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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Medicare Billing Alert: Be Sure to Use the New ABN Form
Renewed Advance Beneficiary Notice of Noncoverage (ABN) Form (OMB 0938-0566) must be used as of August 31.
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.