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
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.
SCOTUS Won’t Weigh in on How Whistleblowers Make Valid FCA Claims
The court recently denied the petition to hear a case that would have helped offer clarity on what evidence whistleblowers need to file qui tam lawsuits under the FCA.
White House Unveils New “Bill of Rights” for Responsible Use of AI
The US has taken its first steps to establish legal limits over AI use by publishing a voluntary code to ensure responsible corporate use of AI.
The State of State Licensing Law Restrictions on Telehealth
With temporary waivers of restriction relating to telehealth likely to end soon, here’s a roundup of the current state of state telehealth licensing law.
Four Things You Need to Know About the 2023 OPPS Payments Rule
The final Outpatient Prospective Payment System Final Rule for 2023 provides for a rate increase of nearly four percent.
Court Nixes COVID-19 Lab Test Reimbursement Lawsuit Against Private Payor
Despite Congress’ clear policy on private insurer payment of COVID-19 tests, many labs have been struggling to get reimbursed.
What Can You Do About Medical Lab Staffing Shortages?
Solutions you can implement right away to address current lab staffing concerns and prepare for the future.
Heart Attack Diagnostics Market to Be Worth More than $22B in a Decade
Increasing incidences of heart disease, as well as technological advances, will drive growth over the next eight to 10 years, reports say.
