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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
Case of the Month: Fraud or Legitimate Rural Hospital Lab Outreach Business?
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Dissolution: The Final Act of the Theranos Tragedy
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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LDTs: FDA Does an End Run on Regulatory Proposal Lab Industry Helped Create
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Medicare Reimbursement: How CMS Price Transparency Proposal Could Hurt Labs & Patient Relations
From - National Intelligence Report
Last April, CMS issued a proposed rule to make Medicare rates more transparent. While designed to "empower patients and reduce administrative burden," the proposed changes would…
PAMA: OIG Backing of CMS Heats Up Market-Based Lab Rates Controversy
From - G2 Compliance Advisor
CMS did it right and saved Medicare a boatload of money in the process, concludes a new OIG report reviewing the methods CMS used to establish…
Toxicology Laboratories Play Key Role in Curbing the Drug Addiction and Opioid Epidemic
From - Laboratory Industry Report
The National Independent Laboratory Association's (NILA's) Opioid Task Force is releasing a white paper entitled…
Preimplantation Genetic Testing Improves IVF Outcomes
From - Diagnostic Testing & Emerging Technologies
Preimplantation genetic testing for aneuploidy (PGT-A) can mitigate the negative effects of maternal age on in vitro fertilization (IVF) outcomes by…
Shareholders Sue Missouri Hospitals for Alleged Lab Billing Ripoff
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The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
After a busy July, the pace and volume of new product launches slowed significantly in August…