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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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
Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service
From - National Intelligence Report
The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect…
Cytokines Could Predict Risk of Side Effects From Immunotherapy
From - Diagnostic Testing & Emerging Technologies
Blood-based cytokine markers may help identify cancer patients at greatest risk of developing side effects from immunotherapy treatment, according to…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Here are some of the more notable launches from the busy October-November period…
New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
Mergers, Acquisitions & Asset Sales Analysis – December 2018
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Texas Lab and Owner Get 15-Year Exclusion for Medicare Mileage Swindle
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LDTs: FDA Announces New Approach to 510(k) Approvals
From - National Intelligence Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…
Earnings Report: Top Payers Announce Q3 Earnings
From - Laboratory Industry Report
The country's five largest commercial payers posted strong results for the third quarter of fiscal year 2018…
Most Oncologists Report Using Sequencing-Based Panels In Practice
From - Diagnostic Testing & Emerging Technologies
The majority of U.S. oncologists report using next-generation sequencing-based (NGS-based) tests to guide patient care, according to a study published…
Compliance Alert: New Private-Pay Opioid Law Puts All Drug Addiction & Rehab Labs at Risk of Federal Prosecution
From - Lab Compliance Advisor
Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of…