Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
New Study Provides Most Comprehensive Overview of Genetic Test Development, Usage and Spending
From - Diagnostic Testing & Emerging Technologies
As might be expected, there has been rapid growth in genetic test availability and spending on these tests since 2014. But, comprehensive new collaborative analysis conducted by…
Compliance Perspectives: The 12 Things to Include in Your Drug & Alcohol Testing Policy
From - G2 Compliance Advisor
No! No! No! The truth is that state laws on marijuana use and possession have little to no direct impact on workplace drug policies and the testing methods used…
PAMA Reimbursement: CMS Explains How to Get ADLT Status for New Lab Tests
From - National Intelligence Report
Although the 2018 market-based Clinical Laboratory Fee Schedule (CLFS) is officially in effect, implementation of the new PAMA Part B payment rules for lab tests remains…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
The pace of deal making has picked up a bit, but deal volume remains relatively low on both the M&A and strategic alliance fronts. As usual, smaller molecular and genomics firms are…
DX Earnings Report: PAMA Cuts Make Little Dent on Q1 Lab Earnings
From - National Intelligence Report
One quarter into its existence, the new PAMA Medicare Part B fee schedule seems to be having only a marginal impact on at least publicly traded labs. In fact, the recently published…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Agilent, Bio-Techne and Mission Bio were among the producers launching multiple products. Here's a rundown of the key diagnostic product launches from…
Expanded Carrier Screening IDs Rare Variants in Diverse Populations
From - Diagnostic Testing & Emerging Technologies
Expanded next-generation sequencing-based carrier screening improves detection of rare and novel pathogenic variants even in…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: The feds accused a Missouri lab of submitting false claims to Medicare for travel fees in transporting specimens from April 2011 to December 2014. In addition…