Rivas Goldstein, LLP Call : 512-481-8000

Clinical labs: How does a new federal law impact your business?

Lawmakers often pass or change laws with good intentions. In some cases, those intentions may not translate in the real world. An attempt to thwart wrongdoing can result in an unnecessarily confining situation.

A recent change to the federal laws regarding payment to clinical laboratories may be one such case.

What did lawmakers change? Lawmakers recently passed the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). As of As of October 24, 2018, this law changes how clinical laboratories can collect payment for referrals. These changes extend to include arrangements present in sales and marketing relationships.

Why did lawmakers make this change? Lawmakers pushed the change through in an attempt to combat fraud and the current opioid crisis.

In reality, the change has expanded restrictions under the Federal Anti-Kickback Statute (AKS) in such a way that it now covers essentially all compensation arrangements between clinical labs regardless of the insurance provider responsible for reimbursement. The law now gives the federal government the ability to monitor all provider arrangements designed to generate business for any laboratory services. This was exemplified by language in EKRA that exempts payments made to employees and contracts that does not vary based on the number of individuals referred, procedures performed or the amount of final bill.

What does this mean for clinical laboratories? The Centers for Medicare and Medicaid Services (CMS) will need to provide additional guidance to confirm payments that fit existing safe harbors of AKS are compliant with EKRA. However, it is important for clinical laboratories to remain up-to-date of these changes to avoid allegations of kickback violations.

No Comments

Leave a comment
Comment Information
Email Us For A Response

Rivas Goldstein LLP: On Your Side, Protecting Your Future

Our experienced Texas-based health care lawyers are here to help you and your business succeed. Please call 512-481-8000 or contact our law firm online.

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

Toll Free: 800-761-5190
Phone: 512-481-8000
Fax: 512-481-0022
Austin Law Office Map

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

Phone: 212-541-2451
Fax: 917-368-8005
Map & Directions

McAllen Office By Appointment Only
1100 East Jasmine Ave
Suite 105
McAllen, TX 78501

Phone: 512-481-8000
Map & Directions

Review Us