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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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
Lab Company Layoff Ledger: First Half of 2023
In the first half of this year, US companies have cut the second-highest total of jobs since 2009, according to a recent report.
Brief Your CEO: New SCOTUS Case May Help Your Lab Defend Meritless Whistleblower Cases
A recent SCOTUS ruling on a healthcare fraud case could help defend labs against baseless whistleblower cases.
Billing & Coding: The Expanding Role of Z-Codes
Labs will have to submit Z-Codes with every molecular pathology testing code billed to UnitedHealthcare, starting Aug. 1.
August 2023 Labs in Court
Last month’s key cases involved the outcome of a UHC lawsuit and fines for misleading claims about a COVID-19 test.
Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.
CMS Provides New Guidance on When International Labs Must Seek CLIA Certification
Recently released Centers for Medicare and Medicaid Services guidance shares when CLIA regulations apply to international labs.
Congress Moves to Require Medicare Coverage of Multi-Cancer Early Detection Tests
Federal lawmakers have renewed efforts to pass legislation ensuring Medicare coverage of multi-cancer early detection (MCED) tests.
Whistleblowers: SCOTUS Gives DOJ Wider Authority to Dismiss Meritless Qui Tam Cases
Ruling could spell good news for labs and other healthcare providers targeted by whistleblowers in False Claims Act qui tam lawsuits.
Enforcement Trends: The Urine Drug Testing Crackdown and Three Ways to Avoid It
False billing of urine drug tests (UDTs) continues to be a focus for enforcement agencies in 2023, here’s how to avoid compliance issues.
Billing & Coding Alert: CMS Adds 15 New PLA Codes to Medicare Clinical Laboratory Fee Schedule
Here’s what to know about the new codes that CMS recently added to the national HCPCS table as well as which ones were removed.
