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
Medicare Reimbursement: New HOPPS Date of Service Rules for ADLTs & Molecular Pathology Tests Take Effect
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The 10 Policies You Need to Stop Lab Employee PHI Breaches
From - G2 Compliance Advisor
Safeguarding personal health information (PHI) data from hackers, identity thieves and other cyber threats isn't just a legal obligation but…
PAMA Unlocks Golden Age for Innovative Diagnostics
By Chance Scott bio
The publication of the 2018 Clinical Laboratory Fee Schedule (CLFS) in January saw a long and heated debate within the lab community come to fruition…
Insurer Accuses Florida Lab, California Hospital of Toxicology Test Billing Fraud
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Case of the Month: Jury Socks HDL Blood Test Fraud Principles with $114.1 Million Verdict
From - G2 Compliance Advisor
Roughly three years ago at this time, mega-scandals were in the news featuring diagnostic giants like Millennium, Health Diagnostic Laboratory (HDL), Biodiagnostic Laboratory Service and…
OIG Semiannual Report: Opioid Crackdown Is Making Labs a Prime Enforcement Target Once Again
From - G2 Compliance Advisor
Once the favorite whipping boy of federal enforcers, labs have been demanding less and less of the OIG's attention in recent years. But the newly published…
How to Adjust to the April 2018 Medicare Beneficiary Cards
By Sean McSweeney bio
In a press release on May 30, 2017, the Centers for Medicare & Medicaid Services (CMS) commented regarding their fraud prevention initiative program and their planned changes regarding…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: Anthem Blue Cross Blue Shield is suing Reliance Laboratory Testing for allegedly conspiring with California hospital Sonoma West Medical Center to create a fraudulent…
The End May Be Near for Theranos & Elizabeth Holmes
From - G2 Compliance Advisor
Four years ago, Theranos was a $10 billion company poised to turn a breakthrough blood testing technology into a diagnostics dynamo to the tune of…
How PAMA’s Effect in 2018 Molecular Diagnostic Reimbursement Will Make Labs More Money
By Sean McSweeney bio
The year 2018 is slated to be much brighter for molecular diagnostic labs as PAMA fee schedules show a higher payment rate and amount for many cancer genomics and…
