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
Medicare Reimbursement: MIPS Bonuses Are Easy to Earn, IF You Can Get into the Program
From - Lab Compliance Advisor
On July 11, CMS announced the results of 2018, Year 2 under the Merit-based Incentive Payment System…
Genetic Testing: Multigene Panel Testing Detects Hereditary Risk Variants in Metastatic Breast Cancer Patients
From - Diagnostic Testing & Emerging Technologies
The clinical value of performing multigene panel for inherited cancer in patients with metastatic breast cancer has…
LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
From - National Intelligence Report
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict…
Adoption Quickening for Genomic Cancer Testing in Community Settings
From - Diagnostic Testing & Emerging Technologies
Clinicians are increasingly using genomic cancer testing in community health care settings, although there are…
Are Erratic Scheduling Practices Causing Financial Instability for Your Hourly Lab Employees?
From - Laboratory Industry Report
A study reveals that for today's hourly workforce, missing a single shift comes at a steep cost…
Explaining the Legal News: Why ACLA Court Win Boosts Chances of PAMA Pricing Relief
From - Lab Compliance Advisor
By now, you've no doubt heard the news that the American Clinical Laboratory Association (ACLA) "won" its lawsuit against…
Genetics Update: Internet Use Can Help Patients Self-Diagnose Rare Genetic Disorders
From - Diagnostic Testing & Emerging Technologies
The notion of empowering patients to take control over their own health care is particularly powerful within the realm of…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Here's a summary of the key product launches announced from late July through the third week of…