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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
FDA Watch: Agency Approves DTC Genetic Breast Cancer Test—But Attaches Strings
From - National Intelligence Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…
FDA Authorizes First Direct-to-Consumer Genetic Test for Cancer Risk
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Racial Disparities in Access Reduce Utility of Genetic Testing
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Even a Single PSA Screening Test Does Not Cut Mortality
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Mass. Settlement Could Speed HCV Testing For Prisoners Nationally
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Procalcitonin Testing Improves Antibiotic Stewardship
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Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer
From - Laboratory Industry Report
In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements…
Tests Emerging to Advance Cardiovascular Risk Assessment
From - Diagnostic Testing & Emerging Technologies
While testing for cardiovascular conditions does not garner the headlines that oncology testing does, several recent studies demonstrate how the introduction of genetic testing and…
Case of the Month: $11.4 Million Natera Settlement Shows Genetic Billing & Coding Remains a False Claims Hot Button
From - G2 Compliance Advisor
Before the opioid crackdown, false billing of genetic tests was the hottest thing in federal fraud enforcement against clinical labs. But while drug testing related to…
Enforcement Trends: Labs Getting Swept into the Opioid Crackdown Vortex
From - National Intelligence Report
Best known for its employment applications, urine drug testing is also medical protocol for patients prescribed opioid drugs…