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
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Health System Pays $6.5 Million to Settle Urine Test Upcoding Charges
Case: A lab director filed a whistleblower suit claiming that…
Genomic Testing: Oncologists Want More Education & Less Hype
From - National Intelligence Report
When it comes to measuring Dx product effectiveness, few things speak louder than the attitudes of ordering physicians. With that in mind…
HIV Testing Remains Low in Young Adults
From - Diagnostic Testing & Emerging Technologies
The United States is falling behind national goals to identify patients unaware of their positive HIV status and link them to care…
Clinical Laboratories Continue to Figure Less Prominently in New OIG Enforcement Report
From - G2 Compliance Advisor
The Office of Inspector General just published its most recent Semiannual Report to Congress. To the untrained eye, the newest OIG Report, which covers Oct. 1, 2016 through March 31, 2017, is not substantially different from…
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…