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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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- Business deals in the diagnostics space, and more
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
Whistleblowers: SCOTUS Gives DOJ Wider Authority to Dismiss Meritless Qui Tam Cases
Ruling could spell good news for labs and other healthcare providers targeted by whistleblowers in False Claims Act qui tam lawsuits.
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.
