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
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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
ACLA Meeting Spotlights Value of Clinical Diagnostics in Face of Reimbursement, Regulatory Challenges
From - National Intelligence Report
Despite the looming challenges of a proposed overhaul of the Medicare payment system for clinical laboratory services and…
Kickback Case Settles for Record-breaking $646 Million
From - G2 Compliance Advisor
It has been billed as the largest total amount in U.S. history paid for alleged violations of the Anti-kickback Statute by…
Veritas Launches Below-$1,000 Whole Genome Test
From - Laboratory Industry Report
Veritas Genetics is launching a whole genome test under the four-figure price point…
More Than 1/4 of FDA’s 2015 Drug Approvals for Targeted Therapies
From - Diagnostic Testing & Emerging Technologies
More than 28 percent of the novel new drugs approved by U.S. Food and Drug Administration (FDA) in 2015 were…
FDA LDT Regulation Could Affect 60,000+ Tests
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Presidential Election Campaign Sets Tone for 2017 Congressional Activity
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ACLA Uses Cancer Initiative to Lobby on PAMA, LDTs
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CMS Offers Long-Awaited Clarification of Deadline for Returning Overpayments
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Labs and Diagnostics Central to 2017 Federal Budget Requests
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Consensus Needed on Recontacting Patients With Updated Genetic Results
From - Diagnostic Testing & Emerging Technologies
The majority of U.K. clinical genetics services report that they recontact patients or family members about new findings relevant to…