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
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Enforcement Trends: The Urine Drug Testing Crackdown and Three Ways to Avoid It
False billing of urine drug tests (UDTs) continues to be a focus for enforcement agencies in 2023, here’s how to avoid compliance issues.
Billing & Coding Alert: CMS Adds 15 New PLA Codes to Medicare Clinical Laboratory Fee Schedule
Here’s what to know about the new codes that CMS recently added to the national HCPCS table as well as which ones were removed.
July 2023 FDA Watch
Key approvals announced in June represented important steps forward for the lab testing industry.
Special Report: Financial Firms Project Rapid Growth of Genetic Testing Market through 2030
The outlook of the global genetic testing market based on recent reports from five financial consulting firms.
M&A & Strategic Dealmaking: Illumina May Finally Be Ready to Unwind GRAIL Acquisition
After an eventful month in the Illumina-GRAIL saga, the story may soon be over.
Billing & Coding of Infectious Disease Testing
Recent developments pose reimbursement and compliance challenges for billing and coding infectious disease testing—here’s how to manage them.
Dx Deals: Walmart Teams with Simple HealthKit to Provide Accessible At-Home Testing
The national retailer recently signed a deal with Simple HealthKit to provide Walmart customers online access to at-home diagnostic test kits.
July 2023 Enforcement Roundup
Though UDT-related enforcement actions predominate, an uncommon vendor-related case was in the mix this month.
July 2023 Labs in Court
Recent cases involve COVID-19 fraud, UDTs, and the latest HIPAA Right of Access settlement.
Compliance Perspectives: The Risks of Using ChatGPT & How to Manage Them
While ChatGPT has its place, allowing lab staff to use it exposes you to liabilities—here are some ways to manage the risks involved.