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
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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
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.
Health System and Care Providers Settle FCA Allegations for $70.7M
Ventura County’s organized health system and three medical care providers were accused of falsely billing Medi-Cal.
Advance Beneficiary Notice of Noncoverage (ABN) Form (Spanish Version)
Here’s the Advance Beneficiary Notice of Non-Coverage that you should present to patients who speak Spanish, starting August 31, 2022.
Advance Beneficiary Notice of Noncoverage (ABN) Form (English Version)
Here’s the Advance Beneficiary Notice of Non-Coverage that you should present to patients, starting August 31, 2022.
New Test May Make It Faster, Cheaper, and Easier to Detect Aneuploidy
New Short-read Transpore Rapid Karyotyping test can identify fetal chromosomal abnormalities in a variety of samples.
Can You Increase Your Bottom Line While Putting Patients First?
Technology can make it possible for labs and other healthcare providers to boost revenue while still providing a positive patient experience.
SNAP Diagnostics Pays $3.9M to Settle Sleep Testing False Claims Charges
Federal enforcers and whistleblowers home in on billing of medically unnecessary sleep tests.
