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
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
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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
When Qui Tam Retaliation Lawsuits Get Tricky
What happens when a compliance officer is the whistleblower in a qui tam retaliation lawsuit?
Model Policy on Employee Time Theft
This useful template can be used to develop a clear written policy on time theft for your lab in order to help prevent it.
Managing Lab Staff: How to Crack Down on Employee Time Theft
Six common forms of time theft to be on the lookout for, and how lab leaders can stop each one.
CMS Sheds New Light on Proper Use of Modifier 59
Due to the common misuse of this modifier, the Centers for Medicare & Medicaid Services recently issued important new guidance on its proper use.
False Billing of Lab Tests and Two Dismissed Lawsuits
This month’s key lab cases involve false billing of urine drug and PGx tests and two lawsuits that were tossed.
Feds Lower the Boom on Home Sleep Test False Billing and Kickbacks
A recent $3.5 million settlement illustrates the kinds of pitfalls that can result in liability for hospital and freestanding sleep labs.
Compliance Tool: Healthcare Equity Plan Model Form
Follow the steps in this form to help you develop and implement an effective healthcare equity plan for your lab.
Feds Not Backing Away from Punishing CGx Testing Scams
Recent case shows that fraud and kickback schemes involving CGx testing continue to be on the federal enforcement radar.
Brief Your CEO: The New Joint Commission Health Equity Standard
As of January 1, 2023, your lab may need to develop and implement a full-blown health equity plan to maintain its Joint Commission accreditation.
Getting Paid: How to Complete the ABN Form
Completing the Advance Beneficiary Notice of Noncoverage form can be extremely complex; this guide helps simplify the process.
