Compliance Concerns: Laboratory Regulations in 2024 and Beyond
Earle S. Collum, chair of the CAP Council on Accreditation, talks through regulatory changes in 2024 and what to expect from 2025
Essential
Subscribe today for access to
Articles and Reports
Out with the Old: The 2024 Clinical Lab Experience
What challenges and opportunities affected the experience of medical lab professionals in 2024—and what might the new year bring?
FDA Watch: How Could the Change in US Government Affect IVDs and Labs?
Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing
CMS Clarifies Rules for IDTF Medicare Billing of Diagnostic Tests
The agency recently issued new guidance exempting indirect independent diagnostic testing facilities from some requirements.
Proposed Rule Puts Labs at Greater Risk of FCA Liability
CMS recently proposed a rule that would make the False Claims Act rule the standard for overpayments under the Affordable Care Act regulations.
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.
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.
Partnership to Promote Multi-Ancestry PRS Breast Cancer Testing
Genomics software developer Allelica to collaborate with Taiwanese precision medicine firm to develop a multi-ancestry breast cancer test.
How to Reduce Liability Risk for Lab Sales and Marketing
A code of conduct for sales and marketing staff is essential to allow staff to do their jobs while avoiding liability risk.
