How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Lab Compliance Advisor
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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Explaining the Legal News: Why ACLA Court Win Boosts Chances of PAMA Pricing Relief
From - Lab Compliance Advisor
By now, you've no doubt heard the news that the American Clinical Laboratory Association (ACLA) "won" its lawsuit against…
Genetic Testing Fraud Prosecutions are on the Rise around the Country. Are Your Genetic Testing Practices Compliant?
By Robert Liles bio
Over the last year, a number of genetic testing fraud investigations and prosecutions have been initiated by…
Texas Scammer Gets 20 Years for Role in $50 Million Lab Test Ripoff
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Lab Management: Billing Company Contract Liability Risks & How to Avoid Them
From - Lab Compliance Advisor
Like many labs, you may outsource your billing and coding to an outside medical billing company. While this…
Texas Health System Fined $431K for Falsely Billing Genetic Tests
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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OIG Monthly Work Plan Review: August 2019
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Compliance Perspectives: What to Do When Respiratory Safety & Religious Rights Collide
From - Lab Compliance Advisor
A lab requires all employees who work with or near materials emitting toxic vapors to wear respirators with…
Pennsylvania M.D. Used Addiction Clinics as Front for Opioid Scheme
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New York Breaks Up $28 Million Medicaid Diagnostics Mill
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