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
- Healthcare-related laws
- FDA approvals
- 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: Private Insurers Are Cracking Down on the Labs that Scam Them
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Screening Blood Donations for Zika, Costly With Low Yields
From - Diagnostic Testing & Emerging Technologies
Screening the entire U.S. blood supply for Zika virus may not be worth the $42 million price tag. Fifteen months of screening all…
OIG Work Plan Monthly Review: May 2018
From - G2 Compliance Advisor
Of the seven new Work Plan items, none directly impact labs and lab services. However, one item on Medicare Part B reimbursement of outpatient cardiac and…
Medicaid Fraud: Enforcement Continues to Trend Down as Labs Drift Deeper into the Background
From - National Intelligence Report
Last month, the OIG published its annual summary of Medicaid Fraud Control Unit (MCFU) activity for FY 2017. Here is a summary of the key findings, trends and…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
While M&A activity in the wider healthcare industry is heating up deal making in the diagnostics space remains relatively light, not so much in terms of volume but…
Model Drug & Alcohol Testing Policy
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Industry Trends: Small Labs Relying on Antitrust Laws to Protect Their Market Position
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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New FDA Guidance Aims to Ease Approval for New NGS Tests—But It Probably Won’t Work
From - National Intelligence Report
Test makers have long complained about the FDA's unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address…
