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
Current Diagnostics Merger & Acquisition Trends
M&A deals in the diagnostics industry have been lower in number, but higher in impact in recent months.
December 2022 Labs in Court: FCA and a Sex Discrimination Case Dismissed
Key cases over the past month were the usual FCA-related fare, apart from a dismissed sex discrimination case.
Compliance Tool: Model Policy on Telecommuting & Remote Work
It’s important to have a clear policy in place for approving remote work requests and ensuring employees remain productive.
December 2022 Enforcement Scorecard: Unusual Suspects
Federal enforcement actions at the end of October and first two weeks of November featured some unusual characters.
Court OKs Qui Tam Lawsuit against Lab for Not Following Medicare LCD
Could not following MAC guidance constitute evidence that a party knowingly submitted, or caused the submission of, false claims?
Lab Staffing: How to Guard Against “Digital Nomad” Liability Risks
There are potentially significant legal ramifications of employing digital nomads who work from abroad—for both you and your employee.
Billing & Coding: MAAA Coding 101
What labs and billing managers need to know about multianalyte assays with algorithmic analyses coding for tests based on molecular platforms.
Clinical Lab Owner Pleads Guilty to Healthcare-Related Scheme
On Nov. 15, a psychiatrist and clinical lab owner pled guilty to his role in a complicated $3.8 million fraud scheme.
White House Proposes New AI “Bill of Rights”
US takes first steps to rein in abusive and privacy-invasive use of AI by corporations.
Theranos in Court: Holmes Sentenced to 11 Years Behind Bars
After delays in sentencing and attempts by her legal team to win a mistrial, Holmes was sentenced last week for her role in defrauding investors of millions.
