Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
LDTs: Congress Set to Scuttle VALID Act at the Eleventh Hour
Congress reportedly set to pass a stripped-down version of the FDA user fees bill without the VALID Act component regulating LDTs.
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.
Ex-CEO of Health Clinic Found Guilty of Medicaid Fraud
In this week’s enforcement roundup, the former executive was convicted of healthcare fraud relating to mental health diagnosis and treatment.
‘Digital Mask’ Tech Could Help Solve Patient Privacy Issues
A new technology could help protect patients’ privacy when it comes to the use of facial images in medical diagnoses.
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.
Amazon Shuts Down Telehealth Service
Retailer stubs a toe on its way to disrupting health care.