Rivas Goldstein, LLP Call : 646-859-3790

Compliance violations and diagnostic labs: Top three violations

Lab owners must balance a multitude of tasks to have a successful business. They need to make sure they have the staff needed to run a safe, accurate and efficient facility. In addition to watching the bottom line, these entrepreneurs also need to have a basic understanding of applicable regulations. A failure to abide by these rules can result in allegations of fraud - which can come with serious penalties.

One of the best ways to avoid such allegations is to avoid common errors. Three of the more common compliance violations for diagnostic labs include:

#1: Use of third-party marketing firms

Lab owners want to make sure their facilities get as much business as possible. In an effort to meet this goal, lab owners may consider using a third-party marketing firm to help increase business. In some cases, these arrangements pose a risk of a compliance violation. For example, a compensation agreement based on a percentage of claims is likely a violation of the False Claims Act (FCA).

#2: Ineffective regulatory compliance program

It is important for diagnostic labs to have a regulatory compliance program. Implementation of an effective program is arguably one of the most effective ways a lab can proactively reduce the risk of a violation. This should include provisions to avoid potential violations of the FCA mentioned above as well as the Eliminating Kickbacks in Recovery Act (EKRA) and federal Anti-Kickback Statute (AKS). Our next post will delve into the importance of regulatory compliance in more detail. 

#3: The Yates Memo

Released by then Deputy Attorney General of the United States Department of Justice, Sally Yates, in 2015, the Yates Memo focused on individual accountability for corporate wrongdoing. As a result, individuals within the lab (like lab owners, pathologists and staff) are at an increased risk of individual liability in the event of a compliance violation.

No Comments

Leave a comment
Comment Information
Email Us For A Response

Schedule A Consultation With An Attorney

Bold labels are required.

Contact Information

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.


Privacy Policy

Austin Office
3345 Bee Cave Rd, Suite 104
Austin, TX 78746

Phone: 512-481-2916
Map & Directions

New York Office
By Appointment Only
405 Lexington Ave 26th Floor
New York, NY 10174

Phone: 646-859-3790
Map & Directions

New Jersey Office
By Appointment Only
1 Gateway Center, Suite 2600
Newark, NJ 07102

Phone: 646-859-3790
Map & Directions

Review Us