A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
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Articles and Reports
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
Lawyers Give Their Tips to Spot Clinical Lab Fraud
Medical laboratories should monitor fraud cases across the country and also stay vigilant of suspicious patterns of behavior
Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
Reporting Noncompliance in Clinical Labs Requires the Right Channels and Culture
A lawyer advises medical laboratories on how to improve their avenues for reporting unethical behavior
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Updates to CLIA Personnel Requirements May Lengthen Hiring Times
Changes ‘have had a significant impact on the recruitment process for laboratory directors and technical supervisors,’ recruiter says
Proposed FTC Ban on Noncompete Agreements Could Be Highly Disruptive to Lab Staffing
A proposed move to make noncompete agreements illegal could impact retention of some laboratory employees.
Normal Kickback and Billing Rules Return When PHE Ends on May 11
A look at the US end-of-emergency game plan and how it will impact lab compliance.
The Year in Lab Compliance: The 6 Biggest Stories of 2022
The year was certainly an interesting one in terms of regulatory change in the medical laboratory space.
CMS Dishes Out First Penalties for Hospital Price Transparency Violations
After the price transparency rules took effect in January 2021, CMS finally issued the first penalties for violations.
Three Key Changes Your Lab Staff Need to Know About
CMS recently announced some important changes affecting PAMA price reporting, along with a list of 17 new PLA codes that will be recognized.
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