Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Lab Industry Advisor Subscriptions Include
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
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 PLA Codes Billable Under the Medicare CLFS to Be Aware Of
Here’s a quick briefing of the new codes that come into effect on April 1 that your billing staff should know about.
Federal Court Strikes Down No Surprises Act Dispute Resolution Rules
The rules unfairly favor insurers in out-of-network payment disputes, court says.
Recent Blood-Based Tests May Help Increase Colorectal Cancer Screening
Though not yet recommended for screening by the ACS or other medical groups, recently developed blood-based tests show promise.
Weekly Enforcement Report: Medical Centers Pay Big
Recently announced enforcement actions saw three big settlements, with two of those coming from medical centers.
OIG Sounds the Warning on Overbilling of G0483 Definitive Drug Tests
Labs may be billing Medicare for high-reimbursing and medically unnecessary drug tests, according to the OIG.
Amazon Makes Bold Move into DTC Healthcare Services
Though the e-commerce giant recently closed its acquisition of One Medical, FTC antitrust intervention could disrupt Amazon’s plans.
Weekly Enforcement Report: All Quiet on the Laboratory Front
Though labs were again absent from recent key enforcement actions, sentences were handed down in other healthcare-related cases.
Amazon Closes One Medical Acquisition but FTC Intervention Looms
The deal closed Feb.22, but the FTC has expressed concerns about the acquisition and Amazon’s business practices in general.
What COVID-19 Labs Must Do to Prosper in a Post-Pandemic World
With COVID-19 testing demand all but dried up, labs will have to make—or at least contemplate making—significant changes to their business.
What Happens to COVID-19 Tests after the EUA Pipeline Closes Down?
Companies in the COVID-19 diagnostic products market will need to decide whether to wind down their EUA-based investments.