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
OIG and CMS Clash on Medicare Overpayment Recoveries
OIG says the agency is leaving millions of dollars on the table, but CMS doesn’t want to hear it.
Eight Charged in Alleged $150M Crestar Labs Fraud Scheme
Individuals were supposedly paid kickbacks to obtain genetic samples for unnecessary genetic testing, which was then falsely billed to federal healthcare programs.
Most Lab Professionals Work in Understaffed Labs, Are Burnt Out
According to a recent survey of 1,112 respondents, despite modest salary increases, most medical lab professionals are struggling in understaffed labs.
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.
