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
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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
OIG Monthly Work Plan Review: January 2019
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Medicare Reimbursement: CMS Provides Needed PAMA Relief—But Newly Covered Hospital Labs Must Report in 2019
From - Lab Compliance Advisor
The battle between CMS and the lab industry over Medicare Part B pricing for lab tests could be on the road to…
Provider Fined for Not Taking Compliance Measures Required by Its CIA
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New Broad All-Payor Kickback Law Impacting Laboratories, Commission-based Compensation and more
Texas Lab and Owner Get 15-Year Exclusion for Medicare Mileage Swindle
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Compliance Alert: New Private-Pay Opioid Law Puts All Drug Addiction & Rehab Labs at Risk of Federal Prosecution
From - Lab Compliance Advisor
Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of…
Florida Lab Owners Convicted for Role in Notorious Drug Distribution Scheme
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Case of the Month: Texas Court Strikes Down Obamacare—So, Now What?!
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By the Numbers: DOJ Recovers Billions in FY 2018
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