water for Billing-Related Issues
While again light on lab-related cases, this week’s healthcare-related enforcement actions featured improper billing, kickbacks, and telemedicine.
AACC Revises Reproductive POC Lab Test Guidelines
POC tests offer speed and simplicity, but are less reliable than tests performed in labs.
New Breast Density Reporting Final Rule Set to Be Released
FDA confirms the new rule, which will update the Mammography Quality Standards Act, will publish before the end of 2022, or early 2023.
Changing Times and Eroding Margins: RCM Solutions
Learn how to comprehend the difficulties of revenue cycle management and practical technology-based solutions in this free webinar.
FDA to Consider Health Disparities in Granting Breakthrough Device Designation
Medical device makers will have to show that their products will be accessible to disadvantaged populations.
The State of State Licensing Law Restrictions on Telehealth
With temporary waivers of restriction relating to telehealth likely to end soon, here’s a roundup of the current state of state telehealth licensing law.
Four Things You Need to Know About the 2023 OPPS Payments Rule
The final Outpatient Prospective Payment System Final Rule for 2023 provides for a rate increase of nearly four percent.
