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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
HIPAA vs OSHA: What to Do When Laws Collide
What happens when lab personnel’s OSHA rights to access illness and injury records seemingly clash with HIPAA privacy laws?
OIG Gives the OK to Free Genetic Testing & Counseling Arrangement
New OIG Advisory Opinion offers valuable insight into where the agency draws the line on free genetic tests.
Recent Kickback Cases Range from $300 Million Scheme to a Free Service
Of this month’s four Labs in Court cases, three involved kickbacks resulting in widely varying penalties.
Billing & Coding of Outside Pathology Consultations
A briefing of the current requirements you can use to avoid billing and coding errors at your own lab or pathology practice.
Genomic Tests for Prostate Cancer Risk Stratification Are Now Covered
A newly finalized local coverage determination from MAC Palmetto GBA sets out coverage criteria for two applications of these tests.
Review: NIPS Accurate in Detecting Most Common Genetic Abnormalities
A systematic evidence-based review from the ACMG shows NIPS tests are an effective screening tool for general-risk pregnancies.
Apple Employee Uprising Shows Dangers of Ending Remote Work
Lab employees who’ve worked from home may be less than willing to return to the facility, if the situation at Apple is anything to go by.
Plunging Test Rates Threaten Efforts to Detect New SARS-CoV-2 Variants
Despite the emergence and rise of new Omicron variants, COVID-19 testing has declined as much as 90 percent, according to some reports.
Blood-Based Alzheimer’s Tests Have Officially Arrived
Recent developments suggest that we are on the precipice of a new age offering expanded options for Alzheimer’s diagnosis.
Telehealth Encounters Lead to More Follow-Ups than In-Person Visits
Recent study suggests those being treated for acute conditions are likelier to schedule follow-up appointments after telehealth visits.