EKRA‘s Real Impact on Clinical Laboratories

With the opioid epidemic becoming an increasingly serious issue in the United States, our government has responded with the Substance Use-Disorder Prevention that Promotes Opioid Recover and Treatment for Patients and Communities Act, also known as the Support Act. This act essentially aimed to reduce access to opioids. One of more than 70 bills in the Support Act is the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). This act was implemented to address patient brokering in exchange for kickbacks for individuals with substance abuse disorders. EKRA makes it illegal to knowingly and willfully do the following:

1. Solicit or receive remuneration for referring a patient to a “recovery home, clinical treatment facility or laboratory”
2. Pay or offer remuneration to either “induce a referral of an individual to” or “in exchange for an individual using the services of” a “recovery home, clinical treatment facility, or laboratory”

It is important for labs to understand that failing to meet an exception does not equal a violation, the elements of the crime must still be proven. However, if proven guilty for an EKRA violation there are huge potential penalties for each occurrence. These penalties include:

While Enforcement of EKRA for a criminal offense is only done by the federal government, there are other factors to be cognitive of, like: 

1. Disclosure obligations

• Public companies under the securities exchange act
• Securities transactions under the securities act and state laws
• Banking laws and contracts
• M&A

2. Whistleblower laws

3. Other laws

• State anti-kickback laws
• Other state criminal laws
• Other state civil laws

4. Payor reimbursement

• Payors can assert EKRA violations as basis for nonpayment (burden of proof)

5. Standard care and contract issues

Big Takeaways

The two most important things for lab leaders to consider related to the billing impact of EKRA are that not everything about EKRA is negative. First, the parity brought by EKRA by creating the risk of a federal felony for “routine” write-offs and discounting for patient responsibility is a positive change that can help reduce the overall cost of billing, remove the “grey” from billing policies and level certain playing fields. Second, the risk brought by EKRA to traditional incentive-based compensation, even compensation previously permitted under federal law.

Your RCM solution provider can advise on mitigating the impact of EKRA by optimizing reimbursements, assisting with documenting and tracking of patient financial programs and pursuing secondary payors before assigning non-reimbursed balances to patient responsibility.

Want to learn more about EKRA and how it affects labs? Check out our recent webinar with Dark Daily.