Rivas Goldstein, LLP

Call Our Austin Office: 800-761-5190

Celebrating Our 20th Year Representing the Interests of Health Care Professionals and Entities

An Austin Firm Dedicated to
Health Care Law

Attorneys Image
  1. Home
  2.  → 
  3. Diagnostic Testing And Reference Labs
  4.  → Lab owners: 3 things to know about the AKS

Lab owners: 3 things to know about the AKS

Those who own and operate diagnostic testing and reference labs must balance their desire to serve hospitals, health centers, and other clients with the basic demands of business operations while simultaneously making sure their lab remains in full compliance with all applicable rules and regulations. A failure to comply with these rules and regulations can lead to allegations of a violation. If the allegations are supported, the lab can face serious penalties.

One of the most important is the Anti-Kickback Statute.

1. What is the Anti-Kickback Statute (AKS)?

The Anti-Kickback Statute is a federal law that prohibits any healthcare provider from willfully inducing referrals or generating business through remuneration.

2. What are some common compliance challenges for lab owners?

Although the details vary depending on the case, some common examples include:

  • Compensation structures: Compensating sales and marketing activities based solely on volume or value can trigger allegations of a violation.
  • Free or below fair market value services: Any provision of goods or services below fair market value may lead to an investigation.
  • Patient bling policies: Regularly review billing practices to better ensure they do not favor specific physicians to encourage referrals.

It is important to conduct regular internal audits to check for any possible issues and resolve the matter before it becomes a bigger problem.

3. Are these laws final?

Like everything in the legal world, it is important to note that these laws evolve. The United States Department of Health and Human Services (HHS) announced updates to this law in 2020 that included changes and additions to safe harbor rules — rules that significantly impact diagnostic lab operations.

Diagnostic lab owners need to do more than just operate a medical facility, they also need to abide by federal and local regulations. Compliance is an ongoing process. As such, it is important for lab owners to regularly review the lab’s practices and consult legal experts to ensure the lab is on the right track.

Attorney John Rivas is responsible for this communication.