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
Congress Acts to End PAMA Price Cutting Reign of Terror
After years of resistance, the lab industry’s hopes and prayers for relief from the flawed pricing scheme may soon be answered.
6 Key Items in CMS’ Proposed 2023 Physicians Fee Schedule
Changes to PAMA reporting timelines and requirements, as well as payment cuts, are just some of the main takeaways labs should know about.
15 Doctors Pay $2.8 Million to Settle Lab Referral Kickback Allegations
A total of 33 doctors have now paid settlements in relation to an alleged lab testing referrals scheme, according to the DOJ.
Recent Studies Show Promise of AI and Wearables for COVID-19 Screening
Research shows that AI algorithms trained with data collected from wearable devices were effective in identifying COVID-19.
Liquid Biopsy Can Rule Out Need for Chemotherapy After Stage II Colon Cancer Surgery
New study shows that ctDNA liquid biopsy testing after stage II colon cancer may determine whether chemotherapy is required.
Theranos In Court: Balwani Convicted on All Counts
The former Theranos CEO was found guilty of 10 ten counts of wire fraud and two counts of conspiracy to commit wire fraud.
As Concern Over Monkeypox Grows, Testing Expands in US
Labcorp begins offering CDC’s PCR test for orthopoxviruses, including monkeypox, with plans to further expand testing capacity.
Blood-Based Tests Can Detect Early-Stage Lung Cancer
Team creates a mass spectrometry-based blood lipid test that, when combined with AI, identifies early signs of the disease.
National HCFAC Program Health Fraud Recoveries Top $5 Billion
According to a recently released report, in FY 2021, of 831 new criminal healthcare fraud investigations, 312 resulted in convictions.
Carolina Lab Owners Shell Out $6 Million to Settle FCA Charges
Owners of now defunct Physicians Choice Laboratory Services were accused of paying kickbacks to physicians to order tests from the lab.
