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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.
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.