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
Fate of Illumina’s Grail Acquisition Remains Very Much in Doubt
It’s beginning to look like Illumina’s roll of the dice is going to come up snake eyes regarding the potential acquisition.
Infectious Disease Test Segment Poised for Strong Growth
The market is expected to grow at a CAGR of 3.21 percent from 2021 to 2028 and reach $17.432 billion by 2028, according to a recent report.
Labs on Notice Following Healthcare Fraud Enforcement Action
Danielle H. Tangorre discusses key takeaways for labs from the DOJ’s recent nationwide takedown of $1.2 billion in alleged schemes.
Surprise Billing Rules Would Give Private Health Plans Advantage in Disputes
The way the No Surprises Act is implemented would essentially allow private health plans to set out-of-network rates in billing disputes.
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.
