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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Articles and Reports
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
December 2022 Labs in Court: FCA and a Sex Discrimination Case Dismissed
Key cases over the past month were the usual FCA-related fare, apart from a dismissed sex discrimination case.
Compliance Tool: Model Policy on Telecommuting & Remote Work
It’s important to have a clear policy in place for approving remote work requests and ensuring employees remain productive.
December 2022 Enforcement Scorecard: Unusual Suspects
Federal enforcement actions at the end of October and first two weeks of November featured some unusual characters.
Court OKs Qui Tam Lawsuit against Lab for Not Following Medicare LCD
Could not following MAC guidance constitute evidence that a party knowingly submitted, or caused the submission of, false claims?
Lab Staffing: How to Guard Against “Digital Nomad” Liability Risks
There are potentially significant legal ramifications of employing digital nomads who work from abroad—for both you and your employee.
Billing & Coding: MAAA Coding 101
What labs and billing managers need to know about multianalyte assays with algorithmic analyses coding for tests based on molecular platforms.
Labs in Court: Could Elizabeth Holmes Get a New Trial?
In this month’s roundup of key lab-related cases, a bizarre twist in the Theranos saga leads to a slim chance of a mistrial.
November 2022 Enforcement Scorecard: UDTs and Genetic Tests
Most of the recent settlements and enforcement actions involving labs related to medically unnecessary UDTs and genetic tests.
How to Use and Report ICD Codes
An overview and general briefing on some of the most common ICD codes concerns for labs.
Compliance Tool: Whistleblower Non-Retaliation Policy
How to create a written policy banning retaliation for whistleblowing and for investigating retaliation complaints.
