Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Lab Industry Advisor Subscriptions Include
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
FDA Reports Progress in Advancing Regulatory Science for Diagnostics
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the…
Palmetto Gives Okay to Medicare Coverage of 5 New Molecular Tests
From - Laboratory Industry Report
Medicare contractors are slowly coming around on covering unproven molecular assays. The most notable new baby steps come from, Palmetto GBA (Columbia, SC), one of Medicare's most important contractors in the form of…
Compliance Scorecard: Significant New HIPAA Fines
From - National Intelligence Report
Health data and information security figured prominently in May enforcement activity. In addition to the blockbuster eClinicalWorks EHR software settlement discussed on page 3, there was an unusually high volume of…
CMS Dished Out $729.4 Million in Wrongful EHR Incentive Payments & We’re Going to Get that Money Back
From - G2 Compliance Advisor
Wrongful payments of Electronic Health Records (EHR) incentives are at the focus of two of the month's biggest stories in health care compliance. The first came down on…
FDA Watch: User Fees Dodge a Bullet, a Cancer Drug Approval Breaks New Ground and the Supreme Court Serves Up a Biosims Blockbuster
From - Laboratory Industry Report
The FDA budget pot continues to boil. In March, the Trump administration proposed a controversial provision to double the medical user fees that diagnostics, medical device and…
Notorious File: Feds Take Down Three More Doctors in BLS Lab Bribery Scheme
From - National Intelligence Report
The Biodiagnostic Laboratory Service (BLS) case continues to be the poster child for the evils of fraud and greed in the health care industry…