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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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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”
Combining Certain Genetic Tests for Heart Conditions Provides Better Results
A recent study shows that combined cardiomyopathy and arrhythmia genetic testing catches things disease-specific testing would miss.
New Guidelines Recommend Molecular Testing for Pediatric Brain Cancer Treatment
For labs, the big takeaway is how prominently molecular testing and profiling figures in so many aspects of the NCCN’s recommendations.
Repeat At-Home COVID-19 Antigen Tests to Avoid False Negatives, FDA Says
The agency is advising people to perform repeat, or serial testing after a negative result, regardless of symptoms.
Telehealth Doesn’t Discourage In-Person Care or Drive Wasteful Use
Two recent studies show that most people see telehealth as a supplement to in-person visits, rather than a replacement.
Getting Paid: How to Complete the ABN Form
Completing the Advance Beneficiary Notice of Noncoverage form can be extremely complex; this guide helps simplify the process.
Inform Diagnostics Pays $16M to Settle False Billing Allegations
In this Labs in Court monthly roundup, the Texas-based pathology lab was accused of falsely billing Medicare for unnecessary tests on biopsy specimens.
Do Whistleblowers Get a Share of What’s Recovered in Related Criminal Actions?
How much, if any, should a whistleblower get of what the government recovers in criminal or related legal actions resulting from a qui tam suit?
How Labs Can Avoid Problems When It Comes to Standing Orders
New CMS guidance includes information on how labs can avoid Medicare claims denials and documentation violations related to standing orders.
Unnecessary Drug and Genetic Tests the Theme in Recent Enforcement Actions
Most healthcare-related enforcement actions from July and August involved urine drug tests and genetic testing.
HHS Issues Final Rules for Surprise Billing Price Dispute Resolution
The process is now slightly less rigged in insurers’ favor.