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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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- Business deals in the diagnostics space, and more
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
Enforcement Trends: 5 Takeaways from OIG’s New Semiannual Report
From - National Intelligence Report
Veteran OIG semiannual report aficionados will find little in the most recent edition to distinguish it markedly from its predecessors. But while a new…
Cybersecurity: New Bill Would Make Lab Employees Criminally Liable for Concealing Data Breaches
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Medicare Reimbursement: CMS Finalizes Controversial PAMA Fee Schedule
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FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval
From - National Intelligence Report
The FDA's longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to…
CMS Ignored Congressional Intent in Implementing New Clinical Lab Payment System Under PAMA, ACLA Charges in Suit
From - G2 Compliance Advisor
The government agency that runs the Medicare program failed to follow a congressional directive to implement a market-based laboratory payment system…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - Laboratory Industry Report
Case: A California cardio clinic and its physician owners will pay $1.2 million to settle charges of falsely billing Medicare and Medicaid for…
CMS Final Fee Schedule Will Impact Patient Access to Laboratories: COLA
From - Diagnostic Testing & Emerging Technologies
The CMS Final Fee Schedule will hurt patient access to clinical laboratories, says the lab accreditation bureau COLA…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
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CMS Finalizes Controversial PAMA Fee Schedule
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