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
Urine Drug & Genetic Testing Remain Top Enforcement Targets
In an analysis of enforcement actions from the end of 2022 to early spring 2023, cases involving urine drug testing were the most prevalent.
How to Perform a Billing, Coding, & Reimbursement Process Compliance Audit
Auditing in medical laboratories is critical for reviewing processes to identify erroneous outcomes, as well as areas for improvement.
Compliance Tool: Model Whistleblower Protection Policy
This model can help you create a whistleblower protection policy for your lab to encourage employees to voice their compliance concerns.
Turning Whistleblower Lemons into Compliance Lemonade
A False Claims Act whistleblower lawsuit can do significant damage to your lab and its reputation, even if the case lacks truth and merit.
Medicare to Pay for 22 Additional PLA Codes, Starting April 1
To ensure proper Medicare Part B billing and coding, your billing staff must be aware of all 22 of the newly recognized PLA codes.
The ABN Modifiers and How to Properly Use Them
Proper usage of ABN-related modifiers is a significant issue that has a direct impact on your lab’s reimbursement and compliance.
Labs in Court: Three Lawsuits Tossed
In this month’s roundup, three cases—including two whistleblower lawsuits and one workplace discrimination case—get dismissed.
What Can Go Wrong with Outsourcing Lab Billing and Coding?
Lab leaders must be able to make a sound assessment of both the costs and benefits, and the liability risks involved.
A Due Diligence Checklist for Vetting Medical Billing Company Compliance
Labs have a duty to inquire into what their billing company is up to and whether it complies with all applicable regulations.
OIG OKs Pharma Company’s Use of Financial Help for Patients
Recent Advisory Opinion sheds light on offering patients financial assistance so they can receive the provider’s products and services.
