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
FDA to Continue Remote Regulatory Assessments after Pandemic Ends
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.
Above-Market Lease with Landlord Doctors Costs BioReference $9.85 Million
In this month’s Labs in Court roundup, BioReference pays big to settle kickback allegations, among several other kickback-related cases.
Five Changes You Need to Know about New CLIA Proficiency Testing Rules
With the final rule on PT published July 11, here are the five things lab managers need to know to keep their labs compliant.
Federal Court Calls PAMA Rule “Arbitrary,” but Refuses to Strike It Down
D.C. Circuit Court of Appeals agrees with lab industry that CMS got Medicare lab pricing all wrong, but says it’s unable to intervene.
Nationwide Takedown Headlines Busy Enforcement Week
Last week saw a takedown of $1.2B worth of alleged fraud schemes involving labs, genetic testing, and telemedicine.
Regular Screening Finds Pancreatic Cancer at Earliest Stage
A recent study shows that the disease was detected sooner in high-risk individuals who underwent screening than those who did not.
Lab Companies Launch New Tests for Monkeypox
Centers for Disease Control and Prevention spearheads US effort to quickly increase lab testing capacity and access.
Prior Authorization and Benefits Verification Automation for Diagnostic Labs
In this Q&A, Tyler Wince of Myndshft discusses the key issues labs face when it comes to benefits and prior authorization, and how technology can help.
How to Guard Your Lab from Telehealth Liability Risk
The OIG’s new Fraud Alert can help labs and other providers steer clear of potentially suspect arrangements with telemedicine companies.
OIG Warns Providers to Steer Clear of Telehealth Scams
First Special Fraud Alert in nearly two years cites six red flags of suspect arrangements with telehealth companies.
