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
What’s the Best Time to Take a COVID-19 Test?
A recent study shows that just before you leave for a social event is best when it comes to testing for COVID-19.
Pharmacy Settles Prior Authorization Fraud Allegations for $115,000
New York-based specialty pharmacy allegedly altered documentation, including lab test results, to obtain insurance coverage of expensive drug.
Compliance Lessons for Labs Following Massive Takedown
Here are some steps labs may want to take in the wake of the 2022 National Health Care Fraud Enforcement Action.
Illumina Faces Loss of Grail, Massive Fines
European Commission accuses sequencing giant of “jumping the gun” on Grail acquisition.
FDA Re-Opens Pre-Submission Requests for Non-COVID-19 IVD Tests
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
Quest and Color Health Join CDC to Promote Equitable COVID-19 Testing
In July, ICATT took a major step toward equitable access to testing by enlisting two of the country’s leading COVID-19 PCR test providers.
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.
