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
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…
Genetic Testing Emerges As New Trendy Workplace Benefit
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HCV Screening Rates Very Low Among Exposed Infants
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Home-Based Hospital Care Model Cuts Lab Utilization
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Men Undergo Hereditary Cancer Testing Less Frequently Than Women
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Enforcement Trends: Private Insurers Are Cracking Down on the Labs that Scam Them
From - National Intelligence Report
Once the almost exclusive domain of federal law enforcers and inside whistleblowers, the lucrative industry of going after labs for improper billing has…
Current Testing Criteria Miss Breast Cancer Mutations
From - Diagnostic Testing & Emerging Technologies
Women who do not meet breast cancer genetic testing criteria have a similar number of cancer-associated mutations as women who do meet the criteria…
FDA Watch: Why the New NGS Guidance May Be a Paper Tiger
From - Laboratory Industry Report
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing…
Brief Your CEO: Medicaid Enforcement Trends & Their Impact on Labs
From - G2 Compliance Advisor
While they do not have to embroil themselves in the day-to-day compliance program details, the C-Suiters do need to be on top of…