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
Federal Court Dismisses Urine Drug Test False Billing Claim
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Enforcement Trends: New Takedown Is Evidence that Genetic Testing Has Become an Enforcement Priority
It’s a pretty good sign that fraudulent billing of genetic lab testing has become a priority for federal fraud enforcers when it gets its very own “takedown.”
Work Plan: OIG Targets Medicare Part B Urine Drug Testing
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The New CMS Medicare Exclusion Rules & How to Comply with Them
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Labs In Court
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Compliance Perspectives: California Case Illustrates Lab’s Liability Risks for “Causing” MDs to Submit False Claims
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LabCorp Must Go to Trial to Defend against Deceptive Trade Practices Charges
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Special Report: Long Awaited Kickback Relief Rules Keep Labs in the Cold
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Kickbacks: Medical Practices and Doctors Settlements for Accepting Millennium Freebies
In 2016, Millennium Health settled one of the largest lab kickback schemes ever concocted for $256 million. In September 2017, federal enforcers turned their attention to the practices that accepted bribes from Millennium in the form of...
Tool: Model PHI Amendment Denial Letter
There are two things you must do to lawfully deny a patient’s request to amend his/her own PHI: i. Have a legal basis for the denial, i.e., at least one of four circumstances described in the main article must be present; and ii. You must put the denial in writing and ensure it meets the criteria for a denial notice in the HIPAA privacy regulations.