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
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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
Feds Lower the Boom on Home Sleep Test False Billing and Kickbacks
A recent $3.5 million settlement illustrates the kinds of pitfalls that can result in liability for hospital and freestanding sleep labs.
Compliance Tool: Healthcare Equity Plan Model Form
Follow the steps in this form to help you develop and implement an effective healthcare equity plan for your lab.
Feds Not Backing Away from Punishing CGx Testing Scams
Recent case shows that fraud and kickback schemes involving CGx testing continue to be on the federal enforcement radar.
Ex-CEO of Health Clinic Found Guilty of Medicaid Fraud
In this week’s enforcement roundup, the former executive was convicted of healthcare fraud relating to mental health diagnosis and treatment.
‘Digital Mask’ Tech Could Help Solve Patient Privacy Issues
A new technology could help protect patients’ privacy when it comes to the use of facial images in medical diagnoses.
Brief Your CEO: The New Joint Commission Health Equity Standard
As of January 1, 2023, your lab may need to develop and implement a full-blown health equity plan to maintain its Joint Commission accreditation.
Amazon Shuts Down Telehealth Service
Retailer stubs a toe on its way to disrupting health care.
New FDA Bill Bypasses LDTs Reform—Again
It now appears that Congress is going to dash the lab industry’s hopes yet again by reauthorizing FDA user fees without VALID.
Clinical Lab Owner Pleads Guilty to Three Healthcare Fraud Schemes
The owner of several clinical labs and other businesses will pay big for the schemes that involved money laundering, kickbacks, and fraud.
House Passes Legislation to Better MA Prior Authorization Process
According to healthcare groups, the Improving Seniors’ Timely Access to Care Act would help fix problems with current system.
