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
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.
COVID-19 Losses Take a Toll on Q4 Earnings—but It Could Have Been Worse
Though Q4 earnings in the lab industry took a beating as predicted, the earnings picture wasn’t nearly as bleak as many had feared.
UnitedHealthcare Expands Coverage of Genetic Cancer Tests
The health plan issued a new policy expanding coverage of molecular genetic tests for personalized cancer diagnosis, prognosis, and treatment.
